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PhotographyMental disorders are very serious ailments, and the prevalence of true positives is high enough to warrant a lot of funding into research and intervention.
However, there is agreement among a lot of scientists and clinicians that there is a shocking amount of false positives, people who are overdiagnosed and receive treatment nonetheless. It is also agreed that pharmaceutical companies are not innocent when it comes to creating demands for new drugs.
Now, I know very little about bipolar disorders, but the following paper by Dr Healy makes a lot of sense to me:
Healy, D. (2006). The latest mania: selling bipolar disorder. PLoS medicine, 3(4), e185. doi:10.1371/journal.pmed.0030185
“What might once have been thought of as sober institutions, such as Massachusetts General Hospital, have run trials of Risperdal and Zyprexa on children with a mean age of four years old [34,35]. Massachusetts General Hospital in fact recruited trial participants by running its own television adverts featuring clinicians and parents alerting parents to the fact that diffi cult and aggressive behavior in children aged four and up might stem from bipolar disorder.”
See also: articles I wrote on drug fraud in the last 3 months (1, 2, 3).
(thank you for pusblishing open access, Dr Healy!)
August 24th, 2012 at 22:26
O_o
und wenn die Kinder anfangen, eine eigene Meinung zu entwickeln, hat es hoechstwahrscheinlich mit dissoziativer Identitaetsstoerung zu tun …
mache aber zur zeit ganz gute erfahrungen im bereich psychiatrie / medikamentenvergabe
August 24th, 2012 at 22:36
Gut zu sehen dass das auch immer mal wieder gut läuft., ich habe da z.B. in der Heckscher in München auch gute Erfahrungen gemacht (gerade bei Kindern finde ich das so immens wichtig). Es ist einfach verrückt, was da verschrieben wird. Und jetzt nehmen sie z.B. auch noch das Bereavement Kriterium aus den DSM-V raus! Wir brauchen mehr Ausnahmen, nicht weniger. Die WHO schätzt dass sobald das neue Buch auf den Markt kommt, 22 Millionen Menschen auf der Welt, die vorher noch gesund waren, plötzlich eine Störung haben und Medikamente “brauchen”. Nope. Die haben einfach einen Partner oder ein Kind verloren. Die brauchen ein paar Wochen und vielleicht Monate, und wir wissen dass es den allermeisten dann von selbst wieder besser geht.
Hier in den Staaten läuft das halt alles einfach noch mal anders. Im Fernsehen und Radio kommt ständig Werbung für Psychopharmaka. Klinische Trials zu Bipolar Disorder an vierjährigen Kindern. Holy cow. Ich habe hier ein paar Kollegen kennengelernt. Antidepressiva in Tierversuchen werden getestet, indem man männliche Ratten (es gibt keine Forschung mit weiblichen Ratten) mit dem Schwanz nach oben irgendwo hinhängt. Als AV wird gemessen ob Ratten nicht mehr dagegen ankämpfen, also aufgeben. Wenn das so ist wird ein Medikament als potentiell erfolgreiches Antidepressivum gemarkt, und falls verträglich genug, an Menschen getestet.
Ich habe nichts gegen Psychopharmaka. Sie sind leider oft notwendig, und solange wir keine besseren haben, geben wir eben die, die wir haben. Aber ich finde es unfassbar, wie viele Menschen damit behandelt werden, und bei denen eigentlich keine Indikation vorliegt. Und wie stark ignoriert wird, wie wenig effizient sie sind (ich kenne mich hier aber wirklich nur gut mit Antidepressiva aus, bei denen die letzten 5 oder 6 Metaanalysen gezeigt haben, dass sie bei leichter und mittlerer Depression nicht über Placebo wirken).
Ich behaupte ja jetzt übrigens schon immer wieder mal, möglichst laut, dass wir in ein oder zwei Jahrzehnten nachweisen werden können, dass Psychopharmaka als Nebenwirkungen unter anderen auch unser Epigenom verändern. So dass ich dann eben sagen kann: Jupp. Hab’s euch gesagt. We’re fucked now. Denn der gesellschaftliche Medikamentenmissbrauch wird über den ontogenetisch erworbenen, aber dennoch vererbbaren Teil des Genoms (Epigenom) an unsere Kinder weitergegeben.
August 25th, 2012 at 19:20
E–Well, now you are stuck with me!
