Anthrax Vaccine -- posts by Meryl Nass, M.D.

Justice Dept. takes on itself in probe of 2001 anthrax attacks/WaPo

2012-01-28T17:13:00.000-05:00

The Washington Post reviews the spectacle of the Florida DoJ denying that Bruce Ivins had the ability to prepare the anthrax that killed five and made at least 17 people ill. He didn't have the equipment within the hot room to dry anthrax. That does seem to be a limiting fact.

But then the DC DoJ got into the act, forcing its Florida team to withdraw such damning assertions...and settle the case with Bob Stevens' widow that the Florida DoJ attorneys were defending.

Since it began a decade ago, the federal government’s massive investigation of the 2001 anthrax attacks has been plagued by missteps and complications.

Investigators initially focused on the wrong man, then had to pay him a nearly $6 million settlement. In 2008, they accused another man, Bruce E. Ivins, who killed himself before he could go to trial.

Now, in the latest twist, the government has argued against itself...

Biothrax for Kids is Back! Now for an Ethics Review! / DHHS

2012-01-28T16:55:00.002-05:00

The DHHS' momentum to test anthrax vaccine in kids did not abate after the NBSB advisory committee suggested the pediatric trial should go forward, following review by an ethics panel. That way the NBSB members would not be the last ones holding the bag.

On January 10, DHHS Secretary Sibelius (ex-Governor, insurance commissioner and lobbyist) -- who has looked increasingly pinched since coming to head DHHS and carry Obama's dirty water -- asked the Presidential Commission for the Study of Bioethical Issues to fast-track a review of testing countermeasures in children. They begin their study on Feb 2-3, with a final report due late in 2012.

With Ass't Secretary Nicole Lurie busy defending herself and her department against a Congressional investigation of their smallpox drug contract, Sibelius has put herself in the anthrax vaccine line of fire.

Medical Countermeasures for Children:

On Jan. 10, Secretary of Health and Human Services Kathleen Sebelius asked the Commission for ethical advice on the development of medical countermeasures for children. The Commission is well aware that this issue garnered significant public interest last fall when another Federal advisory committee recommended pediatric testing of the anthrax vaccine. The Commission is honored that the Secretary has asked for its advice on this important ethical issue. The Commission is reviewing the request carefully and expects to begin work shortly on a timeline to deliver a report in late 2012.

Under the Code of Federal Regulations (46.407) the proposed study can't be done, since anthrax is not a serious problem affecting the health and welfare of children... and in any event, the vaccine is NOT a treatment for an acute exposure (antibiotics are) -- since it takes at least 35 days to develop high antibody levels:

SUBTITLE A: DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A: GENERAL ADMINISTRATION

PART 46: PROTECTION OF HUMAN SUBJECTS

Subpart D: Additional Protections for Children Involved as Subjects in Research

46.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

HHS will conduct or fund research that the IRB does not believe meets the requirements of 46.404, 46.405, or 46.406 only if:

(a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

(1) That the research in fact satisfies the conditions of 46.404, 46.405, or 46.406, as applicable, or

(2) The following:

(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) The research will be conducted in accordance with sound ethical principles;

(iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in 46.408.

The emperor is marching around buck naked/BMJ

2012-01-28T09:21:00.000-05:00

The validity and quality of research underpin the entire research enterprise worldwide. However, a number of studies have shown that many researchers take "shortcuts" and that perhaps 1-3% of research is grossly false, fitting into the category of research misconduct.

Research misconduct has been defined in US federal law as fabrication, plagiarism and/or falsification. Identified cases have been few, often limited to easy-to-identify falsified figures in published papers.

However, these may be the tip of the iceberg. “Ginny Barbour, a senior editor with the PLoS group of journals, said one third of authors could not find the original data to back up figures in scientific papers when these were questioned.” OUCH! Have 1/3 of authors fabricated or falsified data?

Certainly, the incentives to do so are great: career advancement in a highly competitive environment and obtaining grants that enable you to perform more research. While the disincentive -- being publicly identified and having one's career destroyed -- occurs so infrequently the risk is negligible.

As John Noble notes below, the measures currently in place to guarantee reliability of research (peer review and professional ethics) fail miserably. Additional standards are desperately needed.

Godlee’s report of widespread research misconduct is disturbing and, I believe, generalises to the US.1 2 It’s not just the fact that it is happening, but that it reflects a culture within which new researchers are socialised. Previous research indicates the motivators for dishonesty include a high pressure achievement oriented environment, where “if everybody else is doing it, it must be OK.”3
The problem also underscores how important are reanalysis and replication of reported research, a recent topic on the US Institutional Review Board Forum (www.irbforum.org/forum/). But, get this, “Ginny Barbour, a senior editor with the PLoS group of journals, said one third of authors could not find the original data to back up figures in scientific papers when these were questioned.” I wonder how many journal editors seek to discover and reject such authors. I wonder how meticulous the US Food and Drug Administration is in policing the input it receives in support of marketing approval for new drugs and medical devices.
These behaviours are beyond the reach of surveillance by institutional review boards and research ethics boards, and they indicate the need for a new end product quality control system.4 The simplifying assumptions about the efficacy of peer review and professional ethics and responsibility fail miserably when the emperor is discovered marching around buck naked.

Effectiveness of seasonal influenza vaccination in healthcare workers: a systematic review.

2012-01-28T05:09:00.001-05:00

J Hosp Infect. 2011 Dec;79(4):279-86. Abstract is here.

Ng AN, Lai CK.

Infectious Disease Control Training Centre, Hospital Authority/Infection Control Branch, Centre for Health Protection, Department of Health, Hong Kong SAR, China. ngngaiming@gmail.com

Abstract
Vaccination is considered a key measure to protect vulnerable groups against influenza infection. The objectives of this review are to determine the effect of influenza vaccinations in reducing laboratory-confirmed influenza infections, influenza-like illnesses (ILIs), working days lost among vaccinated HCWs, and associated adverse effects after vaccination. Twenty-two healthcare-related databases and internet resources, as well as reference lists, and the bibliographies of all of the retrieved articles were examined. All randomized controlled trials (RCTs) comparing the effectiveness of any kind of influenza vaccine among all groups of HCWs with a placebo/vaccine other than the influenza vaccine/no intervention were included in the review. Only three RCTs matched the inclusion criteria.

There is a limited amount of evidence suggesting that receiving influenza vaccination reduces laboratory-confirmed influenza infections in HCWs. No evidence can be found of influenza vaccinations significantly reducing the incidence of influenza, number of ILI episodes, days with ILI symptoms, or amount of sick leave taken among vaccinated HCWs. There is insufficient data to assess the adverse effects after vaccination. There is no definitive conclusion on the effectiveness of influenza vaccinations in HCWs because of the limited number of related trials. Further research is necessary to evaluate whether annual vaccination is a key measure to protect HCWs against influenza infection and thus increase their confidence in the vaccine. In the mean time, the direction of promoting influenza vaccination to HCWs can be shifted from staff protection to patient protection, with accurate information to address concerns and misconceptions.

And in Germany, only 20% of health care workers acept flu vaccine:

Dtsch Med Wochenschr. 2011 Jun;136(24):1299-304.

Roggendorf H, Sprave T, Hertel S, Morscheck F, Roggendorf M.
Source
Institut für Virologie, Universitätsklinikum Essen.
Abstract
BACKGROUND AND OBJEKTIVES: In 1988 the German Vaccination Board (STIKO) at the Robert-Koch-Institute (RKI) in Berlin, recommended that German health care workers should be vaccinated annually against influenza. Despite this, vaccination rates have remained low (20%). Between January and March 2009 a study was performed at the University Clinical Centre in Essen to determine reasons for low influenza vaccination rates and to assess improvement strategies...

The vaccination rate of 29% among this group of health care workers was higher than the average (20%) in German hospitals and highest among medical doctors...

Afghanistan’s Soldiers Step Up Killings of Allied Forces/ NY Times

2012-01-20T03:35:00.002-05:00

Damon Winter/The New York Times

The NY Times obtained a classified coalition report that acknowledges "a rapidly growing systemic homicide threat, a magnitude of which may be unprecedented between 'allies' in modern military history"-- i.e., US soldiers are being murdered by the very Afghani forces they are training and working alongside. A full 6% of coalition forces deaths are due to this "unfriendly fire."

American soldiers training Afghan police officers in 2010. A report cites growing friction between the ostensible allies.

By MATTHEW ROSENBERG
KABUL, Afghanistan — American and other coalition forces here are being killed in increasing numbers by the very Afghan soldiers they fight alongside and train, in attacks motivated by deep-seated animosity between the supposedly allied forces, according to American and Afghan officers and a classified coalition report obtained by The New York Times.
A decade into the war in Afghanistan, the report makes clear that these killings have become the most visible symptom of a far deeper ailment plaguing the war effort: the contempt each side holds for the other, never mind the Taliban. The ill will and mistrust run deep among civilians and militaries on both sides, raising questions about what future role the United States and its allies can expect to play in Afghanistan...

“Lethal altercations are clearly not rare or isolated; they reflect a rapidly growing systemic homicide threat (a magnitude of which may be unprecedented between ‘allies’ in modern military history),” it said. Official NATO pronouncements to the contrary “seem disingenuous, if not profoundly intellectually dishonest,” said the report, and it played down the role of Taliban infiltrators in the killings...

UPDATE JAN 20: KABUL, Afghanistan President Nicolas Sarkozy of France suspended military operations as part of the American-led coalition in Afghanistan on Friday and said he was considering an early pullout of his nation’s forces after a man in Afghan Army uniform shot and killed four French soldiers...

Flu Season Off to Slow Start, So Far/ US News

2012-01-18T19:19:00.000-05:00

From US News and World Report:

Relatively few cases reported, experts say, but that doesn't mean a surge can't happen...

One barometer of flu activity, the percentage of visits to hospitals or doctors' offices linked to influenza, also suggests a mild season so far. For example, just 1.4 percent of outpatient visits during the week ending Jan. 7 were for flu, the CDC said, compared to a seasonal average (over the past three years) of 2.4 percent. And just one in every 200,000 people had flu so severe that it required hospitalization, the CDC added.

The best news of all may come from statistics regarding children, who are particularly vulnerable to the flu. According to the CDC, no children in the United States have died from the flu so far, compared to the four pediatric flu-linked deaths that had already been reported by Jan. 1, 2011...

Mental scores decline precipitously at 30 months after anthrax vaccine, but CDC spins study to say vaccine safe/ Vaccine

2012-01-12T05:37:00.001-05:00

A new paper on anthrax vaccine safety, presumably published to support DHHS' desire to test the vaccine in small children, has just been published online. Its authors are all from CDC, and most have previously published papers of very poor quality supporting the so-called safety of anthrax vaccine. I don't understand why they still have careers...except none have left CDC's pro-vaccine coccoon for academia.

The paper's title is: Health-related quality of life in the anthrax vaccination program for workers in the laboratory response network. Authors:

* Brock Stewarta, e,

* Yujia Zhangb, e,

* Charles E. Rose,Jr. c, e,

* Jerome I. Tokarsa, e,

* Stacey W. Martinc, e,

* Laura H. Franzked, e,

* Michael M. McNeil a, e,

* a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, United States

* b Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Atlanta, GA, United States

* c Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Atlanta, GA, United States

* d Division of Applied Sciences, Scientific Education and Professional Development Program Office, Office of Surveillance Epidemiology and Laboratory Services, Atlanta, GA, United States

* e Centers for Disease Control and Prevention, Atlanta, GA, United States

This is the group at CDC (Michael McNeil's group) who fudged the data on anthrax vaccine safety and optic neuritis (see my published comment and that of others criticizing the CDC methodology at the end of this page) and were supposedly defunded as the CDC's anthrax vaccine network for the poor quality of their anthrax work in 2010.

But now we have this so-called scientific paper in which none of the analyses achieve statistical significance. Great work, guys! How do you get the chutzpah to even submit something like this for publication?

In fact, the only analysis that comes close to significance, p= 0.06, shows appreciably worse mental functioning in those who received anthrax vaccines, 30 months later, relative to controls. Naturally, the authors blow off this finding and hope we don't notice:

"For mental scores, the average change from baseline was −1.50 for exposed vs. −1.64 for controls at 12 months (p = 0.86) and −2.11 for exposed vs. −0.24 for controls at 30 months (p = 0.06). In multivariable analysis, the difference in mental score change between exposed vs. controls at 30 months was less pronounced (p = 0.37) [and much less significant--Nass] but other findings were similar to univariate analyses.

Conclusions

These results do not favor an association between receipt of AVA and an altered health related quality of life over a 30-month period.

Highlights

► We evaluated quality of life after AVA in Laboratory Response Network workers. ► 437 exposed and 139 controls enrolled to complete the SF-36 at 0, 12 and 30 months. ► We found no change from baseline in either SF-36 physical or mental scores. ► Our study suggests no association between AVA and quality of life over 30 months."

Where is peer review? Why have we allowed spin to be exchanged for scientific discourse?

Anthrax jabs stockpiled in (Olympics) biological terrorism alert/ London Evening Standard

2012-01-11T22:14:00.000-05:00

Interesting that the authorities vaccinated 500 health workers with smallpox vaccine, but are only stockpiling anthrax vaccine, not using it preemptively. Yet you can vaccinate with smallpox vaccine up to several days after an exposure and it will still prevent the disease, due to smallpox's several week long incubation period.

On the other hand, one needs several doses of anthrax vaccine to generate a high antibody titre (of uncertain effectiveness) -- so in order for anthrax vaccine to be effective against a terrorist exposure, you must be vaccinated ahead of time. Antibiotics, however, can be used instead of vaccine, since anthrax is a bacterium while smallpox is a virus against which drugs are less effective.

Makes me wonder if the UK authorities understand that the dangers from anthrax vaccine far outweigh those from smallpox vaccine. Smallpox is admittedly the most dangerous licensed vaccine in the US. (DHHS has conveniently given a waiver of liability to the manufacturers of both anthrax and smallpox vaccines.)

Britain is building up stocks of vaccine to cope with an anthrax attack at the Olympics, the Standard can reveal.

The Government is replenishing its anthrax jabs stockpile in time for April to safeguard the 2012 Games as part of London's biggest security operation.

The supply of inoculations to combat anthrax poisoning to the Department of Health was hit by delays between October 2009 and March 2011. The resulting shortfall in supply is set to be made up within the next four months.

More than 500 health workers have also been vaccinated against smallpox, enabling them to respond to a biological terror attack.

Clinical Trial Tests Unsafe Anthrax Vaccine For Post-Exposure Use

2012-01-11T22:01:00.000-05:00

From The Vaccine Exchange:

We have been writing about the anthrax vaccine here at Vaccine Xchange for some time. It seems clear that Emergent BioSolutions, the maker of the only human anthrax vaccine (BioThrax) currently available in the US, is working to aggressively market the vaccine, including ensuring that its vaccine is authorized for use for use after inhaling anthrax, as well as before an exposure, despite serious concerns about its safety and effectiveness. Earlier this year, the company was awarded a $1.25 billion contract to supply the U.S. Government with 44.75 million additional doses of the vaccine over a five year period. A few weeks ago, a story in MarketWatch informed us that Emergent BioSolutions has announced a new study evaluating the safety and effectiveness of the vaccine for future treatment of individuals after they have been exposed to anthrax. This story follows on the heels of the Department of Health and Human Services backpedalling on conducting a trial of the same vaccine on children.

The study, which is funded by the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), could potentially expand the use of BioThrax beyond its current use as a pre-exposure vaccine so that it will be used along with antibiotics as an adjunct to treat people who have been exposed to anthrax spores.

It is obvious that such an expansion in the use of the vaccine would be heavily profitable for Emergent BioSolutions. However, it seems unnecessary – it has been demonstrated in many studies that early treatment of anthrax with antibiotics is very effective. Is it really necessary to replace this (reliable) treatment with a treatment that is not only highly expensive but also proven to have significant risk of adverse reaction?

Emergent BioSolutions does not intend the vaccine to work alone, but in tandem with antibiotics. This would have to be done because the vaccine is given in three doses two weeks apart post-exposure. This means that peak antibody levels will not occur until at least 35 days after beginning the vaccine course. In other words, you wouldn’t expect the vaccine to work until at least 35 days after starting taking the vaccine. But the reason Emergent BioSolutions has given for using vaccines post-exposure is to decrease the amount of time patients are on antibiotics. With the vaccine only beginning to work after 35 days at the earliest, there really does not seem to be a good reason to take the vaccine, particularly since vaccines have been shown to be less effective than antibiotics for anthrax (unless the anthrax strain has been made resistant to multiple antibiotics, which is theoretically possible but has never occurred). In any case, the CDC and the FDA would both still recommend a full 60-day regimen of the antibiotics, even if the patient is vaccinated, so the amount of time the patient is on the antibiotics will not be affected at all.

Not only this, but the data they are examining in this study – immunogenicity, which refers to antibody levels or similar blood parameters – is unreliable at predicting whether the vaccine will actually be effective upon a person’s exposure to the actual disease. In addition, similar data already exists, gathered in the trial conducted by the Center for Disease Control a few years ago. It seems puzzling that the government is investing even more taxpayer dollars to gather the very same data gathered by the CDC in its 2002-2007 clinical trial about this vaccine which has long been found to be unsafe and questionably effective.

However, for Emergent BioSolutions, this study could be extremely lucrative (particularly since it is being funded by the government, and therefore costing them nothing). If there is, God forbid, a biological attack using anthrax in the United States, and some people agree to take the vaccine, they would currently have to be studied, since this would be an unlicensed use of the vaccine. However, if Emergent BioSolutions can convince the Food and Drug Administration that, based on this study of 200 adults, the vaccine should be approved in post-exposure circumstances, then such a study would not have to be conducted on potentially thousands or millions of people who choose to get vaccinated post-exposure. In other words, in conducting this study now, where Emergent BioSolutions can control the data generated (as sponsor and conductor of the study), the company prevents a later study being conducted that will not be under their control and, because it would include many thousands of recipients, would be much more likely to identify problems with the vaccine’s safety and effectiveness. Not only this, but if the vaccine is approved for use after anthrax exposure, the government might even mandate its use after an anthrax attack in the future, thereby netting the company even more money.

Really, conducting the study makes tremendous financial sense for Emergent BioSolutions, even if the vaccine itself does not seem to be effective.

Compensation paid out for vaccine-related narcolepsy sufferers/ YLE

2012-01-11T20:33:00.002-05:00

Per YLE, the government of Finland is paying out small sums to 80 children who developed narcolepsy after Pandemrix vaccination, while 30 cases are still being evaluated. That is a lot of childhood narcolepsy in a country of only 5.4 million people, and only about 44 swine flu-related deaths.

Compensation is being granted to youngsters who suffer from narcolepsy resulting from a swine flu jab given last year.

Long-awaited compensation is now being paid to those who developed narcolepsy as a result of the swine flu vaccine Pandemrix.

Decisions on compensation have been given to just under eighty sufferers. Around 30 cases are still under review. A medical insurance pool will cover claims up to 30 million euros. The state will pick up the tab for compensation exceeding this sum.

YLE reported on Wednesday that a ten year-old patient is to receive initial damages of 11,700 euros to be followed by another lump payment when he turns 18. An 18 year-old patient has meanwhile been awarded 22,000 euros for the injury sustained.

UPDATE: A correspondent called my attention to this document from Finland's Department of Health. I am told it says (in Finnish) that Pandemrix swine flu vaccine may be used if there is insufficient influenza vaccine available.

In Finland, approximately 1 in every 5,000 children aged 5-20 developed narcolepsy after receiving Pandemrix vaccine. Less than one in a million unvaccinated children generally die from influenza. (I have not seen any statistics on child flu deaths from Finland; only 44 people overall were said to die in Finland from 2009 Swine Flu... which is less than one in 100,000 Finns.)

Is the Finnish Health Department seriously suggesting it would use a vaccine in kids to prevent flu that will cause many times more cases of narcolepsy than it will prevent deaths from influenza? Or are they minimizing the risk of the vaccine to protect themselves and the manufacturer?

My interview on vaccine safety with Gary Null and Associates

2012-01-10T20:15:00.003-05:00

Fifteen minutes on vaccine regulation/safety on YouTube.

My Guantánamo Nightmare/ NY Times

2012-01-09T09:09:00.000-05:00

In my view, the term "American exceptionalism"had a meaning, which stemmed from our adherence to the Constitution and Bill of Rights. Those days are gone, and institutionalized brutality is no longer unlawful. The NY Times essay below, published on the 10th anniversary of the opening of Guantanamo prison, was written by the former Sarajevo Red Crescent director of humanitarian aid for children, who was wrongly imprisoned for 7.5 years there, and finally released after Federal district court review.

ON Wednesday, America’s detention camp at Guantánamo Bay will have been open for 10 years. For seven of them, I was held there without explanation or charge. During that time my daughters grew up without me. They were toddlers when I was imprisoned, and were never allowed to visit or speak to me by phone. Most of their letters were returned as “undeliverable,” and the few that I received were so thoroughly and thoughtlessly censored that their messages of love and support were lost.
Some American politicians say that people at Guantánamo are terrorists, but I have never been a terrorist. Had I been brought before a court when I was seized, my children’s lives would not have been torn apart, and my family would not have been thrown into poverty. It was only after the United States Supreme Court ordered the government to defend its actions before a federal judge that I was finally able to clear my name and be with them again.
I left Algeria in 1990 to work abroad. In 1997 my family and I moved to Bosnia and Herzegovina at the request of my employer, the Red Crescent Society of the United Arab Emirates. I served in the Sarajevo office as director of humanitarian aid for children who had lost relatives to violence during the Balkan conflicts. In 1998, I became a Bosnian citizen. We had a good life, but all of that changed after 9/11.
When I arrived at work on the morning of Oct. 19, 2001, an intelligence officer was waiting for me. He asked me to accompany him to answer questions. I did so, voluntarily — but afterward I was told that I could not go home. The United States had demanded that local authorities arrest me and five other men. News reports at the time said the United States believed that I was plotting to blow up its embassy in Sarajevo. I had never — for a second — considered this.
The fact that the United States had made a mistake was clear from the beginning. Bosnia’s highest court investigated the American claim, found that there was no evidence against me and ordered my release. But instead, the moment I was released American agents seized me and the five others. We were tied up like animals and flown to Guantánamo, the American naval base in Cuba. I arrived on Jan. 20, 2002.
I still had faith in American justice. I believed my captors would quickly realize their mistake and let me go. But when I would not give the interrogators the answers they wanted — how could I, when I had done nothing wrong? — they became more and more brutal. I was kept awake for many days straight. I was forced to remain in painful positions for hours at a time. These are things I do not want to write about; I want only to forget.
I went on a hunger strike for two years because no one would tell me why I was being imprisoned. Twice each day my captors would shove a tube up my nose, down my throat and into my stomach so they could pour food into me. It was excruciating, but I was innocent and so I kept up my protest.
In 2008, my demand for a fair legal process went all the way to America’s highest court. In a decision that bears my name, the Supreme Court declared that “the laws and Constitution are designed to survive, and remain in force, in extraordinary times.” It ruled that prisoners like me, no matter how serious the accusations, have a right to a day in court. The Supreme Court recognized a basic truth: the government makes mistakes. And the court said that because “the consequence of error may be detention of persons for the duration of hostilities that may last a generation or more, this is a risk too significant to ignore.”
Five months later, Judge Richard J. Leon, of the Federal District Court in Washington, reviewed all of the reasons offered to justify my imprisonment, including secret information I never saw or heard. The government abandoned its claim of an embassy bomb plot just before the judge could hear it. After the hearing, he ordered the government to free me and four other men who had been arrested in Bosnia.
I will never forget sitting with the four other men in a squalid room at Guantánamo, listening over a fuzzy speaker as Judge Leon read his decision in a Washington courtroom. He implored the government not to appeal his ruling, because “seven years of waiting for our legal system to give them an answer to a question so important is, in my judgment, more than plenty.” I was freed, at last, on May 15, 2009.
Today, I live in Provence with my wife and children. France has given us a home, and a new start. I have experienced the pleasure of reacquainting myself with my daughters and, in August 2010, the joy of welcoming a new son, Yousef. I am learning to drive, attending vocational training and rebuilding my life. I hope to work again serving others, but so far the fact that I spent seven and a half years as a Guantánamo prisoner has meant that only a few human rights organizations have seriously considered hiring me. I do not like to think of Guantánamo. The memories are filled with pain. But I share my story because 171 men remain there. Among them is Belkacem Bensayah, who was seized in Bosnia and sent to Guantánamo with me.
About 90 prisoners have been cleared for transfer out of Guantánamo. Some of them are from countries like Syria or China — where they would face torture if sent home — or Yemen, which the United States considers unstable. And so they sit as captives, with no end in sight — not because they are dangerous, not because they attacked America, but because the stigma of Guantánamo means they have no place to go, and America will not give a home to even one of them.
I’m told that my Supreme Court case is now read in law schools. Perhaps one day that will give me satisfaction, but so long as Guantánamo stays open and innocent men remain there, my thoughts will be with those left behind in that place of suffering and injustice.

