Placebos as good as anti-depressants?

Great Debates
1

In this article: http://www.washingtonpost.com/wp-dyn/articles/A42930-2002May6.html the conclusion seems to be that prescription anti-depressants are pretty much useless. I’m not sure I buy this, but there the evidence sits. It’s like the study Cecil did with the laundry balls.

One problem I had with the study and something they alluded to in the article- one of the things they did was talk to the subjects at length about their emotional states- basically they paid attention to them, which is a form of therapy. So to state that the people who got placebos were not treated is not actually correct (then again the people taking anti-depressants got the same attention, so perhaps this is the control). I can’t really think of a way to correct for this though, since you have to discuss the subject’s feelings to know how they’re doing. Perhaps make them fill out forms as opposed to talking to a live person.

2

I don’t have citations for this, but I can tell you that some practitioners of psychological therapy will freely admit that among those patients who decline therapy after an initial intake, the rates of “reported improvement of symptoms” are not profoundly different than those receiving therapy, over similar time periods.

Placebo reactions to inactive ingredients identified to patients as pain killers cause identical changes in brain activity as opiate based analgesics. The fact is we are still in the earliest stages of understanding the chemistry of emotion, and no one has real hard evidence about their favored therapeutic method.

The FDA accepts that any amount of improvement greater than placebo response indicates therapeutic activity In some cases the difference is well inside the range of normal statistical error for the sample size, but the law lags behind in such esoterica as statistical analysis. You beat the Placebo, you get to market your drug. Once on the market, the decisions are made by Psychologists, and crazy people. Don’t be to sure that the emphasis in that division goes the way you think it should.

Tris

3

The Post, IMO, has it’s head firmly inserted.

The FDA requires solid statistical proof of efficacy before it will approve a drug. To be efficatious, a drug has to be measurably superior to placebo.

Most studies that get as far as human studies do show placebo is superior to the compounds under study, but them, those compounds never get approved, because they lack efficacy. I want to see the Post’s collected raw data and studies, but I strongly doubt that results will be any different from what I’ve just said. The FDA is staffed by professional sceptics, and the Media has along history of cherry-picking it’s data to achieve a desired impression.

Further, I’d like to see evidence that Mayberg’s research techniques are even applicable, and if so, if they’ve withstood peer review.

Without all the ‘information’ the Post claims to have seen, and knowing the curmudgeons at the FDA, I’m inclined to use that Post story for wrapping fish.

4

I’ve taken a depressant (same one) twice. The first time I really felt depressed (cried for no reason, felt paranoid, etc.) I thought that I had immediate improvement and stopped taking them after a couple of months. They actually should not have kicked in until I’d been taking them for 3 weeks.

Second time, doctor said I was a Type A personality and since I’ve had a heart attack he thought I should be on a depressant. I never felt it helped and the only effect was a side effect that I didn’t need or want.

I probably would have been better off taking a placebo.

5

Considering my recent horrible anti-depressent experience , I am a little biased on this subject.

When you read these articles, look carefully at what the experts are saying. It usually amounts to “we don’t know much about the brain, we don’t know much about depression, we don’t have any idea why these drugs work and now we don’t really know if they do work”.

The claims of anti-depressents have always been a little hard to make sense of, anyway. Sometimes they help, sometimes they don’t. Sometimes one anti-depressent works, sometimes another one does. Sometimes you only need them shortly, sometimes you need them for the rest of your life. Usually depression comes back no matter what you do.

Added to this is the fact that doctors are prescribing them almost at random to nearly anyone that steps into their office. The people that take them are often fanatical and evangelical about them (if you do take them, more power to you, but I have seen a lot of breathless and seemingly mindless advocacy among users). Anti-depressents are not treated like normal drugs. What we are seeing is a whole new paradigm of psychiatric medication, which is driven by brand-names, self diagnosis, consumer demand and a proffessional attitude that amounts to “well, why not?”.

Okay, I’ll try to get back on topic…These findings don’t surprise me in the least, although for different reasons. People usually seek help when they are on an upswing anyway. There is no way you are gonna get yourself to a doctor when you are in the depths of depression- you get to doctors when you are feeling better enough to start doing positive things in your life. Naturally you have a pretty decent chance of improving. When you add this to the fact that you are getting shiny new drugs that seem powerful (the side effects will convince you of that) and have a lot positive attention from the media and very likely those around you, it isn’t a mystery that there would be some effects.

