The Cannabis Conundrum: Steering Policy and Medicine with Insufficient Data

The current issue of the International Review of Psychiatry issues a call for marijuana regulatory science.

An editorial introducing the issue notes that marijuana’s use as a medicine began with compassion for people with terminal or debilitating conditions for which no standard treatment existed but has expanded into multiple conditions which are neither life-threatening nor debilitating for which effective treatments exist. This expansion has given rise to a “large-scale, for-profit industry fraught with public health concerns.”

“Quality control issues abound in this industry as there are no established standards for cultivating, processing, testing, or labeling cannabis products. There is also concern over advertisements and product labeling that include misleading or unsubstantiated health claims, as these products have not been vetted by traditional drug development methods. The speed in which cannabis policies are changing is rapid, and the fact that these are happening as a direct result of legislation or by voter referendum is reckless given the absence of consensus standards and, in many cases, appropriate regulatory oversight,” writes researcher Ryan Vandrey of Johns Hopkins School of Medicine.

He notes that the US food and Drug Administration (FDA) was recently granted regulatory oversight of nicotine and tobacco products. This has generated an abundance of policy research resulting in regulations that will likely have a positive impact on public health. He writes there is a critical parallel need for marijuana regulatory research.

“Novel products and cannabis delivery devices are rolling onto the shelves of dispensaries at a rapid rate, product development appears to be geared towards high potency/high dose products, and it is all being carefully marketed to increase consumption,” he says.

In addition, Dr. Vandrey says more research is needed to evaluate the risks and benefits for both medicinal and non-medicinal (recreational) marijuana use.

“Currently there is inadequate data for a confident determination of risk/benefit of cannabis use as a potential therapeutic in psychiatry, yet it is being recommended to individuals for use in the treatment of anxiety, post-traumatic stress disorder (PTSD), attention deficit-hyperactivity disorder, opioid use disorder, dementia, and psychotic disorders,” he writes.

Although there is a lack of data, he says, there are numerous cases where people have been helped by marijuana and some of its cannabinoids. This should be used to motivate the development of “reliably formulated cannabinoid medications,” he concludes.

Read International Review of Psychiatry article here.

Lack of communication about marijuana for medical use between doctors and their patients

Researchers surveyed 242 patients and their primary care physicians in three family medicine practices in Denver, Colorado. Patients’ and doctors’ surveys were linked by numbers rather than names. The surveys were distributed in the doctors’ offices for patients to fill out anonymously. Only primary care physicians whose patients completed a survey filled out the doctor’s survey.

• 22 percent of patients reported marijuana use in the past six months.
• Of those, 61 percent said they used marijuana for medical purposes.
• None obtained their state medical marijuana card from their primary care physicians.
• Primary care physicians were aware their patients used marijuana only 53 percent of the time.
• Primary care physicians identified conditions they believed could be adversely affected by marijuana use in 31 percent of their patients.

Read the Journal of the American Board of Family Medicine article here.

Jimmy Buffett brand to develop cannabis products with Surterra

Margaritaville’s Jimmy Buffett, whose fans are known as Parrotheads, has licensed his band’s name—Coral Reefer—to Surterra Holdings, which will produce a line of marijuana products for medical use under the band’s brand name.

Surterra is a $100 million, five-year-old company based in Atlanta that has done no business in Georgia except to contribute to Georgia politicians. Surterra’s former president holds a seat on a legislative study commission to decide whether to legalize marijuana cultivation in Georgia. The commission’s report is due to the full legislature in time for the 2019 legislative session.

The Wall Street Journal reports the venture will produce Coral Reefer products in the form of vape pens, gel caps, edibles, and lotions. Beau Wrigley, the chewing gum scion who sold the family business a few years ago to establish a family investment firm, raised $65 million for Surterra and became its chairman last month. He said at the time that while Surterra is focused on products for medical use, it plans to compete in the recreational market as well.

Read the SunSentinel story here.

When two studies contradict each other, how do scientists decide which one is true?

People who want marijuana to be legalized for medical and/or recreational use often point to studies that re-enforce their viewpoint. People who don’t want pot legalized often do the same, pointing to studies that are diametrically opposed. How can there be so many studies that contradict each other?

We asked Michael Kuhar, PhD, Candler Professor of Neuropharmacology at Emory University and author of The Addicted Brain, how scientists determine which studies are valid and which are not. Here are his answers:

There are a number of ways scientists evaluate conflicting results.

1. The scientist will evaluate the two conflicting studies on her own, looking closely at both.

• She might look at the patient population. Are they different? If yes, it might be that both studies are correct for the patient population involved.

• He might ask which study has more patients because a larger group of patients tends to produce more reliable results.

• She might compare the methodology, experimental design, and statistical analysis. Does one study look more rigorous than the other?

• A scientist might look at the authors of the two studies and ask which one has more experience in the field.

• While the above approach might reveal the best study, even a close review of the papers might not reveal which is more reliable.

2. If the scientist is unsure or is unable to critically evaluate both studies on his own, he might go to another scientist who is expert in that area and who knows more about it. Opinions of other highly trained people are important.

3. She is likely to look for other published studies in the area because confirmation and support for either study is important. The scientist wants to see if someone else has gotten similar results to those of one of the contrary studies. It is possible that, in the face of conflicting studies, everyone may have to wait until additional studies are carried out to see which result is the correct one. Confirmation is a cornerstone of the scientific method.

Scientists are trained to deal with such conflicts. Scientists do not expect a perfect world, and they often look for the preponderance or greatest evidence for a result. Every study may not produce exactly the same result, but the overall bulk of the data (from several studies) will support one view or another. Overall, this is referred to as evidence-based thinking.

FDA cracks down on Juul and e-cigarette retailers

As noted in the first article of today’s The Marijuana Report, the FDA now has jurisdiction over nicotine and tobacco regulation. FDA declared that some 2 million teenagers are using e-cigarettes and vaping products like the popular Juul, pictured above, and are becoming “hooked” on nicotine. The issue has reached epidemic proportions.

Today, FDA announced that it is giving Juul, RJR Vapor Company’s Vuse, Altria Group’s MarkTen, Imperial Grand’s blu and Logic 60 days to prove they can keep their products away from minors. If they fail, FDA may remove the flavored products from the market.

FDA also sent warning letters to 1,100 retailers, including 7-Eleven stores, Walgreens, Circle K convenience shops, and Shell gas stations. It has issued another 131 fines for selling e-cigarettes to minors.

Read the New York Times story here.

Breaking: Marijuana legalization in Colorado not so great after all

The 2018 Rocky Mountain HIDTA report released this morning shows marijuana legalization is having a negative impact in many areas:

• Marijuana-related traffic deaths have increased 151 percent compared to all Colorado traffic deaths, which have increased 35 percent.

• Past-month marijuana use among Coloradans age 12 and older is 85 percent higher than the national average.

• Marijuana-related ER visits have increased 52 percent since Colorado legalized pot.

• Hospitalizations related to marijuana jumped 148 percent.

• Violent crime increased 18.6 percent; property crime increased 8.3 percent.

• 65 percent of local jurisdictions throughout the state have banned both medical and recreational marijuana.

Read full report here.

---