How a renowned fertility doctor profits from an unproven supplement

Gleicher tells most of his patients to take DHEA, short for dehydroepiandrosterone, to help their ovarian follicles mature in preparation for in vitro fertilization (IVF). Among the brands he recommends is one sold by a company he owns — an arrangement he acknowledged in an interview is a potential conflict of interest. He said he doesn’t always directly inform every patient of his ownership stake but “I think the patients who care, know about it.”

A publicity-conscious entrepreneur who prides himself on bucking consensus, Gleicher is part of a group of fertility gurus filling the yawning void of information around women’s reproductive health, sometimes with answers that benefit themselves financially. In recent years, Gleicher has gone into business with a former patient — obtaining patents with her for DHEA’s use as a fertility treatment — and partnered with a popular fertility book author who cites Gleicher’s research and recommends the supplement sold by his company, Fertility Nutraceuticals. His company’s prices are around four to seven times as high as other popular brands.

The Food and Drug Administration and the Federal Trade Commission warned Gleicher in 2021 to revise his claims for DHEA and two other products, saying they “are not generally recognized as safe and effective” for use as fertility boosters. Independent experts such as the Mayo Clinic caution against taking DHEA, citing “serious side effects” and a possible link to cancer.

Gleicher said he believes the evidence for DHEA is strong and that he is driven by a single goal: helping the most desperate patients get pregnant. “We wanted to become known as the center where you go if things don’t work elsewhere,” he said.

Women’s fertility begins to decline around age 30, and drops rapidly after 35. Still, a rising number of older women are seeking to get pregnant. In 2021, women over the age of 42 began more than 12,200 IVF cycles, according to preliminary data from the Society for Assisted Reproductive Technology, a 25 percent increase from 2020.

The average age of Gleicher’s patients is 43, and the population he treats is “by far the oldest of any reporting IVF center in the country,” he said. The vast majority come to his clinic after failing to get pregnant elsewhere.

DHEA is no miracle drug: Among his clinic’s patients over 40 using their own eggs, only 2 percent of IVF cycle starts resulted in live births in 2020, according to data collected by the federal government. That’s lower than the percentage for women over 40 at clinics nationwide, who report live births in 7.6 percent of attempts.

Gleicher says that, given the ages of his patients and their difficulty getting pregnant elsewhere, his success rate, however slight, is “actually pretty astonishing.”

“He works with a very different patient population, with very low chances to get pregnant at all,” said Emanuela Molinari, a former laboratory director at Gleicher’s clinic, the Center for Human Reproduction. “It’s kind of a hopeless idea.”

DHEA is a small part of a fertility process that is physically taxing — and expensive. Each weeks-long IVF cycle can cost upward of $20,000 for procedures and medications — meaning that women are often spending significant sums at Gleicher’s clinic for a minuscule chance at having a baby.

Gleicher said he is “brutally honest” with patients about what their chances are. “And then,” he said, “it is for them to decide.”

Reproductive and women’s health are infrequent and underfunded subjects of research, in part due to long-standing stigmas and gender biases, as well as restrictions on federal funding for research involving embryos. As a result, droves of people seeking to start families in later years are left struggling.

“You have patients who are, very frequently, desperate to find answers,” said Marcelle Cedars, director of the University of California at San Francisco’s Center for Reproductive Health.

Gleicher’s company is one of many that sell fertility-focused supplements, several of which have been criticized for alleged overpromising in their marketing. Unlike drugs, which must be proven effective before they go to market, U.S. regulation of supplements is more lax.

“You’re left to kind of scroll through Reddit and Mumsnet and all these weird places to see what kind of information you can glean,” said Hannah Horne-Robinson, 34, who lives in the United Kingdom and is trying to conceive. She has taken DHEA, along with other supplements, and is frustrated by a lack of scientific consensus on combating infertility.

“Women, myself included, we’re at a point of desperation,” said Rachel, 36, another woman struggling with fertility. She spoke on the condition that she only be identified by her first name because of privacy concerns. She lives in New York but is not a patient of Gleicher’s. After two miscarriages, she began taking DHEA and coenzyme Q10, an antioxidant, after reading about them on an online community board.

“If they told me to walk around with Q-tips sticking out of my ears, I’d do it,” she said.

Last year, Ali McMullin, 37, of Falls Church, Va., added DHEA to other supplements in her regimen. For months, she has timed the pills, powders, capsules and injections carefully throughout her day. She credits better results in her last two IVF cycles, in part, to DHEA.

The American Society for Reproductive Medicine has issued no guidelines on the use of DHEA. The European Society of Human Reproduction and Embryology said in 2019 that its use “is probably not recommended” for women who respond poorly to IVF, citing “inconsistent evidence.” Studies on DHEA’s effectiveness have been mixed.

