Should HIV drugs get off-label use for chronic fatigue?

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Off-label use of HIV drugs to treat chronic fatigue syndrome is growing. However, their use comes at a time when some HIV patients can't get access to the medications because of budget cuts, the New York Times reports. Critics point out that antiretroviral drug use for chronic fatigue is based on the idea the condition stems from a retrovirus known as XMRV--a link that's now in serious dispute.

In fact, Science magazine published a partial retraction of the XMRV-and-chronic-fatigue study just today. The authors of the original, controversial paper in 2009 have backed away from their XMRV findings, the Wall Street Journal reports. Science also features a new paper investigating the XMRV issue, which reports that labs screening blood for XMRV or XMRV infection in chronic-fatigue patients and healthy donors either didn't find the virus or couldn't reproduce their findings.

Some of the authors of the original study still believe in a link between a retrovirus and chronic fatigue, however. "We have to dig in to find the right viruses. We need to keep looking," Judy Mikovits of the Whittemore Peterson Institute told the WSJ.

If a retrovirus is the cause of chronic fatigue syndrome, then antiretrovirals used against HIV might be an appropriate treatment. And doctors are perfectly free to prescribe the drugs as they choose, even if that use isn't FDA-approved. But in a budget environment in which AIDS patients are on waiting lists for drugs they can't afford--and states can no longer provide through assistance programs--the idea that some non-HIV patients are using the drugs has touched off the controversy.

And, fairly or not, the questions are rebounding on HIV drugmaker Gilead Sciences ($GILD)--partly because the company's pricing has stirred up protests over the years. No one is accusing Gilead of marketing its drugs for off-label use in chronic fatigue patients. And a company spokeswoman said Gilead's own patient assistance programs wouldn't deliberately provide drugs for free for an off-label use.

- see the WSJ story
- get more from the NYT

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