Tomorrow morning, the United States Court of Appeals in Washington DC will hear oral arguments in the landmark case, Americans for Safe Access v Drug Enforcement Administration. The case argues that the Drug Enforcement Administration acted irrationally in ruling that cannabis belongs in Schedule I of the Controlled Substances Act. The plaintiffs argue that this scheduling of marijuana has harmed them physically and financially. Below are the courageous patients and caregivers who have taken on the federal government in this important case.

William "Bill" Britt is a 52-year-old resident of Long Beach, California, who developed polio as a child, which caused him to have scoliosis, a fused left ankle, shortened left leg, and bone degeneration in his left hip. Mr. Britt also suffers from epilepsy, depression and insomnia, and uses marijuana to treat chronic pain in his leg, back, and hip. Marijuana has reduced Mr. Britt's seizures and depression, and helps him sleep. Although Mr. Britt has taken prescription medication such as Marinol, Robaxin, Soma, and Xanax, none has proven as effective as marijuana. Read Mr. Britt's post about why he is suing for safe access.

Al Byrne is co-founder and Secretary-Treasurer of Patients Out of Time, a national non-profit devoted to educating health care professionals and the general public about the therapeutic uses of marijuana. He works with five of the seven remaining federally supplied Cannabis patients, who are enrolled in the Compassionate Individual New Drug (IND) Program. As the son of a cancer patient who used Cannabis in 1966 to relieve the negative aspects of cancer chemotherapy, he has maintained activism in reforming Cannabis laws since that time. He served on the Board of Directors of the National Organization for the Reform of Marijuana Laws (NORML) from 1989 to 1994 acting as Managing Director of the organization during 1991 and 1992 and as the National Secretary 1992 to 1994. Mr. Byrne is the United States representative of patient advocacy for the European based International Association for Cannabinoid Medicines (IACM). He sits on various Boards of Cannabis orientated organizations. He has moderated a number of debates and confer- ences about Cannabis reforms including the ongoing clinical conference series of Patients Out of Time. He is a consultant to several state representatives actively engaged in writing legislation to reform Cannabis prohibition.

Catherine Jordan is a medical marijuana patient. When she turned 36, she was diagnosed with ALS and given 3-5 years to live. Catherine was told she would choke or drown in her own fluids or suffocate from the total collapse of her lungs and chest muscles. By 1989, the disease had devastated her body. While vacationing in Florida, Cathy tried a strain of cannabis called Myakka Gold. She went back home to Delaware and attempted to explain this to her neurologist, who immediately suggested she be institutionalized because she wasn't handling the bad news of her health well. After assuring him she would never speak of it again, he relented. Now she has seen 30 Neurologist, and been to 4 Universities. Not one doctor has suggested she stop smoking cannabis, though she has been warned that her use of cannabis would prevent her from getting a cure if one is found. In 2004, she met with doctors working on the theory that cannabis would slow the progression of ALS. While meeting with the doctors she realized she was living proof of their research. She soon contacted Gov. Jeb Bush that this issue, who said this was a federal matter that he had no control. So with the cards stacked against her, she committed herself to activism. Currently she is the president of FL CAN.

Michael Krawitz is a 49-year-old resident of Elliston, Virginia, who suffered an automobile accident in 1984 while serving in the United States Air Force. Mr. Krawitz has been rated by the United States Department of Veterans Affairs (VA) as being totally and permanently disabled. Mr. Krawitz uses marijuana to treat chronic pain and trauma associated with his accident. He also uses marijuana to treat central serous retinopathy. However, because of Mr. Krawitz's medical marijuana use, he has been denied pain treatment by the VA. Read Mr. Krawitz's post about why he is suing for safe access.

