The God of Sperm26 Sep 2007, Posted by in
The world’s largest collections of stored genetic material are found in Sussex, England, Spitsbergen, Norway — and Los Angeles.
Sussex hosts the Millennium Seed Bank, which houses some 750 million species of plant seed. Spitsbergen, an island less than 600 miles from the North Pole, is the site of the Svalbard Global Seed Vault, which safeguards — inside a tunnel, inside a mountain — every variety of all of the Earth’s 21 major food crops. And Los Angeles is home to the California Cryobank, the largest sperm bank in the world, with enough human seed supercooled on-site to repopulate the planet several times over.
The first two projects are international efforts to preserve our genetic future; the last is a private enterprise on L.A.’s Westside run by a man occasionally known as “The King of Sperm.”
The King of Sperm wears Buddy Holly glasses. He is of medium height and medium build, balding, 69 years of age, with a penchant for flashy shirts and comfortable shoes. His name is Dr. Cappy Rothman and “Cappy” is not a nickname. It is the colorful moniker given to him by his colorful father — if by colorful one means mobbed up. See, the King of Sperm began his career in casinos. His father, Norman “Roughneck” Rothman, ran the San Souci Club in Havana, so Dr. Rothman spent his teenage years in Cuba.
One of his earliest jobs was ferrying cash — in a briefcase handcuffed to his wrist — between Cuba and banks in the States. One of his later jobs was working as an organizer for Jimmy Hoffa — to raise extra cash for medical school at the University of Miami. This led him to a residency at the University of California in San Francisco, where he studied under the legendary urologist Frank Hinman Jr. Hinman was in the habit of assigning his students yearlong research projects on medical mysteries. How sperm got from testicle to outside world was the puzzle Rothman was assigned to solve during his first year of medical school. In his second year, it was the mechanism of erection. Two topics that explain both Rothman’s entrance into the world of infertility and the long way we’ve come in 40 years.
“I loved infertility immediately,” says Rothman. “There was so much we didn’t know. I felt like a pioneer.” By 1975, the pioneer was board-certified in urology and took a job at the now-defunct Tyler Clinic, becoming Los Angeles’ first male infertility specialist. Rothman established the Southern California Cryobank as an offshoot of the Tyler Clinic. A year later, he went out on his own, and the California Cryobank was born. That year, a U.S. senator’s son (Rothman prefers not to name him) was killed in a car crash. The statesman contacted Rothman and asked if his boy’s sperm could be saved. In 1977, Rothman published the very first article on sperm banking in the Journal of Urology.
In 1978, because of the work he’d done on the senator’s son, he published the first article on postmortem sperm retrieval, soon thereafter appearing on Oprah to explain it. Despite these accolades, what Rothman remembers most was a young couple who came to see him. “The man was infertile and the woman was angry. In the middle of that discussion, she turned to her husband and said, ‘Because I married you, I’ll never be a mother.’ It was a statement I never wanted to hear again. Then and there, I decided to open a sperm bank.”
If you adjust for size, the distance sperm must swim from testicle to ovum is the equivalent to that of a human running from Los Angeles to Seattle. Because of serious concern about transmission of diseases like AIDS to unborn children, and the drastic rise of what is known as “single mothers by choice,” the human seed in the King of Sperm’s collection now travels much farther — serving women in all 50 states and some 28 countries.
This is no small piece of the pie. In the United States, the fertility industry is an annual $3.3 billion business, with sperm banking accounting for $75 million of that. Thirty percent of that business flows through the California Cryobank — but even these numbers do not truly capture Rothman’s influence. Frozen sperm and eggs — which the California Cryobank also stores — are the first step in the assisted-reproduction chain, so wherever the sperm- and egg-bank business goes, so goes the rest.
As Rothman himself points out, “When California Cryobank makes a decision, some six months later the rest of the industry tends to follow.”
Increasingly, these decisions are no small thing. For almost four decades, the industry has operated almost completely unmolested. Outside of a mostly inept series of somewhat bizarre FDA rulings, there is no top-down governance in the field. It is, as it has always been, self-policing.
Which means that California Cryobank, alongside a few other key industry players, wields enormous influence over growing ethical, legal and biological issues: the problem of donor anonymity; rules involving genetic diseases occasionally passed on by sperm and egg banks; preventing accidental incest between half brothers and half sisters when donor children are concentrated in cities with prolific sperm donors; and strange quandaries resulting from a government increasingly using science to play politics.
All of this raises a key question: Do we really want the very people profiting from this industry to be the ones driving these issues?
Lives in the making: A Cryobank cryotank can hold 20,000 ampoules of sperm.
