THE USA FDA IS THE LAP DOG OF BIG PHARMA, RATHER THAN THE WATCHDOG FOR CONSUMERS
by Justice Lover


According to the Wikipedia definition, the USA Food and Drug Administration (FDA) role is as follows http://en.wikipedia.org/wiki/Food_and_Drug_Administration :

“The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices…”

In other words, the FDA is supposed to be the watchdog of the USA federal government for protecting the public from fraudulent drugs and other products which could damage the health of consumers.

Furthermore, the FDA Consumer magazine, in its December 1999 issue, had an article by an FDA member, under the title,How to Spot Health Fraud , which states as follows

http://www.fda.gov/fdac/features/1999/699_fraud.html :

“Because of limited resources, says Joel Aronson, team leader for the nontraditional drug compliance team in FDA's Center for Drug Evaluation and Research, the agency's regulation of health fraud products is based on a priority system that depends on whether a fraudulent product poses a direct or indirect risk.

When the use of a fraudulent product results in injuries or adverse reactions, it's a direct risk.”

The reality, however, is exactly the opposite, namely, instead of protecting the public the FDA is acting is a rubber stamp for Big Pharma. The following report by AHRP proves the point :

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org/ <http://www.ahrp.org/> and http://ahrp.blogspot.com/

FYI

A little noticed critique in The New England Journal of Medicine by Sheila Weiss Smith, Ph.D. focuses on FDA's continued sidelining of drug safety infavor of industry's rapid approval marketing goal. Dr. Smith, a drug safety and epidemiology expert with dual positions at the University of Maryland: School of Pharmacy, and School of Medicine, notes that "the IOM implored the agency to "embrace a culture of safety" by increasing the priority accorded to the safety of patients" but sadly, "the FDA's official response falls far short of what the American public expectsand deserves. Indeed, it highlights the very reason that the agency - with which I have had some first hand experience - is in need of monumental change: its philosophy is no longer aligned with its regulatory mandate."

Dr. Smith notes that rather than "embrace a culture of safety" by ensuring that a drug's toxicity and known safety problems are considered when weighing the benefit/risk ratio, the FDA described its "fundamental dilemma" as weighing the "trade off between safety and access." This, in a nutshell is what's wrong with the culture at the FDA and why consumer safety is shown repeatedly to be trumped by fast-track approval.

Dr. Smith reminds readers that mechanisms intended to speed access to potentially lifesaving medicines were broadly interpreted by FDA officials who allowed drugs for the treatment of common chronic conditions such as diabetes (troglitazone), obesity (dexfenfluramine), and pain (rofecoxib) to be approved under expedited programs.Those lethal drugs and a dozen more were withdrawn from the market only after preventable deaths had been documented.As Dr. Smith notes: The public expects the FDA to be the final arbiter of drug safety. Accelerated development programs and expedited reviews hasten the introduction of lifesaving drugs, but they should not be an option for treatments intended for chronic conditions; these drugs should have safety standards that tolerate minimal uncertainty.

By pitting safety directly against "access and innovation," the agency betrays its mandate to ensure that U.S. drugs are both safe and effective.

We note that an entire class of drugs linked to an array of life-threatening risks--the so-called second generation anti psychotics (a.k.a. neuroleptics)were approved despite a negative risk / benefit ratio. Indeed, in premarketing trials, these drugs only demonstrated "proof in principle" of abenefit. Documented evidence--from manufacturers' internal documents and since the drugs' approval--show that these drugs have the propensity to induce diabetes, hyperglycemia, cardiovascular disease, neuroleptic malignant syndrome, not to mention psychiatric adverse effects.

An analysis by MEDCO Health Solutions, the nation's leading pharmacy benefit manager, of the use of psychotropic drugs in children is so disturbing that the company's chief medical officer, Dr. Robert Epstein, expressed concern about the "unparalleled rise in adolescent girls using prescription drugs to treat diabetes, for sleep problems, and psychological disorders." FDA approved these drugs and failed to restrict their use even though evidence demonstrates that the life-threatening risks are NOT outweighed by ANY demonstrable benefits.

These drugs are being widely used primarily as chemical restraints.

Several IOM recommendations speak to the importance of including safety experts as integral players in the drug-review process.

Yet instead of undertaking a fundamental restructuring to integrate the relevant offices--safety and evaluation--the FDA merely initiated two pilot projects that involve OSE personnel in drug reviews to determine the "logistics and value" of doing so. But something akin to a pilot had already been done.More than 10 years ago..."In my view," Dr. Smith concludes, "the FDA's response to the IOM report demonstrates a lack of understanding of the magnitude of the changes required to create a culture of safety.

Apparently, the agency's leadership has yet to recognize that the adoption of such a culture would benefit all stakeholders - industry, the community of scientists, and most important,the American public."A response by Steve Galson, MD, former director of the FDA's Center for Drug Evaluation and Research, underscores the intractable culture that prevents FDA officials from addressing FDA's dismal safety track record over the pastdecade. Public outrage about FDA's dismal track record is what prompted the agency to contract the IOM investigation. But top brass at the FDA are disinclined to restructure the drug review process so as to ensure that safety is a priority.See: http://content.nejm.org/cgi/content/full/357/24/2520

Regardless of the rhetoric, nothing that the agency has done so far will prevent future regulatory safety failures. And those failures will likely to be repeated, resulting in additional preventable deaths of thousands of citizens.

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

(Emphasis by Justice Lover)