Icelandic academic and Neuroskeptic reader Steindór J. Erlingsson reports that thanks to his efforts, pharmaceutical company GlaxoSmithKlein (GSK) has stopped distributing a booklet promoting the monoamine hypothesis of depression to pharmacies and doctors offices in Iceland.His report is here, and it has links to more details on the story, although these are in Icelandic, a language I'm unfortunately not familiar with. In a nutshell, Erlingsson says he spoke to the Icelandic Medical Director of Health who, after some back-and-forth and consultations with psychiatrists, contacted GSK.
On September 29th GSK announced that they
have received information that its information booklet on depression needs to be improved. The company views favorably well argued suggestions and as a result it is going to review the booklet.They went on to say that the booklet, which had been around since 1999, should no longer be distributed. According to Erlingsson, the booklet made three claims:
1. An imbalance in the neurotransmitter serotonin causes depression. 2. SSRIs treat depression by correcting the serotonin imbalance. 3. Psychological treatment is ineffective in treating the serotonin imbalance.
Personally I believe that serotonin probably is involved in some cases of depression. My views on the serotonin hypothesis of depression are therefore more favorable than those of many critics for whom the whole idea is a myth. But even so, I'm happy that to hear that this booklet has been withdrawn. Drug companies have no business promoting the serotonin hypothesis to the public.
First off, because it's controversial science. There's no "smoking gun" proof linking serotonin to depression. There's a lot of circumstantial evidence, but we don't really know how antidepressants work, or indeed how well they work, at all. For once, we should be "Teaching the Controversy". Most of the time when people say that, they're wrong, because they're talking about science which is rock solid, like the theory of evolution. The monoamine theory, however actually is controversial, which is why there are articles in major scientific journals criticizing it and others defending it.
Second, because the monoamine theory is certainly not true in any simple sense. Low serotonin levels cannot be the sole cause of depression because you can temporarily deplete someone's serotonin with a technique called tryptophan depletion and for most people, this does nothing at all to their mood. On the other hand about 50% of people who have suffered from depression in the past do get depressed again after tryptophan depletion, which is why I think there is some truth in the serotonin theory, but this shows that it's not a straightforward picture.Third, the idea that only drugs can correct the "chemical imbalance" and psychotherapy can't is simply wrong. I don't know what the wording of GSK's booklet was, but from Erlingsson's summary, it sounds like it was giving people medical advice - you won't benefit from therapy - via leaflet, which is very irresponsible. Only a clinician with personal experience of an individual patient can say what treatment is best for them. Some people benefit from therapy, others do well on medication, and some people get better with no treatment at all. It sounds like GSK is behaving just as Oliver James did when he used the Guardian to recommend Freudian psychoanalysis over drugs and other kinds of therapy for postnatal depression. They're both wrong.
On the other hand, information leaflets telling people about depression and encouraging sufferers to seek professional help sound like a great idea to me, because many people with depression go undiagnosed and untreated and that's a real tragedy. But drug companies are unlikely to be the best people to provide such information.
22 comments:
Excellent post.
May I add that the chemical imbalance hypothesis is perhaps further undermined by a drug named Tianeptine (Stablon, Coaxil, Tatinol). I'm sure you are aware that this compound is considered to be a selective serotonin reuptake ENHANCER (SSRE); it does the opposite of the popular SSRIs, yet appears effective in the treatment of MDD. It is approved for this use in France, Asia and Latin America.
I guess I'm oversimplifying here, but I'd like to hear your views on this.
The pros and cons of the monoamine hypothesis have been discussed to death in many peer-reviewed review articles. The most obvious refutation is that SSRIs increase extracellular monoamine concentrations within hours of administration, but require weeks of administration for antidepressant effects to occur in humans. The neurogenesis hypothesis is probably the best one at the moment.
Can we say anything that is both scientifically accurate and useful to patients with depression? Do we really know anything about the pathophysiology of a patient who walked thru the door and complained about mood? Perhaps this is a case where ignorance is an advantage and can increase the chances of a placebo based response. Maybe that booklet was the more important part of the treatment than the chemicals in paroxetine.
Speaking as a family member caring for several relatives ill most of their lives, I know all too well that no one class of drugs fix the problem. Although not a medical expert, I have been researching these things as an amateur for 30 years or more, hoping to help my relatives. I read the research studies that aren't locked up for royalties or only open to subscribers. I wouldn't bother with "consumer-oriented" pamphlets, but obviously many people do.
The truth is less thrilling than the pamphlets, and murkier: that some drugs help some people (we do not yet know why)some of the time. In general, similar drugs help people from the same family with a particular condition.