Lakhdar Boumediene was the lead plaintiff in Boumediene v. Bush. He was in military custody at Guantánamo Bay from 2002 to 2009. This essay was translated by Felice Bezri from the Arabic.

Proven Ways to Avoid Influenza Safely and Inexpensively

2011-12-28T21:11:00.002-05:00

How well does flu vaccine work?

Two major reviews have come out in the past two months. Michiels et al from the University of Antwerp found that the vaccine does prevent influenza among those aged 6-65, "however, there is strikingly limited good-quality evidence of the effectiveness of influenza vaccine on complications such as pneumonia, hospitalization and influenza-specific and overall mortality..." as well as efficacy over 65. It is less the flu than the complications and deaths from flu that we want to avoid... but these complications are precisely what no one has been able to show are improved by vaccination. Vaccine 2011. Nov 15; (29) 49: 9159-70.

Michael Osterholm's group (U Minnesota) found effectiveness of standard (killed) flu vaccine for adults aged 18-59. His authors used as gold standard the presence of influenza virus by PCR or culture. No trials in adults over 65 or children below 18 met the strict criteria. For live flu vaccine, efficacy was shown for 9 of 12 seasons in 10 trials, but only for children aged 6 months to 7 years.

The group concluded, "Influenza vaccines can provide moderate protection against virologically confirmed influenza, but such protection is greatly reduced or absent in some seasons. Evidence for protection in adults aged 65 years or older is lacking. New vaccines with improved clinical efficacy and effectiveness are needed to further reduce influenza-related morbidity and mortality."

What to do?

Excerpted from: A Home Toolkit for Primary Prevention of Influenza by Individuals and Families. Finkelstein et al. DISASTER MEDICINE AND PUBLIC HEALTH PREPAREDNESS 2011; 5: 266-271. The authors of this review article are members of MIT’s Engineering Systems Division. They suggest the following proven methods:

• Wash your hands thoroughly after leaving a sick person’s room. Scrub with soap and water or an alcohol-based hand sanitizer for 20 to 30 seconds.

• Wear a mask. At minimum, the mask prevents a healthy person from transferring a virus to his/her own nose and mouth—the highway to infection.

• Install air filters. High-efficiency particulate air (HEPA) filters can remove nearly 98 percent of virus particles; portable air purifiers and pointing a window fan out the window of the sickroom can also help.

• Control temperature and humidity. Higher temperatures and humidity levels can kill or disable viruses.

• Install an ultraviolet light. UV light is antimicrobial, and portable air purifiers with both UV lamps and HEPA filters can be purchased for $180 to $370.

Judge says no to inquest on weapons inspector Dr Kelly/ Mail

2011-12-20T21:15:00.001-05:00

And the judge adds insult to injury by asking retired surgeon Halpin to pay Attorney General Grieve's legal costs. The Mail provides the details:

A retired surgeon lost a major court battle yesterday in his campaign to secure a proper coroner's inquest into the death of weapons inspector Dr David Kelly.
Dr David Halpin was refused permission to challenge Attorney-General Dominic Grieve's refusal to hold an inquest into the Government scientist's mysterious death.
As the decision was announced at the High Court in London yesterday, there were cries from the public gallery of 'Shame' and 'This is not justice'.

A High Court judge refused a plea to open an inquest into the death of government weapons advisor Dr David Kelly
One woman shouted at the judge, Mr Justice Nicol, 'What about the fingerprint evidence?', a reference to the fact that no fingerprints were found on the knife Dr Kelly allegedly used to kill himself.
Dr Kelly was found dead in an Oxfordshire wood in July 2003 after being named as the source of a BBC report accusing Tony Blair's government of lying to take Britain into the Iraq war.
His death was the subject of a public inquiry in 2003 chaired by Lord Hutton which found he committed suicide by slashing his wrist and swallowing painkillers.

He is believed to be the only person in modern times to have died in suspicious circumstances in this country whose final hours have never been fully examined by a coroner.
Reviewing the controversial case in June this year Attorney General Dominic Grieve said the evidence of suicide was 'overwhelming'.
But yesterday Dr Halpin, 71, a retired trauma surgeon, claimed Mr Grieve had acted 'unlawfully' and 'irrationally'.

An aerial view of Harrowdown Hill, Oxfordshire where Dr David Kelly's body was found

Dr Kelly allegedly slashed his wrist and swallowed painkillers after being named as the source of a BBC report accusing Tony Blair's government of lying to take Britain into the Iraq war
Hundreds of Daily Mail readers were among 830 members of the public who contributed around £40,000 to cover Mr Halpin's legal fees.
Rejecting Mr Halpin's application to seek judicial review, the judge told a packed courtroom yesterday it was the Attorney General's role to act as a 'filter' before matters got to court.
Mr Justice Nicol said: 'Parliament considered it necessary for such a filter. In my judgment he [the attorney general] has exercised that discretion and power lawfully.'
After the hearing Mr Halpin, from Newton Abbot, Devon, said: 'Nothing has changed as a result of today's decision.
'Dr Kelly has still not had an inquest, which makes him unique. I still think it is impossible to bleed to death by cutting an ulnar artery. I still don't understand why there must be so much secrecy around this case.
'This case was shackled by the law and the facts were obscured by that. The Hutton Inquiry had more holes in it than a Swiss cheese.'
Mr Justice Nicol ordered Mr Halpin to pay £5,568 towards the Attorney General's legal costs.

UPDATE: Interview with Dr. Halpin.

Dr Halpin said he was going to 'take stock and reflect on what to do next' as a result of the decision.

Judge to hear campaigner's plea for inquest into Dr Kelly's controversial death/ Mail

2011-12-19T07:08:00.000-05:00

From the Daily Mail:

A retired surgeon campaigning for a full coroner’s inquest into the death of Dr David Kelly will have his case heard by a High Court judge on Monday (December 20).

David Halpin, 71, is seeking permission to challenge the Government’s decision in June not to order a coroner’s inquest into the controversial death...

Mr Halpin, a former trauma surgeon from Newton Abbot in Devon, said: ‘More than 800 members of the public worldwide, hundreds of them Daily Mail readers, have given about £40,000 to cover legal fees associated with this case. I am enormously grateful...

SIGA's sweetheart deal for smallpox drug questioned by Anderson Cooper/ CNN

2011-12-10T23:36:00.001-05:00

This story, detailed by David Willman in the LA Times (and blogged by me 4 weeks ago) has now been re-reported (in great detail for television) by CNN. It certainly deserves plenty of scrutiny, especially after SIGA's stock rose 32% yesterday, supposedly due to board member Fran Townsend's denying company interference with the contract. DHHS (what a surprise!) even had the temerity to tell CNN that replacing the government's chief negotiator saved the taxpayer lots of money!

In case you forgot, the issues are these:

SIGA is selling the govt (for $433 million to 2.8 billion) a drug developed with government money to treat smallpox. No one knows if it works. SIGA's controlling shareholder is Ron Perelman, a billionaire Democratic donor. Contracting requirements were changed several times to ensure SIGA got the contract, and at a very high price.

Former administrations made sweetheart deals for 2 smallpox vaccines, for a total cost over a billion dollars, during the Clinton and Bush administrations. There is enough vaccine for every American in a stockpile. The vaccine works up to 4 days after an exposure. There is no real need for a drug too.

The Obama administration, it appears, did not want to miss out on the opportunity (which generating fear of bioterrorism has provided) to spend huge amounts of taxpayer funds on useless products. At least now a light is shining into the fetid swamp of bioterrorism procurements. SIGA's is only one of many questionable deals.

UPDATE: SIGA stock down 85% in 2011.

FDA disqualifies advisory committee member due to "intellectual conflict of interest"/ NJ.com

2011-12-06T23:45:00.001-05:00

Sidney Wolfe, MD, is a well-known drug safety advocate and founder/ director of the organization Public Citizen's Health Research Group. FDA finally blessed the quality of his work and reputation by inviting him to join its Drug Safety and Risk Management Advisory Committee in 2008.

But suddenly FDA has disqualified him from full voting membership at the committee meeting on the drug YAZ due to a claimed intellectual conflict of interest. Let's look first at the basis of FDA's claim, and then look into what is generally considered a conflict of interest.

According to the Newark Star-Ledger, Public Citizen gave a "Worst Pills" rating to Yasmin, the predecessor to YAZ oral contraceptive, now the leading contraceptive pill by sales in the US:

The FDA said it disqualified Wolfe, the director of Public Citizen’s Health Research Group, from the meeting on the contraceptives for his "intellectual conflict of interest.’’
The agency recently learned that Public Citizen, a non-profit consumer advocacy organization, had placed one of the contraceptives, Bayer’s Yasmine — a predecessor to Yaz — on its list of "Do Not Use Pills’’ in 2002.
"He did not volunteer this information,’’ said agency spokeswoman Erica Jefferson. "It was brought to our attention.’’
The FDA offered Wolfe two options: He could present information to the advisory committee like other members of the public or he could sit on the committee, participate in the discussion but refrain from voting.
Wolfe declined both options.
Advisory committee members, she said, are asked by the agency to disclose such information. "We do value Dr. Wolfe’s contributions,’’ Jefferson said, "but we are committed to preserving the integrity of the committee process.’’

The Public Citizen website appears to give YAZ a balanced report.

What precisely is the meaning of "conflict of interest"? According to the Columbia University course "Responsible Conduct of Research" syllabus:

There are many varieties of conflicts of interest, and they appear in different settings and across all disciplines. While conflicts of interest apply to a "wide range of behaviors and circumstances," they all involve the use of a person's authority for personal and/or financial gain.²

2. Bradley SG. Managing Conflicting Interests, p. 136. In: Magrina FL, editor. Scientific Integrity: An Introductory Text with Cases. Washington, DC: American Society for Microbiology; 2000, pp. 131-157.

According to this definition, because Sid Wolfe did not stand to gain from either the presence of YAZ and Yasmine on a Public Citizen website, nor from his presence on the committee as a voting member,
he had no conflict of interest and therefore had no obligation to disclose to FDA what was on the Public Citizen website (or anything else).

FDA is plagued by many members of its advisory committees having financial conflicts of interest, which are not always disclosed. Sometimes 50% of members have such conflicts, for which waivers are routinely granted.

Yet here comes physician Sid Wolfe, whose clear, career-long interest is in making the US pharmacopiea safer, and who may have preexisting knowledge about the drug in question. Shouldn't FDA encourage members with more knowledge of a specific drug to participate in discussions about that drug?

Yet FDA finds this an intellectual conflict of interest. I recall the CDC advisory committee that voted to expand the indications for anthrax vaccine. None of them were experts on the vaccine... and this meant they were easily led by factual omissions and spin in the way information was presented to the committee by CDC staffers. No one had the knowledge to detect the spin.

I just discovered that Ed Silverman at Pharmalot is blogging about this subject, so please go to his site for more information, including a pending inquiry to FDA. Note also that Janet Woodcock of CDER is the person who pulled the plug on Wolfe in this case... and she is someone not known for her integrity in the relicensure of Lotronex. Public Citizen also discusses Lotronex and Woodcock on its website.

Eliot Spitzer: A Secret Scandal/ Slate

2011-12-02T22:05:00.000-05:00

Half the US GDP was loaned to banks with no collateral. Recall that (former NY Attorney General and Governor) Eliot Spitzer was investigating the Wall Street banks at the time his indiscretions with call girls led to his resignation, ending any hopes of seeking the presidency. Not only American, but many foreign banks were bailed out in the program Spitzer discusses. An excerpt follows:

... During the deepest, darkest period of the financial cataclysm, the CEOs of major banks maintained in statements to the public, to the market at large, and to their own shareholders that the banks were in good financial shape, didn’t want to take TARP funds, and that the regulatory framework governing our banking system should not be altered. Trust us, they said. Yet, unknown to the public and the Congress, these same banks had been borrowing massive amounts from the government to remain afloat. The total numbers are staggering: $7.7 trillion of credit—one-half of the GDP of the entire nation. $460 billion was lent to J.P. Morgan, Bank of America, Citibank, Wells Fargo, Goldman Sachs, and Morgan Stanley alone—without anybody other than a few select officials at the Fed and the Treasury knowing. This was perhaps the single most massive allocation of capital from public to private hands in our history, and nobody was told. This was not TARP: This was secret Fed lending. And although it has since been repaid, it is clear why the banks didn’t want us to know about it: They didn’t want to admit the magnitude of their financial distress.

The banks’ claims of financial stability and solvency appear at a minimum to have been misleading—and may have been worse. Misleading statements and deception of this sort would ordinarily put a small-market player or borrower on the wrong end of a criminal investigation.
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So where are the inquiries into the false statements made by the bank CEOs? And where are the inquiries about the Fed and Treasury officials who stood by silently as bank representatives made claims that were false, misleading, or worse?

Only now, because of superb analysis done by Bloomberg reporters—who litigated against the Fed and the banks for years to get the information—are we getting a full picture of the Fed and Treasury lending. The reporters also calculated that recipient banks and other borrowers benefited by approximately $13 billion simply by taking advantage of the “spread” between their cost of capital in these almost interest-free loans and their ability to lend the capital.

In addition to the secrecy, what is appalling is that these loans were made with no strings attached, no conditions, and no negotiation to achieve any broader public purpose....

Fukushima nuclear catastrophe closer than thought/ The Australian

2011-12-01T19:25:00.001-05:00

The Japanese government and TEPCO have released new information (based on simulations, however) on the extent of damage to the Fukushima nuclear reactors. The Australian reports on the catastrophe:

MOLTEN nuclear fuel in one reactor at Japan's stricken Fukushima Daiichi plant burned through the steel pressure vessel and three-quarters of the surrounding concrete containment vessel that formed the reactor's last substantial internal barrier...

... In the case of the No 1 reactor, any fuel that escaped the secondary concrete vessel would have landed on a protective steel plate. Had it burned through that, it would then have confronted a 10m thick steel foundation beyond which lays ordinary soil.

The TEPCO and government analyses - which may not be the final word on the extent of the meltdown - showed that the fuel burned through a total of about 2m of the 2.6m thick secondary containment vessel.

The operator and the government agencies in charge of regulating the nuclear industry have consistently underestimated the severity of events at the plant...

More than 80,000 people have been forced out their homes as a result of the disaster, which ranks second only to the 1986 Chernobyl incident in terms of severity. Japan has also been forced to endure a run of food scares thanks to radioactive cesium deposited across wide areas around the plant.

The Japanese government has conceded that it may take 30 years to fully decommission the plant and that some areas around it may be uninhabitable for decades...

New Swine Flu Strain Keeps Health Officials on Alert/ ABC News

2011-11-30T01:01:00.000-05:00

ABC News reports that a new strain of influenza has appeared in several states. CDC officials are worrying that it might become the predominant strain this flu season. Based on modelling, CDC thinks Tamiflu might help. (However, Tamiflu only shortens bouts of flu by one day, according to the package insert. It is probably a CDC favorite because it is better than nothing, which is the alternative.)

Does the new flu strain mean the seasonal flu vaccine won't work? That seems to be the major concern, since no one has said it is killing its victims.

CDC scientists said they expected this years’ seasonal flu vaccine to provide adults with limited protection from the new flu virus, but that it wouldn’t help children.

What? How can it work for adults but not for kids? The "killed" child vaccine uses the identical antigens as the adult flu vaccine. And the live child vaccine should also have those antigens, plus others.

Read between the lines: adults (vaccinated or not) have had more exposures to influenza viruses than children, and it's an old exposure that will provide the immunity. Adults who don't get vaccinated may even have better immunity than those who do, as the natural protection gained through exposure is more robust and long-lasting. The elderly did not get sick from swine flu because an antigenically similar virus had come through many decades ago. Immunity persisted.

But kids have had fewer seasons of influenza exposures, and therefore are less likely to be protected.

CDC wants you to get your shot, regardless. So its spin docs are claiming "limited protection" for this year's shot.

And after you get vaccinated, I have a flying pig to sell you.

Australian Medical Association urges watch on vaccines/ The Australian

2011-11-29T22:19:00.002-05:00

This article is by Natasha Bita, who just won a Walkley journalism prize for her series on flu vaccine dangers in The Australian.

UPDATE: The public's responses to her story "Virus in the System." It is astounding that after the widely publicized problems with last year's childhood flu vaccine, the Health Minister (a lawyer) has the temerity to force 3 more vaccines on Australia's children--or have their parents forfeit $2100.

Health Minister Nicola Roxon's 'Big Brother' approach has even the AMA squirming ... and pointing out that Australia's drug regulatory agency is entirely funded by pharmaceutical user fees, which equates with lax regulation:

DOCTORS demanded more monitoring of vaccine side-effects yesterday after the federal government announced penalties for families who fail to immunise their children.
Australian Medical Association president Steve Hambleton said the government must introduce "active surveillance" to monitor side effects instead of relying on doctors and patients to report problems through "passive surveillance".

Last year, health authorities took weeks to suspend a flu vaccine that caused febrile fits in children.

"For a vaccine, you are taking healthy people and trying to keep them healthy so surveillance of the side effects is doubly important," Dr Hambleton said.

"We need to maintain confidence in the program. We can't just say to people, 'Don't worry, it's safe'. "

Health Minister Nicola Roxon has added three vaccines -- meningococcal C, pneumococcal and chicken pox -- to the national immunisation program from July 2013. From July next year, families will miss out on $2100 in family tax benefit Part A payments unless they immunise their children with every vaccine on the government's list.

Dr Hambleton said doctors strongly supported immunisation to protect children against life-threatening illness.

But he called for taxpayer funding of Australia's medicines regulator, the Therapeutic Goods Administration, which is entirely funded by user-pays charges on the pharmaceutical industry.

He said the TGA needed to work "better and quicker" to ensure prescribing advice to doctors always included the most up-to-date data on clinical trials and side effects.

"We have to make sure regulators do their job," Dr Hambleton said.

"We do rely on the TGA for good quality, independent advice.

"Everything the TGA does is in the public interest so it should be publicly funded to do the extra work and notify the public of any changes that do come up. If it can't do what it needs to do, we need to ask why."

The Australian revealed yesterday that drug giant CSL had changed its prescribing information for next year's flu vaccine, to warn doctors that two toddlers had to be hospitalised during clinical trials of Fluvax in 2006.

The previous prescribing information for doctors had stated there were "no reports of adverse serious events". The TGA admitted that CSL had told it about the side effects in 2006.

Dr Hambleton said yesterday doctors might have blown the whistle on last year's Fluvax fits earlier had they been aware of the data that was left out of last year's prescribing information.

Unused German swine flu vaccine goes up in smoke (about 250 million Euros worth)/ The Local

2011-11-29T21:38:00.001-05:00

... But the [2009 swine] flu was much milder than expected, and this, combined with safety fears over the new vaccine, led to only around seven percent of Germans opting to get the vaccine.

Germany actually purchased two different types of swine flu vaccine: one with a novel adjuvant (that used less antigen and instead included a novel booster) and one without. The one without the vaccine booster (a.k.a. novel adjuvant) was purchased for government officials and the military. Not many ordinary Germans wanted the boosted, second class version that had been designated for them. Other European countries generally purchased only one vaccine: the one with the new adjuvant. However, Poland bought neither, noting that the waiver of liability for vaccine injuries or vaccine failure demanded by the vaccine manufacturers was unacceptable.

The US government bought lots of novel adjuvant, but in the end chose not to use it in the swine flu vaccine. Don't worry: it remains in the stockpile, ready for the next dire (or not) threat.

US to pay $2.5M in photo editor's anthrax death/ AP

2011-11-29T21:13:00.002-05:00

From the Associated Press, Maureen Stevens settles with the US government for her husband's death by anthrax, due to lax control of the material at government's Fort Detrick lab.

UPDATE: From Scott Shane at the NY Times:

... A Justice Department spokesman, Charles S. Miller, said he could not comment on why the government was trying to preserve the secrecy of documents beyond what was already in the public court file. Court orders prohibit the disclosure of security measures at the Army lab and records of missing pathogens and other lapses.

For the Justice Department, simultaneously pursuing a criminal investigation and defending the Stevens civil suit has made for a tricky balancing act. By hunting for the anthrax mailer at Fort Detrick, F.B.I agents and prosecutors highlighted the very security problems the lawsuit was seeking to expose.

In a July filing in the civil case, Justice Department lawyers said Dr. Ivins “did not have the specialized equipment” in his lab to make the dry anthrax powder in the letters — appearing to contradict the department’s claims in the criminal case. Days later, the lawyers retracted the statement.

An Army spokesman, George B. Wright, said “significant progress” has been made in improving security at the biodefense lab, including continual evaluation of lab workers, tighter control of access to areas where pathogens are stored and continuous monitoring by closed-circuit television. [Interesting name of the spokesman, as George G. Wright, another army employee, was the original developer of the US anthrax vaccine.]

What Really Happened to Strauss-Kahn?/ NY Review

2011-11-28T21:29:00.000-05:00

More details emerge from this piece by Edward Jay Epstein about the Dominique Strauss-Kahn affair at the New York Sofitel hotel. This does not wrap up the case, but provides additional information about the sequence of events and about the missing Blackberry, which DSK had arranged with his wife to be examined for a security breach upon his return to France... arranged two hours before the alleged sexual encounter took place.

Important Advantage from Actually Getting Flu?

2011-11-22T23:29:00.001-05:00

Infectious Disease News has posted a report of a paper, "H1N1 pandemic less severe among adults with history of flu." The paper suggests that people with preexisting antibodies to different H1N1 strains had more immunity to swine flu H1N1 than those without. Getting a flu infection (whether or not you actually get sick... since the majority of people with influenza infections show few if any symptoms) leaves you with long-lived antibodies, and many more of them, than someone has who got vaccine. And they protect against similar strains, which flu vaccine usually fails to do.

This might explain the data from Canada and Hong Kong (that I have blogged about several times) which showed that receiving flu vaccine in 2008 led to almost double the likelihood of getting sick from swine flu in 2009. In other words, the unvaccinated from the previous flu season fended off swine flu much better than the previous season's vaccinated people did.

