Suing the company – for NOT developing a new HIV drug

Was Gilead putting a steady flow of profits from its cash cow ahead of developing a new and safer drug? According to a large number of US HIV patients in a legal case with an unusual twist, the answer is yes.

When patients sue drug manufacturers, they usually allege injuries or side effects caused by an existing product.

Yet in a lengthy legal process currently taking place in the US, the plaintiff’s argument is quite another – namely that Gilead acted negligently by deliberately delaying the development of a new drug, reports Fierce Pharma.

It all started in 2001 when Gilead launched the HIV drug TDF (tenofovir disoproxil fumarate), which was an effective treatment for the disease, but could cause side effects in the form of bone and kidney injuries.

At the same time, Gilead discovered another substance, TAF (tenovir alafenamide fumarate), which had similar properties except that it was safer. However, the allegations suggest that the company deliberately delayed the development of the new drug in order to maximise its profits from TDF. The latter drug, TAF, was only approved in 2015.

The roughly 24,000 HIV patients who joined the lawsuit claim that they suffered unnecessary adverse effects from TDF. They argue that by depriving patients of a choice between two options for a long period of time, as well as not disclosing that a new drug was being developed, Gilead breached its obligation to take due care of patients.

Gilead rejects the allegations and emphasises the unreasonable nature of claiming compensation for damage caused by a product that has not been proved defective. Furthermore, the company argues that a manufacturer cannot be held liable for decisions about the pace at which it develops new drugs.

Nevertheless, a California Superior Court has accepted the plaintiffs’ arguments, confirming in a ruling that they are sufficient to take Gilead to court.

Gilead is reviewing the chances of appealing the decision, and will be pursuing a defence, according to Fierce Pharma.

“If not overruled, the court’s decision will have wide-ranging, negative consequences in all areas of innovation and manufacturing, undermining the development of new products and discouraging improvements to existing products,” a company spokesperson said.

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