Business Week offers an insightful cover story on the promise of and impediments to smart drugs — products that target narrower subsets of a population depending on individual genetics and the specifics of the condition. The stories are fascinating reads, containing material familiar to industry insiders and hangers on but news to the public.
Embedded in the tale is the central role of profit-seeking companies, such as Switzerland’s Roche. The company bet against the best advice of its own scientific advisors and laid down $300 million in 1991 on a poker hand that indirectly led to the development of AmpliChip, a device that promises to pinpoint which drugs will help specific individuals. The stifling role of regulation is indirectly covered through a feature on FDA Deputy Commissioner Janet Woodcock, who recognizes and is addressing legitimate industry fears about narrow markets and overbroad regulation. “It isn’t that there are some bad drugs and some good drugs,” says Woodcock, in a quote that could be entered by the defense in any number of Merck’s Vioxx trials. “It’s that some drugs run into bad problems with a small subset of people.”
And, of course, unnamed naysayers and professional worriers appear, fretting that any progress may lead to increased spending on health care and life insurance denials.
“Not only is the field still immature but it is also beset with concerns about public policy and privacy. Experts fear individuals may be denied life insurance, health insurance, or even a job if they’re known to harbor genes for a debilitating illness. Also, there is a debate about whether personalized medicine will reduce or increase health-care spending. Better diagnostics would let doctors intervene more quickly, avoiding some costly procedures. But hospitals may also order more and more tests indiscriminately to cover themselves against possible lawsuits for not detecting diseases before it’s too late. And those tests can be expensive: A test for abnormalities on the BRCA1/2 genes implicated in certain breast and ovarian cancers costs $3,000 a piece.”
The possible lawsuits ought to be addressed with medical malpractice reform, not a halting of progress. As for the $3,000 price tag, ask yourself if this is too much to pay if the person in question was your husband or wife, partner, child, mom, or yourself? I’d take two just for safety, as would many others. The larger issue has to do with price controls. Although unstated, every promised advance detailed in this feature would disappear tomorrow if drugs were subject to price controls. That’s the real risk.