Gilead Sciences is no stranger to furious patients and advocates, many of whom have said over the years that the company puts shareholder interests over their own. Now, two patients allege that the drugmaker shelved better HIV treatments in favor of monopoly sales and at the detriment of their health.
Gilead's Viread, or tenofovir disoproxil fumarate (TDF), won FDA approval in 2001. The plaintiffs, California residents Michael Lujano and Jonathan Gary, allege that the company knew the compound carried serious health risks, but hid that info and secretly advanced research on better drugs.
Before those drugs, based on a less toxic compound, tenofovir alafenamide (TAF), would hit the market, Gilead released two drugs, Truvada and Atripla, each of which contained the original TDF. Lujano and Gary took those drugs for many years and are now suffering from osteopenia and osteoporosis. Gary additionally suffers from Fanconi syndrome.
The patients say Gilead concealed knowledge that TDF drugs carry kidney and bone risks. The company could have released Truvada and Atripla by incorporating a safer alternative, TAF, which it had been researching, but it held off instead. TAF drugs wouldn't come out for many more years.
"By holding on to its research and shelving TAF, Gilead could patent TAF separately and save it for development when their patent and exclusivity on TDF ran out, in twenty years," the lawsuit says.
Gilead previously defeated a lawsuit making similar claims brought by the AIDS Healthcare Foundation; that case is under appeal. In a motion to dismiss the previous suit, Gilead lawyers said the company had "no duty" to advance newer drugs "on any particular timetable."
It wasn't until Odefsey and Descovy came out in 2014 and 2016, respectively, that HIV patients were able to access TAF compounds. The plaintiffs allege that the drugmaker didn't release TAF earlier because it would have reduced the marketability of its patent-protected TDF drugs. Viread's patent protections ran out last year under a settlement with Teva; the deal includes confidential generic launch dates for Truvada and Atripla.
Gilead representatives didn't immediately respond to a request for comment.
In 2004, Gilead's former CEO, John Martin, said the company was discontinuing TAF research, according to the suit. The suit calls that statement a "misrepresentation intended to mislead the purchasing public, including prescribing doctors and patients taking TDF, into continuing to prescribe and take TDF."
The company never actually discontinued the program, according to the plaintiffs. Between that statement in October 2004 and May 2005, the drugmaker applied for seven TAF patents, the suit says.
"By hiding research about TAF's superior safety profile and efficacy, and by continuing to downplay the risks associated with TDF, Gilead continued its scheme to mislead the public and maximize profits for TDF," the lawsuit states.
Lujano and Gary filed their lawsuit in Los Angeles Superior Court on Tuesday. They're asking for damages to "hold Gilead accountable for its malicious and profit-driven refusal to design Truvada and Atripla in a safe and effective manner." The plaintiffs filed a separate lawsuit asking for class action status, according to the LA Times.
It's not the first time Gilead has faced the allegations. The AIDS Healthcare Foundation fell short in its previous lawsuit alleging anticompetitive business practices. A judge found that, while Gilead may have delayed bringing TAF drugs to market, the foundation was unable to show “how the delay constituted unfair competition.” The decision is under appeal.
With the new lawsuit, the foundation and plaintiffs are making different claims. Lujano and Gary's suit alleges design defect and failure to warn, negligent product liability and breach of implied and express warranties. The foundation is supporting the plaintiffs in the new case.