Join

or

Existing user? Login

Drug development and funding

Pharma industry should fund trials for medical cannabis, chief medical officer tells MPs

Dame Sally Davies told MPs that randomised controlled trials are the only way to get medical cannabis products licensed, and the process should start as soon as possible.

Dame Sally Davies

Source: Wikimedia Commons

Speaking to the House of Commons Health and Social Care Select Committee evidence session on medical cannabis policy, Dame Sally Davies said the funding of trials would improve access for patients

The pharmaceutical industry should fund randomised controlled trials (RCTs) of medical cannabis, to improve access to drugs for patients, Dame Sally Davies, chief medical officer for England, has told MPs.

Speaking to the House of Commons   evidence session on medical cannabis policy, Dame Sally said that while the public sector had a role in funding RCTs, such trials “would normally be funded by the industry”.

“I think it is time that the industry started to say what it’s going to do about funding trials to get the licences so patients can have access. This can’t be just left to the public sector,” she added.

Asked if RCTs were the only way to establish the drug’s efficacy and safety, Dame Sally said that these kind of trials were the only way to get products licensed, adding that the process needed to begin “as fast as we can”, and that the trials could be ended if strong evidence arises “one way or the other”.

The National Institute for Health Research, funded by the Department for Health and Social Care (DHSC), ; however, responding to the same question from MPs, Alette Addison, head of pharmacy and regulation at the DHSC, said that while more than 80 patients were currently receiving Epidiolex (Greenwich Biosciences, California), a cannabidiol (CBD) oral solution for severe epilepsy, “our difficulty is that the evidence for adding [tetrahydrocannabinol (THC)] to CBD, and whether that makes any difference, doesn’t exist at the moment. That’s what we need the trials for”.

Peter Carroll, director of , which campaigns for access to medical cannabis, said that although RCTs were “the gold standard … we have to take a broader view of the evidence”.

“There is a point where multiple anecdotal stories do actually build up to a pattern of evidence.”

Carroll’s view was echoed by Mike Barnes, professor of neurology and chair of the Medical Cannabis Clinicians’ Society, who added that observational trial data should be taken into account. 

“I agree, totally, that we need RCTs, but it would be very difficult to conduct those studies,” he said, citing the different levels of THC needed by individual patients.

Addison added that she was not surprised by the small number of medical cannabis prescriptions issued since 1 November 2018. “When we look at the experience of other countries, it is a very slow start and it does build.”

She added that “doctors are only going to be confident prescribing if they have the evidence base to do so. And it’s just not there at the moment”. 

Helen Cross, head of developmental neuroscience at the UCL Great Ormond Street Institute of Child Health, who works with patients with complex epilepsy, said that patient expectation had meant that “probably 70% to 80%, if not more, of my clinics now are taken with explaining the position”, and said that it in a minority of cases it had made relationships with patients “quite difficult”.

 A will be held on 26 March 2019.

 

Citation: Electronicjuice DOI: 10.1211/PJ.2019.20206322

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00
  • Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (The Orange Guide)

    Commonly known as the Orange Guide, this book is an essential reference for all involved in the manufacture or distribution of medicines in Europe.

    £82.00
  • Rules and Guidance for Pharmaceutical Distributors 2017 (The Green Guide)

    Essential guidance for distributors of medicines for human use in Europe, compiled by the MHRA.

    £72.00
  • Essentials of Nonprescription Medications and Devices

    Essentials of Nonprescription Medications and Devices provides a quick, comprehensive reference of products available for self-care.

    £33.00
  • Integrated Pharmacy Case Studies

    Over 90 case studies based on real life patient-care scenarios. Each case includes learning outcomes and references.

    £47.00

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.

http://steroid-pharm.com

www.101binaryoptions.com