Mary Lynn Mathre received her BSN from the College of St. Teresa and began her nursing career in the US Navy Nurse Corps serving at Portsmouth Naval Hospital in Virginia and at the Naval Hospital in Roosevelt Roads in Puerto Rico. In 1985 she earned her MSN at Case Western Reserve University and began teaching at the University Of Virginia School Of Nursing. In 1987, she changed her specialty to addictions nursing and returned to clinical practice. She served as the charge nurse of an inpatient addictions treatment program and later as the addictions consultant for the UVA Health System. She then worked as the Executive Director of a private opioid treatment center and now works independently as an addictions consultant. Ms. Mathre's focus on medicinal cannabis began in 1985 with the completion of her graduate thesis, Disclosure of Marijuana Use to Health Care Professionals. Ms.Mathre served as the Director of NORML's Council on Marijuana & Health from 1986 - 1992 and on NORML's Board of Directors from 1988 - 94. Ms. Mathre is also a co-founder and President of Patients Out of Time. Ms. Mathre has written resolutions for several professional organizations in support of patient access to medical marijuana, including those of the Virginia Nurses Society on Addictions, the Virginia Nurses Association, the National Nurses Society on Addictions, and the American Public Health Association.

Steph Sherer is a resident of Washington, D.C. and the founder and Executive Director of Americans for Safe Access (ASA). In April of 2000, Ms. Sherer suffered a physical attack that has caused her to suffer from a condition that produced inflammation, muscle spasms, pain throughout her body, and decreased mobility in her neck. Because of multiple pain medications she was prescribed, Ms. Sherer suffered kidney damage. After her doctor recommended medical marijuana, Ms. Sherer successfully reduced her inflammation, muscle spasms, and pain. This prompted Ms. Sherer to found ASA in April of 2002 to share what she learned about the therapeutic value of marijuana and to change public policy.

Americans for Safe Access is the largest national member-based organization of patients, medical professionals, scientists and concerned citizens promoting safe and legal access to cannabis for therapeutic use and research. ASA works to overcome political and legal barriers by creating policies that improve access to medical cannabis for patients and researchers by engaging a multifaceted strategy that incorporates public education, impact litigation, grassroots development and advocacy, media campaigns, and direct support services. The scheduling of cannabis as "without accepted medical use" forces ASA to spend its organizational resources fighting for patients.

Jonathan Bair is ASA's Social Media Director.

Shortly after California passed Prop. 215 in 1996, I asked the chief physician at my county clinic for a verbal or written recommendation to use cannabis medicinally. He told me that, while he had no problem with me using cannabis for my conditions, he was afraid to make any kind of recommendation without proper authorization and guidelines. He said as long as cannabis is a Schedule I drug, he could not prescribe it to me.

Over the years living with epilepsy and Post-Polio Syndrome, I have been prescribed and used a myriad of over and under the counter medications for pain, seizures, inflammation, nausea (Marinol), anxiety, insomnia etc. and none of the medications I have taken are as effective, tolerable and free of side-effects (both short term and long term) as cannabis.

After being denied by my doctor, I met with the clinic director who said the same thing as every medical professional and county/state health department representative I communicated with: "As long as cannabis is a schedule I drug, I cannot help you."

In 2002 when I heard that ASA was going to DC to protest at the Dept. of Health and Human Services for rescheduling, I felt it was a perfect opportunity to take my quest to ease my own, and other patients' suffering, to the federal government. It was my first trip to DC, but I didn’t tour the Washington Monument or the Lincoln Memorial. I did end up touring the downtown jail facility along with 14 other patients (including ASA Director Steph Sherer), from 11 different states.

We were arrested for blocking the entrance the HHS Building holding a 300 ft. banner with the names of 7,000 MD’s that support cannabis rescheduling. We also served notice that we wished to challenge the federal scheduling process regarding cannabis.

Ten years later, we finally have a chance in court to challenge the government’s position that cannabis has no medical value. Being fortunate enough to live in a state that allows patients the right to use cannabis medicinally, I have experienced the benefits of using cannabis, and noted its superiority over other accepted medications. Working as a patient advocate for 15 years, I have spoke with thousands of patients who also profess its benefits.

Recently, the federal government has stepped up efforts to close down any group or organization that tries to distribute cannabis to patients, which forces patients to purchase on the street, or go without.

Patients in states without medical cannabis laws and states with restricted access are being forced to suffer needlessly. Cannabinoid research must be allowed to go forward. Cannabis, and the chemicals it contains, have the potential to replace many of the prescription drugs on the market today with a safer, more effective medicine.

