Medication exposure in pregnancy risk evaluation program (MEPREP) - medical marijuana not in study

A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.

No mention was made in the press release about including medical marijuana in the study.  The text of the press release follows.  After reading the press release, we hope you will answer the survey.  But not before you read the other side of the story.

December 30, 2009.  FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy
New collaborative research program to study effects on mothers and their babies

A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.

About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child.

“This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice."

To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about 1 million births over the past seven years (2001-2007). Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network.

“This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children,” said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. “Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy.”

The program blends clinical and research expertise and population-based databases from 11 health plan-affiliated 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, and the FDA. The HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, led by Richard Platt, M.D., M.S., is the coordinating center for the program.

Lead researchers include Susan Andrade, Sc.D. HMO Research Network William Cooper, M.D., M.P.H. (Vanderbilt); Robert Davis, M.D., M.P.H. (Kaiser Permanente Georgia); Craig Cheetham, Pharm.D.; (Kaiser Permanente Southern California); and De-Kun Li, M.D., Ph.D. (Kaiser Permanente Northern California). The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, as well as studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes.

A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. FDA epidemiologist, Pamela E. Scott, Ph.D., is the FDA project lead and chair of the Steering Committee. FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy New collaborative research program to study effects on mothers and their babies A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University. About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child. “This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice." To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about 1 million births over the past seven years (2001-2007). Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network. “This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children,” said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. “Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy.” The program blends clinical and research expertise and population-based databases from 11 health plan-affiliated 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, and the FDA. The HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, led by Richard Platt, M.D., M.S., is the coordinating center for the program. Lead researchers include Susan Andrade, Sc.D. HMO Research Network William Cooper, M.D., M.P.H. (Vanderbilt); Robert Davis, M.D., M.P.H. (Kaiser Permanente Georgia); Craig Cheetham, Pharm.D.; (Kaiser Permanente Southern California); and De-Kun Li, M.D., Ph.D. (Kaiser Permanente Northern California). The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, as well as studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes. A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. FDA epidemiologist, Pamela E. Scott, Ph.D., is the FDA project lead and chair of the Steering Committee.

Dr. Melanie Dreher, Refer researcher Dr. Melanie Dreher disagrees.

Q: Is it possible that American women didn't know how to use marijuana intelligently? Did you find that Jamaican women had more ganja wisdom?

A: American drug use often takes place without cultural rules and in an unsupervised context. The Jamaican women we studied had been educated in a cultural tradition of using marijuana as a medicine. They prepared it with teas, milk and spices, and thought of it as a preventive and curative substance. Smoking it during pregnancy was a way of relieving nausea, increasing appetites, combatting fatigue and depression, providing rest and relaxation. Some of these women were in dire socioeconomic straits, and they found that smoking ganja helped allay feelings of worry and depression about their financial situation.

Our testing showed that the children of women who used ganja had better alertness, stability and adjustment than children of women who didn't use ganja. This was measured at the age of one month. We measured children again at four years and at five years of age, and found that there were no apparent deficits in the children of marijuana-using mothers. In fact, in many ways, they were better off than children of non-smoking mothers. The ganja-using mothers also seemed better off than non-users.

Flickr photo above  - Pregnant with Twins 1976