For the past several months, the U.S. government has been lambasted by AIDS activists for ostensibly failing to seek royalties from Gilead Sciences (GILD) for an expensive HIV prevention pill sold by the company and therefore not using the funds to help thwart the virus.
Now the federal government may have another chance — or yet another dispute may arise.
On Tuesday, the Department of Health and Human Services was awarded a new patent that broadly covers medicines derived from tenofovir and used to prevent HIV. Tenofovir is the basis for both an older Gilead drug called Truvada and its newer Descovy pill.
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I have seen Truvada advertisements all over the media (print, online, and television). The advertisement, despite the disclaimers, almost promotes sex without condoms.
It seems the advocates for the lower drug prices would save the people they are speaking for even more money if they pushed condom use more than trying to lower the cost of the drug. We seem so preoccupied with finding a cure, that prevention has gone the wayside.
Although the Federal government might have a right to royalties on its pre-exposure-prophylaxis-use patents on tenofovir- and emtricibatine-based antiretrovirals, a better, more effective strategy for trying to ensure affordable and equitable access to all 1.1 million-plus people who might benefits from PrEP in the United States would be to negotiate with Gilead to ensure that licenses are given (or taken by the government) that would allow for generic competition. Although generic prices for PrEP might not drop as low as the $60 per year price available from quality-assured generic producers for use in most low- and middle-income countries, very substantial savings from the $20,000 per person per year price in the US would be achieved if generic competition, including for new TAF/FTC combinations were allowed. The US paid for the PrEP clinical trials and has a patent on PrEP-use to boot. Isn’t this investment sufficient to justify government action and Gilead acquiescence to allow us to truly achieve dramatic reductions in new HIV infections that would result from affordable access to PrEP? Low prices, achieved through generic competition, would dramatically reduce the costs to government, insurers, and private individuals who need PrEP and the psycho-social services needed to support uptake, adherence, and monitoring of HIV status. It would be far easier to convince payers of the need for accelerated roll-out of PrEP if it did not cost a projected $20 billion a year in the US just to buy the quantity of PrEP needed at the price Gilead will otherwise charge. By the way, Gilead’s offer to gift some PrEP and to allow generic competition for TDF/FTC next year will provide minimal benefits as it continues to collect $20,000/pppy for “ungifted” patients on PrEP and as it switches former TDF/FTC PrEP users to its new TAF/FTC product Descovy that has a much longer period of monopoly protection.
Any life saving drug should be taken over by FDA, and manufactured by them. Price gouging is a no-no. Saying to patient pay 100k for your drug or die is not right.