Dr. Gary Berger is founder and medical director of Chapel Hill Tubal Reversal Center. The reproductive surgeon graduated with honors from Harvard University and the University of Rochester Medical School. Following a medical internship at Duke University Medical Center, he began his residency in obstetrics and gynecology at the Johns Hopkins Hospital. He went on to serve in the U.S. Public Health Service at the Centers for Disease Control as an Epidemic Intelligence Service officer in the Family Planning Evaluation Program. Dr. Berger completed his residency in obstetrics and gynecology, and simultaneously earned master’s degree in maternal and child health at the University of North Carolina School of Public Health at Chapel Hill. During his appointment as assistant professor of obstetrics and gynecology at the UNC School of Medicine, Dr. Berger trained abroad in tubal microsurgery techniques and initiated the tubal microsurgery program at the UNC Medical Center. He then entered private practice specializing in tubal reconstructive surgery. Dr. Berger is board certified in obstetrics and gynecology, preventive medicine and epidemiology. He is a charter member of the Society of Reproductive Surgeons.
for Makena will fall primarily to Medicaid
not answer the question of how much
since low-income women are at high risk for
regulatory approval is worth?
premature birth. Medicaid is facing massive budget cuts across the US and will almost
Women will be receiving the same drug, in the
certainly not be able to cover these costs. With
same formulation and dosage, as before. But
compounding pharmacies being threatened
now it’s FDA-approved. The FDA places a high
by KV with legal action if they provide 17HP,
value on it – seven years of market exclusivity.
fewer women may get the drug than in the
As long as the FDA’s stamp of approval for
past, resulting in even higher numbers of
old drugs is valued this highly, there will be
premature births.
companies like KV that will take advantage of it to make as much money as possible. This
KV has announced a patient assistance
is one of the reasons that health care is so
program for Makena based on income
expensive in the United States.
eligibility requirements. However, this does
How can KV justify the 15,000 percent increase in price for this potentially lifesaving drug? The company cites medical costs, estimated at approximately $50,000 in the first year of life and lifelong disabilities that may result from prematurity. However, KV has incurred no costs in research and development of a new drug. Its approval was based on studies that had already been published. Admittedly, there were legal costs involved in the FDA application, and as a condition of orphan status, KV will need to continue to study the safety and effectiveness of the drug. Since winning approval from the FDA, KV has sent a “cease and desist” letter to compounding pharmacies to stop producing 17HP, warning they face FDA action if they continue to sell cheaper “unbranded” versions of the drug. The burden of paying the exorbitant cost Womens Wellness half vertical.indd 1
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