Summersgill testifies in favor of Marinol reclassification
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Summersgill testifies in favor of Marinol reclassification

Testimony on Bill 13-639,
the Uniform Controlled Substances Amendment Act of 2000

Committee on the Judiciary
D.C. Council

May 10, 2000

Chairman Brazil, Members of the Committee, and Fellow Citizens:

My name is Bob Summersgill. I am President of the Gay & Lesbian Activists Alliance of Washington, DC (GLAA), the nation's oldest continuously active gay and lesbian rights organization.

We welcome this hearing as a valuable opportunity to brief the Committee on the Judiciary on the importance of reclassifying the drug Marinol-generically known as dronabinol-from schedule II to schedule III.

Marinol is an artificial form of THC, the active chemical in marijuana. The FDA has approved Marinol for treatment of nausea in cancer chemotherapy patients and anorexia associated with weight loss in patients with AIDS.

In July 1999, the federal Drug Enforcement Administration reclassified Marinol from Schedule II to Schedule III of the Controlled Substances Act. Schedule III is the typical schedule for prescription drugs.

The DEA action does not affect DC law. In order to assist doctors and patients in treating debilitating nausea, the DC Code needs to be updated to move Marinol from 33-516 (4)(G) to 33-518(a)(4). 27 States have already taken this action. All other states are expected to make this change as well.

Rescheduling of a drug from Schedule II to Schedule III relieves patients, physicians and pharmacists from several imposed restrictions. Once DC reschedules Marinol to be consistent with Federal guidelines, it should be easier for patients to receive this medication. It can mean less paperwork for physicians to prescribe Marinol, more convenience for patients to have their prescription phoned-in, and one prescription can be refilled for up to five months. Currently, no refills are allowed, requiring a new doctor visit, each month, for a new prescription. After rescheduling, the storage requirements for Marinol will allow pharmacies to store the product with their general pharmaceutical inventory. A separate vaulted storage location will no longer be required.

At the request of the manufacturer, DEA and FDA reviewed the abuse potential for Marinol. Based on this review these agencies determined that the low level of circulating THC, the slow onset of action, and the extremely low incidence of withdrawal symptoms all demonstrate that the abuse of Marinol, if it occurs, may lead to low physical dependence and low psychological dependence on the drug. Thus, the drug should be rescheduled from Schedule II to Schedule III.

The DEA found, consistent with the tests for schedule III in DC Code 33-517, that:

(1) Marinol has a potential for abuse less than the substances listed in Schedules I and II;

(2) Marinol is an FDA-approved drug and has currently accepted medical use in treatment in the United States and the District of Columbia; and

(3) The abuse of Marinol may lead to moderate or low physical dependence or high psychological dependence.

Bill 13-639, as introduced, requires an amendment. Section 2 of the bill amends DC Code 33-516(1)(G) by striking the paragraph. While we originally thought that paragraph described Marinol it describes chemically different compounds. Jim Abley, of Chairman Brazil's staff, accurately identified 33-516(4)(G) "Dronabianol" as a misspelling of dronabinol. This paragraph should be deleted instead.

The amendment is needed because of Department of Health Director Ivan Walks' failure to respond to Chairman Brazil's letters of February 14 and March 9 which asked for simple information on dronabinol.

GLAA was able to confirm the misspelling with a search of Medline, an online database of peer-reviewed medical research since 1966. We found 3,529 references to Marinol, 3,532 to dronabinol but no references at all to dronabianol. If dronabianol is a drug, there no medical research on it, or mention in the federal drug schedules.

An amendment that is not needed or advisable is the suggested requirement that dronabinol only be on schedule 3 when suspended in sesame seed oil. The concern is that dronabinol might be extracted if not for the sesame seed oil. The difficulty involved in extracting the medicine, compared to the ease of cultivation or purchase of marijuana makes this point moot. Marinol is currently only available suspended in sesame seed oil in capsule form. However, swallowing a capsule is an ineffective delivery system for an anti-nausea medication. Suppository and inhaler forms are currently under development by Marinol's manufacturer. These formats would be significantly compromised by the sesame seed oil requirement, and would result in a new round of legislation to undo that amendment.

As amended, Bill 13-639 will be a significant help for people who are too sick to overcome bureaucracy and other obstacles to obtaining life-preserving medication. We encourage you to pass this bill.

Thank you, I am available to answer any questions that you may have.

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