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A healthcare insurance company has filed a lawsuit alleging Gilead worked with other drug companies to illegally manipulate the HIV drug market, resulting in inflated prices and the withholding of safer versions of its drugs, as part of scheme to maximize profits and delay generic competition.
MSP Recovery Claims (MSPRC) filed a complaint (PDF) in the U.S. District Court for the Southern District of Florida on January 15, indicating that Gilead and other companies engaged in a plant to suppress competition for its HIV drugs, including Truvada, Viread, Atripla, Complera and Stribild, which resulted in patients, and thus health insurers, paying high prices for drugs that were unnecessarily toxic.
In addition to Gilead Sciences, Inc., the lawsuit names Bristol-Myers Squibb, Japan Tobacco, Inc., Akros Pharma, Inc, Johnson & Johnson, and its Janssen R&D Ireland subsidiary as defendants, seeking class action status on behalf of MSPRC and other similarly situated healthcare insurance companies who have paid inflated prices due to the scheme.
“Through an array of anticompetitive practices—including horizontal agreements constituting per se violations of the antitrust laws, Gilead acquired and maintained a monopoly for drugs that comprise the modern HIV treatment regimen known as ‘combination antiretroviral therapy’ (‘cART’),” the lawsuit states. “The scheme enabled Gilead and its co-conspirators to unlawfully extend patent protection for their drugs, impair entry by generic competitors, and charge exorbitant, supra-competitive prices for the drugs that people living with HIV need to survive.”
The HIV drug lawsuit notes Gilead and the other defendants constructed a web of joint development agreements, preventing each co-conspirator from competing against Gilead’s tenofovir disoproxil (TDF) based drugs. This also included allowing them to combine some of their HIV drugs with Gilead drugs, specifically the booster drug Cobicistat, in order to enjoy the latter’s much longer patent protection period. These fixed-dose-combination (FDC) drugs allowed all of the companies involved to continue to sell their drugs at inflated prices without fear of generic competition for an extended period of time.
In addition, the lawsuit claims Gilead has known for years that a less toxic version of the drugs could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF). However, the drug maker allegedly placed its desire to increase profits ahead of consumer safety, and withheld the safer alternative for years, until the patent protections expired on TDF drugs and generic equivalents were introduced that would have cut into sales.
“Gilead forced patients into treatment with TAF-based FDCs by intentionally degrading some of its key products. Before it sought FDA approval of Stribild, its TDF-based FDC, Gilead knew that it contained a much higher dosage of TDF than necessary, subjecting patients to increased risk of significant adverse side effects,” the lawsuit states. “But Gilead already planned to replace that product with a TAF-based version. Refusing to reduce the dosage in the TDF version artificially magnified the safety differences between it and the TAF-based version, helping Gilead to drive patients to the TAF version and its much longer No-Generics Restraint.”
The company did not begin to sell TAF-designed drugs until 2015, which extended Gilead’s essential monopoly on HIV treatments until 2032. TDF drug patents began expiring last year. While generic versions have been introduced, Gilead now markets TAF drugs as a safer and superior alternative, preserving the profits generated from the brand-name medications.
The lawsuit joins a growing number of individual complaints filed by plaintiffs nationwide, who say they suffered side effects from Gilead HIV drugs, which all contain TDF, which is toxic to the kidneys and bones, resulting in acute kidney injuries, chronic kidney disease, kidney failure, bone fractures, dental injuries and other complications associated with bone density loss.
All of the complaints raise similar allegations that consumers and the medical community have not been adequately warned about the potentially toxic side effects of TDF drugs used for treatment of HIV.