MUTINY BY AN FDA ADVISORY PANEL
By Byron J. Richards, CCN
October 12, 2006
The FDA has created its own monster. Could it be that an FDA advisory panel actually has enough impartial members to be truly concerned about the health and well being of all Americans? No doubt, the top FDA officials were squirming in their boots as five current and past members of the Drug Safety and Risk Management Advisory Committee went public with their call for sweeping changes at the FDA.
The October 9, 2006, issue of the Archives of Internal Medicine contains the article “FDA and Drug Safety: A Proposal for Sweeping Changes.” The lead author is Curt D. Furberg, M.D., Ph. D., an expert in epidemiology and biostatistics and current member of the FDA safety committee. He is a professor at the Department of Public Health Services, Wake Forest University School of Medicine. In an interview by Amanda Gardner, HealthDay reporter, Dr. Furberg states:
This criticism comes from a collection of experts that the FDA assembled to give them advice on the safety of drugs. Numerous experts on the Drug Safety and Risk Management Advisory Committee felt the FDA was not following their advice regarding needed drug-safety improvements. The message is loud and clear: The FDA, an agency that maintains a cozy and profitable relationship with Big Pharma, is incapable of protecting the American public from harm.
Drug Safety and Risk Management Advisory Committee
This particular committee is unique among FDA advisory committees in that it deals in a general way with the topic of drug safety, including the need for post-marketing surveillance. Other FDA advisory committees usually focus on one drug or topic area. The importance of this committee has been elevated since the Vioxx scandal.
Grumbling from committee members has been going on for some time. While the committee feels they have made some inroads, progress has been on simple issues that can be acted on in a short period of time. On the tough issues, the core problems of drug safety at the FDA, the FDA has been slow to adopt committee recommendations that would protect Americans from harm.
Why Won’t the FDA Protect Our Children?
The FDA was shocked when earlier this year the Drug Safety and Risk Management Advisory Committee voted 8 to 7 to place a black box warning for cardiovascular risk on all ADHD medications. Such a move would cost Big Pharma dearly, eroding the ten billion dollar children’s market in ADHD meds, antidepressants, and atypical antipsychotic meds. Americans are worried, and rightfully so, that the true risks of these medications are being hidden and downplayed thus placing an entire generation of children in danger.
The FDA thought the advisory committee was going to review depression and suicide risk relating to ADHD medication. Instead, the meeting spun out of FDA control and resulted in a major catastrophe, from the perspective of the FDA. In no way, shape, or form did the FDA want the committee delving into cardiovascular risk in the manner they did. Of course, the FDA does not have to follow the advice of their advisory panels. But how could they prevent more fallout on their already existing lax-on-safety image problem, especially when their own appointed panel of experts is telling them to act quickly to protect children? Stunned, FDA spokesperson Robert Temple offered this lame explanation, “You don’t want to over scare people with data that aren’t very solid.”
In high-level damage control the FDA shunted the issue to a different advisory panel, one that would water down the recommendations. One month later the new panel stated a black box warning for cardiovascular risk was not warranted. The FDA strategy is clear; if one panel warns of a need for safety, another panel can be used to quell concern. After the cover up meeting Temple stated, “The committee was not impressed with the level of cardiovascular risk to children.” Twenty-five reported cardiovascular deaths from ADHD medication don’t impress the FDA when Big Pharma blockbuster profits are at stake.
However, safety advisory panel member Steven E. Nissan, M.D., was not going to take this insult lying down. After all, the safety of our children was at stake. Dr. Nissan launched his attack in the New England Journal of Medicine. On April 6, 2006, his article was published, ADHD Drugs and Cardiovascular Risk. In it, he outlines the significant cardiovascular risk of this class of medication and the committee’s plea for the FDA to act decisively. To this day, the FDA ignores the severity of the problem, which in my opinion is simply to protect the profits of Big Pharma.
Americans Must Respond
The unusual and public call for reform by members of the Drug Safety and Risk Management Advisory Committee tells us the FDA is hopelessly broken. When members of their own committees feel the agency is not listening and putting the well being of Americans in jeopardy, it is time to act.
Americans must wake up before it is too late. The FDA, the White House, and elite leaders of both parties are owned by Big Pharma. True reform at the FDA must occur, and will not occur unless American citizens demand it and actually know what is going on.
Already, Senators Michael Enzi (R-WY) and Edward Kennedy (D-MA) have introduced a sham safety bill (S3807) that is a gift to Big Pharma and actually intends to make part of the FDA a drug company! It is clear that politicians will work deceptive spin under a pretense of safety.
Big Pharma must be banned from all lobbying and drug advertising. The 80,000 drug reps that routinely bribe doctors with perks, as well as their “free” samples, must be stopped. The FDA needs total reorganization with a focus on drug safety. Big Pharma’s illegal off-label drug promotions to children, via the TeenScreen program, require criminal investigation. All user fees paid by Big Pharma to the FDA, which currently amounts to over half the FDA drug approval budget, must be discontinued.
The current Bush-appointed FDA leadership, such as temporary head Andrew von Eschenbach and second in command, Scott Gottlieb, must have all their extensive Big Pharma connections fully exposed. There is a reason they want to speed drugs to the market, reduce safety testing, and prevent Americans from suing drug companies when drugs injure and kill our people.
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Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, educator, and author.
Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. Author of Mastering Leptin and Fight for Your Health, Richards is now joining forces with health freedom leaders in the U.S. and throughout the world. Visit his health blog for up to date happenings. www.truthinwellness.com
As founder of Wellness Resources, Inc. of Minneapolis, MN (since 1985), he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com
of the International and American Associations
of Clinical Nutritionists (IAACN) (since 1991) Richards has presented
hundreds of educational classes to health professionals and individuals
who want to take charge of their health!
The FDA has created its own monster. Could it be that an FDA advisory panel actually has enough impartial members to be truly concerned about the health and well being of all Americans?