One of the worst-kept secrets in medical research is that much of what passes for cutting edge knowledge is actually thinly-veiled advertising by the drug industry for drugs that have already been FDA-approved. Example: A company has an anti-inflammatory pain pill that has been approved for arthritis pain; they now want to test it on dental patients with tooth aches. Such studies add almost nothing to medical science, yet they routinely appear in the medical literature, especially in the less prestigious journals that cater to specialists.
These trials are sometimes referred to as seeding trials because their real aim is to encourage the physicians who enroll patients in the trial (at a nice fee per patient, of course) to continue prescribing it for them and other patients once the trial is over. Another major benefit for the drug firm is that after the study appears in a specialty journal, the sponsor can buy thousands of reprints for its salesmen to distribute to the offices of physicians in that specialty, even though it hasn't been approved for the condition they're actually treating. While the law prohibits drug industry salesmen from promoting the off-label use of drugs, they are allowed to drop off published literature that accomplishes the same thing.
It now appears that industry has gotten Medicare involved in the game. Yesterday, I attended an all-day hearing at the Center for Medicare and Medicaid Services (CMS) where an advisory committee debated whether Medicare should continue reimbursing the routine costs of caring for seniors who are enrolled in clinical trials. At the end of the day, they said yes with a few limitations that may not stop the abuses.
Some background: Older people have historically been underrepresented in clinical trial research, which is unfortunate since older people consume well over half of all drugs. To rectify the situation, President Clinton in 2000 issued an executive order requiring Medicare to pay for their participation. His order was triggered by an Institute of Medicine report calling for the change, and it was widely heralded as a good thing.
But earlier this year, the agency announced it wanted to revisit the issue. While the rule has provided some researchers, especially in cancer research, with needed support, not all the Medicare-funded studies were so noble. "There were trials (funded) that we think were inappropriate," Steve Phurrough, the director of the coverage and analysis group at Medicare, told the 18-member advisory committee. Pressed for examples, he was vague, citing studies that "lacked scientific merit" and one study of a drug "with significant side effects."
The advisory committee endorsed a number of restrictions for industry-funded trials seeking government support. They included requiring future trials to register with ClinicalTrials.gov, the government-run registry; the trial sponsor must also explicitly outline the method and timing for releasing data from the trial; and the study should make an attempt to enroll patients that demographically reflect the overall Medicare population.
About half of the 250 clinical trials registered each week with the government-run database originate in the U.S., and just half of those are funded by the National Institutes of Health or other government agencies. That leaves lots of industry-funded trials eligible for the program. With the new rule expected early next year, it remains to be seen if CMS will come up with a scheme that puts a halt to the abuses.