Device Won Approval Though F.D.A. Staff Objected - New York Times
Device Won Approval Though F.D.A. Staff Objected - New York Times
Recent court rulings have gone against consumers based on the fact that medications involved in the case were approved by the FDA. Congress is considering placing caps on pharma and medical malpractice law suits, even to the point of precluding all law suits against FDA approved drugs, treatments and devices. Doing so would remove the constitutional guarantee of pursuing matters of equity and access to the courts for redress of grievances. We need to preserve the right to file suit as a constitutional guarantee. But we also need to recognize that the FDA is subject to a political process that is not always cognizant of, or in compliance with, sound medical science. There is a pricniple of due process involved as well... and in this case due process was circumvented and ignored for political reasons.
In the above cited case we have to ask what lobbying, "lucrative benefits" or political pressures from the Bush administration were brought to bear to push this product, which was proven not to be effective, through the process? Given the secretive nature of this administration and the number of times it has refused to be forthcoming with the release of documentation, we will not be able to determine how this was accomplished easily. Where are the inspector generals and why aren't they doing there jobs?
"WASHINGTON, Feb. 16 — A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday. The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the Food and Drug Administration repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc., to sell it as such a treatment, said the report, written by the staff of the Senate Finance Committee.
But Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health at the agency, kept moving the application along and eventually decided to approve it, the report said. That approval did follow the backing of a divided F.D.A. advisory committee. Still, the Senate committee, which for two years has been investigating the decision-making processes at the F.D.A., could find no previous instance in which the director of the center had approved a device in the face of unanimous opposition from staff scientists and administrators beneath him, the report said."
Recent court rulings have gone against consumers based on the fact that medications involved in the case were approved by the FDA. Congress is considering placing caps on pharma and medical malpractice law suits, even to the point of precluding all law suits against FDA approved drugs, treatments and devices. Doing so would remove the constitutional guarantee of pursuing matters of equity and access to the courts for redress of grievances. We need to preserve the right to file suit as a constitutional guarantee. But we also need to recognize that the FDA is subject to a political process that is not always cognizant of, or in compliance with, sound medical science. There is a pricniple of due process involved as well... and in this case due process was circumvented and ignored for political reasons.
In the above cited case we have to ask what lobbying, "lucrative benefits" or political pressures from the Bush administration were brought to bear to push this product, which was proven not to be effective, through the process? Given the secretive nature of this administration and the number of times it has refused to be forthcoming with the release of documentation, we will not be able to determine how this was accomplished easily. Where are the inspector generals and why aren't they doing there jobs?
posted by Jim Downey at 7:18 AM
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