Study Ptsd Study Ammongst 8 Studies Shut Down At Nyu

[Anarchy]

New York University’s medical school has quietly shut down eight studies at its prominent psychiatric research center and parted ways with a top researcher after discovering a series of violations in a study of an experimental, mind-altering drug.

The violations “jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site,” the F.D.A. said in a letter, obtained by The Times, to Dr. Alexander Neumeister, the studies’ lead investigator.

http://www.nytimes.com/2016/06/28/health/nyu-cannabis-ptsd-psychiatry.html?_r=1

H/T Wendy McElroy

 

[joeylittle]

That whole thing just makes me frustrated.

Somehow they were missing one very important early step - if a person wants to register for a trial, and they will need to voluntarily stop their current medication, they are prohibited from participating if they cannot do so safely, usually for at least 6 months - regardless of the scheduled start date.

So, chick in the article shouldn't have been there in the first place. For that, the accountability is mutual.

But researchers....come on, researchers.....

I think Pfizer is trying to beat out a British company that is already very far along with synthetic THC and CBD. When it hits the market, and it will, anyone wanting to make money off of synthetically creating the benefits of cannabis will need to wait out the patent expiry...

Grrrr.

 

[Diane Ruffcorn]

I participated in this study, and two others also by Dr Neumeister. One was a brain imaging study done in collaboration with Yale, and two were drug trials. All three were related to the treatment of PTSD.

I blogged about the experience as I was going through it, but can't post the url here without permission from forum admin.

 

[Diane Ruffcorn]

... if a person wants to register for a trial, and they will need to voluntarily stop their current medication, they are prohibited from participating if they cannot do so safely, usually for at least 6 months - regardless of the scheduled start date.

So, chick in the article shouldn't have been there in the first place. For that, the accountability is mutual.

I'm the chick in the article. Could you expand on what you mean by the accountability is mutual? I don't understand quite what you mean there...

 

[joeylittle]

Hi @Diane Ruffcorn - welcome.

By accountability is mutual, I meant that if you had some prior knowledge of the strain you'd undergo by stopping your meds, agreeing to the study (which I'm making an assumption that you volunteered for), and voluntarily stopping your meds, you are partially accountable for your own distress suffered in the lack of them.

I'd also see them accountable for not having a more precise disclosure mechanism for that though, as well.

The lack of proper follow up and documentation is on them.

This is only my opinion.

(Since we don't allow self-promotion on the forum, I'd not be able to allow your blog address anyway - but people I'm sure can easily find it on their own).

 

[Diane Ruffcorn]

Oh in that case yes...nobody twisted my arm, I wasn't forced to do it. It is something I did willingly so as to have the opportunity to participate in the trials. Although I must say that after the third or fourth time of starting/stopping, I became quite invested in following through with it. The whole "I've come this far" thing.

I was not expecting to be coming off of meds that many times. The expected delay of treatment time far exceeded the time frame suggested in the consents.

 

[PTSDfree]

Drug companies test their products on homeless people pretty often, so this doesn't surprise me.

Also, they should know that synthetic cannabinoids can kill people (if they don't already :O_o:).

 

[joeylittle]

Drug companies test their products on homeless people pretty often, so this doesn't surprise me.

As in, drug companies kidnap the homeless and give them drugs against their will?

I'm not a supporter of Big Pharma, nor am I a super-fan of how the FDA in the US does its approvals process; there is much room for improvement, and since drugs are ultimately a commodity, the drug companies often pursue profit at the risk of the consumer.

But - I think it's an oversimplification of the process to presume that all collaborating researchers who work for non-corporate entities are also corrupt.

I'm only saying this because I've had personal experience with research trials and good doctors/researchers. It's not always black and white.

I'm honestly curious about synthetic cannabinoids causing death - can you point me towards what event you are referring to, @DissociativeBelle, so I can learn more about it?

 

[PTSDfree]

As in, drug companies kidnap the homeless and give them drugs against their will?

I'm not a supp...

I can't post links yet, but there's an article on Medium called "The Best-Selling, Billion-Dollar Pills Tested on Homeless People" and another on Forbes called "Why Synthetic Marijuana Is More Toxic To The Brain Than Pot" that'll show up when googled. They are much more potent than even pure THC and it's very easy to OD on something like that. It also doesn't contain CBD, which naturally occurs in marijuana and can help act as an antipsychotic.

The homeless people used in those drug studies may not be kidnapped against their will, but they're screwed if they end up with health problems as a result of a clinical trial. There's a bit about it in Ben Goldacre's book Bad Pharma, too.

 

[joeylittle]

Thanks - I'll check it out. :tup:

 

[Diane Ruffcorn]

In this instance, the trial drug was a FAAH inhibitor, compound PF-04457845.

 

[joeylittle]

Yes - I understand that it was meant to somehow mimic the effects of a cannabinoid...or somehow address the potential lack of the specific endocannabinoid anandamide.

Here's a link to the initial study by Dr Neumeister that sought to prove connection between cannabinoid receptors and PTSD.

http://nyulangone.org/press-release...d-receptors-to-post-traumatic-stress-disorder

What's really significant in that study (in my opinion) is the possibility to develop a diagnostic testing protocol for PTSD. I know developing medication is ultimately more attractive to research institutions...but wish he would have run with that information, rather than moved towards identifying a pharmaceutical.