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FDA: 'Mistake' Not To Include Doctor At Eli Lilly Drug Panel

-(Dow Jones)- U.S. federal regulators on Monday acknowledged it was
a mistake to “dis-invite” a leading cardiologist to a panel that was deciding
whether to recommend approval for a controversial anti-clotting drug made by
Eli
Lilly & Co.
(LLY).
Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Heart Institute in
, was scheduled to participate in a
Feb. 3
Prasugrel, an anti-clotting drug that has been linked
to dangerous internal bleeding.
Read the rest of this entry »

Daschle Ends Bid for Post; Obama Concedes Mistake

withdrew his nomination as secretary of health and human services on Tuesday after weathering four days of scrutiny over unpaid taxes, prompting
to concede having “screwed up” in undermining his own ethical standards by pushing the appointment.
“I’ve got to own up to my mistake, which is that ultimately it’s important for this administration to send a message that there aren’t two sets of rules,” Mr. Read the rest of this entry »

Mistake At William Beaumont Hospital Puts Thousands At-Risk

EL PASO, Texas –
William Beaumont Army Medical Center announced Thursday that 2,114 diabetic patients treated at the hospital may be at risk for contracting blood-borne illnesses.
“I would like to say that the staff of William Beaumont Army Medical Center deeply regrets that this situation has occurred,” Col. Jim Baumchauk, of William Beaumont, said.
Hospital administrators told KFOX, diabetic patients at the hospital were being injected with Read the rest of this entry »

FDA ‘Mistake’ Tossing Lilly Critic May Slow Prasugrel

Feb. 24 (Bloomberg) –
experimental blood
thinner prasugrel may face delays getting U.S. approval after
regulators said they made a “mistake” removing a critic of the
drug from an advisory panel at the company’s urging.
after Indianapolis-based Lilly complained about research
articles written by Kaul questioning prasugrel’s safety and
effectiveness, said
, director of the FDA’s Center
for Drug Evaluation and Research. The controversy Read the rest of this entry »