These talking points were compiled in collaboration with the following federal agencies: Office of National Drug Control Policy, Department of Health and Human Services, (Food and Drug Administration (FDA), National Institute of Health, Substance Abuse and Mental Health Services Administration), Department of Justice, and the Department of Education.

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Medicine in the U.S. is based on science.

• This nation has long relied on a science-based review and approval process for medical products. The purpose is to protect patient and promote public health by ensuring that medical products are safe and effective.
• The FDA process requires that adequate scientific studies be performed to provide a rational basis for concluding that the benefits of a medical product outweigh its risks.
• A medical product's chemistry must be known. The product must also be able to be produced in standardized dosage forms, so that its safety and efficacy can be ensured.
• The FDA process also requires that an approved product be accompanied by sufficient information to permit its accurate and appropriate prescription and use.

Smoked Marijuana has not been demonstrated by science to be a safe and effective medicine.

• FDA has neither approved nor received a marketing application for a drug product that contains marijuana.
• It is well documented by research that marijuana is comprised of more than 400 constituent chemicals, some of which can cause cancer and many of which affect brain functioning, including perception, learning, memory, emotions, and motor coordination.
• There is currently little evidence about the effectiveness of smoked marijuana as a medicine.
• The safety and efficacy of specific chemicals in marijuana should be demonstrated by research before use as medicine.

THC can already be prescribed and taken in pill form.

• A synthetic form of a psychoactive component of marijuana, tetrahydrocannabinol (THC), has already been reviewed and approved by FDA.
• This form of THC is available for use in a pill, and is currently being prescribed.
• In addition to THC, there are many other FDA-approved medicines that are safe and effective for the control of nausea and the stimulation of appetite.

The existing scientific literature is being reviewed.

• The existing scientific literature on the uses of marijuana and its components as a medicine is now being reviewed by the Institute of Medicine. A report is due in early 1999.
• NIH, the world's leading supporter of drug research, convened a group of scientists in 1997 that concluded that additional research is needed to clarify whether smoked marijuana can be safe and effective as a medicine for specific purposes, such as for the control of nausea, the stimulation of appetite, and the reduction of ocular pressure in glaucoma.

Additional research is being funded.

• NIH continues to invite researchers to apply for grants to study the possible uses of smoked marijuana and its components as a medicine.
• Such applications must still go through a peer review process, which is a hallmark of NIH that ensures the high quality of NIH-funded research.
• NIDA is now funding a research study on the safety and efficacy of smoked marijuana for medical purposes for individuals with HIV infection and AIDS wasting syndrome.
• Other studies from various sources are under review for funding.

Alternative delivery mechanisms are being explored.

• Because some individuals say that the pill form of THC is inadequate, FDA has encouraged the pharmaceutical industry to develop other techniques for administering THC, for example, by patch, suppository, or inhaler.
• These techniques may make it easier for individuals to realize the therapeutic benefits of THC under controlled and prescribed conditions.

Compassionate medicine must be based on science.

• Truly compassionate medicine must be based on science, and drugs should be monitored and prescribed by physicians and other health professionals.
• Moreover, existing medicines (including THC) can meet the needs of patients covered by the various medical marijuana initiatives.
• Abandoning the science-based FDA process is irresponsible. We must require the demonstration of the safety and efficacy of proposed medicines before they are approved for use. The consequence of shortcutting this established process is prematurely available, inadequately tested medicines that could cause unnecessary harm. That wouldn't be compassionate at all.

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