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Off-label use of H.I.V. medications is catalyst for more controversy

Thursday 29 September 2011

From The New York Times:

 

Viread
A bottle of AIDS medication called Viread.
(Photo: Joe Raedle/Getty Images)

Off-Label Use of H.I.V. Medications Is Catalyst for More Controversy

By SCOTT JAMES
Published: September 23, 2011

At a cafe on 18th Street in San Francisco, David sipped coffee and talked about the regimen of daily H.I.V. pills he recently started: Viread in July, and then last month, Isentress. He looked exhausted.

David does not have H.I.V. For 20 years he has endured a debilitating case of chronic fatigue syndrome, which has left him unable to work.

“All of a sudden my brain dies,” said David, who asked that only his first name be used for privacy reasons. “I have such a narrow range of concentration.” He hopes the medications will help.

Thirty years into the AIDS epidemic, the antiretroviral drugs that have provided lifesaving treatment for many of those infected with H.I.V. — 1.1 million in the United States today — are now being used or considered for treating other ailments.

When medications have proved safe and effective for most patients, it is standard practice for pharmaceutical companies to see if the drugs have other applications. But with H.I.V. drugs, the practice has been unusually contentious, fostering debates about questionable science, safety and profiteering, and concerns that thousands of Americans infected with H.I.V. cannot get the medications.

At the center of this controversy is Gilead Sciences, a pharmaceutical company based in Foster City. Gilead is the nation’s largest producer of H.I.V. medications (including Viread, Truvada, and Atripla), accounting for nearly half the United States market for them. The drugs produce $3.5 billion in annual revenues, with profit margins reportedly twice the industry average.

The Food and Drug Administration approved Viread to treat chronic hepatitis B in adults in 2008. And after a 2009 study linked chronic fatigue syndrome — a mysterious tiredness believed to afflict a million Americans — to a retrovirus called XMRV, there was hope that H.I.V. drugs might also work against that ailment.

But that idea soured when other scientists could not reproduce the study’s results and concluded that the findings were incorrect. Science, the medical journal that published the research (conducted by the Whittemore Peterson Institute of Reno) has taken the unusual step of asking for a retraction. The institute declined to comment for this column.

Many doctors still believe that some type of virus, even if not XMRV, causes chronic fatigue, and an unknown number of patients continue to try H.I.V. drugs as a treatment. With a doctor’s prescription, Dave said he received his medications from drug makers without charge, because of his low income.

But critics say the speculative use of H.I.V. medications is ethically dubious because a growing number of Americans infected with H.I.V. are apparently unable to get the medications.

Atripla, a combination of three H.I.V. drugs including Viread, wholesales for nearly $20,000 per patient annually. The recession has created greater need for financial aid, with jobless Americans losing health insurance, and strapped states (11 so far, but not California) have placed infected people on waiting lists to receive medication free or at reduced cost — more than 9,000 now, up from just 100 in 2008.

“They are giving these lifesaving drugs to people who do not have H.I.V., while those who need them are going without,” said Ged Kenslea, a spokesman for AIDS Healthcare Foundation, a patient advocacy group and medication provider.

Mr. Kenslea said there was also concern about research into using the drugs as prophylaxis, to prevent H.I.V. infection in high-risk groups. Research in San Francisco and elsewhere has found that preventative use is only partly effective, raising safety concerns that such use would create a false sense of protection and increase infections. The foundation has protested the idea in news media campaigns and at Gilead’s headquarters.

Officials at Gilead declined to be interviewed. But in an e-mail, Gregg Alton, a Gilead vice president, said the company recognized the “crisis” emerging with states’ H.I.V. medication financing and had reduced or frozen prices and was providing drugs for free to many on waiting lists.

“We take our responsibility to patients seriously and we are working hard to ensure that H.I.V. patients who need our medicines have access to them, regardless of their ability to pay,” Mr. Alton wrote.

Cara Miller, a Gilead spokeswoman, acknowledged in e-mails that the use of the company’s drugs for H.I.V. prevention, rather than just disease treatment, has spurred a discussion “about an important topic.” She also wrote that Gilead had not knowingly given away drugs for free for treating chronic fatigue, since that was not an approved use.

Approved use or not, David continues the regimen, hoping for results. “I just had five days of what I call C.F.S. hell,” he said. “I couldn’t leave the apartment.”

Scott James is an Emmy-winning television journalist and novelist who lives in San Francisco. sjames@baycitizen.org

 

The above originally appeared here.

 


 

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