Was drug trial report a 'whitewash'?

Following the Northwick Park medical trial which left six trial volunteers seriously ill, the Department of Health is to establish an Expert Working Group to assess clinical testing authorisation procedures. Ann Alexander, a Irwin Mitchell personal injuries solicitor who is representing the two most seriously affected victims, tells Greg Bousfield why answers are needed...

The Department of Health will establish an Expert Working Group to assess the clinical testing authorisation procedures for monoclonal antibody (MAb) medications, in the wake of the Northwick Park medical trial involving a MAb product which left six trial volunteers seriously ill.

“Unfortunately it doesn’t appear that the Working Group will be looking at the Northwick Park incident, but I think it is very important that lessons are learnt from what has happened to these men,” says Ann Alexander, a Irwin Mitchell personal injuries solicitor who is representing the two most seriously affected victims. She says that she is preparing a compensation package for her two clients.

The government announced the inquiry a day after the medicines regulator, the Medicines and Healthcare Regulatory Body (MHRA), published a report about the aborted Northwick Park hospital trial, which found little wrong with procedures used by the trial organiser or any intrinsic problems with the MAb product (TGN1412) administered to the volunteers.

The adverse effects on the six men were not caused by manufacturing errors of TGN1412, its formulation, dilution or administration to trial participants, the MHRA report said, but rather were the result of an “unexpected biological effect.”

The report is a “whitewash” which fails to include pre-clinical animal testing evidence about the side-effects of TGN1412, Ms Alexander says. “It gives no detailed information about the pre-clinical trials, about which there has been conflicting information since the drugs trial was suspended. Were the animals involved appropriate for a comparison with human subjects? What were the effects on these animals? We question the report's findings that the reaction was unpredictable, and we call for independent scrutiny of these and many more questions raised, and/but not answered by the report.”

The MHRA report noted that Parexel, the company which organised the trial, had failed to complete the full medical background of a trial subject and the medical history of one of the volunteers was not updated. There was also no contract in place between TeGenero, the makers of the drug, and Parexel at the beginning of the trial. In addition, the MHRA reported one of the doctors involved did not have adequate training or experience.

The Department of Health Expert Working Group is to provide advice for the future authorisation of trials involving monoclonal antibodies medication, especially in view of the recent development of this medication.

"We demand answers to the questions raised by the manner in which the human trials themselves were conducted,” Ms Alexander says. “We have now had access to evidence that suggests that the human subjects were not treated for up to five hours after the first symptoms were reported.”

Another question is why the subjects were given the drug at a gap of only ten minutes, and not a longer period, she adds. “This would have saved at least a couple of the volunteers from suffering. And why did the MHRA not seek any outside expert opinion before they conducted this new and dangerous procedure? My clients and the general public are entitled to answers to these questions.”

Funded entirely by pharmaceutical licensing fees, the MHRA has recently been pressed by the government to require members its Committee on Safety of Medicines to reveal if they own shares in or work in institutions that receive research grants from pharmaceutical firms. The new Medicines for Human Use (Clinical Trials) Regulations 2004 requires sponsors of pharmaceutical trials to disclose any adverse effects of preparations, but not to disclose all research done on a product. But the new Freedom of Information Act may override the Medicines Act 1968, which restricts what information the MHRA can make public and allows pharmaceutical companies to withhold unpublished data from such bodies as the National Institute for Clinical Excellence, which is responsible for developing guidance for the NHS on effective treatments.

“I now have little faith in the MHRA’s ability to seek, obtain or make public detailed and relevant information about the clinical history of this trial or the manner in which it was conducted,” Ms Alexander says.

(05/06/06)

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Legislative annotations in other services:-
Freedom of Information Act 2000; Medicines Act 1968