The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 10 No. 3 • November 2007


FDA’s Body Count Mounts as the Agency Increases
Its Suppression of New Medical Therapies

Where are all the new treatments for old diseases that continue to kill millions? It’s hard to believe, but the FDA’s rules and regulations for drug development are getting worse, more chaotic, and increasingly more expensive. The Oct. 1, 2007 Genetic Engineering & Biotechnology News provided up-to-date FDA information in an editorial by Henry I. Miller, M.D. (fellow at the Hoover Institution and director from 1989 to 1993 of the FDA’s Office of Biotechnology; e-mail: miller@hoover.stanford.edu).

According to the editorial, the latest data (2006) from the Tufts Center for the Study of Drug Development reports that on average it takes more than eight years and costs $1.2 billion to develop a biopharmaceutical. (That includes stem cell therapies; one has to wonder whether the politicians and government-funded scientists clamoring to get billions of dollars of taxpayer money to spend on stem cell research have considered—or even care—whether the public will actually get access to treatments based on this research.) Of the $1.2 billion development costs, about $615 million are capitalized out-of-pocket preclinical costs, while clinical testing accounts for $626 million.

According to Dr. Miller, regulatory excesses account for the huge costs and lengthy development times. He notes that, despite highly publicized recent drug safety events, including inadequate warnings on antidepressant drugs and the discovery of previously unknown adverse reactions (increased risk of heart attack) from the use of selective COX-2 inhibitor pain drugs, the common perception that FDA oversight had become lax is incorrect. “. . . drug regulation in the U.S. in recent years has actually become progressively more risk adverse, as the FDA has steadily made it more difficult to initiate and perform clinical testing of new drugs.”

As a result of drug-safety criticisms from Congress, the media, and others, the FDA has been requiring ever larger number of patients in clinical trials, and demands for postmarketing clinical trials have “proliferated wildly.” Dr. Miller also says that “[FDA’s] risk management plans for newly approved drugs have been inconsistently applied, punitive, and often more appropriate for weapons-grade plutonium than prescription drugs.” [Emphasis added]

The following example given in Dr. Miller’s editorial for what would appear to be a minimal-risk drug indication illustrates the FDA problem. In this instance, Somaxon Pharmaceuticals is testing doxepin, an already approved drug (approved for treatment of depression since 1969), for a new indication (where it would be used in very low doses as a sleeping pill). “. . . FDA initially assured the company that it could begin clinical trials without first doing animal tests because of doxepin’s long history of use in people and because Somaxon was using a dose [in the new indication] less than one-tenth of that used to treat depression.” However, in May 2006, after the company had already completed several clinical trials, the regulators suddenly demanded a full battery of testing in animals.

This magnifies the importance of what we call the parallel medical system—therapies developed from natural products (which can be sold without FDA approval) as a result of rapidly expanding knowledge of mechanisms of action of these natural substances. The FDA fly in the ointment here is that this will work well only for those who are knowledgeable about these substances, which hopefully includes those of you reading this newsletter. The market will stay small with FDA-restricted information, as it is very difficult to sell natural products without being able to tell people what they do.

The FDA has also turned down most applications for scientifically well-supported (though not conclusive) qualified health claims, recently disallowing, for example, the health claims that green tea may reduce the risk of cardiovascular disease and that consumption of tomatoes may reduce the risk of prostate cancer.

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