why you should never trust new wonder drugs

ignorance is bliss

medicines out of control

More Zyprexa Postcards From the Edge by Evelyn Pringle

 PAROXETINE, SUICIDE AND PLACEBO

 The Seroxat/Paxil story is far from over, in spite of the monumental 

admission this week by GlaxoSmithKline (GSK) that depressed adults treated 

with paroxetine might be six times more likely to exhibit suicidal 

behaviour than matched adults treated with placebo. There is a whole new 

chapter to be written, but it will take more than this to sort out the 

underlying problem: the management of drug health and safety issues is in 

some ways intensely poor.

 Charles Medawar      This new, improved analysis of the risk of 

adult suicidality is mostly of data from clinical trials conducted 10 years 

ago or more. The main thing new is that this was the first independent 

analysis based on a blinded re-evaluation of the raw data. When the UK drug 

regulators, the MHRA, ran their 'independent' investigation of SSRI 

antidepressants, in 2003-4, they relied not on the raw data, but on 

summaries and analyses the manufacturers had prepared.

 The limitations of this approach are evident from our on-going 

correspondence with the MHRA about the true nature of the so-called 

'placebo suicides' reported in paroxetine-versus- placebo clinical trials. 

Briefly, both the MHRA and the European regulators (EMEA) accepted the 

company's claim that, in these trials, three people on placebo committed 

suicide, compared with only one person on paroxetine. This was a key 

finding and central to the regulators' enquiries, but an inherently 

implausible result. Moreover, it was based on brief summary evidence 

provided by a company then (and still) under investigation for suspected 

concealment of related evidence. Nevertheless, EMEA, the MHRA and its 

Expert Working Group saw no need to examine the raw data.

Those data are now in the public domain and they demonstrate that 

the three 'placebo suicides' were no such thing. Now it is up to the 

regulators to respond to our complaint that they have systematically 

deceived others as well as deluding themselves.

 Meanwhile, the enormity of GSK's recent admission has yet to sink in 

- as it was clearly never meant to do. How long will take for the media to 

recognise that the risk of suicidal behaviour in depressed adults on 

paroxetine - officially and emphatically denied for many years - may be 

twice as high as the risk for children? So far, the media have been thrown 

right off the scent, led to believe that this new finding is just a blip 

that mainly reflects the sensitivity of young adults - and therefore just a 

firmed-up result of a risk that was very tentatively trailed by the 

MHRA / EMEA a couple of years ago:

"There is no clear evidence of an increased risk of self-harm and 

suicidal thoughts in young adults of 18 years or over. However, given that 

individuals mature at different rates and that young adults are at a higher 

background risk of suicidal behaviour than older adults, as a precautionary 

measure young adults treated with SSRIs should be closely monitored." 

(Expert Working Group report, p. 119)

 In fact, GlaxoSmithKline made no statement to prescribers in the UK, 

but left it to the MHRA and the Commission on Human Medicines - the parrot 

that rose from the ashes of the CSM. "What is the issue?" asks the Chairman 

of the CHM: "The MHRA has been made aware of a new analysis of Seroxat 

clinical trials which suggest that adults, particularly young adults with 

depressive illness, may be at increased risk of suicidal behaviour when 

treated with Seroxat." The thrust of the MHRA/CHM alert statement was that 

their 18-month 'expert', 'independent' investigation of SSRI 

antidepressants (2003/4) had been up to scratch:

"I am writing to inform you about the new analyses of paroxetine 

clinical trials that are being published by the manufacturer of Seroxat, 

GlaxoSmithKline .These new analyses examine the risk of suicidal behaviour 

in clinical trials in the adult population, and were conducted as part of a 

review by the US FDA. The new analyses highlight the importance of 

monitoring all patients treated with SSRIs for worsening of their symptoms 

or mood changes but do not alter the prescribing advice for SSRIs issued in 

December 2004 following the review by the CSM Expert Working Group on the 

Safety of SSRIs."

Here is a fine example of the Conspiracy of Goodwill at work - 

everyone united around a seemingly altruistic cause, but also for ulterior 

and self-interested motives. The underlying theme here is that that failure 

to treat depression is potentially far more dangerous than the drugs 

themselves might prove to be - and therefore that bad news about drug 

treatments for depression should so far as possible/credible be suppressed.

