AHF files complaint against Gilead

Earlier this month, AIDS Healthcare Foundation and its president Michael Weinstein issued a press release accusing Gilead of creating a direct-to-consumer advertisement which encouraged situational PrEP use in violation of FDA guidelines.

As we illustrated, it was filled with falsehoods and insinuation and made claims that even at the most casual glance proved to be false.

Well now AHF has gone one step further. They’ve issued a letter of complaint against the maker of pre-exposure prophylaxis (PrEP).

On Thursday, AHF sent a letter to Dr. Stephen Ostroff, M.D., Acting Commissioner of the U.S. Food and Drug Administration (FDA), alerting him to the fact that Gilead financed a video ad campaign promoting situational use of its AIDS treatment, Truvada, for PrEP, misleading viewers into believing that Truvada is safe and effective for use on a situational basis, despite knowing that the drug is not FDA approved for such off-label use.

Box Turtle Bulletin, along with other sources, has debunked AHF’s claims. Frankly, it just wasn’t that hard.

So why does Weinstein and his organization continue a campaign of deception? I think there is a purpose behind the complaint.

As anyone who actually watched the video knows, it did not promote off-label use. And it wasn’t launched by Gilead. So that’s not the issue. AHF knows that their letter does not reveal any wrongdoing and I don’t think that’s their intent.

Rather I suspect that Weinstein is hoping that the theme of the video (“I like to party”) will frighten the FDA and will elicit a fear based response along the lines of “you can’t promote drug use!!!”

This isn’t about truthful marketing, it’s about punishing Gilead and hindering the advancement of Truvada as a tool against the spread of HIV. And if Weinstein can imply that Gilead tacitly supports the use of illicit drugs, that might be sufficient to push politicians to apply pressure.

So this is where Weinstein’s recommendations for punishing Gilead become interesting:

In contravention of statute and regulations, Gilead launched an ad campaign to mislead viewers into believing that Truvada is safe and effective for use on a situational basis despite knowing that the drug is not approved for such use. Consequently, the ad campaign constitutes impermissible off-label promotion, and we urge the FDA to take immediate action to (1) require Gilead to cease and desist all such off-label promotion; (2) require Gilead to publically [sic] correct the misinformation disseminated by the ad campaign; and (3) impose any sanctions permitted by law.

But Gilead hasn’t performed any off-label promotion which it can cease or desist. And sanctions would not hold up in any court. So what would this mean in practical terms?

A clue is found earlier in the press release:

Gilead, which we believe has been deliberately mounting an under-the-FDA-radar, guerilla-style marketing and media campaign for PrEP for the past three years by funding scores of community and AIDS groups across the nation to promote PrEP…”

AHF wants to put pressure on Gilead to cease funding other community and AIDS groups. Yes, it appears that Weinstein and AHF want to reduce the funds that community groups across the country use to fight transmission and treat those infected with HIV. That is unthinkable, but that is what they are asking.

And as despicable as this seems, it might not to be a novel attitude for AHF. They have been accused by many AIDS activists of a long pattern of seeking to diminish funding for other groups so as to funnel more funds, more program support, more connections, and more political power to AHF and Weinstein.

And as it is primarily community based HIV activists who are encouraging and driving the effort to get those persons at high risk for HIV transmission on the preventative drug regimen, these are the voices that Weinstein and AHF need most to silence in order for their campaign against PrEP-based HIV prevention to succeed. That these local activists are the front-line warriors in the fight against the HIV pandemic is immaterial, and the message seems clear: they must be taught that standing up against Weinstein and AHF comes with consequences.

I’m beginning to think that “vile” and “abhorrent” are adjectives that need a revival.