Recent studies prove that cannabis has the potential to be an effective medicine for many different conditions and illnesses. Doctors, nurses and patients agree that cannabis should be made available. Nearly 80% of the general U.S. population also agrees it’s time to legalize cannabis for medicinal use. Red tape and preserving the status quo can no longer be an excuse to allow needless suffering and wasted resources: cannabis must be rescheduled.

William Britt is a plaintiff in the case Americans for Safe Access v Drug Enforcement Administration.

The Los Angeles City Council voted to repeal an ordinance banning medical cannabis patients’ cooperatives and collectives yesterday, clearing the way for a new ordinance to regulate hundreds of facilities in the city. The City Council adopted the ban in July after negotiations to settle dozens of lawsuits resulting from the city’s 2010 regulatory ordinance failed to produce a settlement. The repeal is the latest development in a struggle to regulate medical cannabis that dates back to 2005, when Americans for Safe Access (ASA) first engaged city staff and Council Members asking for sensible regulations to protect patients’ access and the community.

In a separate motion authored by Council Members Herb Wesson and Jose Huizar, the City Council adopted a resolution asking the state legislature to “address inadequacies of state law” regarding medical cannabis. Some of the provision in the resolution call for the legislature to declare that financial transactions (sales) are not legal and that cooperatives and collectives must have local authorization to operate. Both of these were contentious issues in the long debate about regulations in the city, and both issues are currently before the California Supreme Court. The resolution also calls for enforcement against lenient medical cannabis doctors and a “finite list of conditions” for which cannabis can be used – a proposal that clearly violates the language of voter-approved Proposition 215. The resolution is not binding as law, and the state legislature is under no legal obligation to respond.

I want to say a special thank you to the ASA members and friends who helped gather more than 49,000 signatures to call a voter referendum on the ban, donated their time and money, and kept believing we could win. Thanks to grassroots persistence, we have another chance to secure the proven benefits of regulations for Angelenos. Special thanks is in order for our coalition partners – the United Food and Commercial Workers Union Local 770 (UFCW), which represents works at dozens of local facilities; and the Greater Los Angeles Collective Alliance (GLACA), the state’s oldest medical cannabis trade association. Both did a great job in gathering signatures, talking to City Council Members, and more.



Patients and advocates hope that the repeal will encourage City Council Members to adopt a new ordinance with which everyone can live. Otherwise, the city may have no tools to protect patients and neighborhoods from real and imagined harm. The City Council voted to create a new regulatory ordinance when they approved a motion by Council Member Paul Koretz on the same day that they voted for the ban. Now we need city staff to move quickly to finish the ordinance, get it to committees, and back to the City Council. There is no need for further delay. The voters of Los Angeles clearly want regulations, not a ban. The debate about this ordinance may be contentious, but it is past time to live up to years of promises to regulate medical cannabis in Los Angeles.

Enforcement actions against medical cannabis cooperatives and collectives in Los Angeles has already begun. There is no reason to believe that the ban’s repeal will stop the pressure. The Los Angeles City Attorney and District Attorney (DA) regard all of the city’s collectives and cooperatives as illegal, with or without a ban, and they are working to close them down. The Los Angeles Police Department (LAPD) routinely raids facilities, and DA’s office has already prosecuted some operators. The City Council turned up the heat last month when they called in the Drug Enforcement Administration (DEA) to help out. LAPD and DEA agents raided three collectives, filed civil asset forfeiture cases against three property owners who rent to medical cannabis tenants, and sent nearly seventy letters threatening other property owners.

ASA urges cultivators, providers, staff, and patients to know your rights and be prepared to assert them in the event of a raid by the LAPD and DEA. We are going to see a lot more of that before the dust settles in Los Angeles. Patients and advocates will hold a lively and peaceful protest of the recent attacks in front of the federal building on Thursday. You can meet ASA , UFCW Local 770, and GLACA in front of the Edward Roybal Federal Building in downtown Los Angeles at 1:30 PM. The federal building is located at 255 East Temple Street, Los Angeles, CA 90012.

