Thursday, February 2, 2012

Misconduct pervades UK research/ Financial Times

From the Financial Times' Science Editor, Clive Cookson:
UK research is plagued with misconduct, according to a survey of 2,700 scientists by the British Medical Journal. It found that 13 per cent had first-hand knowledge of UK-based researchers deliberately altering or fabricating data, while 6 per cent were aware of misconduct that had not been properly investigated. 
The BMJ released the results at a conference in London where experts pushed for stronger action to tackle what they said was a problem being ignored by many universities, hospitals and other scientific institutions.
Fiona Godlee, BMJ editor, said the survey showed “that there is a substantial number of cases and that UK institutions are failing to investigate adequately, if at all.
“The BMJ has been told of junior academics being advised to keep concerns to themselves to protect their careers, being bullied into not publishing their findings, or having their contracts terminated when they spoke out,” she added.

Speaker after speaker at the meeting said Britain should not be complacent just because the most publicised cases of fraud in recent years had taken place in other countries. “The British public do not know what is going on,” said Dr Godlee. “People need to realise that misconduct is affecting patients every day and it is a misappropriation of public funds.”

Journal editors were often the first to come across cases of misconduct, when they spotted inconsistencies in scientific or medical papers, said Elizabeth Wager, chair of the Committee on Publication Ethics, a forum for editors and publishers. “But they are not the right people to investigate misconduct,” she said. “That responsibility lies with the researchers’ institutions.”

“This BMJ survey chimes with our experience from COPE where we see many cases of institutions not co-operating with journals and failing to investigate research misconduct properly,” Dr Wager added.
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.

Unlike some other countries, the UK has no official national body to deal with research misconduct. The closest equivalent is the UK Research Integrity Office, established in 2006 as a voluntary body funded mainly by universities.

“UK RIO is a fairly modest organisation and we have had a bumpy ride [getting established] because some players wanted us to die a death,” said vice-chair Mike Farthing, vice-chancellor of Sussex University. But he hoped for more institutional support to expand its activities in future.

Saturday, January 28, 2012

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

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

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.

Nicole Lurie
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

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.

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

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...

Friday, January 20, 2012

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


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.

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...

Wednesday, January 18, 2012

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

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... 

Thursday, January 12, 2012

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

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.  


    * 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?

Wednesday, January 11, 2012

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

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

 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

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?

Tuesday, January 10, 2012

My interview on vaccine safety with Gary Null and Associates

Fifteen minutes on vaccine regulation/safety on YouTube.

Monday, January 9, 2012

My Guantánamo Nightmare/ NY Times

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.

Wednesday, December 28, 2011

Proven Ways to Avoid Influenza Safely and Inexpensively

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.

Tuesday, December 20, 2011

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

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
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
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
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.


Monday, December 19, 2011

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

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...


Saturday, December 10, 2011

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

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.

Tuesday, December 6, 2011

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

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.

Friday, December 2, 2011

Eliot Spitzer: A Secret Scandal/ Slate

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....

Thursday, December 1, 2011

Fukushima nuclear catastrophe closer than thought/ The Australian

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...

Wednesday, November 30, 2011

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

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.

Tuesday, November 29, 2011

Australian Medical Association urges watch on vaccines/ The Australian

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

... 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

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.] 

Monday, November 28, 2011

What Really Happened to Strauss-Kahn?/ NY Review

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.

Tuesday, November 22, 2011

Important Advantage from Actually Getting Flu?

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

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.

Sunday, November 20, 2011

Future cancers from Fukushima plant may be hidden/ AP

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.

Monday, November 14, 2011

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

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.

Saturday, November 12, 2011

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


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.