Sen. Bernie Sanders is once again keeping drug makers in check, suggesting that people living with cancer are being preyed on by greedy interests.
On Monday, Sanders demanded a Department of Health-led investigation into a proposal to grant a company with an exclusive patent license for cancer treatment and methods, produced with public resources and a potential conflict of interest.
The sexually transmitted infection Human papillomavirus (HPV) can lead to six types of cancer and most cervical cancer, the National Cancer Institute (NCI) reports. It can be dormant for years or cause genital warts or worse. Last month, National Institutes of Health (NIH) proposed granting Kingston, New Jersey-based Scarlet TCR a patent for a T-cell therapy for HPV, which has undergone a Phase I trial and has a Phase II trial scheduled to conclude in 2025.
There’s no cure for HPV, but drug developers are examining T-cell therapies to combat HPV and the cancers it leads to, including Scarlet TCR. Sometimes they’re gene-engineered. (CBD is also being explored for its potential to inhibit cervical cancer cells.)
There’s a problem though. The patent proposal and the company’s ties to an ex-government employee and other inconsistencies were revealed in an Oct. 18 report by The American Prospect. The NIH quietly applied to be granted “an exclusive patent for a cancer drug, potentially worth hundreds of millions or even billions of dollars, to an obscure company staffed by one of its former employees,” The American Prospect reports.
Sanders, chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, demanded a probe of the patent proposal in an Oct. 23 letter to Christi Grimm, who is inspector general of the U.S. Department of Health and Human Services. The HELP committee also announced Sander’s open letter on Oct. 23.
Sanders suggested the NIH is allowing a company to take advantage of a life-saving cancer drug.
“I am growing increasingly alarmed that not only has the NIH abdicated its authority to ensure that the new drugs it helps develop are reasonably priced, it may actually be exceeding its authority to grant monopoly licenses to pharmaceutical companies that charge the American people, by far, the highest prices in the world for prescription drugs,” Sanders wrote. “One particularly egregious example has recently been brought to my attention that I believe demands your immediate attention.”
Sanders argued that the NIH should be doing more to lower the cost of drug therapy.
“There does not appear to be anything reasonable and necessary about granting a monopoly for a treatment that was invented, manufactured and tested by the NIH, is already in late stage trials and could potentially enrich a former NIH employee who was one of the major government researchers of this treatment,” Sanders wrote. “Based on current law and the best interest of U.S. taxpayers who paid for this cancer therapy, it would seem to make more sense for the NIH to offer non-exclusive licenses so that multiple manufacturers can produce this important cancer therapy at reasonable and affordable prices. The apparent abuse of the system by the NIH with respect to the exclusive patent license for this cancer therapy is so egregious that it has been characterized as a ‘how-to-become-a-billionaire program run by the NIH.’”
“If accurate,” Sanders wrote, “that would be absolutely unacceptable. The NIH should be doing everything within its authority to lower the outrageously high price of prescription drugs. It should not be granting a monopoly on a promising taxpayer-funded therapy that could cost hundreds of thousands of dollars for cancer patients in a way that appears to exceed its statutory authority.”
The American Prospect story pointed out that the NIH offering an exclusive license for a cancer treatment to a company with no website or SEC filings staffed by a former NIH employee
There is historical precedence on life-saving drugs or therapies that didn’t need a patent: On Jan. 23, 1923, Sir Frederick G. Banting, James B. Collip, and Charles Best, discoverers of insulin, were awarded U.S. patents on insulin and the methods used. They all sold these patents to the University of Toronto for $1 each. Banting said, “Insulin does not belong to me, it belongs to the world.”
While things have changed and the price of insulin skyrocketed, new efforts are being made by the drug’s top three makers to make insulin affordable once again.
When the polio vaccine was found to be 90% effective, its discoverer wasn’t in it for the money. On April 12, 1955, Edward R. Murrow asked Jonas Salk who owned the patent to the polio vaccine. “Well, the people, I would say,” Salk responded. “There is no patent. Could you patent the sun?”
In today’s pharmaceutical world, some of those values are lost.
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