anti-d warnings... whats next?

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psisci said:
First of all, of course drug companies have their own agenda! They are in the business to sell their drugs and to make $; it is naive to think differently, and even more so to expect them to somehow be altruistic when the rest of the business world is not.

\.

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Sure they are trying to sell more than the opposition in a competitive market.

But ethically, are they really trying to sell stuff that is dangerous / does not work?

I understand the tricks like rebranding something into a new / different format that is essentially the same drug, etc.

I suppose I just had my views on what ACTUALLY goes on challenged somewhat recently. I always had a big bad monster image too.

*shrug*.

To clarify, I am normally quite ANTI drug.

I have always thought Pharmac was EVIL (see funding issues with Herceptin - breast cancer drug - etc).

There are always two sides though ...

> alexandar_k your understanding of the thought process that goes into prescribing meds is way off base and shows little understanding of the medical model, clinical medicine in general, and how people come to choose one med over another med or over another therapy.

i have no desire to get into a pissing contest with you. i'm still not appreciating the rhetoric 'way off base' and 'shows little understanding'. while you at least go on to provide examples, i still fail to see why you need to express your thoughts in such a disrespectful way.

> I have to say that I have never met a doctor who...

it is important to distinguish between:

1) what doctors are told they should base medication decisions on
2) what doctors say they are basing medication decisions on (which is of course likely to fall into line with 1)
3) what doctors actually are basing medication decisions on.

these things can come apart, you see. it is important to distinguish them because while you probably know more about 1 than me i'm more interested in 3. while your opinion might be authoratative on 2 i have no reason to believe you are more authorative on 3 than me...

but really...

the discussion is being side tracked from the initial topic of:

the efficacy of SSRI's.

> "okay they said it works so I am giving you this, take it regardless of side-effects and regardless of whether you want to or not".

have you heard of the 'principle of charity'? it is roughly... don't attribute stupid views to smart people. do you really believe that i was trying to say that journals are the ONLY source of information? you really think i am that simple minded / stupid?

> The most important aspect is prior experience with a certain med

are you talking prior experience in general (as is shown in the studies done with a big sample of people in a journal) or are you talking PERSONAL experience? if the latter... lets say there is this medication that is given to people when they are having a heart attack. lets say i (as a doctor) give it to someone when they are having a heart attack. lets say they die. you don't mean to say that i should base my future decisions on that do you? that i should not give it to the next person? i can't remember what this medication is cilled. 99% of the time it brings heart rate back to normal. 1% of the time it kills the person. if i'm unlucky enough to kill someone... with a sample size of one...

i don't think you meant to say this. principle of charity and all...

that is the whole point in doing the studies. instead of having a biased / contaminated sample that one encounters in daily life... one gets to really isolate the variables one is interested in with a big sample matched for severity and the like. there is a continuum between observation (and description) and the kind of systematised observations (and manipulations) that scientists / researchers do. but surely it would be unwise for a doctor to go with the tally in their head on the perceived effectiveness of some medication rather than the objective peer reviewed research findings.

> then comes the myriad of medical issues, genetic issues, and psycho-social issues that need to be considered, and lastly is research base.

is this the real world or the ideal world? uh... how many hours later is one writing the script?

> Why would I give Remeron to one patient and Effexor to another? Both work on serotonin and NE in a predictable way? Any thoughts? I can guarantee the answer, and the answer for every other doc has nothing to do with double-blind studies, drug company advertising, free pens or meals or any of the things you mentioned.

seems like you know something i don't know. does it make you feel special? why can't we just have a discussion (e.g., you provide the example) without all the side crap?

if you ask people in a supermarket how they picked the product they did the majority of them surely won't mention shelf placement but research has shown that shelf placement has a considerable effect. similarly i don't imagine any doctor in their right mind is going to say 'i prescribe my patients whatever they request (within limits) so i get good consumer satisfaction ratings' or 'i prescribe effexor 'cause the add on tv makes me feel all warm 'cause i had a puppy like that...'

to say doctors are affected by those kinds of considerations isn't to suggest that doctors are stupid or evil it is merely to suggest that they are HUMAN. and that like the rest of humans they could well lack insight into the true motivations of their behaviour.

