Portfolio at NYU

Posted 03.30.03
The Egg Market: the (Lack of) Regulation of the Egg Donation Industry

By Caroline Binham

Ron Harris is a businessman. You might remember his name from headlines in 1999: after a successful career breeding Arabian horses and directing pornographic videos in California, Harris progressed to mingling his interests in both genetic selection and beautiful women. He set up an online auction of models' eggs, with bids starting at $30,000.

As it turned out, the venture was a hoax intended to lure people to the $24-a-hit website. Yet, however unsavory and unethical, www.ronsangels.com was perfectly legal in its premise. The United States is one of the few developed nations that permit egg donors to be paid (as "compensation" with a current market rate of $5,000). Egg donation and assisted reproductive technologies have become a billion-dollar industry in the United States, where genes are commodities to be bought and sold. Just ask Ron Harris.

Ever the savvy entrepreneur, Harris tapped into a fast-growing industry: in 1991, there were 63 programs offering in vitro fertilization (I.V.F.), the process in which donated eggs are used; by 1995 that number had jumped to 189. Already, more children are born in this country with the help of reproductive technologies than are adopted. Mirroring the growth, needing a constant supply of eggs to meet demand, the compensation donors received leapt from $250 in 1984 when the practice first became available, to today's standard $5,000. Despite the growth, it was also an industry left unregulated. The bioethical issues and wider effects of this growing use of the human body - from whether it is right to be able to select an egg donor with certain selected traits and pay her; to the legal parental rights of all parties involved; to the number of times a woman can safely donate - have never been addressed in federal regulation. The only law this market is subject to is that of supply-and-demand. This might be about to change.

As of January 2003, all facilities that handle human cells and tissue, including eggs and sperm, must register with the Food and Drug Administration (F.D.A.), which also will begin mandating the testing of donors for diseases such as hepatitis and H.I.V. This will be the first federal regulation of egg donation in this country.

Although this is a welcome development in terms of the potential for increased efficiency in the industry, experts say it will do little, if anything, to tackle the bioethical dilemmas that shroud egg donation.

While the medical practice will become more business-like and efficient through the regulation, the openly commercial side that already exists in the egg donation industry - the ads offering competitive rates for egg donation, and brokers (an extreme example of whom Harris purported to be) -- will be left unchecked. The worry is that when making money is the priority behind an industry, questions of respect for the source of the "product" - in this case a human person - become neglected. So the familiar tug-of-war between business and ethics ensues, only on this occasion both sides are ballasted by the constitutional rights of reproductive liberty on one side, versus a ban on the commodification of the human person on the other.

The FDA's concerns are normally food, drugs and labeling. They guarantee the consumer the safety of a product. Likewise with the new regulation. In the agency's report on the new guidelines, it states: "Consolidating the regulation of human cells and tissues into one regulatory program is expected to lead to increased consistency and greater efficiency." They are ensuring the quality of a disease-free product (the egg) for the consumer (the recipient couple). There is no mention of the donor's welfare in the new regulation. Paul Richards, with public affairs for the FDA's Center for Biologics said: "Recipient protection was the emphasis because of reports of the transmission of infectious diseases."

Any F.D.A. regulation would, by its nature, be limited, according to Dr. Cynthia Cohen of Georgetown University's Kennedy Institute for Bioethics. "They deal only in the safety and efficacy of the procedure, they're not a group to look at public policy issues," said Cohen, who sat on a bioethics advisory board for the Clinton administration. "We're looking at the impact on children, what it means to be a parent, what it means to commodify the human person - there are many broader issues that cannot be addressed by the F.D.A."

The first baby born from egg donation is now 18 years old. Yet the law has been slow, if not reluctant, to catch up with these medical advances. So why the lack of legislation and regulation? "Ultimately, it comes down to vested interests, money, and political capital," said Ken Baum, M.D., a Yale lecturer in bioethics and a lawyer specializing in medical litigation. "The providers are in a race to get women pregnant, so they have higher success rates, thus a more marketable facility. The patients are another vested group; they want access to as many technologies as possible. There is social ambivalence, so politicians, particularly the present administration, just leave the issue alone: they're bound to alienate half of the electorate."

