FDA To Fund Study On Meds Used In Pregnancy
8 CommentsBy Ed Silverman // December 30th, 2009 // 4:15 pm
The program will be called Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) and is a collaboration between the FDA, researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente research centers and Vanderbilt University.
What’s the rationale? About two-thirds of women who deliver a baby have taken at least one med during pregnancy, according to the FDA, which cites a journal article published in the American Journal of Obstetrics and Gynecology. In a statement, the FDA says there are few clinical trials that test drug safety in pregnancy due to concerns about the health of the mother and child, but FDA commish Margaret Hamburg says the data will guide regulatory policy and should influence medical care.
The research program will link health care info for mothers and their babies in each of 11 participating sites, which health care info for about 1 million births between 2001 and 2007, the agency says. The assumption is many moms likely used meds during their pregnancies, so the FDA believes it now has a “systematic and timely way” of retrieving info from this network.
These are the research sites including Kaiser Permanente (Northern California, Southern California, Georgia, Pacific Northwest, and Colorado regions); Harvard Pilgrim Health Care Institute, Group Health Research Institute, HealthPartners, Lovelace Clinic Foundation, the Meyers Primary Care Institute, and Tennessee State Medicaid. The coordinating center for the program is HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, which is led by Richard Platt.
Lead researchers include Susan Andrade, HMO Research Network William Cooper (Vanderbilt); Robert Davis (Kaiser Permanente Georgia); Craig Cheetham (Kaiser Permanente Southern California); and De-Kun Li (Kaiser Permanente Northern California). The investigators have collaborated on numerous studies related to drug use during pregnancy and birth outcomes, as well as studies on the effects of antidepressants, antibiotics, and cardiovascular meds on birth defects and perinatal outcomes, according to the FDA.
A steering committee composed of reps from each participating site and the FDA will oversee MEPREP and provide overall scientific leadership. FDA epidemiologist Pam Scott is the agency’s project leader and steering committee chair.
photo courtesy of 3neus Flickr creative commons
Evelyn Pringle
The study was sounding all good and well until I saw “Harvard Medical School.”
I wouldn’t trust anything from anybody at Harvard Medical School and I resent that my tax dollars are going used to give these people the opportunity to pump out more fraudulent research.
Absolutely disgusting!
Justice in MI
Evelyn–I’m no “champion” of Harvard Med School, but it’s a big place–includes Jerry Kassirer (_On the Take_), Arnold Relman, Marcia Angell, John Abramson (_Overdosed America_), Arnold Relman, et. al..
Biederman may be God, but he doesn’t run the whole place (especially not at the moment).
Happy new year!
Evelyn Pringle
It’s not just Biederman. Right off the top of my head, the names Timothy Wilens, Thomas Spencer, Jeff Bostic, Lee Cohen, Robert Fogel, and Jack Gorman come to mind, for starters.
Biederman always seems to gets all the attention but he is not the only academic on the take at Harvard, that’s for darn sure.
The people you name are indeed good guys but they haven’t been able to do anything about Pharma’s corruption of the Harvard research mill.
I don’t want my tax dollars going to Harvard for anything.
Justice in MI
Since we’ll probably go a few more days before our Pharmalot fix, I will take the liberty of (mostly) changing the subject.
The NYT reports that James Goddard has died. Goddard was FDA Commish from 66-68, and he did not hesitate to call things as he saw them, which made him a lot of enemies. Phil Hilts has described him as one of the 3 or 4 best Commssioners the FDA has ever had. Johnson/Humphrey dumped him after receiving a large campaign donation (not from PhRMA).
Read all about it, and about what FDA can sound like when it has this kind of leadership:
http://www.nytimes.com/2010/01/02/health/02goddard.html?emc=tnt&tntemail0=y
Lisa Van Syckel
I couldnt agree more with Evelyn!!!
M Helm, MD
I think we could quibble over whether or not the addition of the CERT center at Harvard may or may not be a good choice, and whether or not including so many HMO organizations who already have fairly tight control over prescribing behaviors and medication selections are really the best places for this research to occur.
Or we could shout “Hurrah” to Commisioner Hamburg for moving this much needed, long overdue and very important research forward. We know babies have been harmed by medications - sometimes their mothers too. We don’t reliably know which medicattions should be avoided, and which are relatively less risky. I doubt that any are “safe” in the classic sense, but perhaps time will tell.
I would like to see the same research replicated in a ‘non-HMO’ population. In my experience, things can be wild and wooly in a private plan or a Medicaid program without specific prescribing limits relating to pregnancy. These misadventures seem to me to usually happen early in pregnancy and appear often the result of multiple MDs involved in a single patient’s care. These may also result from patient’s continuinng medications previously prescribed by others without consideration of possible pregnancy - a system failure, not an information/research deficit.
Lisa Van Syckel
Dr. H… Thanks for your input
Amy Philo
I can’t wait to see if this turns out as a big joke of a study. Will they be looking for long term effects like SIDS and learning problems and the effects of birth defects? Or will they simply pick a few select defects and sugarcoat the results?