There has been a deluge of stories about medical equipment shortages, rising positive cases, and lagging policy responses around COVID-19. As labs rush to manufacture a vaccine, pharmaceutical companies are swiftly advancing in trial Phases to be the first company to tout an effective medication to cure COVID-19.
Gilead Sciences, the company most notable for HIV-prevention medication Truvada has been in the process of developing COVID-19 medications since early March. Gilead recently published a summary of their Phase 3 trial results, indicating that the experimental medication Remdesivir could have potent efficacy in adults diagnosed with COVID-19.
A renewed scrutiny of Gilead and the system by which we produce life-saving medications is needed, especially while they are tasked with a leading role in providing prescription medication for a deadly virus. Based on what we know of Gilead’s history, it’s COVID-19 venture looks to be unaffordable and inaccessible.
Gilead’s handling of the HIV medication market and the pushback it has received in recent years from LGBTQ groups is important for healthcare and consumer advocates to remember. Gilead has systematically profited off of taxpayer-funded research and succeeded in expanding their market power, all while keeping HIV-prevention medication out of reach for those that need it.
PrEP-ed and Ready
Truvada for PrEP (pre-exposure prophylaxis) is a pill taken daily that can reduce the risk of contracting HIV by up to 99%. Gilead’s Truvada was originally marketed to HIV-positive individuals starting in 2004 as a method of reducing the viral load count of HIV in the bloodstream. Truvada was approved for PrEP marketing in 2012 to gay and bisexual men, and trans women. Verifiably HIV-negative patients could then take Truvada to decrease their risk of contracting HIV.
Truvada has become one of Gilead’s most profitable drugs. In 2019, it was Gilead’s third-largest selling medication, earning nearly $2.6 billion in revenue, or roughly 20% of Gilead’s total HIV-medication lineup sales. Truvada has come to be known as a revolutionary step forward in HIV-preventative medicine, especially among the LGBTQ community. Despite this, only about 35% of gay men are taking PrEP, and HIV infections continue to surge in gay men, especially nonwhite populations. Of the roughly 1 million people in the United States that could benefit from PrEP, less than 25% of them are taking it.
In November of 2019, the Department of Health and Human Services (HHS) sued Gilead for its marketing of Truvada for PrEP. Gilead, they alleged, had been unfairly profiting off of Truvada for PrEP and infringing on the CDC’s patented method. HHS prevailed, but despite their legal victory, Gilead has continued to effectively monopolize the market for HIV prevention medication.
Multiple pharmaceutical companies have attempted and failed to break through into the United States PrEP market. After a lengthy lawsuit, Teva Pharmaceuticals reached an agreement in 2014 with Gilead to launch a “generic” version of Truvada in September of this year. In an effort to undermine Teva’s generic manufacturing, Gilead applied for and received exclusivity for Descovy, a newer drug similar to Truvada. Descovy has been shown to have a safer drug profile regarding kidney and bone density side effects compared to Truvada.
Activists have raised concerns over why this new drug’s release is only now showing up on the market shortly before Gilead loses exclusivity for Truvada, given that Gilead’s research on Descovy dates back to 2005. In 2011, then-COO John Milligan confirmed that the delay of Descovy-like drugs was created in order to maximize profits on more harmful drugs like Truvada, while giving Gilead “longevity” on “single-use tablets.” Under the drug’s exclusivity patent, Descovy won’t face generic competition for another four years.
Gilead’s conveniently-timed Descovy discourages widespread generic drug use in the market. Gilead is aggressively marketing the drug and encouraging patients to switch from Truvada to Descovy.
Despite calls from 12 progressive Senators and representatives in Congress for a thorough investigation into Gilead’s use of Descovy as a strategic medication launch, the US Patent and Trademark Office granted Gilead’s patent extension request for Descovy, presenting the pharmaceutical company with an extended monopoly on life-changing HIV medication that is already out of reach for many.
The Cost of Safety
As of November 2019, a 30-day supply of Truvada can cost up to $2000 without insurance in the United States – which is over 5000% of what one month’s supply costs in peer countries. According to the testimony of Professor Robert Grant MD, MPH, one of the pioneer’s in early PrEP research, Truvada costs roughly “$6 per person per month” to manufacture and distribute. Taken together, we can infer that Gilead’s profit margin on the upper-cost tiers approaches $1994.
For a majority of privately-insured PrEP patients, this cost is mitigated by a combination of insurance coverage and Gilead’s own copayment assistance programs. The “Advancing Access Program” provides eligible privately insured patients with a card that pays for up to $7200 in copays in a given year. Where this program falls short, however, is in covering patients without adequate health insurance. Those who do not have private coverage are unable to utilize these cost-saving benefits and must often shoulder the entire cost burden of the drug themselves. Such high retail costs put PrEP out of reach for those that would most need it. A 2017 Harvard study found that gays and lesbians were twice as likely to uninsured, and a 2015 study by the National Center for Transgender Equality (NCTE) found trans individuals were 3% more likely to be uninsured than the general US. population
Mandated blood and STI screenings every 3 months to maintain a valid PrEP prescription require material financial resources and access to a primary care provider. However, many consumers, especially LGBTQ and other marginalized communities, lack these assets. The NCTE’s study found that 33% of trans people didn’t go to the doctor because of the cost of care, and another study found that Black Americans utilize a primary care provider at a lower rate than their White counterparts.
In addition to economic factors, the medical profession itself proves to be structurally racist and transphobic, leading to higher mistrust and greater disparity. Black and Latinx men were significantly less likely to be aware of PrEP, and less likely to be taking it than their White counterparts, according to a study released by the CDC in September of 2019.
Access for All
There are valuable lessons to be learned from Gilead’s history of Truvada and Descovy, whereas Gilead seems poised to repeat their history with Remdesivir. The COVID-19 medication has been reported to cost upwards of $3000 per patient with private insurance. Repeating their misdeeds, Gilead is taking a federally-funded drug compound, privatizing it, and planning to profit off it.
Multiple avenues can be explored in order to increase access to vital HIV-preventative care while decreasing Gilead’s unfair control of the market:
- Since the CDC claims the rights to PrEP, as set forth in their lawsuit, they could activate their “march-in rights.” Under the Bayh-Dole Act, march-in rights allow the federal government to break patents to increase competition and lower drug prices.
- Use Gilead’s pricing procedures and anti-competitive practices to penalize Gilead using antitrust laws.
- More versions of PrEP are also being tested, some of which require a shot received once every 3 months in place of a once-daily pill. This would likely lower the cost of access, enticing more to adhere to a less strict regimen.
- Accelerated studies on expanding the patient pool for PrEP beyond men and trans women, such as improving the efficacy for women, would allow for broader access.
- Making LGBTQ discrimination illegal in healthcare and closing loopholes (such as so-called “religious freedom” laws) that are utilized to thwart claims of anti-discrimination.
- Increasing competency and training of health professionals in dealing with issues presented by LGBTQ and other marginalized patients, as well as raising the number of LGBTQ and minority health care workers that can provide competency.
The United States’ healthcare system is fundamentally flawed in that it does not deliver adequate care to the most at-risk populations. This must be changed.
Activists and private citizens interested in supporting increased access to drugs like PrEP and Remdesivir should use every tool available to pressure policymakers and business leaders to make sure that the needs and wellbeing of its people are prioritized over pharmaceutical greed.