Insight

The Sunday Times November 26, 2006


A DRUG company is under criminal investigation for the way it has marketed an unproven "wonder" treatment for multiple sclerosis to thousands of patients.
The firm, Daval International, chaired by a discharged bankrupt described by a High Court judge in 2002 as a liar, has been promoting its drug as a "major scientific breakthrough" .

It is being distributed across Britain using a licence granted by a government agency last year despite serious concerns from doctors and multiple sclerosis (MS) experts.

A Sunday Times investigation has found claims that the company misrepresented research to present the drug, Aimspro, in a more positive light.

The Department of Trade and Industry has expressed concern that the company is trading "on future hope" - taking money from vulnerable investors in the expectation that it will become a clinically proven drug.

So far the drug, which is based on a serum from goats injected with inactive HIV virus, has never been properly tested in full clinical trials to assess its safety and efficacy.

However, the Medicines and Healthcare Products Regulatory Agency (MHRA) and government ministers have allowed it to be sold under a "specials" licence which is not designed for the marketing of drugs.

The MHRA was the body that authorised the so-called "elephant man" drugs trial at Northwick Park hospital, which left six healthy young men critically ill.

A key figure lobbying for the drug has been Lord Elder, a friend of Gordon Brown since their schooldays and former adviser to Tony Blair. The peer, who has £300,000 worth of shares in the company and acts as its paid adviser, attended meetings between Daval executives, Brown and other ministers.

This weekend, following The Sunday Times inquiries, the MHRA disclosed that it had been investigating the drug for some time. It is now understood to be looking into the way Aimspro has been sold and marketed to patients in possible breach of the Medicines Act.

The statement said: "The MHRA is conducting a criminal investigation into an unlicensed medicinal product known as Aimspro which is promoted by Daval International Limited."

Daval has built significant demand for Aimspro among Britain's 85,000 MS sufferers. Last month, a petition with more than 20,000 signatures was presented to Downing Street calling for NHS backing for the drug.

Daval and its supporters claim that Aimspro "dramatically" alleviates the symptoms of MS, a chronic disease that attacks the central nervous system. Over the past two years a number of stories have appeared in the media claiming patients have regained eyesight and thrown away their walking sticks after taking the drug. During this time, Daval has raised almost £4m from investors on the promise that Aimspro will one day become a clinically proven drug.

David Shotton, Daval's chairman and main shareholder, was discharged from bankruptcy shortly before he set up the company. The company's finance director, Graham Ralph, is also a discharged bankrupt.

Shotton, 65, has twice been castigated by High Court judges. In a 1995 case over a disputed bank loan the judge said he was a "wholly unreliable witness" who had a "willingness to advance claims he knew were unjustified"