Monday, September 27, 2004

Big Pharma snared by net

UK The web has helped consumers turn tables on the drug giants, says Cheryll Barron.

What if ants could turn the microscopes on the scientists studying them and, after beady-eyed surveillance, demand a revolution in their scrutinisers' accustomed ways?

This is more than a variation on Lilliputians for a new Jonathan Swift to consider; it's a metaphor for a real-life reversal of multinational power that has no precedent.

Management tomes of the late 1990s - like Bill Gates's droning Business, the Speed of Thought - explained how the internet might be used to study customer behaviour minutely, through, for instance, 'data mining'.

Companies, they said, could use the intimate understanding so acquired to address customers' needs and preferences, on the companies' terms. What no one foresaw was the shocking extent to which the internet would change the terms of trade between corporations and society.

Certainly not that one of the world's largest drug companies, which is among the richest and most influential industries of all time, would be the first victim of the shift.

The crisis that began the containment of pharma power is a runaway rate of drug injury. In England alone, reactions to drugs that led to hospitalisation followed by death are estimated at 5,700 a year and could actually be closer to 10,000, according to a study in The British Medical Journal in July. The researchers reckon that adverse drug reactions are costing the NHS £466m a year.

Drug injury has been worrying experts for decades. But after the thalidomide tragedies of the 1950s, the subject failed to catch fire for politicians and the public until the recent antidepressant controversy.

Last month, that debate made headlines when Britain's GlaxoSmithKline, the world's second-largest pharma, denied any wrongdoing, but agreed to pay $2.5m to settle a lawsuit filed by the State of New York accusing it of fraud for concealing evidence of its antidepressant Seroxat's potential for harming children, while doing them no measurable good.

In a sequel last week, a group of about two dozen American parents sued GSK seeking refunds for treatment of their children with the drug. The GSK suit created the tipping point in the pharmas' change of fortune and has revealed the force behind it.

The formal complaint drew heavily on research by public health campaigners and consumer advocates about the hazards of antidepressant use. These activists had toiled in deepest obscurity - some of them, for a decade - until their discoveries were featured on a Panorama programme, 'Secrets of Seroxat', in autumn 2002.

A follow-up broadcast the next spring, 'Emails from the edge', analysed 1,370 messages from viewers about the first programme, mostly from people reporting antidepressant withdrawal reactions including shock-like sensations in their heads, and thoughts about self-mutilation, violence and suicide.

The outcry that followed forced GSK to make a stunning admission. In June 2003, it corrected its prescribing instructions for Seroxat, revising its estimate of the risk of withdrawal symptoms from one in 500 to one in four.

Infinitely more frightening than that reluctant confirmation of a drug's potential for harm was that in the years GSK spent denying it, this pharma had the backing of institutions that we, the public, rely on to protect us from poisoning by prescription.

The Royal College of Psychiatrists had insisted only a year earlier that 'there is no evidence that antidepressant drugs can cause dependence syndromes'; a patient information leaflet approved by a regulatory body also said as much. The events that led to Seroxat's exposure would seem to suggest that it was television power that forced GSK to recant. But it was really the internet that allowed public health activists to do an end run around GSK's and the medical authorities' denials of the drug's risks. An explosion of websites dedicated to vivid accounts of antidepressant reactions told these campaigners about hundreds of thousands affected by a problem that officially did not exist.

The internet was 'groaning with evidence'; over time, the 'cover-up became more obvious as the weight of scientific evidence got stronger and public protest grew'. Those are quotations from a magisterial history and analysis of the antidepressant crisis by two leading campaigners, Charles Medawar and Anita Hardon, in Medicines Out of Control?, a new book recommended by the Lancet as essential reading for members of the parliamentary committee examining pharma influence on health policy, whose hearings began last week.

As critical to the pharmas' outing as the raw data on the internet was this medium's capacity for handling complexity - at the speed of firing neurons. Mood medicines are arguably even more complicated than computers. Software's complexity is largely restricted to the science behind it, and to products and their intermeshing with other products. Pills have extra intricacies that follow from variations in formulations of the same types of drugs, in the range of possible reactions, some of them subtle, in patients - even to different doses, in the same person - and consequences not just from interactions with other drugs but with non-pharmaceutical treatment and lifestyle aspects such as diet.

Health campaigners trying to decide what the pharmas could reasonably be blamed for shared vast stores of data about such complexities by - among other means - encyclopaedic technical postings on their websites. Some of these sites also feature open access to years of correspondence between the activists and regulatory officials and pharma executives. Postings like these have allowed rapid international co-ordination between the campaigners.

Pharmas bent on redeeming their reputations have suddenly begun to use the internet to publish what they once fought for the right to conceal. GSK's first notable response to the filing of the recent lawsuit was to start posting both negative and positive findings from drug tests on its web site. But it is far from the only pharma with a history of secretiveness about trials, and at least three of its rivals have copied its turnabout, with Eli Lilly and Merck making the most radical moves towards transparency.

Even top-ranking pharma executives might not yet grasp that this is only the start of a progressive stripping away of power. They could do worse than adopt for a model Gulliver, who reacted to his entrapment by the Lilliputians with a 'promise of honour', for fear that the showers of tiny arrows his captors used to disable him might be far from the worst they could do.

Bitter pills

Bit by bit, health activists in Britain and America have uncovered the core of pharma might: a sinister mesh of hidden influences in the regulation and practice of medicine that is painstakingly dissected in Medicines Out of Control? by Charles Medawar and Anita Hardon.

In both countries, clinical drug tests are paid for by the pharmas, who tweak the trials' design for the best possible results. Until recently, only the most favourable findings got published in the 20,000-odd biomedical journals, many of them dependent on pharmas for funding.

The drugs are approved for marketing by regulators, whose salaries are mostly financed by the subjects of their evaluations - since pharmas pay to have their products vetted. The medicines are then prescribed by doctors routinely courted with pharma gifts - from free pens to family skiing holidays - meant to persuade them to change their prescribing habits.

By Just Us posted 27 September 04

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