Medical marijuana regulation in the United States: past, present, and future

Psychotropic drugs are dangerous and should be under lock and key.  At least, this is what many believe [1].  Of course, applying that logic, all Starbucks would have to be shutdown because coffee contains caffeine, a psychotropic drug.  Prejudice thwarts the uninformed from understanding the benefits of many drugs.

Marijuana is one of those drugs, used for thousands of years by those ailing from various diseases.  But, this drug has been banned for over forty years with the passage of the Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970.  Marijuana is classified as a Schedule I compound, which bans the use, sale, and possession except for approved scientific studies.  Unfortunately, this classification limits the use of the plant, tying the hands of those working in the health care industry from prescribing it, or to those suffering from diseases from using it.  It is contrary to the growing recognition of the benefits of the drug,

What is Marijuana?

Marijuana is a simple preparation of dried flowers and leaves of plants of the Cannabis genusCannabis sativa or indica.  It is composed of over 400 chemicals and over 60 cannaboids.  The naturally occurring cannabinoid component of cannabis is Δ9-tetrahydrocannabinol (THC).  Recognizing the utility of the drug, the U.S. pharmaceutical industries developed a synthetic versions, such as dronabinol (Marinol), nabilone (Cesamet), and WIN55,212-2 (Canasol).  All of these pharmaceutical agents were clinically studied, approved, and cleared for marketing by the Food and Drug administration (FDA).

Past [2]

Marijuana was first introduced to the Americas in 1611 when Jamestown settlers brought hemp plants to Virginia to produce hemp [3].  Hemp was primarily used to produce rope, sails and clothing [4].  Cultivation of marijuana was an important industry until after the U.S. Civil War due to changes in technology [3].  Cannabis was listed in the United States Pharmacopeia in 1850 and was used for a variety of ailments such as neuralgia, gout, rheumatism, tetanus, seizures and uterine bleeding [3].

The early 20th century brought in societal reform to reduce recreational use and abuse of many uncontrolled substances.  In 1906, the Pure Food and Drug law was signed by President Theodore Roosevelt to establish proper labeling and interstate commerce for legal drugs (at that time) like cocaine, heroin, and cannabis [5].  This law assured that drugs sold on the market were properly labeled with accurate contents and dosage as advertised.  This information led to monitoring of the products’ purity and dose, as well as providing consumer education on proper use.

In 1917, the Harrison Act passed and required a prescription for narcotic drugs [5]. The Eighteenth Amendment and the Volstead Act established prohibition of alcohol in the United States.  The 1938 Food, Drug, and Cosmetic Act mandated a prescription for all habit forming drugs such as narcotics and barbiturates [5].

In the 1920’s, recreational use of marijuana increased, and there were many concerns over the violence that was associated with marijuana.  In order to further control these problems, the Marijuana Tax Act was passed.  This Act discouraged the use of marijuana by taxes associated with the sale and distribution of the drug.  While it did not specifically ban marijuana for medical use, the bureaucracy and taxes subsequently killed marijuana as a medical treatment option [7].  Research of the drug within the medical community was dampened by the Tax Act.

In 1965, noted psychologist Timothy Leary was caught crossing the U.S. border with several marijuana cigarettes and small amounts of semi-refined marijuana [10].  He was arraigned and during his case Leary v. United States,  Leary argued successfully that the Marijuana Tax Act violated the Fifth Amendment of the Constitution, that a person has the right to refuse to answer questions that are self-incriminating.  Mr. Leary’s conviction was reversed, and the Act was found unconstitutional. 

Unfortunately, Leary v. United States, and the growing countercultural revolution of the 1960’s, led the Congress to pass the Controlled Substance Act (CSA) of 1970 [8], and the subsequent complete ban of marijuana even for medical use.  The CSA organizes substances into five categories or Schedules based on use and abuse potential.  Under the CSA, marijuana is a Schedule I drug, similar to heroin and LSD. Drugs in this class are declared  to have a "high potential for abuse"; "no currently accepted medical use in treatment in the United States"; and "lack of accepted safety for use of the drug or other substance under medical supervision."  During its initial classification between either Schedule I or II, Dr. Roger O. Egeberg recommended that it be classified as Schedule I until the National Commission on Marihuana and Drug Abuse complete its study and recommendations.  Despite recommendations by the Commission to decriminalize marijuana, it has remained a Schedule I drug since for mainly political reasons.