This means that catching the garden variety flu could protect you in future from the much-anticipated, threatening Pandemic Flu. And the protection could be expected to last for many decades. Vaccine protection only lasts months, or a year or two. Maybe your body makes lemonade out of flu lemons.

UPDATE: Apparently this article, in French, suggests the same thing:

Geriatr Psychol Neuropsychiatr Vieil. 2011 Mar;9(1):11-9.

Adverse effects of the herd immunity or When childhood vaccination becomes deleterious for the epidemiology of infectious diseases in adults.

Lang PO.

Département de réhabilitation et gériatrie, Hôpital des Trois-Chêne, Thônex-Genève, Suisse. pierre.o.lang@hcuge.ch

Abstract

The irremediable ageing of the world population, the aged-related increasing in the prevalence of infectious diseases the fear of any influenza pandemic rife have recently led the European Union Geriatric Medicine Society (EUGMS) et the International Association of Geriatric and Gerontology European Regions (IAGG-ER) of establishing vaccine recommendations dedicated to individuals aged of 60 years or above and promoting a life-course vaccination programme. This approach is mainly motivated by the herd immunity-associated effect on the epidemiology of infectious diseases observed within the adult and old adult population. This review (1) after a presentation of the concept and its demonstrated beneficial effects; (2) will detail that herd immunity acts with adverse effects on the epidemiology of the infectious diseases in the adult and aged individual population; (3) in order to demonstrate that maintaining a vaccine pressure in every age groups is imperative.

Future cancers from Fukushima plant may be hidden/ AP

2011-11-20T13:42:00.000-05:00

As long as the research is methodologically sound and designed to capture a broad range of possible adverse outcomes from radiation released at Fukushima (where people have been exposed to many different isotopes through skin contact, inhalation and ingestion at widely varying doses), you will probably learn a lot about how the radiation affected health. However, if you limit what you are looking for to only a few outcomes, such as childhood thyroid cancer, you will never identify the full range or number of adverse effects. From today's article by the AP's Malcolm Ritter:

Even if the worst nuclear accident in 25 years leads to many people developing cancer, we may never find out.Looking back on those early days of radiation horror, that may sound implausible....

The idea that Fukushima-related cancers may go undetected gives no comfort to Edwin Lyman, a physicist and senior scientist with the Union of Concerned Scientists, a group that advocates for nuclear safety. He said that even if cancers don't turn up in population studies, that "doesn't mean the cancers aren't there, and it doesn't mean it doesn't matter."

"I think that a prediction of thousands of cancer deaths as a result of the radiation from Fukushima is not out of line," Lyman said. But he stressed that authorities can do a lot to limit the toll by reducing future exposure to the radiation. That could mean expensive decontamination projects, large areas of condemned land and people never returning home, he said. "There's some difficult choices ahead."

Japan's Cabinet this month endorsed a plan to cut contamination levels in half within the next two years. The government recently announced it plans to study the risk from long-term exposure to the low-dose radiation level used as a trigger for evacuations...

Eisuke Matsui, a lung cancer specialist and a former associate professor at Gifu University School of Medicine, criticized the project. He said it appears to largely ignore potential radiation-induced health risks like diabetes, cataracts and heart problems that have been hinted at by some studies of Chernobyl.
"If thyroid cancer is virtually the only abnormality on which they are focusing, I must say there is a big question mark over the reliability of this survey," he said.
He also suggested sampling hair, clipped nails and fallen baby teeth to test for radioactive isotopes such as strontium that are undetectable by the survey's current approach.
"We should check as many potential problems as possible," Matsui said.
Yasumura acknowledges the main purpose of his study is "to relieve radiation fears." But Matsui says he has a problem with that.
"A health survey should be a start," Matsui says, "not a goal." [In other words, if you already have the outcome in mind, your study is biased before it starts.--Nass]
Tatsuhiko Kodama, head of the Radioisotope Center at the University of Tokyo, urged quick action to determine the cancer risks.
He said big population surveys and analysis will take so long that it would make more sense to run a careful simulation of radiation exposures and do anything possible to reduce the risks.
"Our responsibility is to tell the people now what possible risks may be to their health," he said.

Dr. Joe Mercola's wide-ranging interview with me

2011-11-14T08:28:00.000-05:00

Last month I went to Chicago to do a video interview with Dr. Joe Mercola on bioterrorism issues, anthrax, government responses and some of their ramifications (especially vaccines). I thought he performed masterfully, asking the right questions and providing perspective. The material he elicited builds a surprising story, which encapsulates most of my work over 23 years. It is a long interview (77 minutes), but there are also bullet points, a synopsis and transcript, so readers can get as deep as they wish into the story.

Cost, need questioned in $433-million smallpox drug deal // aka Biodefense: Giving from the 99% to the 1% / LA Times

2011-11-12T21:50:00.012-05:00

UPDATE: Senator Claire McCaskill calls for DHHS IG to investigate the government's sole-source contract with Siga.

If you are unconvinced that government seeks ways to buy products from "insider" companies that tithe to those at the center of government, read David Willman's article in today's LA Times. A few grams of anthrax, grown from stock at the USA's premier biodefense lab, kicked off quite the $69 billion dollar federal biodefense spending spree. And it ain't over.

Actually, the spending spree started earlier, with Clinton, who bought millions of doses of smallpox vaccine for about $365 million. The anthrax letters just ramped it up a few notches for Bush2. Then-DHHS SecretaryTommy Thompson said it was going to cost a lot more than the $509 million he'd expected, to buy enough smallpox vaccine for every American.

The US had a 25 year old stockpile of old smallpox vaccine that not only had been tested and still worked, but was good at a 1:5 dilution. There were at least 15 million doses of old vaccine available, and perhaps a lot more. The new vaccine was made using a virus from the old vaccine, so did not involve any major new technology. It had the same serious side effect profile as the old vaccine. One in 200 people getting smallpox vaccine for the first time developed heart inflammation. Once the new vaccine was delivered, all stocks of the old vaccine were destroyed.

Soldiers are still receiving smallpox vaccine when they deploy overseas, despite the considerable risk and questionable benefit.

Obama has continued in the same vein with the purchase of an untested drug for smallpox (see below). When the drugs and vaccines expire in a few years, the feds get to do it all over again. What a business model!

Why did government work so hard to make us afraid? Cause we had few toys in the biodefense toy box, which meant government would be able to Buy, Buy, Buy (aka SPEND). New products and new companies could be invented. There were no rules for what we might need, nor how much. This was an opportunity to create limitless sweetheart deals from the absolute bottom up. Mr. Willman gives us the dirt. Dr. Nicole Lurie at DHHS is the Dems' enforcer for this contract, as well as for the pediatric anthrax trial. Excerpts below, but read the entire article here:

Over the last year, the Obama administration has aggressively pushed a $433-million plan to buy an experimental smallpox drug, despite uncertainty over whether it is needed or will work.

Senior officials have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world's richest men and a longtime Democratic Party donor...

Dr. Thomas M. Mack, an epidemiologist at USC's Keck School of Medicine, battled smallpox outbreaks in Pakistan and has advised the Food and Drug Administration on the virus. He called the plan to stockpile Siga's drug "a waste of time and a waste of money."

The Obama administration official who has overseen the buying of Siga's drug says she is trying to strengthen the nation's preparedness. Dr. Nicole Lurie, a presidential appointee who heads biodefense planning at Health and Human Services, cited a 2004 finding by the Bush administration that there was a "material threat" smallpox could be used as a biological weapon... [See the 2005 IOM report on the Smallpox Vaccine Program to confirm that the Bush administration never provided any evidence to support this claim, nor has the Obama administration. Why is she hearkening back to Bush? She needs some new talking points--Nass]

Negotiations over the price of the drug and Siga's profit margin were contentious. In an internal memo in March, Dr. Richard J. Hatchett, chief medical officer for HHS' biodefense preparedness unit, said Siga's projected profit at that point was 180%, which he called "outrageous."

In an email earlier the same day, a department colleague told Hatchett that no government contracting officer "would sign a 3 digit profit percentage." [But the DHHS official(s) who bought stocks of anthrax vaccine 3 times since 2008 did so as well, with a 300% markup--Nass]

In April, after Siga's chief executive, Dr. Eric A. Rose, complained in writing about the department's "approach to profit," Lurie assured him that the "most senior procurement official" would be taking over the negotiations.

"I trust this will be satisfactory to you," Lurie wrote Rose in a letter...

Lurie denied that she had spoken with or written to Rose regarding the contract, saying such contact would have been inappropriate. [Or is the accurate term illegal?--Nass]

But in a subsequent statement, an HHS spokeswoman acknowledged Lurie's letter to Rose, saying it "reflects the critical importance of the potential procurement to national security."

... Two months after Project Bioshield was established, Siga purchased the rights to what became known as ST-246 and other assets from a Pennsylvania company, ViroPharma Inc., for $1 million in cash and 1 million shares of Siga's common stock. Over the next three years, the National Institute of Allergy and Infectious Diseases awarded Siga two research grants and a related contract, worth a total of $23.5 million, to develop the new drug.

From the outset, there was only one potential customer: the U.S. government.

For Siga, the stakes were high. ST-246 was its most promising experimental compound.

From 2005 through September, the company has paid three lobbying firms $800,000 to represent its interests in Washington, public records show. Disclosures filed by the lobbyists said they focused on Project BioShield and "issues related to homeland security and HHS," along with "government procurement of vaccines."

Siga representatives told The Times that the company had lobbied only "generally" for biodefense spending, adding: "Neither Siga nor anyone else on Siga's behalf ever lobbied anyone to get this contract."

Perelman and others at Siga's affiliate, MacAndrews & Forbes, have long been major political donors. They gave a total of $607,550 to federal campaigns for the 2008 and 2010 elections, according to records compiled by the Center for Responsive Politics. About 65% of that money went to Democrats. Perelman donated an additional $50,000 to President Obama's inauguration.

From December 2007 to January of this year, Rose, Siga's chief executive, served on the U.S. National Biodefense Science Board, which has advised Lurie on how to respond to biological terrorism and other potential health emergencies. (Rose was appointed during the Bush administration.)

... On Oct. 13, 2010, Siga announced that the government intended to award it a contract for ST-246 worth as much as $2.8 billion. Within days, Siga's stock price soared...

But the federal contract required that the winning bidder be a small business, with no more than 500 employees. Chimerix Inc., a North Carolina company that had competed for the contract, protested, saying Siga was too big.

Officials at the Small Business Administration investigated and quickly agreed, finding that Siga's affiliation with MacAndrews & Forbes disqualified it.

The Obama administration could have awarded the contract to Chimerix as the only eligible small-business applicant. Or it could have reopened the competition to companies of any size.

Instead, the administration moved to block all companies — except Siga — from bidding on a second offering of the contract.

In early December, officials completed a required "justification for other than full and open competition," which said an antiviral against smallpox was needed within five years and Siga was the only company able to meet that timetable.

The rationale was questioned by some in HHS, including contracting officer Brian K. Goodger, who in an internal email called it "a stretch..."

Siga and government officials soon began tangling over the price the company would be paid. Because the contract was no longer to be awarded based on competition and because the only customer was the government, officials sought to assess whether the company's proposed price was "fair and reasonable," as required by federal law.

In so doing, officials looked at how much government money had already gone into developing ST-246. Public records show $115 million in federal support, not including the stockpile contract.

After reviewing Siga's costs and the prices of other drugs produced in low volumes compared with commercial products, the HHS negotiators wanted to pay about $170 for each treatment. The company argued for more based on ST-246's potential value to the nation.

"Siga did not derive its price based on any cost information, and, from Siga's viewpoint, such information is not relevant to determination of an appropriate price," the company's chief financial officer, Daniel J. Luckshire, wrote to Lurie's office and others on March 4.

"Siga has created extremely valuable intellectual property, embodied in ST-246, and Siga has priced ST-246 based on the value of that intellectual property," Luckshire added...

Rose said "any further negotiation should occur with a more senior official [with] the authority to take into account the important policy issues that surround this procurement."

Two days later, Lurie wrote her conciliatory letter to Rose, pledging to install a new lead negotiator. Her top subordinate, Balady, followed through by naming Goodger to replace Early, who continued to work on the contract but not as lead negotiator.

A financial analyst for RBC Capital Markets reported to investors in May that the agreed-upon price per dose appeared to be $255. He arrived at that estimate by dividing the $433-million contract by the 1.7 million doses to be delivered. Siga told The Times that this would give a rough approximation of the per-treatment price.

On May 13, HHS announced what amounted to the second awarding of the contract, worth between $433 million and $2.8 billion, depending on whether the government exercised options to buy more of the drug in future years. Siga hailed it as a "historic event for the biodefense industry."

Throughout the negotiations over price and profit, a separate issue loomed: uncertainty over whether the Food and Drug Administration would approve ST-246 for use in humans.

For more than a year, the enthusiasm of HHS officials for stockpiling the drug has stood in contrast to the skepticism of the FDA. The agency's stance is important because the contract requires Siga to develop its drug "for ultimate approval by the FDA."

In a June 2010 email, Gary Disbrow, a virologist in HHS' biomedical unit, shared with colleagues his assessment of where the FDA stood on the smallpox drugs being developed by Siga and Chimerix, the North Carolina company: "My interpretation of their current position is that there is NO foreseeable path to licensure."

The problem was the inherent limits of animal testing in determining whether the drugs would be safe and effective in fighting smallpox in humans. Researchers are prohibited from infecting humans with the virus...

Lurie said she hoped the FDA would ultimately approve ST-246. "We would not have gone ahead with a procurement unless we thought there was a pathway," she said... [You couldn't make this stuff up--Nass]

The administration had intended to award Siga the exclusive option to replenish or expand the stockpile, but officials relented after Chimerix formally protested. In June, the government settled the dispute by dropping the exclusivity provision. That limited the value of Siga's contract to $433 million and meant that other companies could compete to fill future orders for the drug... HHS officials were concerned about how Siga might react. Goodger reassured his higher-ups that despite its disappointment, the company would not seek "any negative publicity."

And if you still think the top pols in Washington play by the same rules as the rest of us, then read today's 60 Minutes story about how insider trading is legal--if you are a member of Congress.

Secret reports: With security spotty, many had access to anthrax /McClatchy

2011-11-10T22:56:00.000-05:00

A McClatchy piece I thought was duplicative, but there is more meat than I realized at first glance:

... The existing security procedures _ described in two long-secret reports _ were so lax they would have allowed any researcher, aide or temporary worker to walk out of the Army bio-weapons lab at Fort Detrick, Md, with a few drops of anthrax _ starter germs that could grow the trillions of spores used to fill anthrax-laced letters sent to Congress and the media.
The two reports, which have not been made public for more than nine years, describe a haphazard system in which personnel lists included dozens of former employees, where new hires were allowed to work with deadly germs before background checks were done and where stocks of anthrax and other pathogens weren’t adequately controlled.

... Marked “for official use only,” the two reports were completed in 2002. One was conducted by a seven-member team from Sandia National Laboratories in Albuquerque, N.M. The other was by auditors for the Army’s inspector general’s office.

... The Sandia report emphasized that terrorists had obtained germs from research labs before. It cited a February 2001 National Defense University study that found 11 cases in which terrorists or other “non-state operatives” had acquired biological agents from “legitimate culture collections,” including three research or medical laboratories.

... The report said no rules governed movement of germ specimens from one building to another, for example, and that a test tube containing some of Ivins’ spores was left for weeks in a refrigerator in a second building.

... the examiners said, there was little way to detect diversions from flasks of germs, because a “malevolent” worker could grow more of the pathogen or find other ways to conceal the removal of a small amount....

Infamous Endorsement of Anthrax Vaccine for Children/ AHRP

2011-11-04T21:58:00.000-04:00

The Alliance for Human Research Protection has written about the NBSB recommendations for testing anthrax vaccine in children:

... The NBSB recommendation was made despite its own report acknowledging that:

“Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration.”
“There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit.”
Their justification is without substance, relying on a hypothetical, highly exaggerated risk from an unlikely event:
"Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security.”
What evidence exists of any "national and potentially global threat from anthrax"?

... Knowledgeable critics believe this vote demonstrates the insidious influence federal biodefense funding exerts on academics and physicians who can be counted on to sanction even the most egregious, ill-conceived government initiative and lend credence to hypothetical, unsubstantiated risks.

FDA's latest label warnings (2008) states:

"Since the risk of anthrax infection in the general population is low, routine immunization is not recommended."
"Safety and effectiveness of BioThrax have not been established in pregnant women or nursing mothers, or in pediatric or geriatric populations"...

High Court judge will hear call for inquest on Dr David Kelly's death/ Daily Mail

2011-11-03T22:14:00.000-04:00

From the Daily Mail's Miles Goslett:

The death of Dr David Kelly is to be examined at the High Court next month after a senior judge ordered a special hearing as part of his review of the case.
Mr Justice Kenneth Parker is considering an application from retired West Country surgeon David Halpin to challenge the Government’s decision this summer not to hold a coroner’s inquest...

Public Citizen Goes on Record Opposing Unethical Anthrax Vaccine Trial in Children

2011-11-02T17:44:00.002-04:00

From the Public Citizen advocacy organization, discussed by periodical The Hill:

November 1, 2011

The Honorable Kathleen Sebelius
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

RE: Proposed Clinical Trials Testing the Anthrax Vaccine on Children

Dear Secretary Sebelius:

Public Citizen, representing more than 225,000 members and supporters nationwide, urges you to reject the National Biodefense Science Board’s (NBSB) recommendation to conduct pre-event clinical trials of the anthrax vaccine in children. Such trials would be unethical and are prohibited under the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations for the protection of human subjects.

The proposed research would be unethical, because the research does not present any prospect of direct benefit to the children who would be the subjects of the research, and the vaccine poses significant known risks of potentially serious harm. The most serious known risk of anthrax vaccine is anaphylactic shock. Other potential risks identified in either clinical tests or postmarketing surveillance include:1

 Serious allergic reactions, including angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction and Stevens-Johnson syndrome;

 Nervous system disorders, including headache, paresthesia, syncope, tremor, ulnar nerve neuropathy;

 Musculoskeletal, connective tissue, and bone disorders, including arthralgia, arthropathy, myalgia, rhabdomyolysis, alopecia;

 General disorders and administration site conditions, including injection site reactions (including pain, nodule, edema, induration, erythema, warmth, pruritus, cellulitis), fatigue, pyrexia, flu-like symptoms; and

 Multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, and musculoskeletal system.

Furthermore, such research could only be supported by HHS if both you, in accordance with the requirements of HHS human subject protection regulations at 45 C.F.R. 46.407, and the commissioner of the FDA, in accordance with the requirements of FDA regulations at 21 C.F.R. 50.54, consult with a panel of experts in pertinent disciplines (for example, science, medicine, education, ethics, law) and, following an opportunity for public review and comment, determine that:

(a) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious health problem affecting the health or welfare of children;

(b) the research would be conducted in accordance with sound ethical principles; and

(c) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians.

Regarding determination (a), anthrax currently is not “a serious health problem affecting the health or welfare of children” in the U.S., and the extremely remote chance of children being exposed to anthrax is not sufficient justification for testing the anthrax vaccine in children, particularly since there are antibiotics approved by the FDA for use in children to treat post-exposure cutaneous or inhalation anthrax, including penicillin and doxycycline.

Regarding determination (b), as we have noted above, the proposed research would not be consistent with sound ethical principles, because exposing vulnerable children, who lack autonomy to make an independent decision about participation in research, to a high-risk experimental intervention is not justified given the lack of any direct benefit to the subjects and the fact that anthrax is not a serious health problem affecting the health and welfare of children.

Finally, regarding determination (c), it is highly unlikely that parents who are truly informed about the nature of the anthrax vaccine, the absence of benefits to the subjects, the availability of FDA-approved antibiotics for post-anthrax exposure treatment, and the highly unlikely possibility of anthrax exposure to children would give permission for their children to be in such research.

Millions of taxpayer dollars currently are being spent to maintain a national stockpile of anthrax vaccine. Exaggerating the risk of an anthrax bioterrorism event for both adults and children may help justify such expenditures, but should not be used to justify unethical research in children.

In closing, we urge you to immediately reject the NBSB’s recommendation to conduct unethical pre-event clinical trials of the anthrax vaccine in children.
Thank you for your prompt attention to this matter.

Sincerely,

Michael A. Carome, M.D.
Deputy Director
Public Citizen’s Health Research Group

Sidney M. Wolfe, M.D.
Director
Public Citizen’s Health Research Group

cc: Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response

1 Emergent BioDefense Operations Lansing Inc. Biothrax Label. Revised December 2008. Available at http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/UCM074923.pdf. Accessed October 31, 2011.

Critically important piece on biopreparedness: How Ready Are We for Bioterrorism?/ NY Times

2011-10-31T22:48:00.003-04:00

Here is another blog post coming from the long NY Times article on our government's response to the threat of bioterrorism. This article is brilliant in its simplicity. It simply covers the field. The author interviewed over 100 people who work in biodefense, and he makes clear that the $60+ billion spent on bioterrorism efforts since 2001has not been well spent. To say the least. Excerpts and commentary follow.

... And a report by the Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, formed in 2007, concluded: “To date, the U.S. government has invested most of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism. The commission believes that it should make the more likely threat — bioterrorism — a higher priority.”

This refers to the fact that the USG has failed to pursue the most obvious way to protect Americans from bioterrorism: adding teeth to the treaty banning biological weapons. The 1972 treaty bans biological weapon production and use, but lacks any inspections or sanctions, making it almost imposible for the treaty to be enforced.

... After spending hundreds of millions of dollars, for example, to develop a new vaccine for anthrax that would replace the controversial formula developed 50 years ago by the Army — which is known to have serious side effects and has never been approved for children — there is still no new vaccine.

The anthrax vaccine manufacturer is unique in the amount spent on lobbying, and is also unique in the 300% markup it receives for the vaccine over the cost of production.

... Last year, two separate review boards evaluated the state of the country’s biodefense program, and each report came back scathing. The National Biodefense Science Board, a nonpartisan task force created in 2006 to oversee countermeasure development, delivered a 103-page report to the secretary of Health and Human Services, Kathleen Sebelius, describing “lack of urgency,” “lack of coherence,” “lack of prioritization” and “lack of synchronization.” The title of the report was “Where Are the Countermeasures?” And the commission created by Congress in 2007 to evaluate all defenses for chemical, biological, radiological and nuclear threats delivered its final report, offering letter grades in several categories. For attention to the safe storage of toxins, the government received an A. For openness and transparency, a B-minus. For biodefense, the grade was an F.

... Even within the biodefense community, there is a widespread sense that the countermeasure program is failing. Early this year, Sebelius described the effort as “full of leaks, choke points and dead ends,” and in more than 100 interviews with senior officials from each of the federal agencies related to countermeasure development — including past and current program heads at the White House, the Pentagon, the National Institutes of Health and the Departments of Homeland Security and Health and Human Services — I heard an endless series of grim diagnoses on the health of the nation’s biodefenses. As one senior official in the Obama administration put it: “We need a new model. This is never going to work.”

... Officials at Health and Human Services were also determined to produce and store a large supply of anthrax vaccine, but they were unsatisfied with the existing formula. Some veterans blamed the vaccine for gulf war syndrome, citing research at Tulane University, and after vaccination was made mandatory in 1998, hundreds of service members actually refused the shots. Some resigned from service in order to avoid it; a few were court-martialed for insubordination. In 2002, the most comprehensive study of the vaccine, by the Institute of Medicine at the National Academy of Sciences, concluded that while the vaccine was “reasonably safe,” a new vaccine was “urgently needed.”

