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TAGline Spring 2016

NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS

April 2016

Fair Pricing: Reclaiming Drugs for the Common Good
By Tim Horn

The way I see it, you can go down in history as the poster boy for greedy drug-company executives, or you can change the system—yeah, you.
—U.S. Representative Elijah E. Cummings (D-MD)

With these words, directed at execrated former Turing Pharmaceuticals CEO Martin Shkreli at a House Oversight and Government Reform Committee hearing on Capitol Hill this February, ranking member Elijah E. Cummings drew attention to a serious culpability problem that continues to dominate public discourse on the egregious pricing of prescription drugs in this country. The hearing was political theater at its most compelling, and Shkreli, smug, snide, and intransigent in his refusal to answer questions from committee members, was ideally cast in the role of villain. But to suggest that Shkreli and other pharmaceutical executives bear the sole responsibility for actually changing the system—a hodgepodge of laws, regulations, and loopholes underscoring health care as a commodity and unregulated profits as a free-market right of the prescription drug industry—misses the mark entirely.

Greed and the Necessity for Regulation
The story of U.S. drug pricing run amok isn’t just about corporate arrogance and avarice—it is also about government permissiveness and inaction

By Tim Horn, Erica Lessem, and Kenyon Farrow

On December 1, 2015, the U.S. Senate Finance Committee issued a scathing investigative report concluding that Gilead Sciences strategically priced its curative hepatitis C virus (HCV) treatments Sovaldi and Harvoni to yield an immediate financial windfall for the company, ignoring evidence and expert opinion that doing so would bust the budgets of public and private insurers and, consequently, prevent the medications from becoming available to all who need them. In February, Valeant Pharmaceuticals Limited and Turing Pharmaceuticals stood before members of the House Committee on Oversight and Government Reform, which conducted its own investigations into the sudden, inexplicable price increases for a number lifesaving drugs. A month later, Turing executives were back on Capitol Hill, this time in front of irate members of the Senate Special Committee on Aging.  

PrEP Pricing Problems
A number of barriers to pre-exposure prophylaxis (PrEP) uptake, use, and adherence have been identified—cost shouldn’t be one of them
By James Krellenstein and Jeremiah Johnson

On July 16, 2012, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences’ Truvada (co-formulated tenofovir disoproxil fumarate and emtricitabine) for HIV pre-exposure prophylaxis (PrEP). The approval of Truvada is a historic advance for HIV prevention efforts. Results of multiple randomized controlled trials indicate that PrEP is highly effective in preventing HIV infection; the risk of sexual HIV acquisition can be reduced by more than 99 percent in individuals who take the drug consistently. Despite the overwhelming success of PrEP in preventing HIV infection in trials and postapproval demonstration projects, uptake in the real world has been painfully slow. In February of this year—nearly four years after FDA approval—Gilead estimated that only 40,000 U.S. residents were on Truvada for PrEP, less than four percent of the 1.2 million for whom the Centers for Disease Control and Prevention (CDC) estimates PrEP is indicated.

The Low Cost of Universal Access
Generic treatments for HIV, viral hepatitis, and cancer can be affordably—and profitably—mass-produced for broad, unobstructed availability

By Tracy Swan

TAG talks with Andrew Hill, senior visiting research fellow in the University of Liverpool’s Department of Pharmacology, about his group’s work exploring what it actually costs to profitably mass-produce generic drugs for HIV, viral hepatitis, and cancer. These estimates are based on the molecular structure, complexity, dose, and duration of treatment with each drug.

Achieving these prices—between $200 and $400 for a course of sofosbuvir and daclatasvir for hepatitis C virus (HCV), for example—is necessary to facilitate the mass scale-up of HCV treatment programs in low-, middle-, and high-income countries.