Thanks again for helping stop the ban. Now let’s roll up our sleeves and keep doing the kind of effective grassroots work that makes a difference. We will need you back on the phones, at City Hall, protesting on the streets… maybe even gathering signatures for a new voter initiative. Be sure to join ASA’s email list to stay up-to-date, and join us in person at the LA-ASA meeting on Saturday, October 20, in the Community Room (152) at the West Hollywood Gateway Mall located at 7100 Santa Monica Blvd., West Hollywood, CA 90046.

 

 

 

 

 

 

 

 

 

 

Today is the 75th anniversary of marijuana prohibition in the U.S. and, as a society, we’re no better off for it. In fact, many would argue that we’re far worse off with prohibition than if at any point we had developed a sensible public health policy with regard to marijuana use.

The effects of marijuana prohibition have been unmistakable from a law enforcement standpoint -- the U.S. imprisons more people for marijuana than any other country. However, the effects on society of criminalizing marijuana for therapeutic use are also significant and undeniable.

Before the Marihuana Tax Act (MTA) was passed in 1937, medical marijuana (also known as cannabis) was commonly sold by pharmaceutical companies like Eli Lilly. However, Harry Anslinger, the country’s first drug czar, made sure that no exception was made for such therapeutic uses.

Today, the federal government maintains a similar policy on marijuana. Ever since President Nixon ushered in the Controlled Substances Act of 1970, subsequent administrations have upheld the unscientific conclusion that marijuana is a dangerous drug with no medical value.

The federal government employs this outdated policy on marijuana not only to obstruct meaningful research into cannabis, but also to target patients and providers of medical marijuana with aggressive SWAT-style raids and costly criminal prosecutions.

Despite President Obama’s purported relaxation of marijuana enforcement, his administration has conducted an unprecedented attack on medical marijuana with more than 200 Drug Enforcement Administration (DEA) raids and over 70 new federal indictments.

Tragically, a month ago, Richard Flor, 68, a medical marijuana provider in Montana died while in federal custody after being convicted and sentenced to 5 years. Flor was raided by the DEA in 2011, and like so many others, was denied a medical marijuana defense or the ability to provide evidence of state law compliance.

This past Wednesday, federal agents worked with local and state police to raid more than 40 locations in Sonoma and Butte Counties. Approximately 300 law enforcement officials were used to aggressively target medical marijuana patients and providers. From the 10 homes raided in Butte County, officials allegedly came up with less than 100 plants per parcel, an acceptable amount even for personal use in some areas of the state. And the 1,150 plants allegedly seized from 33 locations raided in Sonoma County, amounted to less than 35 plants per parcel.

In Sonoma County, law enforcement targeted a poor Latino neighborhood, reminiscent of the Drug War’s racist roots. Families, including women with babies in their arms, were made to wait outside while their homes were ransacked by police. An alphabet soup of federal agents --including FBI, DEA, DHS and ICE -- were dressed in military garb, armed with automatic weapons, and came with an armored vehicle. To call the raids overkill would be an understatement. The involvement of ICE also underscores the cynical tactic of targeting Latinos in the U.S. Drug War.

So, this is where we find ourselves after 75 years of prohibition. The U.S. continues to imprison people for marijuana crimes at unprecedented rates, while simultaneously denying the scientific evidence of marijuana’s medical efficacy.

Seventy-five years is a long time, but this indefensible position cannot be maintained forever. Later this month, on October 16th, Americans for Safe Access will use scientific evidence to argue before the federal D.C. Circuit that the federal government has acted arbitrarily and capriciously in its classification of marijuana. The government may yet be forced to prioritize science over politics. Only then can we begin to develop a public health policy that will replace this country’s antiquated Drug War.

I am a disabled United States Air Force veteran who is one of the plaintiffs suing over the placement of marijuana in the Controlled Substances Act, in the ASA v DEA case which will be heard by the United States Court of Appeal for the DC Circuit on October 16th. In order to understand why I would be willing to put my name on the line in this lawsuit over the schedule number of cannabis it is first important to review a little bit of history.