Executives at Emergent acknowledge the campaign against VaxGen but say it was not directed at the company so much as the structure of the BioShield contract. “Our issue was not with respect to VaxGen,” the president of Emergent, Daniel Abdun-Nabi, told me. “It was with respect to the approach of moving to a single supplier with an unproven technology. We thought it was premature. We thought it added risk to the country.” According to Abdun-Nabi, the company’s message to legislators was: “You shouldn’t put all your eggs in one basket. There’s a role for multiple suppliers.” The fact that this lobbying contributed to the implosion of VaxGen and another five years in which Emergent was the only supplier of anthrax vaccine, which has earned the company $1.5 billion, also troubles Abdun-Nabi, he said. “It puts us in a very difficult position to be the sole supplier. I mean, the whole nation is reliant on Emergent. And in one sense, we’re very honored to be in that position, but it’s a tremendous responsibility.”

General Russell, who led the early countermeasure program, told me: “It was Emergent lobbying that killed VaxGen. Period. Emergent bought the Congress. Congress killed VaxGen.” Several current officials share Russell’s view. When I asked one senior biodefense official about the lack of a new anthrax vaccine, the official nearly exploded: “Why don’t we have a second-generation anthrax vaccine? The reason is Emergent lobbying!”

"Emergent bought the Congress." You saw it in the NY Times. A poisonous vaccine, for which you can't get the CDC data or the military data on safety (data collected at taxpayer expense), has been stockpiled for the American public. At a total cost of about 2.5 billion dollars. The threat of bioterrorism has been used to justify enormous expenditures for a vaccine nobody wants to receive.

The latest scam proposed to test the vaccine in children, to expand the vaccine indications. (Anthrax vaccine is not currently approved for those under 18 or over 65.) Both Republican and Democratic administrations have supported mandatory anthrax vaccinations. The last (Bush) administration approved the vaccine for civilian first responders. The Obama administration proposed testing the vaccine in children. Money seems to be one of those things that ignores party lines.

UPDATE: However, the public seems to have had enough of business as usual in Washington. According to the Nov 1, 2011 NY Times:

According to a New York Times/CBS News poll in September, only 33 percent of registered voters believe their own member deserves to be re-elected, and a mere 6 percent said the same about most members of Congress, both the lowest figures since The Times started asking this question in the early 1990s.

The anthrax vaccine boondoggle/ Forbes

2011-10-31T20:48:00.001-04:00

Thanks to author Steven Salzberg, who worked sequencing anthrax for the FBI letters investigation, writing in Forbes:

The anthrax vaccine is a truly bad idea. The U.S. has wasted billions of dollars on it, and it just seems to go from bad to worse. Now a government panel has recommended that we test the vaccine on children, which raises a whole new array of ethical questions.
Don’t get me wrong: vaccines are the greatest boon to public health of the last 200 years. We eradicated smallpox, we’re close to eradicating polio, and childhood deaths from infectious diseases are far, far lower thanks to the vaccines we give our children. These are truly wondrous advances.
But the anthrax vaccine is different, from start to finish.
For starters, anthrax is not infectious. [What he is trying to say is that it is not contagious from person to person. It is, however, infectious, in that it does infect people and animals--Nass] This might come as a surprise to those who’ve only heard about this through the media. An anthrax “outbreak” is impossible, because the B. anthracis bacterium cannot spread from person to person. Vaccines against diseases such as measles, mumps, and influenza protect millions of people each year, because these are common infectious diseases that spread easily between people.
Anthrax was never a public health threat, and it isn’t one now. We don’t need an anthrax vaccine. And by developing and then promoting one, the government is abusing the good will that the public has towards vaccines, possibly endangering the public health further by playing into the hands of the anti-vaccine movement.
The Centers for Disease Control (CDC) does not recommend that children be vaccinated against anthrax. In fact, it doesn’t recommend that anyone get routine vaccinations against anthrax:

“Vaccination is recommended only for those at high risk, such as workers in research laboratories that handle anthrax bacteria routinely.”
The CDC recommendation makes sense. Therefore I was stunned to learn this week that the National Biodefense Science Board (NBSB) recommended that we launch an anthrax vaccine testing program in children (see page 37 of their report).
The NBSB report admits that

“Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration.”
It also states that

“There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit.”
Case closed, right? We can’t conduct vaccine trials in children if there’s no benefit.
Somehow, though, even after these statements in their own report, the NBSB managed to recommend testing the vaccine in children. As justification, they present this claim:

“Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security.”
This is a massive overstatement. A national and global threat? Anthrax is not infectious, as the NBSB knows. The only people affected in an attack would be those directly exposed to the bacterium, likely only a handful of people. We don’t vaccinate millions of people just to protect a hypothetical few: this is an abuse of the public trust in vaccines.
So why are we wasting billions of dollars to develop, test, and administer a vaccine against something that hardly infects anyone? The anthrax vaccine development project was on its way to being cancelled by the U.S. before the 2001 anthrax attacks. In an ironic twist, the likely perpetrator of the attacks, Bruce Ivins, was allegedly motivated by his interest in reviving the anthrax vaccine program. If so, then he succeeded in a big way: in 2004, the government announced Project Bioshield, which dedicated $5.6 billion to biodefense, much of that going to anthrax vaccine research.
I’m not surprised that if the government dedicates billions of dollars to biodefense, and distributes it to companies and universities who then become dependent on these funds, then advisory panels such as the NBSB will recommend an ever-increasing number of security measures. After all, some of the members of that committee are funded by biodefense dollars, and if we cut the funding, their own livelihoods might suffer.
Speaking to the Washington Post, panel member Ruth Berkelman said:

“We need to know more about the safety and immunogenicity of the vaccine as we develop plans to use the vaccine on a large number of children in the event of a bioterrorist’s attack.”
No, we don’t. We don’t need to know about the safety of the vaccine in children because it would be unethical to test it on them. And if there is an attack, we shouldn’t respond by vaccinating “a large number of children,” because anthrax doesn’t spread from person to person. This is one vaccine we can do without.

CDC's Withholding Information on its Civilian Anthrax Trial is a Travesty

2011-10-30T01:03:00.002-04:00

Why did the most important trial to have been conducted on anthrax vaccine safety (by CDC between 2002 and 2007, with 1564 civilian subjects) only publish an interim report, and never discussed the 229 serious adverse events reported in trial participants? The trial tested serologic efficacy also. The investigators published partial data in JAMA on October 1, 2008, but only for the first 7 months of a 43 month trial, and only for 2/3 of the subjects.

The 2008 data were used to reduce the initial vaccine course from 6 to 5 doses, and to switch from subcutaneous to intramuscular doses. Within 4 weeks of publication, DHHS bought 14 million more doses of vaccine, in addition to about 25 million already stockpiled, and CDC's Advisory Committee on Immunization Practices (ACIP) approved anthrax vaccine for first responders. An earlier 2000 ACIP report had recommended against use in groups for whom a risk-benefit calculation could not be made:

"Although groups initially considered for preexposure vaccination for bioterrorism preparedness included emergency first responders, federal responders, medical practitioners, and private citizens, vaccination of these groups is not recommended. Recommendations regarding preexposure vaccination should be based on a calculable risk assessment. At present, the target population for a bioterrorist release of B. anthracis cannot be predetermined, and the risk of exposure cannot be calculated. In addition, studies suggest an extremely low risk for exposure related to secondary aerosolization of previously settled B. anthracis spores (28,83). Because of these factors, preexposure vaccination for the above groups is not recommended. For the military and other select populations or for groups for which a calculable risk can be assessed, preexposure vaccination may be indicated."

Although the final CDC trial results, carefully collected during about 20 clinic visits for each subject, have not been released:

a federal advisory committee voted in favor of testing the vaccine in children,
an additional $1.25 billion worth of anthrax vaccine was purchased for the civilian stockpile 3 weeks ago (44.75 million doses),
the decision to approve use of the vaccine in civilian first responders were all made without these data.

All 3 decisions were made by DHHS agencies or their advisory committee, while a DHHS agency withheld the most important scientific evidence about vaccine safety and serologic efficacy. Is there any rational, scientific or ethical justification anyone can make for how DHHS can behave like this? How can anyone claim the Department of Health and Human Services is acting in the public good?

The real question is who gave DHHS its marching orders, and what did they get in return?

Congress ordered a civilian trial of anthrax vaccine in 1999, yet 12 years later we have thousands of injured people, but the CDC data on anthrax vaccine safety has not been shared with the public, though it was publicly funded.

Do the data so challenge government policy that they have to be hidden? How could any policymaker, knowing this cache of data exists, not demand it before buying $1.25 B worth of vaccine, or proposing vaccine for first responders, and then children?

The principal investigator of this trial for CDC is veterinarian Jennifer Wright. Jennifer briefed the ACIP (with significant omissions), leading to their vote in 2008 in favor of first responder vaccinations. Before Jennifer, veterinarian Nina Marano at CDC was in charge. It seems relevant that veterinarians supervised a human clinical trial; MDs have different ethical obligations than veterinarians.

The following quote from the journal Nature is about the controversial early release last week of data from a malaria vaccine trial. It makes clear that the release of the very early CDC anthrax vaccine data was odd, and failure to publish the final data unacceptable, for a trial that ended 4 years ago. CDC would have us accept the cherry-picked preliminary data as the last word on this trial. We must demand the real thing.

"Some researchers question whether the results should have been published before all the data were available; full results are expected in 2014. Interim trial data are usually reported only to regulatory authorities, and clinical trials published only once all the data are in, noted Nicholas White, a malaria expert at Mahidol University in Bangkok, in an editorial³ accompanying the interim results. "There does not seem to be a clear scientific reason why this trial has been reported with less than half the efficacy results available," he wrote."

No anthrax vaccine testing on children — for now/ AP

2011-10-29T23:36:00.004-04:00

I decided to just say briefly what happened yesterday at the NBSB conference call.

Every member of the NBSB, with the exception of Iowa's top public health officer, Patricia Quinlisk, MD, voted in favor of testing anthrax vaccine in children. Kudos to Dr. Quinlisk for making clear that her public health background precluded agreement.

Panel member Ruth Berkelman suggested that a sentence be added to the recommendation, asking for a national ethics board to review the trial. Her suggestion was tweaked slightly and accepted by all. Were the panel members relieved to add another layer of review?

Whether the Presidential Commission for the Study of Bioethical Issues or a newly created panel would serve as the ethical-legal reviewing body is uncertain. Vera Sharav, president of the Alliance for Human Research Protection, and I remain of the opinion that the trial is legally unapprovable under the language of 46 CFR 45 Subpart D which would require:

the Secretary ...determines that the research presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting children’s health or welfare, and, in addition, determines that the research will be conducted in accordance with sound ethical principles and that adequate provisions are made for soliciting the assent of children and permission of their parents or guardians as discussed in 46.408.

Sound ethical principles, of course, means you have to tell the truth about what is known regarding safety and efficacy of this vaccine, and furthermore, tell parents that the HHS secretary has given anthrax vaccine a PREP Act waiver, and the manufacturer cannot be sued for damages.

Reader comments appended to the online news articles about the meeting (Google says there are 289 articles) almost uniformly pan the vaccine trial. The most frequent comments have to do with whose children should be those tested first: those of panel members, DHHS officials, Congress or Obama. It seems everyone except the professionals understands this trial involves human sacrifice, regardless of media reports that the vaccine has been sufficiently tested in adults.

In the end, Assistant DHHS Secretary Lurie told the panel that the department would decide whether to follow their advice, and when. "We're not ready to make a decision at this time but will continue the dialogue," Lurie said.

To me she sounded lukewarm. For the first time, the issue of "finding the money for the trial" came up. Reading between the lines, I heard, 'this seemed like a good idea at the time, but with an election coming up, we don't need to antagonize yet another constituency.' If self-preservation is the strongest impulse of a bureaucrat, I don't see Lurie authorizing this trial in the next 12 months. Maybe never: if it bombs, she'll take the fall.

On the other hand, there is a lot of money involved, with a new contract inked on October 3 by DHHS for an ADDITIONAL $1.25 BILLION anthrax vaccine for the civilian stockpile. Always follow the money. DHHS didn't ask where it was going to find the money for that in the federal budget.

NY Daily News Polling Readers on whether anthrax vaccine should be tested in children

2011-10-29T12:11:00.000-04:00

From the Daily News: Take our Poll

Poll Results

Do you think an anthrax vaccine should be tested on children?

Yes	11%
No	80%
Not sure	8%

Reforms Seen Failing to Rescue U.S. Biodefense Drug Efforts/ GSN

2011-10-29T08:57:00.001-04:00

From the NY Times, adapted by Global Security Newswire:

... The nation's preparations for a biological strike face numerous challenges, according to more than 100 interviews with high-level officials at participating federal entities such the National Institutes of Health and the White House, as well as the the Health and Human Services, Defense and Homeland Security departments.
Industry specialists have pointed to possible political motivations behind the 2006 cancellation of a deal for development of a new anthrax vaccine, shortly after the creation of a new Health and Human Services Department office intended to facilitate the creation of such treatments. In addition, the National Strategic Stockpile of medical countermeasures still lacks vaccinations for any potential biological "material threats" beyond anthrax and smallpox, and production of no such vaccine is slated to begin in the near future.
The National Biodefense Science Board in a 2010 report said a "lack of U.S. capability to rapidly recognize, respond and recover from a biological attack is the most significant failure" found during the assessment. “Especially troubling is the lack of priority given to the development of medical countermeasures -- the vaccines and medicines that would be required to mitigate the consequences of an attack.”
Health and Human Services Secretary Kathleen Sebelius earlier this year said the countermeasure program was “full of leaks, choke points and dead ends."
A high-level Obama administration source added: “We need a new model. This is never going to work.”
The 2001 anthrax mailings prompted an increase in biological defense funding from $633 million to $4 billion the following year, with a focus on adding to a medical countermeasure cache established in the late 1990s that comprised primarily of 15 million smallpox vaccinations as of mid-2001.
The National Institutes of Health and numerous independent scientific groups in the United States pushed from 2001 until 2004 to refine new manufacturing procedures and expand the stockpile of vaccine for smallpox, a disease eradicated from nature that is known to spread readily and result in death for roughly every third person infected. The United States now holds in excess of 300 courses of smallpox countermeasures in the Strategic National Stockpile.
Still, a $5.6 billion funding tranche unveiled by the Bush administration in 2003 for the development of new biological-weapon countermeasures was insufficient for initiating development of a next-generation anthrax vaccine by the following year, officials said...

Later that year [2006], though, the Health and Human Services Department indicated it would terminate a deal with the biotechnology firm VaxGen for development of a new anthrax vaccine. Issue experts have continued to dispute what prompted the move. One target of blame has been Maryland-based Emergent BioSolutions, which produces the only anthrax vaccine now licensed by the Food and Drug Administration.
“It was [Emergent BioSolutions] lobbying that killed VaxGen. Period. Emergent bought the Congress. Congress killed VaxGen,” said Philip Russell, a one-time head of the Army Medical Research and Development Command. “Why don’t we have a second-generation anthrax vaccine? The reason is Emergent lobbying.”
“They bought the technology and buried it,” Russell added. “We are five or six years behind where we should be. We should be working on a third-generation vaccine.”
“Should we have kept it? I think there’s a long debate,” BARDA head Robin Robinson said in reference to the canceled vaccine project. “They had brought in some really top-flight people in there, and [former VaxGen head] Lance Gordon was really good at judging talent. Unfortunately, there was a lot of political pressure.”
Countered Emergent President Daniel Abdun-Nabi: "Our issue was not with respect to VaxGen. It was with respect to the approach of moving to a single supplier with an unproven technology. We thought it was premature. We thought it added risk to the country." [Emergent btw is a single supplier with an unproven technology--Nass]
Meanwhile, the BARDA office has only received small portions of its intended $1 billion yearly budget.
“What does it take in the pharmaceutical industry?” Health and Human Services Assistant Secretary Nicole Lurie asked in 2009. “A billion dollars per product! The advanced development part of that might be about $350 million, so that’s the part that we should be funded for.”
The office has received additional funding since 2009, but some firms have described organizational complications created when Lurie asked contractors to coordinate with her rather than Robinson.
“Now you really have two bosses,” said Eric Richman, chief executive offerer of PharmAthene, one of four firms working on a potential successor to the anthrax vaccine. “We actually spend as much time managing our contracts as we do developing our drugs. It’s a real burden.”
“This becomes very frustrating for [Robinson],” one HHS official added. “What does he tell the companies -- ‘Now I have to go ask for permission?’”
Lurie and Robinson also provided diverging explanations for the agency's move way from vaccine development in favor of drugs that are potentially usable against multiple agents.
Lurie described said the move was prompted by budgetary concerns. “You’d like to have vaccines further along in the pipeline for all the threats we have, and you’d like to have a way to manufacture them quickly,” Lurie said. “But I don’t think there’s anywhere near enough money in the system.”
Robinson, though, said the changing emphasis was motivated by the questionable medical feasibility of vaccines for additional agents. “There are only two biothreats -- smallpox and anthrax -- that we feel vaccination is the appropriate way to go,” the official said.
“I don’t think there’s a case to be made for" vaccines for other bioterror threats, he said. "What we’re doing is therapeutics.”
That position was questioned by Tara O’Toole, who heads the Homeland Security Department's Science and Technology Directorate. “Vaccines are essential. If there’s a bioattack, people are going to want their children vaccinated. It’s the only defense against reload.”
Former Navy Secretary Richard Danzig elaborated on the "reload" idea: “When we talk about terrorists’ acquiring a nuclear weapon, we’re talking about just that -- they’re acquiring a weapon. With biological weapons, we’re talking about acquiring the ability to produce weapons. So if you acquire the ability to produce 100 grams of anthrax, you can keep doing that. You really have to think about biology as potentially the subject of a campaign, where somebody keeps attacking, rather than a one-shot incident.”
“You can reassure people that there will be antibiotics available for them, and you can keep producing ever greater numbers of antibiotics. But you can see that if you had the ability to vaccinate people and protect them, it would provide a larger degree of protection. So to the extent that these things come to pass, I think there will be more pressure to develop vaccines,” Danzig said.
Brett Giroir, a former head of the Defense Sciences Office at the Pentagon's Defense Advanced Research Projects Agency, also endorsed the development of vaccines for a wider range of threats.
“Vaccines are critical components of a biodefense posture, and anybody who thinks they’re not isn’t thinking seriously about how we approach this,” Giroir said. “If we got sprayed with tularemia in College Station [Texas] and a biodefense sensor went off, that would be an ideal opportunity for vaccine.”
Fauci questioned the practicality of the "material-threat" list.
“It’s less of a priority to say, ‘OK, now here’s our menu for the Strategic National Stockpile,’” he said. “We call that the military model.”
“Do we have this little thing in the stockpile or not? I don’t judge the safety of the country on that basis. To me, the idea of a naturally occurring threat is infinitely greater,” he said.
The official described the list as a remnant of Cold War-era planning for a biological strike by the Soviet Union.
“So when the decision was made to make an investment into developing countermeasures,” Fauci said, “that was essentially their matrix from the beginning: these are what we know the Soviets had. We know they have stockpiles. This is what we’re going to protect against.”
“I think the unknown threat of a mutant microbe is infinitely greater than someone coming and dropping a glanders on us,” he said. “I mean, seriously. Get real about that.”
O'Toole said Fauci's remarks were "completely wrong" regarding the list.
“We use current intelligence as an integral part of every material-threat determination,” the official said. “I’m surprised anyone in NIH would think otherwise, particularly since the details of the material-threat determination process are briefed at the White House. It does raise a troubling question about how seriously NIH is engaged in the biodefense mission.”
The absence of one person at the White House who would work solely on biological readiness matters is another concern, according to past and present officials. Currently, four top White House staffers have some level of involvement on the issue while also dealing with other matters, according to the Times (see GSN, Oct. 19).
“The only way that you can get all of those people in the room is to call them into the White House, and to have a coordinating group under a single person,” said Kenneth Bernard, a health security specialist for the Clinton and Bush administrations.
Randall Larsen, chief executive officer of the WMD Center, described a lack of a central coordination as a problem.
“Today, there are more than two dozen Senate-confirmed individuals with some responsibility for biodefense. Not one person has it for a full-time job, and no one is in charge” (Wil Hylton, New York Times, Oct. 26).

Lantana anthrax widow settles $50 million lawsuit against federal government

2011-10-29T08:06:00.001-04:00

From the Palm Beach Post:

... While he is legally prohibited from revealing much of what he learned and many of the court documents are sealed, Weisser said he was stunned by the lack of security at the lab. In court papers, the government conceded that before the attacks, Fort Detrick didn't have cameras to monitor the labs and didn't search workers for pathogens when they were leaving the base...

Attorney Jason Weisser said he couldn't divulge the terms of the settlement until it is formally approved by the U.S. Justice Department...

UPDATE: Judge to hear arguments on unsealing documents in this case.

NBSB urges pre-attack studies of anthrax vaccine in kids/ CIDRAP

2011-10-28T22:11:00.002-04:00

From the NY Times, adapted by the Center for Infectious Disease Research and Policy, U Minnesota:

Oct 28, 2011 (CIDRAP News) – An expert advisory panel today approved a recommendation that the US Department of Health and Human Services (HHS) develop a plan to study the use of anthrax vaccine in children before an attack with Bacillus anthracis.
A National Biodefense Science Board (NBSB) working group presented a draft of its final report to the full board today during a public teleconference. It weighed the pros and cons of gathering safety and immunogenicity data about the anthrax vaccine either before or after an attack.
The NBSB working group advises the federal government on biodefense countermeasure issues.
Before the vote, board members had the opportunity to voice their support or concerns. Ruth Berkelman, MD, director of the Center for Public Health Preparedness and Research at Emory University in Atlanta, said she agreed that data are needed before a bioterror event, but noted that the science arguments collide with ethical issues.
Though she said the working group was sensitive to ethical issues, she proposed that the group's recommendation be forwarded to an appropriate group for additional ethical consideration. The board tweaked its recommendation to include Berkelman's suggestion.
John Grabenstein, RPh, PhD, senior medical director for adult vaccines at Merck, said he has served on ethics review boards for about 20 years. "Kids are recognized as a vulnerable population, and there are special requirements to protect them," he said. "I'd rather know what the response is before the vaccine is offered to many, may kids."
The report's recommendations support the writing of a good protocol that would give parents a lot of information and plenty of time to consider all the aspects of a pre-event study, he added.
In April Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response (ASPR) at HHS, asked the NBSB's anthrax working group to explore complex scientific, ethical, legal, and regulatory issues related to pediatric anthrax vaccination. The group held a public engagement meeting in July, and in September presented the report's executive summary to the full board and fielded comments from the public.
Anthrax vaccine adsorbed (AVA) has been used in about 2.5 million military members, so researchers are more familiar with the vaccine's safety and immunogenicity profiles in adults. Though US bioterror response plans say both adults and children should receive three doses of the vaccine with antibiotic prophylaxis after an anthrax attack, no studies have been conducted in children, which make up about a quarter of the US population.
During the public comment part of the meeting, members of the public strongly opposed the NBSB's recommendation, while others spoke in favor of it. Vera Sharav, with the Alliance for Human Research Protection, told the group that there is no evidence that anthrax is a threat that affects US children, and she accused the board of making the decision to protect vaccine company profit margins.
Meryl Nass, MD, an internist who has studied anthrax vaccine injuries and bioterror issues, said she believes the US public is almost unanimously against pursuing anthrax vaccine studies in children in advance of a bioterror attack. "But the people inside the beltway see things differently," she added.
However, Steve Krug, MD, a pediatrician and emergency physician in Chicago, said he took part in the NBSB's public engagement session in July. "The ethical issues are very pertinent, but I support the recommendations of this working group," he said.
The report and recommendation passed by a 12 to 1 vote. Patricia Quinlisk, MD, MPH, the board's chair, opposed sending the recommendation to HHS. "My background has influenced how I feel. I don't know if a pre-event option is the appropriate response," she said during the comment period before the vote. Quinlisk, a microbiologist and epidemiologist, is medical director for the Iowa Department of Public Health and has served on a host of vaccine safety and bioterror advisory groups.
After the vote, Lurie said she wanted to make sure the public knows that the NBSB is an advisory body and that its recommendations are not binding. She said the issue of studying the anthrax vaccine in children is very complex, and she predicted that dose-sparing studies being conducted in adults will have affect AVA issues related to children.
"We're not ready to make a decision at this time but will continue the dialogue," Lurie said.

