By Brian Deer

The Sunday Times (London) 1 Aug. 1993

Wellcome, the drug company that dominates AIDS research, is facing fierce criticism from doctors after it tried to overturn government-sponsored research. This found that AZT, the anti-AIDS drug, does not prevent the disease.

In a move without precedent since the drug appeared on the market six years ago, AIDS specialists have attacked the manufacturer. They have accused Wellcome researchers of misleading the scientific community following the publication of a report that appeared to show AZT was effective in AIDS prevention.

Leading doctors expressed outrage at what some regarded as a public relations stunt by Wellcome. The company's study, they said, was old, flawed in its methodology and had been terminated before anything meaningful could be reported. Their anger comes at a critical time for the company, which is seeking a licence to allow more widespread prescription of AZT. If successful, sales could be boosted by up to 2billion annually.

The article at the centre of the row was published on Thursday in an American medical journal. It was based on a study carried out for Wellcome in Australia and a number of European countries, mainly in the late 1980s.

According to the researchers, AZT halved the rate at which AIDS-related diseases developed; they urged extending the use of the drug to HIV-positive individuals who were otherwise healthy. If implemented, this would multiply by many times Wellcome's 250m market for the product.

The researchers' conclusions contradicted findings from the world's biggest study of the drug, conducted on behalf of the British and French governments and released four months ago. This, the "Concorde trial", found that AZT (or zidovudine) had no effect in preventing AIDS.

As The Sunday Times reported in May, Wellcome's financial dominance of AIDS science and treatment means it is seldom criticised by doctors or AIDS organisations. But this weekend Concorde researchers were the first specialists to break ranks over Wellcome's role.

Professor Ian Weller, of the Middlesex hospital in London, who was chairman of the Anglo-French study, said research of the sort published last week was aimed more at raising sales than knowledge. "Company trials are very much product-oriented," he said. "Government-sponsored studies are trying to answer bigger questions."

Weller whose previous academic post was sponsored by the Wellcome Trust, parent of the drug manufacturer said that if Concorde had not been supervised by government agencies he believed it would have been stopped at a point advantageous to AZT. This has occurred with all other tests of the drug.

Ann Marie Swart, a consultant at the Medical Research Council's HIV clinical trials centre in London, said AIDS specialists had seen and discounted the "new" research more than 18 months ago. "This paper is very misleading," she said. "It's a Wellcome trial. That's actually one of the problems."

The latest research was led by Professor David Cooper at St Vincent's hospital in Sydney and has been circulated by Wellcome since early last year. Cooper is a familiar face on the company-sponsored conference circuit and has been provided with media services by its public relations firm.

Cooper's work is helpful to the company because it supports an extension of the drug's vital European licence. This restricts AZT to patients with clear symptoms of AIDS. Although Britain and France are committed to these controls, Cooper has collaborators in five other Community countries which may now see it differently.

However, there is growing evidence that the tide is turning against AZT. In June a federal panel of experts in the United States, convened by the Food and Drug Administration, tightened advice on the drug's prescription. At its meeting, Cooper's paper was considered and its broad conclusions rejected.

Concorde counted 67 AIDS-related deaths among trial participants who took a placebo against 79 among those who took AZT. "There's been a huge change in the last year or so," said Weller, who believes doctors should ignore the company's claims.

"What we've seen as a result not only of Concorde, but of recent trials in the United States is that it's dawning on people that the drugs we have are not that useful." *