Article : Are Regulatory Bodies Prioritising Drug Company Interests Over Public Safety?

[Arnie Pye]

Title : Are Regulatory Bodies Prioritising Drug Company Interests Over Public Safety?
Subtitle : The Disturbing Case of the Street Drug Ketamine

https://www.madinamerica.com/2019/1...ng-drug-company-interests-over-public-safety/

The UK’s Medicines & Healthcare Products Regulatory Agency [MHRA] is refusing to respond to the concerns of psychiatrists, parliamentarians, patients and other experts about the impending licensing of the street drug ketamine as a treatment for depression.

In March this year, the USA’s Food and Drug Administration approved Spravato (esketamine), on the basis of just one efficacy study.

On 17.10.19 the European Medicines Agency [EMA] issued a ‘positive opinion’ recommending the granting of marketing authorisation for esketamine for depression in adults and sent it to the European Commission, which has 67 days to make a final decision (December 23).

The MHRA (UK) has deferred a decision, pending the EMA/EC ruling. However, during the 67 days, member states can submit new information not addressed by the EMA opinion.

On 31.10.19 twelve experts, including eight psychiatrists, wrote to the MHRA and EMA.

Article continues at : https://www.madinamerica.com/2019/1...ng-drug-company-interests-over-public-safety/

I think the answer to the question posed in the title is "Yes, most definitely".

The comments are mostly worth reading, too.

 

[shak8]

This being California (anything that quacks), a local board-certified shrink who sells vitamins on his website, is offering IV ketamine for a host of psych problems (listed: OCD, depression, PTSD, and anything and everything).

He also gives talks to physicians about the benefits of ketamine therapy, for referral purposes, natch.

For six months of treatment, the patient will pay $3000+. I hope the insurance companies here will be wise enough to demand more research. If we do get medicare-for-all, the cost of this treatment may be prohibitive.

Yes, depression kills. But so may the dissociative effects of ketamine.

Very worrisome. If it later is deemed safe for severe patients and beyond the six months of the study, perhaps its use should be confined to a few reputable centers, although that wouldn't reach enough patients.

As with any new drug, after the phase III clinical trial and the drug is approved, you don't find out the true extent of the side effects until thousands of people have used it. The phase IV (or post-marketing phase) is that.

I'll wait for the generic.