Other stories about this can be at the Washington Post, Science and Fox.

Current Vaccine Safety Concerns: Preflucel

2011-10-27T22:47:00.003-04:00

From the Scottish Press and Journal:

Don't panic, says Scottish government probe launched into drug batch

Flu vaccine doses recalled in scare over side effects

The Scottish Government is recalling thousands of flu vaccines over fears that the drug is making some people ill, the Press and Journal can reveal.

About 300,000 doses of Preflucel are being withdrawn immediately from surgeries and pharmacies across the UK and Europe.
Health chiefs have warned that one of the most recent batches, issued at the beginning of September, is causing more side-effects – muscle pain, headaches and fatigue – than previous vaccines.
They have been recalled while its manufacturer and the Medicines and Healthcare Products Regulatory Agency investigates what has gone wrong.
Doctors and nurses in Scotland – where 2,500 vaccines have been recalled – have been told not to use any Preflucel until further notice.

How critical is it to test drugs and vaccines in kids before giving them to kids?

2011-10-27T22:15:00.000-04:00

According to the FDA:

As of 2008, an estimated 50 to 60 percent of prescription drugs used to treat children have been studied in some part of the pediatric population. Still, the likelihood that a medicine has actually been studied in neonates—children less than a month old—is close to zero.
So nearly a decade into the 21st Century, most medicines intended for children, including many over-the-counter (OTC) products, haven’t been clinically studied in children—and certainly not in all age populations that comprise the branch of medicine known as “pediatrics.”

In other words, we "guesstimate" pediatric doses most of the time. Guesstimating an anthrax vaccine dose, particularly since we have tested the vaccine in many small monkeys, would not be a stretch from standard pediatric practice.

1-2% of those receiving anthrax vaccine have had serious adverse events: Milvax and Vaccine Healthcare Centers

2011-10-26T22:51:00.000-04:00

Possible study of anthrax vaccine’s effectiveness in children stirs debate/WaPo

2011-10-25T22:09:00.004-04:00

The people on the NBSB could only come up with a recommendation to test anthrax vaccine on children if they were ignorant about the vaccine and/or the law's requirements for testing children under 45 CFR 46.407. I will have much more to say about this unfolding story over the next few days. Here is Rob Stein's comprehensive WaPo piece, with my comments in italics:

The Obama administration is wrestling with the thorny question of whether scientists should inject healthy children with the anthrax vaccine to see whether the shots would safely protect them against a bioterrorism attack.

The other option is to wait until an attack happens and then try to gather data from children whose parents agree to inoculate them in the face of an actual threat. [Every child exposed in 2001 got antibiotics and survived. The CDC designed a child consent form in 2001, offering the vaccine to children and hoping for takers, but parents were too smart to volunteer their children when there was an actual event and a safer alternative.--Nass]

A key working group of federal advisers in September endorsed testing, sparking objections from those who consider that step unethical, unnecessary and dangerous. The National Biodefense Science Board (NBSB), which advises the federal government, is to meet Friday to vote on its working group’s recommendation.

“At the end of the day, do we want to wait for an attack and give it to millions and millions of children and collect data at that time?” said Daniel B. Fagbuyiof Children’s National Medical Center in Washington, who chaired the group. “Or do we want to say: ‘How do we best protect our children?’ We can take care of Grandma and Grandpa, Uncle and Auntie. But right now, we have nothing for the children.” [The vaccine has not been approved for those over 65, so Gramps cannot legally obtain the vaccine. Why does this working group co-chair not know this? And why not test in those over 65 before subjecting children who cannot provide informed consent, to a vaccine that could leave them with a permanent injury?--Nass]

The vaccine has been tested extensively in adults and has been administered to more than 2.6 million people in the military. But the shots have never been tested on or given to children, leaving it uncertain how well the vaccine works in younger people and at what dose, and whether it is safe. Unlike with measles, mumps and other diseases, the chance that children will be exposed to anthrax is theoretical, making the risk-benefit calculus of testing a vaccine on them much more questionable.

“It’s hard to believe that it’s something that makes a great deal of sense,” said Joel Frader, a pediatrician and bioethicist at Northwestern University’s Feinberg School of Medicine. “It would be difficult to justify testing it on kids simply on the hypothetical possibility that there might be an attack.”

Anthrax is a life-threatening infection caused by a toxin-producing bacteria long considered a bioterrorist’s likely choice because it is relatively easy to produce and distribute over a large area. A week after the Sept. 11, 2001, attacks, letters containing anthrax spores arrived at several media offices and two Senate offices, killing five people and sickening 17 others. The FBI eventually concluded that the letters were mailed by Bruce Ivins, a disgruntled scientist at Fort Detrick in Maryland who committed suicide in 2008, although some experts question the FBI’s findings.

As part of broad effort to better protect Americans against bioterrorism, the Pentagon began a controversial military anthrax immunization program in 1998 that was challenged in court over questions about the vaccine’s safety and reliability. Currently, the Pentagon requires the shots for personnel assigned to bioterrorism defense activities and some other special units, as well as those deployed 15 or more days in the Middle East and some nearby countries, and in South Korea.

The federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack. Antibiotics would help protect those immediately exposed. The vaccine would defend against lingering spores, which is how the pathogen lurks in a dormant state. The vaccine is made from a piece of a strain of anthrax that doesn’t cause the illness. [The government spent an additional $1.25 billion for extra anthrax vaccine to protect civilians on October 3, 2011. Anthrax vaccine expires in 3 years, and requires yearly boosters after an initial 5 doses, guaranteeing a captive market for the foreseeable future. Did I mention the vaccine's 300% markup?--Nass]

In April, Nicole Lurie, the assistant secretary in charge of bioterrorism at the Department of Health and Human Services, asked the 13-member biodefense board to evaluate whether the vaccine should be tested in children. A federal simulation of an anthrax attack on San Francisco, called Dark Zephyr, raised quesions about how to handle children.
“If there were an anthrax release and we needed to administer anthrax vaccine, we have no experience with kids. It’s never been in the arm of a kid,” Lurie said. “I started asking myself, ‘Is this the right way to respond in an emergency?’ ” [The more germane question is whether anthrax vaccine provides a high degree of protection in humans. We don't have the answer for adults yet, and this trial won't tell us if it works in children. Studies have repeatedly shown that antibody levels (in many animal species) generated by this vaccine fail to predict survival. Since this trial can only measure antibody levels, it will be unable to predict survival. Therefore, it cannot generate useful information on dosing in children.--Nass]

Those concerns were heightened by the public wariness that had been shown toward the H1N1 influenza pandemic vaccine. “There is a lot of skepticism on the part of the public about vaccines in general,” Lurie said. “If you had a situation where a vaccine has never been given to a child, it’s pretty hard to think what you could say to people about its safety and efficacy.” [Funny, the CDC knew what to say back in 2001--Nass]

But testing drugs and vaccines in children is problematic. Parents generally are allowed to let their children participate in studies only if they would face minimal risk or would be likely to benefit directly or indirectly in some way.

“With this, you’re putting children at risk for no clear scientific or medical benefit,” said Meryl Nass, a doctor in Bangor, Maine, who is one of the most outspoken critics of testing the vaccine in children. Nass and others maintain that there are serious questions about the vaccine’s effectiveness in adults as well as concerns about sometimes serious complications among those vaccinated in the military. A variety of complications have been reported, including nervous system and autoimmune disorders, Nass said.

“Really, the core question is ‘Why? Why test?’,” said Bruce Lesley, president of First Focus, a Washington-based advocacy group for children. “We don’t want to be subjecting kids to risks needlessly.”

Some question the value of a study, saying that testing in animals indicates it will be difficult to determine what level of immune system response will be protective.
“What exactly are we going to learn?” said Vicky L. Debold, an associate professor of health administration and policy at George Mason University. “We’ll know what antibody levels these infants produce, but do we know those antibodies are going to protect against death due to anthrax exposure?” [Excellent point, since antibody levels are a poor surrogate for survival--Nass]

UPDATE: Professor Les Baillie, who directed anthrax research at Porton Down, UK and also worked on biodefense for the US Navy, made exactly the same point in the November 2 New Scientist: "The proposal is to vaccinate children and measure their immune response, but no one knows what level of immunity will protect humans against infection. "What will these tests show?" Baillie asks." This is the real question: what could the trial actually glean of scientific value? The answer is: nothing. A child trial, without exposing children to anthrax, is only a cynical marketing ploy and nothing more.

Back to the Rob Stern WaPo article:

After sifting through the scientific, social and ethical conundrums raised by this question, the eight-member working group concluded that it would be ethically justifiable to conduct a study, which would provide crucial information, such as whether the vaccine is safe and how many doses would be needed. “A lot of things have happened that we didn’t think could happen. I think the threat is real, and we should be prepared,” said Fagbuyi, an assistant professor of pediatrics and emergency medicine at the George Washington University School of Medicine. Fagbuyi and others dispute concerns about the vaccine’s safety, noting that the Food and Drug Administration, the National Academy of Sciences and many other independent authorities have concluded that it is as safe as other commonly used vaccines, producing serious complications very rarely. [This is not actually true. What happened was that the IOM committee studying anthrax vaccine in 2001 requested a report that made this claim, but there have been NO clinical trials that looked at anthrax vaccine adverse events and compared them to those of other vaccines. No other licensed vaccines have a 1-2% serious adverse event rate (See slide 3 of this military powerpoint presentation).--Nass]

“Our role is to protect children,” said John S. Bradleyof the University of California at San Diego, who advised the working group on behalf of the American Academy of Pediatrics. “If the military is telling us there is a credible threat, the best way to protect children is to have the data.” [A 2010 article of Dr. Bradley's indicates:
Potential conflicts of interest. J.S.B.'s employer has received research grants from Johnson & Johnson and Wyeth Pharmaceuticals and holds consultant contracts with Johnson & Johnson, Wyeth Pharmaceuticals, and Bayer Pharmaceuticals.
Supplement sponsorship. This article was published as part of a supplement entitled “Workshop on Issues in the Design of Clinical Trials for Antibacterial Drugs for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia,” sponsored by the US Food and Drug Administration, Infectious Diseases Society of America, American College of Chest Physicians, American Thoracic Society, and the Society of Critical Care Medicine, with financial support from the Pharmaceutical Research and Manufacturers of America, AstraZeneca Pharmaceuticals, and Forest Pharmaceuticals.--Nass]

If the board endorses the recommendation, Lurie will meet with counterparts at the FDA, the National Institutes of Health and other agencies to work out the details, including how many children would be studied, at what ages and doses, and how costs would be covered.
“Because it’s such a heated issue, I’ve tried hard to keep an arm’s length until the board makes a recommendation to me,” Lurie said. “To be honest, the safest and easiest thing to do would be to not make a decision and kick the can down the road. But it seemed to me it that would be socially irresponsible. [By seeing whose children become subjects in this trial, we will see how socially responsible it is.--Nass] I would hate for a lot of children to die because we didn’t have enough information for the public to feel comfortable getting vaccine.”

A UPI story on this subject is here.

With security spotty, many had access to anthrax at Army lab/McClatchy, ProPublica

2011-10-24T13:25:00.000-04:00

Greg Gordon and Stephen Engelberg continue their important series of reports for McClatchy and ProPublica, here focusing on the inadequate security at USAMRIID and potentially wide access to Ivins' anthrax spores by 419 or more people:

The Army laboratory identified by prosecutors as the source of the anthrax that killed five people in the fall of 2001 was rife with such security gaps that the deadly spores could have easily been smuggled out of the facility, outside investigators found.
The existing security procedures - described in two long-secret reports - were so lax they would have allowed any researcher, aide or temporary worker to walk out of the Army bio-weapons lab at Fort Detrick, Md., with a few drops of anthrax - starter germs that could grow the trillions of spores used to fill anthrax-laced letters sent to Congress and the media.
The two reports, which have not been made public for more than nine years, describe a haphazard system in which personnel lists included dozens of former employees, where new hires were allowed to work with deadly germs before background checks were done and where stocks of anthrax and other pathogens weren't adequately controlled.
Fort Detrick since has adopted new bio-security measures. But the security reports by independent government specialists suggest that deadly anthrax stocks may have been more accessible than investigators assumed in declaring Army scientist Bruce Ivins the perpetrator.
The letters, mailed to two U.S. senators and at least three media outlets, panicked the nation in the immediate aftermath of the 9/11 terrorist attacks. The Justice Department says the letter spores derived from a flask controlled by Ivins at Fort Detrick.
Marked "for official use only," the two reports were completed in 2002. One was conducted by a seven-member team from Sandia National Laboratories in Albuquerque, N.M. The other was by auditors for the Army's inspector general's office.
The teams evaluated security at the U.S. Army Medical Research Institute of Infectious Diseases, or USAMRIID, then the lead federal lab for developing vaccines and other medical defenses against biological weapons.
McClatchy Newspapers, the online investigative newsroom ProPublica and PBS's "Frontline," which have collaborated in an examination of the Justice Department's case against Ivins, obtained copies of both reports.
The reports are expected to be made public later this week in a $50 million lawsuit filed in federal court in West Palm Beach, Fla., by family members of Robert Stevens, a photo editor for American Media Inc., who was the first person to die from the anthrax attacks.
"It's about time," said Richard Schuler, a lawyer for the family. "The public should know about the way security for deadly pathogens was being handled - or mishandled - by the Department of the Army and the government in the period leading up to the 2001 anthrax attacks."
A psychological report on Ivins, who committed suicide in July 2008, said Ivins had "diagnosable mental illness" when he was hired in 1980, and that his mental health should have disqualified him from obtaining a "secret-level" security clearance.
Ivins died of an overdose soon after learning that prosecutors were seeking approval to charge him with five counts of murder. The FBI case was largely circumstantial, although prosecutors say their most direct evidence was the genetic link between anthrax in the letter powder and spores in Ivins' flask of liquid anthrax.

Before posthumously declaring Ivins the killer, the Justice Department said, the FBI eliminated as suspects as many as 419 people. Those individuals would have had access to Ivins' flask, which was stored in an airtight "hot suite" at Fort Detrick, or to spores he had shared with colleagues or outside researchers, including scientists at the Battelle Memorial Institute in West Jefferson, Ohio.
The Sandia report emphasized that terrorists had obtained germs from research labs before. It cited a February 2001 National Defense University study that found 11 cases in which terrorists or other "non-state operatives" had acquired biological agents from "legitimate culture collections," including three research or medical laboratories.
Despite USAMRIID's sobering mission, the Sandia report said, the western Maryland lab had developed a work environment in which employees failed to make the same "indisputable commitment to security" as they did to research.
"The current biosecurity system at USAMRIID does not adequately protect HCPTs (high-consequence pathogens and toxins) and related information," wrote the Sandia team, headed by security expert Reynolds Salerno.
The report said no rules governed movement of germ specimens from one building to another, for example, and that a test tube containing some of Ivins' spores was left for weeks in a refrigerator in a second building.
Fort Detrick's personnel database failed to list 213 of USAMRIID's employees but did include 80 who had left their jobs, the Sandia report said. A separate human resources roster listed 56 people who had left but not 12 who worked there.
Conflicting rosters didn't necessarily signal a security weakness, the Sandia team wrote, but they contributed to "perceived chaos in the personnel system" at the facility.
Even if all those things had been perfect, the examiners said, there was little way to detect diversions from flasks of germs, because a "malevolent" worker could grow more of the pathogen or find other ways to conceal the removal of a small amount.

Asked about the studies, a Justice Department spokesman said in a prepared statement that the FBI looked at everyone who had card-key access to the "hot suites," including researchers with up-to-date vaccinations, then thoroughly investigated "all individuals with theoretical access" to Ivins' spores in advance of the mailings.
The Army auditors, who studied security throughout Fort Detrick, not just at USAMRIID, made clear that pathogens in the bio-weapons facility were "not afforded a standard, minimum level of protection" similar to that for nuclear and chemical weapons.
Although a 22-year-old Army regulation governing the management of hazardous biological substances was in effect in 2001, the Army auditors wrote, two of the three labs at Fort Detrick weren't aware of it and the other ignored it as outdated.
The Army report also said that contractor labs, such as Battelle, had limited regulation and no screening of individuals working with anthrax and other pathogens, creating "the potential for unauthorized access to these materials."

USAMRIID has long since committed to a major overhaul of its security system and adopted a comprehensive Army "biosurety program" in 2003 that included closer tracking of inventories of various germs.
Employees with access to the "hot suites," which are designed to contain anthrax and other pathogens during experiments, must now submit to regular medical, mental health and behavior screening, including monitoring of their use of prescription drugs.
"The safety of the USAMRIID staff and the security of the biological agents on which it works," spokeswoman Caree Vander-Linden said, "have always been top priority, even before the events of 2001."
(McClatchy collaborated with the investigative newsroom ProPublica and PBS's "Frontline" on its inquiry into the FBI's case against the anthrax killer. Gordon works for McClatchy. Engelberg works for ProPublica.)

Vaccine Safety in the News

2011-10-23T22:14:00.001-04:00

From the Irish Herald:

We need a jab inquiry

The link between the Pandemrix swine flu vaccination and narcolepsy in at least 16 children has to be scrutinised.
Manufacturers GlaxoSmithKline were indemnified by the State from any liability for side effects as the vaccine was rushed through. We need a full explanation from the Irish Medicines Board about how this vaccine was researched and tested.

From The Australian:

CSL slow to reveal flu jab reactions

AUSTRALIA'S drug regulator will demand an explanation from drug-maker CSL after it emerged the company knew two years ago about research suggesting a sharp rise in fevers linked to its seasonal flu vaccine, but omitted this from information given to doctors.

As health authorities noticed a number of serious reactions to the vaccine early last year, the legally required product information sheets continued to rely on figures from 2005. These showed 22.5 per cent of children under three experienced a fever afterwards, dropping to 15.6 per cent among three- to nine-year-olds.

The same study that produced the 2005 figures contained updated figures for 2006 that showed the rate of fever had nearly doubled, to 39.5 per cent for children aged six months to three years and to 27 per cent for older children.

Both sets of results were published in 2009, but CSL has still not included the more alarming set of figures in the product information...

From The Australian:

Dark Specks in Flu Vaccine 'No Risk'

DARK specks floating in vials of swine flu vaccine posed no safety hazard, CSL has concluded after an investigation sought by the US Food and Drug Administration.
CSL was aware a month before it launched its pandemic vaccine in Australia in September 2009 that "foreign particles" had been found in samples for the US market, the FDA reveals in its 2010 audit of CSL's Melbourne laboratory. [The most interesting thing about this short articles is that it fails to tell us what those nasty particles are, exactly. Stopper material? Aluminum? Mercury? Fungi? How does the consumer know these particulates are safe when injected into our bodies?--Nass]

New adjuvants on horizon for influenza vaccines/ IDSA Annual Mtg

2011-10-23T21:53:00.001-04:00

From the Infectious Diseases Society of America annual meeting comes this [WHO] discussion of how novel adjuvants affect the immune response, and how we can expect to see more of these adjuvants added to vaccines in the US:

... Martin Friede, PhD, who heads the Technology Transfer Team within the Department on Innovation, Information, Evidence and Research at the World Health Organization in Geneva, Switzerland, spoke about influenza vaccine adjuvants.
Adjuvants are added to vaccines to improve the immune response. They are known to increase antibody titers; reduce antigen dose (dose sparing for a pandemic); reduce the number of doses needed because they provide more rapid protection; enable immunization in patients with weakened immune systems; provide appropriate bias; and induce cell-mediated immunity, according to Friede.
“They are a critical enabling component for subunit/recombinant vaccines,” he said.
Adjuvants currently approved for global use include aluminum (alum); MF59 (squalene emulsion); AS03 (squalene/tocopherol emulsion); AF3 (squalene emulsion; Virosomes (liposomes)); and polyoxidonium (poly-electrolyte))...

Friede said alum adjuvants are widely used in pediatric vaccines — including DTP, Hepatitis B virus and pneumococcal vaccines — because they enhance titers and they have a long record of safety.
The drawback with alum adjuvants is that they are not really suitable for yearly administration because the adjuvant effect is dependent on many factors, according to Friede. He added that there are challenges that are specific for influenza, including that the antigens are variable and that the benefit for influenza vaccines is not convincing.
“Each year, the influenza antigen with aluminum changes and it is very different to make it consistent,” Friede said.
Despite its limitations, there are several influenza vaccines with alum — whole killed virion vaccines and split vaccines — that are approved for use around the world but not in the United States, according to Friede.
Oil-in-water emulsions are simply droplets of oil in water (~100 nm), the most common of which are squalene & tocopherol and tween & lecithin.
The MF59 adjuvant (Novartis) is made from squalene in water with Tween + Span and has been used in influenza vaccines in European countries since 1996. The push toward development of the MF59 adjuvant began with the last emergence of H5N1 because it required an enormously large dose of antigens needed to get an immune response.
“However, the moment you add oil and water, the immune results were enhanced enormously,” Friede said.
In 2009, when MF59 was incorporated into the 2009 H1N1 pandemic vaccine, it increased global vaccine production capacity to more than 200 million doses distributed for all ages.
The caveat is that there is an increase in local reactogenicity, according to Friede. (And what about systemic reactogenicity?--Nass)
“You cannot have an omelet without breaking the eggs,” Friede said. “The influenza vaccine with this adjuvant often results in some local site reactions and some redness, but it’s nothing serious...”

“I would say to stay tuned because you may have an influenza vaccine with this adjuvant available in your country soon,” Fried said.

Anthrax Whodunit/ Frederick News Post

2011-10-22T08:10:00.000-04:00

Barry Kissin's Opinion piece at the Frederick News-Post

Back on Aug. 29, 2008, The FNP published a column by Katherine Heerbrandt titled "If not Ivins ..." Heerbrandt began with the viewpoint of Norm Covert, a well-known former Fort Detrick public affairs officer: "The anthrax in the mailings, he says, was 'highly bred, weapons-grade ... with a silica coating and a slight electrical charge so that each particle repelled the other ... each particle no more than five microns.' Ivins had neither the expertise nor the equipment to create such a sophisticated form of anthrax ..."

