The current war between Pharma Giant Gilead and the U.S. Congress over Truvada drug pricing, its effectiveness and the realities of “Undetectable Equals Untransmittalbe, “U = U,” plus the expiring U.S. patents for the drug and the availability of the drug to at-risk and low income communities in the U.S., belies a key point in all the hubbub. Where has the National Institutes of Allergy and Infectious Diseases (NIAID) been as the drug prices went sky high, the mythology of “U = U” has spread throughout HIV communities – with NIAID’s complete assistance – and as Gilead’s revenues soared? The present fist fight between the Pharma Giant and the House Oversight Committee largely overlooks NIAID’s role in creating and abetting the situation in the first place.
For the past two presidential Administrations, NIAID has remained a silent partner as tenofovir disoproxil fumarate (TDF) drug prices almost doubled, the company generated $3 billion a year and NIAID brokered the myth of “Undetectable equals Untransmittable.”
Thanks to the work of Chairman Cong. Elijah Cummings and the House Oversight Committee, Gilead is being challenged. But what about NIAID and the mythology of U=U?
NIAID once had a tool box for HIV prevention that cost the American taxpayer millions to develop. This toolbox included microbicides, a plethora of vaccines and condom research. These were dumped in favor of Truvada (TDF) and PrEP as the King of the Hill. Why? Has NIAID been in collusion with Gilead? The Oversight Committee is examining Gilead’s practices, patents and pricing. Shouldn’t it examine NIAID’s actions, policies and practices as relates to Gilead and TDF as well?
At the Committee’s last hearing (May 2019), the Committee requested a substantial number of documents to backup its high pricing for TDF. Gilead has furiously rebutted as it tries, and probably ultimately fails, to use the Trump U.S. Patent Office to justify its rip-off pricing in the U.S. market. Why does the drug cost less than a quarter of its U.S. pricing in overseas markets?
What about NIAID’s role in “marketing” the drug through its pronouncements like “…an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others.”
Many advocates and activists in the HIV community have bought this hook, line and ultimately sinker without any challenges to what it really means. The AIDS Healthcare Foundation (AHF) has pioneered the fight against the harmful side effects of Gilead’s TDF-based (tenofovir disoproxil fumarate) drugs as part of its treatment for HIV/AIDS or as a part of the HIV prevention strategy pre-exposure prophylaxis or PrEP. AHF’s has called for a victim compensation fund from Gilead that comes as its attorneys announced a filing in the Superior Court of California County of Alameda of a lawsuit seeking compensation and accountability for Gilead’s actions for failure to publicly communicate defects in TDF’s drug formulation. The lawsuit alleges Gilead knew almost a decade in advance that a safer version of tenofovir existed. The Company kept silent publicly on the availability of tenofovir alafenamide (TAF) “to retain its profits from and monopoly of the harmful version of TDF.” This lawsuit alleges that Gilead failed to warn patients of the damaging side effects of TDF and actively misrepresented TDF’s efficacy and risks knowing that TAF, the safer alternative, existed in its own laboratories. But where was NIAID?
This justifiable confrontation between AHF representing HIV patients and Gilead brings to the forefront the question, “Where was NIAID in communicating the dangers of TDF and why does it continue to market “U = U” when the foundation for PrEP is TDF, the same drug that has potentially harmed a great number of HIV and AIDS patients?
NIAID should be further scrutinized for potential collusion with the drugmaker because it is the foundation for what Trump called for during a paragraph in his second State of the Union, the Ending of the AIDS Epidemic by 2030 plan. If TDF, and by extension PrEP, are the basis for ending of the epidemic, not only are the prices for the drug another means for the company to expand its profits, but the drug itself will put even more HIV and AIDS patients at risk thanks to NIAIDs silence about its dangers.
Gildead’s has announced that it will provide 200,000 individuals, or 2.4 million bottles of PrEP to those who are uninsured and at high risk of HIV with free or low cost access to the drug. That should be chilling news to the Oversight Committee. Instead, the Committee has said that this insufficient access to the drug and has pointed out that Gilead could provide an additional 1.1 million people with the drug. That is frightening.
While well intentioned, the Oversight Committee does not have the scientific expertise to review this drug without an impartial NIAID’s analysis of what Gilead is doing and has done. And NIAID impartiality itself could be called into question. While Gilead is now attempting to market a less harmful version of tenofovir, tenofovir alafenamide (TAF) – potentially making billions more in profit at the expense of U.S. HIV and AIDS patients, the House Oversight Committee and the Trump Administration need to hold the National Institute of Allergy and Infectious Diseases accountable for its Rip Van Winkle act for nearly a decade. Plain and simple, Gilead needs more competition in the marketplace with additional tools in the HIV and AIDS drug development tool box and it needs a change of direction when it comes to drug development and the denial of other avenues of funding drug development research for the epidemic. Without this competition, the Company – with covert help from NIAID – can continue to expand its marketplace for a drug that potentially has and can continue to harm thousands of HIV patients and displace other therapeutics that may have better results with appropriate Federal assistance.
———
Originally published on PanAware on Wordpress.com on July 20, 2019. By Jeannie Wraight (column by Rick Blake, Washington Correspondent).