Monday, May 14, 2012 at 5 a.m.
Last week, a committee of experts recommended that the Food and Drug Administration approve the first drug for protecting against HIV transmission.
On the surface, it sounds like great news. But as The Pulp reported in January
, some doctors have serious concerns that the pill is not as effective as it should be and could encourage people to engage in risky behaviors in the bedroom. Now, as approval inches closer, advocacy groups are sounding alarms and calling on the FDA to exercise some caution.
The AIDS Healthcare Foundation says one problem is that the FDA doesn't think a registry of patients taking the drug for preventive means is needed, nor does it think those people should be required to be tested for HIV on a regular basis after they are given a prescription.
The FDA's reasoning seems to be that in order for the drug, Truvada, to thrive in a preventive capacity, there need to be few barriers for doctors to write scripts and for patients to seek out the drug. It makes sense. Tying a prescription to regular HIV tests could scare away potential users, and doctors might be wary of handing out scripts if they know each patient is going to be tracked in a statewide or national database.
The crux of the issue is adherence, or making sure the drug is taken each day as indicated. If people are already failing to use condoms on a regular basis, why would we think that they'll exert the effort needed to take a pill each day and keep the prescription filled and up to date?
There's the very real possibility that marketing a pill as a way to protect healthy people from HIV transmission will foster a false sense of security and lead some to forgo condoms. The AIDS Healthcare Foundation says that the "consequences of non-adherence and lowered condom use could be life-threatening."
The group goes so far as to say that approving the drug without requiring regular HIV testing for users "will go down in the annals of FDA history as one of its most shameful moments."
Rebecca Colon, a doctor at Fort Lauderdale's AHF Northpoint Healthcare Center, told us earlier this year that in some studies, the drug was only 44 to 66 percent effective at curbing HIV transmission -- and that's with near-perfect adherence. She said that if a birth control pill was only 66 percent effective, it would never get green-lighted by the FDA.
Still, there are approximately 1.2 million people in just the U.S. who have HIV. Around the world, more than 30 million people are infected. Some experts have suggested that we've gone as far as possible with education, condom distribution, and similar efforts in the developed world. Approving a preventive pill would have tremendous implications both here and abroad, representing a scientific milestone that seemed like a distant possibility only a decade ago.
The FDA approved Truvada, made by Gilead Sciences, in 2004 as a treatment option for those already infected with the virus. It's highly effective and highly profitable. In 2011
, the drug generated $2.88 billion, an 8 percent jump in sales from 2010's $2.65 billion.
The AIDS Healthcare Foundation has for months expressed concern that market pressure and bottom lines are forcing Gilead to rush the drug to market as a pre-exposure prophylaxis, or PrEP in medicalese. In August 2011, the group alleged in a press release
that Gilead's push to obtain PrEP approval for Truvada has created a "black market" for the drug in Florida.
From the press release:
"The fact that a 'black market' has cropped up in response to Gilead's campaign to obtain FDA approval for Truvada shows what a dangerous game Gilead is playing," said Michael Weinstein, President of AIDS Healthcare Foundation. "The increased demand that has been created by Gilead's reckless push to have Truvada approved prematurely for this new use is only a preview of what is to come. If the company succeeds, Gilead will have free reign [sic] to market Truvada to HIV-negative individuals. This will open up a demand for the drug that will inevitably create an even bigger 'black market,' ultimately resulting in increased infections, viral resistance and a huge step backwards in efforts to fight the epidemic."
It's not illegal for doctors to write prescriptions of Truvada to protect against HIV. It's a practice known as off-label prescribing. It is illegal, at least right now, for Gilead to market the drug to patients or doctors as having the ability to reduce the possibility of HIV transmission. That's what's known as off-label marketing, a crime that costs Big Pharma billions in fines each year.
A final decision on whether the drug will be approved as a preventive measure is expected by June 15. Rest assured that whatever ad agency handles the Truvada account is watching closely.