Heerbrandt continued: "Since Nixon terminated the offensive weapons program at Detrick in 1969, there has been only one corporation in our country that operates laboratories where anthrax is weaponized: Battelle Memorial Laboratories, the corporation that does the bio-lab work for the [intelligence agencies] ...
"How do Americans even begin to confront the reality that the only bio-attack in our history came from an American military/intelligence lab?"
On Oct. 10, The New York Times ran a front-page story that contained the following statement: "If Dr. Ivins did not make the powder, one conceivable source might be classified government research on anthrax, carried out for years by the military and the Central Intelligence Agency." Looks like The New York Times is catching up to The Frederick News-Post.
An unavoidably critical piece of evidence has come to light. Scientists have discovered in among the 9,600 pages of documents provided by the FBI to the National Academy of Sciences in 2009 a chart revealing substantial levels of silicon and tin in the attack anthrax as measured in an FBI lab. These levels establish the presence in the attack anthrax of a very advanced weaponizing technology.
The best-selling book "Germs," published in 2002, exposed the existence of up-until-then secret anthrax weaponization projects being managed and operated by Battelle for the CIA and the Defense Intelligence Agency. The very advanced technology that went into the attack anthrax must have been developed in one of those projects.
But specifically whodunit? Mainstream authorities are realizing what Heerbrandt wrote about three years ago. Alice P. Gast, president of Lehigh University and the chairwoman of the National Academy of Sciences panel that reviewed the FBI's science in Amerithrax, was cited by The New York Times thusly: "Dr. Gast, the head of the NAS panel, noted that her group strongly recommended that future investigations of the attacks examine the government's classified work on anthrax."
Future investigations? According to a recent McClatchy Newspapers report, senior Republican Sen. Charles Grassley who has "been skeptical of the case against [Ivins] said adamant opposition from the FBI and Justice Department is likely to block further inquiry into the case."
The FBI and Justice Department have been caught not only peddling a bogus case against Ivins, but also covering up evidence of the anthrax letters' connections to "the government's classified work on anthrax." And all it's going to take to block further inquiry is their "adamant opposition"?
Grassley, certainly no rabble-rouser, also just said, "it would take a powerful grass-roots movement ... to reopen the ... investigation." Frederick is the most natural site for the birth of such a movement.

barrykissin@gmail.com

New questions about FBI anthrax inquiry deserve scrutiny/ Washington Post Editorial

2011-10-22T00:46:00.000-04:00

The Washington Post calls for Congress to perform a definitive investigation of the anthrax letters attacks, adding to the impact of the NY Times' editorial asking for the same 3 days earlier:

BRUCE E. IVINS has been dead for three years, but questions still abound about whether he carried out the 2001 anthrax attacks that killed five people and seriously sickened 17 others.

The FBI compiled what appeared to be an overwhelming case against the former microbiologist at Maryland’s Fort Detrick. In the weeks before anthrax-laced letters were mailed, FBI affidavits claimed, Mr. Ivins stayed late nights and weekends at the Army lab that allowed him to work undetected while cultivating the deadly spores. And the FBI provided a possible motive: An anthrax vaccine program Mr. Ivins was working on had run into trouble; an attack could give the project a boost.

But the coup de grace, according to the bureau, was provided by a cutting-edge genetic test of the anthrax spores that linked Mr. Ivins to the attack. Mr. Ivins took his own life in 2008 just as the Justice Department was preparing to charge him.

This scientific evidence came under fire in February when the National Academy of Sciences, which was commissioned by the FBI to review the case, reported that the bureau had not performed enough tests or been precise enough to conclude definitively that Mr. Ivins was the lone culprit.

Now three independent scientists have teamed up to publish a paper in the Journal of Bioterrorism and Biodefense that points to other alleged failings in the FBI’s testing procedures. Also this month, a joint investigation by PBS’s “Frontline” newsmagazine, the ProPublica online newsroom and McClatchy Newspapers raised additional questions about the accuracy of the FBI investigation. For example, the journalists revealed that Mr. Ivins handed over to investigators lab flasks that contained telltale markers found in the anthrax used in the attacks. This revelation appears to contradict FBI assertions that Mr. Ivins withheld or manipulated evidence.

Doubts about the investigation were bound to linger since Mr. Ivins killed himself before he could be tried. But the uncertainty is unacceptable. Congress should convene a panel of independent law enforcement specialists and scientists to pore over the evidence collected in the course of the FBI investigation — including classified information that was withheld from the NAS panel. Such an inquiry should attempt to get to the bottom of the 2001 attacks and assess the nation’s ability to prevent a similar attack.

Anthrax countermeasures better than in 2001, but work remains/ CIDRAP

2011-10-19T02:36:00.005-04:00

What does $60 billion buy in terms of enhanced security? From CIDRAP we get a detailed look at what our government's bioterrorism establishment has been shopping for:

If someone tried to kill Americans with Bacillus anthracis spores today, the nation would have a better medical tool chest for treating the sick and those potentially exposed than it had 10 years ago, when the anthrax letter attacks killed five people, but anthrax defenses are still a work in progress.

In the event of an anthrax attack, federal response plans call for treating those at risk with a 60-day regimen of antibiotics, and also for offering three doses of anthrax vaccine for longer-term protection against the risk of late-germinating B anthracis spores.

The government has enough doses of antibiotics in its civilian stockpile to treat 60 million people for the recommended 60 days... US Department of Health and Human Services (HHS) officials won't disclose the amounts of materials in the Strategic National Stockpile (SNS), citing national security concerns.

The SNS also contains enough doses of anthrax vaccine—the same one that was in use in 2001—to protect a few million people... Meanwhile, several companies are working on second-generation vaccines with the aim of providing protection with fewer doses at less cost, but their availability is still several years away.

The government also has something it didn't have 10 years ago: a supply of antitoxins—anthrax immune globulin (Cangene's AIG, serum extracted from vaccinated servicmembers, at $14,000/dose) and other antibody products (Human Genome Science's monoclonal antibody, at $8,000/dose)—that could be used to treat people with anthrax infections potentially too far advanced for successful antibiotic therapy. None of these have yet been approved by the Food and Drug Administration (FDA), but they can be used under emergency authorizations if needed, federal officials say. One of them was used in a man who was treated in Minnesota for inhalational anthrax in August....

Great. So we are "ready" for anthrax. Except, if we are well prepared for anthrax, any serious enemy would pick some other microorganism. Smallpox, anyone? Plague? Tularemia? Ebola? How about a newly synthesized bug?

If the US government really wanted to protect us, instead of wasting our childrens' tax dollars on pet pork, it would not have walked out of negotiations to strengthen the Biological Weapons Convention . It would have cooperated with nearly the entire world to enact provisions in this treaty for verification of compliance, including inspections and sanctions. But this logical and relatively cheap approach to reducing the threat from state actors has been unpopular in US government circles.

OTOH, can we afford to keep spending $60 billion every few years for a piecemeal, very limited response to the BW threat? Our current approach offers no meaningful protection against an apparition that, given the technology, can take millions of forms.

Who Mailed the Anthrax Letters?/ NY Times Editorial

2011-10-18T19:29:00.005-04:00

Today's NY Times wants to know if the FBI's evidence -- linking Bruce Ivins to the anthrax letters -- really holds up. Frontline/ProPublica/McClatchy last week informed us, after reviewing thousands of FBI documents obtained through FOIA, that the FBI misled us. Ivins' late-night hours at the lab in September-October 2001 were not really that different from usual. Furthermore, Ivins had submitted additional anthrax samples to the FBI, undercutting the FBI claim he failed to cooperate with a sample request in order to hide his involvement in the case.

An article by Martin Hugh-Jones et al. points out that there was too much silicon and tin in the second batch of anthrax to be a contaminant. Instead it suggested special processing. Anthrax with these additives was never found in the labs at Fort Detrick, where Ivins worked. Had the anthrax been grown there, some of these contaminants would have been left behind, and would have been discovered by environmental sampling. Failing to find them exonerates Ivins, and Fort Detrick, from involvement in preparing the letter spores.

The National Academies panel found the FBI failed to demonstrate Ivins was the perpetrator, and also found that the letters' anthrax was not necessarily grown from Ivins' seed spores. Ivins' RMR1029 spore preparation had been shared with other labs, and any of those labs (wittingly or unwittingly) might have supplied the seed spores for the letters. If the FBI misled the public on the "morphotypes" it found in the many anthrax samples tested, the seed spores could have come from other, additional sources.

There was a strong sense of relief when the federal government concluded that a lone psychologically troubled government scientist mailed anthrax-laced letters in 2001, killing five people and terrorizing the nation. Now its evidence is looking increasingly shaky.

Dr. Bruce Ivins, an Army biodefense expert at Fort Detrick in Maryland, committed suicide in 2008 before the case against him could be tested in court. Independent inquiries this year have raised questions both about the genetic analyses that traced the anthrax to Dr. Ivins’s laboratory and a web of circumstantial evidence. There needs to be a new independent evaluation of the findings.

The government’s scientific case has been weakening for months. In February, the National Academy of Sciences warned that the genetic analysis “did not definitively demonstrate” that the mailed anthrax was derived from spores grown in Dr. Ivins’s laboratory. Last week, The Times reported that one of the leading anthrax authorities and two colleagues believe that distinctive chemicals in the mailed anthrax suggest it was produced by sophisticated manufacturing, which the scientists deemed far beyond Dr. Ivins’s capabilities. Although some experts think the chemicals might be meaningless contaminants, the chief of the academy panel and the leader of a pending Government Accountability Office review think the group’s assertions in a future paper need to be addressed.

As for the circumstantial evidence, an investigation by PBS Frontline, assisted by ProPublica and the McClatchy newspapers, cast doubt on two elements that prosecutors had declared important. A contention that Dr. Ivins worked extraordinarily long hours alone at night in his laboratory just before the mailings looked less suspicious after the journalists found that he regularly worked late hours in other labs and offices. And a contention that Dr. Ivins tried to mislead investigators by submitting an anthrax sample free of genetic markers looked questionable after the journalists found that he had submitted other samples that contained the markers.

Federal investigators insist that there is a vast amount of evidence supporting their conclusion of Dr. Ivins’s guilt. The Government Accountability Office needs to dig deeply into classified materials to judge how well the evidence holds up. Otherwise, Congress ought to commission an independent assessment to be sure there are no culprits still at large.

Previous NY Times editorials here and here got down in the weeds, pointing out big problems with the FBI's case. The Times editorial brings to mind the critical role the anthrax letters played in recent American history:

building the case for war in Iraq, despite Saddam Hussein being an enemy of al Qaeda
helping pass the Patriotic Act
helping to justify a national security state
justifying 60 billion federal dollars for bioterrorism readiness since 2001, much of which has been wasted (and here is one recent example)
relicensing the anthrax vaccine manufacturer, renewing the military anthrax vaccine program, and leading to the purchase of over 2 billion dollars' worth of anthrax vaccine

This is why their true perpetrator(s) needs to be identified and held accountable.

First, airplanes were used as missiles. The public stopped flying. Then, anthrax-laden letters, which announced what they contained and how to protect against it ("Take penacilin now") sowed fear of contagion through the mail.

That did it. The United States changed course. There were a few big winners, but most of us became losers. We have to find out why.

Despite evidence of FBI bungling, new probe into anthrax killings unlikely/ ProPublica

2011-10-16T08:59:00.000-04:00

From Pro Publica:

A senior Republican senator says it would take a powerful grassroots movement or startling new evidence to reopen the Justice Department's investigation that branded a now-deceased Army researcher as the anthrax mailer who killed five people a decade ago.

Iowa Sen. Charles Grassley, the ranking Republican on the Senate Judiciary Committee, and others on Capitol Hill who've been skeptical of the case against the late Bruce Ivins said adamant opposition from the FBI and Justice Department is likely to block further inquiry into the case.

Even if he were the committee chairman, Grassley said, "I would question my capability of raising enough heat (to reopen the case) when you're up against the FBI. And I've been up against the FBI."...

Rep. Rush Holt, D-N.J., who has criticized the FBI investigation as "botched" and from whose district the deadly letters were mailed, said he may try for a third time to win support for legislation creating a special commission to investigate the attacks.

"There are so many reasons to want to get to the bottom of it," Holt said in an interview. "I hate to think of what lines of investigation have been shut off. "Nearly all of the evidence was circumstantial, however, and PBS' Frontline, McClatchy and ProPublica, in a one-hour documentary and a three-part newspaper series, disclosed evidence challenging prosecutors' assertions...

Among the evidence the three news organizations scrutinized:

FBI claims that Ivins worked unusually late hours in a "hot suite," a secure bio-containment lab at Ft. Detrick, in the weeks before the letter attacks. Records show that Ivins had worked similar evening hours in other USAMRIID facilities in the preceding months.
Assertions that Ivins tried to mislead investigators in April 2002, by manipulating anthrax samples from a laboratory flask he submitted for FBI testing. At issue was whether Ivins was trying to keep investigators from discovering that spores in the flask contained the same genetic variants as those in the anthrax contained in the letters. But while the April samples tested negative for the variants, Ivins gave three other samples to the FBI or fellow researchers between 2002 and 2004 and, ultimately, the bureau recorded positive results in tests of all three, FBI and Army records show.
Claims that Ivins was motivated to create fear about anthrax because the government's anthrax vaccine program was under heavy fire. The existing program was under fire, and Ivins helped to address problems, but his job was to develop a second generation vaccine that at the time had full funding.
Assertions that science showed that Ivins' flask was "effectively the murder weapon." A panel of the National Academy of Sciences and two scientists who worked on the FBI investigation described holes in that and other laboratory conclusions...
Holt and Rep. Roscoe Bartlett, R-Md., whose district includes Ft. Detrick, tried to push through an amendment to a spending bill last year requiring the inspector general for the intelligence community to investigate whether all relevant foreign intelligence had been passed to FBI investigators. The measure was torpedoed when the Office of Management and Budget objected, calling it "duplicative" and expressing concern about Congress directing an inspector general "to replicate a criminal investigation."
Last May, McClatchy disclosed that the FBI had never explained tests showing the presence of unusually high levels of silicon and tin in the letters sent to the New York Post and to Democratic Sen. Patrick Leahy of Vermont. That renewed suspicions -- denied by the FBI -- that the perpetrator used a chemical additive to keep the spores from clumping so they'd be more easily inhaled.
Another issue is the FBI's method for collecting anthrax samples from U.S. and foreign labs to narrow the suspect list. Because the samples were subpoenaed and couldn't be seized for multiple reasons, critics have said their submission amounted to an honor system in which the killer would have no incentive to participate.
Further, a still-confidential 2002 review of security at USAMRIID by a seven-member team from the Sandia National Laboratories found that "the culture at USAMRIID does not reflect the same indisputable commitment to security as it does to research."
The "diversion of small quantities" of deadly pathogens can be significant, noted the report, a copy of which was obtained by McClatchy, ProPublica and Frontline. That's presumably because they can be used as seed material to grow large quantities of germs for an attack. The problem is heightened, it said, because germs "cannot be reliably detected," underscoring the importance of an alert and cooperative research staff.

Science in anthrax letter case comes under attack/ Sacramento Bee

2011-10-15T23:31:00.000-04:00

David Willman continues to write stories designed to sell his book on Bruce Ivins, and buttress the FBI 's Ivins theory. I thought journalists were required to at least make a stab at even-handedness, but this once-great journalist didn't bother.

Here's an example: Willman mentions, then tries to discredit, the paper of Hugh-Jones, Rosenberg and Jacobsen by saying they paid to have it published in an online journal. Yet today, this is considered the best way for scientists to get their work out to the public in a timely manner, by publishing in PLOS (Public Library of Science) or a similar group of journals. You pay a small fee to cover secretarial/peer review costs, and in return you get immediate publication after acceptance, and free online availability of the journal for all readers. Universities generally cover this cost. Paying the cost does not mean the authors have bought their way in: peer review can be even stricter with the online journals than with for-profit journals. Willman has covered scientific issues for many years, and must have known this.

If you want to read his piece, it is here.

Useless, Expensive Anthrax Vaccine Has Everyone On Board/ The Vaccine Xchange

2011-10-13T07:08:00.001-04:00

From the vaccinexchange website, on October 12, 2011 · Leave a Comment

It seems that Emergent BioSolutions, the only manufacturer of the anthrax vaccine in America, has been working aggressively to promote its vaccine throughout our nation. Its efforts have paid off: according to MarketWatch.com, the company has been awarded a $1.25 billion contract to supply the U.S. government with 44.75 million doses of the anthrax vaccine over a five year period.
The government has invested in this vaccine despite the fact that there are numerous problems with the drug itself. As we posted earlier this year, both the vaccine’s safety and its effectiveness are doubtful. In addition, Emergent BioSolutions charges the government an exceedingly high price for the vaccine, with a mark-up of 300%.
Our post drew greatly upon a chilling expose of Emergent BioSolutions’ marketing practices and the ineffectiveness of the vaccine that was released by the Center for American Progress (CAP). Imagine our surprise, then, to hear that, in a move that seems to contradict everything they wrote in that brilliantly researched report, the think-tank is now hosting an event titled “Anthrax Revisited” which asks “Are we better prepared today” to handle biological attacks than we were ten years ago?
This event seems designed to promote the very vaccine that CAP proved was unsafe and ineffectual. In addition, the blurb about the event notes that, “This October marks another solemn 10-year anniversary, as a decade has passed since a series of letters containing anthrax spores infected 17 Americans and killed 5, and introduced the United States to the dangers of a biological attack.” Nowhere is it mentioned that the anthrax “attacks” ten years ago were concluded by the FBI to be an inside job by a scientist who had himself worked on the anthrax vaccine, or that anthrax has over a hundred strains, which should be treated with different antibiotics due to their differences. The EBS vaccine has never been proven to be effective against inhalation anthrax in humans; in fact, the current vaccine has not even been proven effective against skin anthrax. And that doesn’t even take into account the fact that genetic modification could theoretically create an anthrax strain resistant to the vaccine.
The blurb also does not mention why a terrorist organization would stick to anthrax if plotting a bioterrorist attack. Personally, it seems far likelier to me that they would choose a disease for which we have not ordered 44.75 million doses of vaccines, but I am only a lowly civilian.
CAP’s event features a host of panelists who seem to have associations to anthrax vaccine manufacturers and promoters. Panel I, for instance, features Dr. Tara O’Toole, the current Under Secretary for Science and Technology at Homeland Security. Not mentioned is the fact that before her appointment she served as a key adviser for the Alliance for Biosecurity, a group funded by the pharmaceutical industry that lobbied for greater government funding on anthrax vaccines and biodefense research. According to a Washington Times article in 2009, the Alliance spent over $500,000 lobbying Congress and federal agencies (including the Department of Homeland Security, where O’Toole now works) since 2005. O’Toole has also been accused of giving preferential treatment to another anthrax vaccine manufacturer, PharmAthene, and throughout her career in biosecurity, has been known to err on the side of fear-mongering. With all this in mind, it is difficult to understand why CAP decided to ask her to be one of the few panelists at their event.
The two other people on O’Toole’s panel are Senator Tom Daschle and Governor Tom Ridge. Senator Daschle was one of the people targeted during the 2001 anthrax attacks; Governor Ridge was the Secretary of Homeland Security at that time. It is notable that Senator Daschle received the anthrax letter shortly after challenging the anthrax vaccine immunization program. As a result of the anthrax attacks, the anthrax vaccine was made widely available to Capitol Hill workers – a decision that Governor Ridge must surely have been involved in making.
The second panel at CAP’s event features James Davis, Executive Vice President of Human Genome Sciences, manufacturer of an anthrax treatment drug, as well as Thomas Inglesby, from the Center for Biosecurity at the University of Pittsburgh Medical Center, who has written a number of articles promoting the vaccine as safe and effective despite the significant amount of contradictory data. He has also frequently collaborated with Dr. O’Toole, whose dubious credentials are noted above. The last panelist is Jeff Levi of Trust for America’s Health, who seems to be on board with fear-mongering in favor of vaccines in the event of an attack.
Looking at all of this, it seems clear that CAP has done a sudden about-turn on the issue of the anthrax vaccine. How could they change so dramatically in such a short time? Well, just keep in mind that Emergent BioSolutions and Pharma in general forms a powerful lobby. It is unfortunate that we have lost their voice, because we need more of the kind of research they did only a year ago.

FBI's case against anthrax suspect rife with questions/ Kansas City Star (McClatchy)

2011-10-12T22:25:00.000-04:00

In case you were looking for a synopsis of the important parts of the Frontline anthrax letters program, here it is. This piece was written by the TV show's investigative team, and details important flaws in the FBI's case. Definitely worth a read, and maybe a reread, to feed your anthrax letters obsession.

Watch Frontline's "The Anthrax Files"/ PBS

2011-10-11T22:58:00.000-04:00

See Part I of The Anthrax Files. This terribly important 1 hour documentary uncovered new evidence in the case. Additional videos related to the case are accessible at the site. Enjoy.

New California law lets 12-year-olds consent to "preventive care for STDs" aka Gardasil/ LA Times

2011-10-10T11:19:00.002-04:00

From the LA Times:

California Gov. Jerry Brown stepped into the middle of a debate over parental rights Sunday by signing legislation giving children 12 or older the power to consent to medical care involving the prevention of sexually transmitted disease.

Asssemblywoman Toni Atkins (D-San Diego) sponsored AB 499 with the aim of providing young people with timely preventative treatment, including the human papillomavirus [HPV] vaccine that proponents say can reduce the risk of certain cancers, precancerous cervical cell changes and genital warts.

The measure was backed by groups including the California STD Controllers Assn., the Health Officers Assn. of California, ACT for Women and Girls and the American Civil Liberties Union.

The bill was opposed by the California Catholic Conference, which opposed previous measures that allow minors to consent to certain treatments without the involvement of parents.

That group wrote to legislators that "this bill is dangerous because it expands a faulty law which assumes that children know better than their parents and because it will allow minors access to HPV vaccines which may cause them permanent harm."

And who will be able to link the Gardasil shot to any adverse side effects, when the shots are "secret": obtained in the absence of parental consent, so the pre-teens and teens would not have to disclose sexual activity to their parents? See"Gardasil Side Effects Tough to Monitor" in US News.

Who pays for treatment of the side effects? Since sexually transmitted diseases should not be getting transmitted at schools, why has the state of California chosen to bypass parental consent? What is its interest in this matter?

A national organization of female state legislators has been blessed by Merck largesse since at least 2004. The organization, Women in Government, wants to wipe out cervical cancer, using Gardasil as its primary weapon, while becoming a well-funded organization in the process. Here is how Women in Government wrap themselves in the cloak of science. Here you can see how they pay lip service to other cancers, but cervical cancer and Gardasil vaccine are the major issues of concern to this group. Here you can see how Women in Government have mapped out a plan to increase (and government fund) Gardasil vaccinations state by state--except some of the links have been removed.

When candidate/Governor Rick Perry of Texas mandated Gardasil vaccine in 2007 for all girls entering sixth grade, the Associated Press/MSNBC ran an excellent piece pointing out how Merck had funded this initiative through funding Women in Government and using well-placed lobbyists. Here's an excerpt:

Laws could mean billions in sales

The New Jersey-based drug company [Merck] could generate billions in sales if Gardasil — at $360 for the three-shot regimen — were made mandatory across the country. Most insurance companies now cover the vaccine, which has been shown to have no serious side effects. [This claim is questionable--Nass]
Cathie Adams, president of the conservative watchdog group Texas Eagle Forum, said the relationship between Merck and Women in Government is too cozy.
“What it does is benefit the pharmaceutical companies, and I don’t want pharmaceutical companies taking precedence over the authorities of parents,” she said.
Adams said Merck’s method of lobbying quietly through groups like Women in Government in addition to meeting directly with legislators are common in state government but still should raise eyebrows. “It’s corrupt as far as I’m concerned,” she said...