Most people know that marihuana (spelled just that way) was the subject of a national law called the Marihuana Tax Act but less known is the fact that this law was based upon the Machine Gun Tax Act. It was legal trickery at best, as the whole point of the new law was to prohibit the sale and possession without the bother of a Constitutional Amendment as was done with alcohol prohibition.

I think the chief drug bureaucrat at the time, Harry Anslinger, knew full well that the Marijuana Tax Act was on shaky Constitutional ground as he made it his life's work to sure up the law. In the 1960¹s he succeeded with the Single Convention treaty and thereby sought a back door Constitutional authority for his prohibition because it is written in our Constitution that treaties, once ratified, become “the supreme law of the land.”

The United States Supreme Court wasn¹t impressed with Mr. Anslinger¹s efforts. however, and in 1969 they sided with Dr. Timothy Leary and ruled the Marihuana Tax Act unconstitutional. This opened the door for Congress to create a new federal law on marihuana using the Interstate Commerce Clause to define their jurisdiction and the new treaty system as part of its basic constitutional authority.

The new federal law, the Controlled Substances Act, is a basically good law that allows for fairly seamless control of and access to thousands of medicinal substances, but unfortunately the arbitrary inclusion of marihuana in the most restrictive category - Schedule I - makes this good law as bad at the Marihuana Tax Act in practice.

Every day the federal government maintains marihuana's Schedule I status, the more damage it causes to our system of government. It is no surprise that this Schedule I placement of marihuana is now causing a serious rift between many states and the federal government that to an outside observer appears to be an extraordinary conflict, even a constitutional crisis.

The definition of cannabis as Schedule I has caused my fellow patients to be imprisoned, denied work, housing, right to own a firearm, a place on a transplant list, and of greatest concern to me, is the latest casualty of the drug war, my VA doctor. My Veterans Affairs Medical Center doctor is now prohibited from recommending cannabis to me and instead the VA has explicitly relegated their sovereign power to the state to handle all aspects of a veteran¹s medical treatment with cannabis. Since the recommendation of cannabis has been shown by court cases in the 9th Circuit to be a free speech activity crucial to the doctor patient relationship it is now apparent that the VA can not effectively operate while this conflict between state and federal law exists.

That is why I am very proud to put my name on this effort to right a wrong and acknowledge that cannabis does in fact have accepted medical use in the United States.

Michael Krawitz is a plaintiff in the case ASA v DEA.

David Sack in his recent HuffPo post entitled "Marijuana: The New Snake Oil" challenges the status of medical marijuana, an increasingly popular alternative treatment, as "good medicine." This question is particularly relevant because the Washington DC federal Court of Appeals will soon hear a lawsuit disputing the status of marijuana in Schedule I of the Controlled Substances Act, brought by Americans for Safe Access, a national member-based organizaton advocating for medical cannabis access and research. I am a doctor and a board member of the ASA Foundation, and I'm proud to present a medical professionals' perspectives to the cause.

Dr. Sack’s anti-marijuana platform is built on the foundation of addiction psychiatry, practiced through the lens of pharmaceutical medicine, resting primarily on a characterization of the FDA approval process as a gold standard of medical evaluation. This same contention, that without FDA approval marijuana cannot have medical value, has been repeated as medical cannabis laws are decided by voters. However, the FDA process is not an infallible one, and it is important to point out about half of FDA approved drugs have been subject to recall or black box warnings. There is no need to belabor this point, but just bear in mind: Accutane, Serzone, Clozapine Pradaxa, Reglan, Yasmin, Chantix, Celebrex and Rosiglitozone, to name a few. The FDA process is not perfect, and the "gold standard" randomized controlled clinical trial is not a one-size-fits-all process: it was particularly designed for single molecule synthetic compounds. As a clinical study tool, it has its limitations, especially where integrative medicine and herbal supplements are concerned.

