This is a final order of the Administrator of the Drug Enforcement Administration denying the petition of the National Organization for Reform of Marijuana Laws to reschedule the plant mate-rial marijuana from Schedule I to Schedule II of the Controlled Substances Act....

The two issues involved in a determination of whether marijuana should be rescheduled from Schedule I to Schedule II are whether marijuana plant material has a currently accepted medical use in treatment in the United States, or a cur-rently accepted medical use with severe restrictions; and whether there is a lack of accepted safety for use of marijuana plant material under medical su-pervision. After a thorough review of the record in this matter, the Administrator rejects the recom-mendation of the administrative law judge to re-schedule marijuana into Schedule II and finds that the evidence in the record mandates a finding that the marijuana plant material remain in Schedule I of the Controlled Substances Act.

The pro-marijuana parties advocate the placement of marijuana plant material into Schedule II for medical use in the treatment of a wide variety of ailments, including nausea and vomiting associated with chemotherapy, glaucoma, spasticity in amputees and those with multiple sclerosis, epilepsy, poor appetite, addiction to drugs and alcohol, pain, and asthma. The evidence presented by the pro-marijuana parties includes outdated and limited scientific studies; chronicles of individuals, their families and friends who have used marijuana; opinions from over a dozen psychiatrists and phy-sicians; court opinions involving medical necessity as a defense to criminal charges for illegal pos-session of marijuana; state statutes which made marijuana available for research; newspaper articles; and the opinions of laypersons, including lawyers and associations of lawyers. The Administrator does not find such evidence convincing in light of the lack of reliable, credible, and relevant scientific studies documenting marijuana's medical utility; the opinions of highly respected, credentialed experts that marijuana does not have an accepted medical use; and statements from the American Medical Association the American Cancer Society, the American Academy of Ophthalmology, the Na-tional Multiple Sclerosis Society, and the Federal Food and Drug Administration that marijuana has not been demonstrated as suitable for use as a medicine.

The record contains many research studies which have been published in scientific journals and many unpublished studies conducted by individual states....

...Both the published and unpublished research studies submitted by the pro-marijuana parties in this proceeding to support marijuana's medical use suffer from many deficiencies. They are, in essence, preliminary studies. None of these studies has risen to the level of demonstrating that marijuana has an accepted medical use for treatment of any medical condition....

Nausea and Vomiting

Five studies were presented by the pro-mari-juana parties to support the medical use of mari-juana as an antiemetic....

The research studies presented by the pro-marijuana parties in this proceeding do not sup-port a conclusion that marijuana has a therapeutic use for treatment of nausea and vomiting associated with chemotherapy.

The pro-marijuana parties presented many tes-timonials from cancer patients, their families, and friends about the use of marijuana to alleviate nausea and vomiting associated with chemotherapy. These stories of individuals who treat themselves with a mind-altering drug, such as marijuana, must be viewed with great skepticism. There is no scien- tific merit to any of these accounts.... The accounts of these individuals' suffering and illnesses are very moving and tragic; they are not, however, reliable scientific evidence, nor do they provide a basis to conclude that marijuana has an accepted medical use as an antiemetic.

There were many physicians and other medical experts who testified in this proceeding. In review-ing the weight to be given to an expert's opinion, the facts relied upon to reach that opinion and the credentials and experience of the expert must be carefully examined. The experts presented by the pro-marijuana parties were unable to provide a strong scientific or factual basis to support their opinions. In addition, many of the experts pre-sented by the pro-marijuana parties did not have any expertise in the area of research in the specific medical area being addressed. The pro-marijuana parties presented the testimony of five psychiatrists to support the use of marijuana as an an antiemetic. None of these invividuals is an oncologist, nor have they treated cancer patients. Three of the psychia-trists, Drs. Grinspoon, Ungerlieder and Zinberg are current or former board members of NORML or ACT....

