The FDA Says a Drug That Is Supposed To Reduce Premature Birth Doesn't Work—It's Still Being Sold
Earlier this week, the Los Angeles Times published an investigative piece that asked why a drug called Makena is still being prescribed to pregnant people to prevent preterm births even though the U.S. Food and Drug Administration (FDA) has proven it doesn't work. It might sound alarming and bizarre, but like most aspects of pregnancy, it's complicated. So, let's break down this latest news.
Rates of Prematurity Are Nuanced
According to the CDC, 1 in 10 American births is premature, which is defined as a live birth before 37 weeks of gestation. When we look closer at the 10 percent, we see some shades of nuance; not all birthing groups experience the same rate of premature births. For example, African-American pregnant people had a rate of 14.4 compared to Hispanic (9.8 percent) and white (9.1 percent).
Some of the most common causes of premature birth include smoking, substance abuse, expecting multiples, and a short time period between pregnancies. But even if these risk factors are not present, a pregnant person can still experience a spontaneous preterm birth. So, it is no wonder that doctors have long tried to find ways to bring pregnancy full term. And that is where Makena comes in.
What Exactly Is Makena, and What Does It Do?
"The drug Makena is administered for mothers with a history of preterm labor or a history of preterm rupture of membranes in a previous pregnancy. The medication is injected into the muscle of the buttocks or arm once weekly from 16 weeks up until 36 weeks," explains Greg Marchand, M.D., a board-certified OB-GYN based out of Mesa, Arizona. "Recent trials have led the FDA to consider withdrawing approval because the treatment does not appear to work as well as studies performed prior to approval seemed to show."
The story of Makena is a wild ride that starts back in the 1950s when doctors wanted to find a way to synthetically create progesterone, known as the pregnancy hormone that can help patients bring their pregnancies to full term. In a lab, sometime in 1953, scientists created a drug called 17-alpha hydroxyprogesterone caproate, or 17P for short. The synthetic hormone therapy was approved for use by the FDA to prevent spontaneous premature births, particularly in pregnant people with a history of preterm births.
It was given the name Delalutin and put on the market where doctors could prescribe it to their patients. But the drug wasn't the medical miracle that doctors thought it would be. In 1999, Bristol-Myers Squibb, the company that owned and sold the medicine at the time, essentially took it off the market but left the recipe intact at compounding pharmacies so that doctors who wished to use it could have it made to order.
It Was Financially Advantageous to Prey on Hope
According to the Los Angeles Times, AMAG Pharmaceuticals executives saw a "billion-dollar opportunity" in Delalutin. According to the investigative piece, drug executives realized they could make a billion dollars annually if they could convince 140,000 pregnant people to take 16 or more injections during their pregnancies.
The company used an old, taxpayer funded drug trial from 2003 that showed the drug, now called Makena, worked to prevent preterm births. However, some contend that the 2003 drug trial was flawed and should never have been used to green-light Makena. In 2006, the FDA asked experts to weigh in on Makena, and in a vote of 19 to 2, they agreed that the study failed to show that the drug works. These experts also agreed that more extensive studies should be done on the drug to determine if it leads to miscarriage or stillbirths and to test its safety. In a vote of 13 to 8, experts said that the data on safety was "adequate" to "support approval." In 2011, Makena was approved by the FDA for use in pregnant patients.
"The drug has not been found to be in any way harmful, just not as good as was thought. There may be some women helped by this medication, but there is growing consensus that it is not very useful and obstetricians will likely stop routinely prescribing it for patients soon," Dr. Marchand says. "In my own personal practice, I go over the data with every patient who has had a preterm birth and let the patient decide for themselves."
The drug Makena is now owned by AMAG Pharmaceuticals, a financial contributor to the Society for Maternal-Fetal Medicine, which has more than 5,000 members that include physicians, scientists, and women's health professionals. AMAG also contributes financially to the American College of Obstetricians and Gynecologists, according to The Los Angeles Times. And despite strong data and a growing consensus that Makena does not work, both the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists has not pulled back their support for the drug. The optics here are worrying.
The Prematurity Risk Is Still Present, but the Odds of Survival Are Better
The gloomy financial details of how Makena made its way through FDA approval and stayed on the market despite red flags as described by the Los Angeles Times is enough to make anyone feel pessimistic about the intentions behind why a drug is prescribed to a patient in the first place. However, this is 2022, not 1953, and many advances have been made to help preterm babies live and thrive.
"Most babies after 32 weeks do really well if they are born prematurely, and there is nothing else wrong with the pregnancy," says Kim Langdon, M.D., an Ohio-based OB-GYN. "However, the biggest risk is that the organs, primarily the lungs and brain, are not developed enough, so cerebral palsy is the biggest fear. Neonatal care has vastly improved, so even extremely premature babies can do well."
Until science can solve the mystery of why some pregnancies are preterm or how to create effective prevention measures, the best way to lower the risk of preterm labor is to have preventative screenings while pregnant if access to affordable health care is an option. That includes screening and treating for vaginitis, sexually transmitted infections, urinary tract infections, and other infections that can damage the health of an unborn baby.
It's important to note that access to prenatal care is much harder for marginalized people. Black and Latinx communities face higher barriers to care than other groups.
Pregnancy can be messy, beautiful, exciting, and nerve-racking for anyone going through it. But having to worry about the efficacy of a drug meant to prevent something terrible from happening shouldn't be a burden any patient should carry. Talk to your doctor about prescriptions, procedures, and lifestyle habits to make sure that you feel confident about the health care that you receive.
Wow. I was advised that I had to receive treatment with Makena because my first born was premature. This drug is around $1300 a shot. Thank God for insurance. I feel awful for women who paid out of pocket for a drug that doesn’t work!!!Read More