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Posted on October 21, 2019 at 9:58 AM

In recent years HIV prevention
science has been revolutionized by the realization that some of the drugs
originally approved to treat HIV infection are also very effective at preventing
HIV infection in people considered at high risk, such as those with
HIV-positive partners. Known as “pre-exposure prophylaxis” or “PreP”, the HIV
medication Truvada (tenofivir plus an older antiviral called emtricitabine) is
now taken on a daily basis by millions of people worldwide in order to prevent
HIV infection. While optimists see PreP as an important step on the road to
“ending AIDS”, critics note that the drug’s
$20,000-a-year price tag impedes adequate access both within the U.S. and globally

On October 3, the politics of
PreP became even more fraught when the FDA granted approval to a second HIV
drug to be used preventatively – but
only by men. “Descovy” is made by Gilead Sciences—the same pharmaceutical
company that makes Truvada—and in fact differs from Truvada only slightly in
its chemical structure. For reasons that Gilead has failed to make clear, the
clinical trial of Descovy was conducted almost exclusively in men (transgender
women made up about 1% of the 5400 person cohort). For this reason, the FDA
refused to approve its use in
“those who have receptive vaginal sex.”

The case of Descovy is ripe with
some of the same ethical issues that have plagued HIV drug development since
the epidemic began.

First, AIDS activists have been
fighting pharmaceutical price-gouging since 1987, when members of the newly
founded group ACT UP
occupied the New York Stock Exchange to protest the high cost of AZT. Since
then access to HIV medications has improved both domestically and globally due
to generic competition and dedicated funding programs, but Truvada’s $20,000
price tag shows that companies are still willing and able to charge whatever
the market will bear. Moreover, by all appearances Descovy’s FDA approval was
timed to coincide with the 2020 expiry of the Truvada patent, thus allowing
Gilead to charge what they will for a new PrEP formulation just as they lose
market exclusivity on the old one.  This
is despite the fact that Descovy is
neither a superior drug nor a new one. (The clinical trial showed
that it was simply “
non-inferior” to Truvada, and although it was only recently submitted for FDA
approval, records show that it was invented
no later than 2000.)

Secondly, women have fought for recognition
from the AIDS scientific community (and the scientific research community more
broadly) since the early days of the epidemic. 
Until 1993 the CDC’s list of “AIDS-defining illnesses” failed to include
the gynecological conditions most often suffered by women with advanced HIV
disease. In protest, the activist art collective Gran Fury made a poster
quipping “
Women Don’t Get AIDS, They Just Die From It” and posted it in bus shelters across New
York City.  HIV/AIDS is not the only
scientific arena that has failed to include women in research. It was only in
2014 that the National Institutes of Health established a policy requiring its
scientists to use
both female and male animals and cells in their
research
. Many NIH-funded
scientists, it turns out, prefer to use only male animals because they feel
that the estrous cycles of females would muddy their results.

The ethical principle at stake
here is justice. Both the high price of PrEP and the exclusion of women from
PrEP (and other) trials are unjust, though in different ways. The pricing of
PrEP represents a breach of social justice in that it contributes to an unequal
society in which people’s physical well-being is determined by their ability to
pay for life-saving medications. In other words, health is stratified by
wealth. Unfortunately, this problem is hardly limited to HIV medications (got
insulin?
Millions don’t). In addition, the exclusion of women from the Descovy trial is
an example of unjust research design, as it effectively prevents women from
benefitting equally (or at all) from this research. Worldwide, the majority of
adults living with HIV are women, and women also account for
48% of new HIV infections. Yet, a 2016 literature review found that women remain significantly
underrepresented in HIV/AIDS trials, making up an average of only 19% of
participants in trials of antiretroviral drugs. HIV medications—including
tenofivir, the main ingredient in Truvada and Descovy—can metabolize
differently in women versus men, and antivirals can also act differently in
vaginal versus rectal mucosa, the two major avenues of sexual infection. In
other words, there are clear epidemiological and biological reasons why HIV
drug trials need to include women as well as men.

In the case of Descovy, it is
unclear why a clinical trial of over 5000 people conducted across 93 locations
in the U.S., Canada, and Western Europe didn’t face scrutiny earlier for its
exclusion of cisgender women.  Did Gilead
feel that including women would “muddy” their results? Or are women simply a
less lucrative drug market, given that most women at high risk for acquiring
HIV live in low income countries where antiretroviral drugs are discounted or
donated if they are available at all? The Gran Fury artists first made their
sardonic protest poster in the early 1990s. Nearly 30 years later, why does
Gilead still think “women don’t get AIDS”?

 

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