Two pharmacologists, Drs. Morgan and Jobes, presented testimony on behalf of the pro-marijuana parties. Dr. Morgan is a professor at the City Col-lege of New York. He does not treat patients, nor is he an oncologist. His opinions are based upon a review of scientific studies and stories told to hisn by others. He has ties to NORML and is in favor of legalizing marijuana. Dr. Jobe is a pharmacologist and psychiatrist. He testified that his knowledge of marijuana's effects as a drug are based upon a review of the literature and stories from individu-als undergoing chemotherapy....

Two general practionors, Drs. Weil and Kaufman, also provided testimony on behalf of the pro-marijuana parties, neither are oncologists, nor do they treat cancer patients. Dr. Weil is a wellness counselor at a health spa, and Dr. Kaufman is an officer of a company that audits hospital quality control programs....

Four oncologists presented testimony on behalf of the pro-marijuana parties. They were Drs. Goldberg, Silverberg, Bickers, and Stephens. Dr. Goldberg is a board certified oncologist, but prac-tices primarily internal medicine. She only ad-ministers chemotherapy to one or two patients a year. In her career, she has administered chemo-therapy to no more than 10 patients whom she believed to be using marijuana. On cross-examination, she could not recall any studies regarding marijuana. Dr. Goldberg was a member and finan-cial contributor to NORML. Dr. Silverberg has practiced oncology for 20 years. He is a Professor of Clinical Oncology at the University of California at San Francisco, but is not a board certified oncologist....

...Although Dr. Silverberg has advised patients to use marijuana to control nausea and vomiting associated with chemotherapy, he has never been involved in any research nor has he documented any of his observations. Dr. Bickers is an ocologist in New Orleans and is a Professor of Medicine at the Louisiana University School of Medicine. Although Dr. Bickers claims that young patients have better control over nausea and vomiting after us-ing marijuana, he has never documented this claim. Dr. Stephens, an ocologist professor of Medicine and Director of Clinical Oncology at the Univer-sity of Kansas, characterized marijuana as a "highly effective, and in some cases, critical drug in the reduction of chemotherapeutically-induced emesis." During cross-examination, Dr. Stephens stated that he was unaware of any scientific studies which had been done with marijuana, and that he had never done research or treated patients with marijuana. He indicated that he received his information about the patient's use of marijuana from the nursing staff or the patient's family....

The pro-marijuana parties presented cases in which courts did not convict individuals of a crime associated with possession and use of marijuana based upon a legal defense of "medical necessity." These cases have no relevance to this proceeding which relates to marijuana's possible medical use. The courts found only that these individuals, who were seriously ill and believed that marijuana would help them, did not have criminal intent in possess-ing or using marijuana....

The pro-marijuana parties also presented evi-dence that 34 states passed laws permitting marijuana's use for medical purposes in those states. These laws provided that marijuana should be available for medical research. The term "research" is essential to a reading of these statutes. These laws made marijuana available for research and, in some states, set up research programs to study marijuana's safety and effectiveness as a medicine. These statutes are read for what they are, encouraging research involving marijuana. They are not an endorsement by state legislatures that marijuana has an accepted medical use in treatment.

The numerous testimonials and opinions of lay persons which were presented in this proceeding by the pro-marijuana parties are not useful in determining whether marijuana has a medical use. While experiences of individuals with medical con-ditions who use marijuana may provide a basis for research, they cannot be substituted for reliable scientific evidence. For the many reasons stated in the previous discussion of scientific evidence, these statements can be given little weight. Similarly, endorsements by such organizations as the National Association of Attorneys General, that marijuana has medical use as an antiemetic are of little persuasive value when compared with statements from the American Cancer Society and the American Medical Association.

Glaucoma

The pro-marijuana parties presented several stud-ies to support their contention that marijuana has a medical use for treatment of glaucoma. In order for a drug to be effective in treating glaucoma it must lower the pressure within the eye for prolonged periods of time and actually preserve sight or visual fields. The studies relied upon by the pro-marijuana parties do not sci-entifically support a finding that marijuana has a medici-nal use for treatxnent of glau-coma. Five of the studies pre-sented by the pro-marijuana parties are pure THC studies. As previously noted, THC is only one constituent among hundreds found in marijuana. Therefore, the consequences of an individual ingesting pure THC as compared to smoking marijuana are vastly different. A few of the studies presented do document that heavy doses of marijuana over a short time period reduce eye pressure in most individuals. However, there are no studies which document that marijuana can sustain reduced eye pressure for extended time periods. The acute, or short-term, studies also show various side effects from mari-juana use....

