Thursday, April 29, 2010

Australian parents describe flu vaccine reactions/ ABC

But many of the parents had trouble getting their children's reactions reported to the authorities and followed up.  Asking parents to report directly to government should reveal much more about adverse events following this vaccine.  Hopefully, the system developed to receive reports will remain in place after this flu season, so that enhanced adverse event reporting is permanently built into the public health system of Australia (and everywhere else).  Only when "the system" is willing to acknowledge that vaccines may cause serious reactions, will a practical means of reporting reactions be created, and the data be collected to assess vaccine safety in a reliable way.

Illinois Public Health spends $2 Million to advertise swine flu vaccinations in April/ Chicago Tribune blog

Chicago Tribune blogger Eric Zorn wondered what was up with a "shock radio" commercial for swine flu vaccine this month.  So he investigated.  Apparently the US Government is not sufficiently in debt:  it made grants to all the states to educate us about swine flu.  Is there anyone left who needs to be educated?  Zorn then went to the CDC site with swine flu statistics, and learned that there is almost no swine flu circulating in the US at this time.  (See graph below; we are currently in week 17 of 2010 and there is almost no swine flu to be found.)  Here is what the Illinois Health Department told Zorn:
As with any educational campaign, there is a cost.  Radio and television stations don’t give prime airtime away for free, no matter what the message is.  This campaign cost approximately $2 million – IDPH used public health emergency response funding to pay for this educational ad campaign. The CDC and the federal government recognized the importance of educational campaigns and awarded public health emergency preparedness money to every state, and many major cities, specifically for educational campaigns.  The CDC stipulated that the money be used only for H1N1 flu efforts.
INFLUENZA Virus Isolated 

How much did Swine Flu Cost?/ Business Week

The US and UK won't tell what they spent.  But the US bought vaccine from 5 different manufacturers (Glaxo, Novartis, CSL, Astra-Zeneca (MedImmune was acquired by A-Z in 2007 after passing through multiple owners) and Sanofi-Pasteur, and bought antiviral drugs from 3 (Tamiflu (Roche), Relenza (GSK also) and Peramivir (BioCryst)).  They will have to report sales figures. Last July, WebMD posted the following on anticipated US purchases from each manufacturer:
Pandemic swine flu vaccine is already rolling off the production lines of the five different vaccine makers supplying the U.S: 46% will come from Novartis, 26% will come from Sanofi Pasteur, 19% will come from CSL, 6% will come from MedImmune, and 3% will come from GlaxoSmithKline.  [Glaxo sold much more overseas than in the US--Nass]
 From Business Week:
Glaxo said first-quarter swine flu vaccine sales reached 698 million pounds. Witty repeated that the vaccine’s sales this year will be about equal to the 883 million pounds the shot generated in 2009.

Wednesday, April 28, 2010

Seasonal flu risk--benefit/IBT Australia

Why so many reactions following seasonal flu vaccination?  Some have suggested it is due to children who had had earlier, subclinical flu infections.  Such silent infections would have left them with robust immunity.  They may then have responded to vaccination with an excessive response, triggering fever, convulsions and potentially death.  This idea remains a theory at this time.

Professor Peter Collignan points out that in a report on childhood swine flu vaccinations published in JAMA, 35% had fever. That seems rather high.  According to IBT Health, Australia:
The deputy director of the National Centre for Immunization Research and Surveillance, Kristine Macartney said more reactions were reported in Western Australia because it was the only state to have a policy of immunizing all children under five with the seasonal flu vaccine.

"Western Australia are immunizing many more young children than other states and territories, where children [elsewhere in Australia] are only recommended to have the vaccine if they are in a high-risk group," she said.

After receiving immunization, she observed that up to 40 per cent of children will develop elevated temperature and 3 per cent of children will have febrile convulsions at some stage.
Flu vaccines are only expected to provide immunity for a few months to a year.  So that is a lot of adverse reactions for a small benefit, especially when you take into account that most infections are silent [asymptomatic].  And convulsions are potentially life-theatening.  Who performed the risk-benefit calculation for this vaccine?  What is the precise makeup of the vaccine?  I will have more on this later.

Tuesday, April 27, 2010

Anthrax War Book Launch

Launch Party:  ANTHRAX WAR

By Bob Coen and Eric Nadler

May 3,   7pm

Melville House Bookstore

Come celebrate the paperback release of Anthrax War: Dead Silence . . . Fear and Terror on the Anthrax Trail by Bob Coen and Eric Nadler.
An in-depth look into the new biological arms race, Dead Silence conveys the inside story of the U.S. anthrax attacks and their connection to the existence of a frightening global germ warfare underworld. Coen and Nadler’s investigations take them across four continents and inside classified labs, revealing a web of secrecy, corporate greed, and global manipulation.
Author talk, Q&A -- with beer and wine followed by a screening of the documentary film the book is based on. 

Buy the book here.
@ The Melville House Bookstore
145 Plymouth Street in DUMBO, Brooklyn. (Corner of Plymouth and Pearl).

Saturday, April 24, 2010

H1N1 vaccine study investigating hints of complications from vaccine/ Washington Post

Rob Stein at the Post discusses a "hint" that swine flu vaccine may have caused increased cases of Guillain Barre Syndrome, Bell's Pallsy and thrombocytopenia.

The US CDC, unlike its counterpart in Australia, manages the news on vaccine adverse events closely, especially for swine flu.  Remember that CDC hosted a meeting for invited journalists and bloggers to teach them not to report small numbers of adverse events at the start of the swine flu vaccination program.  Attendees were not permitted to report on the meeting.  I blogged on this some months back.

We would therefore not be hearing about this hint unless the evidence was quite strong.  Furthermore, all 3 diagnoses are known to be side effects of other vaccines.  GBS has been caused by flu vaccinesCDC identified increased cases of Bell's Palsy reported following influenza vaccination in 2004.  Thrombocytopenia cases are increased after measles vaccine, according to FDA,  and increased after MMR vaccines

This increases the odds these diseases may be side effects of swine flu vaccine.  Because of enhanced swine flu vaccine adverse event surveillance in multiple countries, it will be difficult for one or two countries to cover up their findings.