But Merck has doubled its spending on lobbyists in Texas this year, to between $150,000 and $250,000, as lawmakers consider the vaccine bill for girls entering the sixth grade.

The drugmaker has hired one of the state’s most powerful lobbyists, Mike Toomey, who once served as Republican Gov. Rick Perry’s chief of staff and can influence conservatives who see him as one of their own...

Drug-industry analyst Steve Brozak of W.B.B. Securities has projected Gardasil sales of at least $1 billion per year — and billions more if states start requiring the vaccine. “I could not think of a bigger boost,” he said.

Frontline's 'Anthrax Files' takes hard look at FBI role in suicide of Ft. Detrick scientist: Report asks if FBI overstated case against Frederick resident Bruce Ivins/ PBS Frontline

2011-10-10T09:46:00.000-04:00

David Zurawik at The Baltimore Sun writes about tomorrow's important Frontline story on Bruce Ivins and the anthrax letters. This will be the first episode.

Nobody does investigative journalism on TV like Public Television's "Frontline" -- nobody, and week in, week out that includes "60 Minutes."

And Tuesday night at 9, the venerable series revisits Ft. Detrick in Frederick, Maryland, and the case of anthrax researcher Bruce Ivins who killed himself in 2008 as the FBI zeroed in on him as its prime suspect in the case of deadly envelopes of anthrax sent through the mail.

According to this hard-edged report done in partnership with McClatchy Newspapers and Propublica, the FBI did more than zero in. Under tremendous pressure to solve the case that started in 2001 with anthrax mailed to U.S. senators and network anchors, the agency squeezed Ivins hard -- using every trick in the book to get a confession out of him even as he insisted on his innocence to the end.

Ivins was a troubled guy with some distinctive kinks, the report acknowledges, but even FBI consultants in the case now admit that the agency overstated its evidence and never found a smoking gun to prove the researcher's guilt. In fact, evidence was revealed last summer that shows Ivins did not have the equipment needed to make the powdery kind of anthrax sent through the mail. That didn't stop the FBI then -- or now -- in acting like it found its man.

"The Anthrax Files" is chilling report on several fronts.

First, it is a reminder of what paranoid and scary times have been living though since 2001 when the envelopes first appeared -- and the horrible events we just commemorated took place on September 11. These are indeed dark times, and with the economy getting worse and worse, there seems to be no light anywhere in sight.

Second, the report shows how a federal agency can shred an individual's life -- with or without the proper evidence to convict. "The Anthrax Files" suggests that anyone with the psychological issues Ivins had might have cracked under the weight of the FBI invading his privacy, exposing his secrets and ultimately getting him kicked out of the community of researchers that he called home at Ft. Detrick.

And finally, this is a chilling report, because if Ivins was not the person who sent the anthrax, then that killer is still on the loose. And we are left with an FBI that not only failed to solve such a huge case, but overstated and maybe lied about what it did accomplish.

"The Anthrax Files' premieres at 9 p.m. Tuesday on MPT (Channel 22).

Scientists’ Analysis Disputes F.B.I. Closing of Anthrax Case/ NY Times

2011-10-10T09:06:00.000-04:00

William Broad and Scott Shane have written a very useful NYT piece on the anthrax letters. It discusses a new academic paper by Martin Hugh-Jones, Stuart Jacobsen and Barbara hatch Rosenberg, which explores the meaning of the tin and silicon found in the anthrax spore preparation of the anthrax letters.

A decade after wisps of anthrax sent through the mail killed 5 people, sickened 17 others and terrorized the nation, biologists and chemists still disagree on whether federal investigators got the right man and whether the F.B.I.’s long inquiry brushed aside important clues.

Now, three scientists argue that distinctive chemicals found in the dried anthrax spores — including the unexpected presence of tin — point to a high degree of manufacturing skill, contrary to federal reassurances that the attack germs were unsophisticated. The scientists make their case in a coming issue of the Journal of Bioterrorism & Biodefense.

F.B.I. documents reviewed by The New York Times show that bureau scientists focused on tin early in their eight-year investigation, calling it an “element of interest” and a potentially critical clue to the criminal case. They later dropped their lengthy inquiry, never mentioned tin publicly and never offered any detailed account of how they thought the powder had been made...

Both the chairwoman of a National Academy of Science panel that spent a year and a half reviewing the F.B.I.’s scientific work and the director of a new review by the Government Accountability Office said the paper raised important questions that should be addressed.

Alice P. Gast, president of Lehigh University and the head of the academy panel, said that the paper “points out connections that deserve further consideration.”

Dr. Gast, a chemical engineer, said the “chemical signatures” in the mailed anthrax and their potential value to the criminal investigation had not been fully explored. “It just wasn’t pursued as vigorously as the microbiology,” she said, alluding to the analysis of micro-organisms. She also noted that the academy panel suggested a full review of classified government research on anthrax, which her panel never saw.

In interviews, the three authors said their analysis suggested that the F.B.I. might have pursued the wrong suspect and that the case should be reopened. Their position may embolden calls for a national commission to investigate the first major bioterrorist attack in American history...

In a reprise of the DOJ's "hang tough and deny" MO:

Dean Boyd, a Justice Department spokesman, said the paper provided “no evidence whatsoever that the spores used in the mailings were produced” at a location other than Fort Detrick. He said investigators believe Dr. Ivins grew and dried the anthrax spores himself.

“Speculation regarding certain characteristics of the spores is just that — speculation,” Mr. Boyd said. “We stand by our conclusion.”

The tin is surprising because it kills micro-organisms and is used in antibacterial products. The authors of the paper say its presence in the mailed anthrax suggests that the germs, after cultivation and drying, got a specialized silicon coating, with tin as a chemical catalyst. Such coatings, known in industry as microencapsulants, are common in the manufacture of drugs and other products.

“It indicates a very special processing, and expertise,” said Martin E. Hugh-Jones, lead author of the paper and a world authority on anthrax at Louisiana State University. The deadly germs sent through the mail to news organizations and two United States senators, he added, were “far more sophisticated than needed.”

In addition to Dr. Hugh-Jones, the authors of the new paper are Barbara Hatch Rosenberg, a biologist, and Stuart Jacobsen, a chemist; both have speculated publicly about the case and criticized the F.B.I. for years.

In 2008, days after Dr. Ivins’s suicide, the bureau made public a sweeping but circumstantial case against him. Last year, the bureau formally closed the case, acknowledging that some scientific questions were unanswered but asserting that the evidence against Dr. Ivins was overwhelming.

Investigators found that the microbiologist had worked unusual late-night hours in his lab in the days before each of the two known anthrax mailings in September and October 2001; that he often mailed letters and packages under assumed names; that he had a history of homicidal threats and spoke of “Crazy Bruce” as a personality that did things he later could not remember.

Dr. Ivins had hidden from family and friends an obsession with a sorority — Kappa Kappa Gamma — with an office near the Princeton, N.J., mailbox where the letters were mailed. The F.B.I. recorded Dr. Ivins’s speaking ambiguously to a friend that he did “not have any recollection” of mailing the letters, that he was “not a killer at heart” and that “I, in my right mind, wouldn’t do it.”

Yet no evidence directly tied Dr. Ivins to the crime. Some of the scientist’s former colleagues have argued that he could not have made the anthrax and that investigators hounded a troubled man to death. They noted that the F.B.I. pursued several other suspects, most notoriously another former Army scientist, Dr. Steven J. Hatfill, whom the bureau eventually exonerated and paid a $4.6 million legal settlement.

In its report last February, the National Academy of Sciences panel sharply criticized some of the F.B.I.’s scientific work, saying the genetic link between the attack anthrax and a supply in Dr. Ivins’s lab was “not as conclusive” as the bureau asserted.

If the authors of the new paper are correct about the silicon-tin coating, it appears likely that Dr. Ivins could not have made the anthrax powder alone with the equipment he possessed, as the F.B.I. maintains. That would mean either that he got the powder from elsewhere or that he was not the perpetrator.

If Dr. Ivins did not make the powder, one conceivable source might be classified government research on anthrax, carried out for years by the military and the Central Intelligence Agency. Dr. Ivins had ties to several researchers who did such secret work.

The Government Accountability Office, the investigative arm of Congress, is conducting its own review of the anthrax evidence. Nancy Kingsbury, the official overseeing the project, said the agency had spoken with the paper’s authors and judged that “their questions are reasonable.”

Beyond the world of forensics, tin is a humdrum additive used to kill micro-organisms in products like paint, wood preservatives and even toothpaste. But microbiologists say that the nutrients and additives used to grow Bacillus anthracis, the anthrax bacteria, are typically free of tin.

So in late 2002, when the F.B.I. found significant quantities of tin in the mailed powders, it set out to find its source. By 2003, the bureau was calling tin “an element of interest” — echoing its terminology for human suspects — according to disclosures culled from 9,600 pages of F.B.I. documents by The Times.

Over the years, the bureau performed hundreds of tests to explore tin’s use in microbiology and significance in the attack germs. It also hunted for clues to how the spores had become laced with silicon, which the United States had used decades ago as a coating in germ weapons. In 2005, scientists at an internal F.B.I. symposium called tin a possible fingerprint of the attack germs.

After that, the forensic clue disappeared from public discussion, except for a passing mention in a 2009 press release. “Although the chemical fingerprint of the spores is interesting,” the release said, “it was not relevant to the investigation.”

In the end, the F.B.I. — without alluding to its private tin labors — declared publicly that the attack germs had no special coating, saying that conclusion supported its finding that Dr. Ivins had grown and dried the spores alone, using standard equipment in his lab at Fort Detrick.

Several anthrax scientists who reviewed the new paper at the request of The Times said they believed it neglected the possibility that the tin and silicon were meaningless contaminants rather than sophisticated additives.

Johnathan L. Kiel, a retired Air Force scientist who worked on anthrax for many years, said that the spores “pick up everything” and that the silicon might be residue of a commercial product used on laboratory glassware to keep spores from sticking. He said tin might even be picked up from metal lab containers, though he has not tested that idea.

“It doesn’t have to be some super-secret process,” Dr. Kiel said. Other experts suggested that the tin might have come from anti-foam products, disinfectants or water.

The trouble with such conjecture is that the F.B.I. spent years testing for tin in microbiology lab supplies — and reported none, according to bureau documents.

Dr. Gast, the head of the National Academy of Sciences panel, noted that her group strongly recommended that future investigations of the attacks examine the government’s classified work on anthrax.

She called access to secret records “an important aspect of providing more clarity on what we know and what we don’t know.”

CIA's vaccine ruse in Pakistan carries fallout/ LA Times

2011-10-08T17:00:00.000-04:00

From the LA Times:

The phony campaign was aimed at helping find and kill Osama bin Laden, but the doctor involved now faces treason charges, and real immunization workers say Pakistanis don't trust them.

...Aid teams heading polio vaccination drives reported that more parents were refusing to allow their children to be vaccinated after news of the CIA ruse.

The phony campaign's repercussions on polio vaccinations is particularly alarming because Pakistan is one of four countries where the disease is still considered endemic, according to the World Health Organization. This year, 100 new cases of polio have been recorded in Pakistan, according to WHO statistics...

UW Professors: Accused Anthrax Killer Couldn’t Have Done It

2011-10-08T16:50:00.000-04:00

From the University of Wyoming:

... "The scientific evidence clearly shows that the (anthrax) wasn't produced in our laboratory (USAMRIID)," the two UW professors say. "The FBI based part of its case on unusual activity that took place in our lab for one week. There is no way he could produce that amount of spores in our lab during that time."
Other independent laboratories couldn't produce anthrax under similar lab conditions, and the FBI could not recreate the attack strain, Adamovicz says.
"The FBI's own evidence suggested a more advanced laboratory produced it," he says...

Calculating the risk and benefit of the Pandemrix vaccine program for swine flu

2011-10-07T21:49:00.005-04:00

Let's do a back-of-the-envelope risk-benefit calculation on swine flu vaccine:

In 2009-10, 44 Finns of all ages died of swine flu. [With 5.3 million Finns, this is one death per 120,000 people of all ages.]

About half the population of Finland received Pandemrix. Had the vaccine been given before the pandemic struck (a near impossibility) and had it been 100% effective (also an impossibility) it would at the very best have saved the lives of 44 people.

Seventy-nine children developed narcolepsy following Pandemrix vaccinations. [This is about one case per 17,000 children.] If the whole population received Pandemrix, probably at least 79 more children would have developed severe cases of narcolepsy (RR 12.7), and likely there would be additional adult cases as well, which were not deemed statistically significant, thus far. There would also have been a few extra cases of Guillain Barre Syndrome (RR (1.77), and probably additional cases of other autoimmune disorders, which have not been identified because the relative risk has not been sufficiently higher than expected to be noticed.

If the vaccine had been developed and administered before there were any swine flu cases in Finland, and if it had been 100% effective and prevented every death, you would still be trading seven children developing severe narcolepsy for every person whose life was saved by vaccination.

Since Pandemrix was far from 100% effective (its effectiveness depends on the age and health status of the person being inoculated, and whether they were already immune), the health of ten, twenty, thirty or more children was probably exchanged for each life, of any age, that might have been saved by Pandemrix in Finland.

And some people who developed additional illnesses, such as Guillain Barre Syndrome, also had their health traded for the few lives the vaccine may have saved. Now add in the costs of purchasing and administering the vaccine, and the lifetime costs of treating and compensating those who became ill. Do you think this is a valid trade-off? How should public health systems handle pandemics in future?

The CDC and WHO are carefully watching out for new viruses that might cause future pandemics, so we will be prepared ahead of time, right? But according to Dr. Steve Salzberg in Forbes, nobody is watching:

... The 2009 pandemic originated in pig farms in Mexico. We don’t know precisely where it made the first leap into humans, but it appears that two different strains joined together in a pig somewhere to create the new H1N1. The flu has a nasty habit of jumping the species barrier, hopping to humans from both pigs and chickens.
So now that we know all this, next time will be different, right? The world’s influenza scientists are monitoring pigs and chickens closely now, keeping a close eye on any new flu strains. Right? RIGHT???
Er, no. Not exactly. For one thing, surveillance in pigs appears to be nonexistent. I checked to see how many flu sequences from pigs in Mexican have been desposited in the public archive at GenBank since 2009 (using this terrific database). The result? One, in 2009. Nothing from 2010 or 2011. Hello, is anyone awake at the CDC and the WHO?...

Why did Finland and Sweden have many narcolepsy cases, but we are not hearing about them elsewhere? The most likely reason is that Sweden and Finland vaccinated a much higher percentage of their population than other countries, causing a much greater percentage of adverse reactions. I have written previously about the difficulty learning how many Americans were vaccinated. In Israel, 11.6 percent of the population took the shots against swine flu. In Spain, 10 percent were vaccinated, while in Greece, a mere 3 percent got the shots. In Sweden, by comparison, 60 percent of the population were vaccinated, and in Finland, 50 percent.

Meryl Nass, MD

From Finland's National Institute for Health and Welfare:

1 Sep 2011

An association between Pandemrix and narcolepsy among children and adolescents in Finland is confirmed.
In its final report, the National Narcolepsy Task Force confirms the tentative conclusion published in its Interim Report last January that the Pandemrix vaccine used in the winter of 2009–2010 contributed to the increased incidence of narcolepsy observed among 4–19-year-olds in Finland. According to the report, the increased risk associated with vaccination amounted to six cases of narcolepsy per 100 000 persons vaccinated in the 4–19 age group during the eight months following vaccination. This was 12.7 times the risk of a person in the same age group who had not been vaccinated. No increased incidence of narcolepsy was observed among children under the age of four or among adults over the age of 19.
In all the cases examined, narcolepsy associated with Pandemrix vaccination has been identified in persons who carry a genetic risk factor for narcolepsy. Because of this very strong association with the genetic risk factor which regulates immune responses, narcolepsy is considered an immune-mediated disease.
In approximately one quarter of those who developed narcolepsy following Pandemrix vaccination, the THL Immunology laboratory found antibodies binding to the AS03 adjuvant component of the vaccine. Adjuvants containing squalene have not previously been reported to induce the production of antibodies. (Depends what literature you read--Nass) The significance of this preliminary observation will be the subject of further research.
Tests on viral antibodies indicated that less than 10 per cent of the children and adolescents who developed narcolepsy had been infected with swine flu. Swine flu infection thus does not appear to play a significant role or be in joint effect with the Pandemrix vaccine in the onset of narcolepsy...
By 25 August 2011, the National Vaccine Adverse Event Register maintained by THL had received notifications of 98 cases of narcolepsy subsequent to vaccination with Pandemrix; 79 of the subjects were between 4–19 years old at the time of vaccination. Narcolepsy was associated with cataplexy in 78 of the cases. Most of the persons affected developed symptoms within a couple of months after receiving the vaccination...
The Pandemrix vaccine was used in the winter of 2009–2010 to prevent the swine flu epidemic. About half of the Finnish population chose to be vaccinated. There were 44 deaths from swine flu confirmed by laboratory tests. A significant number of severe cases were prevented during the 2009–2010 season, even if vaccines were given at about the same time as the epidemic reached Finland. (Perhaps, but vaccine was given late, and no data are given--Nass)
During the influenza season 2010–2011, 13 succumbed. Most of these were unvaccinated. Combining the data on morbidity and mortality with data on vaccinations in the 2009–2010 pandemic season indicate that a swine flu vaccination taken in the pandemic season had provided 75–88 per cent protection against the swine flu virus in winter 2010–2011. Based on these vaccine effectiveness figures, it has been estimated that during the first wave in 2009-2010, the swine flu vaccine prevented approximately 40 000 cases of swine flu, and during the second wave in 2010-2011, another 40 000 cases of swine flu... (But are these numbers ignoring the fact that most people had already developed immunity during the previous year of the swine flu pandemic? --estimated at over 60% of the US population by NIH researchers. The stronger, natural immunity of people who were exposed but later vaccinated, is likely being counted as vaccine-induced protection--Nass)

Finland vows care for narcolepsy kids who had swine flu shot/ AFP

2011-10-06T03:05:00.004-04:00

From Agence France Presse:

HELSINKI — The Finnish government and major insurance companies announced Wednesday they will pay for lifetime medical care for children diagnosed with narcolepsy after receiving the swine flu vaccine.

"The compensation will provide much-needed financial assistance for the families, although it cannot take away the emotional distress caused by this condition," Social Services and Health Minister Paula Risikko said in a statement.

Finnish and international researchers recently found a conclusive link between the Pandemrix swine flu vaccine and new cases of narcolepsy, a chronic nervous system disorder which causes people to often uncontrollably fall asleep.

The Finnish Pharmaceutical Insurance Pool (LVP), which represents insurance companies, said Wednesday it would honour all insurance claims in this category.

LVP said it would review each claim individually to calculate the scope of the payout.

The Finnish government meanwhile agreed to cover any medical costs exceeding the insurance claims.

In Finland, 79 children between the ages of four and 19 developed narcolepsy after receiving the Pandemrix vaccine in 2009 and 2010.

Of these cases, an unusually high number, 76, also suffered from bouts of cataplexy, suffering hallucinations or paralysing physical collapses, according to Finnish research.

From Finland's YLE:

The amount of compensation has not yet been set, as each case will be investigated individually. Medical care, medication and travel costs are eligible for reimbursement, along with other costs incurred as a result of narcolepsy caused by the Pandemrix vaccinations.

Where the victim is a child, loss of earnings compensation could be paid to parents. After the 30-million euro fund for compensation is exhausted, the state will take responsibility for funding payouts.

The link between Pandemrix and subsequent onset of narcolepsy has been supported by research from Finland’s Institute for Health and Welfare (THL).

UPDATE: Sweden also begins compensating kids for narcolepsy.

The first children in Sweden who fell ill with the sleeping disorder narcolepsy after being given the swine flu vaccination Pandemrix, have been awarded 50,000 kronor ($7,340) in compensation.

“It is difficult for me to say if 50,000 kronor is a lot or too little. We have nothing to compare it to, “ said Herman Afzelius, father of 10-year-old Arvid, who suffers from the disease after getting the swine flu shot, to daily Dagens Nyheter (DN).

In total, 118 children and youngsters have reported being struck by the disease after the vaccination drive in 2009 and 2010.

Twelve families have so far been told they will receive compensation, according to DN.

According to Anders Öhlen, the CEO of insurance company Läkemedelsförsäkringen, the amount is in line with other severe illnesses, such as deafness or paralysis. . .

When the children turn 18, a new medical assessment will decide if they are eligible for any other financial recompense...

Wall Street hits us with a permanent Katrina/ thx to Mark Crispin Miller

2011-10-04T18:36:00.000-04:00

Editorial: Anthrax Attacks Still A Mystery After 10 Years/ Hartford Courant

2011-10-04T18:33:00.001-04:00

From the Courant:

October 5, 2011

After the World Trade Center was destroyed 10 years ago, death arrived once again — in the mail. Anthrax, a terrifying and deadly bacterium that multiplies rapidly when inhaled, began to appear in letters sent to a variety of places. Among these were the New York Post, the offices of two U.S. senators, the office of NBC News anchor Tom Brokaw, and, bizarrely, the home of 94-year-old Ottilie Lundgren of Oxford.

Mrs. Lundgren and four others died; 17 were injured. Thousands were exposed and had to take powerful antibiotics. The government seemed paralyzed. The FBI investigators careened from one false lead to another. After 10 years, 9,000 interviews and 6,000 subpoenas, the anthrax attacks are still unsolved

For years, the FBI harassed scientist Steven Hatfill as the only suspect in the case until the agency was forced to apologize and award him $5.8 million for slandering him and destroying his career. After Army microbiologist Bruce Ivins committed suicide in 2008, the FBI announced that he was the likely source of the anthrax attacks. But the agency's case is circumstantial and important questions remain unsolved:
The anthrax spores were "weaponized" with a high percentage of silicon, making the bacteria even more lethal. Yet there's no evidence that Dr. Ivins either had the equipment or was capable of the elaborate process necessary to add the silicon.
One of the 9/11 hijackers, Ahmed Alhaznawi, reported to a Florida hospital with a dark wound that the attending physician told the FBI was consistent with cutaneous anthrax, which causes skin lesions.
The cave at Tora Bora where Osama bin Laden hid for a time twice tested positively for the same strain of anthrax found in the letters, according to Pulitzer-prize winning author Laurie Garrett, author of "I Heard the Sirens Scream: How Americans Responded to the 9/11 and Anthrax Attacks."

The Government Accountability Office is currently examining the FBI's botched investigation. U.S. Rep. Rush Holt, from whose New Jersey district the perpetrator mailed the anthrax-laced letters, has for years proposed congressional hearings into the anthrax attacks. So far, nobody's listened.

Such hearings are the least that should occur. A decade without clear answers is infuriating — and unacceptable.

More Anthrax Vaccine Stockpiled for Civilians: Cost $1.25 Billion

2011-10-03T18:06:00.000-04:00

Read it an weep; each American is paying $4.00 for their share of this stockpile of poison.

press release

Oct. 3, 2011, 7:00 a.m. EDT

Emergent Biosolutions Receives Award to Supply 44.75 Million Doses of BioThrax to US Government Over Five Years

ROCKVILLE, Md., Oct 03, 2011 (BUSINESS WIRE) -- Emergent BioSolutions Inc. /quotes/zigman/429174/quotes/nls/ebs EBS +11.15% today announced that, in response to solicitation RFP-2011-N-13414, it has received an award to supply the U.S. government with 44.75 million doses of BioThrax(R) (Anthrax Vaccine Adsorbed) over a period of five years for a total value of up to $1.25 billion. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection...

