CALPIRG Blog

A fascinating article on new information about a prostate drug highlights many aspects of what's wrong with our health care system -- overuse of unnecessary care, drug companies' single-minded pursuit of blockbuster drugs, and the problems of the FDA drug approval process.

Prostate cancer is one of the most frequently-diagnosed cancers in older men. But in many cases, it's not very fast-growing, doesn't lead to death or severe symptoms, and in fact might not pose a great risk to health. Nonetheless, very many patients with the condition opt for aggressive treatment they often don't need -- and these unnecessary treatments can cause severe side-effects, such as impotence or incontinence, as well as driving up the costs of medical care.

This sort of treatment, which often doesn't provide any real benefit to the patient, is sadly all too prevalent in American health care -- often at the expense of proven, effective preventive and primary care that helps stop conditions before they develop. Promoting evidence-based medicine and reforming payment structures so that doctors are rewarded for providing effective care rather than just more care are important steps to take to change things. But in this case, there's a novel solution on offer.

Drug makers have developed a drug, finasteride, which reduces patients' risk for prostate tumors -- both the dangerous, aggressive kind and the smaller, harmless ones. Some doctors are hoping that prescribing the drug to men without any current prostate problems, will lead to many fewer diagnoses of prostate cancer. In addition to preventing the dangerous kind, however, the doctors also think that there will be a significant benefit to preventing the harmless ones, because that way the unnecessary treatments will be avoided: if it's never diagnosed, it'll never be treated.

Something about this seems backwards -- taking a drug that might not be needed in order to avoid a different treatment that might not be needed? -- but there is a logic to it, since finasteride is a generic drug, and reasonably inexpensive as a result (better an unneeded cheap pill than unneeded surgery!) Getting our health care system to stop providing costly, ineffective treatment is very hard to do, but it's very good at prescribing new pills, so this might actually be the simplest stop-gap solution. But there's another twist: because the drug's patent has expired, the big pharmaceutical companies just aren't interested. So while this group of doctors talk about trying to prescribe a daily dose to millions of Americans, the drug companies are turning up their nose, since they've shifted their business models to focus only on chasing the next big blockbuster, patent-protected, high-priced drug.

Of course, finasteride is still being produced by generic manufacturers, so you might think that it wouldn't matter that the big drug companies don't want in on the action. The problem is that the FDA has only approved finasteride for its role in shrinking prostates, not in preventing prostate cancer. Without specific FDA approval of the cancer-prevention function, doctors can prescribe it but many insurers won't cover the drug, meaning that insured Americans would be on the hook to pay the full cost themselves, over and above their usual health care premiums and co-pays. And getting FDA approval for a new function is a long, expensive process that's invariably bankrolled by the big drug companies -- the mere fact that this drug might provide a benefit won't be enough to get it approved without some deep-pocketed corporation standing behind it.

Oh, and meanwhile the pharmaceutical firm GlaxoSmithKline is pushing forward with its efforts to get one of its patent-protected drugs approved by the FDA for a similar prostate-cancer-prevention use. So we could wind up with a system where doctors prescribe, and insurance companies pay for, the overpriced brand-name drug rather than the cheaper alternative that does the same thing, with much of the benefit of the medicine coming from eliminating benign tumors that otherwise might be treated unnecessarily.