Monday, September 14, 2009

FDA Approval of Medical Marijuana Impossible and Unnecessary

Critics say they would support medical marijuana if only it obtained Food and Drug Administration (FDA) approval. This sounds good, but it is really an impossible and unnecessary precondition.

It takes many millions of dollars to get a drug through the current FDA approval process. Pharmaceutical companies spend this kind of money with the expectation that they will be able to patent new drugs and charge exorbitant prices for them. But no one can patent marijuana—it grows wild, and is cultivated, in all 50 states. No company can expect to recoup its expenses after conducting the type of trials of marijuana that the FDA currently considers standard for newly developed drugs. Nor should this be necessary. Marijuana is not a newly developed drug. Marijuana has been used medicinally for thousands of years and was included in the U.S. Pharmacopoeia until the 1940's.

Even if some non-profit medical center or university was inclined to spend the hundreds of millions of dollars to obtain FDA approval, the Drug Enforcement Agency (DEA) has been obstructing, and continues to obstruct, scientific research in this area. The University of Massachusetts at Amherst is currently suing the DEA to allow it to grow its own marijuana to conduct clinical trials. The DEA refuses to allow anyone but itself to legally grow marijuana even for research or compassionate use programs. With very few exceptions, independent clinical trials of marijuana's medical benefits simply cannot get done here in America.

Look at New Jersey. In 1981, the New Jersey legislature unanimously passed into law the “Dangerous Substances Therapeutic Research Act.” This law was designed to protect New Jersey patients who were engaged in clinical trials of marijuana. In 28 years not a single New Jersey resident has been able to take part in a clinical trial of medical marijuana here. The National Academy of Sciences' 1999 Institute of Medicine report, which recommended immediate access to clinical trials of marijuana, called the DEA's death grip on marijuana “a daunting thicket of regulations to be negotiated at the federal level.”

There is only one federal study currently being done--one--and it has been closed to new applicants since 1992. There are fewer than a half dozen patients still involved in this Investigational New Drug (IND) study. Every month, the federal government sends these patients 300 marijuana cigarettes. They have been doing so for over 20 years. In all that time the federal government has never once asked these patients how they are doing. It fell to a private organization, Patients Out of Time, to gather these patients together and study them. Patients Out of Time found that none of the IND patients suffered any adverse effects from marijuana, their conditions were all under control, and marijuana was the only therapeutic agent they were using. The federal government simply does not want to know how effective marijuana is—reality would clash too greatly with its preconceived notions that marijuana has no recognized medical uses and is unsafe for use even under medical supervision.

It was a political decision to ban marijuana, not a medical or scientific one. Previous scientific studies have been routinely ignored. The Schafer Commission studied the issue for two years. In 1972, they reported, “Marijuana has important therapeutic qualities which should be aggressively explored.” Nothing came of this.

Also in 1972, some groups petitioned the federal government to reschedule marijuana to make it available for doctors to prescribe. The government refused to hold hearings for 14 years. Finally in 1986, after three court orders, hearings were held which lasted two years. The DEA testified why marijuana should remain unavailable. Doctors, nurses, patients and researchers testified that marijuana should be available. The decision was given by the US Department of Justice, DEA Administrative Law Judge Francis L. Young on September 6, 1988. He said:
“The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasoning, arbitrary and capricious for DEA to continue to stand between these sufferers and this substance in light of the evidence in this record...Marijuana, in its natural form, is one of the safest therapeutically active substances known to man.”

Marijuana should have been approved nationwide for medical use then and there. Unfortunately, the Administrator of the DEA overturned the judge's decision, acting in an arbitrary, capricious and unreasoning manner.

The whole point of any “compassionate use program” is to allow innovative therapies for seriously ill patients prior to FDA approval. This is why we must pass into law the “New Jersey Compassionate Use Medical Marijuana Act.” Patients in New Jersey have a right to the best possible care available, and there is ample evidence of marijuana's safety and efficacy. FDA approval of this program is both impossible and unnecessary.

Ken Wolski, RN, MPA
Executive Director
Coalition for Medical Marijuana—New Jersey
844 Spruce St.
Trenton, NJ 08648-4530

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