Volume 205 - Issue 9
Medicinal cannabis in Australia: the missing links
Authors: Jennifer H Martin and Yvonne Bonomo
Med J Aust 2016; 205 (9): 425. || doi: 10.5694/mja16.00763
Published online: 7 November 2016
Published online: 7 November 2016
In reply
In reply:
In their letter, Reece and Hulse point to a lack of high quality comparative efficacy data for cannabis use in many conditions, in distinction to the efficacy data required for therapeutic goods already registered for these same indications. As outlined in our article,1 there are a number of “missing links” that need to be considered before Australia is confident that safe and effective cannabis can be available to people in need. Moreover, recent publications provide summaries of the evidence for and against its safety and efficacy.2,3
The community deserves to benefit from the balance of scientific evidence in this area, as it would for any other area of medicine. Even then, there are several examples of rapidly registered therapeutic goods where product removal was required once the “real world” phase 4 data became available. A recent article suggested that registration approval can be made too early for drugs with limited data or data reliant on biochemical surrogate markers, which can potentially translate into less chance of identifying adverse drug reactions before marketing.4 We found evidence of at least 35 drugs removed — not including those with reduced indications or black box warnings —after United States Food and Drug Administration registration due to adverse drug events.5-7 The case of medicinal cannabis is no different, and accurate and reproducible data collection and careful post-approval pharmacovigilance will be imperative to managing this process to ensure safety and efficacy. It is hoped that the recent state-funded trials in Australia, as well as attention to ongoing good quality trials in the future, will help fill this evidence gap.
References
- Martin J, Bonomo Y. Medicinal cannabis in Australia: the missing links. Med J Aust 2016; 204: 371-373.
- Hill KP. Medical marijuana for treatment of chronic pain and other medical and psychiatric problems. A clinical review. JAMA 2015; 313: 2474-2483.
- Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 2015; 313: 2456-2473.
- Martin J, Shenfield G. The hazards of rapid approval of new drugs. Aust Prescr 2016; 39: 2-3.
- Prasad V, Mailankody S. The accelerated approval of oncologic drugs: lessons from ponatinib. JAMA 2014; 311: 353-354.
- ProCon.org [website]. 35 FDA-approved prescription drugs later pulled from the market. Santa Monica: ProCon.org; 2014. http://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528 (accessed June 2016).
- Lexchin J. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy. Br J Clin Pharmacol 2015; 79: 847-859.