Progressive efforts at both the state and federal levels to cap drug prices drug have evoked a classic industry lament: Regulate us or threaten our profits and we won't have the incentive or the means to do life saving research. This media campaign does illustrates this industry's greatest strength, its ability to toot its own horn. A look behind the rhetoric, however, shows another story. The industry often subordinates development of genuinely new drugs to its ongoing efforts to corner markets and to manipulate the process by which our "wonder drugs" are judged.
Charges that price controls limit funds for medical research obscure basic facts about this industry. Most of the biomedical research on which new drugs are based is not done by private corporations for patents. It is sponsored by non profit foundations or the government.
The patent system itself is an inefficient instrument of drug innovation. The New York Times reported recently that medical volunteers are reluctant to take part in research without compensation when they realize that the researcher or her employer stands to profit from it. In addition, much patent-oriented research is devoted to medically dubious purposes. Office of Technology Assessment studies showing that two thirds of all patent work and a third of corporations' twenty billion in research spending is devoted to the pursuit of "copycat" drugs. These are variation-on-a-theme products the principal purpose of which is to evade another firm's patents.
The damage from copycat medication does not stop with economic waste, as Steven Pomper has demonstrated in a recent Washington Monthly article. Responding to legitimate concerns about the slow pace of new AIDS drugs, in the early '90s Congress fashioned a faster drug approval process. The FDA was to hire more professional staff and speed up reviews without sacrificing rigor. But, as Pomper points out, "The new law created a faster review process for all drugs -- not just breakthrough treatments for diseases like AIDS."
Fast review coincided with other trends in industry/government relations to create a drug marketing behemoth that would be the envy of a Columbian drug lord. At the same time that funds for the approval of new drugs have escalated, budgets to monitor the health effects of established drugs have been held constant. The FDA now spends nearly 300 million to approve new drugs and less than fifteen million to monitor the effects of existing ones.
Three other corporate strategies have altered the supply and demand equation. The industry spends ten billion on its detailing efforts to physicians. Such "educational" efforts include free meals, seminars in exotic locations, and tickets to major sporting events. Secondly, it now funds many of the academic studies assessing the long term efficacy of drugs. With public funding for such medical research declining, the dangers of biasing the content of such research grow. Finally new regulations now make the United States the only advanced industrial nation to allow direct consumer advertising for prescription medication. Such advertising requires only vague disclosure of risks. The industry is spending two billion dollars a year on a flurry of image ads worthy of Coke or Bud. Many of these medications are classic copy cat drugs. We as consumers pay for the initial "research" on these drugs, the purportedly unbiased studies of them, and for their heavy ad costs.
A system that is all sails and no anchors takes lives. Since increasing numbers of rapidly tested drugs are being introduced into a system poorly geared to assess their long-term impacts, instances of drug toxicity mount. Six new drugs approved since mid-1996 have been pulled off the market. All six were drugs for which older and widely used alternatives were available. 150 deaths were linked to these medicines. The Food and Drug Administration estimates that toxic reactions to marketed drugs cost more than $30 billion per year and are among the ten leading causes of death in the United States.
These developments all put into question a drug production and distribution system so heavily dependent on corporate incentives and direction. At the very least, we need a social commitment to fund more drug research and more adequately staff FDA monitoring. Most importantly, not only physicians but interested patients need a system of drug information not dependent on corporations. Two Harvard professors have recommended "academic detailing," a plan whereby medical schools send their impartial detailers without drug company ties to brief doctors on the latest drug advances. In Australia, the government funds detailing of this nature. Such a system here should include efforts to develop and publicize sources of drug information accessible to the average lay person.
Such reforms would hardly deny opportunities to drug firms seeking profits from health enhancing advances. They would, however, allow us not only better to assess their real contributions but help insure us against the disasters when the urge to profit from drugs trumps humane considerations.
John Buell lives in Southwest Harbor and writes regularly on labor and environmental issues. He is co-author, with Etta Kralovec, of The End of Homework: How Homework Disrupts Families, Overburdens Children, and Limits Learning (Beacon Press). He invites comments at firstname.lastname@example.org