SAFE HANDS? Vioxx and Seroxat are just the latest in a long line of

Sunday Herald, The, Aug 28, 2005 by Judith Duffy Health Correspondent

ROBERT Ernst, a marathon runner and part-time personal trainer, took a commonly prescribed drug to ease the pain in his hands. Less than a year later, the 59-year-old American died from a heart problem, which a jury this month ruled was caused by the painkiller Vioxx.

Vioxx was heavily marketed as the safest and most effective drug for arthritis and related conditions, but it is thought to have caused the deaths of around 60,000 people worldwide before being withdrawn from sale.

The drug's manufacturer, Merck, now faces thousands of lawsuits.

Concerns have also been raised over the use of GlaxoSmithKline's Seroxat after several patients taking the antidepressant reported feeling suicidal. Researchers have now recommended that patients be warned of this potential side effect.

These are just two of a number of high-profile cases which have recently thrown the drugs industry into its biggest crisis since the thalidomide scandal of the 1960s.

This new crisis threatens to seriously undermine public confidence in many commonly prescribed drugs.

If the experts can get it so badly wrong over Vioxx, how can we trust them to get it right with other drugs - particularly when the financial stakes are so high?

Medicine is big business, the third most profitable economic activity in the UK after tourism and finance, but developing new treatments does not come cheap. It takes around 10 to 12 years and an average of GBP500 million to get a drug onto the market, so it is hardly surprising that the pharmaceutical companies go to huge lengths to persuade doctors to prescribe their drugs.

The days when patients accepted everything their doctor told them without question may be gone, but the public continues to trust the medical profession to make sure that any drugs prescribed are safe. In the UK, it is the Medicines and Healthcare products Regulatory Agency (MHRA) that bears this trust.

Controls that a new drug has to go through appear rigorous enough on paper. There are strict guidelines on clinical trials, three phases of which are carried out before a medicine can be put on the market.

After research has been carried out in the laboratory, a small number of healthy volunteers will initially receive the medicine so that the effects on the body can be studied and understood.

The new drug will then be tested on between 100 and 200 people who are suffering from the disease it is designed to treat, to test that the drug works and that there are no unacceptable side- effects.

In the third phase of trials, 1000 to 3000 patients take the medicine under supervision for an appropriate time. Studies are also carried out involving thousands of people after the drug has been made available to doctors, to help identify any previously unforeseen side-effects.

But there are growing concerns about how this system operates in practice. Following its inquiry into the use of Vioxx, after the drug was withdrawn from the market last year, the health select committee of the House of Commons concluded that the pharmaceutical industry had "been left to its own devices for far too long".

The select committee raised particular concerns over the effectiveness of the MHRA itself, stating in its report: "The regulator [the MHRA] has failed to adequately scrutinise licensing data and its postmarketing surveillance is inadequate - The organisation has been too close to the industry."

That is a view backed by others in the medical world. Professor David Healy, a reader in psychological medicine at Cardiff University and one of the first people to raise concerns over the use of selective serotonin re-uptake inhibitor antidepressants such as Seroxat, is concerned that the regulator makes decisions based on reports prepared by pharmaceutical companies.

He said: "As opposed to a real bloodhound in there - which you and I would hope is in there to keep an eye on these drugs - you have a Snoopy dog, past which the pharmaceutical companies can get anything they want."

Healy is also concerned that the MHRA relies completely on fees paid by pharmaceutical companies to finance its activities, while the equivalent regulatory body in the USA, the Food and Drug Administration, is only partially funded by the pharmaceutical industry.

"The MHRA is funded 100% by the industry, " Healy said. "It is a little bit shocking. You do think, 'Well, if that is the way they're funded then they really can't afford to bite the hand that feeds them.'" Healy also claims that more than half of all reports on new wonder drug trials published in medical journals such as The Lancet are actually ghostwritten by professional medical writers and not by the independent doctors or academics credited. And he argues that the raw data which is obtained from clinical trials is kept within the company and not made publicly available.

"Often data are handled within the company, written up in the company or handled within a company working for the pharmaceutical company, or they are written up by one of the writers of the company, " he said.