Monday, July 30, 2012

Catch-22 Accurately Describes Science of Medical Marijuana

Two different commentators to the Arizona Department of Health Services (ADHS) invoked the same literary reference while stating their views on whether four conditions should be added to those for which the Arizona Medical Marijuana Act (AMMA) legalizes the medical use of pot.  As we reported in a July 23, 2012 post, ADHS Director Will Humble denied all of the petitions this first time around.

In Joseph Hellerʼs satirical novel Catch-22, the title was an absurd military rule that prevented the World War II bomber pilot protagonist from ever avoiding combat missions.  It has come to mean any circular, self-contradictory bureaucratic policy that renders absurd results.

In the general written comments submitted to ADHS, someone who self-identified as a social science researcher, implored Humble: "Please help eliminate this 'Catch-22.'"
There is a "Catch-22" in this process. Because marijuana is illegal for the most part, research is sparse.  And, because pharmaceutical companies seem to prefer their medications, there is little funding available for research on marijuana and it takes a lot of time. . . . More research will likely not occur until marijuana is legal.  However, states want research to show it should be legal for some individuals.
The other commentatorʼs reference was more indirect.  One of the speakers at the May 25, 2012 public hearing that ADHS conducted referenced an article written by J. Michael Bostwick, M.D., who is in the Mayo Clinicʼs Department of Psychiatry and Psyhcology in Rochester, Minnesota.  The article, "Blurred Boundaries: The Therapeutics and Politics of Medical Marijuana," was published in February 2012 in the Mayo Clinic-sponsored, peer-reviewed general and internal medicine journal, Mayo Clinic Proceedings

Dr. Bostwick writes that the purpose of his article is to educate physicians, "so that they can decide for themselves whether marijuana is a panacea, a scourge, or both."  He concludes that it is both, finding great promise in the pharmacological development of the active ingredients in pot, which he calls "botanical cannabis."   He identifies the same federal barriers to good scientific research as did the other commentator: 
The involvement of an alphabet soup of federal agencies with divergent missions creates a series of potential barriers because several have the power to veto proposed [research] initiatives.  The FDA, for example, authorizes research to proceed on safety and efficacy, the National Institute on Drug Abuse provides the research material, and the Drug Enforcement Agency grants the investigator the actual license to perform the research.  Any one of these agencies has the power to halt an initiative in its tracks.
His Catch-22 reference is to the poor quality of pot available even for research that clears all of the federal hurdles.  "The current catch-22 is that the cannabis that should be studied—diverse strains hybridized by entrepreneurial drug dealers—is illegal and the cannabis that can be legally studied—the decades-old Mississippi strain—is essentially kept off-limits," he says.

Policy makers want to base their decisions on science.  Bad federal policy prevents good science.  Which leaves all of us − patients, physicians, regulators, employers, citizens − in the current Catch-22 state we find ourselves:  dealing with the reality of medical marijuana without a full understanding of its risks and benefits.

Monday, July 23, 2012

Humble Wonʼt Grant Any New Conditions

As Arizoneout predicted in the July 16, 2012 post, the University of Arizona (UA) evidence review gave Arizona Department of Health Services (ADHS) Director Will Humble all the justification he needed to deny the four petitions seeking to add debilitating medical conditions whose sufferers can become certified cannabis users under the Arizona Medical Marijuana Act (AMMA).

Humble announced his decision to deny all four petitions on Thursday, July 19, 2012, just two days after ADHSʼ Medical Advisory Committee issued its recommendation that he do so.  Based on the UA medical reviews, the committee concluded:  "Because marijuana has not been subjected to any high quality, scientifically controlled testing for any of the petitioned conditions, we find no convincing evidence that marijuana provides a benefit."

If I were on the side of the medical marijuana advocates, I would be arguing that Humble and his committee set an impossibly high standard for the evidence reviews because of the difficulty in getting approval for solid scientific research from the federal government, which is the only legal source of pot for research use.  The argument would be that by the standards set, the current debilitating medical conditions that the voters authorized would not get approval under those standards either.  Thus, Humble, an opponent of the AMMA before it was approved by voter initiative in November 2010, applied the wrong standard, one that frustrated the votersʼ will.

