Sunday, June 10, 2007

Congress Tried to Solve the Problems with Anthrax Vaccine, But Failed

Congress tried to fix the worst aspects of the anthrax vaccine program, and obtain more reliable information on anthrax vaccine between 1999 and 2002.

Congress appears to have failed for two reasons: it does not like to step on DOD's toes, and it was outsmarted.

Congress demanded Vaccine Healthcare Centers

Congress likes win-win situations and has tried to solve the anthrax vaccine problem by creating win-win solutions. When it faced the wrath of the upper levels of the Department of Defense, on the one hand, and injured and scared troops, on the other, instead of ending the vaccine program, Congress mandated the creation of Vaccine Healthcare Centers, where those who believed they had received a vaccine injury would be treated, and their illnesses could be researched.

The House–Senate conference report that was generated in conjunction with fiscal year 2001 appropriations legislation and with fiscal year 2001 funding provided by Public Law 106-554 said the following:

“Regarding the anthrax study, the conferees understand that clinical studies will be greatly facilitated by the establishment of the Vaccine Healthcare Center Network, with the first site at Walter Reed Army Medical Center. This Network will facilitate data collection, standardization of the anthrax immunization, training and general data collection for this project.”

However, six years later, soldiers do receive treatment at the four Vaccine Healthcare Centers --but overall, no one has been cured, and only a few have been significantly improved. The Centers themselves have had to fight for funding each year, and face threats of closure. They have done research, according to a 2007 talk by the Clinics' founder/director, Renata Engler M.D., recently retired head of Allergy-Immunology at Walter Reed Army Medical Center. But none of it has been published in medical journals or made available to the public. Only one 2002 abstract, describing the first 82 patients treated, can be found. Yet over 2,000 more patients have had complete evaluations at the Vaccine Healthcare Centers since.

Dr. Engler has given a number of talks about anthrax vaccine issues, many of which are available on the internet. On the one hand, while on active duty, Dr. Engler claimed that vaccine safety concerns have been based on rare cases -- but on the other hand, she also said in April 2007 that serious adverse events in 1-2% of vaccine recipients may need exemption management, and admitted that the adverse effects from mixtures of drugs and vaccines are unknown. One million six hundred thousand soldiers have received anthrax vaccinations since 1998. If 2% had a serious adverse reaction, that would be 32,000 already-injured people.

Thus the Vaccine Healthcare Centers, at Walter Reed, Fort Bragg NC, Norfolk VA and Wilford Hall TX, have neither clarified questions regarding adverse reactions from anthrax or other vaccines used in the military, nor have they developed curative treatment protocols. Most military medical providers are not aware the Centers exist, and injured soldiers frequently fail to be referred to them for assistance.

Congress demanded Medical Research on Anthrax Vaccine

Congress also required that the Centers for Disease Control and Prevention (CDC) research adverse reactions to anthrax vaccine. To ensure that adequate and effective research projects were undertaken, Congress demanded in 2000 that an Institute of Medicine Committee be formed to guide CDC in this endeavor.

The Institute of Medicine Committee did a good job of evaluating CDC's proposed research projects and recommending which were most valuable. This Committee also emphasized the need to perform longitudinal research to assess the possibility of reactions developing months or years after vaccination. Its report was published in 2003.

However, CDC (which has been paid many millions of dollars by DOD to do this research) has failed to follow the Institute of Medicine recommendations regarding use of military medical databases to assess long-term adverse events. Its one published study, of optic neuritis following vaccinations, used an arbitrary cutoff of 18 weeks following vaccination for a diagnosis of optic neuritis to be made. (Incidentally, this required that soldiers had to receive the diagnosis while in a war zone, given the fact they are vaccinated immediately before deploying to Iraq or Afghanistan for six to twelve months. This virtually guaranteed that only the most severe cases would meet the inclusion criteria established by CDC.) It was therefore no wonder that, although military optic neuritis hospitalizations are much commoner after anthrax vaccination, CDC failed to find more cases in the vaccinated. Other studies are pending, but are being carried out by the same group that 'cooked' this first study. I expect they will reach whatever conclusion the funder desires.

Congress supported research on 2nd and 3d generation "replacement" anthrax vaccines

However, the 2nd generation VaxGen anthrax vaccine, made by using a higher concentration of the same active ingredient as the current anthrax vaccine, Biothrax, failed during advanced development, and will not be able to supercede Biothrax. HHS cancelled the contract in December 2006.

