Doubts over Aids drugs first expressed in 1985

SENIOR doctors in Switzerland have been expressing concern since 1985 about the drugs that an American company plans to market as an Aids treatment from a Harley Street clinic.

The drugs, Rovital and Carciviren, were invented by Dr Jozsef Roka, 68, at his Zurich surgery, and were originally offered as a treatment for cancer.

In June 1985, Professor Hans Jorg Senn, the head of oncology at St Gallen's cancer centre, wrote a confidential letter to Dr J. Huppi, the president of the area's doctors' association, that said: 'For years or even decades, Dr Roka has obviously been carrying out the illegal manufacture of drugs, or rather remedies, for several methods of administration for which he has no authorisation.

'They are being administered . . . as therapy to patients with all kinds of cancer and it is clear that there is no documentation of clinical tests. Dr Roka's 'documentation' on Rovital and Carciviren contains only an extraordinarily sketchy, fragmentary and highly dubious collection of preclinical test data . . . which are bulky but divulge little and contain no test data on humans.'

According to the president of the doctors' association in Schwyz, Dr Roka, a Hungarian with Swiss citizenship, still practises despite being the first doctor to be barred by the association.

While practising in Uznach in St Gallen in the mid-1980s, Dr Roka's use of the drugs on cancer patients was called into question. Dr Walter Felix Jungi, the Kantonsarzt or surgeon general for St Gallen, said that a number of patients had been treated with Rovital and Carciviren although other recognised drugs were available. But while the authorities in St Gallen were considering taking action against Dr Roka, he moved to the neighbouring canton of Schwyz, outside St Gallen's jurisdiction. Dr Richard Schibli, former president of the cantonal doctors' association in Schwyz, confirmed that his members had refused to accept Dr Roka as a member and the Interkantonalen Kontrollstelle fur Heilmittel in Bern, which controls medicines in Switzerland, said neither Carciviren nor Rovital had ever been registered.

An IKH official said the Department of the Interior in Schwyz had successfully applied to the courts for a ban on the sale of the drugs in 1989. The official said any breach of the ban in Switzerland would be a criminal offence. The Federatio Medicorum Helveticorum, the doctors' federation, said Dr Roka had not been a member since 1987.

The name of Dr Roka began seeping into the Aids community around 1986 when American victims heard tales of miraculous cures. Some victims wrote articles about the remarkable improvements they underwent after receiving the doctor's medicines in Switzerland.

Hundreds of people visited Dr Roka but, according to Advanced Biological Systems (ABS), his records of patients outside Switzerland were not kept up to date. The effectiveness of the product became a major source of controversy in the US, but Dr Roka appeared reluctant to submit it to formal human trials.

Sceptics say the drugs make patients feel better because treatment is conditional on them ceasing other drugs, including AZT which has a number of strong side effects. At the start of the treatment, patients are also given a transfusion of oxygen-enriched blood which some doctors say will result in a temporary feeling of well-being. But some patients have reported improvements lasting years.

A researcher who acquired a sample of the Roka compounds submitted it for testing at the National Cancer Institute in Washington. A confidential report into the testing of the product, obtained by the Independent, concludes that there was: 'No apparent antiretroviral effect at doses which are non-toxic . . .'

ABS rejects this test, arguing it was not conducted under controlled conditions, and in a prospectus produced last year detailing its plans for London, it said trials were being carried out by Professor Manley West at the University of the West Indies in Jamaica. According to Professor West, these tests were terminated earlier this year because Dr Roka refused to supply the university's ethics committee with the chemical make-up of his compounds.

Instead, ABS now points to laboratory tests carried out by the Department of Biochemistry at King's College, London, in May 1992. These show that the compounds submitted to the researchers, Dr Okezie Aruoma and Professor Barry Halliwell, contained high levels of anti-oxidants which some experts believe may help in controlling free radicals, unstable chemicals that are over-produced by the body in Aids sufferers.

Neither researcher could be contacted. However, Professor Don Jeffries, Professor of Virology at St Bartholemew's Hospital in London, said the high oxidant levels are not necessarily an indicator of efficaciousness against HIV-infection in humans. 'One would need to see evidence of activity in the laboratory against HIV-infected cells,' he said.

Laboratory tests conducted in Poland and Yugoslavia in 1983 report high anti-viral activity - contrary to the National Cancer Institute's findings - but they were not carried out on Aids-infected cells.

ABS said Dr Roka was not available for comment but Emanuel Floor, the president of ABS at its headquarters in Salt Lake City, Utah, said the company was anxious to comply with all UK medicines control regulations. 'We do not make any claims of a cure - ever,' he said. 'We believe that the medicine is effective treating patients early on in the disease and we believe that the anti-oxidant qualities of the medicine seem to be a major factor in how they are working. We plan to know a lot more about where we are after we finish our research.'

Paul Mortensen, vice-president of ABS, said the company was aware that Dr Roka was viewed as a controversial figure in Switzerland and said that was one reason why ABS was attracted to him. He said: 'You need the mavericks out in the world who shake things up and get things turned in other directions that can help people.'

Mr Floor said the clinic in London would be used as an information exchange for plant-based treatments for Aids and, pending an application for a Medicines Control Agency CTX exemption, a three-year research certificate which allows companies to carry out trials on drugs without a formal licence, Roka treatments would be used on patients as part of the trials.

The cost of a one-year course of treatment would be dollars 6,000 (pounds 3,900), he said. Patients at Dr Roka's surgery in Schwyz are charged dollars 3,200 (pounds 2,100).

(Photograph omitted)