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Author Topic:   Holistic Doctors, and medicine
pink sasquatch
Member (Idle past 4214 days)
Posts: 1567
Joined: 06-10-2004

Message 286 of 304 (424257)
09-26-2007 11:34 AM
Reply to: Message 269 by Kitsune
09-26-2007 8:41 AM

STAR*D misinterpretations and cynicism towards science
Hello LindaLou,

It seems your interpretation of the STAR*D study design and motives is flawed. I'm not sure if you've read the original literature or just others' reviews of it - my own comments come from what I believe to be the original general overview of the study:

Rush, AJ et.al. 2006. Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report. Am J Psychiatry 163:1905.

LindaLou writes:

That studies published in the most prestigious journals can be flawed... For example, the STAR*D study that was much-touted.

I don't see the same flaws as you do, and I hope that if I respond to some of your negative comments regarding the STAR*D report, that it will influence your outlook on biomedical studies in general. Overall it would seem you would like perfectly designed clinical studies, but in the real world such studies would be downright unethical - humans are not lab rats, essentially.

LindaLou writes:

They first excluded from the study anyone who was known not to respond to the drugs they were testing or even to SSRI antidepressants in general.

First of all, this is not quite correct. In reality, they excluded patients who had previously undergone treatment with drugs from the first two steps of the STAR*D protocol, regardless of a positive or negative outcome of those treatments. They wanted a clean slate, not a padding of their data.

Secondly, it would be doubly unethical to put someone in need of treatment on a treatment that is known to produce no positive outcome in that patient. Unethical first because you are prescribing someone unnecessary drugs, and second because by doing so you are not attempting to alleviate their symptoms.

Moreover, there was no placebo control in this study. Why not? Perhaps because most AD studies show little or no efficacy over placebo.

Perhaps not.

The STAR*D study was NOT a clinical trial. It was a "real world" clinical study. The STAR*D study was not so much a designed study but rather a framework in which to follow a large number of patients attempting successive treatment options.

Each drug used had already gone through independent clinical trials - the STAR*D study aimed to identify a best-course of treatment with available drugs, not to bring new drugs to the table. In fact, the patients and doctors had a range of treatments to choose from at each step, including non-drug cognitive therapy. The patients had multiple treatment options at each step, as well as the option to leave the study. In other words, they were receiving "real world" treatment.

Furthermore, being a "real world" study of over 3,600 patients, it would be unethical to allow a significant subset to go untreated, especially with suicide as a possible outcome.

Would you expect a couple of thousand of breast cancer patients to go completely untreated in a clinical study to re-examine the assignment of existing cancer treatments? I would hope not.

This study does not show that ADs help millions of people, though I'll hazard a bet that many were put on the drugs anyway after this study was published.

Many were already on the drugs long before the STAR*D study. Again, the STAR*D study aimed to make the most effective identification and use of existing treatments for a given individual.

What you don't see are studies on how stopping these meds abruptly and switching them affects the body and specifically the CNS. No one seems to be interested in doing those.

Except all of those people doing those studies... Have you used primary literature searches like www.pubmed.org? All you have to do is enter something like "SSRI discontinuation syndrome" or "citalopram withdrawal" and you'll find some of those studies that you claim "you don't see". I'm concerned that if you're using secondary sources, you're only exposed to selectively chosen literature - a biased pool of studies.

In fact, in the same issue of the American Journal of Psychiatry containing the STAR*D report, there is at least one study of potential side effects of antidepressant treatment.

LindaLou writes:

NIMH also hired researchers for this study with extensive financial ties to the pharmaceutical companies that manufacture the ADs that were studied. As I said, the case with most of these kinds of studies is that they are done by the very people who manufacture the drugs and who have a vested interest in a certain outcome. I would like to see many more independent studies done with no such conflict of interest.

Okay, a good thing to consider, but all of the potential conflicts-of-interest are clearly listed in the paper:

Rush et.al writes:

Dr. Rush has served as an advisor, consultant, or speaker for or received research support from Advanced Neuromodulation Systems, Inc.; Best Practice Project Management, Inc.; Bristol-Myers Squibb Company; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals, Inc.; Gerson Lehman Group; GlaxoSmithKline; Healthcare Technology Systems, Inc.; Jazz Pharmaceuticals; Merck & Co., Inc.; the National Institute of Mental Health; Neuronetics; Ono Pharmaceutical; Organon USA Inc.; Personality Disorder Research Corp.; Pfizer Inc.; the Robert Wood Johnson Foundation; the Stanley Medical Research Institute; the Urban Institute; and Wyeth-Ayerst Laboratories Inc. He has equity holdings in Pfizer Inc and receives royalty/patent income from Guilford Publications and Healthcare Technology Systems, Inc.

