trust Gilead? not a chance
Criticism[edit]Several class-action lawsuits have been filed against Gilead over allegations that the company deliberately delayed development of antiretroviral drugs based on
tenofovir alafenamide fumarate (TAF) in order to maximize profits from previous-generation medications containing
tenofovir disoproxil fumarate (TDF).
[78] Plaintiffs allege that Gilead suspended TAF in 2004 despite clear evidence indicating that TAF-based medications were safer than TDF, a compound whose long-term use was associated with adverse side effects such as
nephrotoxicity and
bone density loss.
[79][80]Gilead intentionally withheld results of clinical trials demonstrating TAF's relative safety and efficacy and shelved TAF-based therapies until 2010, when the
Food and Drug Administration approved Gilead's application to patent TAF.
[81]Gilead's first TAF medication, marketed under the trade name Genvoya, came out in 2015. In the interim period, many HIV patients who continuously took Gilead's older TDF-based drugs suffered permanent, debilitating kidney and bone damage, often developing conditions such as Fanconi syndrome and osteomalacia.[82]Gilead has come under intense criticism for its high pricing of its patented drug
sofosbuvir. In the US, for instance, it was launched at
$1,000 per pill or $84,000 for the standard 84-day course.
[83][84]Gilead has also tried to eliminate competition in lucrative markets by entering voluntary licensing agreements (VLA) with companies from developing countries such as India, which mandated the limitation of the latter's operations to less lucrative markets. The company has also been criticized for creating harsh restrictions within countries where they have been denied rights, or are engaged in VLAs. For example, in India, they tried to create an 'anti-diversion' program to determine who could buy the drug, which was considered a coercive and policing move by
Médecins Sans Frontières since it could lead to the exclusion of vulnerable groups like refugees and migrants from accessing the medicines.
[85]On January 21, 2020, the
Wuhan Institute of Virology applied for a Chinese "use patent" on
remdesivir, for the novel use of treating
COVID-19.
[86]Gilead sought and obtained
orphan drug designation for remdesivir from the US
Food and Drug Administration (FDA) on March 23, 2020.
[87] This designation is intended to encourage the development of drugs affecting fewer than 200,000 Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees.
[88][89] Remdesivir is a candidate for treating COVID-19; at the time the status was granted, fewer than 200,000 Americans had COVID-19, but numbers were climbing rapidly as the
COVID-19 pandemic reached the US, and crossing the threshold soon was considered inevitable.
[88][89] Remdesivir was developed by Gilead with over $79 million in U.S. government funding.
[89] After facing strong reactions, Gilead gave up the "orphan drug" status for remdesivir on March 25.
[90] Gilead retains 20-year remdesivir patents in more than 70 countries.
[91]Gilead has also been accused of price-gouging on other medications developed with public funding, including AIDS PrEP drug Tenofovir and hepatitis C drug sofosbuvir as well as Remdesivir.[92]