I challenge you because I am much more interested in giving people here good information that making you feel accepted. I work with doctors every day and have for over 10 years, I teach them in residency training, I consult for them regarding meds, so YES I know what they do to make a medication decision. You have professed to know so much about how doctors make decisions, and how it is so flawed, why can't you answer a simple question that is directly relevant to this topic of antidepressants and their effectiveness?
By the way I have ample research training, and yes we are trained to tear down research to learn how to examine it, but one moves beyond that exercise in futility when as a practicing doctor you have 15-30 minutes to make a very important decision about someone's life.

> I am much more interested in giving people here good information that making you feel accepted.

please repeat the 'good information' that you have offered on this thread because i seem to have missed it.

you (and drunksunflower) are of course correct that a number of factors play in to doctors medication decisions.

i am prepared to defend the thesis that the most influential factor *should* be the randomised control double blind studies that have been published in the leading journals. why? because those trials are more likely to provide generalisable information than other factors like advertising and the like.

my concern, however, is the quality of the interpretations that have been published in the leading journals.

> I work with doctors every day and have for over 10 years, I teach them in residency training, I consult for them regarding meds, so YES I know what they do to make a medication decision.

well i have shopped in supermarkets several times a week for over 13 years. i see many others shoppers and we often discuss our product choices so (by analogy) YES i know what they do to make a product choice.

the point here is that psychological research has shown that shoppers are actually very bad at knowing what factors actually are influencing their product choice. as such, while i might well think that i know and think that my many years of experience makes me an authority on how people make their product choices i am simply mistaken.

as such, i do believe that it would be wise to at least be open to the possibility that doctors medication decisions are not fully transparent to you and of course to them. i mean really, given the psychological research on decision making it would be more surprising if doctors treatment decisions were fully transparent to them and their supervisors.

> By the way I have ample research training, and yes we are trained to tear down research to learn how to examine it, but one moves beyond that exercise in futility when as a practicing doctor you have 15-30 minutes to make a very important decision about someone's life.

yeah. so... a patient presents and requests an SSRI. the patient has seen the ads. the patient has heard that a few of their friends are on SSRI's and they believe that an SSRI might well be that magic bullet to cure their depression.

and the treatment decision is...

based on the APA reccomendation that patients take their anti-d's and stay on them? based on the research (that was behind the APA reccomendation) for the efficacy of SSRI's?

_____________________________________

what is getting to me is the reccomendation that people take and stay on SSRI's GIVEN the way the studies are being reinterpreted now.

would you prescribe SSRI's to children?
how about adolescents?

how about adults?

what reinterpretation of the findings would lead to your changing your decision about prescribing them to adults?

if the APA changed its policy decision?

alexandra, I hate to disagree with you, but the research is quite clear in the overall efficacy of SSRIs to treat depression. While some specific SSRIs are weaker than others in terms of their efficacy, the overall positive therapeutic effects of SSRIs on depression are undisputed.

And when I say "undisputed," I mean that no researcher seriously believes SSRIs, as a class of drugs, have no or just minimal positive effects on depression. Ask any depression researcher who's done work in the SSRI world and they will tell you straight up -- these are not just small statistical effects when taken as a whole.

Now, the actual news article on the recent FDA warnings might be helpful to refer back to: http://psychcentral.com/news/2007/05...tidepressants/

<blockquote>
The drug agency reached its conclusions after analyzing nearly 300 studies of antidepressants, which in total included over 75,000 adult research subjects. The analysis found no increased risk of completed suicides in people taking antidepressant medications.

However, among 19- to 24-year-olds taking the antidepressants, 21 people did attempt suicide. This resulted in the panel concluding that antidepressants presented twice the risk in young adults of the same age who took placebo pills.
</blockquote>

So out of 75,000 research subjects, 21 people had committed suicide. On placebo, only 10 or 11 people did. While this was significant enough for them to issue the new warning, you can see the global risk remains quite small. To put it into perspective, a person suffering from depression is far more likely to be involved in a serious car accident that will result in their death than to commit suicide while on an SSRI.

DocJohn

If you would like some more research / methodological information explaining how we shop the FMCG category that is based on cognitive psychology, do let me know, alexandra

I have used it in chocolate, icecream, and wine research ... hehe.

