March 30, 2007

Implications Of New STEP-BD Study On Anti-Depressants

As I noted yesterday, a new NIMH-sponsored study of anti-depressant use in bipolar disorder (or bipolar depression, if you prefer) showed that placebo outperformed anti-depressants in treating bipolar depression in patients already taking a mood stabilizer. Twenty-seven percent of patients getting a placebo held off depression for at least 8 weeks during the 26-week study while anti-depressants only worked in 23.5 percent of patients. The study was just published in the New England Journal of Medicine. If you want to read it for yourself, it's actually a freebie for now.

It's as big a landmark study as the initial CATIE paper and drives a stake through the heart of the clinical practice of giving an anti-depressant to people with bipolar disorder. We've known for at least a decade that that's not likely to produce good results, but it's nice to have some academic cred for such assertions.

We'll see how that translates into the real clinical world, but it is very bad news for anti-depressant makers. A lot of their sales come from bipolars. Meanwhile, I'd guess that there were high fives 'round the offices of Glaxo Smith Kline and AstraZeneca. GSK makes Lamictal and AZ makes Seroquel. Both have been marketed heavily as bipolar drugs that work on bipolar depression. I'll avoid nit-picking on either for now, especially since AZ is the focus of a Congressional investigation for its handling of Seroquel (as is Eli Lilly).

Enjoy your day of good news and new market segmentation opportunities! No phone booth ads though guys, OK?

My small complaints about the study are that it didn't break out response rates between Paxil (ironically, made by GSK in its patented form) and Wellbutrin. Nor did the study present data on how many of the people who saw an 8-week remission on either drug later relapsed. Maybe such data will be in a forthcoming paper.

I've long been leery of the argument that depression in bipolar disorder is so wildly different from unipolar depression, especially since the 23.5 percent remission rate here is not so much different from the 30 percent remission rate in the first STAR*D round. But then again those weren't BPI or II patients. So maybe there is a difference of some kind after all.

Posted by Philip Dawdy at March 30, 2007 12:03 AM
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Hi Phil,

I applaud your thorough analysis of the NEJM study and your reference to STAR*D.

I have nicknamed the STAR*D study "Two strikes and you're out". If a patient has failed two adequate trials of two different antidepressants, then the patient is highly likely to fail antidepressants "three, four and five, etc."

I was saved from a life of chronic depression thanks to vagus nerve stimulation therapy.

www.MyDepressionSpace.com

Posted by: Charles Donovan at March 30, 2007 04:03 AM

Yes, I absolutely believe this story, and am really glad you posted it. I've experienced both - unipolar and bipolar depression, and there's a *huge* difference. Bipolar depression is much worse in its' own way - not to alienate anyone who has only experienced unipolar depression. It's just DIFFERENT. They say that physicians can even tell by physical appearance those that have uni- versus bi- depression (I wish I had the link now...)

Honestly, it really is different....

Posted by: KansasSunflower at March 30, 2007 04:12 AM

I agree with most of what you've said, but think these two points are worth considering:

1. Perhaps this is an example of how science is exponential: we know more now than we did, say 5 years ago.

2. This is an example of how NIH is doing good things. This landmark study, like CATIE, is public money well spent.

Posted by: Steve at March 30, 2007 05:40 AM

Great article

It never ceases to amaze me though how depression/bi-polar depression and unibipolar depression are still being tested for treatment with antidepressants or any other chemicals for that matter. Depression is primarily an emotional/spiritual disconnection. The brain chemistry changes are purely a result and symptom of that disconnection.It is the brains response. And there is nothing unnatural about it.Granted, there are possibly some factors predetermining an individuals likelyhood of developing depression or bi-polar depression( genetics etc), but for the most part, it is a learned behaviour usually developed in adolesence or childhood and it is a natural response and reaction to truama. In essence it is a shutting down of the bodies systems and it originates as a protection mechanism.


Biological psychiatry and the drugs it peddles will never be effective as an acceptable long term treatment for any type of depression as they are not treating the cause. And sometimes the cause may be so far back in the subconsious mind that the sufferer may not even be aware of it. Psychiatrists are well aware of what depression really is, and they know that the drugs prolong recovery and they know the dugs compund the "illness" but many have been so misguided for so long into the regime that they really don't know any better.

The danger with Biological Psychiatry is that it is tinkering with neurons, brain chemicals and synapses, which are the symptom of the "depression" and by doing this they are recklessly playing god. All these new drugs, from Paxil/Prozac to Risperadal/ Lamictal and Zyprexa were only originally tested in short term clinical trials for short-term efficacy, benefit and performance. The public, who have been prescribed these drugs in large quantities for the past 20 years or so, have been the long-term clinical trial study. It is a disgrace what biological psychiatry has gotten away with and it is a disgrace how Psychiatry itself has become just another commercial wing of the pharmaceutical companies. Psychiatry is a regime, and that regime survives solely because it has the backing of the drugs industry. Without the drugs industry, psychiatry would not exist in this day and age. Future and more evolved generations will look back on this era of mankind in disbelief at the behavior of the pharmaceutical companies in alliance with Psychiatry and their disgraceful behavior .


CNS (Central Nervous System) drugs such as Paxil and Risperadal
are big business, and the pharmaceutical companies have no real interest in "healing" those suffering from depression or any other mental / Emotional conditions. Paxil was originally classed as a "hypnotic" drug for human use before being aquired by GSK and then tested, passed and marketed for a range of so called "psychiatric" labled conditions from Depression to OCD and even for Shyness (which they like to call Social Anxiety). Paxil isn't a "special" chemical by any means. It was just a drug that GSK invested a lot of money in, they banked on it to compete for market share of the "mental illness market" with Prozac. Whether it really worked or not was not really the issue, if it appeared to work , then that was good enought for GSK. Side effects and withdrawal issues were of no issue to GSK either as they used their skills of marketing and their commerical power to play down the side effects and withdrawal issues as long as they could get away with it. Seroxat/Paxil has been GSK's biggest selling drug in its entire history. But also one of the most notorious of the past decade.
And it didn't become a blockbuster because it was some kind of "wonder" drug or "miracle of science. It was purely aggressive marketing and clever and devious advertising which resulted in its success. After 9/11 , GSK went on a Marketing Blitz with Paxil in the US , they cashed in on the nations anxieties and further pushed Paxil to be approved for a range of other lesser known psychiatric conditions such as post traumatic stress disorder. They saw a possible market to exploit and they went for it. GSK's off the shelf "hypnotic" chemical has now become infamous not because of its wonderous properties but because of its severe, deadly and toxic side effects. And it will go down in history as the "mental health thalidomide"...

For more on the whole Seroxat/Paxil story please check out my blog :

http://truthman30.wordpress.com/

Posted by: Truthman at March 31, 2007 08:08 AM

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