More on that youth suicide study

This from the Boston Globe article “Suicide rates as a public relations tool”

Alison Bass asks two questions that reporters suffering from shyness are afraid to ask:

1. “Why are some in the psychiatric community, despite lack of evidence, working to convince the American public that the FDA may have erred in putting the most serious kind of warning possible on the use of [SSRI antidepressants] in young people?”

Answer: The alarmist call by such ‘pillars of the psychiatric community’ as Dr. David Shaffer and Dr. J. John Mann of Columbia University, to rescind Black Box suicide warnings on antidepressant drug labels, may be viewed as protecting their investment in the antidepressant drug business. Both Dr. Shaffer and Dr. Mann–and an army of other academics who, like them, are ‘on the take’–can be counted upon by drug manufacturers to ring the fire alarm despite the lack of evidence of any fire.

In fact, Bass, points out, the authors of the AJP study overlooked the fact that prescription rates did not drop in the year when suicide rates among youth increased, (2003-2004). Since suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention, there is no evidence of a connection between variations in youth suicide rates and antidepressant prescription usage.

2: “Who stands to benefit from the latest alarm about an apparent upturn in youth suicide rates?”

Answer: The sharp drop in the sale of SSRIs since 2004 has put a big dent in their manufacturers’ bottom line. These companies have an enormous stake in reversing the current FDA warnings. That might explain why Pfizer (the maker of Zoloft) contributed $30,000 to cover the cost of collecting data for the American Journal of Psychiatry study, which was also funded by the National Institute of Mental Health.

“It’s also worth noting that the two lead authors of the paper have disclosed financial conflicts of interest: Columbia professor of psychiatry Dr. John Mann has been a paid consultant to at least two SSRI makers, Pfizer and GlaxoSmithKline (the maker of Paxil), and Robert Gibbons has served as an expert witness for Wyeth Pharmaceuticals (the maker of Effexor, another SSRI).”

More can be found here at the AHRP blog.

You MUST watch this video

The video contains TV clips about the controversy, snippets of an FDA meeting about the drugs, and interviews with now-familiar critics, including Harvard’s Joseph Glenmullen and David Healy of the University of Wales. The video opens and closes with a 911 call in which a New Jersey teen can be heard threatening to kill herself. This is not for the faint-hearted, and it’s likely to upset anyone who believes antidepressants can help people.

Watch it here.

BMJ and Doctor happy to be taken in by unsafe study conclusions

Yep this is another story about THAT study – you know the one – where ‘leading psychiatric researcher’ Robert D. Gibbons, linked a 2004 increase in the suicide rate for children and adolescents to a warning by the Food and Drug Administration about the use of antidepressants in minors. The F.D.A. warning, the researchers suggested, might have resulted in severely depressed teenagers going without needed treatment.

This study was published in the USA in the American Journal of Psychiatry and then featured in an article in the UK in the British Medical Journal entitled “Teen suicide rate rises as prescribing of SSRIs falls, study finds”

Oh yeah?

Anyway, the article in the BMJ gave Dr Chris Manning another chance to continue his bizarre campaign of attacking Professor David Healy whenever possible.

Manning is pro SSRI and sees no conflict of interest between his pro SSRI/anti Healy stance and the fact that for years Primhe (his organisation) has received grant funding from pharmaceutical companies that manufacture SSRIs. You can find out more here, here and here.

I think Manning ought to open his mind to the possibility that the conclusions of the study are flawed before he climbs once more onto his soapbox. The black box warning in the US was not applied to anti-depressants until Oct. 15, 2004, so it is difficult to believe that the warning could have affected suicide data for the entire year.

The New York Times reported on September 14 in fact, prescription rates had not changed much in 2004:
“While suicide rates for Americans ages 19 and under rose 14 percent in 2004, the number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially, according to data from the study. Prescription rates for minors did fall sharply a year later, but the suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention.

There doesn’t seem to be any evidence of a statistically significant association between suicide rates and prescription rates provided in the paper” for the years after the F.D.A. warnings, said Thomas R. Ten Have, a professor of biostatistics at the University of Pennsylvania.

In an interview, Robert D. Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago and the lead author of the journal article, acknowledged that the data from the United States that he and his colleagues analyzed did not support a causal link between prescription rates and suicide in 2004. “We really need to see the 2005 numbers on suicide to see what happened,” he said.