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alexandra_k said:

> Why would I give Remeron to one patient and Effexor to another? Both work on serotonin and NE in a predictable way? Any thoughts? I can guarantee the answer, and the answer for every other doc has nothing to do with double-blind studies, drug company advertising, free pens or meals or any of the things you mentioned.

seems like you know something i don't know. does it make you feel special?


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I think psisci is trying to get you to consider how he and other professionals might make decisions in this context.

Why don't you give it a go and see what you come up with? At least you will demonstrate how your decision process would work ... and you can then compare it to his. Might make for some interesting learnings / discussion ...

Btw the reason I mentioned supermarket shopping is that sure placement is important but so are packaging incl colour, size, logo, imagery, font ... need I go on? There are many factors that interplay (albeit more subconsciously) when you're making decisions in the supermarket. I don't know if I think the analogy is that great really.

There is a black box warning on anti-depressants for kids. It seems to me that the increased risk for suicide has been known for a while. This is why it is important to monitor a person's mood when on an SSRI.
As for prescribing it, I suspect my doctor would know the information as listed in PDR (Physician's Desk Reference). In other words, a professional researches the most current and accurate drug information and compiles it into a thick resource. I also have read and believe that doctors use their experience with other patients. When my doctor first prescribed Lexapro to me, she described the side-effects that her own patients had experienced. There is published information on known side-effects and some of the incidences that have been reported concerning that drug but my doctor also used her knowledge with her own patients. I researched the drug and discovered that a lot of books confirmed her claim that it had the least amount of side-effects and less drug interaction concerns.
As for efficacy, I have heard of some studies finding them to not be much better than placebo but I find that Lexapro works for me. Is it the placebo effect? I don't know. I doubt it though. I am not sure how many studies show them as not effective and how many show them as effective. I suspect that one of the other posters might know that better. Do I find myself creeped out by the idea of taking a drug? You bet. I told my doctor that I am scared of drugs but I tried talk to for around six months before trying a drug. I have read that many of the anti-depressants are pretty close to each other in effectiveness and doctors try to chose one based on side-effects. I can see this. If the client is sleepy all the time, maybe an activting anti-depressant might be more helpful that one with a side-effect of drowsiness. Does the person care more about keeping his/her sex drive or the desire not to gain weight? What is the person's most annoying symptom? My most annoying symptom was sleep. Also I have read that anti-depressants work better on vegetative symptoms such as sleeping problems, lack of energy etc. So, maybe some depressions are more psychological while some is both psychological and biological. Then some people have more of a biological issue with no or little psychological issues. If so, this might also cause problems with the studies. Depression can be different for different people.
Of course I have no real expertise in the field, I am just a biology graduate who did some reading in an attempt to decide whether or not to try an anti-depressant.

Hopeful, your logic is definitely on the right track.

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Hopefull said:
Also I have read that anti-depressants work better on vegetative symptoms such as sleeping problems, lack of energy etc. So, maybe some depressions are more psychological while some is both psychological and biological. Then some people have more of a biological issue with no or little psychological issues. If so, this might also cause problems with the studies. Depression can be different for different people.

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Yea is this a potential confound in some studies?

E.g. what were recruitment screening / criteria / sample structure?

For some reason I keep thinking about Masters students recruiting for 'depression-based' studies based on a 12-item BDI ...

:>

okay that was just a smartass comment but I think Hopefull raises an interesting point about sample structure.

All depressions are both, actually all anything is both. You cannot have a thought, feeling or sensation with the resulting biology. Yes all antidepressants work best on vegetative symptoms.

Yes so would the studies have analysed *which* symptoms were treated most effectively (and conversely, what were not) or do they measure improvement by lowering of 'depression scores' ...?

/disclaimer total pleb here.

I have no idea. I read studies when I can, but I am much busier treating patients than examining my navel. My first questions in a clinical interview are vegetative.

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psisci said:
I have no idea. I read studies when I can, but I am much busier treating patients than examining my navel. My first questions in a clinical interview are vegetative.

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Navels can be interesting ...

:>

hey docjohn, thanks for your thoughts. i'm actually not quite sure on how we are disagreeing, however.