Friday, April 23, 2010

Don't give children flu jab: chief medical officer/ Sydney Morning Herald

Australia's chief medical officer halted seasonal flu vaccinations for children under five, due to a high number of children in Western Australia experiencing fever and convulsions after the shot.  This will give the country time to ascertain whether the problem is due to "bad batches" or whether the makeup of the immunization itself is the problem.  The swine flu vaccine will continue to be used; it is the seasonal vaccine that appears to cause the problem.  New Zealand has followed suit and stopped vaccinations in the under-5 age group.

Kudos to Australia's public health system and chief medical officer for a perfect response:
  1. acknowledging the problem, 
  2. halting vaccinations pending results of its investigation, 
  3. enhancing surveillance for adverse events (even asking parents to report adverse events), 
  4. consulting with colleagues internationally, and 
  5. conducting its own investigation.    
The Australian Broadcasting Corporation has filled in more details, noting that severe reactions are occurring in other states, and in older children.

An healthy two year old girl died in Queensland 12 hours after receiving her seasonal flu vaccine, on April 9.
Professor Collignon says health authorities need to better weigh up whether rolling out a vaccination to millions of people around the country will cause more harm than good.
"If you're in a risk group everybody agrees you need to be vaccinated," he said.  "But the majority of the population don't have risk factors, including children, and before we roll out a vaccine to millions of people, in my view, we need to do studies of thousands of people over a period of time to make sure we are always going to do more good than harm with the vaccine."
Professor Collignon says about 20 per cent of Australian children who received the swine flu vaccine had moderate to severe side effects in the form of a fever of more than 38.5 degrees Celsius and severe muscle aches and pains.
But he says last winter, the risk of someone under the age of 40 getting swine flu and dying from it was less than one in a million.

"You have to start weighing this up because you may actually produce as much influenza-like illness with a vaccine as you prevent with people not getting influenza," he said... [When I had a private practice, it was my impression that about 20% of elderly flu vaccine recipients told me that they developed a flu-like illness shortly after receiving the vaccine--Nass]
Professor Collignon says an effective surveillance system should monitor thousands of people for one or two weeks after vaccination before rolling out the vaccine to the entire population... [This is absolutely what is needed for all vaccines.  But surveillance should be carried out over longer periods as well, since a different set of adverse reactions may occur later.--Nass]
UPDATE April 26:  Vaccinating small children against influenza is a new idea, and in the US was based on the (unproven) theory that vaccinating children will prevent their grandparents from getting flu.  The 2009-10 swine flu epidemic was the first to provide policymakers with a better rationale for vaccinating children: to protect children.  However, even for swine flu, the number of deaths in otherwise healthy children was quite small.  (To estimate total US child deaths, CDC quadrupled the number of known child deaths.  This strategy assumed that public health officials missed counting 75% of children who died.  However, virtually all child deaths occur in hospitals and were therefore counted, making the CDC strategy specious.)

Last October, Rino Rappuoli, MD (the head of Novartis Vaccines in Siena, Italy) wrote in Science magazine that, "At present, only the United States, Finland, and Mexico recommend vaccination of children, and implementation is low." [Public health. Rethinking influenza. Rappuoli R, Del Giudice G, Nabel GJ, Osterhaus AD, Robinson R, Salisbury D, Stöhr K, Treanor JJ. Science. 2009 Oct 2;326(5949):50.]  Thus there was little experience with mass flu vaccination of young children before now.

IMHO, the world's public health policymakers have jumped on the flu vaccines for children bandwagon with very little data on the risks and benefits, taking their cue from swine flu.  But influenza vaccines are made up differently each year, in a rush to be available before the winter flu season, and are therefore not tested in humans prior to use.  Whether children actually get more benefit than harm from such vaccines remains to be seen.  For flu seasons 2005-6 through 2008-9, less than 100 children died per season in the US from influenza.  Most had chronic health problems, and would have been in a high-risk group for whom vaccination is appropriate.  But is it appropriate for the rest of our children?

Thursday, April 22, 2010

Colleague Rebuts Idea That Suspect’s Lab Made Anthrax in Attacks/ NY Times

The New York Times' Scott Shane reports on the testimony of Henry E. Heine, former Ivins colleague, at the National Academy of Sciences panel reviewing the FBI's science at its meeting today.
... Asked by reporters after his testimony whether he believed that there was any chance that Dr. Ivins, who committed suicide in 2008, had carried out the attacks, the microbiologist, Henry S. Heine, replied, “Absolutely not.” At the Army’s biodefense laboratory in Maryland, where Dr. Ivins and Dr. Heine worked, he said, “among the senior scientists, no one believes it.”
... He told the panel that biological containment measures where Dr. Ivins worked were inadequate to prevent the spores from floating out of the laboratory into animal cages and offices. “You’d have had dead animals or dead people,” he said...
More thoughts of Dr. Heine were reported in the Frederick News-Post.

Microbiologist Henry Heine : 2nd interview on Bruce Ivins

Bobcast radio show in Frederick, MD

OPINION: Anthrax letters: Was Bruce Ivins hounded to death?/ UPI

Op-Ed piece by Col. Lawrence Sellin, Ret.
...Reinforced by a number of armchair detectives from academia, the FBI produced a profile of the anthrax mailer who was described as a lone person living within the United States, who had experience working in labs and was smart enough to produce a highly refined and deadly product.  He is a non-confrontational person, at least in his public life. He lacks the personal skills necessary to confront others. He chooses to confront his problems "long distance" and not face-to-face. He may hold grudges for a long time, vowing that he will get even with "them" one day and prefers being by himself more often than not.

In other words, Ted Kaczynski with germs...

Wednesday, April 21, 2010

Jury still out on swine flu handling a year on/ Agence France Presse

From AFP:
But a year on, questions linger as to whether a decision by the World Health Organization to declare swine flu a pandemic, thereby unleashing the slew of health measures, was over-dramatic or even tainted by commercial interests
"It's a decision which costs huge amounts of money, which frightened people throughout the world unnecessarily," said Paul Flynn, a British parliamentarian who led a Council of Europe inquiry on the issue.
The WHO's decision resulted "in the disruption the changing of priorities in health services which were concentrating on swine flu instead of concentrating on matters which were far more important to save lives," he charged.
Flynn noted that huge sums were spent on anti-virals and vaccines, which went largely wasted as skeptical populations refused to get vaccinated.
In France, for instance, the purchase of 94 million vaccines cost the state around 600 million euros, but only less than 10 percent of the population went to get vaccinated...

