Wednesday, February 08, 2006

Healthcare vs. the FDA

It is often claimed by opponents of capitalism that without the mechanism of government regulation we would not be safe from the alleged greed of the pharmaceutical companies. Thus the products of pharmaceutical companies are regarded as guilty until proven innocent as if the companies were simply aching to sell fraudulent medications to innocent patients. The drug companies must subject their drugs, which took years to develop and test, to yet further testing by the FDA and only with FDA approval can their drugs be legally sold within the United States. What is less often understood is the role played by this kind of regulation in preventing information about important applications of drugs from reaching doctors and patients.

Leonard Flynn, an advisor to ACSH, writes:

The federal Food and Drug Administration (FDA) recently won a case against Eli Lilly & Co. when the company agreed to plead guilty and pay $36 million in connection with illegal promotion of its pharmaceutical drug Evista. What did the company do to earn such a penalty?

The company illegally promoted its pharmaceutical drug Evista because Lilly employees had advocated the product for "off-label" uses. Evista was approved for the treatment of osteoporosis, but the company was not allowed to breathe a word that Evista might be good for something else. The company did have evidence for the prevention of breast cancer and heart disease, but according to the federal Food, Drug, and Cosmetic Act (FDCA), as interpreted by FDA regulations, promotion of these other uses was forbidden.

What was the evidence for Evista's other potential uses? Was it on a limited number of test subjects for a short period of time? Far from it. Flynn continues:
Two research articles were published in the Journal of the American Medical Association (JAMA), a prominent peer-reviewed scientific journal that presented scientific data supporting the use of raloxifene (the chemical name for Evista) for breast cancer prevention and heart protection. The first article was published in 1999, and it showed that raloxifene "reduced the risk of invasive breast cancer by 76% during three years of treatment." This was a substantial study that ran from 1994 through 1998 at 180 clinical centers in twenty-five countries, primarily the United States and countries in Europe, and included a total of 7,705 postmenopausal women with osteoporosis as the subject population. A "secondary analysis" of the same 7,705 women was published in 2002, and it demonstrated a "lower risk of cardiovascular events" for a subset of 1,035 women in the study who had an increased cardiovascular risk when the study began.
The FDA is after power, not health. Sadly, most of the time, evidence of regulation's destructive effects is hard to come by, since it involves what Henry Hazlitt referred to as the unseen results of government intervention, for example, the products that did not make it to the market, the businesses that were not started, the money that was not saved, etc. Neverthess Flynn is quite correct to wonder:

So, who cares if drug companies are prevented from informing doctors about additional uses of their products? The drug companies are obviously highly motivated to distribute favorable scientific information about their products because they can make more sales, it is argued, and FDA rules block the claims because the agency's regulatory power rests on this ability. What difference does this regulatory struggle make? It could make a big difference -- to patients.

In the late 1990s my mother, Inge Flynn, was dying of advanced breast cancer. In 1999, the Evista cancer study was published in JAMA. I wonder: if my mother's doctors had known of the raloxifene study, would they have prescribed it during her illness? Might the "off-label" drug Evista have benefitted her? She died on September 30, 2000.

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