> the research is quite clear in the overall efficacy of SSRIs to treat depression. While some specific SSRIs are weaker than others in terms of their efficacy, the overall positive therapeutic effects of SSRIs on depression are undisputed.

i guess here it depends what you mean by 'efficacy'. do you mean:

- measured effects of SSRI's vs no treatment
- measured effects of SSRI's vs inert placebo
- measured effects of SSRI's vs active placebo

i don't deny that SSRI's are very effective on the first measure of efficacy. on the second measure of efficacy efficacy is down on the last measure but still better than no treatment to be sure. on the third measure of efficacy (which is more true to the spirit of ensuring the double blind isn't broken by side-effects and / or taste of the medication) efficacy simply isn't looking so good...

it is this last measure of efficacy that i'm interested in.

> no researcher seriously believes SSRIs, as a class of drugs, have no or just minimal positive effects on depression.

that is correct. i'm interested in a particular kind of efficacy, however: namedly, how much more effective SSRI's are for depression compared with benzo's and anti-psychotics and other psychoactive medications.

> So out of 75,000 research subjects, 21 people had committed suicide. On placebo, only 10 or 11 people did.

and these are the supposedly favourable studies that are disclosed by the drug companies. the studies which they were unable to interpret as favourable aren't disclosed to us. we simply have no idea whether they have similarly misinterpreted 'not beneficial' results from studies that are better interpreted as 'positively harmful' results.

> To put it into perspective, a person suffering from depression is far more likely to be involved in a serious car accident that will result in their death than to commit suicide while on an SSRI.

based on the supposedly favourable studies, yeah. the difference, however, is that it is not claimed that SSRI's will help prevent death by car accident whereas it is claimed that SSRI's will help prevent depressive symptoms (where suicide is surely one of those).

> I think psisci is trying to get you to consider how he and other professionals might make decisions in this context.

ah. well i guess i'm finding him far from transparent.

the topic of the thread is whether SSRI's are more effective than active placebo, however.

> Btw the reason I mentioned supermarket shopping is that sure placement is important but so are packaging incl colour, size, logo, imagery, font ... need I go on? There are many factors that interplay (albeit more subconsciously) when you're making decisions in the supermarket. I don't know if I think the analogy is that great really.

the analogy wasn't supposed to support the notion that decisions are made on the basis of one feature. the analogy was supposed to support the notion that the features that in fact determine our decisions are often not features that we are aware of determining our decisions. this is just to say that how people SAY they make their decisions is one thing whereas how IN FACT they make their decisions can be quite another.

i never said (or meant to say) that doctors make their medication decisions solely on peer reviewed efficacy studies. i'm aware that there are a variety of features that are likely to influence their medication decisions. here are a few:

- advertising
- the 'jazzed up' advertising reported in grand rounds talks and at conference luncheons and the like
- their past experiences of treating clients with the medication
- their supervisors preferences
- their colleagues preferences
and so on and so forth.

i did make the claim, however, that they *should* (where the *should* is PRESCRIPTIVE rather than DESCRIPTIVE) make their decisions on the basis of the peer reviewed literature for the reason that the peer reviewed literature is more likely to be generalisable than these other sources of information.

then my beef... is with the scientific researchers. my problem isn't that people choose to go work with the drug companies. my problem is that people work with universities and convey scientific neutrality while having their eye on current or potential sources of funding... i'm saying that the science has been comprimised. i'm saying that doctors are thereby in an unfortunate position.

This is going round in circles. Those multiple considerations you note have already been well cited by others.

We are clear that that is the case, and also clear that if you were a prescribing doctor, your dominant source of information about medications would ideally be 'double blind studies published in peer-reviewed journals'.

You're correct in that if I were to tell you why I bought my toothpaste, I might tell you it's cos I like the taste.

In fact, it's more likely that I buy that toothpaste out of habit. People are faced with so many decisions in their busy lifestyles that they basically use heuristics / omega rules to define what they buy. It might be a preferred, familiar brand, or their choice may be dictated by another rule - e.g. 'the cheapest'. Unless they are at a point where they may make a decision to change (out of stock of regular brand, alternative brand is on special, tried it in an instore sampling, a friend recommended it) they _will buy out of habit_.

Do you see why I think your analogy between a feature of supermarket shopping and the prescription of psychtropic medication is a poor one? I don't think the psychology of product placement in a supermarket is quite applicable to choice of drugs for mental disorders.

