By Jonathan W. Emord, Troy Media
Doctors and patients worldwide mistakenly presume that when a drug is approved by the U.S. Food and Drug Administration, it is safe.
With over 320,000 patients dying each year from FDA-approved drugs and with a never-ending flight of FDA medical reviewers from the agency to Congress complaining of drugs being approved over their objections, it is clear that drug approval is no assurance of drug safety.
Drug sponsors omit damaging information
Most people will be shocked to learn that the FDA does not test drugs to determine their safety. Instead, it relies on new drug sponsors to do the testing - the very parties that have a financial interest in drug approval. Evidence abounds of drug sponsors’ minimizing and omitting damaging safety information from their new drug applications.
Despite the absence of independent safety data, FDA medical reviewers have repeatedly ferreted out reasons for concern. They have sounded the alarm within the agency, but to no avail, in case after case. The agency’s political managers have favored drug approval, regardless of the safety risks. It is the political managers and, ultimately, the FDA commissioner, not the agency’s career scientists, who decide whether to approve a drug.
Money and power over safety
The political managers’ and the Commissioner’s post-government employment prospects lie either in the drug industry itself or in lobbying firms or academic chairs financed by the drug industry. Satisfaction of industry demands is, therefore, in their self-interest.
The FDA associate director of the Office of Drug Safety, Dr. David Graham, has stated: “FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed.”
Dr. Graham is not alone in believing this. In January, nine additional FDA scientists jeopardized their career prospects by writing to US President Barack Obama stating “managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the law . . . and to accept clinical and technical data that is not scientifically valid.”
FDA’s sordid history of retaliation against whistleblowers
Consistent with Dr. Graham’s observations, former FDA medical reviewer Dr. David B. Ross stated, “industry has become FDA’s client. People at FDA know that they have to be careful about upsetting industry” and that “even if a product doesn’t work, . . . there is pressure on managers that gets transmitted down to reviewers to find some way of approving it.” Former FDA medical reviewer Dr. Robert L. Misbin, now deceased, likewise observed: “One of my superiors said something . . . I have never forgotten, that we have to maintain good relations with the drug companies because they are our customers.” In each case, these career government scientists spoke out, aware that doing so invited agency retaliation; FDA has a long, sordid history of retaliating against whistle-blowers.
Power politics at its worst
Why do FDA political managers push for drug approval despite evidence of unacceptable risks? It is no secret that those who do the bidding of drug companies while in public office often land in lucrative positions at those companies or lobbying firms that serve those companies when they enter the private sector. Former FDA Commissioner Lester A. Crawford, who defended Vioxx despite evidence that the drug caused unacceptable risks of heart attack (resulting in an estimated 140,000 heart attacks and 60,000 deaths from heart attack), was hired by Policy Directions Inc. after he resigned (and after he pleaded guilty to making false statements to the government in not disclosing stock interests in FDA-regulated companies).
Policy Directions Inc. includes among its clients Merck, the maker of Vioxx. Former FDA Chief Counsel Dan Troy, who served as FDA’s lead counsel when the agency intervened in a products-liability suit in support of GlaxoSmithKline, is now the senior vice president and general counsel of GlaxoSmithKline. Former FDA Commissioner Andrew von Eschenbach and former FDA Center for Devices and Radiological Health Director Daniel Schultz are likewise employed by an industry lobbying firm, Greenleaf Health LLC, assisting many of the companies that benefited from their actions while in government service. I could go on.
FDA approves dozens of unsafe drugs
FDA Commissioners have approved at least three-dozen drugs that FDA medical reviewers deemed too unsafe to enter the market. According to Dr. Graham, GlaxoSmithKline’s Serevent, an asthma drug, increases by many times the risk of death from asthma; it remains on the market. GlaxoSmithKline’s Avandia - a type 2 diabetes drug linked to a 43 per cent increased risk of heart attack in a meta analysis published in the New England Journal of Medicine – was approved over FDA medical reviewer Misbin’s safety objections. It remains on the market, but the FDA is reconsidering its decision to approve it, more than a decade after the evidence of its harms first came to light. Sanofi-Aventis’ Ketek, an antibiotic approved even after it was revealed that falsified clinical data were submitted to FDA in the company’s new-drug application, is linked to severe liver injury. The drug was approved over FDA medical reviewer David B. Ross’s objections that it would cause that injury. Ross said the FDA approved Ketek although agency political managers knew “that it could kill people from liver damage and that tens of millions of people would be exposed to it.” Amylin Pharmaceuticals’ Byetta, a type 2 diabetes drug, is linked to acute pancreatitis, renal insufficiency, kidney failure, and pancreatic cancer, yet was approved over FDA medical reviewers’ objections.
Inherently corrupt FDA
To stop the approval of unsafe drugs requires more than “reform” of an inherently corrupt FDA. The solution lies in removing from the FDA the power to approve drugs, creating a blinded system of reviews conducted in academic institutions without the drug industry’s knowing which institution is performing any particular review, and giving legal effect to the determinations reached. (This option is explained in my book The Rise of Tyranny .) To bring that about will require removing from Congress those in both parties who now pocket campaign contributions from the drug industry, replacing them with ones who refuse to take that drug money.
Jonathan W. Emord is a Washington, D.C. based constitutional attorney. He is the author of four books about politics and government, including two Amazon.com best sellers,
The Rise of Tyranny and Global Censorship of Health Information