But Dr. Gibbons defended the paper, saying that when taken in the context of previous studies that linked falling antidepressant use to increased suicide rates, “this study was suggestive, that’s what we’re saying.”

If we look at preliminary suicide data for 2005 (released last week) it shows a 3% drop in suicides for that year–the first full year of the black box warning and a year in which anti-depressant prescriptions actually did drop. This would seem to be the opposite of what the study’s authors argued.

This whole affair is an embarrassment for the AJP and the BMJ. Central flaws in a significant study were not caught by peer reviewers and the journal’s editors. A flawed and fundamentally incorrect paper was published to wide media attention. The world is now in essence being told that down is up and up is down by two hugely influential journals.

This situation must be remedied by the AJP and the BMJ – and quickly. The politics and emotions around the SSRI-suicide debate are too intense and divisive to permit this paper to just sit out in the public realm and be regarded by some forces, especially policy making ones, as ‘evidence.’ It doesn’t make sense for the journal to let whatever debate will erupt over this paper to take place six months from now in the letters section of the journal.

The journals either needs to ensure that a correction is promptly issued for this paper–and done so very publicly–or that the paper itself is retracted.

In addition, I have to wonder why Robert Gibbons, the study’s lead author and a very experienced statistician, could screw things up as badly as has been reported. It kind of makes you wonder how reliable his testimony as an expert witness for Wyeth, makers of Effexor, could have been.

Thanks to the New York Times and Phil Dawdy at Furious Seasons.

Youth suicide and SSRI prescribing – the truth

Two great posts about the recent study that supposedly found a relationship to falling SSRI prescriptions and increasing youth suicides…

Firstly CL Pysch takes apart the study bit by bit and he barely manges to hide his contempt for the authors of said rubbish…

Then, over at AHRP, there’s a simple timeline analysis of what happened when…

The study authors, Dr. Robert Gibbons and Dr. J. John Mann should be ashamed of themselves.

When scientists are for sale and “peer reviewed” journals publish planted commercial pronouncements masquerading as “science” news reports, the public is advised to disregard those “news” reports and wait for the evidence to be independently examined and either corroborated or refuted.

ARGHHHHHHHHHH.

Jim Thomson and the European Alliance for Access to Safe Medicines

The European Alliance for Access to Safe Medicines (EAASM) has its brand new shiny website now… have a look here.

It’s an interesting read – says Jim: “…The Alliance has been formed by a cross-section of European patient safety stakeholders from a variety of backgrounds…”

I think more detail is in order, Jim – who were the founders and who are the funders?

Elsewhere on the website Jim tells us (or at least the person who wrote the copy at Medicom Group tells us):

“The European Alliance for Access to Safe Medicines includes members and supporters from both independent and industry backgrounds, and we make sure there are never more funding partners than non-funding partners.

The actions of the EAASM are approved by the executive board which consists of seven members: four independent and three pharmaceutical industry representatives.”

Phew – that makes me feel better…

… but hold on now, who might the ‘independent’ members be, I wonder? I suppose if Jim’s past initiatives are anything to go they might include, perhaps, Amelia Mustapha, or maybe Rodney Elgie, or Neil Bindemann, perhaps Dr Chris Manning or maybe Dave Titcomb?

However, I’m sure it’ll be none of the above – but I think we should know who the independent members are – don’t you?

I have to admit, that Jim and I have a bit of a history – he’d taken exception to a previous post of mine about another of his initiatives (The Centre for Mental Health) and made some comments to put me right “…Nor do I work for Innervate. I did for a short time, while I was trying to establish the Centre for Mental Health. Oh, and on that subject, you’ll be delighted to learn that the Centre has received penny-not-a-one from GSK…”

True – very true Jim – but why, oh why, neglect to mention the £15,000 of funding that came from Eli Lilly and Boehringer Ingelheim in 2006 for the Centre… (scroll all the way down to the bottom of this page)

And why does the EAASM website have to go live with a page that says:

“Additional information will be posted soon, including for example:
• list of sponsoring companies
• funding policy”
• how to become a member/supporter
• operating prinicples”

What’s the problem – why can’t we have a list of funders/sponsoring companies NOW… what’s the big secret?

