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Tuesday, August 19, 2008

Doctors: Follow the Rules, a safe and simple thing to do

And not only is it the ethical thing to do, it is the legally required thing to do!

Informed consent was something drilled in to my brain while studying pharmacology during five years of my education.

It seems as if prescribers generally skip this section these days, even pharmacists do.

I know a day does not go by when I encounter a person on Rx that has no idea what the risks, benefits or side effects, warnings, etc. might be.

Through one of the services offered for decades through my non-profit organization, we offer reports that are fairly well detailed on this topic, as well as several closely related topics.

The outcome we seek in this work is a person who is then able to understand how to go about doing their own research and gaining the courage to demand this from their health care provider.

See where this has traveled along the yellow brick road. I am behind the effort of these editors,physicians and researchers. You should be too.

Don't forget that Big Pharma is one of the largest contributors to Members of Congress and the current administration.

If the court rules for the FDA, then all of humanity is at risk!

Then we'll know whose money is buying control, not only at the FDA but in the Supreme Court.
In Supreme Court Brief, Journal Editors Fault FDA Safety Record
By Peggy Peck, Executive Editor, MedPage Today
Published: August 18, 2008

WASHINGTON, Aug. 18 -- Some leading journal editors along with influential physicians and researchers have urged the Supreme Court to reject the idea that FDA approval of a drug indemnifies the maker against liability suits for failing to warn adequately against an agent's risks.

They filed a series of amicus curiae briefs with the Supreme Court in support of Diana Levine, a musician who lost her right arm to gangrene that developed after receiving promethazine (Phenergan) by IV push.

Levine was awarded $6.8 million by Vermont Courts. Wyeth is now appealing that judgment in the Supreme Court, arguing that federal law-in this case FDA approval of the drug with risks and benefits spelled out on the label and package insert-preempts failure-to-warn claims brought in state courts.

The amicus briefs were filed by Jeffrey M. Drazen, M.D., editor-in-chief, of the New England Journal of Medicine, Gregory D. Curfman, M.D., the NEJM executive editor, and Stephen Morrissey, Ph.D., the journal's managing editor, along with former editors Marcia Angell, M.D., Jerome P. Kassirer, M.D., and Arnold Relman, M.D. They asserted that the issue before the court was "one of immense importance from the perspective of public health and safety."

The NEJM brief, which was joined by Paul D. Stolley, M.D., formerly of the University of Maryland, Harlan M. Krumholz, M.D., S.M., of Yale, Stuart Rich, M.D., of the University of Chicago, and Eric J. Topol, M.D., of Scripps School of Medicine-all researchers who have multiple publications in NEJM-stated that contrary to Wyeth's premise, "the FDA is in no position to ensure the safety of prescription drugs."

The agency, the NEJM brief said, is not only "seriously hampered in its ability to determine the risks of drugs before they are approved for sale, but it has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public."

Those dangers, the NEJM petitioners continued "are unfortunately quite common."

Levine's cause was also supported in a brief from 47 states' attorneys general, as well as a brief from the Texas Medical Association, the Texas Medical Liability Trust, and the North Carolina Medical Association. Two former FDA commissioners, David Kessler, M.D., and Donald Kennedy, Ph.D., also backed her.

In addition, there were briefs supporting Levine filed by Curt Furberg, M.D., Ph.D., of Wake Forest University School of Medicine, Arthur Levin, M.P.H., of the Center for Medical Consumers, Rahul Sharma, M.D. M.B.A. of New York Presbyterian Hospital-Weill Cornell Medical Center, and a handful of third party payers, including the Health and Welfare Fund and Retiree Health and Welfare Fund of the Detectives Endowment Association, Police Department, City of New York, Canton Electrical Welfare Fund of the International Brotherhood of Electrical Workers Local 540, and the Ohio Carpenters Health Fund.

By contrast the American College of Emergency Physicians and the Washington Legal Foundation filed a brief supporting Wyeth's argument that the FDA approval preempts state tort claims.

In its brief, ACEP argued, "the consequences of striking the wrong balance on the side of excessive caution and overwarning can be as injurious to the public health as those on the side of underwarning."

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