HIV Patients Say Gilead Suppressed Safer Drug to Preserve Profits

A group of HIV patients based in California filed two separate lawsuits on Wednesday against Bay Area drugmaker Gilead Sciences for promoting a drug they say caused permanent kidney and bone damage. The personal injury and class action suits, filed in a Los Angeles district court, accuse the company of shelving a safer version of the drug in order to maximize profits and extend the sales of its existing drug tenofovir disoproxil fumarate.

Tenofovir disoproxil fumarate was sold under the brand name Viread. (U.S. Dept. of Health and Human Services)

Both complaints say the company knew as far back as 2001 that TDF was highly toxic but failed to warn patients of the dangerous side effects. The drug was originally sold under the brand name Viread.

"A company I trusted with my life took advantage of that trust by misrepresenting the side effects of TDF, calling it the ‘Miracle Drug’ and using other deceptive marketing strategies," said Michael Lujano, from Los Angeles, one of two plaintiffs in the personal injury suit. "Gilead shelved a far safer drug called tenofovir alafenamide fumarate simply to increase its long-term profits."

Another plaintiff in the class action suit, Ricardo Wohler, says he has lost 17 teeth in just three years due to the drug. The 52 year-old real estate agent from Marin took TDF for 12 years and was never made aware of its potential side effects, he said.

"I learned how to smile without opening my mouth, how to speak without showing my teeth. This had an entire impact on my life, my self security, my self esteem, but also on my finances."

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Gilead said it is "thoroughly reviewing the complaints and will not provide comment until that process is complete."

The suits accuse Gilead of deceptive marketing practices and putting profits before the health of its customers. The complaint says the company made $18 billion in profits in 2015.

"Under these circumstances, the laws must be read to protect public health from corporate greed,” says Liza Brereton, attorney for plaintiffs and in-house counsel for the AIDS Healthcare Foundation.

AHF, which filed both lawsuits with co-counsel Rutherford Law, says it is funding the litigation and will not accept any financial recovery in excess of its actual costs.

Two other Californians filed a separate class action lawsuit on behalf of all patients living in California who were prescribed the drug from Oct. 26, 2001 through the present and were exposed to Gilead’s alleged misrepresentations, either directly or through their doctor.

The Food and Drug Administration reportedly issued two warning letters to Gilead for false misrepresentations about the drug's risks, according to the personal injury complaint.

A warning letter issued in 2002 accused a company sales representatives of falsely stating that TDF had “no toxicities” and was “benign” and “extremely safe." The company was slapped with another warning letter one year later, requiring Gilead to retrain its sales representatives.

The drugmaker began funding research of an alternative drug called TAF in 2001 but suppressed findings that showed it was far less toxic, according to the class action complaint.

Faced with a sharp decrease in profits, the complaint says, the drugmaker eventually released those findings in 2014, when Gilead’s patent on TDF was approaching expiration.

From the Los Angeles Times:

In April 2001, the scientists published research on a different chemical version of the medicine called tenofovir alafenamide fumarate, or TAF.

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.

Gilead then paid doctors across the country to give TAF to patients in small clinical trials. The positive results of those studies were not published for years — secrecy that the lawsuits filed Tuesday say was "an act of extreme malice."

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.

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A previous federal lawsuit filed in 2016 is currently pending following the publication of a previous Los Angeles Times article that accused the company of stifling development of the safer drug.

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