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Chronic Disease management, Drugs, and Risk/Benefit

Jeffrey Bland, PhD

Some things in medicine appear obvious, while others are more obscure. I have wondered for years how pharmaceuticals are developed, from conception to a final product that receives US Food and Drug Administration (FDA) approval and associated insurance reimbursement for its use. I, of course, knew of the Tufts Medical School study that contended that nearly $800 million is expended to bring a new drug to market.1 I was also aware of the extraordinary research and development achievements of thousands of skilled men and women working in pharmaceutical industry laboratories and clinics, using the latest technology to pioneer new products. What I did not understand is how, after years of basic and applied research and phase 1 through 3 clinical trials, so many new products, after receiving FDA approval and going on the market, could cause unexpected adverse effects, including premature death, that required them to be removed from the market. Over the last few years, several major breakthrough drugs, such as lotronex (Alosteron) for irritable bowel syndrome, troglitazone (Rezulin) for diabetes, and rofecoxib (Vioxx) and valdecoxib (Bextra) for inflammatory pain, have been removed from the market because of the development of life-threatening side effects months after initiation of their use in some patients. We have seen hormone replacement therapies for postmenopausal women, including conjugated estrogen tablets (Premarin) and medroxyprogesterone acetate (Depo-Provera), go from being the number-one prescribed family of medications in the United States to being recognized as potential contributors to heart disease, cancer, and possibly dementia in some women.2 How does this happen in the face of diligent research and government oversight of the drug approval process?

The answer to this question lies somewhere in the wellwritten books by Marcia Angell, MD, the former editor of The New England Journal of Medicine, The Truth About the Drug Companies: How They Deceive Us and What to Do About It, and Jerry Avorn, MD, a Harvard Medical School professor, Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.3,4 The answer that emerges from these

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