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.

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.] 

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.

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: 

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

 

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

Lang PO.

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

Abstract

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

Future cancers from Fukushima plant may be hidden/ AP

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

Infamous Endorsement of Anthrax Vaccine for Children/ AHRP

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

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

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

“There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit.”

Their justification is without substance, relying on a hypothetical, highly exaggerated risk from an unlikely event:

"Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security.” 

What evidence exists of any "national and potentially global threat from anthrax"? 

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

FDA's latest label warnings (2008) states:

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

 

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

From the Daily Mail's Miles Goslett:

The death of Dr David Kelly is to be examined at the High Court next month after a senior judge ordered a special hearing as part of  his review of the case.

Mr Justice Kenneth Parker is considering an application from retired West Country surgeon David Halpin to challenge the Government’s decision this summer not to hold a coroner’s inquest...

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

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

November 1, 2011


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

RE: Proposed Clinical Trials Testing the Anthrax Vaccine on Children

Dear Secretary Sebelius:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sincerely,

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

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

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

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