As we have seen already , the earliest judicial opinions on the AMMA have been deferential to the voters in construing the law and in limiting the discretion of ADHS to enact rules and policies that run contrary to what the voters intended.

Petitioners to add post-traumatic stress disorder, depression, anxiety disorder and migraine headaches have lost round 1.  Arizoneout is confident there will be many rounds to come.  Whatʼs more, ADHS will accept the next set of petitions for a week starting today.

Monday, July 16, 2012

PTSD Petitioners Will Attract Sympathy

Post traumatic stress disorder (PTSD) is by far the most sympathetic of the pending petitions to add to the list of debilitating medical conditions for which medical cannabis can be prescribed under the Arizona Medical Marijuana Act (AMMA).  Arizoneout discussed the petition procedures in a July 5 post.

The Arizona Department of Health Services (ADHS) has not posted the actual petitions on its website.  The written public comments ADHS has received, however, are overwhelmingly in support of adding PTSD.  Many of the supportive comments come from military veterans. 

One of the scientific articles in support of allowing medical cannabis to treat PTSD is authored by Dr. Sue Sisley, a Scottsdale physician in private practice who also is on the clinical faculty at St. Joseph’s Hospital and Medical Center and is an assistant professor in the telemedicine program at the University of Arizona (UA) College of Medicine.  Her paper summarizes a number of research studies, and one that she relies on the most was conducted on rat subjects. 

ADHS partnered with the College of Public Health at UA to have faculty researchers conduct evidence reviews of available peer-reviewed scientific research on each of the four conditions under review for inclusion as AMMA debilitating medical conditions.  The structure of the UA evidence review basically excluded from the starting point of its analysis the types of articles that Dr. Sisley relies on.  The UA reviewers considered only English language articles and human studies, and rejected considering animal studies, case reports or case series, editorials or opinions, and experiments on biochemical or pathophysiological pathways.

As a result, the UA faculty evidence review concluded that there were no studies that directly addressed the benefits and harms of marijuana use for treatment of PTSD, and that no conclusions could be drawn about those benefits and harms from the available scientific evidence.

Because ADHS Director Will Humble, the final decision maker (at least until we get into litigation and a judge will have to decide), has insisted that he will make his decisions on science.  Thus, the UA evidence review gives him the justification he needs to deny the petition to add PTSD as a debilitating medical condition under the AMMA. 

A lot of veterans will be disappointed if Humble decides to reject the PTSD petition. 

The U.S. Department of Veterans Affairs began to allow patients treated at its medical facilities to use medical marijuana in states where it is legal back in 2010.  Because the drug remains illegal under federal law, however, VA doctors themselves cannot recommend it.

Federal law also makes it very hard to conduct solid scientific research on the effectiveness of medical pot in treating PTSD.  Dr. Sisley herself is trying to conduct a research study, and gained approval from the Food and Drug Administration in April 2011.  She is still waiting for the Department of Health and Human Services’ scientific review panel to approve the study; that is the agency that has to supply the marijuana Dr. Sisley must use in her research.  The AMMA itself does not allow for the use of marijuana for research purposes.

One thing the public comments make clear is that a number of Arizonans already are using medical marijuana to treat PTSD.  Several of the public comments in support of  the PTSD petition were from people who already are Qualified Patients authorized to use medical pot for other conditions. 

The comments are similar to these from a military veteran allowed to use cannabis for chronic pain: “ My job evaluations have improved, people at work comment how much better I am to get along with, and did I mention that I have actually started sleeping nearly all night.  Before being on this program, I would be awake every 3-4 hours either with a nightmare or jolting awake to get up and check around the house (hyper-vigilant).”

