The multibillion-dollar sperm donation business has shockingly little oversight, leading to false promises of anonymity, insufficient medical testing and high numbers of half-siblings, according to advocates who are demanding more stringent regulation of the emotionally wrought fertility industry.
“They’re not creating gidgets and widgets. They’re creating human beings,” said Wendy Kramer, founder of the Donor Sibling Registry. “Because there’s a lack of oversight, it’s kind of a free-for-all. If we can’t be ethical in this area, where can we be ethical?”
As it stands, the government requires sperm banks to test for sexually transmitted infections. It recommends — but doesn’t require — genetic testing for certain hereditary conditions, such as cystic fibrosis, leaving families vulnerable to unknown genetic hazards when those tests aren’t done.
Kramer and other members of the registry, a 50,000-member organization for donors and donor offspring, filed a petition last month to the U.S. Food and Drug Administration asking the agency to consider a major expansion of those mandates, including:
•?More comprehensive genetic and medical testing;
•?Tracking and limiting the number of offspring per donor to reduce the number of half-siblings;
•?Updated donor testing to track conditions that may develop over time;
•?An end to donor anonymity.
Sperm banks rely too heavily on donors to disclose accurate personal information, Kramer said, leading women to conceive under false pretenses. It’s an issue that has spurred a number of lawsuits against sperm banks, including Georgia-based Xytex Corp. At least one such lawsuit alleged that a donor had admitted to misrepresenting himself as an Einstein-level genius. The donor, who has at least 36 offspring, is allegedly a college dropout with a criminal history who has been diagnosed with schizophrenia.
The comments on Kramer’s petition to the FDA are riddled with personal stories illustrating the need for more thorough testing, particularly for behavioral and psychiatric problems. One commenter, who obtained sperm from a bank in Virginia, said she was informed in 2016 — one week after she had her second child — that her donor committed suicide three years earlier.
As a result, she wrote, “my children have not only lost their right to seek out their donor at age 18, but they also may or may not have inherited a predisposition to suicide. … This is unconscionable. The FDA needs to step in and regulate this industry on a federal level.”
Beyond testing, the petition requests strong limits on the number of offspring per donor to reduce the chances of random half-sibling encounters. It is recommended there are no more than 25 births per population of 850,000, but this is not always tracked or enforced.
A chance saturation of half siblings in one geographic region is an issue that is all too familiar to Kramer. She lives in Colorado. Her 27-year-old son, conceived with donor sperm from California, has at least 10 half-siblings — four of whom are in Massachusetts. Two have not been informed that they were conceived with the help of a donor. Scenarios like that raise the spectre of unwitting encounters between people who don’t know they are closely related — placing potential offspring at risk of a wide range of genetic disorders.
The petition also asks sperm banks to stop promising anonymity to potential donors. The advent of DNA testing, along with sites like the Donor Sibling Registry where people can pool their search efforts, has made it nearly impossible to conceal donor identities.
Sperm banks are making efforts to expand testing in the absence of federal mandates, said Scott Brown, director of client experience and communications for California Cryobank, which has a facility in Cambridge.
In the past two years, the cryobank has added criminal background checks and psychological screening, as well as testing for 261 genetic mutations.
“As science continues to find new ways to understand who and what we are, I imagine we’ll keep pace with that the best we can,” Brown said.
But regarding the number of offspring per geographic region, Brown said there is simply no feasible way to keep tabs on people’s whereabouts.
“People move around,” Brown said. “There’s no way to enforce that.”
And, Kramer said, there isn’t much impetus for the industry to make the costly changes.
The FDA’s Center for Biologics Evaluation and Research responded to the petition with an email that reads: “Due to the existence of the other FDA priorities, we cannot predict when the review will be complete.”
“We don’t have any power. We don’t have billions of dollars. We don’t have lobbyists,” Kramer said. But, she’s hoping the petition will at the very least “help the industry move forward more ethically and responsibly.”
She added, “So many of us in donor families have been so negatively affected.”
