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Friday, August 12, 2016

"What the _ _ _ _ ?" FDA and DEA Still Consider Marijuana a Schedule 1 Substance



In their seemingly nonsensical way, the DEA and the FDA recently continued to support the classification of marijuana as a Schedule l controlled substance (which keeps intact a 1970 law) – in other words, considering marijuana has "no currently accepted medical use and a high potential for abuse.” This ruling keeps the drug in the same category as heroin and cocaine.

DEA acting administrator Chuck Rosenberg wrote: “... we will remain tethered to science, as we must, and as the statute demands. It certainly would be odd to rely on science when it suits us and ignore it otherwise." What is the “statute” that “demands” this absurdity?

Rosenberg said designating marijuana a Schedule I drug does not necessarily mean it is as dangerous as other drugs.

"It is best not to think of drug scheduling as an escalating 'danger' scale — rather, specific statutory criteria (based on medical and scientific evidence) determine into which schedule a substance is placed," Rosenberg wrote.

The Food and Drug Administration said agency officials reviewed more than 500 studies on the use of medical marijuana, identifying only 11 that met the agency standards for "legitimate testing." For various reasons, none of the trials demonstrated "an accepted medical use," the agency concluded.

The FDA last evaluated marijuana for medical use in 2006 and said in its latest review that the available research "has progressed," but does not meet federal standards of safety or effectiveness

(Alicia A. Caldwell. “US government won't reclassify marijuana, allows research.” WRAL Raleigh, Durham, Fayetteville. August 11, 2016.)

Do not think of marijuana on a “danger scale” but place it in the same category as heroin and cocaine because of “specific statutory criteria”? What in the hell does this mean? Here is the DEA classification of a Schedule 1 substance – “considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and/or physical dependence” ...

Schedule I

Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are:
heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote 
 
My concern is the negative effect of the ruling upon the legitimate uses of medical marijuana, especially in the cases of treatment of pain associated with many serious conditions and the use of cannabidiol for treating children with epilepsy.

For God's sake, oxycodone (OxyContin and the like) is considered a Schedule II controlled substance along with Vicodin, fentanyl, hydromorphone, methadone, morphine, and oxymorphone. How could such substances be considered to have a lower potential for abuse and a higher value for medical use than marijuana? 

No single organization tracks all research studies of medical marijuana and marijuana-based drugs and herbs. But, controlled studies since 1990 found the following:

Alzheimer's Disease: One 1997 trial found that synthetic THC could ease symptoms of Alzheimer's. Patients were less agitated and ate better after treatment.

Autism: Two animal studies show that chemicals in marijuana may help symptoms of some forms of autism. A study of children with autism is underway at the University of California Irvine Medical Center.

Cancer: Several studies on animal and human cells and a small study on 9 people suggested THC and other cannabinoids (chemicals derived from cannabis) might slow the growth of brain cancer. Multiple lab studies in human cells have also shown the potential for them to slow other kinds of cancers, such as breast cancer and leukemia; no studies in people have taken place.

Chronic Pain: More than 45 studies have looked at marijuana and pain related to chronic diseases such as cancer, diabetes, fibromyalgia, multiple sclerosis, HIV, rheumatoid arthritis, and spinal injuries. The studies have included smoked marijuana, along with herbal and man-made forms. The majority of the studies showed an improvement in pain relief in comparison to a placebo or to other traditional pain medications. About a quarter of the studies showed no improvement.

Epilepsy: Personal stories and animal studies have shown that cannabidiol, one of the chemicals in cannabis, may help seizures in children with epilepsy. New York University just announced it will do a study of children with epilepsy and marijuana.

Digestive Disorders: Personal stories and several early studies have shown that smoking marijuana can help people with digestive diseases such as colitis, irritable bowel syndrome, and Crohn’s disease. Some of the results included a reduction in bowel inflammation and reduced acid reflux. Further, some patients were able to retain more nutrients in their bodies, and the disease went into remission.

MS: More than 24 studies have looked at smoked marijuana, cannabinoids, and MS. Most reported that it helped relax patients’ rigid muscles and helped with pain. Sativex is approved to treat MS in 24 countries, but not in the U.S.

Schizophrenia: Two clinical trials showed that THC and cannabidiol could help with psychotic and other symptoms. The National Institutes of Health is funding a small clinical trial that also aims to show whether THC and cannabidiol can ease symptoms.

(Research provided by NORML, the marijuana legalization advocacy group; and data found in PubMed, the National Institutes of Health’s RePORTER; and a database maintained by the International Association for Cannabinoid Medicines, a medical marijuana research organization based in Cologne, Germany.)

(Bara Vada. “Medical Marijuana: What the Research Shows.” Pain Management Health Center. WedMD. 2016.)

Christine Gregoire, the former Democratic governor of Washington state, said, “While I haven’t read it (the ruling), the outcome puts the DEA totally out of touch with the Justice Department, current research, the medical profession, patients and the public.”

(Rob Hotakainen. “DEA says marijuana has no medical value, will remain Schedule 1 drug.” Duluth News Tribune. August 11, 2016.)

Despite two recent petitions asking the agency to reconsider this designation for the benefit of scientific research, the U.S. Food and Drug Administration made this decision based on what they call a “scientific and medical” evaluation.

"The DEA and the FDA continue to believe that scientifically valid and well-controlled clinical trials conducted under investigational new drug (IND) applications are the most appropriate way to conduct research on the medicinal uses of marijuana," said a statement from the DEA.

The agency is taking a step to make the plant more available for research. Now, more universities will be able to grow the plant for research. The DEA said this "will allow additional entities to apply to become registered with DEA so that they may grow and distribute marijuana for FDA-authorized research."

The agency said it has never stood in the way of a researcher conducting an FDA-approved study using marijuana from the NIDA-approved supply of the plant. According to the DEA, as of June, there there were 483 researchers registered with the agency to conduct FDA-approved research with schedule I controlled substances, not just marijuana.

The agency maintains its "commitment to work together with the FDA and NIDA to identify ways of streamlining research on marijuana and its extracts."

At least 25 states and the District of Columbia have approved the use of medical marijuana for conditions ranging from epilepsy to arthritis.

"In reality, marijuana should be descheduled and states should be allowed to set their own policies," said Michael Collins, deputy director of national affairs for the Drug Policy Alliance, which supports marijuana policy reform. Collins said he considered the DEA's decision to be one that puts "politics above science."

I understand “going slow” with marijuana reform. That is why I think Federal agencies should approve medical marijuana legislation before considering recreational use. What I don't understand is the politics that puts the FDA, Big Pharma, political lobbyists, and politicians in cahoots. It's a power game grounded in huge profits, and it has been inconsiderate of real danger for decades. All one has to do is study the history of the prescription drug epidemic in America to see the horrible outcome of failed policies and inept leadership.

Nothing benefits society when Federal agencies mislabel foods and drugs just as nothing benefits society when enforcement branches use their limited resources to pursue petty, even questionable criminal activities in the face of more serious concerns. Politics, indeed … collaborations of the worst kind.

 

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