Monday, June 25, 2007
The DMSS database info has been hidden from the public since some of its data was given to the Institute of Medicine committee in 2001. (I have excerpted from this 2001 data in other parts of the blog.) That leaves us the VAERS reports. How are they being evaluated?
FDA allegedly has a terrible data management system for adverse events of both vaccines and drugs. Some employees said it wasn't fully computerized. FDA has just had to scuttle a very expensive, contracted upgrade to the system, and is starting out to develop another one. As if that wasn't bad enough, it appears that FDA does not get the reports from patients and medical providers directly. Instead, they go first to a private VAERS contractor, which processes the data and regularly presents it to FDA and CDC.
Because the VAERS system is so critical to identifying signals that require more investigation, and to assuring vaccine safety in general, three different federal advisory groups emphasized the importance of improving and increasing the generation of VAERS reports for anthrax vaccine:
1. In 1999, after many reports of military medical provider refusals to file VAERS reports when asked to do so by ill soldiers, the General Accounting Office (the investigative arm of Congress) reported the following to Congress:
We recommend that the Secretary of Defense direct the Secretary of the Army to improve DOD guidance and training on how to report adverse events to the Vaccine Adverse Event Reporting System... [Medical Readiness: DOD faces challenges in implementing its anthrax vaccine immunization program. GAO/NSIAD-00-36. October 1999.]
2. In 2000, the CDC's Advisory Committee on Immunization Practices, which formulates all vaccine policy recommendations for the United States, wrote the following:
To assess the safe use of anthrax vaccine in humans, the Advisory Committee on Immunization Practices recommends several areas of research. Adverse event surveillance through VAERS [FDA and CDC’s Vaccine Adverse Event Reporting System] should be enhanced, which could include development of electronic reporting capability and implementation of strategies to facilitate reporting. [Use of Anthrax Vaccine in the United States. MMWR 2000; 49: RR-15: 1-20. December 15, 2000.]
3. In 2002, the Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine recommended that DOD increase and improve VAERS reporting by using codes to flag vaccine-related medical encounters:
DOD should develop and implement a system to automate the generation of VAERS reports with the military health care system, using codes to identify from automated records those health care visits that are potentially vaccine related. [Institute of Medicine Committee to Assess the Safety Safety and Efficacy of Anthrax Vaccine. The Anthrax Vaccine: Is It Safe? Does It Work? National Academies Press, Washington, D.C. March 2002].
At first, DOD appeared to make an effort to comply. The Vaccine Healthcare Centers website states that "The Vaccine Healthcare Center Network is dedicated to program development for quality improvement in VAERS." This webpage also says, "The VHC is also available to assist you in filing a VAERS. Anyone can file a VAERS, to include the patient and the patient's family."
However, although the VHC network at first filed VAERS reports for all the individuals they were evaluating for alleged vaccine reactions, this policy subsequently took a 180 degree turn. It has become apparent that for the past several years the VHC Network has not been filing VAERS reports for its patients, even for those whose records show the VHC believed them to have a serious adverse reaction to a vaccine.
Thus, the VHC website is apparently communicating a form of DOD doubletalk: its message should be interpreted as, "You, not we, can file a VAERS report, because we will not do so unless you demand our help."
What is the upshot of this failure to file? Probably 1,500 serious reactions that have been evaluated at the Vaccine Healthcare Centers, which produces extremely detailed, complete and accurate reports, have not been shared with FDA, CDC or the public. Thus, although the VHCs try to assist individuals who have been badly injured by the vaccine, they simultaneously collude to avoid sharing this information with the regulatory agencies which assess vaccine safety. This leads to poor regulation and more injured servicemembers. Thus the VHC data go into a black hole, the data that need to be evaluated by FDA and CDC and can be reviewed by the public on-line disappear, and the recommendations of the expert committees are bypassed by DOD--again.
Monday, June 18, 2007
Louis Sullivan, MD. Dr. Sullivan served as Secretary of Health and Human Services in the cabinet of President George H.W. Bush from March 1989 to January 1993.
Jerome Hauer. Mr. Hauer served as acting assistant secretary for public health emergency preparedness of HHS from June 2002 to November 2003 and as director of the office ... of public health preparedness of HHS from May 2002 to June 2002. He also is said to have been responsible for putting the NYC Emergency Center in the World Trade Center prior to 9/11/2001.
Sue Bailey, D.O. Dr. Bailey served as Assistant Secretary of Defense for Health Affairs under President Clinton, where she headed the $17 billion military medical system, coordinating the care for 8 million beneficiaries. After leaving the Defense Department, she became the head of the National Highway Traffic Safety Administration.