The pro-marijuana parties presented testimonials of individuals who suffer from glaucoma and believe their condition has benefited from the use of marijuana. Most of these individuals used marijuana recreationally prior to discovery of their illness. Chief among the individuals presenting statements was Robert Randall. Mr. Randall is president of ACT, and has been on NORML's Board of Directors since 1976. He has been a strong advocate for medical use of marijuana. Mr. Randall also has glaucoma. Mr. Randall began smoking marijuana as a college student in 1966, long before he was diagnosed in 1972 as having glaucoma. At that time Mr.Randall was treated with standard glaucoma medications. In the mid-1970s Mr. Randall was involved in a preliminary research study conducted by Dr. Robert Hepler. Dr. Hepler conducted some of the first
published short-term marijuana studies relating to glaucoma. Dr. Hepler told Mr. Randall that he believed that marijuana in combination with other standard glaucoma medications would be helpful in reducing his eye pressure. In 1975, Mr. Randall was arrested for growing and possessing marijuana. His defense was medical necessity. Subsequently, he began receiving marijuana under an Investigational New Drug (IND) protocol sponsored by his physician. He also continued to receive standard glaucoma medications. Since 1976, Mr. Randall has been treated by Dr. North. Mr. Randall receives marijuana from the federal government and continues to take standard glaucoma medications. Two physicians who treated Mr. Randall, including Dr. North, tes-tified that Mr. Randall's eye pressure appears to have been controlled and his vision kept stable for the last several years.

Mr. Randall smokes approximately 8-10 mari-juana cigarettes a day. Since Mr. Randall continues to take other glaucoma medication, his controlled eye pressure cannot be attributable solely to mari-juana use. In fact, Dr. North testified that Mr. Randall needs the standard medications as well as marijuana, and that the marijuana itself is not to-tally effective in decreasing Mr. Randall's eye pressure. Mr. Randall's experience with marijuana, although utilized under a physician's directions, is not scientific evidence that marijuana has an ac-cepted medical use in treatment of glaucoma. Dr. Merritt, one of Mr. Randall's physicians, responded to the question of why he did not publish the results of Mr. Randall's treatment by saying, "A single iso-lated incident of one person smoking marijuana is norevidence for other ophthalmologists who may want to use the drug."

...The pro-marijuana parties rely primarily on the opinions of two of Mr. Randall's physicians, Drs. North and Merritt, in supporting their con-tention that marijuana has a medical use in treat-ment of glaucoma. Dr. North indicated that his conclusion that marijuana has a medical use in treatment of glaucoma is based solely on his obser-vations of Mr. Randall. Dr. Merritt is a board-cer-tified opthalmologist and researcher who has authored many articles on the use marijuana and cannabinoids to reduce eye pressure. Dr. Merritt based his opinion that marijuana has a medical use in treatment of glaucoma on published scien-tific studies, treatment of Mr. Randall, and treat-ment of other glaucoma patients. As previously stated all the available studies concern high doses of marijuana taken over short periods of time. Even Dr. Merritt admitted that there are no studies to show that marijuana repeatedly lowers eye pres-sure over long time periods. The maintenance of lowered eye pressure is crucial in treating individu-als with glaucoma....

Spasticity

In support of their contention that marijuana has a medical use in treatment of spasticity in amputees and those with multiple sclerosis, the pro-marijuana parties presented three studies involv-ing THC, testimonials of individuals with spasticity who use marijuana, medical opinions, and state court decisions on the medical necessity defense. The three studies presented by the pro-marijuana parties were very small studies. All three totaled 17 patients, and used THC, not marijuana, to treat spasticity. There are no studies using marijuana to treat spasticity....