The National Institutes of Health rescinded their proposal to fund research on a 3d generation anthrax vaccine in March, when they were dissatisfied with all the proposals submitted. Currently no anthrax vaccines appear to be in development, and no replacement for Biothrax is in the works.

Emergent Biosolutions, a.k.a. Bioport, spent millions to acquire a lobbying "dream team" -- then sold 10 million more vaccine doses to the government for civilian use!

Bioport has had on its payroll a former US Secretary of the Department of Health and Human Services, retired Generals, a former head of the Joint Chiefs of Staff, a former Assistant Secretary of Defense for Health Affairs and many others who had responsibility for biodefense procurement in their former roles in government. One of the PR firms employed by Emergent Biosolutions is DC Navigators, which boasts of its ability to do its own grassroots organizing. DC Navigators has had as clients 8 state Governors and 8 US Senators, among others. Emergent spent over 2 million dollars in 2006 alone on nine lobbying firms.

Perhaps as a result, NIH is now considering purchase of 22.75 million more doses for the civilian stockpile. The current cost is $24.78 per dose, or $563 million for this addition to the National Strategic Stockpile. The original 10 million doses of anthrax vaccine in the civilian stockpile cost approximately $220 million. Military vaccine has cost at least an additional $100 million. All told, Emergent Biosolutions has done extraordinarily well since purchasing the vaccine manufacturer for $25 million in 1998, when the vaccine cost about $3.00 per dose.

Fear-mongers scared Americans with images of anthrax weapons and mushroom clouds.

Now we know it was all hype--but we didn't know it then. Failing to prepare for an anthrax attack by Saddam Hussein's troops would have made Congress appear careless. Just in case Congress didn't get it, real anthrax spores were sent to the Capitol, leading to enormous fear throughout the United States, a prolonged and expensive clean-up, and billions of dollars appropriated for responses to bioterrorism, including plenty of anthrax vaccine.

Congress did its job -- but nothing changed

Congress held 13 hearings that dealt with anthrax vaccine between 1999 and 2001. Congress commissioned studies on anthrax vaccine from the GAO, the Congressional Research Service, and the Institute of Medicine. Congress made sure specialized medical care for vaccine-injured soldiers was made available within the military.

Congress learned the vaccine was only questionably effective. Congress learned some people were being severely injured by the vaccine. What was unclear then, and remains unclear today, is how many are injured, how badly, by what mechanisms, and whether they ever recover.

By late 2000, vaccinations had ceased due to multiple manufacturing failures at the anthrax vaccine plant. No new vaccine could be shipped out. FDA withheld a license for the manufacturing facility, even after it was completely renovated at taxpayer expense. Then the anthrax letters were sent, and HHS Secretary Tommy Thompson insisted the anthrax plant would be given its license. Thompson also gave DOD an "Emergency Use Authorization" to use anthrax vaccine after its license was lost in 2004.

In 2004, a lawsuit challenging the vaccine's licensing process led to the license being suspended, and mandatory vaccinations ceasing for two years. Subsequently, the FDA issued the comment period that had previously been missed, ignored the many scientific challenges the comment period generated, and reapproved the vaccine license. Resumption of mandatory vaccinations was announced in October 2006, and several hundred thousand soldiers have since been vaccinated.

It's deja vu all over again:
No documented threat. A suspect manufacturer. A vaccine unlikely to be effective against weaponized anthrax made by a skilled adversary. And lots more people being harmed.

Unfortunately, the vaccine produced now is no better than the vaccine made in the old facility. The FDA continues to receive adverse event reports at the same rate as before: one in every 250-300 recipients reports problems to the FDA Vaccine Adverse Event Reporting System. And the director of the Vaccine Healthcare Centers, Dr. Renata Engler, who has data on thousands of reactions, said there are "No apparent differences between pre-renovation and post-renovation lots."

Congress used various means at its disposal to ameliorate the worst problems associated with anthrax vaccine, and attempted to assure the vaccine was thoroughly investigated. Yet these measures have been thwarted, the research corrupted and the military medical data withheld. False threats were manufactured to spur biodefense spending, including the purchase of inadequate but already existing "solutions" like anthrax vaccine.

It is now time, after nine years of the on-again, off-again anthrax vaccine program, for Congress to stop mandatory vaccinations unless and until a proven safe, effective vaccine becomes available.