Unlearned lessons from the Steven Hatfill case/ Salon (Glen Greenwald)

From Glenn Greenwald's blog at
... It requires an extreme level of irrationality to read what happened to Hatfill and simultaneously to have faith that the "real anthrax attacker" has now been identified as a result of the FBI's wholly untested and uninvestigated case against Bruce Ivins.  The parallels are so overwhelming as to be self-evident.
Just as was true for the case against Hatfill, the FBI's case against Ivins is riddled with scientific and evidentiary holes.  Much of the public case against Ivins, as was true for Hatfill, was made by subservient establishment reporters mindlessly passing on dubious claims leaked by their anonymous government sources.  So unconvincing is the case against Ivins that even the most establishment, government-trusting voices -- including key members of Congress, leading scientific journals and biological weapons experts, and the editorial pages of The New York Times, The Washington Post and The Wall St. Journal -- have all expressed serious doubts over the FBI's case and have called for further, independent investigations.
Yet just as was true for years with the Hatfill accusations, no independent investigations are taking place.  That's true for three reasons.  First, the FBI drove Ivins to suicide, thus creating an unwarranted public assumption of guilt and ensuring the FBI's case would never be subjected to the critical scrutiny of a trial -- exactly what would have happened with Hatfill had he, like Ivins, succumbed to that temptation... Second, the American media -- with some notable exceptions -- continued to do to Ivins what it did to Hatfill and what it does in general:  uncritically disseminate government claims rather than questioning or investigating them for accuracy... Third, the Obama administration is actively and aggressively blocking any efforts to investigate the FBI's case against Ivins through an Obama veto threat, based on the Orwellian, backward claim that such an investigation "would undermine public confidence" in the FBI's case "and unfairly cast doubt on its conclusions"... 
The anthrax attacks were one of the most significant political events of this generation -- as significant as the 9/11 attack, if not more so, in creating the climate of fear that prevailed (and still prevails) in the U.S., which, in turn, spawned so much expansion of government power.  It is worth remembering what happened in the Hatfill case in order to be reminded of just how inexcusable it is that there has been no independent investigation of the case against Ivins and that the current administration is now aggressively and quite strangely blocking any efforts to do so...

Tuesday, April 20, 2010

Setting the Record Straight [when Glaxo Fakes the Data] / JAMA

Steve Nissen, head of Cardiology at the Cleveland Clinic, authored an editorial in JAMA last month on the means by which GlaxoSmithKline tried to cover up increased cardiac events in patients on its drug Avandia (Rosiglitazone).  JAMA's editor, Catherine DeAngelis, wrote her own editorial on this issue, noting:
According to the article by Nissen,1 the report of the Senate investigation,2 and published media accounts,8-9 the manufacturer of rosiglitazone exerted inappropriate influence during the conduct of a pivotal safety study of this drug, the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) clinical trial,10-11 which included undertaking nonprespecified unblinding of study data; attempting to undermine the authority and responsibilities of the study steering committee; expediting publication of an unscheduled interim analysis,10 specifically to counter2 the publication of a meta-analysis by Nissen and Wolski12 that suggested increased cardiovascular risk associated with rosiglitazone; having employees extensively involved in statistical analysis,11 and preparation of the manuscript10 reporting the results of the trial; and reportedly2 failing to fully acknowledge the significant cardiovascular risk associated with this drug...
Given the circumstances surrounding rosiglitazone1-2 and the RECORD trial,10-11 and perhaps other industry-sponsored trials, it is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance. This approach would add powerful support to the fundamental principle that physicians must first do no harm.
Analyzing data from 42 randomized clinical trials, Nissen et al. found a hazard ratio for myocardial infarction (heart attacks) of 1.43 in patients taking rosiglitazone compared to controls.  In other words, by using a drug to treat diabetes, you significantly increased your risk of having a feared diabetic complication:  a heart attack.  Rosiglitazone had more than $3 billion in annual sales.  So it paid Glaxo to take measures to confuse or obliterate this finding... and they did.

Fortunately, the Senate Finance Committee has released a 334 page investigation of this drug and the manufacturer's conduct of an important clinical trial.  (But it can no longer be found at the Senate Finance Committee URL listed by DeAngelis and others, unfortunately.)  Fortunately, Dr. Nissen consults for many drug manufacturers, but accepts no honoraria; instead his fees are donated to charity.

Unfortunately, there is only one Dr. Nissen.  We don't have reports on other drugs for which unscrupulous manufacturers deleted, invented or otherwise manipulated data to support the licensure and use of ineffective and/or unsafe products.

U.S. doctors, minorities still wary of shots: official (Sibelius)/ Reuters

From Reuters:
Doctors and minorities still have a dangerous mistrust of vaccines that became painfully clear during the H1N1 swine flu pandemic, U.S. Health and Human Services Secretary Kathleen Sebelius said on Monday...

In an average year, fewer than 40 percent of doctors, nurses and other healthcare workers get flu vaccines. 
Why don't officials ask why most doctors don't get vaccinated?  Doctors have more experience treating patients with influenza than members of any other profession.  Doctors are the ones who hear their patients report side effects.  Doctors therefore have the firsthand knowledge to balance risk and benefit, more so than anyone else, and they "vote with their feet."  It's unfortunate that people who are not health professionals, such as Secretary Sebelius, find this painful and dangerous. 

Thursday, April 15, 2010

Pharmaceutical firm spied on top FDA official/ Politico and

From Politico, this story of how over $100,000 was spent to dig up dirt on the head of FDA's Center for Drug Evaluation and Research:
For more than two months in late 2008, private investigators working for a drug company gathered information on a high-ranking official at the Food and Drug Administration — unearthing details about her husband, two daughters and in-laws  and retracing her steps on a business trip she took to Thailand.
The drug company, Amphastar Pharmaceuticals Inc., paid more than $100,000 to Kroll, the New York-based private investigative firm, to uncover the information about Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, who oversees the agency’s new-drug approvals...

