Walensky testified before Congress last May about the exorbitant costs of medication to treat HIV. She said the sale of Truvada, which is used to treat and prevent HIV, has resulted in profits of $36 billion and has seen a price increase of 150% since 2004. “Fewer than 150,000 have ever received it. Over 75% of those are white gay men in the northeast and the west coast,” she said. The most affected population is, however, Black gay men, and it was estimated in 2016 that one in two of them would be diagnosed with HIV in their lifetime. Pharmaceutical companies have “already profited enormously,” Walensky said. “Now in the spirit of saving lives, of preventing new infections, of realizing public health, putting forth a cohesive public health response, and realizing a presidential call to action,” she added, “I simply ask that these drugs be reasonably priced so that those most marginalized in that risk can reap their benefit.”
Walensky’s complete speech:
“My name is Dr. Rochelle Walensky. I’m a professor of medicine at Harvard Medical School, chief of the Division of Infectious Diseases at Massachusetts General Hospital, a practicing clinician, and a researcher on the cost-effictiveness of HIV care both in the U.S. and internationally. In 1995, we told patients with AIDS, they would, with certainty, die. AIDS plagued my internship. By the end of that year, we had an FDA-approved HIV cocktail. Three drugs, up to 14 pills a day, which, if taken without fail, allowed AIDS patients to live. At the time, the three drugs of the cocktail cost a total of $15,000 per person per year, and our research team reported its cost-effectiveness. We demonstrated it was good value for many.
Today, we definitively have the tools to end this epidemic. The HIV-three-drug cocktail, termed antiretroviral therapy, is frequently co-formulated into a single daily pill. The regimens have high resistance barriers. That’s good. They have and low toxicity profiles. That’s also good, and projections suggest a normal life expectancy for adherent patients with HIV. We also know that people who take these drugs and effectively suppress their virus cannot transmit it to anyone else. But the cost of these drug regimens today is 40-to-50 thousand dollars per person per year. A 300% increase in 25 years.
Truvada is a co-formulation of two of these three drugs used for treatment, scientifically known as the combination of Tenofovir Disoproxil Fumarate and Emtricitabine. It was FDA approved for HIV treatment in August 2004 and has since then been a mainstay of HIV care. In 2012, following remarkable scientific work, much of which was left by Dr. (Robert) Grant, the FDA approved the expanded indication of Truvada for Pre Exposure Prophylaxis, or PrEP, for HIV prevention. The cost of Truvada when FDA approved in 2004 was $ 7,800 per year. Today, it costs $20,000 per year. A similar drug combination is available internationally at a cost of $60 per year. Please understand I’m not proposing that this is what the price should be in the United States. I simply provide that benchmark for national pricing to put it into global context.
In his February state of the union address, the president announced his initiative to end the HIV epidemic. This will not be easy. The benchmarks for the end-the-epidemic initiative are a decrease in the number of new HIV infections by 75% in five years and by 90% by 2030. Our research group has published work highlighting that even if we get 90% of people with HIV diagnosed, treated, and virologically suppressed, we can only decrease the number of new infection by 40%. In short, to end this epidemic we need both treatment and prevention. Aside from treatment, PrEP offers the most efficacious prevention intervention known.
Make no mistake, even if it was free, PrEP is difficult. In addition to drug adherence, it requires quarterly doctor visits for HIV testing, sexually transmitted infection screening, and laboratory monitoring. But right now the biggest problem with PrEP is access. The CDC estimates that more than 1.1 million people in the United States are at high enough HIV risk to warrant prep. Fewer than 150,000 have ever received it. Over 75% of those are white gay men in the northeast and the west coast. But today’s uncontrolled HIV epidemic is rampant among Black gay men and continues to disproportionately affect women of color, especially in the south.
In 2016, it was estimated that one in two Black gay men would be diagnosed with HIV in their lifetime. We need prevention tools like PrEP to reach these marginalized populations if we are ever even going to make a dent in the epidemic, nevermind to reach the auspicious end-the-epidemic goals. The sale of Truvada has resulted in profits of $36 billion and Truvada, unchanged, has seen a price increase of 150% since 2004. That price tag is simply too high.
We have the scientific tools to end this HIV epidemic, and we are fortunate that Pharma has developed these drugs to get us there. They have already profited enormously. Now in the spirit of saving lives, of preventing new infections, of realizing public health, putting forth a cohesive public health response, and realizing a presidential call to action, I simply ask that these drugs be reasonably priced so that those most marginalized in that risk can reap their benefit. And finally, I would like to applaud Congress for holding this hearing and bringing this issue to the forefront in the public dialogue. I hope that some of these companies, including Gilead, will begin to do the right thing. It’s never too late for that.”
The Georgia runoff is Jan. 5. Click here to request an absentee ballot. Early in-person voting starts Dec. 14.