Unproved drug in HIV clinic plan

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The Independent Online
AN AMERICAN company selling an unproved Aids treatment is planning to open a Harley Street clinic to test its medicines on HIV-positive Britons.

Advanced Biological Systems Inc (ABS) wants to market dollars 6,000 (pounds 3,900) courses of plant-based drugs invented by a doctor who was banned from selling them in Switzerland three years ago.

The medicines, Carciviren and Rovital, were developed by Dr Jozsef Roka, 68, at his surgery near Zurich during 35 years of research into cancer and the human immune system. Dr Roka and ABS, which bought the rights to market the medicines for dollars 2m, claim courses of treatment produce drastic remission in Aids symptoms.

But the treatment is considered controversial by some Aids groups because patients are taken off recognised Aids medication while being given it, and because the same drugs were being offered as a cure for cancer during the mid-1980s.

The Independent has learnt that no formal clinical trials in humans have ever been carried out by Dr Roka and that:

Uncontrolled trials of the drug in Tanzania in 1988 were shambolic. Fifteen people died during a three-month period when doctors ran out of a variety of drugs, including Carciviren and Rovital. Researchers reported that some patients 'absconded' and others were 'lost'.

The Swiss courts banned the doctor from marketing the drugs in 1989 and upheld an appeal against the ban. Dr Roka had been using them on patients for at least six years and continues to use them.

Tests on samples at the National Cancer Institute in Washington found no antiretroviral activity. The tests, not authorised by ABS, have been rejected by the company.

The cantonal association of doctors in Schwyz rejected Dr Roka's application for membership in 1987 after health officials in the neighbouring canton of St Gallen threatened to take action against him for making the drugs without a licence.

ABS, based in Salt Lake City, Utah, approached the Terrence Higgins Trust and Crusaid last year with details of its plans, but failed to secure financial backing. Emanuel Floor, ABS president, said negotiations were now under way for premises that would open by the spring.

The company said it is anxious to fulfill all British medical requirements, but it also hopes to sell the treatment as part of on-going trials in Britain and the US.

The drugs, which have never been licensed in Switzerland, have a controversial history. Dr Roka has produced research data described by the head of St Gallen's cancer centre as 'dubious' and has never carried out formal clinical trials on humans.