Is there a “moral obligation” to offer PrEP?

The implications of Braidwood vs. Becerra

I was recently directed to the article on StatNews.com, Right wing politicians are stoking renewed moral panic over HIV. The article is mostly concerned that this “renewed moral panic” might lead to a reduced uptake in PrEP (pre-exposure prophylaxis). The first paragraph states that “The end of the epidemic may finally be in our grasp.” This might sound familiar; the end of the epidemic has been “finally in our grasp” at many points in the past, including following the disastrous approval of AZT, but most especially in the mid 1990s with the advent of “hit hard, hit early” “highly active antiretroviral combination therapy”, or HAART. When the combination therapies were first approved, we were told that the total elimination of HIV genetic material from an antibody positive individual was a tantalizing possibility. Of course, this failed to eventuate, as here we are 25 years hence, and the figure of HIV antibody positive Americans has stubbornly refused to budge, at about 1.2 million, or a constant 0.3% of the population since testing began.

What this article is concerned with, however, is legal challenges that might make it more difficult for people designated “at risk” to access PrEP. The lawsuit under fire in this case is the case of Braidwood vs. Becerra, in which “self-identified Christian business owners challenged their obligation to provide health insurance covering PrEP and other preventive services.”

Perhaps the most well-known threat to HIV prevention comes from the case Braidwood Management Inc. v Becerra, in which self-identified Christian business owners challenged their obligation to provide health insurance covering PrEP and other preventive services. They found a friend in Judge Reed O’Connor, who agreed that covering PrEP harms their religious freedoms and, further, that this medication “facilitates and encourages homosexual behavior, intravenous drug use, and sexual activity outside of marriage.”

This contradicts a wealth of evidence showing that an individual’s choice to take PrEP doesn’t define their sexual orientation or relationship status, nor does it influence use of injected drugs. Nevertheless in April, as part of his ruling on Braidwood, O’Connor issued a nationwide injunction on cost-free preventive health care for all Americans. The decision is temporarily stayed amid a national uproar and a robust response from the Department of Justice. But higher courts may affirm this precedent. If his ruling stands, my colleagues and I project that Judge O’Connor will be responsible for 2,000 entirely preventable new HIV infections in the coming year if even a small proportion of private insurers refuse to cover PrEP.

Here is some brief background on Braidwood vs. Becerra:

Since the enactment of the Affordable Care Act (ACA) in 2010, more than 2,000 legal challenges have been filed in state and federal courts contesting part or all of the ACA. The most recent challenge involves the ACA requirement that most private insurance plans cover recommended preventive care services without cost sharing. In this case, Braidwood Management v. Becerra, Christian owned businesses and six individuals in Texas assert that (1) the requirements in the law for specific expert committees and a federal government agency to recommend covered preventive services is unconstitutional, and that (2) the requirement to cover preexposure prophylaxis (PrEP), medication for HIV prevention, violates their religious rights. If the plaintiffs prevail on either the constitutional or the religious claims, the government’s ability to require insurance plans to cover evidence-based preventive services without cost-sharing may be limited.

I was intrigued by the concept that limiting PrEP coverage would “be responsible for [more than] 2,000 entirely preventable new HIV infections.” I will also note the following statement made in the article under consideration:

All of this is dire because PrEP is 99 percent effective in preventing HIV. Like a vaccine, PrEP prevents the virus from entering cells in the body. It’s uniquely valuable because it does not rely on condom use or partner disclosure to prevent infection.

Keep this statement in mind as we dive into the actual estimation of “excess transmissions” that would supposedly result from “decreased PrEP coverage.” The scholarly paper from whence this “more than 2,000 preventable infections” figure was derived, Increased HIV Transmissions With Reduced Insurance Coverage for HIV Preexposure Prophylaxis: Potential Consequences of Braidwood Management v. Becerra , uses an “estimation procedure” in which the number of “new HIV transmissions” depends upon the following. Intriguingly, the authors steer clear of claiming “>99% effectiveness” for PrEP.

(Note: I am going to give a very brief summary of the mathematics involved in these estimates; there won’t be a lot of math, and it will only take a paragraph. Here is the explanation of the “estimation procedure” used in this paper.)