And the brain has a huge capacity to affect mental and physical illness through means other than medication. I doubt anyone, even the biggest skeptic, can deny this. I’m no new-ager, but I have witnessed the power of the mind in regards to health. Our first reaction in this society is to medicate, but that is not always helpful or the best thing to do. Medicine can, and does, save lives. But I feel that we too often demand scientific answers to things that science doesn’t understand yet, and that results in prescribing powerful drugs that are not well understood and have a great potential for harm.

6

psssssst…psychiatrists…

There are people for whom placebos will work just as well as real drugs. And then there are people with real problems and real chemical imbalances. For those people, anti-depressants are the way to go.

P.S. I’m not saying that the people who do just as well on placebos are “fakers” by any means. Just that their problems are psychological and not physiological.

7

It seems to me that you can easily take care of that: one group with placebo and talk, one group with drug and talk, one group with neither and talk.

8

—The FDA is staffed by professional sceptics, and the Media has along history of cherry-picking it’s data to achieve a desired impression.—

Except that’s exactly the allegation of what the drug companies regularly do: they just keep doing studies until they randomly get a group that tests positively. Now someone has uncovered all the studies that were never published (since they didn’t get the results the drug companies liked) I wouldn’t put a whole lot of trust in the FDA, not after reading some of the NYTimes articles on how things REALLY work. About as scary as the patent office.

—So to state that the people who got placebos were not treated is not actually correct (then again the people taking anti-depressants got the same attention, so perhaps this is the control).—

Exactly. You want your control group to have basically the exact same experience as the experimental group.

I suspect that one possible reason that the placebo groups could do better is that they wouldn’t have the side-effects from the actual drugs, but do get the talking to.

9

Indeed. I can definitely state that, whatever else they accomplish, there are definite, measurable physiological effects from taking antidepressants; and, conversely, there are severe side effects associated with stopping suddenly. I speak from recent personal experience–going suddenly from a 150mg daily dose of an SSRI to zero for four days is not something I want to do again. Ever.

10

Cite, please!

11

I fully agree.

OTOH talk therapy has NOT been required to meet any FDA standard of proof. So, in some sense, antidepressant medicines have greater validation than talk therapy.

12

Of course that depends on how “efficacy” is defined:

From one of many published meta-studies.
For many similar see this google on placebo "efficacy of antidepressants.

Whether the particular study is correct or not is irrelevent here. What’s important is that the determination of “efficacy” does not match the common perception of how antidepressants work. That confuses people, and leaves the drugs vulnerable to charges that they are “no better than placebos”
It would help matters immeasurably if we could come up with a biochemical and physiological mechanism for depression. That way we’d at least have an objective measure of how well these drugs do what they are supposed to do. Unfortunately the chances of that happening seem pretty low for the next few decades :frowning:

13

Are we talking minor-league pharmaceuticals such as Prozac and Wellbutrin here, or the industrial-strength psychiatric antidepressant meds like the tricyclics?

Indeed. Part of the problem may be that depression may not in any meaningful sense be CAUSED BY biochemical and physiological processes, but rather that certain biochemical and physiological states tend to be part of the organism’s response to social, physical and other environmental stimuli that depress people – then, once those states exist, they self-perpetuate to an extent.

This is hypothetical, but then so is the medical model which assumes biological causes for mental illnesses.

14

Triskadecamus wrote:

Ooh! I really really wish you did have a cite for this!

You see, as a kid I was forced to go through a form of therapy called character-analytic vegetotherapy. I am now trying to discover if there are any objective studies out there showing if this particular form of therapy is any more effective than any other, or if therapy in general is any more effective than no therapy at all. There seems to be almost NO data available on this subject.