Of course, the unregulated and commercial environment of egg donation and assisted reproductive technologies (A.R.T.s) is not unlike the whole of medicine. The federal government has a history of laissez-faire deference to the medical community. "It would be easier to argue for the regulation of egg donation if the government regulated and paid for the rest of the healthcare system," said Baum.

It is only now, 18 years after egg donation became common, that problems are seeping into the legal system. With a growing number of donations every year, this can only exacerbate the situation. The legal dilemmas stem from the fact that egg or sperm donation complicates the child's maternity or paternity (or even both), a legal situation made more knotty if a couple later decide to divorce. In January 2002, the Massachusetts Supreme Judicial Court ruled that children conceived using frozen eggs or sperm of a dead parent could be considered their offspring for inheritance. The same day the court heard that case, it had another to decide on: a couple were asking the court to be able to put their names on the birth certificate of twins instead of that of the surrogate mother. Chief Justice Margaret Mitchell of the court wrote that these decisions should not be left up to individual courts to decide. "The questions," she wrote, "Cry out for lengthy, careful examinations outside the adversary process."

Doctors argue that they already have a code of good practice, legislation or not. Currently, fertility centers report their figures for live births and other relevant data to the Center for Disease Control, which releases an annual report. Beyond statistics, the American Society for Reproductive Medicine (A.S.R.M.) oversees the broader issues of egg donation. It is also the A.S.R.M. that issue guidelines for donation practice. The guidelines advise on every conceivable element, from how much a donor should be paid for her time and inconvenience before the cash might be enough to be considered an inducement ($5,000), to the age of the recipient mother (pre-menopausal).

The A.S.R.M. is a professional organization, which means its guidelines cannot be enforced, but they can throw out of the society any doctors who do not comply. This is in contrast to other countries, such as the U.K. and Australia, which have strict governmental rules on all aspects of egg donation and I.V.F. treatment.
Sean Tipton, spokesman for the organization, said the A.S.R.M. had reservations about the pending F.D.A. regulation, including the six-month quarantine period necessary for testing eggs for HIV. Sperm can be frozen and kept for months, even years; eggs cannot be stored so easily. "Some of their requirements are scientifically unsound," said Tipton. "For instance, it says you can't commingle tissues from two different people, and, well, when you try to make a baby, that's what you do." He also commented that the regulation would do little to change current practices, other than make the process more bureaucratic and more of a financial burden for recipient couples, who already face fees of approximately $8,000 per cycle.

The A.S.R.M. is one of the parties with vested interests in non-regulation, according to Dr. Ruth Macklin, a bioethicist at Albert Einstein School of Medicine. "They have lobbied mightily against any form of regulation," she said. It might seem logical to want to legislate what are now their guidelines, but then one could question the need for the A.S.R.M. should regulation be implemented. Tipton said: "If there were federal regulations, we'd still exist. Our concern is that when government agencies get involved, they have no scientific expertise, as evidenced by the F.D.A. report, and then they lock things in place, and stifle innovation."

The F.D.A. wants to claim that it will be otherwise with this new ruling, but the regulation-versus-innovation concern remains familiar. Baum, who has argued that egg donors should be paid according to market demand rather than at a capped rate, sympathizes with that argument. "There were good and bad outcomes of the self-regulation of the I.V.F. industry, out of which egg donation was born. The industry progressed much quicker than it would have done if it were heavily regulated, but there were a lot of clinics that weren't safe or gave enough information for couples to make an educated choice."

For Baum, it is the dissemination of information that should be a priority for legislators. "I'm anti-paternalistic, but I think you need some legislation for the protection of all parties involved. People should be able to do something for $50,000, but you have to tell them the risk involved." Baum would like to see an independent fertility advisor at all facilities, but who is not affiliated to them, to counsel both donor and recipient couple on the decisions involved in the process.

Aside from the toxicity of the subject in political arena, egg donation will not likely become a priority for legislators: A.R.T.s are not life-saving treatments, and only affect a relatively small percentage of the population - one in ten couples.

