Sponsored Article

The FDA and Me: Medical Cannabis and Regulatory Capture

By Richard Cowan

Newsweek AMPLIFY - The FDA and Me

I became National Director of NORML (National Organization for the Reform of Marijuana Laws) in late 1992, and shortly after Bill Clinton took office, I was invited to a meeting with the FDA to discuss medical marijuana.

The late Robert Randall, a glaucoma patient, had successfully sued the FDA to be allowed to use marijuana to treat his increasing blindness. As a consequence, the FDA had created what was called a "Compassionate Use, Investigational New Drug program" that provided him—and eventually dozens of other patients—with AIDS and other diseases with 300 marijuana cigarettes per month.

This was at the height of the AIDS epidemic and word had spread quickly that medical marijuana really helped patients cope with the symptoms of the disease as well as the side-effects of the pharmaceutical drugs patients were taking. Consequently, there was a growing backlog of applications for the program.

In March of 2002, the Bush Administration closed the IND. See U.S. Rescinds Approval of Marijuana as Therapy/ Consequently, the FDA and the new administration had to make a decision about what to do about medical marijuana, so—to my amazement, I found myself being led through the maze of offices of the Department of Health and Human Services to a meeting with an Assistant Secretary of HHS, an attorney for HHS and a representative of the FDA.

They proposed that—if NORML would provide $1 million for the research, they might get marijuana rescheduled from Schedule 1 (with heroin), meaning it has a high potential for abuse and no medical use, to maybe Schedule 2, with cocaine. (Spoiler alert: it remains in Schedule 1 after 28 years.)

Unfortunately, the 1980s were very bad for NORML and great for the Drug War, so NORML didn't have $10,000, much less $1,000,000 in the bank, so I wasn't exactly bargaining from a position of strength. Consequently, when the nice man from the FDA told me that they might get it rescheduled in 18 months, I replied, "Eighteen months! That's no time at all if you aren't in pain or in prison. Are you going to stop arresting people in the meantime?"

Of course, the answer was that they had to do the research first. So I asked if they were also going to do research on the effects of being arrested. And of course, they had never thought about that. And they still have not done any research on the suppression of research, much less the public health effects of millions of arrests and mass incarceration.

Of course, the FDA is simply the polite part of the Drug War, and it is just following orders. It was created in 1906 to deal with the very real problems of contaminated drugs and "snake oil" peddled by some of the early pharmaceutical industry. However, its role in maintaining marijuana prohibition is also a perfect example of what is called "regulatory capture."

Obviously, the pharmaceutical industry has developed around these regulatory procedures, their ecosystem, and it saves them from having to compete with things like cannabis that lack the millions to pay for the FDA procedures. I have criticized GW Pharmaceuticals for playing that game with Sativex (THC) and Epidiolex (CBD), and even lobbying against legalizing medical marijuana.

See: Is GW Epidiolex Better Than The CBD Products That I Can Buy Online?

However, the FDA's "capture" by the Drug War agencies, the DEA and NIDA, turned out to be a much bigger problem for the health and freedom of the American people. If a pharmaceutical company has millions of dollars to spend on FDA approved testing and research it may get the FDA's approval to sell its patented product via prescription with various restrictions, and no competition. However, if the "product" is a plant-like cannabis that has been used for millennia and cannot be patented, there is no way of paying for the research.

And then this the Drug War, so there are also serious problems with even getting marijuana to do the research. DEA Unveils New Rule To Finally Allow More Marijuana Growers For Research

In the meantime, there is growing evidence that cannabis may be helpful in treating COVID 19 symptoms.

See: COVID-19, AIDS and the Suppression of Medical Cannabis

But I can't tell you anything about that because I have a financial interest in cannabinoids, so let me emphasize again that my point is political, not medical. In my decades of involvement in the marijuana reform movement I have never recommended that anyone use marijuana, only that people should be free to make their own decisions. (And to show that I'm completely delusional, I also think that the government should stop lying.)

From March 27, 2003 MarijuanaNews.com
Analysis By Richard Cowan

The prohibitionist party line is that there is no need for medical cannabis because there are already pharmaceuticals that do everything that cannabis does, and besides there is Marinol, synthetic THC.

Two days ago, I posted a DEA mass email that said, "Scientists have made synthetic THC and put it in a pill form, called Marinol, which relieves the nausea and vomiting associated with chemotherapy for cancer patients and assists with loss of appetite with AIDS patients."

With exquisite timing, the FDA announced yesterday that it had approved a new pharmaceutical, Emend, manufactured by Merck, that can be used "for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy."

Why would Merck spend money to develop a drug for which there was no need? Obviously, they would not.

In fact, the FDA says, "Emend is the first FDA approved treatment that prevents the delayed nausea and vomiting symptoms that many patients experience greater than 24 hours after receiving chemotherapy."

Chemotherapy is often very distressing for cancer patients due to severe nausea and vomiting. These symptoms can be severely debilitating, often resulting in patients' refusing further courses of chemotherapy or in serious limitations on their lifestyle."

In other words, people had rather die of cancer than endure chemo without an effective anti-emetic. That is how badly such a drug is needed... according to the FDA.

Well, now that we have Emend, does that mean that finally there is no need for medical cannabis for chemo? Unfortunately, no. In clinical trials on more than 1,000 chemotherapy patients, only 42 percent of the patients benefited from this important new drug. According to the AP, FDA oncology chief Dr. Robert Justice, said that adding Emend to standard anti-emetics allowed 20 percent more patients to go through a chemotherapy session without any nausea.

New drugs do not even have to benefit a majority of those who need it. Nor do such drugs have to be "harmless."

Patients taking Emend are warned, "Emend may interact with some drugs, including some chemotherapies, birth control pills, blood thinners, and other drugs." (There is something absurd about giving a pill for vomiting, but it appears that emend is to be taken before the delayed nausea hits.)

Merck said Emend will be available by prescription the week of April 14. Treatment requires a pill a day for three days, which will cost $250.

Even black market cannabis would cost patients far less than that, inasmuch as most patients do not need very much cannabis to prevent nausea. Inasmuch as most patients have several chemo sessions, the total cost could exceed $1,000. This is in addition to the other anti-nausea drugs, which are among the most expensive in the pharmacopoeia.

Over 40 million Americans have no health insurance. Billions of people around the world cannot even afford to take an aspirin. What good will this wonderful new drug do them?

So here it is in the FDA's own words. The need for an effective anti-emetic is still a matter of life and death for many cancer patients, and the suppression of medical cannabis is still mass murder...

It's 17 years later... And?

Richard Cowan is a former NORML National Director and co-founded Blue Ribbon Hemp along with Dr. Igor Bussel, MD, MS, MHA.

We may earn a commission from links on this page, but we only recommend products we back. Newsweek AMPLIFY participates in various affiliate marketing programs, which means we may get paid commissions on editorially chosen products purchased through our links to retailer sites.