In October, the Democratic members of the House Veterans Affairs Committee wrote a letter asking VA secretary David Shulkin why his department is not conducting research into medical marijuana.
In the letter, ranking member Tim Walz (Minn.) and the other nine Democratic committee members note that in many states that have medical marijuana programs, cannabis is recommended for PTSD and/or chronic pain — conditions that afflict many of our wounded warriors. The members do not ask Mr. Shulkin to start dispensing medical marijuana from VA facilities. Instead, they ask the secretary why the department is not conducting rigorous research.
Below are copies of the committee letter and the response from Shulkin. That response is an unfortunate combination of false information, incomplete analysis, and incomprehensible logic. Rather than engaging in an honest, comprehensive discussion of the merits of the VA’s position, the secretary appears to wave off committee members’ concerns about an issue that affects the lives of millions of soldiers and veterans across the United States.
There are seven major problems with Shulkin’s response to the Democratic members of the House Veterans Affairs Committee. Those problems range from a mischaracterization of federal law to a faulty analysis of current medical research to a failure to put medical findings in context and more. The shortcomings in the secretary’s response should alarm Democrats and Republicans; House members and Senators; soldiers, veterans, and civilians alike.
What the Veterans Affairs Committee wants
It is important to start by discussing what ranking member Walz and his colleagues request of the secretary. They do not say that they want VA to come out in support of medical marijuana or that they want VA to begin dispensing medical marijuana nationwide or in the states that have passed medical marijuana reforms. They are simply asking that VA’s research arm — the Office of Research and Development — conduct clinical research on the efficacy of marijuana as a therapy for veterans.
This is not a debate about whether states should legalize marijuana nor does it pit liberal reformers against conservative elements of the Trump administration. The request centers on an empirical question in science: can marijuana be used to treat conditions in soldiers? Americans want our veterans to have the best care possible — and they want to make sure the VA is doing all that it can to provide up-to-date, cutting edge, and effective medicines for patients. With hundreds of thousands of patients across the country reporting benefits from medical marijuana and with veterans self-medicating on a daily basis, VA owes it to veterans to conduct high quality, rigorous research into this substance.
No, Mr. Secretary, the VA is not restricted from conducting medical marijuana research
In Shulkin’s response, he claims that “ … Federal law restricts VA’s ability to conduct research involving medical marijuana …” That claim is simply false. Doctors and researchers at the VA or in VA hospitals could conduct research into the medical efficacy of marijuana while remaining completely compliant with federal laws, regulations, and the United States’ obligations under international agreements. Doctors and other researchers across the United States conduct research into the health effects, risks, and benefits of marijuana for medical purposes every day. Nothing under federal law treats a VA researcher differently than it does a doctor at Sloan Kettering or a researcher at the University of Michigan.
Yes, there is a protocol that must be followed in order to conduct such research. I have written extensively about how the bureaucracy surrounding the approval process for federally-approved medical marijuana research has a chilling effect on science, is inappropriately arduous, and puts the government between doctors and their patients who want answers. However, that arduous bureaucracy does not stop VA from conducting research.
If the secretary’s use of the word “restricts” is given the most generous interpretation, he may mean that the bureaucratic process is burdensome for VA. That would be accurate. However, it would be inappropriate for the VA secretary to claim that a challenging bureaucratic process is a reason to avoid research that may help our wounded warriors get well. What’s more, if that bureaucratic process is so onerous that it is preventing VA from conducting important research that should help veterans, it is incumbent upon the secretary to do something about it. Most of the red tape exists because of rules set by HHS and DEA with regard to registration, licensure, evaluation, and the supply of research-grade cannabis. Shulkin should not complain about bureaucracy, but instead work with leadership at HHS, DEA, and DOJ to create a workable process that puts veterans’ needs above bureaucratic inertia.
VA analysis of existing research is embarrassingly incomplete
In his letter to Walz, Shulkin notes that his department “commissioned a report from its Evidence-Based Synthesis Program, which conducted a systematic review of research and literature on the ‘Benefits and Harms of Cannabis in Chronic Pain or PTSD.’” This program may have conducted a review; systematic it was not. In discussing the findings, Mr. Shulkin notes, “[t]he review found insufficient evidence to demonstrate benefits of cannabis use for patients with PTSD or chronic pain.” He also explains the review “identified 10 randomized, controlled trials of cannabis for chronic pain, and two randomized, controlled trials of cannabis for PTSD that are currently underway. For purposes of the review, the literature search included 12 systematic reviews and 48 primary studies.”
