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Thursday, March 15, 2007

Seroxat Archives - Independent, The (London), Oct 5, 2004

Independent, The (London), Oct 5, 2004

If the British pharmaceutical company GlaxoSmithKline has any doubt that it is in extremely bad trouble, it will not find any solace in reports that the US documentary maker, Michael Moore, has been rootling about in Philadelphia. His production team is keen to make friends with people based at the multinational's US headquarters, and eager to talk on camera about goings-on inside the building that will play well in his upcoming film about corporate greed.

Likewise, if the company's executives are in any doubt as to why they have been singled out, they could start by considering their own salaries. Jean-Pierre Garnier, the company's chief executive, for example, gets $18m (pounds 10m), even though the huge conglomerate does nothing but lumber from crisis to crisis.

And these crises have been spectacular. It's not just that the company's profits and turnover keep on declining. It also seems hopeless at fending off bad publicity. GlaxoSmithKline sometimes appears like a company that suffers from all the disorders its drugs claim to alleviate. GlaxoSmithKline, perhaps, should be taking the anti-psychotic drug Thorazine, instead of just making it.

First, there was the magnificently inhumane decision to try legally to block the South African government's attempts to get Aids drugs at prices a little more commensurate with their manufacturing value. Then there was the misjudgement in 2001 whereby the complex and long-sought merger that made the world's biggest pharmaceutical company - between Glaxo Wellcome and Smithkline Beecham - revealed that neither had much in the way of new drugs in development at all. And there's the continuing, ever more stinky, Seroxat scandal.

How long ago was it first reported that some of the anti- depressant wonder- drugs that were supposed to be creating a world without sadness, were prompting suicidal thoughts in some people? It feels life a million years ago. But, it appears, real concerns only started emerging in 1997, when the heroic Dr David Healy, an expert in psychological medicine at Cardiff University, first started raising concerns about SSRIs and suicidal, aggressive or addictive behaviour.

These concerns, upheld by many other respectable people, were scorned by the pharmaceutical industry - not just by the makers of Seroxat, but by the makers of all the selective serotonin reuptake inhibitors, including Eli Lilly's Prozac.

Now, after much battling, doctors are being advised by the UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), that no SSRIs - apart from Prozac - should be used in treating people under 18, because they can prompt suicidal or self- harming thoughts. Even Prozac is said to be capable of causing suicidal thoughts; expert opinion merely concedes with Prozac that the benefits seem to outweigh the risks.

When it comes to working out why it was that the risks now associated with all SSRIs went undiagnosed for so long, GlaxoSmithKline is one of the pharmaceutical companies that should be looked into. The company was subject to a legal challenge by New York state attorney Eliot Spitzer recently, which accused it of withholding evidence for a decade that Seroxat prompted suicidal thoughts in the young.

It paid out a large sum to settle, insisted that the accusations were unfounded, and promised that in future it would publish all of its research findings on the internet. Mr Spitzer is said to be furious though that the multinational batted off the challenge without contrition and swears that he's watching the company "like a hawk". In the meantime, inspired by Mr Spitzer's example, another US lawyer has mounted a large class-action against GlaxoSmithKline. The company is pessimistic enough about its chances to have set aside $1bn for legal expenses.

Now the company faces new allegations, brought into the public domain by Sunday's Panorama. Again focusing on Seroxat, the accusations say that GlaxoSmithKline sat on negative information about the effects of Seroxat on children for two years before passing it on to the MHRA. The regulator responded quickly, issuing a ban on giving Seroxat to children within two weeks of getting the information.

But the MHRA is in trouble too, because Panorama has evidence that information which laid in its own files for a decade also flagged up the possibility of Seroxat causing addiction, aggression or suicide. GlaxoSmithKilne counters that this information existed in the form of nine separate studies which only pointed to difficulties when they were merged. This merged information, they say, was given to the MHRA as soon as it came to light.

If it seems kindly that GlaxoSmithKline should offer this lifeline to the regulatory body, then it is not. While to the casual observer it may look as if there is some kind of problem with restraining the corporate ambitions of the pharmaceutical multinationals, the truth is that very little effort to curb their power is made at all.

The MHRA, for example, has been wholly funded by the pharmaceutical industry ever since it was taken out of the hands of the Department of Health in 1989. Economically, it may make perfect sense for companies to bear the cost of getting its products into the marketplace. But in every other sense, it sounds like a risky kind of business, open not only to deliberate abuse but also to cosied-up, lazy thinking.

It doesn't help either that the personnel in the companies being regulated and the personnel at the regulator are interchangeable. One newspaper recently noted, for example, that the MHRA's head of licensing used to be head of worldwide drug safety at none other than GlaxoSmithKline.

While all this seems almost designed to court disaster on its own, there is the other jaw-dropping detail, which is that nearly all research into new drugs is carried out either by the drug companies themselves, or by independent groups funded by them.

Hilariously, this research does not have to be published in full in any public forum. It can be presented partially, so all the good news is advertised and all the bad news is buried. There's hardly a person on the planet who thinks this is healthy. But even now, stung by the prospect of litigation, the drug companies have been left to put research on the internet voluntarily.

Instead, what is clearly necessary is a body which can organise collation, monitoring and cross-analysis of these studies in full. It may well be true that nine studies on Seroxat festered for a decade because no one made a meta-analysis of them, and realised there were research holes that had to be filled.

Even now, evidence about some SSRIs is emerging, led again by Dr Healy, which suggests that when they are prescribed to people who are not depressed, they can cause aggressive, violent or even psychotic behaviour. With SSRI prescription so widespread that traces of certain drugs have been found in the water supply, this is a very worrying thought.

In fact, the controversy over Seroxat, and over the other SSRIs was entirely predictable, and largely predicted. Sold as a panacea not only for those with depression, but for anyone who felt miserable, they seemed like an ideal drug for a culture that believed happiness was a human right. Now, it appears, that impression came across because that's how they were marketed, and not because that's what they were. SSRIs do help people with depressive illnesses. But the one-size-fits-all approach was never appropriate. The sad fact is that any clown can see that truly independent regulation and a truly accountable pharmaceuticals industry is the missing link. But nobody, politically, fancies forking out for the simple solution.

Copyright 2004 Independent Newspapers UK Limited
Provided by ProQuest Information and Learning Company. All rights Reserved.

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