HIV Prevention Drugs Illustrate just How Bad Pharmaceutical Patents Are for our Health
The United States is the only major economy on the planet where health care is a for-profit industry instead of a free public service; it’s also the only place where the government allows health care not just to be run as an industry, but allows that industry to be run as a cartel. What this means in practice is that pharmacology — the study and development of pharmaceuticals — has become more a branch of industry than of science, and it is therefore controlled by lobbying interests rather than either science or the public good.
The only better example of this than the infamous price gouging of insulin in America is how the drug companies have a captive audience for their many still-patented products not only in HIV-positive Americans but also in the nation’s millions of LGBT people who are encouraged to take the sole HIV-prevention drug, Truvada, to avoid HIV infection.
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Last year, for the first time, it was announced that a generic version of Truvada — the pill used since 2004 to fight HIV infection and since 2012 as pre-exposure prophylaxis (PrEP) for HIV — would finally be available in the U.S. Generic versions are already sold elsewhere in the world and, usually, when drugs go generic in America, it’s an open field, which dramatically lowers prices.
Truvada’s patent holder, Gilead, however, granted rights to produce a generic U.S. alternative to just one company — the Israeli firm Teva — for a six-month period, as the result of a settlement. Truvada currently costs American users roughly $1,700 a month; Teva’s generic, which debuted in October, is marketed for around $1,455 per month.
Gilead’s all-but-proprietary access to sell Truvada is the equivalent of Hershey’s controlling who has access to chocolate milk.
Of course, few people pay the full price of a medicine out-of-pocket. Insurance, for those who have it, helps lower out-of-pocket costs in many cases, though private insurers aren’t required to do so until 2021. Gilead provides some patients a coupon for $7,200 worth of purchasing assistance per year, with no monthly limit (which means some months it might be free and others it might be full price). Teva’s patient discounts are also $7,200 per year, but they’re limited to $600 per month — knocking its monthly cost down to around $855. Unfortunately, California and Massachusetts both forbid the use of pharmacological coupons that made Truvada somewhat accessible if a generic alternative exists; patients who relied on those discounts must now apply for access to other programs or pay out of pocket for the medications they couldn’t afford.
Meanwhile, generic versions of Truvada — Ricovir, Tavin-EM, or Tenof-EM — elsewhere in the world cost $210 to $720 per year.
Ironically, Gilead put little of its own money into the research that developed Truvada, which is a combination of two medicines, tenofovir disoproxil and emtricitabine (though the company says otherwise). The former input was, in fairness, developed as an oral medication by Gilead (heavily based on a drug first developed by a Czech scientist, after a collaboration with scientists at the University of California-San Francisco showed it was effective in treating HIV), but its patent expired in 2018.
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Emtricitabine, the second drug in Truvada and its generic equivalents, was developed at Emory University with NIH grants; Emory then entered into an agreement with a company Gilead eventually acquired to give it control of the drug in exchange for a sliver of the profits. (Until Teva’s generic debuted, Gilead owned 100 percent of the Truvada market in the U.S, pulling in roughly $3 billion a year.)
But the basic research, animal trials and human trials for the combination of the two as preventative drug were all publicly financed by the National Institutes of Health and the Centers for Disease Control and Prevention. The 1980 Bayh-Dole Act, though, allows private grabs of public science; the government can claw patents back under certain circumstances, but Sen. Birch Bayh, D-Ind., and Robert Dole, R-Kan., argued in 2002 that pricing was deliberately not conceived as one such circumstance .
The federal government has the ability to compel broad generic production of Truvada virtually overnight and has refused to act on it.
So the only Truvada-related patent Gilead now owns — until September 2021 — is for emtricitabine; its all-but-proprietary access to sell Truvada is the equivalent of Hershey’s controlling who has access to chocolate milk.
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Still, last year, the FDA also approved Descovy, Gilead’s newest, pricier rival to Truvada; although Descovy results in some improved kidney function versus Truvada because it uses a newer type of tenofovir (tenofovir alafenamide instead of tenofovir disoproxil) patented by Gilead, a Harvard study found an “absence of any clinically meaningful changes in renal or bone markers” between the two. In January, Gilead still hoped to switch 40 to 45 percent of Truvada users to Descovy before the former goes fully generic at the end of 2020, preserving their profits.
It doesn’t have to be this way, as advocacy groups like PrEP4All have been arguing for years. Empowered with the intellectual property equivalent of eminent domain, the federal government has the ability to compel broad generic production of Truvada virtually overnight and has refused to act on its ability — whether in the Obama administration or the Trump administration. (There are few indications that the Biden administration will be any different.)
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The problem with patents thus persists because toxic agents in soulless systems have created a ruthless market for its ostensible solutions.
Unaffected politicians and policymakers — including lobbyists and Big Pharma C-suite cynics — instead cast unsustainable, unaffordable drug prices as a result of tough decisions, difficult circumstances or unavoidable economic realities. But they are wholly avoidable. Such anguish is not a necessary evil of market forces or political gridlock; every other industrialized nation manages to recognize how unnecessary profit-driven health care is.
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The most bitter pill in all of human health is the one we prescribe the least: the truth, without a spoonful of sugar. And the truth is that we are fighting late-stage, metastasized cowardice here, a societal immunodeficiency in which we are unable to defend people over profits, or dignity over dollars. Sadly, as far as we’ve come in our understanding of immunology — a knowledge built almost entirely on the bones and blood of the world’s 32.7 million AIDS deaths and 75.7 million HIV infections — such cowardice is wholly incurable because it is more dictum than dysfunction.
As Americans and the world have witnessed the planet’s greatest economy suffer some of the planet’s poorest Covid-19 health care, it is increasingly clear to everyone that government has all the legal and political power it needs to improve the lives of millions with a snap of its fingers, but none of the willpower. When America’s founders committed — and condemned — us to a government ruled by values of life, liberty and the pursuit of happiness, they unfortunately allowed no checks or balances against how much happiness the powerful can find in their fellow Americans’ misery.