That review may seem significant, but one need look no further than another government entity for a review of the literature that is actually comprehensive and systematic. The National Academies of Sciences, Engineering, and Medicine published “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research,” eight months before VA published their assessment. The National Academies report examined “10,759 unique articles, including 1,488 articles initially categorized as systematic reviews … After filtering … 6,540 primary literature articles and 288 systematic reviews were left to be reviewed by the committee” (411-12). Granted the National Academies report focused on more conditions than simply chronic pain and PTSD; the disparity in numbers is still staggering.
Moreover, the National Academies report notes in its conclusions that “There is conclusive or substantial evidence that cannabis or cannabinoids are effective for the treatment of chronic pain in adults” (14) and “there is limited evidence that cannabis or cannabinoids are effective for improving symptoms of posttraumatic stress disorder” (14). The latter statement on PTSD could square with the findings of the VA report. However, the National Academies’ findings with regard to the treatment of chronic pain precisely refute the VA claims, demonstrating the errors that can be made when a non-exhaustive review of important medical literature is passed off as comprehensive.
The flawed logic surrounding cannabis’ side effects
The VA’s limited review of cannabis’ side effects notes that epidemiological studies show “significantly increased odds of a suicide; an increased incidence of new-onset mania among populations without a diagnosis of bipolar disorder; and low-strength evidence of an association between cannabis use and development of psychotic symptoms.”
The National Academies report would suggest different findings such as “moderate evidence of a statistical association between cannabis use and increased incidence of suicidal ideation and suicide attempts with a higher incidence among heavy users” and “moderate evidence of a statistical association between cannabis use and increased mania and hypomania in individuals diagnosed with bipolar disorders” (20). However, it is critical to put this information in context — which Shulkin’s letter inappropriately fails to do. First, the findings to which the VA report points are statistical associations and not causal relationships. What does that mean? On the point of suicidal ideation or suicide attempts, we do not know if people attempt suicide because of the use of marijuana or if people who are suicidal are more likely to use marijuana in an effort to self-medicate or other possible causal relationships. Correlation does not equal causation. The secretary knows that, and as a science professional, he should have been far more forthcoming about that reality than he was in the letter.
Additionally, much of the research VA relies on is observational research. That is, it is research focused on observing individuals consuming marijuana on their own terms, at their own rate, and in the amounts that they choose. Such studies are not based on marijuana use in a controlled, clinical setting. Finally, statistical associations between the use of a substance should be studied thoroughly to assess causation. Many medicines have side effects including suicidal ideation or attempts, mania, as well as a host of other symptoms and behaviors. Finding out whether a substance causes those symptoms, how clinical dosing can minimize those symptoms, or understanding how specific subgroups (i.e., those diagnosed with bipolar disorder referenced above) tolerate a medicine are basic questions in medical and pharmaceutical research. If VA wants to commit itself to finding the most effective therapies for veterans it will assess the literature in a manner that is truly exhaustive — rather than a handful of studies — and support peer-reviewed, clinical research to find answers. We don’t want to give veterans medicines that will increase incidence of suicide. Nor do we want to take a medicine off the table because of preexisting bias or incomplete information.
The risk of impaired driving is no excuse for limiting research
In discussing risks of harm, the secretary’s letter leads by noting “moderate-strength evidence from analysis of multinational observational studies found that acute cannabis intoxication was associated with a moderate increase in motor vehicle collisions.” Secretary Shulkin is correct that individuals using marijuana should not drive a car. However, this argument is asserted as a reason not to conduct research into marijuana’s medical efficacy. That argument is nonsensical and undermines the medicine practiced in VA hospitals across the U.S. every day.
There are numerous pharmaceuticals that can cause impairment or other symptoms that make the operation of a motor vehicle risky. In fact, many drugs prescribed by a doctor and/or dispensed at a VA hospital come with warnings such as “Do not drive or operate heavy machinery while taking this medication.” If the risk of impaired driving were the threshold for banning a substance, pharmacies would lose significant percentages of their supply. It is further unacceptable to suggest that such a risk serves as a basis for refusing to conduct clinical research on a substance.
