The protocol also required McLeod to document adverse events and determine whether any events were of "special interest" as that term was defined in the protocol. The investigator said, that even though records showed that 2 subjects had lab tests to evaluate what was identified on the lab report as a "Cardiac Adverse Event," the case report submitted by McLeod states that these subjects experienced no adverse events.
For some subjects, McLeod failed to remove the tear-off labels and place them in the Case Report Form so it could not be determined which medication the subjects were given.
Finally, one subject was enrolled despite a documented allergy to the penicillin antibiotic.
Another ace investigator was Dr William Terpstra, of Indiana who had more than 150 patients enrolled in the study. However, an investigation found that he had over 20 violations of the study instructions.
All that said, in April 2006, the results of Study 3014 were cited in an article in the New England Journal of Medicine that claimed Ketek was as safe as other antibiotics. However, five of the 6 six authors had to disclose that they had received consulting fees from Aventis, and that at the time of the study, the 6th author was an employee of Aventis.
In his June 8, 2006, letter, Senator Grassley asked the agency to explain what it is doing to inform parents about the safety issues surrounding pediatric trials of Ketek and pointed out that he had posed the same question to the agency 6 weeks earlier but had not yet gotten an answer.
For information for injured parties go to Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/ketek_approval.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
For some subjects, McLeod failed to remove the tear-off labels and place them in the Case Report Form so it could not be determined which medication the subjects were given.
Finally, one subject was enrolled despite a documented allergy to the penicillin antibiotic.
Another ace investigator was Dr William Terpstra, of Indiana who had more than 150 patients enrolled in the study. However, an investigation found that he had over 20 violations of the study instructions.
In his June 8, 2006, letter, Senator Grassley asked the agency to explain what it is doing to inform parents about the safety issues surrounding pediatric trials of Ketek and pointed out that he had posed the same question to the agency 6 weeks earlier but had not yet gotten an answer.
For information for injured parties go to Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/ketek_approval.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
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