Inquiries in Britain Uncover Loopholes in Drug Trials

The Nefarious NY Times ^ | August 3, 2006 | ELISABETH ROSENTHAL

[neverdem]

The trial of a new drug in a London hospital that nearly killed six men three months ago and left them in intensive care for weeks has prompted numerous reports and recommendations that will change the way drugs are tested.

But the six men, who were all young and healthy just months ago, now suffer from serious medical problems, and they have been unable to get any of the drug companies involved in the trial to cover their medical expenses, or provide compensation — other than a one-time payment of under $20,000 apiece.

In recent weeks, lab tests and medical reports have shown that the men are suffering from severely damaged immune systems that will probably leave them vulnerable to disease for life. All have spent weeks in intensive care with organs failing, and they still suffer myriad symptoms.

One of the men, Navneet Modi, 25, who recently received a master’s degree in business, said that his damaged memory and blackouts made it impossible for him to work, and that he also suffered from fatigue and diarrhea.

“Everyone’s turned their back, and I’m angry, really angry,” Mr. Modi said. He noted that the British National Health Service has covered his medical costs so far, but that the company that performed the trial would not reimburse the cost of travel to the hospital.

New tests and investigations into the incident have highlighted loopholes in a drug-testing system that in some instances seems better devised to bring drugs to market than to protect human safety, especially when it comes to medicines made possible by advanced biotechnology, specialists said. Already, regulators in the United States and Europe say they are taking a go-slow approach as they develop new procedures.

The trial three months ago, conducted at London’s Northwick Park Hospital, “highlighted an urgent..."

[neverdem]

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[neverdem]

Rules urged on when to halt care in cardiac arrest

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[Dr. Scarpetta]

In recent tests on four of the subjects, all showed previously unheard-of severe depletion of a type of immune cell called “regulatory T-cells,” according to reports from Prof. Richard Powell, an immunologist, provided by Mr. Day.

Strange...

[DannyHaszard]

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