As Dr. Sack and other cannabis opponents point out, it is truly unfortunate that there is a dearth of clinical trials assessing the efficacy of a variety of cannabis products for a wide array of diagnoses. We can thank our Federal government for this, because research is strictly limited. However, what little research has been conducted demonstrates an utter lack of detrimental health impacts, including no mechanism for an “overdose” bodily response, which can be triggered by virtually all other drugs. In the last decade or so, the American Medical Association, the National Nurses Association, the National College of Physicians, and even the federally-run National Health Institute have all recommended that cannabis be removed from Schedule I and become available as part of treatment regimes.

Despite Dr. Sack’s firmly-worded assertions, we have much to learn about what predisposes individuals to addictive behavior. In the mean time, there is a massive uncontrolled clinical trial being conducted by millions of Americans who are using Cannabis to treat quite a wide range of symptoms and diagnoses. With an explosiong of marijuana use both recreational and medical since the Controlled Substances Act was passed in 1969, mental illness and other supposed ills of marijuana use have not materialized in the general population.

Regardless of what status cannabis has with the FDA, it behooves us as physicians to be interested in and informed about what our patients are using as medicine. As for meeting FDA criteria, a recent study proposed by the Multidisciplinary Association for Psychedelic Studies on smoked and/or vaporized marijuana for symptoms of PTSD in veterans of war, was approved by the FDA in April of 2001, but hindered by the National Institute on Drugs of Abuse. The National Cancer Institute has published a comprehensive Physician Data Query (PDQ) and The Institute of Medicine both have publications where the science base of Cannabis has been assessed. And unlike drugs that go through the FDA approval process, cannabis had been part of the American pharmacopoeia long before the Pure Food and Drug Act was passed. Federal hindering of new scientific studies of marijuana does not erase millenia of human cultural experience with the medical value of this plant.

Though some physicians are uncomfortable with this fact, we are in an era of a revival of natural approaches to health. The National Center for Complementary and Alternative Medicine in 2008 estimated that 40% of adults in the US are using some form of complementary alternative care, spending 33.9 billion out-of-pocket dollars. Many of the tools and herbs they access have been practiced and used literally for centuries (ten centuries for cannabis), and what Dr. Sacks characterizes as "anecdotal" evidence is the safety data.

There are some in the medical community who question the reliability of the current FDA approval system (especially where complex plant mixtures are concerned), work with their patients toward optimal whole health, and are not threatened by new paradigms of healthcare. The ultimate yardstick under federal law is whether or not a substance has "accepted medical use in the United States." ASA will be challenging the DEA's assertion that marijuana has not medical value in court on October 16th, and we've created a sign-on letter for prescribing medical professionals to express their agreement. Cannabis seems to be opening the door to what some may consider a "Pandora's Box", and other simply see as Robert Frost saw, the gate to a road "less traveled by".

Michelle Sexton, N.D., is an Assistant Research Scientist at Bastyr University Research Institute, and a member of the ASA Foundation Board.

Is Paul Ryan's statement similar to Obama's position on medical marijuana? Is there evidence that marijuana has accepted medical uses? Are there really more dispensaries than Starbucks in LA? Recent news about medical marijuana:

• Paul Ryan’s position on medical pot: “up to Coloradans,” and “not a high priority” for a Romney/Ryan Administration. Associated Press in the San Jose Mercury News
  


• What if Obama called a real marijuana user instead of actors? Huffington Post
  


• From dispensary operator to illicit dealer. Is medical marijuana being driven underground? LA Times
  


• Study shows marijuana use among teens in Colorado, a medical cannabis states, dropped even as it increased nationwide. Huffington Post
  


• Far fewer dispensaries in Los Angeles than ban proponents claimed, UCLA study finds. UCLA Newsroom
  


• Author Martin Lee presents slideshow of seminal moments in the post-ban history of cannabis - Huff Post Books
  


• Summary of research in the Daily Beast finds strong evidence of cancer-fighting effects of cannabis. Daily Beast
  


• Prescribing medical professionals launch sign-on letter disputing Federal position that cannabis has no medical value, in advance of the October 16th hearing. ASA
  


• Southern California’s only Sheriff-permitted dispensary closed by US Attorney Laura Duffy. San Diego ASA
  


• Senior learns to bust the myths around medical cannabis. HuffPost Post 50
  

After this blog was posted, prescribing medical professionals have signed a letter acknowledging that cannabis has medical use and should be rescheduled.