VA has an opportunity to do cutting edge research
In his letter, Shulkin notes that “most of the studies were not specific to populations with PTSD or chronic pain” when examining risk of harm. It is true that many cannabis studies do not focus on populations with those conditions or the intersection of those conditions, or on veteran populations more generally. However, that reality is not a legitimate reason for refusing to conduct research into marijuana’s medical efficacy. In fact, VA has a significant opportunity to study the therapeutic benefits and risks not afforded to other research institutions. The secretary’s letter admits what everyone knows — veteran populations have significantly higher rates of PTSD and/or chronic pain than the general population. As a result, VA has an ideal population to study the effects of cannabis among those suffering from such conditions.
Further, some veterans are hesitant to enroll in cannabis-related clinical studies (of course conducted outside of VA hospitals) for fear that they may test positive for cannabinoids in a VA doctor visit or unrelated hospitalization, resulting in a disciplinary action or change in course of treatment from the facility. Even as VA has ended its prohibition on patients talking to doctors about their medical marijuana use, those fears still remain within veteran populations, and VA must be sensitive to the fact that cultural changes often lag policy changes in such situations. However, a VA-conducted trial will provide a safe space for veterans to enter such trials, knowing that the same institution will recognize the legitimacy of the clinical trial.
Veterans and non-veterans who suffer from PTSD and/or chronic pain can see benefits from VA-conducted clinical trials into the medical efficacy of cannabis. If research demonstrates medical efficacy, it can help change policy and improve lives. If research shows no relationship or a negative relationship between marijuana and specific disorders, the public will be better informed about the risks.
The spillover effects of Sessions’ marijuana policy
Of late, VA has patted itself on the back for scrapping the so-called gag rule. The gag rule as mentioned above forbade doctors and patients from discussing medical marijuana use, even in states that have reformed their medical marijuana laws. While the rollback of that guidance has its skeptics in veteran populations, it was an important step toward ensuring that patients are being honest and forthcoming with doctors, providing physicians with a complete disclosure of their medical history.
However, Attorney General Jeff Sessions’ decision earlier this month to rescind the Cole Memo that protected state-legal marijuana businesses and consumers from federal prosecution reignited a concern among marijuana users about the administration’s position. While the repeal of the Cole Memo does not affect medical marijuana, Sessions has stated that he wants Congress to repeal the provision of law that restricts his ability to spend funds to prosecute medical marijuana companies and users. If marijuana users are skeptical of the administration, its position on marijuana policy, and its likelihood to change policy on a whim in ways that punish marijuana and medical marijuana advocates, problems can abound. Such concerns can and will have a chilling effect within veteran populations. That chilling effect will mean that more veterans will self-medicate, without physician consultation, and such behaviors can lead to some of the same risks the secretary lays out in his letter.
Combining concerns about the attorney general, language from the White House supporting Sessions, and a VA Department unwilling even to conduct research into the possibility that marijuana could have medical value speaks loudly to veterans. It tells them that this administration will be tough on marijuana and that it has no interest in answering important medical questions — even those that could improve the lives and well-being of our wounded warriors. In fact, that message is amplified by a VA secretary who is not even willing to provide an honest assessment of the state of scientific research or the realities of American public policy to a Congressional committee with oversight.
Shulkin has an obligation to do better. He should recommit that his own department examine the questions posed by the House Veterans Affairs Committee more carefully and rigorously than it has previously as outlined in his letter. He should have a frank conversation in-house that distinguishes between conducting research on the medical efficacy of marijuana and endorsing the legalization of marijuana. Conducting basic medical research is important for the advancement of therapies for our veterans and the VA has unique opportunities to advance such efforts. Instead, old-fashioned biases, incomplete evaluations of existing literature, and a mischaracterization of policy has, to this point, won the day at VA.
The irony in the secretary’s response to Walz’s query is that the department’s position and behaviors do not advance health care for our veterans. Instead, it adds further risk that frustrated veterans with a variety of conditions will self-medicate, procure medicine through illegal means and/or fail to be forthcoming with their VA doctors. Veterans deserve better than an administration that produces letters like the one sent to the Congress on December 21.