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Friday, January 09, 2004Lawyers for the six plaintiffs said they would appeal and attempt to make the case a 'class action' lawsuit when they return to court next week. 'In the absence of a proven correlate of immunity between humans and animals, specific to anthrax infection, the FDA's Final Rule's reliance on animal data is illegal, and reflects an arbitrary and capricious decision. Therefore, the government's victory today may only be fleeting,' said attorney Mark Zaid. In a related vein, there's this email from a reporter who covers military affairs. It's hard to take it seriously since it starts with a patent falsehood - the claim that the current vaccine isn't the same one originally licensed in 1970: It's unfortunate that you didn't do real research before writing your recent piece bemoaning the lawsuit on the anthrax vaccine. You might have discovered several significant points: * The current vaccine is NOT the same as the vaccine licensed in 1970. First, the original small batch production vaccine was differen from the one used in the Brachman studies used to establish safety and efficacy. Even more important, the current vaccine is different from the one used up until late 1990 -- in an effort to dramatically increase production at the Pentagon's request in preparation for the 1991 Gulf War, the then state-owned Michigan lab changed the filters used to strain out the Protective Antigen believed to provide immunity, resulting in increases in the concentration of PA as much as 100 times the original levels. (The amount of PA varies widely from lot to lot and even from dose to dose -- there is NO standard for the minimum or maximum amount of PA in a dose.) The current vaccine is the one licensed in 1970. It's not identical to the one tested on the mill workers, but it was very similar and it went through its own testing before being licensed: On April 14, 1966, CDC submitted an IND for the anthrax vaccine to the Division of Biologics Standards, which was then part of NIH, later transferred to FDA. The method of preparing this vaccine was similar, but not identical, to the vaccine used in the Brachman et al. study. The vaccines in both studies were based on the immunity induced by the protective antigen (PA). Persons receiving the vaccine made by the two different methods demonstrated similar peak immune responses (antibody concentration) following the initial three doses. Textile employees and laboratory workers were immunized under this IND. A number of lots of investigational vaccine used by CDC under this IND were manufactured by the Michigan Department Public Health (MDPH), the original manufacturer of the anthrax vaccine, which eventually became known as BioPort. The data submitted to the Division of Biologic Standards described CDC's experience with approximately 16,000 doses of anthrax. This vaccine was administered to approximately 7,000 study participants. Reported local reactions at the immunization site ranged between three percent to 36 percent of the initial series of doses, and three percent to 33 percent of the booster doses, depending on the lot. Reported mild reactions were three percent to 20 percent of all doses. Reported moderate local reactions were one percent to three percent of doses. Severe reactions were reported for less than one percent of doses. Systemic reactions were reported in four cases during the five-year reporting period. These reactions included fever, chills, nausea and general body aches, and were reported to have been transient. The Division of Biologics Standards determined that the data submitted by CDC supported licensure of the vaccine. On November 10, 1970, the Division of Biologics Standards issued a product license to MDPH to manufacture anthrax vaccine. That's the final licensed vaccine that was tested on 7,000 people, not the initial investigational vaccine used in the 1950's on the mill workers. And as to purity, the FDA most certainly monitors the quality of vaccines being produced. There's no substantial evidence that they're doing otherwise with the anthrax vaccine. The sticking point here seems to be that the people in the final trial weren't exposed to inhalational anthrax to see how effective it was against the actual disease. As I pointed out in the Tech Central Station piece, to have done so would have been unethical. But, back to my sneering correspondent: * When the FDA first examined the 1985 proposed rule, its advisory committee determined that there was NO evidence to show that the then-existing anthrax vaccine provided protection against inhalation anthrax. To date, they have shown no studies to refute that finding, yet the 1985 rule is the one the FDA suddenly approved in the wake of the court order. Of course not. As I said before, it would be unethical to deliberately expose people to inhalational anthrax. We'll never have that sort of