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CLINTON SAYS `NO' TO PATIENTS PDF Print E-mail
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Grey Literature - DPF: Drug Policy Letter fall 1994
Written by Dave Fratello   
Tuesday, 06 September 1994 00:00

NEWS BRIEFS

If you're one of the tens of thousands of Americans with chronic afflictions who could benefit by using marijuana as a medicine, keep in touch with your local dealer. You won't be getting the drug from Uncle Sam any time soon.

On July 18, the Clinton administration announced that it would not make marijuana available to patients under a special exception to the law. The "compassionate investigational new drug" program provided marijuana to a
handful of patients on an experimental basis from 1976 to 1992, when the Bush administration closed the program. In its decision this summer, the Clinton administration refused to re-open the compassionate IND program, claiming that marijuana has not been proved to be a safe and effective medication for any ailment.

The announcement came in a low-key fashion, in the form of a letter to several members of Congress. Each had signed a letter to the Public Health Service asking about the status of its review of the medical marijuana issue. Dr. Philip Lee, the Assistant Secretary for Health and chief of the PHS, wrote, "[MT] e have carefully evaluated the current state of knowledge about therapeutic marijuana. This evaluation indicates that sound scientific studies ... are lacking despite anecdotal claims that smoked marijuana is beneficial.... [Also,] it is clear that the single-patient IND process is not the type of clinical trial that would produce useful scientific information.... [I]t would not be adequate for demonstrating safety and efficacy for the FDA approval process."

Lee went on to specifically advocate the use of dronabinol, the synthetic THC capsule, for the nausea suffered by cancer and AIDS patients. Dronabinol, sold under the trade name Marinol, was developed for drug abuse research on rats, then given to a private pharmaceutical company in the early 1980s as pressure built for allowing smoked marijuana in medicine.

National media played the story of Lee's decision under headlines such as MARIJUANA BAN UPHELD, thereby missing its illogic and insensitivity. Since the whole point of the compassionate IND program was to make marijuana available on an experimental basis until such time as it was approved for general use in medicine, refusing to reopen the program because marijuana has not yet been approved made no sense.

The PHS decision does hint at a political reality behind the issue, however. No one ever said that distributing marijuana as a legal medicine would be easy, and the Clinton administration seems to have chosen to avoid the task. But the issue is resolvable, if only the administration would develop the political courage and sense to do it.

Of the 15 patients who were eligible for the compassionate IND program before 1992, eight are still alive and receiving the drug. And while the program was viewed by some as a half-measure more suited to public relations than to serving patients, the compassionate IND program did offer hope to those in need, and relief to the few who were served.

There was a silver lining in Dr. Lee's letter. Lee said that his agency would work with private groups who wished to fund further research on marijuana's medical benefits. The Drug Policy Foundation hopes to use its new grant program to design and fund research that will meet the criteria set tfp by the government.

Perhaps through such an arrangement, the public's demand for marijuana to be medically available will one day be met.

 

Our valuable member Dave Fratello has been with us since Wednesday, 22 February 2012.

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