Gulf War Syndrome: Institute of Medicine Report/ Washington Post

David Brown, M.D., described the most recent Institute of Medicine report on Gulf War Illnesses this week.  Brown tried to deny the existence of the illness back in 2006, with reporting that was either uninformed or misleading.  Here's what he wrote in 2006:
As recently as September, a panel of the National Academy of Science's Institute of Medicine reached the same conclusion that half a dozen other expert groups had: Gulf War syndrome does not exist.
Brown neglected to discuss the many expert groups that did acknowledge Gulf War Illnesses' reality.  I rebutted his comments then.  He continues to undermine the illnesses' reality in 2010, ending his article with the following statement:
Some others, however, argue that "Gulf War syndrome" is an amalgamation of physical complaints that are extremely common in all populations, civilian and military.
This time, the IOM report was very clear that not only are the illnesses real; up to 250,000 Gulf War soldiers have been (and remain) affected.  The IOM does not know the cause(s).  Nor does anyone else, with certainty, since the data needed to sort out the exposures are not available. 

The IOM therefore found a statistical association between multiple illnesses and Gulf War service, but did not state the association was causal.  What else could the IOM do?  The illnesses themselves are poorly understood pathologically.  The exact exposures cannot be pinned down (for any one individual).  Given that, how could causality be proven?  You might infer causality, but you can't prove it.  The IOM panel chairman got it right:
"We concluded that these symptoms are highly prevalent, persistent, and apparently disabling in this veteran population, even two decades after the war," said Stephen L. Hauser, the panel's chairman and a professor of neurology at the University of California at San Francisco. "They defy efforts, thus far, to fully understand their cause."  

Monday, April 12, 2010

Disposing of excess swine flu vaccine: government pays again

This article from the Bucks County Courier Times doesn't address how the 25 mcg. mercury-containing doses (in multidose vials) will be handled, since release into landfills and rivers is not safe or acceptable. Most swine flu vaccine used in the US was packaged in multidose vials, including a mercury preservative, with small stocks of single dose vials reserved for young children and pregnant women.

Too bad the vaccine product wasn't made with a longer expiration date, since this vaccine will be included in the 2010 fall-winter flu vaccine shot.  So our taxes pay to destroy excess vaccine capacity and then pay to buy more identical vaccine antigen for the coming winter's vaccine.  What a brilliant business model.

Stuck with thousands of unused swine flu shots, local health care providers find themselves paying to discard flu vaccine for the first time in recent memory...

Meanwhile, a Centers for Disease Control and Prevention spokesman said the agency is preparing a swine flu vaccine disposal plan but won't offer suggestions in the meantime...
UPDATE April 13:  (Reuters) "It is too soon to determine whether tens of thousands of doses of H1N1 swine flu vaccine may have to be thrown out if they are not used before their expiration date, a U.S. health official said on Thursday... Dr. Anne Schuchat, head of the CDC's National Center for Immunization and Respiratory Diseases, said it was difficult to say how many H1N1 vaccine doses may be discarded. Yet Pennsylvania's state health department reports it has already disposed of 27,000 doses.  And those doctors and clinics left holding the bag (I mean vials) will have to pay themselves to dispose of what is left. UPDATE 2 April 24:  Allegheny County, Pennsylvania has 100,000 doses to destroy, plus an unknown amount in doctors' offices and clinics.
Hello?  The US ordered 251 million doses of swine flu vaccine, according to the LA Times, or 229 million doses, according to Reuters.  It used 1/3 of this stockpile.  Yet instead of admitting there are about 150 million excess doses, most or all of which will expire before the next flu season, A "US health offical" loses 4 decimal places (4 orders of magnitude) and suggests that only tens of thousands of doses may have to be discarded.

Furthermore, the amount spent worldwide to respond to the swine flu pandemic has suddenly shrunk, according to the American delegation to a WHO meeting on swine flu and the role of WHO.  It was only 4 billion dollars, claim the Americans, citing a World Bank estimate.

Yet vaccine cost about $10/dose in the US, so that was about $2.5 billion alone.  The cost to administer the vaccine (wages for those holding clinics, costs of advertising the clinics, syringes, gloves, etc.) is approximately $10-20/dose.   Add to that the costs of Tamiflu and Relenza.  So the cost of the swine flu preparedness program in the United States alone exceeded the alleged cost to the world of swine flu preparation.

UPDATE 3 (April 28): The UK won't admit what it spent on Swine Flu, but Glaxo earned 700 million pounds (1.07 billion dollars) in swine flu revenue during the first quarter of 2010.

Do our government health agencies think the public has no memory and cannot do arithmetic? Where are the names of these anonymous spokespeople?  Is anyone accountable for these spending decisions and shifting of health priorities?

Friday, April 9, 2010

Experts Debate Extent of FDA Reform in Wake of Whistleblower Testimony/ Medscape

From the April 5 Medscape:
... The testimony repeated charges that Dr. Nicholas made in a letter last December to HHS Secretary Kathleen Sebelius and FDA Commissioner Hamburg. He disclosed that he had sought an FDA warning label on the CT scanner in question that would highlight the risk for radiation-induced cancer, noting that between 1.5% and 2% of all cancers "are directly attributable to radiation exposure from CT scanning."

"You could imagine the appalling consequence," Dr. Nicholas wrote Ms. Sebelius and Dr. Hamburg, "of clearing a device that may not be as effective as [optical] colonoscopy, that may be misused to actually prevent patients from being studied with colonoscopy, and that may also cause radiation-induced cancer."
"I was continually harassed and pressured to change my review by managers, but because of my commitment to the public, I could not in good conscience do so, absent a valid scientific reason. I was intimidated and ultimately suffered the most severe form of retaliation against any employee engaged in whistleblowing activity — termination..."

Dr. Nicholas's allegations were riveting, but they are not new. In a series of group letters to Congress and the White House going back to 2008, FDA physicians and scientists depicted the FDA as a broken, corrupt institution more beholden to medical device manufacturers and the politicians that lobbied on their behalf than to the public it was supposed to protect.