"Sue Bailey, acting NHTSA administrator during the final months of the Clinton Administration, was the government's most visible official during congressional hearings and the controversy that swirled around defective Firestone Wilderness tires and the role of the Ford Explorer in more than 200 American deaths. While questions remained about the safety of the Explorer, Bailey became a consultant to Ford. Ford wanted Bailey on-board because "this is a public health issue, and she is an expert on public health issues," according to Ford spokesman Jason Vines."
Zsolt Harsanyi, PhD. Zsolt P. Harsányi Ph.D. has been President of Porton International, a pharmaceutical company, since 1984. He has benefited from spinoff of technology developed at Porton Down, the UK's equivalent of Fort Detrick, as did Emergent's major stockholder, Fuad El-Hibri.
Ronald Richards. Mr. Richard served as Chief Operating Officer and managing partner of In-Q-Tel, the CIA's Venture Capital Fund, for 15 months.
Admiral William Crowe, former Chairman of the Board., was also a former head of the Joint Chiefs of Staff and Ambassador to the United Kingdom. He has sold the Bioport shares he was given to act in this capacity, and is no longer affiliated with Emergent Biosolutions/Bioport. Reporter Bob Evans discussed how Bioport came to "earn" windfall profits.
Saturday, June 16, 2007
Selected Findings and Research Recommendations of Eight Different Committees that have Studied Anthrax Vaccine since 1998
The Committee on Government Reform issued a report on the anthrax vaccine program in 2000 titled "Unproven Force Protection"
I decided to annotate the document to correct many of its errors and omissions.
Army Surgeon General Warned Medical Providers to be Aware of Serious Vaccine Adverse Effects--click here
I discovered the following 3 year old conference presentation on the internet. Information on this syndrome has not been published in the medical literature, nor is information about it available on the VHC website. The recorded presentation is of great interest.
Thursday, May 13, 2004 - 11:45 AM
Reproducible Prolonged Myalgia Syndrome (RPMS) Following Multiple Anthrax Vaccinations: Draft of A New Rare Adverse Event Case Definition Developed by The Vaccine Healthcare Centers (VHC) Network
The Vaccine Healthcare Centers Network is a Department of Defense (DoD) new medical advance developed in response to increasing concerns about rare adverse events temporally linked with mandatory vaccines and the need to provide clinical support services for persistent or more severe adverse events. Myalgias and body aches with varying features of fatigue and arthralgias (without any evidence of joint inflammation or stiffness) are a common side effects reported following routine vaccination. The symptoms are generally of short duration resolving in a few days and responding to over-the-counter analgesics. A small percent of vaccinees develop more severe or prolonged symptoms raising concerns about the safety of continued vaccination in a series.
To present a draft vaccine adverse event case definition from a vaccine safety clinical case review program focusing on a subset of patients who experienced reproducible prolonged myalgia syndrome following multiple doses of anthrax vaccination.
The VHC Network provides clinical expert consultations and case management services for DoD beneficiaries who experience adverse events that are more severe and/or prolonged than expected side effects. A systematic review process to identify patients with adverse events identified the cluster of patients described.
Five cases (male, age range 29 to 52 years, 3 Caucasian, 2 African Americans) who had received 19 doses of anthrax vaccine are described to include details of an informed consent re-challenge that resulted in symptoms lasting more than 4 months and responding to corticosteroid therapy.
Prolonged and more severe myalgias, arthralgias and fatigue, particularly when recurring and worsening with each subsequent dose of a vaccine, results in fear of long term disability. Further studies are needed to improve understanding of this syndrome with a focus on prevention and treatment.
To understand the post anthrax vaccine clinical presentation of prolonged and more severe myalgias.
Friday, June 15, 2007
Although the Institute of Medicine Committee did offer opinions as to the vaccine's safety and effectiveness in its 2002 report, its opinions did not reflect the existing literature on efficacy--which makes clear that efficacy is uncertain for inhaled, weaponized anthrax. Its opinions on safety are contradictory. All the questions Congress posed in 1999 have yet to be resolved, with the exception that gender differences are real and women sustain 2-3 times more adverse systemic reactions than men.
In this critical letter to the editor and author reply, one sees how extensive the review of this case was, in order to make the claim for a link between the vaccine and subsequent illness. The pre-publication review took nearly a year, and included medical specialists from NIH, the Armed Forces Institute of Pathology, and both the Air Force and Navy Surgeon Generals' offices, who agreed with the authors.
Sunday, June 10, 2007
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.
