January 30, 2007

Paxil (Seroxat) On The BBC

As many of you know, the BBC's "Panorama" (essentially Britain's "60 Minutes" or "Frontline") had a program last night on Paxil (Seroxat, as it's known in the UK). It's not the first time the program's reporters have hammered on all kinds of alleged corporate misbehavior by Glaxo SmithKline, its maker, and the horrendous side effects of the drug. I know these side effects personally and will get into that in a separate post.

First, here's a link to the show's website where you can stream a video of the program. I wasn't able to watch it myself since the BBC has yet to learn of a little old video program called Quick Time. I'll get to it eventually. The gist is this:

"Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials. And that GSK-employed ghostwriters influenced 'independent' academics."

In addition, there is this lovely nugget:

"Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329 [a Paxil study in kids]. In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK. He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates."

I cannot even get into that bit except to say that doctors have an ethical charge to work in the best interests of patients--especially children--and that Ryan has failed in that ethical charge. (It's basically a lot like the "protect and serve" charge that cops have or the "If your mother says she loves you, check it out" charge that journalists have.) I hope his colleagues at Pitt find an appropriate manner in which to censure him, and if they don't, then the APA should.

GSK's response to the program can be found here. PharmaGossip has this post on the show (and thanks to the "Insider" for linking to me lately. I love his/her blog but would really like to see the cheerleaders-gone-phamra-reps thing hit a little harder. Like every day).

In addition, I find it heartening that the editor-in-chief of the British Medical Journal, Fiona Godlee, has issued a strongly-worded statement on this matter. It's so good that here it is in full:

"Panorama's account of GlaxoSmithKline's successful attempts to market Seroxat for use in children, despite the fact that its own published trial found evidence of serious adverse effects and failed to show benefit, is fascinating but depressingly familiar. What is even more depressing is that such behaviour is still so widely tolerated within medicine.

There has been no shortage of outcry or official condemnation - including clear statements from the World Association of Medical Editors, the International Committee of Medical Journal Editors, and industry itself through its Good Publication Practice guidelines - that undeclared conflicts of interest and ghost writing are unacceptable. But, you might reasonably ask, what use are such huffings and puffings in the face of the individual rewards on offer from drug companies.

Let's be clear what is and is not acceptable. There is nothing wrong with getting help from medical writers, provided they and their source of funding are clearly acknowledged. Nor is there anything wrong with academics or clinicians working with industry, provided they remain personally accountable for everything they say.

What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record. Legislation is not going to happen soon - the powerful industry lobby will make sure of that. Regulation is still inadequate.

So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure. We shouldn't have to rely on investigative journalists to ask the difficult questions. So at meetings, why not slow hand clap any speaker who does not begin their talk with a sentence or slide declaring their conflicts of interest? And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal and probably retract the paper.

Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking."

The day we get similar statements from the APA and AMA....Ah, I am dreaming there. And, as one British psychologist has found out recently, there is a very high price to pay for breaking from the establishment, a price that David Healy, a psychiatrist knows far too well. Scientific Misconduct and, on this side of the pond, CL Psych have been pounding on this matter. I will soon join them as soon as I have time to learn more about the case, along with all the other little bits of pending news I am juggling here of late.

Posted by Philip Dawdy at January 30, 2007 12:01 AM
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Comments

To: The British Psychological Association

I am given to understand Ms Lisa Blakemore Brown is to appear before you on some disciplinary matter in connection with her views on the Munchausen Syndrome or similar matter

Having seen the work of Ms Lisa Blakemore Brown and consulted with her on her visit to Australia I wish to record I have great respect for the work she is doing in this area.

It may be recalled that since she visited Australia and spoke at a Conference in Sydney there has been a change in the Law in Queensland – no longer do the Courts recognize a diagnosis of Munchausen Syndrome by Proxy and this will no doubt be copied in other Jurisdictions.

Ms Lisa Blakemore Brown is probably the only member of the British Psychological Society recognized world wide for her outstanding work on Autism. It would be shameful if any disciplinary action is taken against her for holding the views she does.

Academic freedom is the lifeblood of progress in Science.

Yours truly,

Michael D Innis MBBS; DTM&H; FRCPA; FRCPath

Posted by: Michael D Innis at January 30, 2007 03:21 AM

You are quite right: Fiona Godlee's statement is to be welcomed. I think we also have to be alert to whether the medical establishment in the UK are completely genuine or just posturing: I hope the former. But it is a considerable concern that they are actually turning a blind eye to such cases as Lisa Blakemore-Brown who case is featured in Aubrey Blumsohn's Scientific Misconduct blog and on NHS Exposed. In fact the BMJ itself witheld evidence regarding the persecution of Ms Blakemore-Brown, refusing to reveal the identity of fraudulent posters who made false allegations against her in May 2004.

From the BMJ we need consistency and a clamp down dirty tricks.

Posted by: John Stone at January 30, 2007 03:29 AM

"From further documentary evidence I have received, these matters are becoming increasingly bizarre and Kafkaesque. It would appear that the BPS would be far wiser to abandon their witch-hunt of Lisa Blakemore-Brown and to investigate instead the credibility, credentials, and motives of her accusers. Evidence suggests that there is definite malice behind the complaints and there has been collusion and collaboration in seeking to defame and discredit Lisa.

The BPS would also be well advised to investigate the mental stability of her accusers, their criminal histories for offences of deceit and dishonesty, and their links with and support by corporate organisations. Such corporate organisations have very considerable vested financial interests to protect and have a history of silencing exposure of their misdeeds and of controlling academic freedom if such academic treatises were unfavourable to their corporate interests.

If the BPS decide to mount such an investigation into the malicious accusers of Lisa Blakemore-Brown, I shall be more than happy to provide them with the documentary evidence."

