The British MHRA (equivalent to the U.S. FDA) reportedly acknowledged that Parexel, the U.S. firm that conducted the catastrophic experiment in London on six healthy volunteers, "failed to follow proper procedures."
One of our astute colleagues noted that a business journalist said that this was very common, that there were hundreds of very small companies that tried and failed to demonstrate the safety of very new drugs. If the human experiments work they can sell the formula on to a big pharma company which can cite the test without any knowledge of the details about the adverse reactions (except in this case).
The opaque system invites corruption and corner cutting measures that reduce safety.
So the culture is one of irresponsibility and quick profits–no individuals will be penalised for wrongdoing.
It was said TeGenero carried insurance for only £2M max. "against "accidents." The lawyers confirmed this but said that apparently the conditions of this "Insurance" are that the funds (£2M) will be withdrawn if a lawyer tries to represent an injured person !
All agreed that £2M was utterly inadaquate. Suing Parexcel will be very protracted. This helps explain why a German fly by night company found it advantageous to contract an experienced fast paced US CRO to conduct a dangerous trial in (what amounts to) a rented floor of a London National Health Service Hospital, in the knowledge that the British oversight agency, MHRA (dubbed by some as a puppet of Pharma) would sign the approval for TGN1412.
This assured the corporate sponsors of the disastrous experiment that if anything goes wrong the hospital would provide critical care at the expense of British taxpayers. Indeed, £2M insurance would not even cover that intensive care.
The man most injured in the deadly experiment is back in the hospital this week to have most toes and some fingers amputated…..while none of those with financail stakes in the catastrophic experiment have suffered any ill consequences.
contact Vera Hassner Sharav
veracare@ahrp.org
BBC NEWS
Tuesday, 4 July 2006, 15:30 GMT 16:30 UK
Drug maker files for insolvency
http://news.bbc.co.uk/2/low/health/5146692.stm
The German firm that produced a drug at the heart of a disastrous clinical trial that left six men seriously ill has declared itself
insolvent.
TeGenero, a German pharmaceutical company, said it could not continue in business.
Because of the fallout from the UK trial, it was impossible to attract investment, TeGenero said.
Claims for compensation arising from the trial will continue to be handled by TeGenero’s insurers.
Parexel, a clinical research organisation, carried out the trial on behalf of TeGenero.
Six previously healthy men who took part in the trial of the drug, TGN1412, suffered multiple organ failure.
The Medicines and Healthcare products Regulatory Authority (MHRA) said Parexel failed to follow proper procedures.
It found there was also no contract in place between TeGenero, the makers of the drug, and Parexel at the beginning of the trial.
TeGenero has maintained that the men’s reactions were "completely unexpected" and did not reflect the results obtained from the earlier
laboratory studies.
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