History Forum / General / British History / November 2008

It works like this

They make a fortune on the claim that FDA approvals "preempt private
litigation" So they can sell devices and walk away when they kill people
at the same time they are corrupting the approval process

Congress Probes ‘Corrupted’ FDA Device Approvals
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By Ed Silverman // November 17th, 2008 // 1:32 pm

The House Energy and Commerce Committee received a letter dated October
14 from a ‘large group’ of scientists and physicians at the FDA’s Center
for Devices and Radiological Health division, who complained that CDRH
managers have “corrupted and interfered with the scientific review of
medical devices.”

In a statement, John Dingell, who chairs the committee, and Bart Stupak,
who chairs the Subcommittee on Oversight and Investigations, say they
are probing allegations that the FDA “approved or cleared medical device
applications in gross violation of laws and regulations….such activity
could allow potentially unsafe and ineffective medical devices into the
US market.”

The CDRH allegedly “ordered, intimidated and coerced FDA experts to
modify their scientific reviews, conclusions and recommendations in
violation of the law.” The CDRH staffers also claim they were forced to
use “unsound evaluation methods, and accept clinical and technical data
that is not scientifically valid or obtained in accordance with legal
requirements, such as obtaining proper informed consent from human
subjects.”

And in a letter to FDA commish Andy von Eschenbach, the lawmakers note
that the same CDRH employees wrote last May to FDA officials to
complain, and that William McConagha, assistant commissioner for
integrity and accountability, investigated the allegations and
recommended removing some CDRH managers.

Although McConagha called the “evidence is ‘compelling,’ ‘convincing,’
and ‘sufficient’ to justify disciplinary and curative actions,” Dingell
and Stupak say no action has been taken, and that retaliatory behavior
against the employees occurred.

end quote

Not to mention the pretend that they made money without using the vast
and productive infrastructure of the USA

Newton at least admitted that "If I have seen farther it is by standing
on the shoulders of Giants."

anyone who claims they "made it on their own" and that they have no
social obligation e.g. "f*ck you and yours its all mine"  is welcome to
go to Afghanistan and repeat the trick

Vince

Your beanie has stopped working. You need some new foil...