Most would agree with the premise that medical decisions regarding the appropriateness of a treatments are best left to doctors and other medicine prescribers in conjunction with patients. When it comes to herbal marijuana or cannabis, Congress and federal regulatory authorities have taken it upon themselves to judge across the board whether this substance has a currently accepted medical use in treatment in the United States, taking little or no input from clinicians who are responsible for actually providing treatments in this country.

Responding to the fact that nothing has been done to organize individual medical professionals to clearly state with one voice to the federal regulatory authorities that there are indeed currently accepted medical uses for cannabis (aka herbal marijuana) in the United States today, the medical prescribers on the board of ASA have started a sign-on letter to give the opportunity for their colleagues to stand and be counted. On Friday August 31st, in collaboration with fellow ASA board and staff, an open national-sign on letter was launched. This sign-on letter is in advance of the federal DC Circuit Court of Appeals hearing on October 16 when judges will consider questions regarding the appropriate classification of marijuana or cannabis in the drug scheduling framework.

Invited signatories to the letter are licensed physicians, physician assistants, and advanced registered nurse practioners - professions with prescribing privileges - who recognize that safe, currently accepted medical uses in treatment for marijuana presently exist in the United States. The letter cites national medical professional consensus statements which signal that the current Schedule I status of cannabis is suspect.

Maintaining the Schedule I status for marijuana in federal law requires drug regulatory authorities to assert and maintain that no accepted medical use in treatment in the US currently exists for marijuana. To do so in the face of the accumulated evidence requires strained and ill-conceived arguments. In their July 2011 decision rejecting ASA’s petition to reschedule marijuana (the appeal of which is the subject of the upcoming hearing), the DEA included the required scientific assessment from the US Department of Health and Human Services (HHS) which had been prepared 5 years prior. Writing on December 6, 2006, HHS found that there were no "NDA-quality [new drug application] studies that have assessed…efficacy and…safety…of marijuana for any medical condition." They went on to say that "at this time, it is clear that there is not a consensus of medical opinion concerning medical applications of marijuana," that "a material conflict of opinion among experts precludes a finding that marijuana has been accepted by qualified experts", and finally that there is no opportunity for "adequate scientific scrutiny" of the existing scientific evidence as the data were "only in summarized form, such as a paper published in the medical literature, rather than in a raw data format."

It is without merit to assume that the only way that a drug or substance can be judged to have accepted medical use is through the completion of "NDA-quality studies," which is another way of saying "Phase III" randomized controlled trials. There are many medically accepted uses of drugs for indications that have not undergone Phase III level testing. For example, take the use of platelet-rich plasma (PrP) injections for the treatment of Achillies tendonitis or tennis elbow. While it is being prescribed by a great number of physicians and being reimbursed by insurance companies, there are no completed Phase III "NDA-quality" studies that have been done to evaluate this medical application. However, it would be wrong to say that that PrP has no currently accepted medical use in treatment in the United States – just ask the American Academy of Physical Medicine and Rehabilitation or other medical specialty societies who hold, sponsor, or advertise training workshops on PrP. Clearly, medical acceptance for treatments depends on presently accepted clinical practices by the medical community. Given that the two largest physicians groups in the United States, the AMA and the ACP, have both come on record saying that the Schedule I status of marijuana needs to be reviewed and that, according to the ACP, such a review would likely lead to reclassification of the drug, it is not accurate to say that there is not a consensus medical expert opinion about the medical utility of marijuana. While it is true that these positions of medical associations were formally taken after the 2006 position prepared by the HHS, they were available at the time the DEA issued its ruling.

