Four years on — Gilead gets its way

 Posted by on 2014-11-19 at 5:01 pm
Nov 192014
 
It's all about the marketing.
It’s all about the marketing

The notion of Gilead’s antiretroviral combo drug Truvada as PrEP, or a preventative against acquiring HIV, is not new. The reality is that early analyses of the evidence for efficacy, like this one, published by the Foundation for Integrative AIDS Research (FIAR),  put the skids on massive and rapid deployment after the first human study—iPrEx—was published almost 4 years ago.

What has changed since 2010? In a word, marketing. Marketing to the FDA; marketing to the CDC; marketing to AIDS service organizations; and most importantly, marketing to the product’s target audience: sexually active gay men, especially those who disdain condoms. Marketing that finagled the actual relative risk reduction from 42% to 92% (more recently billed as 99%!) and that failed to mention the absolute risk reduction is more like 1.7%!

All of these numbers assume that condoms are being used and other safer sex practices are being followed. The evidence that PrEP is an option for those who choose or desire to bareback is:  0.

Zero.

Look at it this way. Say you are an HIV-negative gay man. You ask your doctor to prescribe Truvada. She agrees. You must then take it every single day. You must be able to pay for it. You must be able to tolerate the unintended weight loss and nausea that a significant number of participants experienced (see FN2). You must face the risks of bone destruction over time and the slight risk of lactic acidosis. You must use condoms still. And after a year, your chance of becoming HIV infected will have been lessened by 1.7% than had you not taken the drug and done all those things we know can drastically reduce the risk of infection.

About that ability to pay for it. Truvada will cost roughly $1,200 to 1,300 per month! While most pro-PrEP articles emphasize that Medicare and many insurers cover PrEP, they fail to mention Medicare Part D’s “donut hole”, or that the drug is likely to be listed on private plans’ highest price tier for co-pays.

Let me be clear. I would not be so vocally opposed to FDA approval of Truvada as an option for a very small group of people who might actually benefit from PrEP, if the data supported that decision. My objections are primarily based on the excessive marketing push I see, and the rush to convince gay men to jump on board. What offends me is the hype… the attempts to create a new market for expensive and troublesome pharmaceutical drugs, where none existed before.

What troubles me is the apparent willingness of an entire community to consider embracing Truvada as some sort of symbol of sexual freedom… evidenced by charges that those of us who are skeptical are guilty of being sex-negative and “slut-shaming”.

All of this on the basis of research that has been manipulated and twisted by Gilead to create a false reality of safety. Truvada pills are being held out to sexually active gay men much the same way antibiotics were offered to us prophylactically in the 1970s, in an attempt to reduce the spread of syphilis and gonorrhea. We all know how that turned out. Self-proclaimed “Truvada Whores” may as well be telling their peers: “here… take this pill and you can fuck like it’s 1980!”

There’s a certain perspective that once a guy starts PrEP, he will begin to forgo condoms. There isn’t a lot of evidence to support this theory of risk compensation. This may or may not be true, but many people who are now on PrEP weren’t using condoms regularly to begin with.  And if people on PrEP aren’t using condoms anymore, what’s the big deal? Results from iPrEx shows that daily Truvada adherence yields protection estimated at 99% when used under daily compliance.

I am resigned to the fact that after four years of an intense marketing campaign by Gilead Pharmaceuticals that Truvada as PrEP is here, regardless of what I or others fear. All that those of us who are skeptical of Gilead’s good intentions can do at this point is continue to highlight important information that is not included in the marketing campaign. Information that gay men have a right to know and should be aware of if they ever hope to make an informed choice. That’s not slut shaming, it’s part of one’s responsibility to be informed and knowledgeable about the known risks and the claimed benefits of such an important decision.

Now it’s mostly a question of time to see if PrEP meets the expectations of sexually active gay men…. and Gilead shareholders. The former is yet to be proven; the latter is a foregone conclusion.

 

(Be sure to read George M Carter’s analysis here.)

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