I was glad to see that you have posted several times on off-label (fraudulent) marketing of drugs, and especially psychiatric drugs. As your blogs suggest, pretty much every large pharma company that sells either antidepressants or “atypical” antipsychotics has been busted by the Department of Justice for such fraudulent marketing, often including suppression of key risk data as well as inaccurately hyping benefits for both approved (by FDA) and unapproved uses.
(Along with my forays into psychoanalysis, I also teach about pharma, regulation, and ethics at U-Michigan.)
You ask why aren’t people going to jail? There are a few key reasons.
–It is often difficult to tie these activities to specific perpetrators since. They are organized with intentional “deniability” so that it is difficult to pin responsibility on anyone in particular. Thus, DOJ opts for monetary fines and “corporate integrity agreements” (contracts which say “We won’t do it again.”) Many big pharma companies currently carry a number of such agreements…..As you’ve suggested, even the largest of such fines–$3B in the latest Glaxo case–are easily absorbed into the “cost of doing business.”
–DOJ has threatened to use the “Park doctrine” which would hold top execs accountable even if it could not be shown they were directly cognizant of the scam. They have balked so far. Part of the reason is that any exec convicted of felony fraud (which these activities are) could no longer do business with the federal government. That means having anything to do with sales of drugs to medicare, medicaid, the VA, etc., which together make up more than 50% of all prescriptions written. To remove top execs (CEO etc. level) from work with the feds would do potential violence to the company as a whole (including innocent employees) as well as to innocent patients who genuinely need their products when there aren’t other options. They are thus almost always viewed as “too big too jail.” Along with fines, they sometimes plead guilty to misdemeanors, which does not lead to the exclusion from fed contracts.
3. Of course, same is true of busting an entire company for felony fraud, which never happens although there are plenty of cases in which the evidence would support holding the company, as company, criminally guilty. Again, “too big to jail.”
4. Even if some top execs were busted and served time, there is no evidence this would impact corporate practice. Indeed, some companies have people whose (sub rosa) title is “Vice President in Charge of Going to Jail)–people who are prepared to fall on swords in order to protect company as a whole from significant penalties.
If you want to get your hair raised, a number of internal documents have become public as a result of the DOJ busts and other litigation. If you google around for AstraZeneca Seroquel, Lilly Zyprexa, etc., you’ll be amazed what you’ll find–people emailing each other about burying studies, finding high profile docs who are willing to sign onto industry-written “studies” in exchange for big moolah ($hundreds of thousands), and every possible version of spining supposedly scientific info, even as published in the top peer-reviewed journals (JAMA, NEJM, etc.)
August 25th, 2012 at 20:22
Henry, that’s so interesting! Thank you so much for that comprehensive overview.
I think if personal consequences were more strictly enforced, it might make people think harder about such crimes, maybe. And I find it difficult to believe that companies can cover up who made these decisions. I understand that they play the “we don’t know who decided this” card, but of course they know. We just need ways to force them to intimate these information. Of course no one can ever know the numbers, but imagine about 10% of these frauds come to light (which, I think, is not an unrealistic number) … who knows what of the evidence is made up.
Currently it seems to be like this: you rob a bank (in fact, it’s worse than robbing a bank, because you fool around with the health of, in many cases, many thousand people, if not more.) If you get caught, the worst thing that happens is that the police says: well, we will take 50% of the money you just robbed as a fine. Please enjoy the other 50%.
Again, drugs are important for many people. But giving antipsychotics to 4 year old kids? That’s a criminal offense in my opinion (and I’m by no means an expert, but I did work in psychiatries, both for adults, and for children and adolescents, for a bit).
August 25th, 2012 at 23:09
Here is a link to a CNN story re: the “too big too nail” issue and the big Pfizer bust:
http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/?hpt=Sbin
The issue there was prosecuting felony fraud against the company qua company. Marketing schemes such as those for Zyprexa, Risperdal, et. al. usually involve a great many people in marketing along with affiliated docs/pitchpeople, etc. It might be possible to isolate those most responsible (highest up the chain). But it would be relatively arbitrary.
Most folks who involved in these issues think that civil liability (lawsuits) are a more effective punitive deterrent than criminal prosecution of execs.
But, btw, do you know that is is _impossible_ to bring suit against a drug company in Michigan _even_ if they have committed the kind of fraud discussed here? Our state is unique in this regard. That’s an issue I’ve been working on for about eight years. If anyone is interested, check out.
http://www.pharmaccountability.org and click the Michigan tab.
It’s weird out there, folks!