Wednesday, February 18, 2009

Legislating Evidence-Based Medicine

Tucked away in the stimulus bill that Obama just signed is a provision that will fund research to compare medical treatments head-to-head. As the New York Times reported last weekend, funding will underwrite research to answer questions such as:
Is it better to treat severe neck pain with surgery or a combination of physical therapy, exercise and medications? What is the best combination of “talk therapy” and prescription drugs to treat mild depression?
This is basically a good idea. Having studied the history of childbirth, I'm vividly aware of how many interventions, from routine episiotomy to fetal monitoring, have been adopted without solid evidence to back up their effectiveness. By now, research has shown both of these interventions to cause a great deal more mischief than good: routine episiotomy increases the number of severe perineal tears, and near-universal fetal monitoring has helped drive the c-section rate into the stratosphere.

And yet, while I welcome policy that would both encourage and enable evidence-based medicine, I worry about how this comparative research will be used. The Times article mentions the problem of factoring cost into calculations of "effectiveness." Knowing how insurers work, I would expect them to refuse to cover more expensive procedures and drugs unless their benefits were overwhelming.

The Times article also highlights the problems of generalizing such research to everyone without regard to racial or sex differences:
“Some drugs appear to be more effective in women than in men, while other medicines are more likely to cause serious complications in women,” said Phyllis E. Greenberger, the president of the Society for Women’s Health Research. “It’s important to look for these sex-based differences.”
But beyond this, health policy needs to recognize that individuals can respond to different drugs in very individual ways. For instance, I've been reading up on the drugs used in multiple sclerosis. This isn't a purely theoretical concern for me, because odds are good that I'll be put on one of them if the neurologist I see next Monday judges me to be at high risk of developing MS. Some people don't respond at all to the basic MS drugs (interferons that try to down-regulate the immune system). Others suffer from side effects that force them to try out medications in a different class. It's really kind of a no-brainer that people with MS need to be able to choose among all the drugs currently on the market, including a couple that can have very grave side effects. Yet it's easy to imagine an insurance company using comparative research to deny coverage of all but the cheapeast drug. This problem will only grow more acute as the experimental MS drugs currently in the pipeline (hopefully) reach the market over the next few years.

I'm not arguing that comparative research shouldn't go forward. We need medicine to be anchored more firmly in scientific evidence. I'm just insisting that we equally need guarantees in law that insurance companies can't use the results of such research to keep tightening the scews on sick people who need treatment.


Heather Munro Prescott said...

Howard Dean had a good article on this subject in the Huffington Post yesterday. He argues that evidence based medicine has been pushed aside by drug marketing. New drugs are not necessarily better than old ones, and sometimes the older ones are more effective and safer.

Sungold said...

Thanks for the tip, Heather. Howard Dean's article is here in case anyone else is interested in checking it out.

I totally agree with him that comparative effectiveness research is an important counterweight against the drug companies' marketing juggernaut. The drug companies will always have a vested interest in steering people toward medications still under patent protection. And Dean points out one reassuring fact: The bill prohibits the government from denying coverage on the basis of this research.

Problem is, it apparently says nothing about private insurers. I have had such bitter experiences with drug coverage in particular. So I have to assume that private insurers *will* use this research to restrict coverage.

Here's one example. Following his chemo, my husband didn't get some of his anti-nausea drugs reimbursed because we were in Germany at the time and the drugs came in different dosages and package sizes. This was a standard drug, Zofran, that would've been covered if he'd been in Ohio when he got sick, and that would've cost more than twice as much here in the U.S. So we were simply denied coverage to the tune of thousands of dollars because some pointy-headed bureaucrat couldn't make a reasonable decision. The irony is that overall, our insurance would've had to pay *tens* of thousands more for treatment if we'd been in the U.S. at the time.