Pharmaceutical company Gilead Sciences is broadcasting "PrEP Up Step Up" television ads in the Portland media market.
"PrEP" stands for Pre-Exposure Prophylaxis — a new trend of prescribing daily chemotherapy to HIV-negative gay men in a belief this will prevent HIV seroconversion. As of 2018, 5,011 Oregonians were prescribed PrEP charged to various taxpayer-funded programs at a retail price of $1,800 a month. This represents about $108,200,000 in public funds annually accruing to Gilead Sciences to buy drugs for people who are not sick.
I recently downloaded and logged into a gay "hook-up app." Of the first 16 men on the app, 15 disclosed, "I am taking PrEP."
As a former activist with ACT-UP, I had been skeptical of PrEP since its rushed 2012 FDA approval. In markets where PrEP use has increased, public health departments are seeing an uptick in STIs in gay men — especially syphilis. This indicates PrEP is substituting for condoms. The FDA's PrEP indications are limited to "high-risk gay men" who are required to be counseled in comprehensive risk reduction (i.e. told to use condoms).
Unlike the ads on the television, the Oregon Health Authority's website mentions nothing about side effects. This is a problem in public health messaging because it blurs the line between pharmaceutical marketing and patient education. Oregon's major AIDS service organizations receive funding from PrEP's manufacturer, and The Lund Report indicates pharmaceutical manufacturers put $277,000 into Oregon political campaigns.
Until 2019, the FDA prohibited Gilead from advertising PrEP due to an FDA "Risk Evaluation and Mitigation Strategy"; therefore, Gilead turned to third parties such as the Cascade AIDS Project to promote the drugs. These are "Black Box Drugs" meaning when taken at normal doses, they can be lethal, because they have killed others. Public health agencies are not required to disclose black box conditions and side effects on their websites. They are also not required to be accurate in safety and efficacy claims.
To illustrate the problem: The websites of the Cascade AIDS Project and the Oregon Health Authority claim PrEP is "99% Effective." The website of the Oregon HIV Alliance states PrEP "can reduce the risk of sexually acquired HIV infection by more than 90%." The training materials of the Oregon AIDS Education & Training Center state, "PrEP is more than 90% effective at preventing HIV."
The FDA-approved package insert states: "In a key controlled clinical trial [PrEP] was shown to reduce the risk of HIV-1 infection acquisition by 42% for high risk men who have sex with men who also received comprehensive prevention services."
Gilead makes no efficacy claims on television. Two placebo controlled studies (VOICE and FEMPrEP) conducted before PrEP's approval but published five years later found PrEP to be completely ineffective. The 99% statistic came from the CDC website, which looked at uncontrolled Gilead-funded observational studies.
Drug efficacy can only be determined through placebo-controlled clinical trials, and the Oregon Administrative Rule 581-022-1440 requires OHA and publicly funded NGO health education materials be "medically accurate" and base their statements on the scientific method — true placebo-controlled trials of the type reviewed by the FDA.
The difference between 43% efficacy and 99% efficacy is considerable, and it can lead to risky behavior or a false sense of security. As a matter of policy, public service messaging about drugs really should conform to FDA marketing standards.
Still, in the context of a quick hook-up on an app, who really looks at the package insert to read, "the long term effects of [PrEP] are unknown"?
Tom Busse of Northwest Portland is an activist with Multnomah Libertarians and formerly with ACT-UP/Golden Gate.
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