This year's flu vaccine: Setting things straight

2011-10-03T18:01:00.005-04:00

There is so much written that is dead wrong about this year's flu vaccine, another post is needed. Here are some facts:

1. This year's flu vaccine is the same as last year's vaccine. If you are healthy and got the vaccine last year, you probably still have antibodies against all 3 strains.

2. The antigen used for the 2009 Swine Flu vaccine was an H1N1 hemagglutinin. It was used as a single antigen vaccine in 2009, but was included as one of the three hemagglutinin antigens in 2010 and 2011. In 2009, in some countries, a novel adjuvant was added to the antigen (either MF59 [Novartis] or ASO3 [Glaxo]) to increase the immune response.

In the US, for example, which used no adjuvant, the 2010 and 2011 flu vaccines contain the 2009 swine flu vaccine, plus two more antigens. Therefore, claims that this year the vaccine is entirely different are misleading.

In countries like Ireland and England, which used the ASO3 adjuvant in 2009, the current flu vaccine differs from 2009 because it has no ASO3. But it does have the same hemagglutinin antigen. [I mistakenly wrote adjuvant instead of antigen earlier.]

Narcolepsy cases have occurred after both adjuvanted and unadjuvanted swine flu vaccines were given.

3. How effective is the vaccine? Although 70-90% of recipients develop antibodies, the amount of flu that is prevented is questionable. Remember that studies from Hong Kong and Canada found that if you got flu vaccine in 2008, you were about twice as likely to become ill with a swine flu infection the next year? So the 2008 vaccine had negative efficacy for the 2009 influenza. (Being vaccinated in 2008 made it more likely that recipients would get sick from flu the next year. This is not strange, as some vaccines, in the past, have been found to enhance infection. )

UPDATE: Here is a new article, just published, which supports a causal relationship between getting the 2008 flu vaccine and actually getting sick from swine flu the following flu season.

The effectiveness of the flu vaccine varies from year to year, but it is not very high, and never over 70% for the young and healthy. It is hard to show any efficacy in the aged.

4. The reason narcolepsy was discovered to be a side effect of swine flu vaccine in Finland was because there were 13 times as many cases appearing as usual. That is 1300% more cases than expected, of a very serious condition that can have lethal consequences.

5. Was narcolepsy the only serious adverse reaction to swine flu vaccine? It's unlikely. There is no data on other side effects, except for Guillain Barre Syndrome (GBS). Because GBS was caused by the 1976 swine flu vaccine (see prior posts on this from 2009), CDC and FDA promised to look closely for cases when the 2009 swine flu vaccine program was launched. The same level of scrutiny was not paid to other potential side effects.

You may have seen headlines that swine flu vaccine does not cause Guillain Barre Syndrome; I did, on the same day a report was issued about narcolepsy and the vaccine. However, It seems swine flu vaccine DID cause Guillain Barre Syndrome after all. The full text is here, or you can read the abstract below. CDC calculated it caused 1.77 times as many cases of GBS as expected, or 177%.

MMWR Morb Mortal Wkly Rep. 2010 Jun 4;59(21):657-61.
Centers for Disease Control and Prevention (CDC).

Guillain-Barré syndrome (GBS) is an uncommon peripheral neuropathy causing paralysis and in severe cases respiratory failure and death. GBS often follows an antecedent gastrointestinal or upper respiratory illness but, in rare cases, can follow vaccination. In 1976, vaccination against a novel swine-origin influenza A (H1N1) virus was associated with a statistically significant increased risk for GBS in the 42 days after vaccination (approximately 10 excess cases per 1 million vaccinations), a consideration in halting the vaccination program in the context of limited influenza virus transmission. To monitor influenza A (H1N1) 2009 monovalent vaccine safety, several federal surveillance systems, including CDC's Emerging Infections Program (EIP), are being used. In October 2009, EIP began active surveillance to assess the risk for GBS after 2009 H1N1 vaccination. Preliminary results from an analysis in EIP comparing GBS patients hospitalized through March 31, 2010, who did and did not receive 2009 H1N1 vaccination showed an estimated age-adjusted rate ratio of 1.77 (GBS incidence of 1.92 per 100,000 person-years among vaccinated persons and 1.21 per 100,000 person-years among unvaccinated persons). If end-of-surveillance analysis confirms this finding, this would correspond to 0.8 excess cases of GBS per 1 million vaccinations, similar to that found in seasonal influenza vaccines. No other federal system to date has detected a statistically significant association between GBS and 2009 H1N1 vaccination. Surveillance and further analyses are ongoing. The 2009 H1N1 vaccine safety profile is similar to that for seasonal influenza vaccines, which have an excellent safety record. Vaccination remains the most effective method to prevent serious illness and death from 2009 H1N1 influenza infection; illness from the 2009 H1N1 influenza virus has been associated with a hospitalization rate of 222 per 1 million and a death rate of 9.7 per 1 million population. [This suggests 3,000 people in the US died from swine flu -- a far cry from the 24,000-45,000 said to die each year from influenza.--Nass]

Narcolepsy and Swine Flu Vaccine: Is this the vaccine we use today?/ BBC

2011-09-30T16:49:00.000-04:00

From the BBC: Link between narcolepsy and flu vaccine investigated

Health officials are investigating a link between narcolepsy and the Pandemrix vaccine in two people who were treated for swine flu.

Northern Ireland's Chief Medical Officer has confirmed to the BBC, that Northern Ireland had become the latest country to report suspected cases of the sleeping disorder.

Dr Michael McBride said the vaccine was used during the flu pandemic of 2009.

"Let's be clear - this is not the vaccine that we use today," he added...

Let's be clearer in this blog. The trivalent vaccine used today does include the swine flu (H1N1) hemagglutinin antigen --the main immunizing ingredient in swine flu vaccines. According to the FDA, the 2011-2012 vaccine's "A/California/7/09 (H1N1)-like virus is the pandemic (H1N1) 2009 influenza virus." In the UK and many countries, but not the US, the swine flu vaccine used in 2009-10 also contained a novel adjuvant; in the UK this was ASO3. It is of interest that in one important study, most, but not all cases of post-vaccination narcolepsy were associated with the ASO3-adjuvanted vaccine, while other cases were associated with the plain vaccine...which contained the same ingredients as are found in the current flu vaccine. So far, neither ASO3 adjuvant nor hemagglutinin antigen has been implicated as "the" cause of the narcolepsy outbreak. Certainly, the European Medicines Agency has no clue, below:

In the past six months, the number of narcolepsy cases in Beijing in China, and Scandinavian countries including Finland has risen significantly...

With concern growing about the potential side effects of Pandemrix, the vaccine used during the pandemic flu in 2009, the European Medicines Agency completed a review of the drug in July 2011.

It concluded that the benefits of Pandemrix continued to outweigh its risks, but that it may only be used in people under 20 if the recommended annual seasonal vaccine was not available and if immunization against H1N1 was still needed. [Would the person who calculated this crazy risk - benefit analysis please stand up?---Nass]

US Food and Drug Administration lashes pharmaceutical giant CSL over lab practices/ The Australian

2011-09-28T22:03:00.006-04:00

for video click here

Despite the report below, CSL is one of six flu vaccine manufacturers licensed to sell flu vaccine in the US in 2011. The CSL vaccine, Afluria, is labelled for use over 5 years old. However, the CDC's Advisory Committee on Immunization Practises recommends that Afluria not be used in children aged 6 months through 9 years, because of "increased reports of febrile reactions in this age group." Why use it at all, when Australia had 9 times the expected rate of febrile seizures from Afluria in early 2010? Or are the other five brands equally problematic? Here are the brands and lots released for use by FDA so far this season.

Febrile seizures in small children may not be the only problem with the vaccine. One must also balance the risk of getting flu, and the benefit from vaccination. In the US, approximately 100 children die from flu yearly, half of whom have underlying chronic illnesses. There are about 80 million US children, so yearly deaths from flu are slightly more than one in a million. It appears that about 64 per million vaccinated children developed narcolepsy in Ireland. About 90% of new child narcolepsy cases in Finland were due to vaccination.

UPDATE Oct. 19: CSL accused of not reporting seizures during its flu vaccine's clinical trial.

US FDA accuses CSL of bad practices

SECRET audits by the powerful US Food and Drug Administration have revealed a multitude of manufacturing flaws at Australia's biggest pharmaceutical company, CSL. The FDA's 2010 and 2011 audits, released to The Australian yesterday after a Freedom of Information request, cite a string of "objectionable conditions and practices" used by CSL to make vaccines.
The FDA allegations - which CSL said yesterday had been or were in the process of being resolved - include the failure of laboratory staff to wear masks while dispensing and mixing vaccines, "deficient" tests to check whether viruses were properly split to prevent side-effects and "inadequate" investigations into product failures.
The FDA documents reveal that CSL took six months to start investigating the cause of mysterious dark particles in the national stockpile of swine flu vaccine.
The most recent audit, in March, branded as "inadequate" CSL's investigation of febrile fits among children immunised with Fluvax, its seasonal flu vaccine.
Eleven months after Fluvax was banned for young children, the FDA audit discovered CSL had not compiled an investigations report or even designated anyone to be in charge of the investigation.
Australia's pharmaceutical regulator, the Therapeutic Goods Administration, refused to release the findings of its own audits into CSL.
And CSL insisted the FDA audits contained "observations only" rather than any final determination of compliance.
CSL, the privatised Commonwealth Serum Laboratories, has also been under fire this week after being forced to ration supplies of penicillin in its role as sole Australian supplier of the medicine.
The FDA audit findings form the basis of a "warning letter" the US regulator sent to CSL in June, threatening to revoke its US licence if it failed to address outstanding issues.
This year's audit described as "inadequate" CSL's investigation into the high rate of fever and convulsions among children given the Fluvax shot last year. "There was limited analysis of the manufacturing process to determine why there was a substantial increase of adverse-event reports of fever and convulsions in the 2010 southern hemisphere influenza season in comparison to previous seasons. "There was no evaluation of testing of raw material and potential impact on manufacturing," it said.
The audit found 15 lots of a key ingredient in CSL's flu vaccines, the detergent sodium taurodeoxycholate, failed an "identity test" but were used regardless.
The detergent is used to split the flu viruses used to make vaccines to minimise side-effects.
The Medical Journal of Australia reported last week that CSL was "one of only a few manufacturers globally" to use the ingredient.
The FDA audit also criticised CSL's "inadequate" investigation into the cause of dark particles that appeared in multi-dose vials of vaccines against swine and seasonal flu, produced for the US market in 2009.
"The investigation is ongoing and a root cause has not been determined," its report said.
It also noted that CSL had manufactured products "outside the validated processes" without determining if they would remain stable until their expiry date.
It cited a "formulation error" discovered in July last year, when not enough swine flu virus was used in the vaccine against seasonal flu.
The FDA inspectors raised the problem of black particles in multi-dose vials during an inspection of the Parkville laboratory in April last year.
The same discolouration had been detected in Australia's stockpile of swine flu vaccine, Panvax, for which the federal government paid CSL $131 million of taxpayer funds. Half the stockpile - 10 million doses - had to be destroyed after passing their use-by date last year, while the paediatric version was withdrawn early because the medication lost potency before the expiry date.
The FDA's 2010 audit found CSL's supplier of rubber stoppers had told the company they could react with the mercury in multi-dose vials and should not be used.
The TGA said it agreed with the FDA findings, but it refused to release its own audits.

UPDATE: from the Australian Broadcasting Corporation

Health problems linger for survivors of the anthrax attacks/PA's Courier Times

2011-09-11T21:07:00.000-04:00

The following article talks about an important finding, which I mentioned back in a 2002 NY Times interview: the people who developed inhalation anthrax (or cutaneous anthrax that became generalized) were likely to suffer from the identical symptoms as those who became very ill after anthrax vaccinations. These symptoms have now lingered for ten years in those who got the disease anthrax, and for ten years or more in those I have treated for anthrax vaccine exposures. The symptoms are fatigue, impaired cognition, psychological problems and muscle/joint pains. Perhaps not coincidentally, these symptoms also define Gulf War Syndrome. Many of my patients have developed hormone deficiencies as well (both Gulf War and anthrax vaccine-injured patients) and it appears from the article that research physician Mary Wright at NIH is finding hormonal problems in her anthrax survivors as well.

How can you explain why people who got the vaccine have a similar chronic illness as those who caught the disease? I don't believe any research has been published on this interesting fact, but it isn't hard to speculate. This is particularly important for several reasons: people who are cured of anthrax may never become well, unlike those who recover from most other infectious diseases. What is fundamentally different about anthrax infection in this regard? Furthermore, many monkeys who were given anthrax vaccine, then exposed to anthrax, actually got the disease but survived. (See the July 18, 2000 Washington Post article by Tom Ricks, "Anthrax Shots' Effects Challenged: Army Disputes Expert Who Reviewed Vaccine Tests.")

If people get the same level of protection afforded by the vaccine as the monkeys did, it may not prevent them developing chronic illness, although it may prevent their death. That doesn't speak well for the vaccine, and suggests a better vaccine is needed: both to be more effective at preventing anthrax, in addition to being more safe.

The licensed human anthrax vaccine, produced by Emergent BioSolutions, contains many anthrax proteins and other anthrax molecules produced during bacterial fermentation, and one or more of these probably cause[s] the symptoms, or cause[s] some type of deregulation that not only causes the symptoms, but allows them to persist, apparently forever. The persistence of these symptoms--after the disease is long gone--is another issue crying out for study.

In the 10 years since 17 people survived the deadly anthrax attacks that terrorized the nation in the weeks following 9/11, little recent information is known about their health.
But the National Institute of Health has quietly monitored the health of seven of the those survivors, including Falls resident Patrick O’Donnell. The group represents the largest pool of anthrax survivors U.S. researchers have studied.
The ongoing study will provide the first comprehensive data on the long-term health effects of anthrax exposure, the project’s head researcher said recently.
“No one has ever documented followup in anthrax survivors,” said Dr. Mary Wright, the principal investigator with the NIH’s National Institute of Allergy and Infectious Disease.
Before 2001, the last reported U.S. anthrax case occurred in 1976, and it was reported two years later, according to the NIH. The only previous anthrax studies were 50 years old and contained little data about long-term effects or possible complications.
In fall 2001, 22 people in the U.S. were exposed to anthrax through tainted letters sent through the U.S. mail. Five died. Many of those affected were U.S. Postal Service workers, who either inhaled anthrax spores or were exposed to it through skin contact.
NIAD is the only research agency that is following the health of anthrax attack survivors, a project that started in February 2002.
The study participants include two with inhaled exposure, and all but one are regularly tested and evaluated every one to two years, Wright said. The testing includes neuropsychological, blood and hormone level tests. The study will continue as long as the participants are willing. And one survivor, a woman who has not recently participated, can return at any time, Wright said.
The most recently released information about the health of the survivors came in 2004. It was based on a one-year followup study of 15 of the 17 survivors conducted by the Centers for Disease Control and Prevention. That study used medical interviews, standardized self-administered questionnaires, and a review of available medical records.
The study found that eight of the participants hadn’t returned to work more than a year after the attacks, all were under psychiatric care, and most reported symptoms ranging from chronic cough, fatigue and memory problems to depression, anxiety and hostility. Eight survivors also reported moderate to severe joint problems and decreased physical functioning.
But diagnostic tests performed on six of the eight patients showed no signs of immune or inflammatory disorders or other common medical explanations for the symptoms.
Nearly nine years later, Wright says her data shows the survivors who were the sickest in 2001 continue to experience the most persistent symptoms, including memory trouble and chronic fatigue. These survivors either inhaled anthrax or had it enter their bloodstream after they contracted the skin form.
The sickest patients also have had the most difficulty returning to work. Though some have returned, they can’t perform at the same level as before, Wright said. Those with less severe symptoms appear to have returned to their regular lives.
Wright added that researchers know some survivors will develop common age-related medical problems, but there likely will be no way to prove a cause-effect relationship with the anthrax exposure.
“We are hoping what we learn, once we publish, is if there are new cases, including natural cases, that they can learn from this experience and monitor some of these variables, like hormone levels and memory testing and offer some support to folks,” Wright said.
O’Donnell, now 45 and a U.S. postal worker, was the 12th of the 22 anthrax attack victims. Four coworkers also were exposed and survived.
He returned to his job at the Hamilton, N.J., office in 2005, where he continued to work a “modified schedule” through Workers’ Compensation, according to a recent post on the PostalWorker News Blog, which isn’t affiliated with the U.S. Postal Service.
The Courier Times was unsuccessful in attempts to reach O’Donnell for comment.
O’Donnell came in contact with one of the tainted envelopes, a letter addressed to then Senate Majority Leader Thomas Daschle, while working overtime on Columbus Day 2001. Normally, he didn’t sort first-class mail.
Five days later, O’Donnell noticed a welt-like sore on his neck where he had nicked himself shaving the day he worked the overtime. He was treated at an emergency room for a suspected spider bite and released. The next morning, though, O’Donnell woke to find his neck had swelled to 27 inches around. The welt was now a pus-filled boil and a softball-size lump protruded from his chest.
He returned to the emergency room, where doctors confirmed he had an anthrax infection, triggering emergency infectious disease protocols. After five days in isolation with antibiotic treatments, O’Donnell was released.
O’Donnell last spoke to the newspaper in 2008, after he attended a private FBI briefing discussing Bruce Ivins, the late Army scientist the government said was responsible for the anthrax attacks. At the time, O’Donnell complained of symptoms that he believed were the lingering effects of the anthrax — stuffy head, achy joints, throbbing headaches, insomnia and panic attacks.
In an Aug. 6 post on the PostalWorker blog, O’Donnell wrote that he still suffers severe post traumatic stress disorder, which a doctor has diagnosed. He said his condition has been worsened because he continues to work at a postal center 300 yards from the building where he was exposed to anthrax and he’s required to sort and throw away waste mail.
He added that his repeated requests for a job transfer closer to home have gone nowhere.
“Without having been through this experience, it has been impossible for others, including U.S. Post officials, to comprehend the mental and physical toll I face each day driving back and forth to work and seeing the postal facility, a constant reminder of this terrible, near-fatal exposure I suffered,” O’Donnell’s post said. “This has proven to be no help whatsoever in me trying to obtain closure and getting on with my life. I just want to spend my last years of service at a facility with a less stressful, remindful environment.”
The USPS cannot comment on employee claims without the employee’s written permission, spokesman Ray Daiutolo said.
But Daiutolo said that if an injured worker disagrees with the offered position, that employee can provide supporting documentation to the Office of Workers’ Compensation Programs, which makes the final decision.
If an employee is returned to duty in a “suitable position” and subsequently experiences a worsening of his/her condition or has a change in work tolerances, that employee has the right to submit a claim for recurrence, Daiutolo added.

Probe on narcolepsy–H1N1 vaccine link finds genetic risk factor/ CIDRAP

2011-09-01T22:39:00.001-04:00

Sep 1, 2011 (CIDRAP News) – A final report from Finnish health officials on the link between the 2009 H1N1 Pandemrix vaccine and narcolepsy confirmed the link, finding a greater risk than their earlier estimate and identifying a genetic risk factor in all patients.
In a statement on the findings today, a task force from Finland's National Institute for Health and Welfare also said an immunologic study found that one quarter of those who experienced narcolepsy after vaccination had antibodies that bound to the AS03 adjuvant component of the Pandemrix vaccine, which they said is a preliminary finding that requires more investigation.
Today's report put the increased risk of narcolepsy with vaccination at 6 cases per 100,000 people, which amounts to a 12.7-fold greater risk than in those who had not been vaccinated. The task force's first estimate in a January preliminary report was a nine times greater risk.
Some countries, mostly Nordic, have reported a link between the vaccine and narcolepsy in young people. Pandemrix, made by GlaxoSmithKline (GSK), is one of the 2009 H1N1 vaccines used in Europe during the pandemic.
In July the European Medicines Agency (EMA), in issuing its final review on the link, recommended a labeling change that limits the vaccine's use to protecting children and teens from the 2009 H1N1 virus when seasonal flu vaccine isn't available.
Finnish officials haven't found an increased risk in children younger than 4 or among adults older than 19.
In reporting the genetic findings in vaccinated patients who had narcolepsy, the task force said the risk factor for the condition is strongly linked to genetic factors that regulate immune responses. "Narcolepsy is considered an immune-mediated disease," they wrote.
Antibody tests found that less than 10% of those who had narcolepsy had been infected with the 2009 H1N1 virus, which led the group to conclude that infection with the strain doesn't appear play a significant role or show a combined effect with Pandemrix vaccination and narcolepsy onset.
The task force said so far Finland and Sweden are the only countries that have confirmed the link between Pandemrix and narcolepsy, though Norway and France have reported higher-than-expected numbers of cases. It added that several studies on the link are under way in countries that used considerable amounts of Pandemrix and Arepanrix, another GSK pandemic vaccine made in Canada that included the same adjuvant.
As of Aug 25, Finnish health officials had received reports of 98 narcolepsy cases in people who had been vaccinated with Pandemrix, and 79 were in patients between ages 4 and 19 years old. The condition was associated with cataplexy, a sudden and transient loss of muscle tone, in 78 cases.
Despite the limited number of unexpected and unfortunate narcolepsy cases, Finnish officials said the overall benefits of the vaccine still outweigh the risks.
They added that research teams in Finland and other countries are exploring the immunogenetics, pathogenesis, and clinical course of narcolepsy.
GSK spokeswoman Jennifer Armstrong told CIDRAP News that the Finnish data are similar to what officials reported earlier this year. She said Glaxo is committed to patient safety and is working closely with the EMA and other regulatory groups.
"Further information from ongoing studies is still needed in order to gain additional insight into the cause of the reported cases of narcolepsy," Armstrong said. "In addition, GSK has committed to conduct further research into any potential association between Pandemrix and narcolepsy and will seek independent expert advice on this research activity, as agreed with the EMA."

Doctors unleash legal challenge over inquest Dr David Kelly never had/ Mail Online

2011-08-28T23:38:00.001-04:00

From Miles Goslett at the Daily Mail:

Doctors are preparing to challenge the Government’s decision not to hold an inquest into the death of Dr David Kelly...

This month the doctors were given a 33-page legal opinion by Aidan O’Neill QC, a colleague of Cherie Blair at Matrix chambers in London, indicating that Mr Grieve’s decision could be judicially reviewed, paving the way for an inquest. They are now set to proceed, managed by solicitors Withers LLP...

Speaking on behalf of the other three doctors involved in the case, Dr David Halpin said: ‘We need to raise about £50,000 to cover stage one legal fees to take this to the High Court but we believe this must be done. Britain has great potential for good but many people know it is now mired in mendacity. They must help the doctors get light into the dark corner of the Dr Kelly cover-up. Truth must out.’
The lawyers must be formally instructed by August 30 so that proceedings can begin by September 8, the legal deadline by which the judicial review must be under way...

The doctors’ decision is likely to cause significant unease within Whitehall. No full explanation has been supplied for closing down the inquest into Dr Kelly’s death, which began as a matter of routine immediately after his body was found. It was replaced with a public inquiry chaired by Lord Hutton, who did not hear witness evidence under oath...
Last year it emerged that in 2004 all medical and scientific reports relating to his death – including photographs of his body – were secretly classified for 70 years.
Much of the material affected by this highly unusual gagging order has still not been released and no legal explanation for it has ever been made.
Mr Halpin added: ‘Coroners, not politicians, should determine how, where and when someone has died. That is our law in our country. There is an element of David and Goliath here...’