To fight this classification, a petition was submitted by the National Organization for the Reform of Marijuana Laws (NORML) in 1972 [7] to the Bureau of Narcotics and Dangerous Drugs (now the Drug Enforcement Administration, DEA) to reclassify marijuana to Schedule II from Schedule I.  This change would have made it legal for physicians to prescribe it as a medical resource.

In 1988, the DEA’s Chief Administrative Law Judge, Judge Francis L. Young ruled that marijuana was a safe therapeutic agent and the CSA require and permit the transfer of marijuana from a Schedule I to a Schedule II drug.  He argued that “it would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of the substance” [12].  The DEA rejected Judge Young’s ruling. 

In 1994, the Court of Appeals for the District of Columbia Circuit upheld the DEA’s categorization of marijuana as a Schedule I drug [13].  From 1972 to 1999, NORML has made five unsuccessful attempts to reclassify marijuana from a Schedule I to a Schedule II drug.

Moreover, the FDA was forced to recognize the need for medical marijuana when a patient, Robert Randall, suffering from glaucoma was arrested for possession of marijuana [8].  Arguing that it was a medical necessity, he successfully sued the federal government and won the right to possess medical marijuana.  Mr. Randall was also set up on the recommendation by the National Commission to have delivered to him a medical marijuana delivery by the Compassionate Investigational New Drug (CIND) program, which allowed participating physicians to prescribe medical marijuana.  This enabled Mr. Randall and his fellow sufferers to receive a canister monthly of medical marijuana grown by the University of Mississippi.  At its height, the program had approximately 30 patients.  However, even with the AIDS epidemic, President H.W. Bush decided to put the program on hold and not allow any new patients from participation.  The program continues to deliver medical marijuana to the 5 remaining patients enrolled.

The passage of CSA made an impact on the states.  By 1982, thirty-two states decided to work on laws to allow medical marijuana by prescriptions. Legal measures involved developing state marijuana therapeutic research programs (TRPs), putting renewed efforts to rescheduling marijuana from a schedule I to a Schedule II drug, and other state measures such as allowing physician to prescribe medical marijuana.  But, these measures did not negate the CSA and the illegal nature of marijuana.  In fact, since it's passage, the CSA has been amended several times to strengthen the government’s authority to regulate this controlled substance [5\.

In 1997, a panel of experts from the National Institutes of Medicine (NIH) concluded marijuana is effective in certain ailments, such as HIV/AIDS, cancer, pain, and glaucoma, and that more research was needed.  However, when researchers made proposals to study medical marijuana, federal bureaucracy blocked these efforts [19].

Because of the difficulties in treating those ailing without great medical options, many states have pursued legislation that would attempt to decriminalize marijuana for medicinal purposes.  In 1996, California and Arizona which spear headed legislation with a popular vote to have marijuana regulated by the state and to have it available for medicinal purposes.  California passed Proposition 215 or Compassionate Use Act [9].  The passage of this Act caused the federal authorities to to issue warnings to patients and physicians found to violate the federal CSA; violators would still be subject to fines and or incarcerations as per federal rules.

In 2001, the Supreme Court heard the case U.S. v. Oakland Cannabis Buyers’ Cooperative (OCBC).  OCBC argued that medical necessity allowed the OCBC to dispense marijuana.  However, the court decided against the OCBC.  Writing for the majority, Justice Thomas stated that Congress has the power to define federal crimes.  When it passed the CSA, Congress made a judgment that marijuana had no medical use.  Justice Stevens concurred reluctantly.  He noted that OCBC involved the distribution of the drug.  If the case involved a patient, then a medical necessity exception may be valid.

In 2005, the argument of state law vs. federal law came to a head with Gonzales v. Raich [16].  Raich was a woman who suffered from pain and spasms of the back and legs, and wasting syndrome, due to a car accident.  On the recommendation from her physician, she grew a half a dozen marijuana plants for self-treatment.  Ms. Raich and her physician argued that there were no other medical alternatives.  However, the Supreme Court sided with the CSA and stated that the Federal laws have a higher preference over state laws even if it involves the quality of the persons' life [16, 17].  This opinion was not unanimous.  Justice O'Connor stated home cultivation was legal as long as it for personal medical use and if it followed state law.  She stated that this personal use did not involve commercial intentions, and therefore should be allowable [18].  Justice Kennedy felt that the intent of the CSA was not to regulate the practice of medicine [16].