An April 2 letter to President Barack Obama stated that despite new leadership at the very top, the agency still abounded with veteran managers who have "violated laws, rules and regulations; who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out." The letter recommended disciplinary action against such employees, adding that some cases might need to go to the US Attorney General's office...

Steven Findlay, a senior health policy analyst at Consumers Union (the publisher of Consumer Reports), noted that the agency's tilt toward drug and device makers began before George W. Bush became president. "The culture at the FDA has been problematic for many years," he said. "But it became more acute during the Bush administration," he noted...

More Mandatory Vaccinations Planned for Healthcare Workers/ Inf Disease News

From Infectious Disease News:
ATLANTA, March 18, 2010 — Mandatory vaccination policies increased the number of health care workers who received the influenza vaccine during the 2009-2010 influenza season, according to results from two studies presented here at the Fifth Decennial International Conference on Healthcare-Associated Infections...

Researchers in the first study analyzed the outcomes of a mandatory vaccination/declination policy instituted by the Hospital Corporation of America in 163 hospitals, 112 outpatient centers and 368 physician practices in 20 states. The policy required all health care personnel to receive the influenza vaccine or be reassigned to nonpatient contact roles or use surgical masks.

Ninety-six percent of the hospital employees received their seasonal influenza vaccine by Nov. 1, which was a 65% increase in vaccination rates vs. the mean 58% during the previous season.

“We expect to move forward using this vaccination campaign strategy for future influenza seasons, and we expect other health care institutions to follow suit,” said Jonathan Perlin, MD, PhD, chief medical officer of Hospital Corporation of America. “Our approach enhanced patient safety and our employees delivered with an overwhelming response.

A second study evaluated the disparities in employee vaccination rates over a five-year period at the Children’s Mercy Hospitals and Clinics in Kansas City, Mo. This hospital also implemented a mandatory vaccination/declination policy in 2008, and vaccination rates rose from 63% to 85%. The addition of certain consequences during the 2009-2010 season, including forced leave of absence for noncompliance, further increased rates to 98.8%. 

“Our dramatic increase in vaccination participation over the last few years has been astounding,” [threaten peoples' jobs during a recession and they comply--why is that astounding?--Nass] said Robyn Livingston, MD, director of infection control and prevention at Children’s Mercy Hospitals and Clinics. “Even though the program has exceeded our expectations, we recognize there is still room for improvement. We are considering a fully mandatory influenza vaccination policy to begin next fall.

Thursday, April 8, 2010

Gardasil trial stopped in India after 4 girls aged 10-14 die/ dnaIndia

According to DNAIndia,
... The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche...
More from The Hindu:
Dr. Katoch said a memorandum was signed with PATH-International in February 2007 for a project allotted to it by the Bill and Melinda Gates Foundation for assessing the feasibility of introducing HPV vaccine in India. Merck and GSK were to provide the vaccine and ICMR helped in protocol preparation.

Initially, the NGO conducted a survey of the social acceptability of the project with the help of a questionnaire among the socially disadvantaged groups, as cervical cancer occurred more among the women from the disadvantaged sections with less health facilities and low-capacity for buying expensive drugs. By the time the trial ended, the Drugs-Controller of India gave approval for marketing the two vaccines.
Pointing out that the trial started after approval from the State Advisory Committees and the ethical committees of the Andhra Pradesh and Gujarat governments and the National Technical Advisory Group as per the agreement with the NGOs, Dr. Katoch said: “Everything was going fine until we received complaints of violation of guidelines and exploitation of people from civil society groups some months ago following the death of four girls, who were given this vaccine.”

Wednesday, April 7, 2010

Bruce Ivins: Important new info reported by former colleague Henry Heine

Excerpts from interview with Dr. Heine interview on wfmd and Lew Weinstein's "Case Closed" blog:
"It was clear that they were focused on a small group of us at USAMRIID, one of which was Bruce.   Of the 4 or 5 of us they were focused on, one of them was Bruce.

Dr. Heine says all the USAMRIID scientists were interviewed in mid-October 2001 on where they were on the dates of mailing. (Comment: What did Dr. Ivins say when asked within 2 weeks of the mailing? Why wasn’t his response at the time provided?)

Dr. Heine says that the drying equipment that would be needed was not available — and not protected — in Dr. Ivins’ workspace.  He says Dr. Ivins did not have the knowledge or expertise to grow up large amounts of bacteria — it would have been impossible for Bruce to do.  He says lyophilizer was in non-containment area and could not have been used.

On the government having it all rely on Flask 1029, he analogizes it to the situation of the guy at the Walmart and blaming him for a shooting in town because he had control of the bullets at one point under the counter. He says that’s all they have — and implies that is ridiculous."

Canada: We Were Right. Prior (non-swine) flu shots increased risk of getting swine flu infection/ US News

The traditional seasonal flu vaccine may have increased the risk of infection with pandemic H1N1 swine flu, according to the results of four new studies by Canadian researchers, published in PLOS Medicine.
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly.  Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent.  (Then the license is withdrawn.) For details, see my prior post on this topic.  According to a detailed article in CIDRAP:
If that finding is not the result of chance or bias that occurred despite careful study design, the researchers say, then several hypotheses might explain the increased risk. Immunization might block the cross-protective immunity created by an earlier infection. "Original antigenic sin," or immunologic memory dating back to someone's first flu infection, might create antibody responses that are cross-reactive to other flu strains, but not strong enough to be cross-protective, and thus do not neutralize the virus. Or a related phenomenon called "antibody-dependent enhancement" might lead antibodies to inadvertently enhance virus uptake and production.
Immunity is not a simple thing.  Vaccine theory is in its infancy, and vaccine development is based on trial and error. 

Here then may be a rather serious unintended consequence of flu vaccination:
The researchers found that (getting an earlier year) seasonal flu vaccination was associated with a 68 percent increased risk of getting swine flu (infection).

UK used only 5% of the H1N1 vaccine originally ordered/ BBC

The UK government originally contracted for 120 million doses of swine flu vaccine; it was able to cancel some contracts (by agreeing to buy bird flu vaccine for an epidemic that does not exist, and buying extra flu drugs from GSK), but still purchased 44 million doses.