And nothing is risk-free. Rachel, the New York fertility patient, said she woke up in the middle of the night recently with a racing heart two days after tripling her DHEA dosage to 75 mg per day, the standard therapeutic dose, at her doctor’s recommendation.

She told her husband it felt like she was having a heart attack. The feeling went away after she decreased her DHEA dosage. When she reported the issue to her clinic’s nurse, she was told that DHEA can cause an irregular heartbeat.

‘Fighting for every patient’

Gleicher’s prominence in the fertility field is partly owed to his prolific scientific research as well as an assiduous courting of public attention. The Polish-born septuagenarian’s YouTube videos on fertility sometimes exceed 100,000 views, and he and his research are cited by major news outlets.

In a drawn-out cadence, sometimes tugging at his tufts of sparse white hair, Gleicher is quick to list his accomplishments: being named an assistant professor at a young age at New York’s prestigious Mount Sinai School of Medicine, becoming a leading IVF provider in Chicago in the mid-1980s, and pioneering a new method of retrieving eggs during IVF, among others.

“You will have a hard time finding a person in the infertility field anywhere in the world who does not know us,” Gleicher said in 2021 during testimony in a civil case in New York, according to a transcript.

His career has earned him a lavish lifestyle. In Chicago, he owned a four-story mansion that was the setting for scenes in the 1993 movie “The Fugitive.” In a 2019 New York Times profile, he boasted of his extensive art collection and red Porsche SUV.

“I love beautiful things,” he told the newspaper.

In the 1990s, he built a chain of clinics across the country into an IVF behemoth, with the hopes of eventually taking it public. But a market downturn hurt the public offering, and instead, the company, Gyncor, filed for Chapter 11 bankruptcy protection in 1999, owing creditors nearly $30 million. In the early 2000s, Gleicher moved his practice full-time from Chicago to New York.

Between 2017 and 2021, his New York practice conducted about 550 IVF cycles each year on average, according to data from the Society for Assisted Reproductive Technology.

His approach of working with older women to try to get pregnant using their own eggs has fans and detractors. Several CHR patients who were introduced to The Post by the clinic were grateful for the chance the clinic gave them.

“They’re fighting for every patient,” said one 45-year-old woman who encountered Gleicher through his clinic’s YouTube videos. She spoke on the condition that she not be named because of privacy concerns. After several failed IVF cycles at another, much larger clinic, the woman started treatment at CHR last year, and is now around six months pregnant.

In 2017, Gleicher touted an instance of a 47-year-old CHR patient who became pregnant with her own eggs and gave birth to a healthy girl.

But those success stories represent a fraction of outcomes. In 2018, Gleicher and his colleagues reported in a journal on the results of women aged 43 to 51 treated at CHR between 2014 and 2016. Out of 728 IVF cycles begun in that time, there were only seven live births, they said.

A patient — and business partner

Gleicher said he had never used DHEA in his practice until Dwyn Harben, a 42-year-old finance executive, came to his clinic in 2003. Unbeknown to Gleicher, she began taking DHEA after coming across a small study that showed it improved responses to fertility drugs.

Over the course of a year, in a remarkable 12 treatment cycles, Harben produced more and more eggs, according to news accounts.

“Her ovaries were behaving like those of [a] 20-year-old or 25-year-old,” Gleicher said in a 2004 interview with an outlet called ScienCentralNews, adding that he was “very optimistic — cautiously optimistic” about DHEA’s potential.

DHEA occurs naturally in the body, and its levels decline after early adulthood. Those who support DHEA use in fertility treatment believe it helps to mature ovarian follicles, the fluid-filled sacs that contain eggs, and improves egg quality. Gleicher said he only tells patients to take DHEA if their androgen levels are low, which he says makes them good candidates.

Most steroids are classified as controlled drugs, but DHEA has an exemption pushed in 2004 by a bipartisan team of senators friendly to the supplement industry. As a result, it can be sold over the counter. It is approved by the Food and Drug Administration only as a vaginal insert to treat vulvar and vaginal atrophy.

In addition to the supplement’s use in fertility treatments, it has also been touted for anti-aging and muscle strength. In other countries, DHEA is more tightly regulated, and it is barred for use by athletes by the World Anti-Doping Agency.

After learning about DHEA, Gleicher took an unusual step for a doctor: He went into business with his patient.

In 2004, he and Harben — along with David Barad, another physician at Gleicher’s clinic — applied for a patent on using DHEA during fertility treatments. The trio received several patents on the use of DHEA. Barad did not respond to a request for comment. Harben received annual royalty payments resulting from the patents, she said in a deposition for an unrelated lawsuit in 2021.