With Jim, I’ve learnt that what he doesn’t say can be more important than what he does say. I think there are a lot of questions to be answered and as you read about these people and organisations just remember Jim’s own words “…ask yourself one question… What does this person, or this organisation, have to gain from taking this position?”

So – the question is – sixth form conspiracy theory or just more big pharma astroturfing… ?

Update on Phil Lawrence and his Paxil withdrawal documentary…

I noticed that film maker Phil Lawrence had not posted on his blog – Uncomfortably Numb – for a few months – maybe he’s busy finishing off his documentary about his own withdrawal from Paxil/Seroxat, I thought…

Not quite:

The Journey Continues…

Wow! Earlier today I was looking at my calendar and I realized that a year has already passed. On, September 1, 2006, I went to my doctor and told him that after 10 years of use, I wanted to stop taking Paxil. I knew it might be difficult, but I thought I was ready and that I could handle it. As I look back now, I realize that I really had no idea what I was in for…

In the beginning, I actually remember being excited about cutting my dose and discovering the “new me.” I thought to myself that other people who had tried to stop and couldn’t – and then complained about difficult symptoms – were just weak and unable to cope with their own personal lives. I thought I was different and that I could fight through it. That stuff wouldn’t happen to me. Now, as I look back, I see how wrong I was. How naïve.

That leads me to an explanation for my absence over the past several months…

Early in the year, the film project was steaming along – that is until my withdrawal became too severe. Although I continued to record the entire mess, the toll it was taking on my personal life and my business forced me to step back for a while. Fortunately now, I am feeling well enough to hopefully finish it up – unfortunately, I was unable to break completely away from antidepressants. Around April, I was losing complete control of my emotions and had become so confused by what I was feeling that I was consumed with finding a way to make it stop. I tried to stick it out and get better, but the feelings of desperation and despair were too strong. Despite all I learned about antidepressants and the risks involved – on the advice of my doctor – I agreed to try Prozac. Just saying it makes me feel ashamed. While I must admit that I have found relief, it also feels like the drug still controls me. I’m not sure what’s next for me – or how long I will be stuck in this cycle. I guess, for now, the good news is that I’m alive – and I now have even more of a cautionary story to tell that will hopefully help others.

I’m sure that many of you reading this will be able to sympathise with Phil and what he’s going through. I know I can.

Good luck Phil.

Another Seroxat suicide?

This story from Truthman30

The family of a man who died after being hit by a train at Winnersh Triangle have paid tribute to a unique individual who would “light up a room”.

Peter Mayhew, 30, died instantly on Friday, September 7, after being hit by the 5.54pm Manchester Piccadilly to Gatwick service.

It was not until Monday that they learnt Mr Mayhew had died. Now they have shared their memories of a great son and brother.

Mr Mayhew’s mum Nora said: “He was a decent, good, moral, upstanding person. He was very kind to people. When he was happy he would light up a room. He had a lot of time for other people.

“He had so many good friends, but because he had depression he felt lonely and isolated. He was very sad. He found it difficult suffering from depression.”

Mr Mayhew’s family believe Peter took his own life, although they do not know this for certain. He had attempted suicide previously and had spent time in Tilehurst’s Prospect Park hospital.

Mr Mayhew took Paroxetine, also know as Seroxat, for his depression. His mum believes he should not have been prescribed this because of its side effects which can include increasing suicidal thoughts in some people.

The full story is here.

News catch-up

I’ve been very busy recently and as a consequence, I’m aware that my output has been slipping somewhat, so I think a news catch-up post might be in order.

Bob Fiddaman at Seroxat Suffers has been keeping his finger well and truly on the pulse with some great stories:

In Australia, Bob has managed to get GSK adverts for Aropax (Seroxat/Paxil) removed from the website of the Delphi Centre (their strapline: Expertise you can confidently rely on!) The problem is/was, under Australian law these ads should never have been there in the first place…

In another post, Bob looks at the way GSK tried to deal with criticism of Avandia: Sen. Charles Grassley said in a Senate floor speech Wednesday (Sept. 12) he has two internal e-mails from GlaxoSmithKline showing the company tried to silence a medical researcher who suggested Avandia may have health risks beyond those stated on the label.

