| When Drug Trials Go Wrong, Patients Have Little Recourse |
Author: Jon Merz
Date: 01-31-08 17:15
Source: Wall St. J
URL: http://online.wsj.com/article/SB120173515260330205.html?mod=hpp_us_pageone
Date published: January 31st 2008
From Howard Mann:
When Drug Trials Go Wrong,
Patients Have Little Recourse
Lawsuits Push Liability
Despite Consent Forms;
Ms. Davenport's Decline
By SARAH RUBENSTEIN
January 31, 2008; Page A1
COUPEVILLE, Wash. -- Before Suzanne Davenport entered a clinical trial testing a drug for Parkinson's disease, she could drive, cook and care for herself. Within months, she was wheelchair-bound and living in a nursing home.
Ms. Davenport's family says the trial caused her precipitous decline. It is suing the two drug makers that ran the trial and the university that enrolled her in it for compensation to cover her mounting medical bills.
The case highlights one aspect of the legal and regulatory void surrounding clinical trials. Federal law does not require researchers to compensate participants harmed in such trials. It merely requires that their consent forms spell out whether compensation will be available for research-related injuries in trials that involve more than minimal risk.
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note: pdfs are available on the page of consent forms and the like.
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When Drug Trials Go Wrong, Patients Have Little Recourse new |
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Jon Merz |
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