Only 6 million doses were actually used.  The total cost of the swine flu vaccine procurement was not stated, but probably approaches a billion dollars.  (Neither the UK government nor the manufacturers will divulge the actual price.)  According to Business Week and the Independent:
GSK is in talks with a number of other administrations over plans to par back vaccine orders. A host of northern hemisphere countries are known to want to slash orders after the initial spike in incidents of swine flu cases quickly tailed off. Among them, France, Belgium and Spain are thought to be in talks with GSK.
The company said that it would not be altering its earnings estimates for 2010, saying that it expects to see swine flu vaccine sales of about £880m this year, a similar amount to 2009.

Facts about H1N1 epidemic and vaccine in Australia/ Australian Prescriber

Professor Peter Collignan provides us with facts (finally we get to see some unvarnished information) on how bad the H1N1 virus was for healthy people, as well as learning of much higher adverse event rates for the vaccine than have been previously reported.  However, the CSL vaccines used in Australia were almost certainly different than the vaccines used in the US.  Only one in a million healthy people under age 40 (omitting pregnant women) died.  CDC never broadcast this figure.
In the 2009 Australian winter, swine flu's associated mortality rate was 0.9 per 100 000 people. In those under 40 years with no risk factors, the mortality rate was less than one per million.  While there were some differences (for example pregnant women), the overall effects of this virus as judged by absenteeism, hospitalisations and deaths were similar to those of previous seasonal influenza strains...

In an Australian H1N1 vaccine trial of adults (aged 18–65 years), 27% had protective antibody concentrations and 62% had detectable pre-existing antibodies...

In Australia, we do not have good postmarketing surveillance mechanisms in place and mainly rely on voluntary reporting. This is unlikely to accurately measure the percentage of people who get adverse effects or to identify rare adverse effects in a timely fashion...

The reason these issues are important is that we do not have robust data on which to make proper decisions on the cost-effectiveness of any mass vaccine programs. In young people without risk factors, the rates of death and complications last winter from swine flu were very low and are similar to the risk of serious vaccine-associated adverse effects such as Guillain-Barré syndrome and anaphylaxis. Around 50% of people who received the H1N1 vaccine in the Australian trial had mild to moderate systemic adverse effects and 1.7% had (solicited) systemic adverse effects recorded as severe.  In children, 20% had moderate to severe systemic adverse effects after receiving a single 15 microgram dose of vaccine.  It is very important that we make sure we do more good than harm with any vaccine.

Tuesday, April 6, 2010

Tories will reopen probe into Dr Kelly's 'suicide' (if they win election)/ Mail Online

From the Daily Mail, excerpts follow:
The investigation into the death of Dr David Kelly would be re-opened under a Tory government, according to a senior Conservative.  Shadow Justice Secretary Dominic Grieve said the public has 'not been reassured' that the Whitehall scientist took his own life.

Mr Grieve said that, if the Tories take power, he would 'review' the evidence that Dr Kelly killed himself - a conclusion which has been repeatedly challenged by experts.  An inquiry led by Lord Hutton concluded that the scientist committed suicide in July 2003... [However]
The campaigning doctors say the artery Dr Kelly severed is too small and difficult to access and cutting it could not have caused death...

Mr Grieve's letter, to Dr Michael Powers QC, an expert on coroners' law, follows revelations that Lord Hutton secretly ruled that evidence relating to the case, including Dr Kelly's post-mortem report, should not be released for 70 years.  Lord Hutton later said he would be happy for the doctors to see the records, including photographs of Dr Kelly's body, but still the information is being withheld.  When asked this weekend for his view on the Ministry of Justice's delay in releasing the documents, Lord Hutton refused to comment.

Liberal Democrat MP Norman Baker has claimed Dr Kelly did not commit suicide and might have been the victim of a murder and subsequent cover-up.

Maine Voices: U.S. intelligence reform top priority/ Portland Press Herald

Op-Ed written by Meryl Nass, published April 6:

A surprising tug of war has erupted between the Obama administration and Congress over transparency and oversight of the intelligence agencies.  In September 2009, the Senate passed the 2010 Intelligence Authorization Act, and on Feb. 26 the House passed a similar bill. They were about to be melded. But on March 15, Peter Orszag, director of the Office of Management and Budget, threatened a presidential veto if provisions of “serious concern to the intelligence community” were included.

Congress had many concerns about U.S. intelligence. The intelligence services provided no warning before Sept. 11, 2001. The intelligence that supported going to war in Iraq was deeply flawed; failures of intelligence collection, sharing, analysis and supervision were evident.


What were the Obama administration’s concerns? The first involved notifying Congress of covert activities and other intelligence matters.

Currently, certain matters are only briefed to the “Gang of Eight” – the Senate majority and minority leaders, the House speaker and minority leader, and the chairmen and ranking members of the House and Senate intelligence committees. Although they are “briefed,” they may not take any notes, may not be accompanied by staff, and may not discuss the briefing with anyone. The process neither seeks congressional approval nor allows for objections.

Understandably, Congress wanted to expand such notifications and include all members of the intelligence committees. Congress also sought information on the “legal authority under which an intelligence activity is being or was conducted.” The administration resisted both provisions.

Orszag further objected to a provision in the new bill that would give the Government Accountability Office, the investigative arm of Congress, broader authority to conduct investigations of the intelligence community. Ironically, Adm. Dennis Blair, the current director of national intelligence (and a native of Kittery) had agreed with this during his confirmation hearing last year.

Other objections included the requirements to videotape interrogations and obtain Senate confirmation for additional leadership positions within the intelligence community, and conduct further investigation into the anthrax letters case.

The FBI closed the anthrax case last month despite dozens of unanswered questions. The administration claimed that further investigation “would undermine public confidence … and unfairly cast doubt on its conclusions.” But why shouldn’t Congress review an unsatisfactory conclusion to a crime that had profound repercussions for our country?

Congress has the duty to pay for and oversee federal expenditures, and make sure federal programs accord with our laws. If the tools available are inadequate to the task, more tools must be forthcoming.
Recent congressional precedent, alluded to by Orszag, took a “hands-off” approach to intelligence. The current administration wants the hands-off approach to continue. But is it wise?

