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KEYCODE BAYER #78

16 March 2003

Drug trial 'put 850 patients at risk'

MP calls for inquiry after company went ahead with antibiotic study without backing of ethics committee

The government has been asked to investigate why drug giant Bayer put 850 patients across the UK at risk of potentially fatal infections during a drug trial which experts claim had been denied ethical approval.

The study exposed patients, including some at Glasgow Royal Infirmary, to post-operative infections after they were given a combination of drugs that previous studies had shown to be ineffective in killing bacteria. The trial, involving a particular use of the drug ciprofloxacin, sold as ciproxin by Bayer, took place in 1993 but the results were never disclosed. The company says it has results to show that patients were not exposed to increased risk.

But Sandra Gidley, MP for Romsey, in Hampshire, told the Commons last week she had a sworn statement from retired consultant surgeon Stephen Karran, who previously sat on the ethics committee of one of the hospitals involved in the trials, stating that this is not the case. Karran claims 46% of the 60 Southampton patients on the trial contracted infections. This is disputed by Bayer.

Gidley asked junior health minister David Lammy to launch an investigation and called for all drug trial results, negative or positive, to be disclosed in future. 'Should there not be an onus on drug companies to publish the results of any clinical trial ? The answer that always comes back is 'commercial sensitivity'. I can understand the need for that in the short term but this argument does not stack up in the longer term. What price do we put on patient safety?'

The trials involved giving bowel surgery patients the oral antibiotic ciproxin to protect against post-operative infections. Normally antibiotics are given to surgical patients by injection, and if a tablet proved to be effective against infection it would be in high demand. But as the trial results were unimpressive, Bayer did not apply for a licence to use ciproxin in surgery.

Gidley said Bayer was aware, from previous studies, that ciproxin did not adequately protect patients when given before surgery at the same time as 'pre-med' drugs. Ciproxin is effective if given an hour before the other drugs, but as this would involve administering medication to patients on two occasions, involving two visits from medical staff, this would not be cost effective.

Despite the problem, Bayer began the study by giving ciproxin at the same time as other medication. This was later changed at an unspecified point in the trial. Gidley asked: 'When making the application did Bayer declare the problem caused by simultaneous administration of other drugs ? If it did not , would the minister agree that Bayer's action was fraudulent and that some sanction should be taken against the company?'

Gidley also said that, because of the problems of giving the antibiotic at the same time as other medication, the trial, in its original form, was refused by the ethics committee at Southampton Hospital. The committee was later told the trial would be amended to give the antibiotic earlier than the other drugs. The trial was then approved with this amendment but the MP said the researchers had stuck to the original plan and given all the medication at the same time.

'Somehow the unamended trial went ahead. The patients had all been informed that it had been approved by Southampton ethics committee. That clearly was not true. Bayer had already been given permission for the trial by the Medicines Control Agency, (MCA), the government body responsible for the safety of medicines. Gidley claimed that by granting approval, the MCA failed to protect patients.

'Despite all the known doubts, the MCA issued a licence to Bayer giving permission to undertake clinical research in 850 patients. What this meant is that potentially 850 patients would be put at greatly increased risk of contracting a severe post-operative infection.'

She added: 'The MCA should protect the public from fraudulent and potentially misleading information. Clearly, in this case it has failed -- whether through incompetence or by deliberate intent is unclear.'

Gidley also claimed there was a financial incentive for going ahead with a trial without proper consent. 'There was huge sales potential if a licence could be obtained to use the drug orally for routine prophylaxis. Hence the trial. Unfortunately, commerce appeared to win out over ethics in the drive to operate the trial in the manner Bayer wanted. 'I realised there were wider implications -- and there could be lessons learned that are applicable to the many other clinical trials which are taking place at this very moment.'

A Bayer spokeswoman confirmed the way the trial was run was changed at an unspecified point. She said that results, held by the company, showed there was no evidence that patients in the trial were exposed to an increased risk of infection. She added that the company will now reconsider disclosing full results.

A spokesman for the MCA admitted Bayer's application for permission to carry out the trial did not contain full information of the risks. 'The MCA reviewed Bayer's application for the ciproxin trial. The review showed the application should ideally have contained fuller information. But the company had notified the MCA of the evidence of the drug interactions in another context and had designed its ciproxin trial to take account of that evidence.

'On this basis, the MCA did not believe the company set out to mislead it on the matter.'

Sunday Herald, By Sarah-Kate Templeton Health Editor and Jenifer Johnston