With regard to marijuana's safety for use under medical supervision, the administrator must again rely on the scientific evidence. While the pro-mari-juana parties argue that no one has died from marijuana use, and individuals who use it have testified that they have not experienced adverse effects, there is litde or no scientific evidence to support their claims. For example, while Robert Randall claims marijuana smoking has had no adverse effect on his health or respiratory system, he has not had a physical examination or pulmo-nary function in over 10 years.

In order to be effective, a drug's therapeutic benefits must be balanced against and outweigh its negative or adverse effects. This has not been es-tablished with marijuana. As the previously dis-cussed evidence has demonstrated, there is as yet no reliable scientific evidence to support marijuana's therapeutic benefit. It is therefore, impossible to balance the benefit against the negative effects. The negative effects of marijuana use are well-documented in the record. Marijuana smoking, the route of administration advocated by many witnesses presented by the pro-marijuana parties, causes many well-known and scientifically documented side effects. These include decreased blood pressure, rapid heart rate, drowsiness, eu-phoria, disphoria and impairment of motor func-tion, not to mention various negative effects on the respiratory and pulmonary systems. Therefore, the only conclusion is that marijuana is not safe for use under medical supervision, because its safety has not been established by reliable scientific evidence.

In summary, the Administrator finds that there is insufficient and in many instances no, reliable, credible, scientific evidence, supported by prop-erly conducted scientific research, to support a conclusion that marijuana is safe for use under medical supervision. This agency, and the govern-ment as a whole, would be doing the public a disservice by concluding that this complex psychoactive drug with serious adverse effects has a medical use based upon anecdotal and unreliable evidence....

Conclusion

The Administrator finds that the administrative law judge failed to act as an impartial judge in this matter. He appears to have ignored the scientific evidence, ignored the testimony of highly credible and recognized medical experts and, instead, re-lied on the testimony of pyschiatrists and individuals who use marijuana. The administrative law judge relied heavily on anecdotal accounts of marijuana use by both physicians and seriously ill persons. The administrative law judge's findings of fact ig-nored any evidence presented by the government.

For example, in his findings regarding marijuana and nausea and vomiting associated with chemo-therapy, Judge Young cites many of the physicians presented by the pro-marijuana parties by name as accepting marijuana as "medically useful." Not once in his findings or discussion does the judge ac-knowledge or mention the government's experts. Not once does the judge mention why he chose to find the pro-marijuana parties evidence more credible....

The Administrator rejects the administrative law judge's findings and conclusion. They were erro-neous; they were not based upon credible evidence; nor were they based upon evidence in the record as a whole. Therefore, in this case, they carry no weight and do not represent the position of the agency or its Administrator. The inadequacy of Judge Young's analysis of the case is duly noted and so are the irrational statements propounded by the pro-marijuana parties. Such statements in-clude the following: "marijuana is far safer than many of the foods we commonly consume. For example, eating ten raw potatoes can result in a toxic response. By comparison, it is physically im-possible to eat enough marijuana to induce death." That such a statement would come from the pro-ponents of marijuana is understandable. To give it the weight of an administrative law judge's finding is appalling....

As a final note, the administrator expresses his displeasure at the misleading accusations and con-clusions leveled at the Government and communicated to the public by the pro-marijuana parties, specifically NORML and ACT. These two organizations have falsely raised the expectations of many seriously ill persons by claiming that mari-juana has medical usefulness in treating glaucoma, spasticity and other illnesses. Their statements have probably caused many people with serious diseases to experiment with marijuana to the detriment of their own health, without proper medical super-vision, and without knowing about the serious side effects which smoking or ingesting marijuana may cause. These are not the Dark Ages. The Congress, as well as the medical community, has accepted that drugs should not be available to the public unless they are found by scientific studies to be effective and safe. To do otherwise is to jeopardize the American public, and take advantage of des-perately ill people who will try anything to alleviate their suffering. The Administrator strongly urges the American public not to experiment with po-tentially dangerous, mind-altering drugs such as marijuana in an attempt to treat a serious illness or condition.... NORML and ACT have attempted to perpetrate a dangerous and cruel hoax on the American public by claiming marijuana has cur-rently accepted medical uses.

John C. Lawn, Federal Register., Vol. 44, No. 249, p. 53767, (Dec. 29, 1989).