Clinical Fraud Hearing Held Today

I received an email from my old boss today alerting me to an interesting webinar. I am posting it for other people’s benefit. She states “The webcast below is a hearing to explore fraud at a clinical site for a study conducted by Sanofi-Aventis. The hearing took place this morning. Interestingly, the CRO and the CRA who monitored the site are among the witnesses…”

from the webinar site:

“Ketek Clinical Study Fraud: What Did Aventis Know?

The House Energy and Commerce committee’s subcommittee on oversight and investigations will hold a hearing at 11 a.m. EST to explore what Sanofi-Aventis knew about the problems with clinical trials for its Ketek antibiotic. Last February, the FDA withdrew approval for two of three uses for the drug, and issued a Black Box warning for use in treating community-acquired pneumonia, which was issued in the wake of numerous Ketek patients suffering 93 adverse events, including 12 deaths.

Among the witnesses will be Chuck Grassley, the US Senator from Iowa, and Ann Marie Cisneros served as a clinical research associate for PPDI, a contract research organization that conducts clinical trials on behalf of drug sponsors. Last February, Cisneros appeared at a hearing held by the same committee focusing on the FDA’s failure to ensure safe prescription drugs. Cisneros testified that Aventis knew of fraudulent clinical trial data involving Ketek, but that the company chose to ignore it.”

Feel free to comment on this post or shoot me an email if you have any thoughts or additional questions.

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The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.

2 Comments

  • The Lead CRA

    The Lead CRA

    October 5, 2009

    Hi Y.S., thanks for your question. I have posted a response here in a post about bad employmebnt references.

  • Y.S.

    September 3, 2009

    Hi
    thank you for the advices you offer in your blog. just a small question, i was referred for an intereview at an international pharmaceutical company. i passed the first intreview and was asked to have psychometric test which i was prepared for by a psychologist. they probably called my previous boss and after all that i recieved a negative response. this is the second time that i miss a good position after she was called. what do you think i should do? i have a lot to contribute to any firm, i just cann’t find them.
    thank you
    Y.S

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