The ORG Responds to the DFAA on the FDA

Columbus Free Press | November 7, 2013 | by Mary Jane Borden

Cheryl Shuman’s successful tour of Ohio to promote the Ohio Cannabis Rights Amendment, sponsored by the Ohio Rights Group (ORG), concluded in Cleveland a week ago with a segment by Lee Jordan on the city’s News Channel 5. Success becomes self-evident when the opposition appears, often in the form of the Drug Free Action Alliance (DFAA), which is headquartered on Huntley Road in Columbus. The segment, entitled “Northeast Ohio family seeks medical cannabis in Colorado to find effective treatment for seizures” and aired on October, 25, 2013, included several quotes from DFAA Executive Director Margie Seidel to rebut the use of cannabis for treating the devastating seizures experienced by Jordan Lykes who suffers from Dravet Syndrome, a rare form of epilepsy.

In the first quote, Ms. Seidel states that, “Medicine goes through a very rigid process of study and research through the FDA, a revered system throughout the world." Really?

Many of these FDA approved drugs have proven to be harmful or even deadly. For example, in 2009, drug induced deaths, principally from otherwise legal opiates, exceeded deaths from motor vehicle accidents for the first time since such tracking began. There were 1,373 such deaths in Ohio in 2009. Further, the FDA’s own Adverse Event Reporting System for prescription drugs reveals an epidemic of serious patient outcomes, reporting over 500,000 deaths and 3 million “serious outcomes,” with such outcomes up by 90 percent in just the last five years. By “serious,” the FDA means that one or more of the following were documented: “death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.” Over 200 medicines contain the FDA’s strongest “black box” warning, and a record number of drugs have been recalled from the market.

To add insult to injury, the “very rigid process of study and research” conducted through this “revered system,” is exorbitantly expensive. In its 2012 exposé on drug development, Forbes Magazine estimated the cost of bringing one pharmaceutical drug to market at an average of $4-11 billion, over a time frame of about 12 years. According to Forbes, fewer than 1 in 10 medicines that begin testing in human clinical trials succeed in becoming marketable medicines. The magazine concluded, “The high cost of developing drugs shouldn’t be a badge of honor for drug firms; there’s no reason it has to be this expensive … Just because something was expensive doesn’t make it good.”

Despite this deadly and expensive system, Ms. Seidel goes on to insist the “DFAA's position is that medical marijuana should meet the same standards as other medicines rather than being pushed as a voter initiative.”

She emphasized that, "I've never voted on an antibiotic, or an antihistamine, nor am I qualified to do that. I want to know what research says so (when it's taken) it's the same dose every time. You know the side effects, how it reacts with other medicines, foods. You want the fidelity of it safe and accurate, not just today but in the long term,"

But how can knowledge about potential drugs or an understanding their “fidelity” be achieved when the approval of new drugs is on the decline? Is it possible that the pharmaceutical industry’s profitability has been pinched by safety, accuracy and cost concerns? For these reasons, has it purposefully put the brakes on drug development over the last decade?

In 2010, the FDA reported that 21 new molecular entities (NMEs) had received approval, which was slightly lower than the ten-year average of 23. The agency principally blamed this decline on a significant drop in the number of applications filed by the industry. In 1996, there were 45 applications for FDA drug approval. The 21 in 2010 represented the lowest number in 15 years.

However, Ms. Seidel may be right about cannabis. Few of the studies presently underway will meet that clinical trial threshold for FDA approval. Of the 85 clinical trials for “cannab” listed at ClinicalTrials.gov, only 35 are actively recruiting, only four are in Phase 3 (fairly close to market) and only two concern the alleviation of suffering (ALS and multiple sclerosis). The other two focus on cannabis dependence.

This dearth of clinical trials does not result from a lack of trying. The FDA will approve cannabis studies, but research continues to be hampered by the plant’s presence in the most restrictive Schedule I of the Controlled Substances Act. These restrictions make cannabis the only substance to require study approval from four governmental agencies: not just the FDA, but also the DEA (researcher must hold a DEA license), the National Institute on Drug Abuse (as a source of supply) and the Department of Health and Human Services (which can reject an application even though the study design has been approved by the FDA). Such has been the case with a trial proposed by the Multidisciplinary Association of Psychedelic Research (MAPS) to evaluate the use of marijuana in the treatment of PTSD. This clinical study has been delayed for years.

As Channel 5 reported, the famed Dr. Sanjay Gupta recently changed his position on the use of cannabis in medicine after he personally observed the plant’s positive effects on Dravet Syndrome seizure victims like 4 year-old Charlotte Figi or 18 year-old Jordan Lyles. As he noted, “Those studies [for which Ms. Seidel advocates] are hard to do and that is part of the problem." Noting that cannabis is one of the safest medicines ever used over the course of human history, never having been associated with one overdose death, Dr. Gupta acknowledged, "You start to realize this is a medication, one that can work when other drugs don't work. And it can be a lot safer for children who have this intractable epilepsy."

Which brings us back to the Ohio Cannabis Rights Amendment. The “revered system” of drug development in the United States touted by Ms. Seidel has turned deadly, costly and time consuming. Perhaps the pharmaceutical industry is realizing this as reflected through its growing aversion to FDA approval. “Safe and accurate” research into the medicinal qualities of cannabis has been thrown out the window by an institutional bias against conducting studies, despite the plant’s long standing, extraordinary safety profile. Within this tangled web, what is the quickest and least expensive way by which cannabis-based medicines can be made available to patients such as Charlotte, Jordan and millions of others? The answer? A constitutional amendment – voter initiative – for it will cost as little as $5 million (compared to $12 billion) and take only one year (compared to 12 years). With all of these factors combined, which is the best course? Which medication would you prefer? Which would you give your child?


Update. Cheryl Shuman has given 1,000 percent to the Ohio Rights Group’s campaign to pass the Ohio Cannabis Rights Amendment, and for that we are so very grateful. We were very distressed to learn that Cheryl collapsed while at the Drug Policy Alliance Conference in Denver and remains in the hospital as of this writing. We view Cheryl as one of our own. A sister and friend to our cause. We love and support her in every way. Our hearts and souls go out to Cheryl and her family at this time of need. May the love we and the world have for you, Cheryl, restore you to complete health. We want to again welcome you home.