Vaccines-Bracing Ourselves For More Sham Vaccine Studies-PRN

Bracing Ourselves for More Sham Vaccine Studies The National Institute of Allergy and Infectious Disease’s Addiction to Bad Science Richard Gale and Gary Null Progressive Radio Network, October 13, 2009 When we hear official reports released by the FDA and CDC, transmitted throughout major corporate media and publications, that a particular vaccine is safe, we should immediately perk to attention, raise a red flag, and muster rational suspicion. One of the most important questions is, what kind of studies are performed to determine that any vaccine is safe? And what evidence is there that vaccines are especially safe in infants, small children, pregnant mothers, the elderly, and those with asthma and compromised immune systems? According to the statutes of the FDA’s Public Health Service Act, vaccine manufacturers are required to prove a vaccine complies with three criteria before approval and launch: safety, purity and potency. There are no requirements before FDA approval and licensing that a vaccine undergoes independent studies by researchers with no vested financial interests and industry ties in order to validate a vaccine maker’s claims. Rather, the entire approval process is nothing more than a good-faith relationship between the vaccine industrial complex and the FDA and the CDC’s Advisory Committee on Immunization Practice (ACID), the primary entity determining vaccine policies. In an interview with Dr. Tom Jefferson, one of the world’s most knowledgeable experts in vaccine research and head of the Vaccine Field Group at the Cochrane Database Collaboration, the Financial Times reported that he found less than two dozen studies on the current H1N1 flu vaccine and none have a completion date before December 2010. Moreover there is no knowledge whatsoever that these vaccines are safe.[1] Clinical trials with at-risk individuals, including infants, small children, pregnant mothers and people over 65 of age are not mandatory for regulatory approval. So how do the vaccine makers determine whether or not a vaccine is safe for these at-risk groups? Well, they don’t except by predicting past incidences of vaccine effectiveness and safety using mathematical models. The vaccine industrial complex is under no federal obligation to give sound scientific evidence that their vaccines are safe in anyone except health adults. What is quite extraordinary in the FDA’s Center for Biologics Evaluation and Research’s document, “Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines”, is the large leeway permitted vaccine manufacturers to prove a vaccine’s safety. For example, “the protocol should include a clinic visit or telephone contact at least six months post-vaccination to ascertain serious adverse events.” Or, “we recommend that you assess the safety of your investigational vaccine in several thousand subjects.” Or, “we assume that approval for use in the adult population, including the geriatric population, would be sought with the initial application.” More serious is this allowance given to vaccine manufacturers, “For vaccines using novel manufacturing processes and/or adjuvants, laboratory safety tests including hematologic and clinical chemistry evaluations, may be needed pre- and post-vaccination in the first clinical studies.” (all italics are ours to clearly identify word choice in the official CDC document). As a result of such noncommittal and ambiguous requirements, we find the efficacy clinical trials conducted for the currently approved H1N1 vaccines enrolling only between 100-240 subjects depending on the trial. In the October 28, 2006 issue of the British Medical Journal editor Fiona Godlee commented on Dr. Tom Jefferson’s article attacking the UK’s vaccine policy, which is fundamentally no different than that in the US. As an aside, David Salisbury, the UK’s Department of Health’s Director of Immunization, is the only foreign government representative represented on the ACIP. Godlee wrote, “As if to prove the point, we publish this week a broadside (based on a systematic review of the literature) about the lack of evidence for influenza vaccine. Why, asks Tom Jefferson (p. 912), is there such a gap between evidence and policy? Governments go to great lengths to promote and provide the vaccine. But there is almost no valid evidence that it does any good. Jefferson puts the gap down to our desire to do something, combined with”optimism bias”—an unwarranted belief in the value of interventions. Would randomized trials be unethical? No, says Jefferson, they are the only ethical response to the possible waste of resources on ineffective or only partially effective care.