Rx Care

Medical innovation: What's driving and deterring it

Food & Drug Administration commissioner Mark McClellan has a serious complaint. He wants more new filings for pharmaceuticals and biologics, as well as for new medical devices. A lot of good research, he maintains, is simply not being developed into usable products.

The Medical Innovation Summit, which was recently hosted by the Cleveland Clinic Foundation, in Ohio, attracted several hundred people, including CEOs of medical device and pharmaceutical companies, as well as Cleveland's mayor, the governor of Ohio, patent attorneys, researchers, and clinicians. McClellan told the audience that while the FDA is trying to make it easier for companies to gain approvals more quickly, and while the pharmaceutical industry is spending more money on research and development than ever before, there have been fewer applications in the past few years to approve. He encouraged the medical device makers, as well as the pharmaceutical companies, to try to speed up the pace.

In his talk, McClellan claimed that companies have a lot of research breakthroughs that could be brought forward, rather than just being left to "sit on the shelf."

The CEO of Abbott Laboratories, Miles White, another speaker at the conference, tended to agree that many companies were unnecessarily holding back, although he and others noted that recent public outcries about the cost of drugs and devices in the United States, compared with that of other countries around the world, had made companies cautious. And he and others indicated that a good part of the problem is that other developed nations are not bearing their fair share of the cost of developing these new drugs and devices.

But not everyone was pessimistic. Francis Collins, who is head of the Human Genome Project, was downright enthusiastic. He predicted that in another 10 years the era of personalized medicine would be here. It would be an era in which a person's genetic profile would be readily available so that physicians would be able to prescribe only those drugs that they knew in advance would be effective in a particular patient without causing untoward side effects.

Of course, he continued, there would need to be genetic profiling of a very large group of people to make that possible. Toward that end, Collins suggested developing a kind of "Framingham Project"—after the famous study in Framingham, Mass., in which researchers have been following their original patients and then their descendants for many years, bringing forth new knowledge about the heritability of various forms of cardiovascular disease.

In conclusion, Collins said, using this longitudinal study as a model with which to look for genetic differences on a much larger scale would help greatly to usher in the era of personalized medicine.

Jean McCann

The AUTHOR is a medical writer based in the Cleveland area.

Jean McCann. Medical innovation: What's driving and deterring it.

Drug Topics

Nov. 3, 2003;147:36.