There is little information on the number of women who donate their eggs each year, but a 1998 report from the Center of Disease Control states that of the 81,899 A.R.T. procedures performed, 5,828 used donated eggs. One donor, Karen, is a 31-year-old mother, living with her son in New York. She has donated her eggs three times since her son was born six years ago. She took it upon herself to research the possible side-effects of egg donation before applying as a donor at a clinic. Under the screen name cl-mtoc1996, she is the community leader of an online support group for both donors and recipients. "I do think there are some places that don't give enough information, and there are donors who don't ask," she said. "I don't know which is more frustrating to see."

Depending on who donors ask, they will get a different answer to the question of what risks egg donation entails. On Ron Harris' website, the only medical information he disclosed to his potential donors was: "Eggs are harvested from the donor via hypodermic. We do not believe the process is any more painful than an injection." In fact, egg donation is a lengthy process that requires months of hormone regimens before a surgical operation to extract the many eggs that are induced by the hormones. Risks involve ovarian hyperstimulation, unwanted pregnancy and multiple birth, twisting of the ovarian tubes due to the size of the enlarged ovaries, and a link to ovarian cancer. That is aside from risks related to a procedure requiring general anesthetic. Harris did not reply to a request for comment. Again, however, he did not break the law in not disclosing all the known risks.
Although there is no federal regulation of egg donation, regulation on the state level does exist (though not in every state). New York, in comparison to most states, has advanced regulation. But even New York's Department of Health distinguishes between medical facilities - normally an infertility center where the egg retrieval takes place - and egg donation brokers and agencies. Brokers have no legal responsibility to inform the donor of the medical risks involved, hence the disparity of information given to donors.

With the highest number of A.R.T. procedures behind California (8,689 in 1998, according to statistics from the Center for Disease Control), New York is the only state to have a task force that acts as a bioethics advisory board to the Department of Health, and ultimately to the governor. Dwayne Turner, the executive director of New York State's Task Force on Life and the Law, said that the group had not yet addressed the issue of independent brokers and advertising, as "the members are stacked on the current issues." The advisory group was, however, to release educational material for women considering egg donation. "It addresses the ethics behind advertising," said Turner. "We want to make sure that young women are not being unduly influenced."

Dr. Fred Licciardi is the director of N.Y.U. School of Medicine's infertility center. His center's ads, which appear in NYU's student newspaper, solicit college-age women. There is mention of compensation worth $7,000, but unlike many similar ads, there is also mention of donor screening. Licciardi, a father of three, said that the center started its own "in-house" recruitment of egg donors after some bad experiences with agencies, including having an otherwise-perfect donor who was a Californian sports instructor. Her agency had told her it was fine to continue training: it wasn't, because the enlarged ovaries can twist and cut off the blood supply. "The main problem is that they do not inform the donor completely of the entire process; number two is that they do not screen the donor adequately," he said. "And there's a big fight because the recipient has paid the agency, and the agency has told her the donor is OK, but I'm telling her the donor is not OK." Referring to the fact that agencies are not legally bound to inform the donor of risks, he said: "But they should not misinform either, that's the problem."

Licciardi caps the compensation rate at $7,000 for all donors, even if the recipient couple has offered higher for a donor with specific traits. "It's not enough money to change their lifestyle," he said. "It might pay their rent for a while, which is great, but that's about it." Licciardi said the center offers $7,000 because that is the going rate at other New York facilities. He fears that regulating the compensation might result in a dearth of donors (as is the case in countries with strict regulation, like Israel and Britain). The priority is to keep the donors coming in: in this industry, demand currently outstrips supply.

Ruth Macklin at Albert Einstein says this is typical of not only egg donation, but also medicine in general. "Hospitals advertise, after all," she said. "The simple response is that it's a question of survival. If one clinic pays less than other clinics, donors don't go to it. That's what happens in a business. The question is whether everything in our capitalist society may be put up for sale."

The new F.D.A. regulation, with its emphasis on efficiency rather than ethics, will do little to alter this state of affairs; indeed, the January 2003 deadline for registration has been pushed back until 2004, officially to allow establishments more time to prepare for it.

Cynthia Cohen, for one, is optimistic on the ruling, no matter how slight it might be. "It's a start," she said. "But egg donation is more than individual choice. This practice doesn't just affect the recipient and the donor, but a subsequent child too. It affects us as a society."