“Based on this e-mail exchange, it seems to me that at least two drug company officials did attempt to silence a critic,” said Grassley, ranking Republican on the Finance Committee. “In fact, Dr. Buse stopped making any critical statements about Avandia shortly after this e-mail exchange,” which is dated June 25, 1999.

You can read the whole story here at Seroxat Sufferers.

Meanwhile over at Clinical Psychology and Psychiatry: A Closer Look, CL Psych has any number of great news items.

One that stands out for me is this one: Key Opinion Leader Contradicts Himself. This story concerns our old friend Dr Chuck Nemeroff and his somewhat bizarre and contradictory views on Serotonin and the good old chemical imbalance hypothesis… I think CL Pysch has the answer to the contadictions.

The other standout piece for me is about SSRI prescribing and suicide rates in the USA. You may have read some stories a couple of weeks ago claiming that declining SSRI prescription rates have lead to an increase in suicides… ah, well, perhaps not.

CL Pysch’s post includes a link to the New York Times article that has some great reporting on the story and very some telling quotes from respected researchers that may be slightly more independent than the authors of the original study that seemed to tow the big pharma line.

Lastly CL Pysch returns to the Zyprexa debate, with a post that shows exactly how one Lilly employee thought about different ways to suppress a study’s negative results. You simply must have a look at the email where the options were discussed. Naughty. Very naughty.

I’m sure these links will keep you busy for a while…

UK pension funds vie to lead court action over GSK drug

I wonder if JP Garnier has seen the Times this morning?

Two UK pension funds are vying to lead a US class action lawsuit against GlaxoSmithKline (GSK), accusing the pharmaceutical giant of misleading the market over its controversial diabetes pill Avandia.

North Yorkshire Pension Fund and Avon Pension Fund, local government schemes that together manage more than £3 billion in assets, have both applied to be lead plaintiff in the case – a US term for the institution fronting a lawsuit on behalf of other investors.

While UK funds frequently join US class action lawsuits as minor players, it is highly unusual for them to seek such a prominent role. The funds have jointly appointed Coughlin, Stoia, Geller, Rudman and Robbins, a New York law firm, to represent them.

The two UK funds are understood to be claiming they suffered losses of roughly $5 million as a result. “We are joining [the lawsuit] because it is in our members’ interests to do so,” Neil Sellström from the North Yorkshire fund said.

“We monitor class actions and when one is launched against a company where we hold or have held the shares, we assess its merits and get involved where we think it is appropriate.”

Avon confirmed its involvement in the lawsuit but declined further comment. A German and a US group are also seeking to act as lead plaintiff.

A judge is expected to make a final decision on which group to pick next week. Both UK funds have indicated they will remain involved in the case in a lesser role regardless. The lawsuit, originally filed in New York on June 11 by the law firm Kaplan Fox, alleges that GSK “engaged in a scheme to deceive the market and a course of conduct that artificially inflated GSK’s stock price”. It claims that GSK “failed to adequately disclose” important information about the risks of the drug and accuses the company of “fraud” and “deceit”.

Full story here.

GlaxoSmithKline hid the risks of its Avandia diabetes drug…

…to protect more than $2 billion in annual sales, according to a lawsuit filed by a lawyer who has won multimillion-dollar verdicts against other drugmakers.

Officials at Glaxo, Europe’s biggest drugmaker, knew research showed Avandia users faced an increased risk of heart attack and failed to warn them, attorney Mark Lanier said in the suit filed Sept. 7 in federal court in New York.

Lanier, who won a $253 million verdict against Merck & Co. over its withdrawn Vioxx painkiller, sued Glaxo on behalf of Avandia user Frank Curley. Curley suffered a heart attack in 2004.

“Avandia poses significant safety risks due to defects in its design and inadequate labeling,” Lanier said in the suit, which is seeking more than $100 million in damages.

Full story here at Bloomberg.

And thanks to PharmaGossip as well.

I wonder if JP Garnier will be allowed to see out his time to retirement?

You really wouldn’t bet against the institutional shareholders thinking that JP really ought to be forced out as soon as possible – he just hasn’t delivered for the shareholders – as Napoleon might have said – “give me lucky CEOs”

Sorry JP – that’s not you.