On Drugs and Politics

Under the bill introduced in the U.S Senate on September 06, 2007, drug and medical device manufacturers would need to report publicly, essentially all payments and gifts to doctors1. The bill mandates firms with at least $100 million in annual revenue to disclose, each quarter, gifts or payments valued over $25, the information then posted on the World Wide Web. These firms would need to disclose any direct or indirect payment or benefit, including continuing medical education (CME) funding, and those by universities and by firms that organize conferences for doctors funding from firms stipulated in the bill, which does not apply to no-cost drug samples and clinical trials’ funds.

The need for transparency in both the private and public sectors is not in doubt, and it is possible that such gifts and payments could influence some doctors’ prescribing habits. However, does this bill not also raise issues concerning over-regulation of the pharmaceutical industry for example, particularly pharmaceutical marketing, which the U.S Food and Drug Administration (FDA) already significantly regulates? To what extent should, government regulated this, and indeed, other industries, and does it take another law to get the industries concerned to become transparent in their business dealings or could such transparency evolve via the operations of market forces, unfettered?

Would the market and not legislation address appropriately and effectively such concerns as raised in the U.S recently by Robert Goldberg, vice president of the Center for Medicine in the Public Interest, in a Washington Post opinion piece titled ‘Medical quackery’2? Observed Goldberg, the judgment of a new comparative effectiveness ‘movement,’ wherein consumer advocates compare older with newer drug versions to determine the more cost effective and efficient appears based on ‘bias or fear, not science.’ He noted that while the ‘evidence-based crowd wants us to trust them that their approach to research is purer and better, ... comparative effectiveness trials are rigged to demonstrate cheaper drugs are more effective, even at the expense of patient well-being.’

He mentioned the case in which the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) ‘concluded that diuretics were more cost-effective in reducing death from all forms of heart failure, not heart attacks, and were therefore cost-effective overall’ than newer anti-hypertension drugs. Yet, the “entire 'cost-benefit' of the older drugs (diuretics) was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began”2. In his opinion, such studies ‘are rigged against new drugs and designed to eliminate the individual differences that are at the heart of the next generation of personalized medicines.’ With the total number of retail prescription drugs filled at pharmacies alone in the country in 2006, 3,309,156,096, most in California, 268,742,976, least in Alaska, 4,383,459, total sales $192,041,123,840, most in California, $15,837,088,768, least in Wyoming, $294,317,184 3,  is it a wonder that controversies would emerge in some form or another in the market? Yet, is it not questionable that legislation rather than market operations would resolve them? 

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