LOS ANGELES--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF) will host a Media Availability all day Tuesday, May 31st, to announce its call on both the Food and Drug Administration (FDA) and the United States Congress to open investigations of Gilead Sciences Inc., a maker of HIV/AIDS medications.
AHF will call on Congress and the FDA to investigate the Bay Area drug company and its executives over allegations of drug patent manipulation and anti-trust claims regarding slightly different formulations of tenofovir, a key HIV/AIDS drug used by as many as 80% of American HIV/AIDS patients.
A blistering front page Los Angeles Times article published Sunday (“A question of timing: A lawsuit claims Gilead Sciences could have developed a less-harmful version of its HIV treatment sooner” Melody Peterson, LA Times, 5/29/16) exposed Gilead’s bald-faced greed and disregard for patient safety regarding two formulations of its medication, tenofovir, including an alarming narrative of how the company may have deliberately delayed developing and patenting the second formulation, tenofovir alafenamide or TAF, which is less toxic than the preceding formulation known as TDF (tenofovir disoproxil fumarate), in order to maximize the patent life—and billions of dollars in profit—on TDF despite its well documented potential to cause significant bone loss and kidney damage in patients.
In January, AHF, which operates healthcare centers and pharmacies for AIDS patients, filed a federal lawsuit against Gilead and two other defendants in alleging drug patent manipulation and anti-trust claims regarding these slightly different formulations of tenofovir to keep the drug prices artificially high. [Case # 3:16-cv-00443 U.S. District Court, Northern District of California]
WHAT: MEDIA AVAILABILITY—AHF to call on FDA, Congress to
investigate drug giant Gilead Sciences over drug patent manipulation on
key AIDS drug.
WHEN: Tuesday, May 31st ALL DAY
Michael Weinstein, AHF President
Tom Myers, AHF General Counsel
KEY PULL QUOTES FROM THE LA TIMES ARTICLE on Gilead Sciences:
- Gilead denies the lawsuit’s claims. In stark language contained in a recent court filing, the company’s lawyers said the firm “had no duty to develop, test, seek approval of, or launch its new product on any particular timetable.”
- …critics believe the new, less harmful form of the drug could have been developed sooner – and wasn’t because the company wanted to extend its patent-protected profits.
- Today, tenofovir is taken by more than 627,000 Americans, or about 80% of those being treated for HIV, and 9 million more around the world.
- Two years later, in 2003, the company had received so many reports of patients experiencing kidney failure and other renal problems that it placed a warning on the drug’s label. That label cautioned doctors that a study also had found more bone loss in patients taking tenofovir than another HIV drug.
- The FDA twice told Gilead that its sales reps had violated the law by giving doctors and patients false and misleading information that didn’t reflect side effects listed on the drug label.
- In a rare move the next year, the agency required the company to retrain its sales reps “due to the significant public health and safety concerns” raised by their repeated false statements, according to the FDA’s July 2003 warning letter.
Despite those promising results, in October 2004, then-Chief
Martin announced that Gilead had stopped the [TAF] project.
Based on an “internal business review,” he said, executives had concluded the experimental drug was unlikely to be “highly differentiated” from its successful predecessor.
- John Milligan, then the company’s president, told analysts that the low-dose alternative could add “a great deal of longevity” to Gilead’s blockbuster product and replace its sales.
- Asked why the company didn’t publish the [study] results earlier, Gilead’s Bischofberger said the company wasn’t interested in publishing them at the time because it was turning its attention to the other HIV research.
Despite having fewer negative side effects, TAF is currently only available as a part of combination treatments like Gilead’s Genvoya, a Stribild equivalent, and Odefsey, a Complera equivalent (made by Gilead and Janssen Therapeutics). However, Gilead makes no standalone version of TAF available to patients, such as with TDF, which is branded and distributed as Viread. The availability of TAF, the less toxic form of tenofovir—and Gilead’s patent stranglehold on it—is at the heart of AHF’s patent manipulation case and anti-trust claims.
Separately, and also on Sunday, the New York Times published a list of the 200 highest paid CEOs in 2015. Gilead CEO John Martin was included on the list, with recorded compensation of $18.8 million--$5.5 million of which was cash compensation.
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 612,000 individuals in 36 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare