As many of you know, I have a little fun on The Twitters at Deepak Chopra’s expense. I started my alter-ego @DBagChopra last fall to shine a light on the quantum mysticism and overall new-age gooiness he peddles. My hope was that, through humour, I might cause a few people to realize just how silly his ideas really are.
As a side effect of these activities, I’ve been paying a lot more attention to what Dr. Chopra says and shills. Much of this is related to his own product – his 100+ books and DVD’s, the offerings of the Chopra Center, his Xbox video game – but he often shills for other products as well. So last year, for example, when he showed up in an ad for 50 Cent’s new energy drink, @DBagChopra had a few choice tweets on the subject.
Still, while I’m no fan of energy drinks, I haven’t seen much from Dr. Chopra that I would call overtly dangerous. For example, although he dresses his medical advice up in a lot of obfuscating nonsense that I think is unhelpful to patients, when you peel back the guru-speak much of it boils down to health and wellness best practices + meditation. He certainly makes non-scientific claims about how this benefits us, enables us to heal and slows the aging process — and to the extent that a patient chooses, say, meditation over conventional treatment it could certainly do harm — but I haven’t seen Dr. Chopra himself advocate for this. He just weaves his sticky web and cashes the cheques.
Until last week, that is, when I saw the following:
Dr. Chopra is lending his name to a line of OTC pills that promises to unleash “the healing power of endorphins” to relieve “emotional and physical distress”, increase “energy and alertness”, boost the immune system, and promote, “calm, comfort, well‑being and positive mood.” Better, it’s all natural and has “no negative side effects.”
All of which has my skeptical alarm bells ringing, since it’s the type of language we typically see promoting non-scientific treatments. There are other things drawing my attention as well, such as a reliance on case studies and testimonials, as well as the page telling potential investors what a great business opportunity this is. I’m also suspicious of the attempt to identify and patent a new disorder – Distress Dysfunction – that’s not recognized by the psychiatric community (i.e. it’s not listed as a diagnosis in the DSM-IV).
Bring the Evidence
But these are just warning signs — if the science is solid, none of it matters. So let’s take a look at the three documents presented as evidence on the Endorphinate website:
1. Endorphinate® Case Studies
This one pager summarizes the results of 203 case studies of patients that have used the product, tabulating the percent of patients that have “experienced a substantial reduction in symptoms” for 22 complaints. As such, it’s uncontrolled and unblinded. Additionally, no indication of methodology is indicated, and it’s impossible to say what diagnostic criteria were used to assess the reduction, what qualifies as substantial, or indeed whether the complaints had any diagnostic validity in the first place (they’re all just listed as “concerns”). My assumption is that both the complaints and the reductions are simply patient reported, but I’d welcome a clarification from Pondera, the pill’s makers, if this is incorrect.
The first thing I note is that the response rate is astoundingly high across a very wide range of complaints. There are no pharmaceutical solutions on that market that this would be true of, so either this is indeed a miracle cure for everything, or there’s something more at play here. The second thing I note is that the vast majority of these conditions are ones that traditionally respond well to placebo effects – general complaints that can have a variety of causes and often come and go regardless of any specific treatment. Combine that with the lack of controls, lack of blinding, and apparently patient-reported nature of the data, and it certainly appears to be a typical placebo-response scenario.
But what about the “harder” complaints like tobacco and recreational drug use? First off, their use of the term “concerns” makes it impossible to tell whether this relates to actual addiction or something else entirely; and second, the sample size for these is simply too small for these results to be meaningful even if the methodology weren’t so weak. It may not be coincidental that Alcohol has both a larger sample size than tobacco or recreational drugs, and also the worst results of any complaint in the list.
All in all, I’m rating the case studies ‘unpersuasive’.
2. Summary of Endorphinate® Induced Clinical Pain Trial Results
Ahh, clinical trials — that sounds promising. If only. The summary is comprised of 3 graphs showing how much better various Endorphinate® formulae do in relieving pain than a placebo. So yes, it’s at least single-blinded, but there’s no detail on methodology other than in the headers of the graphs. It’s also extremely low powered – n=12 on the first trial and n=8 on the other two. And of course, it only tests for pain relief, not the other 21 complaints covered by the case studies above.
Since this was a summary, I did attempt to find the original research on PubMed. If it has been published, I wasn’t able to find it. A search for “Endorphinate” came up empty. A search for “Stanley Crain”, the Chief Scientific Officer of Pondera’s Pharmaceutical division, upon whose work the product is based, returned only three results, none of which were human clinical trials. [See Update below]
3. Endorphinate® Science
Those three results were, rather, basic research into opoid receptors in mice. Pondera positions Endorphinate® as based on Dr. Crain’s research in this area, and the Endorphinate® Science document provides a 12 page overview of this.
I don’t have the science background to critique this research – for all I know Dr. Crain may indeed be the leading light in the field and his research a major leap forward in scientific knowledge. But even if this were the case, it wouldn’t matter, because as any pharmaceutical executive will tell you, there’s a long way between basic research and a safe, efficacious drug. This paper does nothing to bridge that gap.
Why Deepak, Why?
Simply put, this product has presented no credible evidentiary base to support its clinical claims, and if one exists outside of its website, I certainly can’t find it. Yet Dr. Chopra is so taken with this supplement that he not only endorses it online, but on TV as well – check this video (at 1:50) of him pimping the product on the Dr. Oz Show.
What’s in it for Dr. Chopra isn’t clear, but it’s lucky for Pondera he’s agreed to lend his name to the cause. In a market with dozens of cure-all supplements, Dr. Chopra’s endorsement has the potential to be worth millions of dollars. Of course, that’s still a fraction of what an FDA-approved version of such a side-effect free wonder drug might bring.
I’ll let you draw your own conclusions as to why Pondera has chosen the more expeditious path to market.
® Endorphinate is a registered trademark of Pondera Biotechnologies LLC.
[UPDATE 2/27/12 - Thanks to commenter Paul for pointing me to Dr. Crain's full list of citations. My author search didn't capture the papers published as "Crain SM", which is the bulk of them. I have not yet been through all of them, but none appear on first blush to be clinical trials of Endorphinate.]