The House Medical Cannabis Clinical Trial Bill Will Not Work

On May 1, a new Minnesota House of Representatives medical cannabis proposal was put forth. We are pleased that Gov. Dayton and law enforcement have moved from a position of outright opposition to medical cannabis to one that acknowledges and accepts its inherent medical value. Unfortunately, the current proposal is in many respects unworkable, and therefore does not meet the public policy goal of providing safe and legal access to sick and dying Minnesotans. We look forward to working with stakeholders to craft legislation that allows Minnesota to join the 21 other states that have effective medical cannabis laws.

Here are the problems with the House’s May 1 proposal:

• The proposal requires state workers to violate federal law. It would therefore be preempted:

• The House proposal would require the health commissioner to violate federal law by contracting with both a medical cannabis producer and with a principal investigator for medical cannabis trials. These would both involve, at a minimum, conspiracy to grow and distribute marijuana, which is a federal crime.

• In addition, in the likely event that no principal investigator stepped up, the department would be required to serve as the investigator for clinical trials. This would involve the department violating federal laws by distributing cannabis.

• Workable medical cannabis laws instead rely on the state to regulate and register third parties who cultivate medical marijuana and distribute it directly to patients. In effect, this means the state identifies those entities that are exempt from state penalties, and the circumstances under which they are exempt. That is very different than having the state contract with someone to grow marijuana or to dispense marijuana itself.

• The bill unrealistically relies on a “clinical investigator” and doctors openly and repeatedly committing federal felonies:

• The 21 medical cannabis laws that actually work rely on doctors making recommendations or certifications. The do not rely on doctors being involved in the distribution of marijuana because doing so violates federal law. (Conant vs. Walters).

• Minnesota’s House proposal would require the principal investigator and physicians to obtain, distribute, and store marijuana. They would also have to determine dosing and the type of cannabis patients get, which also violates federal law. It would be unprecedented to have a medical cannabis program involving physicians openly and repeatedly committing federal felonies. Similar programs have been enacted into law — including one enacted in Maryland last year — but they have simply not worked.

• The law would cost a fortune to implement, if it worked (which it will not):

• Numerous studies have already found that medical cannabis can alleviate debilitating symptoms such as neuropathic pain, nausea, and appetite loss. This would waste millions of dollars to find out what we already know.

• Research is extremely costly. The State of California spent around $10 million to conduct extremely short-term clinical trials that involved fewer than 250 people. Arizona, which has a similar law to Minnesota’s proposal, has 48,231 patients enrolled in its medical cannabis program. It would surely cost many tens of millions of dollars to conduct clinical trials involving all of the Minnesota patients who could qualify and benefit from medical cannabis.

• The proposal includes numerous other unduly restrictive provisions:

• The bill would only allow vaporization if it happened in a doctor’s office and would not allow smoking. Inhaling cannabis is often the most effective, rapid method of administration. Patrick McClellan of Bloomington has testified that he can halt spasms attacks that can leave him immobilized for hours through vaporized marijuana. It is absurd to suggest he could drive to his doctor’s office before he uses cannabis to stem such an attack.

• It appears that many adults would be denied medical cannabis, and would instead be given placebos.

• All patients with intractable pain may be left behind. While the commissioner could approve additional conditions, there is no qualifying condition for severe or intractable pain listed. Sixteen thousand Americans die each year from overdoses on prescription opioids. It is cruel and senseless to leave behind pain patients.

• It appears only a single manufacturer would be allowed in the entire state, which would almost surely lead to shortages, and would prevent the kind of innovation in developing strains that resulted in Charlotte’s Web Oil and other beneficial strains being developed. A single power outage or outbreak of pests could destroy the entire supply.

• The principal investigator would have to decide the mix of cannabinoids in the cannabis that is produced. In addition to this requiring the investigator to break federal law, this would likely result in a lack of diversity of supply that is necessary to develop and identify the strain that works best for individual patients. It would also prevent the kind of innovation in developing strains that resulted in Charlotte’s Web Oil.

• The only patients who would be allowed to have a caregiver help them administer marijuana are those under 18. Several adult patients — including ones with ALS — are physically unable to administer their medicine on their own.