The “industrialization” of Infertility Care

New concepts in infertility care are increasingly “industrialized.” Interesting new ideas now attract equity investors with increasing frequency. In making those investments, their primary interest, understandably, is to earn maximal returns. In companies created around such new ideas, one, therefore, sees concentrated efforts to bring new products to market as quickly as possible and at as little cost as possible.

One, of course, cannot blame companies (and their investors) for trying to maximize their profits, even if this means cutting some corners. They are not in business to conduct proper clinical trials; their purpose is to earn maximal returns for their stock holders.

One, however, has to blame scientists who allow themselves to be manipulated as part of this process to “oversell” products to colleagues and the public since they have the power within company structures to put their foot down, and demand proper clinical investigations before they go “selling” their company’s products. Even if they hold shares in those companies (or maybe especially if they do), we feel that they have an ethical responsibility to try to prevent premature unrestricted introduction of unproven products to the marketplace.

This is exactly what happened with PGS (one of the country’s leading PGS laboratories was recently purchased by the industrial conglomerate, The Cooper Companies Inc., for approximately $50M). Similarly, the newly developed industry of closed incubation systems with time-lapse imaging has already started to consolidate with the acquisition by Vitrolife AB of the two first companies that received certification by the Food and Drug Administration for their systems. Then there is AUGMENT™, currently the only product of OvaScience Inc.

What all of these products have in common is that they represent interesting ideas with considerable promise for future clinical utilization. In earlier developmental stages of IVF, they would have had to prove themselves in clinical practice before being widely accepted into routine IVF practice (i.e., a number of studies in the medical literature would have had to demonstrate their clear clinical utility). Nowadays, however, with major commercial interests invested in these products, they are often aggressively and professionally marketed (almost like pharma products) before evidence of their utility has been established. It, therefore, is not very surprising that many of these products never are able to establish themselves as truly useful.

With this as background, it, therefore, is interesting that serial entrepreneur Martin Varsavsky, according to an article on November 20, 2015 by Amy Or in Private Equity Beat, is raising “hundreds of millions of dollars” from private equity to set up a completely new fertility treatment model, called Prelude Fertility, which he believes will revolutionize fertility care.

Once again, his basic premise is logical and, indeed, very interesting: He correctly makes the point that people increasingly “miss their maternity and paternity goals because they start too late.” He also is correct in stating that “humans are designed to be fertile in their teens and 20s, not late 30s and 40s.” The problem is, however, once again that, as an entrepreneur, he is falling in love with a hypothetical concept, without doing enough in preliminary investigations to validate the concept before raising hundreds of millions of dollars, which may go to complete waste if the hypothesis cannot be proven in appropriately designed studies.

If good ideas were enough to advance medicine, there would be no need for clinical trials. One can assume that Pharma companies are not committing millions of dollars to such clinical trials without significant preliminary studies on candidate drugs; yet, still, a large majority of candidate drugs fail in their clinical trials. It, therefore, is incredibly naïve to assume that just having a seemingly good and logical idea in medicine automatically translates into a new practice model or medical product.

Varsavsky’s Prelude model, indeed, demonstrates this point abundantly: He plans to charge clients a monthly fee for “baby insurance” which has consumers freeze eggs and sperm at young ages, when they are healthiest. Eggs and sperm would then be used when “it was time to have a baby” to create embryos and Prelude would, furthermore, via PGS “help screen out chromosomal abnormalities during IVF.”

To have young women think ahead about their future fertility is, of course, very important. Indeed, CHR has been working on this concept for a number of years in an attempt to identify at young ages those 10% of women who are at risk for premature ovarian aging (POA) because they, later in life, will disproportionately be in need of expensive fertility treatments. CHR secured a U.S. patent for an algorithm that can do that, and this algorithm became the basis for What’s My Fertility?, a new concept (and company) which has the goal of developing increasingly accurate prediction models of risk (with increasing data accumulation), which in turn will offer young women the benefits of much earlier diagnosis of POA. It, therefore, will give them, going forward from an early diagnosis, more reproductive choices, including earlier maternity and egg freezing.

In contrast to Varsavsky’s Prelude model, What’s My Fertility?, however, not only is logical but is transparent in its abilities and, most importantly, realistic in its limitations. It makes sense to select out patients at increased risk for expensive infertility treatments in the future; it does not make sense, in our opinion, to impose artificial conception on everybody. After all, a large majority of women, even nowadays when women are having children later in life, still conceive without need for any fertility treatments. It, therefore, is unclear to us why everybody should be treated at young ages under the Prelude model.

Moreover, the Prelude model’s plan of PGD/PGS for everybody is simply absurd in principle, and, of course, even more so, considering the complete lack of clinical utility of PGS that is increasingly becoming apparent. In short, we would caution Varsavsky and his potential investors from pursuing the Prelude model as a business proposition the way it currently is being advertised, and suggest that they reach out for objective professional advice before embarking on yet another “industrial model” that makes little clinical sense.

As Amy Or also reports in her piece, based on macroeconomic tailwinds, including increasing numbers of women delaying childbirth, and rising social acceptance of single and gay parents, private equity is now eager to invest in infertility treatments. The private equity company TA Associates in August, for example, placed a major investment in one of the country’s better known fertility centers, The Colorado Center for Reproductive Medicine (CCRM), which recently started to open satellite centers outside of their original Colorado home base, and, indeed, also announced a 2016 opening in New York City.

This investment demonstrates that the “industrialization” of infertility does not only extend to products but, now, increasingly also includes the provision of infertility services directly. In Europe this trend has been going on for years, with some of the biggest fertility providers, like Spain’s IVI, originally started in Seville, having expanded all over Spain, and now also establishing branches in other countries in Latin America and Europe as well as in many Indian cities. It, indeed, recently opened two genetic laboratories, mostly specializing in PGS, here in the U.S. Similar commercial corporate models are followed by The U.K.’s Bourn Hall Clinic, now having offshoots in Dubai and India, and Britain’s CARE, currently likely the largest provider of IVF and PGS services in the UK and Ireland. In Germany, some of the largest privately owned fertility centers have been bought up by commercial laboratory giants.

Fertility services, therefore, very obviously in all of their aspects are increasingly undergoing “industrialization.” From the effects we are seeing these developments exerting on patient care, we are not certain that this is happening with primarily the best interests of patients in mind!

This is a part of the December 2015 issue of CHR VOICE.

Norbert Gleicher, MD, leads CHR’s clinical and research efforts as Medical Director and Chief Scientist. A world-renowned specialist in reproductive endocrinology, Dr. Gleicher has published hundreds of peer-reviewed papers and lectured globally while keeping an active clinical career focused on ovarian aging, immunological issues and other difficult cases of infertility.