Poor Michael Weinstein…
He’s the head of the AIDS Health Foundation. Thanks to Weinstein’s “leadership” they’ve gone from a sizeable healthcare foundation with a good reputation to one that’s being quietly whispered about as a water cooler joke.
This time, Weinstein has his knickers in a knot because the head of the FDA Margaret Hamburg refused to meet with him over her group’s consideration on PrEP. (From Politico)
A leading AIDS group is battling with FDA over whether the agency should approve the first drug for preventing HIV infection in gay men, and the fight has gotten nasty.
So nasty that last week the AIDS Healthcare Foundation called for Commissioner Margaret Hamburg to resign over that and other issues, perhaps including egos.
“The arrogance of the head of the FDA not being willing to meet with the largest AIDS organization in the world,” said Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation. “This is supposed to be the most transparent administration yet, but I haven’t seen any evidence of that.”
The fight is a reversal from the early days of the epidemic, when the advocates were pushing the FDA to speed up approval of the first generation of anti-retrovirals. In this fight, they want the agency to take it slow in considering Gilead’s blockbuster Truvada, already approved for use in treating HIV-positive people, as the first drug to be prescribed specifically for preventing HIV infection.
And Truvada has split the AIDS advocacy world, too. While the Healthcare Foundation is citing risks, some other groups are embracing the potential benefits. It’s a bit of a half-full, half-empty perspective arising from the clinical trial data.
One large international study released in 2010 found that Truvada cut the HIV infection in men who have sex with men by 44 percent compared to a placebo, when both were combined with free condoms, monthly counseling and regular testing for sexually transmitted diseases. So far, the drug has not been found to work in women.
The fear is that the drug will give men a false sense of security.
Weinstein contends that a 44 percent improvement is too low a bar, when condoms, properly used, protect against infection about 95 percent of the time. The drug also has significant side effects including potential kidney damage and can generate resistance to the drug that’s widely used to treat HIV infection. Weinstein worries that the promise of a “magic pill” could reverse progress the AIDS community has made in encouraging condom use over decades.
“You’ve got to really be paranoid about your pants falling down to wear a belt and suspenders,” Weinstein said. “There’s no reason to take this drug if you plan to use condoms, but it may well give people an excuse to stop using them. There’s a lot to lose.”‘
The issue has caused a rift within the AIDS community as well, with other groups welcoming an alternative that could protect those who don’t wear condoms.
“This is new terrain in the AIDS world – it’s always been about treatment, and this is prevention,” said Jim Pickett, director of prevention advocacy and gay men’s health for the AIDS Federation of Chicago. His organization was one of 25 that penned an open letter to the FDA in support of Truvada for prevention after the AIDS Healthcare Foundation spoke out against it. “When [Truvada] is used, it works incredibly well and we have to figure out how to make it work in the real world outside of a clinical trial. I think it would be absolutely criminal for us to not do that.”
In the successful study, Pickett notes, the infection prevention rate was as high as 90 percent in those who took the pills consistently as directed. But patient adherence is a problem for all treatments and arguably more so for preventive ones.
Mr. Weinstein is actually the only one who’s been branding Truvada as a magic pill, and he’s been citing half truths, his own botched survey, and a mislead fem PrEP study as his backup. Nobody else with an IQ over 70 has been calling this anything other than what it truly is: a drug with a promising potential that needs to be truly and thoroughly studied.
Imagine the nerve of the FDA not willing to meet with Mr. Weinstein. Hmmm…how ’bout that? (Should tell you something, Michael. The leadership is plenty transparent; it’s your access to the clubhouse that’s been revoked…) Oh, and to counter his point in the article that they’re the biggest AIDS organization in the world? Mmmm, not so much anymore. In terms of warchest alone the Glaser Pediatric AIDS Foundation is sitting on $150,490,569. AHF? About 1/2 of that.
Maybe it’s time for the AHF to consider whether or not the $366,046 a year they are paying Weinstein is money well spent. Charles Lyons II at Glaser makes exactly $1023 less than Weinstein for running an organization twice the size and scope. And he’s not wasting his group’s time and efforts trying to derail patient care.