Thursday, November 10, 2005

It's how we end up with Vioxx

Via Health Care Renewal, an interesting post about shifting trends in drug trial review boards. Roy Poses writes:
The articles noted that most (75%) of US drug trials are now done by commercial firms, rather than by academic researchers. In 1991, 80% of trials were done in academia. Most of these trials have been approved by commercial, rather than academic IRBs.
That's quite a turn around. In only 14 years drug trials have gone majority university run to majority privately run. This has numerous implications, from the private company's incentive to produce favorable results to insufficient research methods. Reporters visiting one test site in Miami found some questionable practices, to say the least:
Visits by reporters to a 675-bed trial site in Miami owned by SFBC International revealed the shoddy condition of its physical plant (a bathroom with "chipped white tiles [which] reeks with urine; its floor is covered with muddy footprints and paper towels.")
The reporters suggested that trial subjects are frequently poor. They may ignore study rules to forego alcohol and narcotics. Most trial participants stated that "they barely read" informed consent documents. Reporters noted that "participants in the Miami clinical trials openly talk about how they violate SFBC rules intended to protect the integrity of the research findings."
To be sure, the reporter's investigation is by no means scientific. But I don't doubt their findings. I'm sure we've all heard those radio ads for drug trials obviously targeted towards people in their early twenties. People who wait tables for a job and need an extra buck or 100. I can certainly envision many of my less responsible friends signing up for a drug trial with pot in their system, or going out drinking at night.

The informed consent language also represents a problem. If the majority of people signing up for these trials are low-income, it's likely their literacy levels are correspondingly low, and they might have trouble understanding informed consent. There's been a lot of talk over at the FDA about making drug inserts at a 6th grade literacy level, which is completely reasonable to me. Have you ever tried to read those? I enjoyed looking at them (particularly the drug molecule structure, but that's because I was pre-med for God's sake), but most people get scared off by the chemistry diagrams.

In any case, I'm quite uncomfortable with drug trials being performed on sects of the population that are in no means representative of it. Faulty trials are how we end up with Vioxx and Guidant's heart devices on the market. There's a lot of room for change over at the FDA -- we should be pushing for stricter drug trial standards, too.


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