data for any anthrax vaccine. * The nation's most knowledgable scientists on anthrax and anthrax vaccine, at the U.S. Army Research Institute on Infectuous Diseases, produced several articles in peer-reviewed scientific journals in the early and mid-90s calling for an improved vaccine, based on recombinent processes, saying it was necessary because the existing vaccine had 1) questionable effectiveness against inhalation anthrax and 2) had an unacceptably high rate of adverse reactions. He doesn't say who these "most knowledgeable" scientists are, but their opinion on adverse reactions appears to be mistaken: In AVA prelicensure evaluations, 6,985 persons received 16,435 doses: 9,893 initial series doses and 6,542 annual boosters. Severe local reactions (defined as edema or induration >120 mm) [swelling and bumps -ed.] occurred after 1% of vaccinations. Moderate local reactions (defined as edema and induration of 30 mm--120 mm) occurred after 3% of vaccinations. Mild local reactions (defined as erythema, edema, and induration <30 mm) [redness, swelling and a bump-ed.] occurred after 20% of vaccinations..... .... In AVA prelicensure evaluations, systemic reactions (i.e., fever, chills, body aches, or nausea) occurred in <0.06% (in four of approximately 7,000) of vaccine recipients. And here's the data on adverse events since the military began using the vaccine: ...Data regarding potential adverse events following anthrax vaccination are available from the Vaccine Adverse Event Reporting System (VAERS). From January 1, 1990, through August 31, 2000, at least 1,859,000 doses of anthrax vaccine were distributed in the United States. During this period, VAERS received 1,544 reports of adverse events; of these, 76 (5%) were serious. A serious event is one that results in death, hospitalization, or permanent disability or is life-threatening. Approximately 75% of the reports were for persons aged <40 years; 25% were female, and 89% received anthrax vaccine alone. The most frequently reported adverse events were injection-site hypersensitivity (334), injection-site edema (283), injection-site pain (247), headache (239), arthralgia (232), asthenia (215), and pruritis (212). Two reports of anaphylaxis have been received by VAERS. One report of a death following receipt of anthrax vaccine has been submitted to VAERS; the autopsy final diagnosis was coronary arteritis. A second fatal report, submitted after August 31, 2000, indicated aplastic anemia as the cause of death. A causal association with anthrax vaccine has not been documented for either of the death reports. Serious adverse events infrequently reported (<10) to VAERS have included cellulitis, pneumonia, Guillain-Barr? syndrome, seizures, cardiomyopathy, systemic lupus erythematosus, multiple sclerosis, collagen vascular disease, sepsis, angioedema, and transverse myelitis (CDC/FDA, unpublished data, 2000). Analysis of VAERS data documented no pattern of serious adverse events clearly associated with the vaccine, except injection-site reactions. Because of the limitations of spontaneous reporting systems, determining causality for specific types of adverse events, with the exception of injection-site reactions, is often not possible using VAERS data alone. To summarize, out of 1,859,000 doses there has been two deaths, two severe allergic reactions (anaphylaxis) and less than ten coincidental diseases. Sounds about as safe as any childhood vaccine. * The Department of Defense, in 1996 (almost two years before ordering the mandatory vaccination program), prepared and filed an Investigational New Drug application with the FDA, seeking to both change the schedule of vaccinations and approve the vaccine for use against inhalational anthrax. That IND is still pending; government documents indicate that is because DoD (and Bioport, the manufacturer now) have been unable to meet the requirements for approval. Could that be because to prove its effectiveness against inhalational anthrax the tests would have to actually expose people to it? Again, unethical. * The National Academy of Science (NAS) produced four reports that dealt with anthrax vaccine. All of those reports, except the last one, admitted there was insufficient evidence to show long-term vaccine safety. The final report, by the Committee to Assess the Safety and Efficacy of Anthrax Vaccine, acknowledged that "statistically significant elevations in rates for outpatient visits were also found for certain malignant neoplasms, portal vein thrombosis, and acute pulmonary heart disease, among others" (page 118 of The Anthrax vaccine: Is It Safe? Does It Work? National Academy Press, Washington D.C. March 2002). Furthermore, there were higher rates of hospitalizations for diabetes, asthma, Crohn's Disease, thyroid cancer, in situ cervical and breast cancer, other intestinal disorders and multiple sclerosis (ibid, pp 120-121). That fourth committee, paid for by DoD, never