Reporting chronic kidney diseases and major bone fractures, more than 50 patients treated with human immunodeficiency virus antiretroviral drugs filed a lawsuit against the Foster City-based Gilead Sciences this month with claims the biopharmaceutical company put profits before patient safety in the marketing and availability of drugs expected to stem the spread of a life-threatening disease.
As consumers of the prescription drugs Viread, Truvada, Atripla, Complera and Stribild, the more than 50 individuals listed as plaintiffs in the suit were exposed to significant safety risks to patients’ bones and kidneys that studies have shown accompany treatment with drugs containing tenofovir disoproxil fumarate, or TDF, according to the suit filed April 10 in San Mateo County Superior Court.
With knowledge of those risks when it began selling its first TDF drug, Viread, in 2001, Gilead falsely promoted it as the “miracle drug” and downplayed the toxicity associated with it, alleged Jack Rutherford, the attorney representing the plaintiffs in the suit. And by withholding the release of a safer alternative HIV antiretroviral medication, drugs containing tenofovir alafenamide fumarate (TAF), Rutherford believes the company exposed patients taking the TDF drugs to some 10 extra years of toxicity to their bones and kidneys in an effort to extend the life of its patents for the drugs.
“They had two options available and for business purposes, in order to make more money, they essentially went with the less safe, less effective version,” he said.
In an emailed statement, Gilead emphasized it prioritizes patient safety and expressed an intent to fight the claims in the lawsuit, which it believes is without merit.
Though doctors have acknowledged kidney impairments and other conditions are among antiretroviral regimens’ side effects, Rutherford said research shows TDF drugs are associated with a much higher incidence rate and severity of side effects, ranging from acute kidney failure and cancer to osteoporosis.
According to the suit, both TDF drugs and TAF drugs, which are taken orally, are versions of the parent drug tenofovir, which is a drug that can be absorbed into a cell and prevent the process by which the HIV virus spreads. Rutherford said that because TDF drugs metabolize immediately, some of the drug is activated by cells where HIV is occurring while some of it remains in the gastrointestinal tract, liver and blood, where it can end up having a toxic effect on the body. Since TAF drugs only metabolize when they have been absorbed by cells affected by HIV, they do not affect other organs and a fraction of the average TDF dose is required of TAF drugs, he said.
Rutherford said Gilead developed both drugs at around the same time and had done studies showing relatively high doses of TDF drugs would be needed at a greater risk of toxic effects for patients, while TAF drugs were proven to target the HIV-affected cells in one’s body and were less likely to accumulate in the kidneys than TDF.
But he is alleging Gilead made a calculating decision to obtain patents for TDF drugs first and withhold putting TAF drugs on the market so the company could extend the life of its patents and attempt to dominate the market share for antiretroviral treatments. By patenting TDF drugs first and putting the development of TAF drugs on hold for a few years, argued Rutherford, the company ensured it could maximize the period of exclusivity during which it could produce and sell the drugs without competition.
By filing for patents for TAF drugs years after Gilead started developing them and discovering they were safer and more effective than TDF drugs, the company could further increase its profits by marketing the new drugs to patients and physicians as safer and more effective drugs as compared to TDF drugs, noted Rutherford.
Though Gilead’s TDF drugs and TAF drugs were approved by the U.S. Food and Drug Administration, Rutherford alleged the company had a duty by the law to produce a safer drug if they have the knowledge to do so. He said the company was responsible for presenting a better drug before it sought FDA approval.
“Regulatory approval is, I think, a floor, absolutely not a ceiling,” he said. “If you know how to make it safer, the law tells you you have a duty to make it safer.”
In the company statement, Gilead affirmed its commitment to developing and improving upon therapies that address unmet needs for people living with HIV for nearly three decades.
“Ongoing collaboration with, and input from, the medical and advocacy communities have always played a key role in helping inform our development programs and decisions. Patient safety is of foremost importance to us,” according to company statement.
Rutherford expected the suit to include more plaintiffs as the case proceeds, and said he hopes the effort to hold Gilead accountable will demonstrate what can happen when pharmaceutical companies are not held to the standard of creating the safest and most effective drugs possible. He noted open-ended questions as to what level of accountability these companies should be held and how much consumers should rely on FDA approvals has persisted over time, and hoped the suit could help answer these questions.
“They could have avoided these injuries that, in most cases, are permanent,” he said. “I think we need to set a better standard for pharmaceutical companies.”
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