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How Forest Labs' Cash Helps Doctors Ignore What Works for Hot Flashes

Never mind the evidence, just treat patients' complaints: That seems to be the message from a Forest Labs (FRX)-funded doctor whose work on the use of the antidepressant Lexapro to treat menopausal hot flashes was recently contradicted by an elegant study in the journal Menopause.

Dr. Ellen Freeman previously published a study in January, in the Journal of the American Medical Association, suggesting that Forest's Lexapro helped reduced hot flashes. Freeman received both "honoraria" and "research support" -- i.e cash -- from Forest, the study notes.

But a more recent study overturned Freeman's results. Whereas Freeman relied on her patients to subjectively self-report their hot flashes in diaries, Robert Freedman's team in Menopause gave their subjects a battery-powered hot-flash detector worn on the skin, which detects flashes even if patients are asleep. The objective results showed no significant difference between Lexapro and a placebo.

Freeman's reaction was interesting, to say the least. She suggested doctors might want to ignore the new evidence and carry on prescribing Lexapro. She said:

Clinicians treat the woman's complaint of hot flashes, and the degree to which they are bothersome or distressing ... An objective monitor has scientific appeal but may not relate to the clinical problem.
So, er, objective evidence might not relate to the problem? It's a novel approach, to say the least, particularly as Freeman previously admitted she has no clue why Lexapro might work on hot flashes. Bloomberg reported:
It's unclear how the medicines, which increase the chemical serotonin in the brain, reduce hot flashes, Freeman said.
The traditional therapy for postmenopausal symptoms is hormone replacement, because menopause is all about hormones. Lexapro doesn't affect hormones. That's why using Lexapro for hot flashes is an unapproved, "off-label" use. It's illegal for Forest to promote the drug for that purpose but not illegal to study it.

The effective difference between "studying" and "promotion" is almost negligible, however. Despite the new study's trashing of Lexapro for hot flashes, there are plenty of health-oriented web sites out there still trumpeting Freeman's good news from January, that Lexapro reduces hot flashes.


Image by Flickr user Todd A. Porter, CC.