Your last point - your 'beef' - is in MY opinion quite valid - in an idea world.

Here's my argument. Quite possibly, I'm making as poor an analogy as you did with shopping - lol.

But I'm going to base this on what I know of research science in the agricultural / pastoral sector of NZ. That happens to be rather a lot ::>

The problem in this field is that funding for 'pure science' is rather thin on the ground. There are the levels of pure science, applied science, and practical science. What industry uses may be based on pure science, ideally, but what industry pays for is applied and practical. Thus, pure science often misses out, much to the chagrin of the scientists themselves. But to get funding, they have to go to the next level. They have to do some quick and dirty shiz, _to get funding_.

With expectations that e.g. Crown Research Institutes now make a profit, it's not feasible for them to concentrate on pure science anymore.

Equally, universities need to stay afloat, it is about funding for them as well.

My point is not that medical research should be 'quick n dirty', OR, as you point out, 'have their eye on ... sources of funding'. IDEALLY, no they would not, they'd be pure scientists and they would start from the base level up and they would have the time and resources to do so.

I suppose I am just saying that there are a whole lot of factors that _control what scientific researchers do__, so perhaps they aren't who you should have your beef with at all.

Just a thought.

> Do you see why I think your analogy between a feature of supermarket shopping and the prescription of psychtropic medication is a poor one?

No, I'm still unclear on that. I'm not saying that there is a perfect analogy (indeed if the analogy was perfect then it actually wouldn't be an analogy because I'd be talking about the same thing twice rather than talking about two quite different things that - i'm claiming - are similar in ONE relevant respect).

> I don't think the psychology of product placement in a supermarket is quite applicable to choice of drugs for mental disorders.

The purpose of the analogy was MERELY that the reason why one makes the choice that one makes is often not transparent to the maker of the choice. consumers confabulate rationales for their decisions. humans do this in general. hence... it would be likely that psychiatrists similarly would have a comperable lack of insight into the reason why they make their treatment decision. that is all i intended to convey with the analogy. i didn't mean to convey that the drugs are all lined up on the shelves and that the psychiatrist prescribes those at eye level i didn't mean to convey that the psychiatrists made their decision on the basis of pretty packaging and taste of the product. i simply meant to convey that human beings in general confabulate reasons and don't have good insight into the features that are relevant to their decision making processes. hence, if we want to know how in fact psychiatrists make their decisions we are better to run an experiment and see rather than to ask them directly.

> I suppose I am just saying that there are a whole lot of factors that _control what scientific researchers do__, so perhaps they aren't who you should have your beef with at all.

the reinterpretation of the statistics isn't to do with new studies being funded. it is to do with people taking their time to conduct a meta-analysis of the studies that have already been funded / conducted. the point is that the stuff that is coming up now should have been picked up on well before now.

by the peer review process. that is precisely the point for peer review.

if a study is published in a leading journal and it has a blatant methodological flaw then that is a major embarrassment for the journal. it undermines its credibility as a leading journal in the field.

that these findings haven't been picked up on well before now is an embarrassment to science. i say this while identifying myself (as a i do periodically) as a scientist.

my point... is basically that people need to be aware of some of this stuff when their doctors tell them they need to be on meds for the rest of their life or they need to be on meds for a time... the doctors don't have time to look into things properly. the doctors don't have to live with the side-effects of the medications.

when i hear people tell others that psychiatric medications are like taking diabetic medication i feel upset because that is NOT how psychiatric medications work. when i hear people tell others that psychiatric medications rectify chemical imbalances so a person is normal i feel upset because that is NOT how psychiatric medications work. when i hear people tell others that they are 'not willing to help themselves' if they don't want to take the medication then i feel upset.

what is happening to the science???

and the drug companies get richer...

ugh.

It has been published in the literture and well known for over 20 years that antidepressants have some association with increased risk of suicidal thinking...nothing new there. Psych meds do change behavior by altering chemical balances?? How else would they work?

> It has been published in the literture and well known for over 20 years that antidepressants have some association with increased risk of suicidal thinking...nothing new there.

right. once again, the issue is efficacy of SSRI's compared with active placebo.