There is full disclosure, for the other authors as well. Also, (and maybe unfortunately), the study made twenty or so patented treatments available to the patients - it's difficult to get these treatments to the patients if the drug companies are completely uninvolved.

But here's why your conflict-of-interest argument really doesn't hold up: The authors spend much of the paper describing the failures of the treatments being used. Indeed, the entire tone of the paper is that of describing what didn't work. From the conclusion:

Rush et.al. writes:

Studies to identify the best multistep treatment sequence for individual patients are needed, as is the development of more broadly effective treatments.

In other words, the authors conclude that the current drugs aren't good enough, and that it is quite difficult to determine the best way to use them in the real world.

I guess my overall criticism of your position is that you want it both ways. You appear to want the biomedical research world to treat patients ethically and with respect, but then fault them when they do so at the expense of perfectly designed trials. You've discounted a study, and apparently an entire field of medicine, based on a fundamental misunderstanding of how clinical medicine proceeds, and without a second thought to ethical considerations. In the process you have strongly implied that a whole host of dedicated doctors and professionals are immoral with no foundation whatsoever - it is patently offensive.

Humans are not lab rats - if you only accept studies that treat them as such, you'll never find a study that suits your taste.

This message is a reply to:
 Message 269 by Kitsune, posted 09-26-2007 8:41 AM Kitsune has responded

Replies to this message:
 Message 292 by Kitsune, posted 09-26-2007 2:26 PM pink sasquatch has not yet responded

pink sasquatch
Member (Idle past 4214 days)
Posts: 1567
Joined: 06-10-2004

Message 296 of 304 (424379)
09-26-2007 6:53 PM
Reply to: Message 294 by Kitsune
09-26-2007 4:53 PM

continued STAR*D misconceptions
Hi LindaLou,

You continue to criticize based on misconception and misinformation.

I thought my information was up-to-date and I wasn't aware that a fourth phase of STAR*D had been conducted.

STAR*D originally involved four phases - this is not new information. Perhaps it is not that your information is not up-to-date but rather it is just plain wrong. In my previous message above I already showed you that you were misinformed on various points.

Most AD trials only last for a total of 6 weeks.

Wrong. Or at least completely unsupported.

The STAR*D study that you like to criticize lasted 12 months.

There are a number of ways that studies can be manipulated to achieve a desired result.

True, but though you have no foundation to distrust any particular study, it seems you don't mind calling the professionals involved liars and charlatans.

Finally, almost all trials are conducted on one drug at a time. Many people are prescribed more than one psychotropic drug. If you are diagnosed as bipolar then you can probably expect a cocktail of at least 3. No one knows what this combo of drugs is going to end up doing to your body because it has never been studied.

Wrong. The STAR*D study examined combinatorial treatment.

Also, regarding your first statement in that quote - Phase I clinical trials, which test the safety of a particular drug, are the most common type of clinical trial. Since safety of the new drug, rather than efficacy, is being examined, it is usually the case that the drug is tested by itself. Again, it appears that you are criticizing a legitimate system because you don't understand its design.

Admittedly I would do better there if I had access to the full, original data from the trials.

Then why don't you get the original data?

It is seriously frustrating to see you make both broad and specific denigration of biomedical professionals and important studies when you haven't even examined them! Instead it appears you are relying on second-hand information, information that you have been shown is flat-out wrong.

Make www.pubmed.org your friend, not books written by biased individuals.

Someone needs to study EXACTLY WHAT is going on within the body, and the CNS especially, when a person is on one of these drugs. Many of the effects of the drugs are unknown.

Okay, but when such studies are conducted, they are either not to your liking, or you distrust them.

I also hate to inform you that your statement is true for most drugs, not just antidepressants. The complex effects on the body of a given drug are generally unknown.

In a simple sense what is known about most drugs is that they have the potential to be curative or alleviate symptoms, occasionally cause side-effects, and rarely outright kill people - and importantly, that the risk of negative effects is acceptable given the chance of positive effects.

There are better, healthier ways of treating mental illness.

That depends on the illness, and the patient. Do you honestly believe that no one could possibly be helped by psychopharmocology? That for some people it is not the best course of treatment? That what worked for you will work for everyone else?

If so, you are far, far, far more close-minded than those that skeptically consider nutritional treatment in the absence of sound studies.

I'm going to avoid them now and in the future, and advise other people to do the same.

That is what worries me. I hope they take your advice for what it is - based on misinformation, misunderstanding, and close-minded bias.

(By the way, I am genuinely happy that you found the appropriate way to manage your own individual illness.)

This message is a reply to:
 Message 294 by Kitsune, posted 09-26-2007 4:53 PM Kitsune has not yet responded

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