It sounded like a miraculous technology when it was introduced in 1992. The wives of men with low to nonexistent sperm counts could get pregnant using a technique called intracytoplasmic sperm injection.
Usage exploded. It quickly replaced conventional in vitro fertilization as the technique of choice for thousands of couples, many of whom were approaching the end of their childbearing years. Use of the fertility procedure more than doubled between 1996 and 2012 to 76% of all couples seeking help, including many cases where the men did not even have low sperm counts.
While the approach added thousands of dollars in additional out-of-pocket medical expenses for patients, it didn't improve pregnancy, miscarriage and birth rate outcomes compared to the conventional method, according to a study comparing 15 years of data on the two procedures that was published last week in JAMA.
The significant increase of patients for whom the intracytoplasmic procedure wasn't indicated was a surprise. “It can be an effective treatment when there is male-factor infertility. But the problem relates to the expansion of its use, without evidence, in patients who do not have a diagnosis. This is not recommended,” said lead study author Sheree Boulet of the Centers for Disease Control and Prevention. Researchers in the study also noted: “Pregnancies resulting from the use of ICSI (intracytoplasmic sperm injection) have been associated with 1.5 to 4 times increased incidences of chromosomal abnormalities, imprinting disorders, autism, intellectual disabilities and birth defects compared with pregnancies resulting from conventional IVF.”
Technologies like ICSI exist in what researchers, cost-control advocates and consumer groups are beginning to call medicine's gray zone. Many drugs, devices and procedures may have been proven effective in the clinical trials that their developers submitted to the Food and Drug Administration. But after they are widely deployed by physicians and hospitals outside that carefully controlled trial environment, they don't achieve the same outcomes. Sometimes they perform worse than cheaper alternatives already on the market or do more harm to patients.
For years, complaints about the poor performance of pricey and sometimes dangerous new technologies were limited to consumer advocates. “It's an all too common scenario, and the motivation is ultimately money,” said Dr. Michael Carome, director of the Health Research Group for Public Citizen. “But it is not in the best interest of patients or public health.”
But now, their concerns are being echoed by mainstream healthcare leaders with a newfound concern for eliminating waste in the system—a concern that's being driven by payers and employers demanding greater value for their healthcare dollars.