Did Merck Use Good Laboratory Practices Getting Gardasil Approved?

September 10, 2009 awellwomansjourney
Tags: Cervical Cancer, gardasil, HPV vaccine, vaccination

In my circle of moms, the discussion about Gardasil has been quite active. A fellow fitness mom and friend Chris Caffey Heidel spoke eloquently about her concerns not only about Gardasil’s efficacy and potential side effects, but to laboratories to use Good Laboratory practices, rules and habits advocated by the Late Senator Edward M. Kennedy (later signed to law) to ensure that research laboratories follow a standard set of guidelines that will help ensure that  Americans are safe and healthy. Chris has graciously allowed me to reprint her blog post here. You can view the original blog post at http://librafitnessaustin.com/?p=270. So here in its entirety is Chris’s post. Thanks Chris!

August 26th, 2009

Thank You, Senator Kennedy

In addition to being a personal trainer, I have worked for over 10 years in the pharmaceutical research field, most of those years in Quality Assurance. My job is to make sure that laboratories and other companies working in pharmaceutical research are following FDA regulations and accurately reporting results. It’s not always pretty, but overall, drugs these days are much safer than they were before the 1970s. Prior to that time, there were no significant laws governing the quality of laboratory research. Mail fraud was about all anyone could be convicted of. In the 1970s, several cases of fraud in studies submitted to the FDA were uncovered that led to a series of hearings in the Senate, chaired by Senator Edward Kennedy (i.e., “The Kennedy Hearings”). These hearings resulted in the creation of the Good Laboratory Practice regulations. Laboratories conducting preclinical research are now required to follow these regulations and to also staff a Quality Assurance Unit. Hence, my field of expertise.

I appreciate these and other efforts by Senator Kennedy throughout his long career to do right by the American people. What an incredible legacy. Thanks, Teddy. I hope that our Congress will honor Senator Kennedy’s passing by truly working together in a bipartisan way to enact meaningful legislation that can help address the current health care crisis in this country. One can only hope.

Below is a favorite quote from Senator Kennedy that is often used in Good Laboratory Practice training sessions.

“Inaccurate science, sloppy science, fraudulent science—these are the greatest threats to the health and safety of the American people. Whether the science is wrong because of clerical error, or because of poor technique, or because of incompetence, or because of negligence, is less important than the fact that it is wrong. For if it is wrong, and if the FDA did not know it was wrong, then the protective regulatory barrier between a potentially dangerous drug and the patient is removed.” – Senator Edward Kennedy (D-Mass.), The Kennedy Hearings

Entry Filed under: The health of our daughters

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