Saturday, June 9, 2007
Hospitalizations for affective psychosis in those who received at least one and less than four doses of vaccine were five times greater than before vaccination. In the same group, hospitalizations for "adjustment reaction" tripled. Hospitalizations for "personality disorders" more than quadrupled. Hospitalizations for depression nearly tripled.
Not every illness is more common after anthrax vaccination. Hospitalizations for the majority of ordinary diagnoses do not rise.
These data, generated by the Army's Medical Surveillance Activity in 2001, are very suggestive that anthrax vaccine affects the brain in susceptible recipients.
Monday, June 4, 2007
Army statistics provided to Institute of Medicine in 2001 but never published
What conditions are found much more often after anthrax vaccinations? The list is surprising, and (unsurprisingly) women are especially affected. This series of 3 tables does not give us the raw data, instead providing data that has been statistically adjusted by the army. Where does this data come from?
Benign breast lumps leading to hospitalization occurred a whopping 9 times as often after anthrax vaccinations as before. Breast and genitourinary cancer hospitalizations occurred more than 3.5 times as often. Abnormal PAP smears led to hospitalization more than 5 times as often after vaccination.
Hospitalizations for nerve damage in the arm--usually the vaccinated arm--or several damaged nerves (mononeuritis multiplex) occurred 1.6 times as often. Eyelid problems leading to hospitalization occurred more than twice as often. This is no joke. Draining, purulent eyelids appear to be a common consequence of anthrax vaccination, and the reason is obscure. Optic neuropathy leading to hospitalization occurred nearly 3 times as often after vaccination. This condition is usually autoimmune, and many cases later develop into multiple sclerosis.
Dermatophytosis is a fungal skin infection. It resulted in hospitalizations nearly 5 times as often after vaccination. Is this a consequence of impaired immunity to fungal infection?
Some illnesses made the list because they simply occur more often during deployments, like malaria, cholera and typhoid. Anthrax vaccinations are required for soldiers who deploy, but not required for other troops. Others illnesses may be miscoded. Many males have reported testicular inflammation after anthrax vaccine, which may lead to low testosterone levels, loss of interest in sex, and difficulties conceiving. (I have evaluated a number of males with this problem.) Perhaps some of these cases were miscoded as hydrocele, which is associated with fluid on the testis but is not due to acute inflammation.
Look at the second table: there are a list of cancers that caused hospitalizations more often after anthrax vaccine. Female uterine cancer hospitalizations were more than 4 times more common after vaccination. Gallbladder and bile duct cancer hospitalizations were nearly 3 times as common.
Blood clots seem to be related to vaccination. Both hospitalizations for portal vein thrombosis and "acute pulmonary heart disease" (pulmonary embolism) are more common. So are hospitalizations for varicose veins, and "injury of blood vessels of upper extremity" which may represent miscoded episodes of deep vein thrombosis.
Here are additional Tables from the Army Medical Surveillance Activity on illnesses pre and post-vaccination.
Anthrax vaccine seems to cause very unusual illnesses and patterns of symptoms that cannot be found in medical textbooks. This might be why nonspecific diagnostic codes are used more often in hospitalizations after vaccination, such as: "other disorders of stomach and duodenum," "other disorders of the respiratory system," "ill-defined descriptions of heart disease," "symptoms involving nervous and musculoskeletal," "other nonspecific abnormal findings," and "complications of medical care, not elsewhere classified." These diagnoses need to be sorted out, so we can discover precisely what kinds of complex illnesses are due to the vaccine.
It is also important to note that, overall, vaccinated soldiers did not have more hospitalizations than unvaccinated troops, or than they did prior to vaccination. Thus it appears there are specific diagnoses, or clusters or symptoms, that vaccinated troops develop at relatively high rates, which unvaccinated troops develop at much lower rates. However, because there seem to be dozens of these diagnoses, rather than just one or two, it has been harder to pin the relationships down. Compounding this difficulty is the military's failure to release hospitalization and outpatient data since 2001.
Here is the way these data were presented in the 2002 IOM report on anthrax vaccine. Each URL represents one page in the report. To get a printable pdf version, click on "printable pdf page" next to the page number:
An HHS-DOD "Anthrax Vaccine Expert Committee" examined 1841 VAERS reports for the government, which had been reported to FDA between 1998 and 2001. This committee found that there was one report for every 282 vaccine recipients. Again, women were disproportionately represented, reporting three times as often as would be expected if there were no gender difference. Flu-like symptoms and rashes often tended to recur with subsequent doses. The Committee's report can be found here. Over 5200 people have now filed VAERS reports for anthrax vaccine.