Would Medical Marijuana Meet the Threshold for FDA Approval?

For most conditions –the answer is no.  A recent study was reviewed by several media outlets including the LA Times.  Here is an excerpt:

A comprehensive review of dozens of clinical trials that have tested medical marijuana for 10 conditions finds that there’s very little reliable evidence to support the drug’s use. The review, by an international team of researchers, was published Tuesday in the Journal of the American Medical Assn.

Patients who use medical marijuana to treat chronic neuropathic pain or cancer pain would probably have the least to fear from an FDA review. The JAMA study considered 28 studies involving 2,454 patients and concluded that there was “moderate-quality evidence” from at least a dozen studies showing that cannabinoids – chemicals in marijuana that produce pharmacologic effects inside the body – reduced pain in such patients by modest amounts….

The other condition for which medical marijuana proved useful was muscle spasticity in people with multiple sclerosis. After assessing 14 studies with 2,280 patients, the JAMA authors determined there was “moderate-quality evidence” to support its use in these patients, although many of the studies reported improvements that weren’t quite big enough to qualify as statistically significant…

One of the things the studies showed most clearly is that people who use medical marijuana had a “much greater risk” of side effects, including serious problems like kidney, liver and psychiatric disorders. The most common adverse effects included dizziness, confusion and disorientation,  according to the JAMA report…

The authors, from the Yale University School of Medicine, lamented the fact that state approval of medical marijuana had been based on “low-quality scientific evidence, anecdotal reports, individual testimonials, legislative initiatives, and public opinion.”

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Zoo Atlanta

Zoo Atlanta

Medical Marijuana -Update

While medical marijuana is not a frequent concern of many pediatric gastroenterologists, our nurses have been getting questions with the recent passage of legislation.  In Georgia, as in many states, marijuana is allowed for certain medical conditions. “Georgia’s medical marijuana law [Haleigh’s Hope Act] does not legalize the production or sale of marijuana, it simply decriminalizes its possession by certain qualified individuals.” –GeorgiaCann Website

in Georgia the patient must suffer from one of these qualifying illnesses:

  1. Cancer, when such diagnosis is end stage or the treatment produces related wasting illness, recalcitrant nausea and vomiting.
  2. Amyotrophic Lateral Sclerosis (ALS), when such diagnosis is severe or end stage.
  3. Seizure disorders related to diagnosis of epilepsy or trauma related head injuries.
  4. Multiple Sclerosis, when such diagnosis is severe or end stage.
  5. Crohn’s Disease
  6. Mitochondrial Disease
  7. Parkinson’s Disease, when such diagnosis is severe or end stage.
  8. Sickle Cell Disease, when such diagnosis is severe or end stage.

While I will not be recommending medical marijuana for my patients, here is a link for How to Legally Obtain Medical Marijuana Oil in Georgia (thanks to AM for information).

Also, Georgia Department of Public Health -Low THC Oil Registry Page

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From CNN:

University of Chicago

University of Chicago

Crohn’s Research: Going to Pot

A recent pilot study using Cannabis for Crohn’s disease is certain to attract a lot of attention (Clin Gastroenterol Hepatol 2013; 11: 1276-80).  The side effects are definitely less frightening than many of the accepted treatments.

Background: Cannabis has a long record of medicinal uses; it contains more than 60 different compounds, though Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are thought to be the most active.  Cannabis has known antiinflammatory properties and has been shown to reduce colitis in a mouse model.

Study design/characteristics: 21 of 51 screened patients participated; these patients had active Crohn’s disease despite thiopurines in 20  or 21 and anti-tumor necrosis factor (TNF) therapy in 18.  These 21 patients were enrolled in a double-blind, placebo-controlled study.  The average age in the cannabis group was 46 years compared with 37 in the placebo group.  Both groups received cigarettes twice daily; the cannabis cigarettes had 115 mg of THC whereas the placebo group had cannabis flowers in which the THC had been extracted.  Though this was a double-blind study and efforts were made to mask the psychotropic effects by recruiting patients naive to cannabis, nevertheless, by the end of the study most of the patients knew whether they were in the active group or the placebo group.

Results:

  • Cannabis group had a 45% remission rate (5 of 11) with a CDAI of ≤150; the placebo group had a 10% remission rate.  This did not achieve statistical significance.
  • The response rate (CDAI drop of >100) was noted in 90% (10 of 11) of cannabis group compared with 40% in the placebo group.
  • The mean CDAI reduction was 177 in the study group compared with 66 in the placebo group (P= .005).
  • There were no significant laboratory changes (eg. Hgb, CRP, LFTs, kidney function).
  • No significant side effects were noted.  The study group reported less pain, improved appetite, and better satisfaction with their treatment.

In their discussion, the authors note that this is a small study.  They chose the smoking route with THC-rich cannabis to achieve higher blood levels, but note that oral dosing may be effective.  The 8-week duration of the study and lack of more objective markers of response precludes firm conclusions.

Take-home message: Cannabis should be studied further for its potential role in controlling inflammation.  This study’s timing will increase the broader interest in medical marijuana applications.

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