New (and hideously expensive) drugs should only be a last resort. Partly because families with chronic conditions may have several members of them on them, and have to eat as well, partly because the main help the new provide is the "new hotness" placebo effect.
I used to say that therapy helps everyone more than meds, now I say that it helps anyone willing and able to do the work. Certain illnesses make a person closed to the process(at least when ragingly manic, for example).
The great virtue of the meds has always been that when one happens upon the right ones, they help even those unwilling to admit that they are ill (the violent, the manic, the psychotic, the delusional). They can also get around stigma if a doctor can tactfully offer the medicine as possibly helping "off label" (tho there is still diagnosis by prescription that one has to dance around--some people will not take lithium, for example, because they think that means that they have one diagnosis they find personally repugnant)
Sometimes the meds primarily help the family and others around the patient, rather than the patient themself. This is not trivial if they keep a person out of jail, prevent violence, keep them in school or meeting their responsibilities to others (my mother and sibling were often manic for months when they had infants and young children depending on them who needed a healthy mother, not a nanny or harried dad). None of us is an island.
Advertising directly to consumers is not good, because most people read uncritically and are already so bamboozled by consumer advertising. Don't mean that patronizingly, but I know too many desperate people who will believe anything because so worn down and because they have so much respect for "experts" that they are ripe for the plucking.
It also piggybacks on the feeling by many people that their doctors (or their relatives' MDs) don't take the time or make the effort to find "the cure" (a Holy Grail that most people still hope for), or at least soldier on with the sufferer.
The big problem with the advertising is that it drums up trade for snake oil. Patent medicine doesn't actually help everybody, or if so, they merely tranquillize (look at how the Victorian ones were mostly opiates or alcohol). I would have less problem with the hype if there were equally compelling stuff out there for, say, Lithium or the MAOis...with low prices and profits.
I have a young relative who spends hours researching their meds and side effects on the net and who flip flops and goes on and off based on what some real idiots rant about. Nevertheless, it was from an online forum that the kid got the idea to ask their doctor to try an older and now out of fashion drug (potentially dangerous). MD was reluctant (waiting room full of glossy free samples for new hotness). However, after nothing working for YEARS on every new one, tried the old one. Finally, modest improvement, gradually.
Hope, placebo, new hotness, genetic variations in response to different drugs, natural cycles of remission and relapse, environmental stress, faith, religious community, love, work, children one loves or is driven to distraction by, all these things determine mental health...
Forgive the rant...
I thought this might be about the frozen-food store.
It might have explained some things.
Neuroskeptic's statement in his/her(?) post that "the idea that only drugs can correct the "chemical imbalance" and psychotherapy can't is simply wrong" is a believe, not the fact.
First, what type of therapy? Freudian? CBT? EMDR? Hypnotherapy??
Second, how can one tell? Who ever put psychotherpeutic industry, "BigPsycha" to test? Neuroskeptically speaking, why pharmaceutical industry is regulated to the gills while psychotherapy gets free ride? How do we evaluate the damage done by the therapists? Do we know cost/benefit ratio of Freudian analysis? Is psychotherapy better than placebo?
I see nothing wrong for a pharmaceutical company promoting their products. They are, after all, in business of selling drugs. There are also 2 barriers (licensed physician and pharmacist) between them and the patient (three if you count ins. company)
If a physician prescribes wrong medication for wrong reason, the regulatory (licensing) body would question the practice. There are (at least in the USA) from four to six agencies at any given time that regulate prescription of medications.
Medications are simply the tools. A toolmaker should be able to compete and advertise its products. If Black&Decker has a new product they are free to advertize to the professionals who use them and to general public.
Why double standards for pharmaceutical industry? That was a rhetorical question. I believe I know why.
To Paul et al:
chemical imbalance hypothesis is naive at best. Biological psychiatry is past beyond that. Presently, thanks to neuroimaging advances of the last decade (fMRI in particular) we are ahead in our understanding of neurobiology of mental illness. As it is, for variety of reasons the classification of mental disorders and pharmaceutical tools lag behind. Psychotherapy, as a field, on the other hand, from scientific (not therapeutic point of view)is reaching proverbial dead end where psychoanalysis has been comfortable resting for almost quarter of a century, from all points of view
I guess Michael, the problem is, whereas you have intricate knowledge regarding biological psychiatry and the limits of the 'chemical imbalance' hypothesis, Joe patient does not. With this in mind, one has to ask if these leaflets are misinforming the public. I'd say the same about say fish oil pills. You'll find many-a-leaflet in alternative medicine circles (from the manufactures of such pills) citing it as some kind of panacea. Of course, it is not, but these sales pitches (leaflets) do not help individuals make informed choices based on current evidence.