In fact, many more patients have been involved in randomized-controlled clinical studies involving cannabis and cannabis-based medicinal extracts than many other drugs. While only a few of these studies rise to the level of Phase III, that does not mean that a strong evidence base is lacking (nearly all controlled clinical trials of cannabis done in the United States have been positive). One pharmaceutical company in England, GW Pharmaceuticals, has conducted large Phase III studies with a cannabis-based medicinal extract produced directly from liquid CO2 extraction of herbal cannabis. While the company would like to contend that studies related to this extract don’t apply to marijuana, as they indicated in a letter from their lawyer to HHS, it is hard to see how they do not apply to marijuana given that the long-standing enforced definition of "marihuana" in federal law since 1937 has been "all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or resins." Certainly the DEA has recently created a separate classification for cannabis extracts in their Scheduling schema, but it is clear that this is little more than pharmacolegal jujitsu to somehow create a privileged parsing of "marijuana extracts" from "marijuana" for the benefit of drug pipelines.

HHS’s claim that "raw data" is needed and that published papers in the medical literature will not do is bizarre and unusual. Medical education, research, and evidence-based consensus-statement writing relies on the same pool of data with findings commonly presented in journal articles. Not having it all together in "one big paper" is really no reason to deny judgment about accepted medical use of marijuana.

The prescribers signing on to the letter are able to judge based on their expertise developed out of clinical experience, study, and collegial discussions, that marijuana or cannabis has an accepted medical use in treatment in the United States. With likely over 10,000 physicians authorizing patients to used cannabis in medical marijuana programs, which have been around for 16 years, and with the string of positive outcome clinical trials of cannabis and cannabis extracts, there is more than enough medical experience and evidence available to recognize that a currently accepted medical use in treatment in the United States exists for marijuana. If strong scientific evidence and clinical professional opinions count for anything in policy, then it is time to re-schedule/de-schedule marijuana.

Sunil Aggarwal, M.D., Ph.D., is an Americans for Safe Access Foundation Board Member

On the heels of introduction of HR 6335, the States’ Medical Marijuana Property Right Protection Act, by Barbara Lee (D-CA) in Congress last week, safe access advocates might want to take a look at the Government Accountability Office (GAO) July 12, 2012 report on the Department of Justice’s (DOJ) Asset Forfeiture Fund (AFF). What the GAO discovered is that the Department of Justice has expended over $1 billion for the past several years on forfeiture, but reporting data remains elusive for Congressional oversight and public scrutiny.

For those unfamiliar with the AFF and how it pertains to medical cannabis, check out some of ASA’s earlier work on this topic. But even those who have been following this issue may be interested to know that the AFF has 3 goals:

1. to punish and deter criminal activity;


2. to enhance cooperation among federal, state, and local law enforcement agencies “through the equitable sharing of assets recovered through this Fund;” and


3. to produce revenues in support of future law enforcement investigations and related forfeiture activities.

To connect the dots for how this relates to medical cannabis, the DOJ is using civil forfeiture (and thereby sidestepping Constitutional protections provided to criminal defendants) to seize property that is associated with legal activity authorized by state and local law, in an effort enhance cooperation with with law enforcement agencies that permit the activity in question. So the only practical purpose the AFF has when applied to medical cannabis dispensary properties is to secure revenue for other DOJ projects.

Costs obscured by lousy reporting and lack of oversight

The cost of how much the DOJ spends in this utterly absurd effort is obscured by the lousy reporting process has for outside oversight. The GOA specifically recommended that “provide more detailed information to Congress as part of the AFF's annual budget process, clearly documenting how DOJ determines” key data. The reason for this is that the reporting data does not appear to have breakdowns for civil and criminal forfeiture, merely some anecdotal examples. However, by checking the tables that are provided, on can see that the AFF revenue has increased nearly 350% since 2003, from $500 million in 2003, to $1.8 billion in 2011. Perhaps more disturbing is the amount of money that it costs the DOJ to run the AFF. Since 2007, expenditures on the AFF have exclipsed a billion dollars each year, reaching a high of $1.3 billion in 2011.

This is one of many areas where the Obama Administration has fallen asleep when it comes to respecting the rights and dignity of medical cannabis patients, caregivers and providers. In addition to illuminating the AFF reporting process, the DOJ is also embarrassing the United States every day by maintaining marijuana in Schedule I of the Controlled Substances Act, asserting that marijuana has no medical value. This lack of transparency and respect is precisely why Congress should give HR 6335 full hearings.

Mike Liszewski is ASA's Policy Director.