Recent precedent led to violations of our Bill of Rights: Warrantless wiretapping by the National Security Agency is prohibited by the Fourth Amendment’s protection from unreasonable search and seizure.

“Extraordinary rendition” is prohibited by the Fifth Amendment’s requirement for due process of law.
Incarceration for years, without benefit of legal counsel, is prohibited by the Sixth Amendment’s rights of the accused, including the right to a speedy trial.

The Eighth Amendment prohibits cruel and unusual punishment (torture), as do our treaties.

These violations arguably make our nation less safe. Thus Congress has a clear mission to oversee and correct the conduct of the intelligence agencies. Do others agree?


The 9/11 Commission Report asked for improved congressional oversight of intelligence, noting, “Of all our recommendations, strengthening congressional oversight may be among the most difficult and important.”

The Report of the President’s Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction warned, “The intelligence community is a closed world, and many insiders admitted to us that it has an almost perfect record of resisting external recommendations.”

Maine’s Sen. Olympia Snowe introduced important new oversight provisions in the 2010 Intelligence Authorization Act.

It is critical for her and the rest of Congress to have the public’s support of their efforts to improve performance and accountability in the intelligence community.

Saturday, April 3, 2010

Health Care Costs (Large Savings Await for a Gov't that Wants to Save)/NYT

Recall that FDA's Device Center was recently shown to make political decisions re medical device approvals, and to grandfather in devices on the basis of earlier approvals of very different devices.  GAO wrote several damning reports including this one from June 2009: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments.  GAO pointed out in January 2009 that only cursory reviews were taking place for most devices.  Thus the Center's Director was let go.

Yesterday's NYT reports on devices that fail, and how the health care system has to eat the very expensive results of such failures.  But in the US, medical devices come with no warranty:
When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty. But that is not how the multibillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers.
The article points out that the new healthcare bill should have addressed this issue, but did not.

Friday, April 2, 2010

Technologies Underlying Weapons of Mass Destruction/Office of Technology Assessment

In 1993 the US Government knew that silicon was used to enhance dispersal of powdered microbial agents and toxins.  OTA produced some very useful research, but the agency no longer exists.

U.S. Congress, Office of Technology Assessment, Technologies Underlying Weapons of Mass Destruction, OTA-BP-ISC-115 (Washington, DC: U.S. Government Printing Office, December 1993).
The stability of a microbial aerosol can be
increased by adding a variety of compounds to the
spray material.58 Moreover, antiagglomerants such
as colloidal silica help prevent the clumping of
freeze-dried microbial agents and toxins that have
been milled into a fine powder.

The Anthrax Attacks and the System That Perpetrated Them — Barry Kissin _on Guns & Butter

This show was broadcast March 29, 2010.
It is now archived here  (But note that the linked website has an annoying "radio" in the upper right corner that turns itself on several times during the radio interview, and must be turned off immediately so the interview can be heard.)

Health official charged in flu vaccine buy/ UPI

SOFIA, Bulgaria, April 2 (UPI) -- Bulgarian Health Minister Bozhidar Nanev resigned after being charged with corruption in the purchase of unnecessary H1N1 flu vaccine doses.
Nanev, 57, was charged with overspending on 200,000 doses of vaccine from the highest bidder weeks after a flu epidemic had ended, The Sofia Echo reported.
Prosecutors allege Nanev signed a deal with Swiss drug maker Roche in December that cost more than $1.6 million more than a lower bid received 20 days earlier from Britain's National Health Service.
Nanev denied the charge and was free on bail, the EU Observer said.
The vaccine is in storage and has a 2014 expiration date, the Echo said.

Anthrax Investigation: Silicon Mystery Endures in Solved Anthrax Case/ Science

Science 19 March 2010:
Vol. 327. no. 5972, p. 1435
News of the Week
Yudhijit Bhattacharjee

What about the silicon?

That question has confounded investigators throughout the probe into the 2001 anthrax letter attacks, which the U.S. government formally concluded in February. Scientists inside and outside the government say there is clear evidence that the high levels of silicon found in the anthrax came not from anything added to "weaponize" the anthrax spores—as researchers had suggested early in the probe—but from the culture in which the spores were grown. That evidence may have settled the issue of whether the anthrax was weaponized, at least for scientists familiar with the case. But it raises a different question: Why did the mailed anthrax have such a high proportion of spores with a silicon signature in comparison to most other anthrax samples?

The answer, according to academic scientists who helped with the case, probably would not change the FBI's conclusion that the attacks were the sole handiwork of now-deceased U.S. Army researcher Bruce Ivins. But it could help illuminate exactly how the attack material was prepared. Resolving the mystery might also pave the way for new techniques using trace elements in a bioterrorism agent to link it to its source.

"There's tremendous interest in using metal signatures as a forensic tool," says Adam Driks, an anthrax researcher at Loyola University Chicago in Illinois. But the science to do that is lacking: "We know very, very little about the diversity of elemental composition within spores when they are produced in different ways."

Figure 1Closer look. Michael (above) saw silicon well inside individual spores, visible as the green lining in the top right image.


The FBI's scientific case against Ivins rests on DNA tests showing that the mailed anthrax came from a flask under Ivins's control at the U.S. Army Medical Research Institute of Infectious Diseases in Frederick, Maryland. Investigators also had the attack material chemically analyzed, first at the Armed Forces Institute of Pathology (AFIP) in Washington, D.C., within weeks of the attack. Examining the spores under a scanning electron microscope, AFIP scientists detected silicon and oxygen and concluded that the spores had been coated with silica to make them float easily, enhancing their power to kill.

A more detailed analysis by Joseph Michael and Paul Kotula of Sandia National Laboratories in Albuquerque, New Mexico, contradicted that conclusion. Studying individual spores with a transmission electron microscope, they found that the silicon was located within the spore coat, well inside the cell's exosporium (outermost covering). By contrast, when they looked at surrogate spores weaponized with silica, the silicon was clearly outside the exosporium.