> Psych meds do change behavior by altering chemical balances?? How else would they work?

of course meds change behaviour by altering neurology. similarly, learning changes behaviour by altering neurology. similarly, psychotherapy changes behaviour by altering neurology. similarly, social intervention changes behaviour by altering neurology. similarly, meditation changes behaviour by altering neurology. similarly, placebo changes behaviour by altering neurology.

the idea of 'rectifying' or 'fixing' or 'undoing' a supposed abnormality... there is no evidence that medication does that. and... once again... i'm concerned about the evidence that SSRI's are more affective than active placebo.

if it has been known for over 20 years that SSRI's are known to cause an increase in precisely the symptoms they are prescribed to alleviate... then why does the APA make the treatment reccomendation that it does?

do you know the justification for it? i don't.

is it to do with it being considered unethical to prescribe a placebo?

i don't think that consumers are typically aware that SSRI's are known to cause an increase in the symptoms they are taking SSRI's for...

You miss my point about pretty much everything I was saying alexandra.

You are just going round and round in circles rather than evolving your argument, and trying to 'win' on semantics. You have beef with the scientists.

I am simply trying to point out how a lot of science works these days.

If you are focussing on your meta-analytic SSRI studies, fine, but I thought we were talking in a broader context here. My bad.

Nighty night!

Btw, my issue with your analogy of supermarket products is not that I think they line them up and choose on whichever has the nicest colour scheme on the packet.

My point is that by making the analogy, you are comparing a very uninvolved decision-making process with a very involved decision-making process.

Sigh. I am sorry, I am going to bed, and shall leave you to debate the best tasting coloured M&M in the packet with psisci ... or whatever you wish to quibble over next.

Btw, I do agree with your last comment on not taking meds. I quite like the mind over matter theory, myself.

This whole debate that's going on here,or at least it appears to be one, brings back something I heard from my former psychologist and then one of the professor's made the same statement which goes on to say, "who knows if these people that were taking the med(s) or not would have gone on to suicide?
There's been cases where a person doesn't even appear depressed, and then to many people's surprise, they are in shock when they learned that person offed themselves, and what's to say for the fact they weren't on meds, is it possible they needed to be on meds and/or in therapy but never were of either one?
Was it really the med(s) or the depths of their depression?
Maybe their dosages weren't proper for them?
How much were they really complying with treatment?
The questions/statements they raised made a lot of sense.
People should read the Medication monologs(sp?) or safety data sheets first and talk any concerns over with their docs and even the pharmacists.
Almost every med,not just the SSRI's, have risks, even OTC meds, doesn't mean everyone is affected in the same way, but the manufactureres have to list every side effect(s) I think it's up to the patient besides or even more so,than only the prescribing physcian to take some sort of responsiblity, ask questions when in doubt, and/or even weigh the benefits vs side effects.
I'm not pertaining to serious side effects, mostly I'm referring to minor and temporary ones.
Again, I think there is a lot of sense to what I heard about a depressed person, rather on meds or not, always can be at risk of becoming suicidal, who really knows for sure.
Not to be cynical but the families of those that killed themselves may find it easier to blame a med and bring lawsuits to gain cash settlements when it may have not or wasn't the meds in the first place, instead the person was not getting the proper treatment or wasn't following through with treatment.
Or the family and/or the deceased had been in denial the person had a mental illness, so many can't deal with that, they fear the stigmas,etc. so sweeping it under the rug satisfies them more. Ah,who knows for sure.
I was taking Accutane when it first was released, like a million other people, I didn't suicide, and either did others, but yet people asscociated a few teenage suicides to Accutane, I believe it was of their own doing, their disorders and/or the adolescent thing of raging hormones.
This is my own personal take on this subject, I do not wish to debate anything I said here, just wanted to share what I had brought to my attention by those in the mental health field, oh, and I forgot to include my former pdoc and my present one.
Take care,
DE

I think your point of 'scapegoating' a drug to explain a suicide is a very good one. I guess it is a coping mechanism for family etc.

Media moral panics are also awesome in situations like this. It is happening with party pills (BZP-based) here. Some plonker mixes legitimate pills with alcohol, ecstasy, and other street drugs, ODs, and the BZP gets blamed (even though instrux explicitly state not to mix the pills with ANYTHING, and even ER docs are trying to say that they see far more alcohol-related damage than anything to do with BZP).

Wicked.