Charles Pragnell Dip.S.W., L.R.C.C.

Posted by: Charles Pragnell at January 30, 2007 03:54 AM

Philip Dawdy wrote " doctors have an ethical charge to work in the best interests of patients--especially children"
You don't understand psychiatry. A psychiatrist beleives what they are doing is the right thing. They use their own morals and beliefs to decide what is right for the patient.
The patients thoughts and feelings are unimportant in biological psychiatry.
Psychiatry is only interested in the flesh of the patient as illustrated by the use of EST/ECT to treat depression. Reasons for being/feeling depressed or crazy are never confronted (in my experiance).
I beleive this is because the psychiatrist answers to the family of the patient and not the patient. This is far more evident in child psychiatry, where the childs percieved problems come from the adults in control.

To understand the world from the patients point of view and to feel empathy is a foreign concept to them.
http://www.successfulschizophrenia.org/articles/ndlisten.html

Posted by: Mark at January 30, 2007 09:36 AM

You can read more about the dangers of Seroxat on my blog at http://fiddaman.blogspot.com/. You will see through the various articles posted on there that the MHRA have known for some considerable time that Seroxat is not only dangerous in the children population but also the adult poulation too

Bob Fiddaman

Posted by: ROBERT FIDDAMAN at January 30, 2007 11:22 PM

[Firstly re "I wasn't able to watch it myself since the BBC has yet to learn of a little old video program called Quick Time. I'll get to it eventually" : there's a handy (free) little programme that doesn't hog resources like RealPlayer does, called "Real Alternative" that will read RealPlayer files and can be downloaded here - http://www.free-codecs.com/download/Real_Alternative.htm ]

A couple of vital pieces of information in the excellent panorama programme re 'Secrets of the Drug Trials' are the following, reminding us that although this programme FEATURES Seroxat (Paxil) the same issues concern many other drugs, including other SSRIs, SNRIs, antipsychotics (Zyprexa for instance), and even medicines for 'phsycial' illnesses:

"Reporter: SHELLEY JOFRE
Malibu, California. It's not where you'd expect to unravel one of the biggest medical scandals of recent times, but that's exactly what this team of lawyers has managed to do. What they've found affects all of us here in the UK, anyone in fact who takes prescription medicine..."

"...Professor DAVID HEALY
University of Cardiff
We're in a situation now where people who are ill generally have been deeply betrayed by the whole process, deeply betrayed by the pharmaceutical companies and by all the experts that have been willing to actually lend their names to the process..."

(http://news.bbc.co.uk/1/hi/programmes/panorama/6317137.stm )


Posted by: paula at February 6, 2007 06:33 PM

The BPS is not a regulatory nor disciplinary body for the profession of psychology.in Great Britain. It is merely a membership-based association and all they can do therefore within their powers is to cancel the membership of Lisa Blakemore-Brown but as she resigned from their membership over five years ago, then such a course of action is not open to them. No doubt they will seek to redress this by making a rule that they can still examine complaints against a former member if the complaint was made during that person’s membership of the BPS. In this case it was not made during Lisa’s membership and therefore there are no lawful grounds for their jurisdiction in these matters. If the BPS were now to make such a rule it could not be applied retrospectively. That would be contrary to legal principles and particularly the principle of natural justice. (You cannot be tried for an offence that was not against the law at the time it was committed).

In effect the BPS has no jurisdiction whatsoever in this matter and as such therefore, the Panel had no legal or administrative basis or validity and the appearance of Lisa B-B before their Panel must therefore have been of her own volition and solely to help them to clear up this matter. The BPS seem to have been unable to find any evidence to support the complaints made against her and the complaints must therefore be assumed to have been groundless and malicious but the BPS appear to have then changed tack and sought to question her fitness to practice on health grounds. This secondary issue appears to have been introduced after it was found there was no evidence on which to consider the original complaints.

I am informed that although she did not have to do so, Lisa B-B agreed to submit a mental health assessment to the BPS Panel and quite naturally such assessment by a respected psychiatrist found her to be totally mentally competent. I would suggest that such would probably not be the case if applied to the BPS Panel.

I am informed that the Panel reached their decision to cancel Lisa B-Bs membership of BPS (although she was no longer a member) without giving reasons for so doing. Surely in any decision-making process the process of reasoning and a clear statement of the reasons precedes the conclusions and justifies the decisions made?. In this instance, the decision was made and then they began searching around for their reasons? (Come back Franz Kafka, all is forgiven).

Such simple and logical processes are obviously beyond the competence of the hierarchy of the BPS and raises serious questions regarding how these people who comprised the Panel were able to get into the psychological profession in the first place and about their own standards of practice.

I think that every psychologist in the UK who is in membership of the BPS must seriously question whether they would wish to continue in membership of such an organisation. Firstly that this case of Lisa B-B has seriously damaged the reputation and standing of the BPS and secondly, that they themselves may be subjected to the same injudicious processes and have their careers wrecked by this incompetent body, especially if they should have the temerity to challenge an unsound and unscientific theory. Academic freedom and the right to a contrary view clearly does not exist in the BPS.

The BPS would desperately like to become a regulatory and disciplinary body under statute and with the support of the government, but this case has clearly shown that they are far from being competent to fulfil such a role and I’m sure the government will have taken careful note of their incompetence and irrationality, when they are already facing similar problems with the GMC.

Charles Pragnell Dip.S.W.., L.R.C.C.

Posted by: Charles Pragnell Dip.S.W.., L.R.C.C. at February 11, 2007 04:44 PM

Check out my new blog for the history of Paxil / Seroxat...

http://truthman30.wordpress.com/

Posted by: Truthman at March 8, 2007 04:13 PM

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