But the Sandia study, presented last September to a National Academies panel reviewing the science behind the investigation, still leaves questions. Out of 124 spores from a letter mailed to Senator Patrick Leahy of Vermont, Michael found the silicon-and-oxygen signature in 97—78% of the sample. The signature was present in 66% of a sample from a letter to former Senator Tom Daschle and in 65% of spores from a letter sent to the New York Post.

Out of nearly 200 other anthrax samples from different labs, none came close to displaying such a prominent silicon signature. The highest, in a sample from Dugway Proving Ground in Utah, was 29%. The researchers couldn't find silicon in the coat of a single spore out of some 300 taken from RMR-1029, the flask in Ivins's lab identified as the source of the bacteria used in the attacks; they concluded that all the silicon had come from the culture.

The unusually high percentage of silicon-bearing spores in the attack material "is a bit of a strange thing," says Michael. "We have no way of knowing how they were really grown." An anthrax researcher who did not wish to be named calls it "awfully weird" and "a particularly inconvenient exception" because it leaves a gap in the case. However, neither scientist thinks the anomaly casts doubt on the broader investigation.

The key to the mystery likely lies in the culture medium the perpetrator used to grow the anthrax spores, says Michael. In a recent study, Japanese researchers grew colonies of Bacillus cereus—a close relative of the anthrax bacterium, B. anthracis—in culture media with and without added silicate. Spores grown in the silicate-containing culture showed silicon within the spore coat. In the absence of silicate, there was no silicon, the group reported in January in the Journal of Bacteriology.

One of the study's authors, microbiologist Akio Kuroda of Hiroshima University in Japan, says the precise amount of silicon in individual spores from the anthrax letters could offer clues about the medium. "If the anthrax spores contained a high amount, the suspect must have used a medium that was supplemented with silicon or that intrinsically contained a lot of silicon," Kuroda says. "If a thorough testing of various media sold in the U.S. identifies a few that contain higher amounts of silicon, those could become an investigative clue."

Thursday, April 1, 2010

Millions of H1N1 vaccine doses may have to be discarded/ WP

From the WaPo:

Despite months of dire warnings and millions in taxpayer dollars, less than half of the 229 million doses of H1N1 vaccine the government bought to fight the pandemic have been administered -- leaving an estimated 71.5 million doses that must be discarded if they are not used before they expire...(and 25 million to be donated to poor countries)...

The World Health Organization, meanwhile, faces mounting charges that it overreacted to the pandemic. The Council of Europe's Parliamentary Assembly is investigating allegations that the Geneva-based arm of the United Nations was influenced by pharmaceutical companies to exaggerate the risk, thereby helping in vaccine sales...
WHO officials have strongly disputed the charges, saying the response was vital given the uncertainty about the new virus and its potential threat. Many independent public health experts have defended the agency.

Nevertheless, the WHO has launched an internal review of its response and announced Monday that a committee of 29 outside experts (chosen by WHO, however--Nass) would conduct an independent assessment. The critique will include whether WHO's pandemic alert system should consider the severity of a new virus, not just whether it is novel and spreading globally.
"Could we have made decisions better? Could we have considered things in a different way at the time?" said Keiji Fukuda, WHO's top flu official, told reporters Monday. "We, along with many others, are asking the same kinds of questions of ourselves and each other...

Internationally, officials are concerned because the virus has started spreading widely for the first time in some parts of the Southern Hemisphere, especially in poor African countries with limited resources to stem the spread and treat cases.

Gulf War Veterans: The VA Takes Important First Steps

by: Paul Sullivan and Anthony Hardie, t r u t h o u t | Op-Ed.  Excerpts follow:
Last week, the US Department of Veterans Affairs (VA) officially recognized several diseases as linked with deployment to the 1991 Gulf War...
As Gulf War veterans, we applaud the VA's proposed new regulations that streamline access to disability benefits for Gulf War, Iraq war and Afghanistan war veterans.
More importantly, the VA's new policy opens access to urgently needed free VA health care for the lingering, disabling health outcomes of these terrible diseases.
The VA's recent decisions were made possible by VA Secretary Eric Shinseki and his Chief of Staff, John Gingrich, a fellow Gulf War veteran. The new regulations, prompted by Gulf War veterans' advocates and the VA's internal Gulf War Veterans Task Force, will impact more than 3.3 million people - the 700,000 veterans of the 1991 Gulf War, the 400,000 veterans deployed to Southwest Asia between 1991 and 2001 plus the 2.2 million who deployed to the wars in Afghanistan and Iraq.
We also applaud the VA's simultaneous decision to expand approval of veterans' disability claims for undiagnosed and ill-defined illnesses which affects at least 25 percent, or up to 210,000, of our Gulf War veterans.
For the historical record and for the new VA's leaders, we hope you understand our cautious optimism:
  • The VA fought against Gulf Research, health care and benefits legislation in 1994 and 1998.
  • After the laws were passed, the VA still fought against implementing them.
  • The VA took four years to create the mandated Research Advisory Committee on Gulf War Veterans' Illnesses until caving to fierce Congressional and veteran advocacy.
  • The VA managers intentionally refused to notify about 15,000 Gulf War veterans of a 2001 law that expanded access to benefits and health care.
  • The VA staff manipulated the scope of the Institute of Medicine scientific research reviews to specifically exclude certain types of studies for consideration for health care and benefits. Specifically, the VA excluded lab animal studies linking depleted uranium (DU) with birth defects and cancer.
  • Last year, the VA impeded and then canceled a Congressionally mandated contract for unparalleled Gulf War illness research at the University of Texas Southwestern (UTSW).
  • This year, the VA used the Gulf War research funds designated for UTSW to buy an $11 million piece of lab equipment of dubious value to Gulf War veterans.
  • The VA staff still fight against critical research about toxic exposures and medical treatments, thus impeding our efforts to obtain health care.
If we as a nation are serious about providing justice to our Gulf War veterans, then the new VA has taken a few very positive first steps. In order to prevent future obstruction of health care for veterans returning home from Iraq and Afghanistan, then the military has a legal and moral obligation to immediately shut down the use of burn pits overseas. The VA must also provide medical exams to our all returning troops and begin longitudinal studies.
When our government takes these steps, then we will have more confidence it is truly heading in the correct direction.