I know I have been railing about federal preemption when it has no legitimate legal justification and amounts to a violation of the reserved rights of states set out in the Constitution. But things keep getting worse. A few years ago the Supreme Court affirmed a preemption for injuries at extrahazardous railroad crossings because the government fronted the cost for luminus paint for cross buck signs--with no thought that this would cause all intersections to be safe.
I keep arguing that big pharmacutical companies, which bully FDA to approve medicine not proved to be safe just to get it on the market at break-neck speed, are at the brink of blanket immunity on the frivilous theory of federal preemption. More evidence keeps piling up that the FDA simply is not equiped to make such decisions. To use the guize of FDA approval to preempt the right of hundreds of thousands of consumers who rely upon the expertise and good faith of the manufactures and subsequently suffer serious conditions and death, is unconstitutional and unethical.
The AP (1/12) reports, "An internal watchdog finds that financial conflicts involving outside researchers who test experimental drugs often remain hidden," and "missing information, loopholes, and weak oversight hamper efforts to uncover financial conflicts involving researchers who test experimental drugs before companies seek government approval." The Health and Human Services inspector general's office's report said, "We found a number of limitations in" the Food and Drug Administration's (FDA) "oversight, leaving FDA unable to determine whether [drug companies] submit financial information for all clinical investigators." According to the AP, "because scientists can be tempted by profits, the government requires disclosure of possible conflicts involving clinical researchers who review medications before drug companies seek FDA approval."
The FDA "does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting," the New York Times (1/12, A10, Harris) adds. Noted was that, "in percent of clinical trials, the agency did not receive forms disclosing doctors' financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday." Another study "by the inspector general last year found that the National Institutes of Health did almost nothing to police the financial conflicts of university professors who received federal money."
Please let me know your feelings. B