Julie Livingston, a spokeswoman for Gleicher’s clinic, said in a written statement that “Dr. Gleicher is not in business with Ms. Harben. They are co-inventors on certain patents involving the use of DHEA.”

Harben ultimately produced and fertilized enough eggs to freeze at least 60 embryos during her treatment with Gleicher — although by 2008, at age 47, she had not tried to become pregnant, she said in a segment on CBS’s “The Early Show” that year, according to a transcript. She saw Gleicher, Barad and another doctor for fertility treatment into her mid-50s, according to statements she made in the lawsuit . It is unclear whether she ever became pregnant.

Harben also continued to take DHEA, according to her statements in the lawsuit. A doctor recommended she stop after being diagnosed with breast cancer in 2013. She reduced her dosage but continued to take it, she said. The Mayo Clinic states that DHEA “might increase the risk of hormone-sensitive cancers, including prostate, breast and ovarian cancers.”

DHEA supplementation “does not, to the best of our knowledge, increase the risk that a woman will develop cancer,” Livingston said. She added that the clinic does not recommend that women undergoing treatment for hormone-sensitive cancers take DHEA without medical guidance.

Harben could not be reached directly, and a lawyer who represented her in the lawsuit did not respond to detailed questions. Gleicher said in an email to The Post that his staff had contacted Harben and that “she does not want to talk to journalists anymore.”

Gleicher owes some of his fame to Rebecca Fett, a patent lawyer who had fertility struggles. In 2014, she published a book, “It Starts With the Egg,” that remains a top seller in the “Fertility and Infertility” category on Amazon.

Fett has drawn criticism on internet forums from some who say her approach pressures women to upend their lives and take multiple expensive supplements. Fett said she sees her role as analyzing and explaining “the science in a way that is clear and understandable.”

One chapter of her book is devoted to DHEA and details Gleicher’s research and recommends his brand, while noting that women should speak with their doctors before taking it. On her website, she recommends his brand and two much cheaper brands.

Fett said in an email that she began consulting for his company in 2020 but has no involvement in its DHEA product.

The website for Gleicher’s supplement company, Fertility Nutraceuticals, sells Fett’s books and until recently, described her as its “lead scientist” and said she has a doctorate and graduate law degree. Fett said in May that those statements are inaccurate and that she asked the company to remove them. Alexandra Rata, who works for Gleicher’s clinic and supplement company, said in a statement that they were “unaware that this statement was incorrect. It was immediately corrected on the website once the issue was brought to our attention.” Some of the claims were removed in mid-July.

Fertility Nutraceuticals was founded in 2011. Gleicher is the majority shareholder, he said, and sits on the board. Until federal regulators stepped in, it marketed its DHEA product as improving pregnancy chances, according to archived versions of its website. Now it says that DHEA “supports” ovarian and reproductive health.

The company presents its products as higher-quality than other brands, touting their development by “fertility clinicians.” It advertises its version of DHEA, called Fertinatal, as “pharmaceutical-grade.”

“Pharmaceutical-grade” has little meaning in the context of DHEA, said Tod Cooperman, founder of ConsumerLab.com, which reviews health and nutrition products. There are no set standards for it. “When they say ‘pharmaceutical-grade,’ they’re making up that term,” Cooperman said.

Gleicher said he got the term from the manufacturer. But Vitaquest, the supplement’s New Jersey-based manufacturer, said it did not provide that language. Rata, the Fertility Nutraceuticals spokeswoman, said that the company interprets the term to mean “stringent batch quality control.”

The company sells a four-week supply of its DHEA supplement, Fertinatal, for $79. Other widely available brands of DHEA cost between $15 and $25 for a month’s supply.

Gleicher said the prices reflect the cost of manufacturing, which he said is higher because it is a small company. Rata said the company’s prices may be higher because of “required ingredient quality and detailed quality control processes.”

Fertility Nutraceuticals is not publicly traded, so its revenue and profits are not known, and the company declined to comment on its finances. Internal documents from Gleicher’s clinic, filed in New York State Court as part of a dispute between the clinic and a former employee, show that it earned $537,000 in revenue from supplement sales between 2015 and 2017 and spent over $400,000 on supplement purchases from Gleicher’s company in that time.

Those documents also show that starting in 2015, Gleicher’s clinic also received more than $330,000 in royalties in that period for a settlement resulting from a patent infringement suit. Public records show that Gleicher’s company has sued six supplement retailers for selling DHEA, including one that settled in 2015. The details of those cases are not public.

One doctor filed a complaint with the FTC in 2021 against Gleicher’s clinic and supplement company, saying he was asked to recommend and sell Gleicher’s supplement line exclusively after being sued by the clinic, according to a copy of the complaint obtained through a public records request.

Gleicher’s clinic and supplement company denied the allegations through the statement provided by Livingston.

