The involvement of private business in medical research is “essential,” according to a recent editorial in the Journal of the American Medical Association. After all, drug and medical device makers fund important product development and marketing. In fact, private industry in the United States funds a significantly larger portion of clinical research – the investigation of new drugs and devices in patients – than do the government and government-sponsored university programs, despite a recent increase the National Institutes of Health budget.
Essential or not, the question remains as to whether the influence of private industry on biomedical research is beneficial overall.
A great deal of public trust is placed in medical research, exemplified by the patients who volunteer to participate in biomedical research. How often do the results of research warrant this trust?
If we look to the rate at which the big pharmaceutical companies bring important new drugs to the market, the answer is abundantly clear: not very often. According to a 2002 Health Affairs study, in 1998 private industry – although the leading funder of research – accounted for just 15 percent of citations in drug patent applications. Academic centers accounted for 54 percent, and government sources 13 percent.
The same study reports that from 1999 to 2001, the FDA approved 1,035 drugs. Of these, only 23 percent were classified as “significant improvements” over existing drugs, while 77 percent were described as having “therapeutic qualities similar to those of one or more already marketed drugs.” Rather than using the sacrifices of volunteers to develop drugs that advance the frontiers of medicine, such studies help companies license “me too” drugs used to retain or capture part of a lucrative market share.
Industry marketing suggests that miracle drugs are the driving force of the industry. For those who receive these drugs, the partnership between the public and private sectors has been not just a bargain, but a blessing. For example, research on anti-rejection drugs has in large measure drastically improved survival for those fortunate enough to obtain an organ for transplant. Heart disease, though still a leading cause of death, is much better managed today, thanks to research that led to a new generation of drugs that help control high blood pressure and help the heart pump better.
The partnership between the public and private sector has been as lucrative for industry as it has been life-altering and saving for some patients. By reaping the rewards of this partnership, pharmaceuticals led all industry sectors for decades in their profitability.
Although profit margins have recently begun to decrease, from 1992-2000, the pharmaceutical industry posted profit margins as a percent of revenue more than triple that of industry as a whole, according to a University of Minnesota study. According to Fortune magazine and industry reports, in 2002 the profits ($35.9 billion) of the 10 pharmaceutical companies among the Fortune 500 were more than the profits ($33.7 billion) for all the other 490 combined.
And how has the industry spent these profits? They get plowed back into more research for more miracle drugs, right? Not exactly. First, remember that industry research brings more “me too” drugs to market than anything else. Second, the industry spends far more on marketing than on research.
According to an analysis of the pharmaceutical industry’s own published profile for 2000, it employed about 88,000 people in marketing and about 49,000 people in research. In that same year, the industry spent approximately 30 percent of revenue on marketing and administration, but only 12 percent on R&D. If this ratio strikes you not just as out of balance but as odd, it should.
As Marcia Angell, former editor of the New England Journal of Medicine, recently pointed out, it really wouldn’t be that difficult (or expensive) to market a cure for cancer. However, to increase sales of a new drug with lots of competition, i.e., a new drug nobody really needs, then you need a large and talented sales force, expensive media campaigns, etc, all of which costs tens of billions of dollars per year.
Would patients be as willing to volunteer for studies that help bring “me too” drugs to market if they knew the stakes were so low? Are such studies a responsible expenditure of the public’s trust in the biomedical research enterprise? Consider that patients can have a lot of leverage.
After all, without patient volunteers, there can be no clinical research. The public can leverage this power to rightly make demands of its partners in the research enterprise, perhaps starting with greater trustworthiness and greater efforts to identify shared research goals.
Mark Yarborough is an Associate professor at the University of Colorado at Denver and Health Sciences Center and director of the Center for Bioethics and Humanities