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

More Ethical Drug Research

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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Young adults in the United States that are using cannabis and hallucinogens spiked to reach “historic highs,” according to new federal research released this week.

The data from the National Institutes of Health found that the use of both pot and hallucinogens among individuals between the ages of 19 and 30 “increased significantly in 2021 compared to five and 10 years ago,” hitting the highest levels among the age group since 1988.

“As the drug landscape shifts over time, this data provides a window into the substances and patterns of use favored by young adults. We need to know more about how young adults are using drugs like marijuana and hallucinogens, and the health effects that result from consuming different potencies and forms of these substances,” National Institute on Drug Abuse Director Nora Volkow said in a statement on Monday that accompanied the study. “Young adults are in a critical life stage and honing their ability to make informed choices. Understanding how substance use can impact the formative choices in young adulthood is critical to help position the new generations for success.”

The data is part of the NIH-sponsored “Monitoring the Future” study, which has been conducted by researchers at the University of Michigan since 1975.

The latest edition of the “MTF” study found that, in 2021, “past-year, past-month, and daily marijuana use (use on 20 or more occasions in the past 30 days) reached the highest levels ever recorded since these trends were first monitored in 1988.”

“The proportion of young adults who reported past-year marijuana use reached 43% in 2021, a significant increase from 34% five years ago (2016) and 29% 10 years ago (2011). Marijuana use in the past month was reported by 29% of young adults in 2021, compared to 21% in 2016 and 17% in 2011. Daily marijuana use also significantly increased during these time periods, reported by 11% of young adults in 2021, compared to 8% in 2016 and 6% in 2011,” the study said.

The researchers said that past-year “hallucinogen use had been relatively stable over the past few decades until 2020, when reports of use started to increase dramatically.” Last year, it reached historic levels.

“In 2021, 8% of young adults reported past-year hallucinogen use, representing an all-time high since the category was first surveyed in 1988. By comparison, in 2016, 5% of young adults reported past-year hallucinogen use, and in 2011, only 3% reported use. Types of hallucinogens reported by participants included LSD, MDMA, mescaline, peyote, ‘shrooms’ or psilocybin, and PCP. The only hallucinogen measured that significantly decreased in use was MDMA (also called ecstasy or Molly), showing statistically significant decreases within one year as well as the past five years – from 5% in both 2016 and 2020 to 3% in 2021,” the study said.

The study indicated that alcohol and hallucinogens were far from the only vices that saw increased usage by young adults last year.

Binge drinking, which is defined as having five or more drinks in a row in the past two weeks, “returned to pre-pandemic levels in 2021 after significantly decreasing in 2020 (32% reported in 2021, versus 28% in 2020 and 32% in 2019),” according to the research.

Meanwhile, high-intensity drinking, which is defined as having 10 or more drinks in a row in the past two weeks,” was at its highest level since it was first measured in 2005, reported by 13% of young adults in 2021, compared with 11% in 2005,” the study said.

The study did, however, show “significant decreases in past-month cigarette smoking by young adults and non-medical use of opioid medications in the past year (surveyed as “narcotics other than heroin”) compared to 10 years ago.” Nicotine vaping, on the other hand, “increased significantly among young adults in 2021 despite leveling off in 2020 during the earlier part of the pandemic,” according to the study.

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Grant funds will soon be available to researchers who are working to treat cannabis. 

A “Notice of Special Interest” (NOSI) (entitled “Basic Mechanisms of Cannabis and Cannabinoid Action in Cancer”) was posted on May 5 by NIH’s National Cancer Institute, with the intent “to promote research in understanding the mechanisms by which cannabis and cannabinoids affect cancer biology, cancer interception, cancer treatment and resistance, and management of cancer symptoms.”

In the notice, NIH explains that the reasoning behind this effort is due to the growing number of cancer patients seeking relief with medical cannabis, but that there are not enough studies to verify its effectiveness. “Cancer patients use cannabis and cannabinoids to manage symptoms of cancer and cancer treatment including anorexia, nausea, and pain,” the NOSI states. “Recent survey evidence suggests that a quarter of cancer patients have used cannabis for symptom management. Despite the increase in cannabis and cannabinoid use, research about their health effects, including potential harms and benefits, remain limited.” 

The notice summarizes what is currently known about cannabis cancer treatment by explaining that data regarding risk for cancer patients is not widely available. “Epidemiological studies of cannabis use and cancer risk have yielded limited and inconsistent results,” the notice explains. “While cannabis smoke generates many of the same carcinogens as tobacco, studies to date have not shown a link between cannabis smoking and lung cancer risk.” The notice uses the example of cannabis smoking being linked to testicular cancer as well.

It also briefly defines the activity of various cannabinoid receptors in the human body through animal models and cancer cell lines. “Cancer cell line experiments show that THC and CBD can mediate many anti-tumor effects, including inducing apoptosis and inhibiting cell proliferation, invasion, and angiogenesis,” the NOSI states. “These anti-tumor activities have led to early clinical testing of THC and CBD for glioblastoma and prostate cancers. While preclinical studies show differing effects of cannabinoids on cancer cells, deeper understanding is needed about how the tumor promoting and suppressive mechanisms of cannabinoid signaling influence cancer biological processes.”

Finally, the notice summarizes the current state of Food and Drug Administration-approved synthetic cannabinoids, dronabinol and nabilone, that are being used to treat chemotherapy. “Increasingly, cancer treatments involve targeted and immunological therapies, but little is known about whether and how cannabis and cannabinoids influence their efficacy.”

The NOSI concludes by inviting researchers whose focus on these topics (Cancer Risk, Cannabinoid Ligands and Receptors, Cancer Biology, Cancer Treatment and Symptom Management) can lead to a wide variety of research opportunities.

The NIH won’t consider any applications for studies that include clinical trials, “symptoms not related to cancer or cancer treatment,” or “projects that lack cancer models, specimens, or cells.” Instead the agency is looking for more specific methods of study in order for researchers to be considered. “Studies that integrate expertise from multiple disciplines, incorporate state-of-the-art, human-relevant models (e.g., organoid or patient-derived xenograft models) and utilize advanced technologies and methods are strongly encouraged.” Researchers can apply for a grant starting on June 5 and onward.

In December 2021, the NCI released a paper addressing the challenges that are holding back cannabis and cannabinoid research. “Conflicting federal and state cannabis regulations hinder research in several ways including the inability of researchers to access products that are legal in their state, a lack of standardization and quality control of cannabis and cannabis-derived products within and across states, and no national oversight of this standardization and quality control or the industry.”

Although government agencies have conducted limited studies in the past in relation to medical cannabis, many other study efforts have begun to explore cannabis consumption among cancer patients. The Virginia Commonwealth University of Massey Cancer Center published a study in August 2021 and found that cancer patients consume less cannabis than those of the general public. A study published in December 2020 found that one-third of Canadian cancer patients were reporting cannabis use as well.

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