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Cancer Drug Derived From Marijuana To Be Sold Soon

April 4, 1986

WASHINGTON (AP) _ An anti-nausea drug derived from marijuana is about to be approved by the Drug Enforcement Administration for use by cancer patients undergoing chemotherapy and will appear in pharmacies in about a month.

The DEA said Thursday it will reclassify the drug Marinol, a capsule form of THC, marijuana’s active ingredient, from its list of most dangerous narcotics to its list of controlled drugs available by prescription for specific medical purposes.

The action came after the National Organization for Reform of Marijuana Laws withdrew a petition objecting to DEA’s handling of the drug. The petition, which already has blocked DEA action for months, would have required lengthy hearings on the reclassification.

NORML, which wants marijuana legalized, said it dropped the petition after the DEA promised in writing to let an administrative law judge decide the broader question of whether marijuana itself should be reclassified to allow medical uses.

As a Schedule I drug, tetrahydrocannabinol, or THC, cannot be sold for any purpose, even though the Food and Drug Administration ruled last June that Marinol was safe and effective in controlling the nausea and vomiting that accompanies chemotherapy.

NORML said the DEA’s decision marks the first time the drug agency has reclassified a Schedule I drug to allow medical uses. The group said the action ″has important implications for the future medical use of other prohibited but potentially beneficial substances like marijuana, heroin, MDMA and LSD.″

Unimed Inc., the Somerville, N.J., pharmaceutical company that produces Marinol, said production and distribution will be tightly controlled. Roxane Laboratories Inc. of Columbus, Ohio, an established firm in the field of narcotic pain relievers, will handle distribution, Unimed said.

Paul V. Bollenbacher, Unimed president and chief executive, said Marinol will first be marketed in about 30 days in ″selected urban areas.″

Despite both FDA and DEA approval, the future of Marinol is considered questionable by some industry observers.

The trade journal American Pharmacy, in an analysis of Marinol’s problems, said the decade-long battle over legalizing the substance may have taken its toll on the drug’s usefulness in chemotherapy. New drugs have appeared that are just as effective in treating nausea, but do not carry THC’s mind-altering effects, the magazine said.

While young people who have used marijuana have no problem with those mood- altering effects, the magazine said, researchers have found that elderly patients often are frightened and disconcerted by them, and may be better treated with the newer drugs.

The DEA reclassification will end a seemingly contradictory fight between NORML and Unimed, both of which want THC marketed for chemotherapy patients.

But NORML has accused Unimed of getting a ″government-enforced monopoly over the manufacture of THC for medical purposes.″ And Unimed’s president has called NORML ″an opportunistic special interest group″ abusing the regulatory system to advance its own agenda.

The unexpected delays in reclassifying Marinol caused Unimed to declare a quarterly loss at year’s end, Bollenbacher said, and another loss was expected in the following quarter because of the delays.

Kevin Zeese, NORML national director, said NORML stopped DEA action because it objected to the agency considering a brand-name drug, rather than THC itself, and to special restrictions the agency wanted to put on Marinol that would not apply to other Schedule II drugs.

He said the organization also was protesting DEA’s failure to comply with a court order requiring hearings on the classification of marijuana itself.

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