Nov 18, 2022
"Cancer does not wait, nor should cancer patients have to wait for years for their government to act."
That's the message patient advocates reiterated in a Friday letter asking the Biden administration to help them secure a lifesaving prostate cancer drug that costs nearly $190,000 per year despite its development being 100% taxpayer-funded.
"Big Pharma's greed is sickening."
Last year, prostate cancer patient Eric Sawyer petitioned U.S. Health and Human Services (HHS) Secretary Xavier Becerra to grant march-in rights--under which the government can grant patent licenses to companies other than a drug's manufacturer--for enzalutamide, which is sold under the brand name Xtandi.
A one-year supply of Xtandi currently costs $189,800 in the United States, or up to five times more than its price in other countries.
"More than 250,000 new cases of prostate cancer will have been diagnosed in the U.S. and more than 33,000 men will have died from the disease during these 12 months. And during this period, Medicare will have spent more than an estimated $2 billion to purchase Xtandi from Japanese drugmaker Astellas," states the letter--which is signed by Robert Sachs, a prostate cancer patient and activist, and advocate Clare Love.
"Meanwhile," the letter continues, "HHS has not taken any action on our petition despite assurances" from the National Institutes of Health (NIH) that the request would be reviewed within a month.
\u201cHHS has the power to end price-gouging of Xtandi.\n \nWe called for @HHSGov to take action last year.\n \nWe\u2019re still waiting. \n \nBig Pharma will continue ripping off cancer patients if they don\u2019t take action NOW: https://t.co/WSGQhYQAxd\u201d— Public Citizen (@Public Citizen) 1668787306
However, 10 months later, the NIH "has apparently not even decided whether to grant the evidentiary hearing petitioners sought based upon prima facie evidence showing that Astellas has discriminated against American prostate cancer patients and U.S. taxpayers."
Discovered by scientists Charles Sawyer and Michael Jung at the University of California, Los Angeles with grants from the NIH and the U.S. Department of Defense, enzalutamide was approved in 2012 by the U.S. Food and Drug Administration for the treatment of late-stage prostate cancer.
Two companies--Japan-based Astellas and Medivation Inc., a San Francisco biotech firm--developed Xtandi. When Pfizer paid $14 billion to acquire Medivation in 2016, the pharma giant's then-CEO, Ian Read, said that "the value of Xtandi and its future growth potential was the principal driver" of the deal.
Astellas--which controls the price of Xtandi and has raised its cost by nearly 90% since 2014--toldLos Angeles Times business columnist Michael Hiltzik in February that the drug "is priced in line with other oral therapies for advanced prostate cancer available in the U.S. today and is widely available for patients across the health insurance marketplace."
Under the Bayh-Dole Act of 1980, federal agencies can exercise march-in rights if certain conditions are met, including if a drug's patent holder fails to make the benefits of the product "available to the public on reasonable terms."
"The standard we have suggested is that the price should be no higher than the median price charged in other large high-income countries."
In a Common Dreamsopinion piece published earlier this year, healthcare access advocates Ambika Verma, Tiffany Cacy, and Ernie Powell wrote that "charging American cancer patients up to five times more for a medication whose invention was 100% paid for by the American people and researched at a public American university--in this case UCLA--is not 'reasonable.'"
"We have asked HHS to set a modest standard for a federally funded drug," the new letter notes. "The standard we have suggested is that the price should be no higher than the median price charged in other large high-income countries."
"HHS' failure to grant a hearing, much less even consider the Xtandi petition, flies in the face of the administration's laudable efforts to lower excessive drug prices and does a disservice to cancer patients like ourselves and other American taxpayers who must bear the cost of the HHS failure," the letter contends.
"HHS can clearly insist on limiting the U.S. price of Xtandi to the median price for other large high-income countries, particularly since the drug has already generated more than $10 billion in sales from Medicare alone based upon these unconscionable pricing disparities," the authors argued.
The signers commended the administration for efforts to reduce drug prices--including with the Inflation Reduction Act (IRA) President Joe Biden signed in August--but noted that "unfortunately, these measures will not reduce the excessive and unreasonable Astellas prices for Xtandi in the U.S. market."
That's because although the IRA requires the government to negotiate prices for some drugs in 2026, Xtandi patents will expire in 2027, meaning HHS is unlikely to qualify the medication for negotiable status.
"After waiting a full year for HHS to even consider our petition, we respectfully ask you as secretary of HHS, and one who has in the past advocated the use of march-in rights, to act on our petition without any further delay," the letter pleads, "or exercise HHS' royalty rights in the relevant patents, providing even more immediate relief."
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