15

People can allege this all they want. I’ve seen pharma’s dump Investigative Compounds that actually show efficacy, simply because there’s already a drug with similar or superior efficacy. Some of these INDs have already had hundreds of millions of dollars expended on them, and you expect me to believe that a pharma would actually waste on red cent on a failed compound?! No Pharma that plans on being in business for more than a year will repeatedly throw money down the rathole of a failed compound. If it fails, it’s done. Period. Anyone that actually claims to believe the theory of 'test ‘til success’ is:

  • Completely clueless on the methodoligy of clinical trials (if it fails in a properly run study, it will always fail in a properly run study),

  • Unaware that improperly conducted studies will be rejected by the FDA (witness I M Clone’s recent embarasment),

  • Unaware that the FDA Auditors are hell-on-earth to the Pharmas, and are very good at their work.

  • or -

They’re pushing an agenda.

  • or -

Both.

Futher, periodic safety updates and adverse events reporting continue after a drug is approved, to catch long-term effects not detected in the pre-approval trials and so on.

16

Indeed. This is a leagal and regulatory matter, one which is well beyond any small say I might have.

Bingo.

Don’t give up hope… There are literally 10’s of thousands of highly qualified and dedicated researchers working on it. ‘Decades’ may be correct, but not from lack of effort.

17

I’ve been on a wide variety of meds. I always experience a kind of “bounce” during the first few days on a new medication. If the meds don’t work, this goes away.

I was on Prozac for 6 months. Prozac was just out on the market and was being hailed as a wonder drug. It didn’t help me in the least.

Last year or so, my anxiety disorder started to worsen. I wondered whether the pills were still working. Upon closer inspection, I discovered that the pharmacy had given me 5 mg tablets instead of 20mg. Thus, without my conscious awareness, I had reduced my dosage and seen a corresponding rise in anxiety attacks.

If all anti-depressants are placebos, why do some meds help me and not others?

In short, I sense a biased article. The average person doesn’t understand the term blood-brain barrier, let alone the complex reactions of medications and neurochemistry. Any article can use science that seems legitimate to demonstrate an invalid point.

18

---- Completely clueless on the methodoligy of clinical trials (if it fails in a properly run study, it will always fail in a properly run study),—

I think you’re completely clueless as to how minimal the demonstrated effect has to be, and the fact that most clinical trials are small enough that it IS quite possible to get positive results in some cases. You simply don’t know basic statistics (or the significance of confidence levels) if you claim that, by throwing out failed studies, it isn’t possible to influence the apparent effectiveness of a drug.

The article about the FDA was on allergy medications like Allegra. Look it up.

(ha ha allergies… you pathetic mortals! I, with my superior antibodies, never make the mistake of classifying a harmless substance as an excuse to release histomin!)

19

Personally, I only take Extra Strength Placebo…

20

Indeed? I’ll spot you on the issue of defining efficacy, but then I’d already stipulated that, above. Legal issues over the definition of
‘efficacy’ aside, lets address the rest: Me, clueless on the subject of clinical trials process…?

I suppose you’re not too familliar with me. I consult to the healthcare and life sciences industries. That means: Bio-sciences companies, hospitals and Pharmas. Lots of Pharmas. In fact, a major pharma just picked me up full time (I start for them Monday after next). My specialty is Regulatory Affairs / Regulatory Systems. Every clinical trial, every preclinical trial, every adverse event report, every clinical summary report, case report form, toxicoigy study, and all the other thousands of reports generated in the process of creating a new drug, flows trough my small division on it’s way to the FDA. We privide the output and final reports that the FDA will review. And the FDA response flows back the other direction. I’ve got a damn good clue about the subject. I’ve seen the FDA come into pharmas and conduct audits. I’ve seen auditors find the smallest, most seemingly trivial discrepancy, and turn it into a red line item, sometimes completely halting work on an IND. I read the reports, I see the lists of failed compounds (and the very few that pan-out).

Throwing away studies and expecting to hide that from the FDA? Not a chance. Waste money on a non-performing compound? Not once it’s found to be a non-performer. The Pharmas have too much at stake, and far too many compounds and indications to investigate to bother wasting time and money on stupid games like that. Even if they did, they have a sceptical amd very powerful agency looking over their shoulder.

Now: Perhaps you’ll enlighten us on your industry knowledge? Your grasp of how the Pharmas do business? Your knowledge of FDA behavior & policy? You supposition on how a pharma might hide fraudulent research?

You’ve leveled some fairly serious charges, and provided little in the way of evidence. The ball is in your court. Show me the smoking gun, or admit you’ve only speculation without foundation to go by.