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FDA Complaint Weinstein's Latest Attempt To Discourage PrEP 

FDA Complaint Weinstein's Latest Attempt To Discourage PrEP 


The largest HIV service organization in the country gets it wrong again in a FDA complaint that says nothing about Gilead and everything about AHF's leadership.

AIDS Healthcare Foundation CEO Micheal Weinstein has filed a complaint with the U.S. Food and Drug Administration alleging Gilead Sciences conspired to promote the use of Truvada for off-label use.

Far from being a whistle blower alerting the government about a corrupt pharmaceutical giant marketing a dangerous drug for unintended and unapproved uses, this is a bogus complaint aimed soley at preventing the use of PrEP.

Why would anyone, especially the head of largest HIV service organization in the nation, want to keep people from using PrEP, when PrEP has been consistently shown to prevent the transmission of HIV? Only Weinstein himself knows the answer to that question. Whatever his motivation, his antagonism to and deliberate misinformation campaign against PrEP have been well documented. (Read more in this Advocate piece). 

Unfortunately, Weinstein is a little like Donald Trump and there are people who will continue to believe his conspiracy nonsense for similar reasons. Even though his accusations might not hold weight, the man with the money always gets heard. 

No surprise, Weinstein has, once again, gotten it embarrassingly wrong. His complaint revolves around the advertising of Gilead's Truvada, a drug that is currently the only FDA-approved PrEP medication. The FDA approved Truvada as a daily medication for preventing HIV among high-risk individuals. Weinstein's complaint alleges Gilead has promoted "situational use" or irregular use of PrEP, which could be considered marketing Truvada for "off-label" uses. 

Specifically, Weinstein's complaint argues, “FDA labeling for Truvada as PrEP is very clear: the drug is to be taken daily and used in conjunction with other safer sex practices, such as condoms, and not on an intermittent basis as the Gilead-financed ad suggests.” 

The first problem with this assertion is that the ad (watch it below), although controversial — it features a porn star, after all —  does not promote the situational or occassional use of PrEP. Secondly, Gilead did not directly fund this ad, they merely gave a general-use grant to an organization that chose of its own accord to do the PrEP education ad campaign. Third, Gilead had no part in the creation or development of the advertisement or any other PrEP advertisement put out by third party organizations.

In fact, Gilead has yet to release a single advertisement for PrEP. Why? They haven't needed to. Between media coverage, clinical trials, and HIV prevention efforts, PrEP has been getting plenty of unpaid attention. So far, the drug company has been content to leave it up to HIV service organizations to educate those at-risk for HIV about the benefits of a HIV prevention pill.

Of course, the effort to spread awareness about PrEP has faced unexpected hurdles. Weinstein can't be blamed for all the "Truvada-whore" slut shaming out there, but, under his direction, AHF has certainly played a significant role in furthering knee-jerk reactions to PrEP. The organization has literally spent thousands of dollars buying ad space, purporting false claims of dangerous side-effects, refering to the revolutionary HIV prevention as a "party drug" and and shaming anyone who even thinks about using the preventative pill.

HIV prevention specialists across the country have had to spend far too many hours trying to cut through the ridiculous hype and fear-based rhetoric so that the people who need PrEP can take advantage of its tremendous benefits. Think of all that time wasted correcting deliberate misinformation. Think of all the effort spent fighting someone who was supposed to be our ally in this battle.  

After years of opposition, in 2015 Weinstein finally seemed to recognize the virtual island he stood on and AHF seemed to alter its stance concerning PrEP. The organization released a new series of advertorials acknowledging the value of PrEP. However, the organization and its leader’s thinly veiled attempts to come across as rational with PrEP after their damaging and moralizing smear tactics were far too late and way too weak for the rest of us to take seriously. Still, PrEP advocates and prevention specialists were thankful for the cease-fire because it meant they could now exclusively focus their efforts on education and awareness. 

Staying above the noise, Gilead has continued to use its resources to support HIV prevention programs. According to a Gilead representative, the organization responsible for developing the video ad received an unrestricted educational grant from the drug company. All told, last year, Gilead gave 66 unrestricted educational grants to organizations across the country as a part of its comprehension prevention strategy. Beyond funding, the rep says, all development and ownership of the content belongs to the grantee. 

Here are the facts. The “I Like to Party” video presents realistic behaviors of a large population who are at high-risk for HIV. It's a part of a PrEP educational series created by Savas Abadsidis and Kenny Neal Shults of Connected Health Solutions for Public Health Solutions (one of the country’s largest public health institutes), whose HIV Big Deal initiative encourages gay men to make healthier choices around HIV. 

On the video, adult film star J.D. Phoenix, admits that he "likes to party,” a subculture reference to using recreational drugs. The scene takes place at a sweaty nightclub, with subtle foreshadowing of sex to come. Then Phoenix is shown in what appears to be his home the following morning. He's sitting on a couch, dressed and alone, when a timer on his phone goes off reminding him to take his daily dose of Truvada. Phoenix concludes, “and I like to be safe.”

Suggestive? Yes. Provocative? Absolutely. But in no way does it promote situational use of Truvada. The very fact that Phoenix has an alarm on his phone reminding him to take his medication suggests a regular occurance, not a one-time event. To draw such a speculative conclusion is clearly evidence that AHF and Wienstein, are still committed to combatting PrEP at all cost, regardless of how counter those efforts are to AHF's mission to "rid the world of AIDS."

Gilead isn't immune to complaints about the high costs of drugs that pharmaceutical companies often get, and it admittedly has a vested interest in efforts that result in more people buying Truvada. But it has also shown a commitment to improving the lives of people living with HIV . The millions of dollars it donates to HIV organizations every year have enabled those nonprofits to provide services to and advocate on behalf of countless HIV-positive people around the world.

Contrast that with Weinstein's AHF, which has consistently received bad press for shady practices and questionable public messaging. (Check out 10 of the worst things AHF has done.) AHF is currently embroiled in lawsuits in numerous cities, and has been accused of perpetrating a $20 million Medicare scam. For some reason, AHF keeps Weinstein around, and, under his leadership, the organization continues to use its funds to pay for advertorials, massive lawyer fees, and Business Wire press releases to advance their agenda against PrEP and anything else they deem inappropriate under their morally superior façade.

If AHF wants to progress as a real leader in the effort to treat and prevent HIV, it needs to quit spending so much time and money fighting PrEP. Not only is that battle at odds with the organization's actual mission, it forces other HIV organizations and activists to spend their time and money fighting AHF's anti-PrEP efforts. Every dollar AHF spends to discredit PrEP is a dollar spent impeding prevention efforts, it's a dollar spent ensuring the epidemic will continue. Worse, every dollar wasted fighting PrEP is another person needlessly contracting HIV.

It makes you wonder: Could that be Weinstein's end goal? Could he actually want more people to need AHF's services? 


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