![]() ![]() Nationwide, safety-net clinics like Prism Health North Texas rely on Gilead’s Advancing Access Patient Assistance/Medication Assistance Program to fund services that keep patients in need HIV-negative. Without Gilead’s help, Carlo said, “none of these people would be in care with us.” The program also helps Carlo generate money to cover the care people on the medication need, like regular doctor visits and lab tests. The drugmaker currently manufactures two PrEP medications. John Carlo is concerned that patients at Prism Health North Texas who rely on the health care safety net will soon be struggling even more to stay on PrEP, a medication that prevents HIV transmission.Ĭarlo, chief executive officer of the clinic, which runs three locations in Dallas, offers free PrEP to roughly 250 patients, he said, thanks to an assistance program run by Gilead Sciences. That case asked the court to invalidate the patents protecting the new drug TAF.Ī judge ruled in July 2016 that Gilead had not illegally manipulated the U.S. In 2016, the foundation filed a similar lawsuit against Gilead, arguing that the company had intentionally delayed research on the safer form of the medicine in order to keep out competition and preserve its high prices. The AIDS Healthcare Foundation, which owns clinics that care for HIV patients, says it isn’t seeking to recover money for itself other than reimbursement of attorneys’ fees. The lawsuits, both filed in Los Angeles Superior Court, seek damages for those harmed by the drugs. Last year, he was diagnosed with osteopenia and osteoporosis at age 59. Gary was diagnosed with Fanconi syndrome, a rare kidney disorder, in 2010. Gary of San Diego County, who took the drug for 10 years, beginning in 2001. The other plaintiff in the personal injury suit is Jonathan C. In 2016, at age 35, Lujano was diagnosed with osteopenia and osteoporosis of the spine, neck and hip. Lujano, one of the plaintiffs, said he took medicines containing the older TDF from 2004 to 2015. “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 20 years,” the lawsuit claims. The lawsuits claim that Gilead delayed the development of TAF in order to extend the number of years where patents shielded the medicines from competition, allowing it to charge high prices. The company’s sales force is now urging doctors to switch their patients to the new drugs to reduce possible harm to their kidneys and bones. Other new pills also containing TAF include Odefsey and Descovy. In November 2015, the FDA approved TAF in a combination pill with three other medicines. The company then began publishing the results of the earlier studies. More than six years after that 2004 announcement, with the older drug’s patent running out, an executive told investors about “an interesting new molecule” the company had added to its research plans. The company also continued to quietly apply for new patents on TAF - the drug it had said it would no longer be developing. Instead, in October 2004, Gilead abruptly announced that it was ending research on TAF after an “internal business review.” And it continued to pour money into selling the older drug, which was bringing in billions of dollars each year. The positive results of those studies were not published for years - secrecy that the lawsuits filed Tuesday say was “an act of extreme malice.” Gilead then paid doctors across the country to give TAF to patients in small clinical trials. That animal study showed TAF had a thousand-fold greater activity against HIV than the original medicine invented in Europe, raising the possibility that it would have far less toxicity. In April 2001, the scientists published research on a different chemical version of the medicine called tenofovir alafenamide fumarate, or TAF. Yet the company failed to adequately disclose those dangers in the medicine’s label, the lawsuits say.Īt the time of the drug’s approval, Gilead scientists were already working to reduce its adverse effects. ![]() The lawsuits say that Gilead knew when Viread was approved in 2001 that it had to be given in high doses to be effective, which meant it could damage the kidneys and bones. Later it was combined with other HIV medicines and sold under additional brand names, including Atripla, Truvada, Stribild and Complera. It was originally sold under the brand name Viread. That medicine - called tenofovir disoproxil fumarate, or simply TDF - was approved by the federal Food and Drug Administration in October 2001. Gilead scientists modified its chemical composition to create a drug that could be taken orally. The original formulation of the drug held little sales potential, however, because it had to be given intravenously. ![]()
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