The CDC must #BreakThePatent and develop a national action plan for universal access to PrEP!

Truvada as PrEP is a scientific revolution — it’s over 99% effective in preventing HIV infection. If you live in NYC or SF or Chicago, you probably already know a lot of people on PrEP and have seen how it has changed attitudes around HIV in high risk communities. But despite this incredible breakthrough being available for over 6 years however, HIV rates throughout the country remain stubbornly high.

We believe a big portion of this failure comes from the price that keeps the drug out of reach for many. At a sticker price of more than $1600 a month, insurance companies force users through a byzantine bureaucracy and charge high co-pays that act as a powerful barriers to access. Like so many other issues, this has left communities of color, women, and transgender people in the US hardest hit.

The price of the drug has consequences far beyond just exorbitant out of pocket expenses for patients however. Instead of spending money on developing innovative public health programs to increase access and awareness of PrEP, train doctors, and decrease stigma, we are helping create record profits for the pharmaceutical company that holds the patents, Gilead Sciences. Imagine what we could do if the CDC, our nation’s premier public health agency, pushed those savings into developing a comprehensive national plan that targeted communities most at risk.

Often, defenders of the drug pricing status quo will note that drug companies spend billions on research, so these high costs are just recouping the company’s expenses. It’s important to note however that in the case of Gilead and PrEP, this argument holds no water. Almost none of the research used to support the FDA approval of Truvada for its use as PrEP was funded by Gilead. It was almost entirely American tax dollars as well as philanthropic grants from The Bill and Melinda Gates Foundation that made this miracle drug available.

What’s particularly galling about thousands continuing to be infected with HIV is that our government has had a solution sitting on the table that it is refusing to exercise. The CDC has the power to allow generic Truvada onto the market TODAY. There is an existing law (28 USC 1498, we just call it “1498”), that gives the government the right to allow companies to sell a generic form of Truvada immediately when there is a need to protect public safety.

At its core, “1498” is just a law that says corporations can’t hold the health and safety of the American people hostage by price gouging access to life-saving innovations.

Think this sounds radical? It’s not. The government uses 1498 all the time with national security as the justification! I think it’s also important to realize that the government isn’t taking anything for free – a court figures out a reasonable price and the government pays that to the company. Fair and square.

We want the CDC to enact “1498” so that we can get Truvada for a very cheap price and use the savings seen by not sending billions of dollars to Gilead to instead fund a National PrEP Program to increase PrEP access in the places that need it most.
Don’t believe us? Check out the New York Times Editorial Board Op-ED on this subject. And for hard-core nerds, here is Yale School of Law paper on the topic.

Aaron Sylvan Lord, MD, MSc