Trial and error: why we should drive the drug industry out of the clinical test business

Washington Monthly, Oct, 2004 by Merrill Goozner

The drug industry argues that its double-digit price increases are necessary to fund the rising costs and uncertain payoff of all this research and testing. But first, it's not industry but government that pays for the most critical research--funding the science and analysis that will enable the drug industry to go after diseases like Alzheimer's, many cancers, and most rare maladies for which there are no cures. Second, while the costs of drugs are going up, the number of truly innovative new drugs approved by the FDA annually have not only failed to rise, but have also fallen precipitously since the mid-1990s. This despite the fact that a decade ago Congress loosened some FDA testing requirements, thus easing industry's ability to bring important new drugs to market quickly.

Pharmaceutical companies excuse their poor performance by arguing that they've already picked all the "low-hanging fruit," i.e. the more obvious, easy-to-find breakthrough drugs, and that it is more expensive than ever to find new ones. Angell offers a different explanation. The industry, she argues, is increasingly devoting its resources not to innovative research but to the pursuit of endless copycat versions of drugs already on the market. Citing a National Institute of Health Care Management study, she points out that more than half of new drugs introduced in the past decade have been deemed insignificant in terms of medical innovation. The steep increase in the costs of pharmaceutical development can be largely attributed to the industry's fixation on me-too drugs for highly lucrative markets. For example, when the generic versions of acid indigestion pills are already 90 percent effective, it costs close to $100 million for a new company trying to horn in on the market to prove the "next generation" antacid is just as good.

Drug industry reformers like Princeton University health-care economist Uwe Reinhardt have proposed creating an independent agency to compare drugs already on the market, a measure that would gently nudge industry away from its current focus on me-too drugs and marketing. Such a change would give doctors the hard evidence, which would enable them to figure out which of a variety of similar drugs actually work best for their patients, and make it harder for pharmaceutical corporations to make me-too drugs profitable through marketing alone.

Angell goes much farther, wanting to drive the drug industry and its subcontractors out of the clinical trial business altogether. "Drug companies should no longer be permitted to control the clinical testing of their own drugs," she writes. "There is too much evidence that this practice biases the research in favor of the sponsor's drug" Indeed, in the January 2003 issue of the Journal of the American Medical Association, a review of a dozen studies evaluating conflicts of interest in medical research showed that industry-funded analyses of a drug are much more likely to turn out favorable than comparable studies conducted by scientists not funded by the industry.