Gilead HIV medication lawsuit reinstated

Gilead Sciences Inc, a research-based biopharmaceutical company, has recently experienced a set-back with the lawsuit filed in 2011 against them that they may have considered to have ended.

A federal appeals court has recently reinstated the lawsuit that was brought by two whistle-blowers alleging that Gilead defrauded and misled the government, as the company allegedly didn’t disclose that their HIV medicines were contaminated, which consequently allowed them to reportedly falsify data to win marketing approval for the medicine.

This false information reportedly led federal healthcare programmes to pay billions of dollars for contaminated medicine, but the case was initially dismissed by the California Court.

Now, it’s back…

Allegations

Recently, the Ninth Circuit Court of Appeals in San Francisco ruled that the claims made by former employees, Jeff and Sherilyn Campie, satisfy the requirements of a False Claims Act complaint. The basis of their claim falls on the fact that Gilead reportedly used synthetic ingredients from a manufacturer in China to lower the production costs of its HIV drugs.

This was not the problem, though; the problem was that the company then allegedly concealed the nature of these ingredients when it sought approval from the U.S. Food and Drug Administration (FDA) for the HIV drugs. They allegedly protested that the ingredient was supplied from South Korea and was FDA-approved, but that was apparently far from the truth.

They “also allege Gilead hid or falsified certain data to aid in their subsequent bid for FDA approval of the Chinese ingredients.” The allegations also extended to Gilead reportedly making false statements to the government and failing to tell the FDA of its additional ingredients. They allegedly tried to hide the ingredients by making up inventory codes as well as mislabelling and altering shipping and tracking information to allegedly conceal the origin of ingredients.

The main ingredients that are used in HIV medicines that were imported and hid were Emtriva, Truvada and Atripla. Some of the unapproved emtricitabine didn’t pass Gilead’s internal quality tests, and the results of this were then reportedly hidden from the FDA.

Impact on individuals and the government

The resurrection of the case isn’t just important for the government to regulate the potential impurities of the drug market, but it may also have a huge effect on individuals who have, or will take, the medicine.

It’s also potentially had an impact on government funding for programmes such as Medicare and Medicaid. Between 2008 and 2009, the U.S. government reportedly spent $5 billion (£3.8 billion) on Emtriva, Truvada and Atripla.

Gilead’s pricing spike

In January 2016, Massachusetts’ Attorney General opened an investigation after allegations arose that the company was charging patients too much for its Hepatitis C and HIV drugs, which violated state consumer protection laws.

Hepatitis C drugs have been scientifically proven to cure patients in approximately 12 weeks. One of the Hepatitis C drugs cost $84,000 (£64,000) for a 12 week treatment. The prices set by companies like Gilead have reportedly strained the budgets of government-funded care such as Medicaid, which may have forced the government to curtail treatment to the most needy.

John Martin highlights the danger that came with Gilead’s allegedly unfair pricing:

“…because Gilead’s drugs offer a cure for a serious and life-threatening infectious disease, pricing the treatment in a manner that effectively allows H.C.V. to continue spreading through vulnerable populations, as opposed to eradicating the disease altogether, results in massive public harm.”

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