N denotes the “number of PrEP-indicated MSM,” i denotes untreated HIV incidence among PrEP-indicated MSM (an annual, per-person probability), e represents “PrEP effectiveness,” defined by the percentage reduction in new cases (this is important), and finally, c represents coverage; specifically, the percentage of PrEP-indicated MSM receiving PrEP. The figure for new transmissions is given as: N · i ·(1 – ec). To derive the total number of “preventable infections,” the term c representing PrEP coverage is further stratified by indicating c_0 to be the current PrEP coverage and c_f to be the “the coverage level should the restrictions on access via Braidwood take effect,” the number of new transmissions becomes N · i · e · (c₀ – c_f). The study concludes:

Under current ACA provisions and 28% PrEP coverage of indicated MSM, we obtain the CDC estimate that 21 867 new HIV infections will occur among MSM in the US annually (Table 2). If suspension of ACA provisions lowers PrEP coverage to 10%, we predict 2057 additional HIV infections in MSM.

Without getting any further into the math here, which is not complicated—it doesn’t need to be, but that is not the problem here—I would like to draw the reader’s attention to the values given for the parameters in the equation above; in particular, for the parameter e representing PrEP effectiveness. The entire list of parameter values can be found in the chart linked here.

Recall that we are told in the legacy media that PrEP is advertised to be “>99% effective”; however, recall also that the actual estimates for effectiveness of PrEP are never close to 99%; in certain populations (i.e. intravenous drug users), there is no effectiveness at all for PrEP, per the scientific literature. In the paper under consideration, the estimate for “PrEP effectiveness” is 75%. 75%. Not 99%, not even 95%. Regardless, this is the estimate given that results in “2,057 new preventable infections.” An estimate of 99% would certainly have only bolstered the authors’ conclusions; I can only guess why the authors do not use this figure, despite the fact that this is the number we are told in the media and that this is the number given in the original piece at StatNews. If PrEP is really “>99% effective,” why is the figure of 75% used to derive these estimates? References are given, but nowhere is the figure of “>99% effective” proven to be anything more than a figment of the researchers’ imaginations.

It is fascinating that we are told, over and over again, that PrEP is almost perfectly effective at preventing the acquisition of HIV-antibody-positivity; yet nowhere in the medical literature is that concept supported; even advertisements for PrEP never give a number, choosing instead to say that PrEP “may reduce the chance of getting HIV through sex.” That’s quite a disparity. Certainly, some of the motivations for this sly deception are obvious (money talks); however, the following passage indicates a potentially more sinister motivation.

Let’s be clear about who needs PrEP most and why. Systemic racism stands between communities of color and state-of-the-art HIV treatment and prevention. But thanks to novel community health approaches, PrEP is breaking through and its benefits are profound. The privacy of PrEP tackles stigma and empowers women in intimate relationships. PrEP protects families, because more than one-third of parents with HIV fear touching or kissing their children. PrEP also dismantles the intolerably high lifetime risks of infection faced by Hispanic/Latino and Black men who have sex with men, which approaches 50% without solid prevention.

The dismal uptake of PrEP in “communities of color” has been a disappointment for PrEP propagandists. How bizarre that members of these communities might be aware of the dangers of consuming toxic chemotherapy for a lifetime. As I have stated before, underestimate the African American population at your peril. From my post from May 15, How to Kill a Book About AIDS:

I also argue that the Black community—for very valid historical reasons—is wise to the systemic racism that has historically tried, and continues to try to entrap them into ethically dubious medical experiments. This may be at least part of why they are reluctant to embark on a lifetime of antiretroviral therapy. Don’t underestimate them.

But the other very important question to me is: How has the public been so thoroughly bamboozled by “science reporters” and AIDS activists into believing statements—like “PrEP is >99% effective” and “U=U”—that are not even supported by the medical literature; worse yet, those of us that dare to point out the gaping discrepancy between what we are clearly meant to believe and what is actually true are vilified and made out to be the bad guys, simply for telling the truth? Something is very wrong.

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