Gleicher said his supplement company hasn’t turned a profit for years. A former company executive stated on LinkedIn that Fertility Nutraceuticals generated around $1.7 million in revenue in 2022.

Gleicher appears to have been paid more than $5 million in total salary and wages from his clinic between 2013 and 2017, according to financial statements in court filings. The salary figures are recorded as being paid to the clinic’s “officer.” Gleicher is the sole owner of the clinic, he said in court testimony in late 2021. In an interview, he said there were other officers of the clinic and declined to state his salary.

Two patients of Gleicher’s clinic interviewed by The Post said they were not told of his ownership interest in Fertility Nutraceuticals, but that it did not bother them. They spoke on the condition of anonymity because of privacy concerns.

A third CHR patient, Nathalie Mantilla, 45, had one child through fertility treatments in 2021. She said Gleicher and Barad recommended Fertility Nutraceuticals’ products, saying they were higher quality, and that they told her about their affiliation with the company.

“They just said that, obviously, they have tons of testing on this product and they recommended that,” said Mantilla, who spoke with a Post reporter after being contacted by Gleicher’s clinic.

Livingston said in the statement that CHR does not “preferentially treat” his supplement line.

While selling your own supplement to patients raises eyebrows in some corners of the medical community, it isn’t a violation of the American Medical Association’s ethical code, as long as patients are informed in person or in writing and the product has scientific backing.

“Are we telling every patient one-on-one that we own the company? I cannot swear to that,” Gleicher said.

He acknowledged that owning a supplement company represents a “potential” conflict of interest but said disclosures in his clinic’s monthly newsletter and in scientific papers are enough notice. CHR’s May newsletter mentioned the patents and stated that the clinic’s employees receive royalty payments from and own shares in Fertility Nutraceuticals. A statement in the February newsletter more clearly stated that the clinic “and its principals” are shareholders in the supplement company.

“For a patient to say that they don’t know, it’s kind of, you have to be blind,” Gleicher said.

The AMA declined to respond to a question regarding whether the newsletter mentions are sufficient disclosure, but an ethics expert said they are not.

“He definitely has to disclose his stake to the patients that he recommends these products to,” said Genevieve Kanter, a professor at the University of Southern California who has researched ethics in medicine. “If he hasn’t been disclosing his ownership interests to every patient during the visit, then he should have had a prominent written notice.”

Steven Joffe, chair of the department of medical ethics and health policy at the University of Pennsylvania, said in general there are not enough safeguards in place to ensure that medical professionals selling products to patients “are doing so in patients’ best interests.”

In 2021, the FDA and FTC sent a joint warning letter to Gleicher. The letter states that Fertility Nutraceuticals’ website claimed its DHEA product “has been show [sic] in multiple studies to … reduce miscarriage risk,” and along with another supplement, can “boost your chance of pregnancy or improve your IVF success rate.”

“The FTC is concerned that one or more of the efficacy claims cited above may not be substantiated by competent and reliable scientific evidence,” the letter said.

Gleicher said the letter was “totally unfair,” because “there was nothing on our website that A, we didn’t believe in, but more importantly, that we did not have … solid data for.

“I was in shock when it happened because we had this website with those statements for years,” he said.

The company revised its claims for its products and rebranded as Ovaterra in 2021, a move Gleicher and the company said was in the works before the federal warning.

Gleicher has co-authored studies that found better IVF results and higher pregnancy rates for those who took DHEA. But none of the studies used randomized, controlled trials — which medical experts say is the gold standard for demonstrating a drug’s efficacy.

Gleicher has argued against such trials for DHEA, writing in a comment to a medical journal in 2016 that DHEA was an “inexpensive and practically risk-free” treatment and that randomized, controlled trials for it would not be “worth the effort.”

That stance is “not acceptable from a scientific point of view,” said Peter Lurie, the president of the Center for Science in the Public Interest, a nonprofit advocacy group in Washington. “If you bring a product to market that raises the hopes of women experiencing infertility, you ought to be undertaking exactly those investigations.”

Other researchers have done randomized, controlled trials on DHEA use in IVF, with mixed results: One found a higher live birthrate among women who took DHEA, and another found higher pregnancy rates. But a third found no difference in response to fertility drugs, or IVF outcomes, between control and treatment groups.

Four reviews and meta-analyses in 2015, 2017, 2021 and 2022 found no benefit to DHEA, especially when only the best-quality evidence was considered, while two others in 2016 and 2018 found that it improved live birth or pregnancy rates.

Rachel McConnell, an assistant professor of obstetrics and gynecology at Columbia University in New York, said her patients sometimes ask her whether they should take DHEA. She said she tries to ensure they understand what the literature says.

“It’s just not evidence-based medicine that we can say for sure is going to make a difference.”