That veteran says he started using medical marijuana because of its ability to moderate the pain he had from a severe back injury.  “[B]ut the benefits to my PTSD makes me wonder why no one is jumping up and down and shouting from the rooftops at the VA that ‘This Works’ and a whole lot better than Trazadone, Zoloft and other . . . medications.  I am more productive at work, more pleasant to be around and feel immensely better than I have in nearly twenty years.”

Whether ADHS Director Humble can turn all these passionate veterans down  remains to be seen.  Nevertheless, it is clear that veterans out there are using marijuana legally while also working a variety of jobs here in Arizona.

Thursday, July 5, 2012

July Is Pivot Point For Scope Of AMMA Impact

The Arizona Medical Marijuana Act (AMMA) as adopted by the voters contained a limited universe of debilitating medical conditions that patients had to have to become Qualified Patients (QP)  legally authorized to possess and use cannabis. That universe included eight specific diseases and five symptoms that could be caused by any chronic disease or condition or the treatment of any of them.  Arizoneout detailed the specifics in a June 6, 2011 post.

But that universe was not static, as the AMMA itself requires a process where the citizens can petition the Arizona Department of Health Services (ADHS) to add new debilitating medical conditions for which medical pot use could be authorized.  ARS § 36-2801.01  The law requires ADHS to set rules for the consideration of such requests, and to act on them within 180 days.

The rules ADHS created allow it to designate a very short window in which ADHS will accept petitions in January and July of each year.  The first such window was open for five days at the end of January 2012, and ADHS received a number of petitions during that window. 

Per ADHS rule, the petition had to include: 
  1. evidence that the medical condition impairs the ability of the individual to accomplish activities of daily living;
  2. evidence that marijuana provides a therapeutic or palliative benefit for the condition; and
  3. whether conventional medical treatments provide a benefit for the medical condition.
Petitioners also had to submit supporting data from peer-reviewed scientific journals.

ADHS' medical review team made a preliminary decision that four of the petitions had enough evidentiary support to warrant a full hearing.  ADHS accepted on-line public comments, and conducted a public hearing on those four petitions on May 25, 2012.  The decision is due by the end of July.

Of the original debilitating conditions in the AMMA − the ones we have been operating with for more than a year − the one the overwhelming majority of QPs cite in their applications is chronic pain.  That condition, which is extremely subjective and, some would say, easily faked, has been cited by nearly 89% of the nearly 31,000 applications ADHS has received so far.  The next most prevalent condition is muscle spasms, at nearly 14%, and nausea, at just over 10% of applicants.  Like chronic pain, muscle spasms and nausea are largely self-reported and subjective.  In other words, a recreational user could fake it easily enough, especially with the help of a cooperative physician.

The four conditions currently under consideration arguably fall in the same category as chronic pain, muscle spasms, and nausea.  The pending petitions seek to add post-traumatic stress disorder, depression, migraines, and generalized anxiety disorder to the list of eligible debilitating medical conditions.

ADHS has assembled a lot of information and public comments on these four conditions, including research ADHS commissioned from the University of Arizona College of Public Health,  all of which is available on its website.  Between now and the announcement of the decision on the four petitions, Arizoneout will be reviewing the collected materials and offering tidbits of particular interest to employers.

ADHS Director Will Humble is quite firm that the decision will be based on the medical evidence.  "I want to make sure I'm basing my decision on good science, and Iʼm really looking at the full weight of the evidence," he told the Arizona Republic.

Humble has no illusions, however, that the ADHS decision on the petitions will go down without challenge.  No, being the litigation veteran he has become since passage of the AMMA in November 2010, he probably expects to be sued no matter what ADHS decides.  The AMMA itself authorizes judicial review of decisions on petitions to add debilitating medical conditions.
July also likely will bring another round of petitions, and some probably will propose the same four conditions now under ADHS review, if more scientific evidence has become available in the last six months.  ADHS will accept such petitions for five days from July 23 to 27.  Just part of the AMMA's never-ending, ever-expanding mechanism for making marijuana available for medical use.