Present

In spite of its classification as Schedule I drug, studies into marijuana have resulted in several drugs that are available for prescription today.  In 1985, two agents were approved by the FDA, Marinol (dronabinol) for suffering from cachexia (aka wasting syndrome) in cancer and AIDS patients, and Cesamet (nabilone) for nausea and vomiting associated with chemotherapy for cancers [14].  Recently, Marinol was approved for the nausea and vomiting associated with chemotherapy indication as well.  Currently studies are underway for Canasol (WIN 55,212-2) for treatment of pain related to glaucoma [15].  However, even with these agents available, many patients do not find them as effective as marijuana, have more side-effects, and are more costly [7].  Marijuana is effective because it is titratable, and has other agents that appear to work in synergy.

Future

The medial marijuana controversy points out an important public health issue: the rights of the patient balanced against federal laws to control substance abuse.  The present state of medical marijuana is political football, controlled mostly by Congress and the Department of Justice.  The medical community has recognized the utility of marijuana in the treatment of several diseases, but our government is slow to change.  This controversy is at the heart of the public health issues and illustrates the unevenness of politics and science.  Unless marijuana is reclassified, the future for medical marijuana is uncertain.

Even though arguments such as increased organized crime, and increased under age use are valid, the need for those ailing is too great to ignore this matter.  Although this subject stirs strong emotions within political parties, cooler heads need to prevail in tackling this matter so that those that need medical marijuana can have an alternative therapy that works for them.  

References

1.   http://www.tennessean.com/article/20110822/COLUMNIST0150/308220002/Movement-legalized-marijuana-ignores-dangers

2.   http://www.pbs.org/wgbh/pages/frontline/shows/dope/etc/cron.html

3.   Pacula RL, Chriqui JF, Reichmann DA, Terry-McElrath YM. State medical marijuana laws: Understanding the laws and their limitations. Journal of Public Health Policy. 2002;23(4):413-439.

4.   Marijuana Timeline. Frontline. August 18, 2011.

5.   Kandra LR. Questioning the Foundation of Attorney General Ashcroft’s, Attempt to Invalidate Oregon’s Death with Dignity Act Oregon Law Review. 2002; Volume 81, Number 2(Summer 2002):1-41.

6.   Musto DF. Opium, cocaine and marijuana in American history. Scientific American. 1991;265(1):40-47.

7.   Newitt DS. Medical use of Marijuana: State Legislation, Judicial Interpretation and Federal Drug Laws, The. J. Legal Advoc. & Prac. 2002;4:156.

8.   LeVay AJ. Urgent Compassion: Medical Marijuana, Prosecutorial Discretion and the Medical Necessity Defense. BCL Rev. 1999;41:699.

9.   Bergstrom AL. Medical Use of Marijuana: A Look at Federal & State Responses to California's Compassionate Use Act. DePaul J. Health Care L. 1997;2:155.

10.  LEARY v. UNITED STATES. May 19, 1969.

11.  Cordaro J. Who Defers to Whom–The Attorney General Targets Oregon's Death with Dignity Act. Fordham L. Rev. 2001;70:2477.

12.  Young F. Opinion and recommended ruling, marijuana rescheduling petition. Department of Justice, Drug Enforcement Administration. Docket. 1988:86-22.

13.  Alliance for Cannabis Therapeutics v. DEA, 15 1131(Court of Appeals, Dist. of Columbia Circuit 1994).

14.  Label and Approval History.

15.  WIN 55212-2 (mesylate). August 21, 2011.

16.  Bryant CA. Third Death of Federalism, The. Cornell JL & Pub. Pol'y. 2007;17:101.

17.  Carcieri MD. Gonzales v. Raich: Congressional Tyranny and Irrelevance in the War on Drugs. U. Pa. J. Const. L. 2006;9:1131.

18.  Pushaw Jr RJ. Medical Marijuana Case: A Commerce Clause Counter-Revolution, The. Lewis & Clark L. Rev. 2005;9:879.

19.  http://www.ndsn.org/marapr97/mmpanel.html

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