May I suggest 'Bad Science' by Dr. Ben Goldacre. He discusses how Equazen, the makers of omega 3 pills, has seemingly gone to great lengths to misinform the public in the name of profit.
I shan't pick up on the point about psychotherapy as I don't think you where addressing me.
Paul,
I have read "Bad Science", a fine book.
My point was that while "alternative cures" are available OTC, it takes two licensed professionals to dispense prescription meds. Therefore, concerns about the leaflets might be misdirected.
Certainly a valid point Michael, and you would hope these safeguards are effective (perhaps less effective in a more free market healthcare system like your own). For clarification though, I was addressing more the "To Paul et al[.]" bit, Paul being me I presumed.
Paul,
These safeguards are effective indeed. And more effective in free-market society, not less. If you compare centralized power society like Soviet Russia and USA, there is substantially more supervision, regulation, and consumer care and responsiveness in the latter.
Government run pharmaceutical industries have less incentive to protect citizens from bad meds or advance medical technology than privately run but government and other forces (competition, lawyers, media) regulated economy.
"et al" is Latin abbreviation for et alii, meaning "and others", used in references where there are many authors.
Whoaaaa soldier. No one mentioned Communism here. I was really comparing the more free market system you have in America to the more socialised system here in the UK. The problem you yanks have is that doctors are effectively in competition with each other. Patients are customers. A patient sees and ad for say Effexor, goes to his doctor and asks to be prescribed the drug. I would argue that an American doctor is more likely to prescribe the drug because he risks losing a customer if he doesn't as the patient may go elsewhere. I believe the statistics show that a doctor is more likely to prescribe a drug that an individual has asked for, than an alternative that hasn't.
In future, I'd recommend addressing points made by individual commenter's individually rather than as an homogeneous lump.
Pedantry Alert: It's 'et al.' with a dot after the al, it being an abbreviation of said Latin word.
My apologies, Paul, but the style and content of your posts made it hard to guess breadth of your sophistication. Your impatience, however, is almost palpable. One thing is certain. You have very caricaturish picture of american medicine in general and american psychiatry in particular.
From my conversations with "brits" - they are very critical of the services and treatments available from national health care system. You, not the "homogeneous lump", might be a puzzling exception.
I have a recommendation of my own. Let's keep it civil.
I'll drink to that, with bells on Doc.
Dr. Levin,
You seem to have a lot of hostilities towards psychotherapy. Do you really believe that drugs are sufficient treatments for mental illnesses?
And there have been several imaging studies which have shown various forms of CBT as inducing similar neuronal structural changes as antidepressants. Wouldn't you agree that it's fair to assume that such therapies affect neurotransmitters in some way?
I wonder if there have been imaging studies showing structural changes in those who've participated in other forms of talking 'therapies'. CBT is being seen as a panacea as is the case with medication. I have a slight problem with the notion of 'psychotherapy' generally. Is it the specific action of one the so called 'therapies' or is it the fact that people are being listened to, given advice, 'counselled' etc (as people have been doing for millennia) that is really bringing about the therapeutic effect.
I'm afraid research into the effectiveness of psychotherapies leaves a lot to be desired.
Michael:
"My point was that while "alternative cures" are available OTC, it takes two licensed professionals to dispense prescription meds. Therefore, concerns about the leaflets might be misdirected."
How is the fact that the alternative medicine industry is unregulated & generally useless relevant to this leaflet? I'm no friend of alt. med by any means but we're talking about Glaxo. "They're better than the alternative medicine guys" is faint praise indeed.
"I see nothing wrong for a pharmaceutical company promoting their products."
Neither do I - so long as they promote them to doctors. They have no business promoting them to patients directly because patients don't have prescribing powers & aren't qualified to decide which drugs they need. That's why we have doctors, after all.
"If Black&Decker has a new product they are free to advertize to the professionals who use them and to general public." - but this analogy is off, because the general public have a good reason to buy Black & Decker products, for use in the home.
A better analogy would be if a company that makes fire trucks started advertising - to the public - about their new fire truck, thus encouraging the public to start demanding that the fire department buy them. The company has a perfect right to promote the trucks to firefighters who know about such things - they're the experts - but the public don't need to know & aren't in a position to make informed decisions.
Dear Anonymus,
I believe you are confusing psychoanalysis and psychotherapy (I was only referring to psychoanalysis) and hostilty with strong criticism. While psychoanalysis deserve a fair dose of hostility, this forum is not the place to vent it.
Paul,
I enjoy being on the same side of the issue with you.
Neuroskeptic,
the question was not whether promoting meds to public is wasteful, but is it damaging. I don't believe it is; annoying perhaps, but not destructive.
ML,
I new we'd have something in common.
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