said the vaccine had proven long-term safety; the best they could come up with was to conclude that the lack of data showed "no convincing evidence at this time that personnel who have received AVA have elevated risks of later-onset health events," dismissing seven different studies that showed a link between anthrax vaccinations and health problems and their own acknowledgement of "statistically significant elevations" of complaints. Again, from the CDC data: No studies have definitively documented occurrence of chronic diseases (e.g., cancer or infertility) following anthrax vaccination. In an assessment of the safety of anthrax vaccine, the Institute of Medicine (IOM) noted that published studies reported no significant adverse effects of the vaccine, but the literature is limited to a few short-term studies. One published follow-up study of laboratory workers at Fort Detrick, Maryland, concluded that, during the 25-year period following receipt of anthrax vaccine, the workers did not develop any unusual illnesses or unexplained symptoms associated with vaccination. IOM concluded that, in the peer-reviewed literature, evidence is either inadequate or insufficient to determine whether an association exists between anthrax vaccination and long-term adverse health outcomes. IOM noted that few vaccines for any disease have been actively monitored for adverse effects over long periods and encouraged evaluate of active long-term monitoring studies of large populations to further evaluate the relative safety of anthrax vaccine. Such studies are under way by the Department of Defense. CDC has conducted two epidemiologic investigations of the health concerns of Persian Gulf War (PGW) veterans that examined a possible association with vaccinations, including anthrax vaccination. The first study, conducted among Air Force personnel, evaluated several potential risk factors for chronic multisymptom illnesses, including anthrax vaccination. Occurrence of a chronic multisymptom condition was significantly associated with deployment to the PGW but was not associated with specific PGW exposures and also affected nondeployed veterans. The ability of this study to detect a significant difference was limited. The second study focused on comparing illness among PGW veterans and controls. The study documented that the self-reported prevalence of medical and psychiatric conditions was higher among deployed PGW veterans than nondeployed veterans. In this study, although a question was asked about the number of vaccinations received, no specific questions were asked about the anthrax vaccine. However, the study concluded that the relation between self-reported exposures and conditions suggests that no single exposure is related to the medical and psychiatric conditions among PGW military personnel. In summary, current research has not documented any single cause of PGW illnesses, and existing scientific evidence does not support an association between anthrax vaccine and PGW illnesses. (emphasis mine) Back to the email: * One of the government's top researchers, in a 1998 interview, described the vaccine to me as "1950s technology unimpeded by medical progress." He went on to describe how there is NO control not only of the level of PA in the vaccine but also no testing or controls of other compounds in any given lot -- basically, no one knows exactly what else is in any given shot of anthrax vaccine. Personally, I find this hard to believe. The FDA has a reputation for being overly cautious when it comes to the contents of vaccines and other medications. There's no evidence that they've been deliquent in overseeing the anthrax vaccine manufacturer. (Although the method of producing it is 1950's technology, and one can make an argument that better methods of making the vaccine can be found.) I have personally interviewed dozens of veterans who had suddenly developed serious health problems after getting the anthrax vaccine. No, that's not scientific proof the vaccine is at fault -- but it does suggest a correlation that deserves honest scientific study. Yet DoD has consistently stonewalled and impeded such studies, while continuing to funnel a $245.6 million contract for the vaccine to a company that has a former chairman of the joint chiefs as a major owner. He doesn't say who that former chairman is who owns the company, but that seems to be a pretty serious accusation against the Department of Defense. It, too, is hard to believe since studies on Gulf War Syndrome have not been "impeded," as Michael Fumento points out. There are those who think that all vaccines are inherently dangerous. Unfortunately, a few of those who happen to be in the military are trying to derail a vaccine that could make a difference between victory and defeat in the war on terrorism. posted by Sydney on 1/09/2004 07:51:00 AM 0 comments 0 Comments: |
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