There is of course some truth in this, but it is much less than half 

of the whole. Yes, some people swear by paroxetine and other 

antidepressants and have found them hugely enabling and indispensable. On 

the other hand, the evidence clearly shows that two-thirds of all 

prescriptions are written for 'mild' depression - and only about 3% for 

'severe' depression - yet there is no good evidence that antidepressants 

are effective when depression is 'mild'. Most people prescribed 

antidepressants therefore have no expectation of benefit, but run 

considerable risks.

 It only prolongs the agony - and compounds the impression of 

regulatory incompetence - that the MHRA / CHM / CSM and EMEA refuse to warn of 

this.

       Charles Medawar

       15 May 2006

For every pill, they invent another ill
By Mary Wakefield
(Filed: 11/09/2005)

It had never occurred to me, before last week, that big pharmaceutical companies might actually be evil. I knew they could be a bit iffy - bribing doctors, failing to mention horrible side-effects, fudging the science - but I always imagined them to be fundamentally well-intentioned.

On Monday I read a new book, Selling Sickness, by an American journalist called Ray Moynihan, and am determined never to be so naive again. Drug companies, it turns out, are not on our side at all. They're misanthropic on an epic, Bond-villain scale. Instead of looking for ways to defeat illnesses, they spend their time trying to create them. Instead of selling cures to the relatively small pool of sick people, they find it more profitable to convince healthy folk that they are unwell. It's creepy and, in a sick way, it's also rather brilliant.

Here's a textbook example of how the disease-mongering works, courtesy of GlaxoSmith Kline. A few years ago, GSK needed to find a new application for one of its anti-depressants, Paxil, in order to extend the patent. What to do? Easy - invent an ailment for it to cure.

They found a brief mention of a little-known nervous condition - Social Anxiety Disorder - in a psychiatric journal somewhere, and hired a PR firm to turn it into a star. The symptoms of SAD - feeling nervous, sweaty, shy at parties - don't amount to much more than the symptoms of being alive, but it was marketed with a serious ad campaign and a catch-phrase: "Imagine being allergic to people."

The PR company rounded up patients, experts, a celebrity sufferer and then presented the SAD story to the press. A new disease? With a famous name? How could an editor could turn it down. The New York Times ran a long, serious feature and American Vogue followed suit.

Instantly, of course, thousands of people decided that they suffered from SAD. Doctors prescribed Paxil, GSK thrived and the PR company won an award for "Best PR Programme of the year".

All week I've been rootling around on the internet, finding out about disease-mongering, and from what I can gather it's a growing, multi-billion-dollar business across America and Europe. Drug companies invent and publicise new "lifestyle disorders" every day, and the public obligingly develop the symptoms and pop the pills.

As all hypochondriacs and pharmaceutical companies know, you only have to read a list of unpleasant symptoms to begin to suffer from them. It's the reverse placebo effect. Once a big drug company has wheedled a disease into the papers, they've as good as sold the cure.

On Wednesday, a PR girl called Charlotte cold-called me to enthuse about vodka. "It's a new brand called Diva," she said. "It's the world's most luxurious drink. Each bottle costs up to £20,000."

Charlotte sounded friendly and so keen to share the exciting news that I stayed on the line and chatted. What do I get for my twenty grand? I asked. "Well," said Charlotte, lowering her voice, "it's a very special product. Each customer tells the vodka company what their favourite precious stones are, and then the vodka is filtered through them into the bottle."

Does that make it taste different? "No," said Charlotte. Then she perked up, "but it looks pretty. I'll send you the press release then you can read all about it."

She did, and I discovered that Diva vodka is by far and away the most fabulously silly product I have ever come across. Each gem is apparently placed inside the bottles by hand by a team of men and women with severe disabilities. "Due to the colours and the vibrancy of the gems, this will be stimulating work," says the press release. "The disabled adults will work only with their favourite colours and every bottle of Diva will have a signature gem from the person who filled it."

There's not much of a bright side to New Orleans at the moment, but the odd cheering fact does leak into the papers. My colleague Dot Wordsworth points out in this week's Spectator that for New -Orleaneans, a sidewalk is (or was) a banquette. And it makes me very happy every day when I remember that the man in charge of the city's cops is called Police Superintendent P. Edwin Compass III.