California Cryobank’s headquarters are not far from where Bundy Avenue intersects the 10 freeway, in a typical West L.A. two-story office building, except this building was specifically designed by Rothman — a serious science-fiction fan — to resemble a set from Star Wars.
Along similarly futuristic lines, outside, in the middle of its parking lot, stands a 6,000-gallon nitrogen tank and a backup generator capable of providing six months of emergency power. Inside, just past the receptionist, sits a large, rectangular room: the home to 10 cryotanks, each containing 20,000 color-coded ampoules of sperm. Each ampoule holds up to 60 million sperm, with the color-coding determining the ethnicity of the donor.
On the wall, hanging above these tanks, four oversize paintings represent the history of life as we know it: the big bang, molecules emerging, sperm forming and embryos developing. Looking up at those paintings, Rothman says, “I designed those too. I like the reminder that something as big as life starts out so small.”
Just down the hall from the cryotanks are the masturbatoriums — the little rooms where prospective donors jerk off. There are three masturbatoriums at California Cryobank, which is something of an upgrade, since the original bank used a spare bathroom for this purpose. These three masturbatoriums come in three flavors: erotic, less-erotic and not-so-erotic. Perhaps because Rothman is a bit old-fashioned, or perhaps because they were designed by a rather attractive young woman from marketing, the photographs that wallpaper these rooms, especially when measured against today’s Internet porn standards, are tasteful to say the least. “For some guys,” notes Rothman, “it doesn’t take much.”
It may not take much to finish one’s business in these rooms, but it takes quite a lot to get into them in the first place. To become a donor at California Cryobank, one must submit to what Rothman calls “the most rigorous prescreening process in the field.”
This process begins with a college education because without one, California Cryobank doesn’t want your sperm. A long conversation follows, where donors are filled in on the obligations that come with the job — specifically that becoming a sperm donor typically means a year-and-a-half-long commitment. During that commitment, donors are paid 75 bucks a pop — with two to three pops a week required, meaning a guy stands to earn anywhere from $11,000 to $17,000 for his services.
If those terms are acceptable, two separate semen samples are taken and analyzed. “We’re looking for very fertile men,” explains Rothman. Normal sperm count is 20 million to 150 million sperm per milliliter of semen. By “very fertile,” Rothman means over 200 million sperm per milliliter. Sixty percent of those sperm must be motile and must look as sperm are supposed to look.
If all of this is shipshape, a three-generation genetic history is taken. More semen is obtained and screened for diseases. Most sperm banks test for 23 variations of the mutation that causes cystic fibrosis, while California Cryobank looks for 97 variations. Jewish donors are screened for Tay-Sachs; African-American donors for sickle-cell anemia. A complete physical is then taken, followed by a six-month quarantine to assure that slow-developing HIV is not lurking in the sperm.
The idea for the six-month quarantine originated at California Cryobank and is one of those practices that have since spread to the rest of the industry. After this waiting period, donors start producing. “We see them twice a week for semen, we see them once every three months for an updated battery of STD tests,” Rothman says. “We get to know them pretty well along the way.”
The first problem facing the industry right now — and all other issues are downstream consequences of this one — is not how well the sperm banks get to know these donors, but how well the prospective parents buying sperm and eggs get to know them.
The vast majority of hopeful parents choose a sperm or egg donor from a thick catalog — known as a “donor catalog” — which includes a description of their eye color, ethnicity and education level, a psychological profile, personal essays, and even audio interviews. Occasionally, adult photos of donors are included, and California Cryobank has just added baby pictures as well.
But the one thing prospective buyers are never permitted to know is the donor’s name. Anonymity is the bedrock upon which the sperm- and egg-bank business is based and, as Jane Mattes, a New York psychotherapist and founder of “Single Mothers by Choice,” an organization that represents the fastest-growing group to utilize frozen sperm, says, “Donor anonymity is the most crucial issue facing the industry today.”
Inside the masturbatorium.
What to do about that issue remains a mystery. While the industry maintains continual contact with its donors during the sperm-collection phase, California Cryobank and others have no way to keep track of donors after their tour of duty is done.
This becomes tricky because of a blizzard of genetic disorders for which there is no test, or which are so rare they don’t merit testing (there are 30,000 genes to look at, and every additional test performed raises the price of sperm). In addition, many diseases don’t manifest until later in life, yet most donors are college students, so these young disease carriers have yet to get sick. Furthermore, though most sperm banks say they are rigorous in their pre-donation investigations, many donors don’t know their own genetic history. Others lie to conceal it.
Add in the fact that there is no government body demanding the banks stay in contact with donors; that cryobanks are not legally obligated to inform new clients about health concerns among any of a donor’s prior children or to release any follow-up medical information about a donor; that, traditionally, sperm banks destroy donor records to preserve anonymity after the bank is done selling their sperm, and — as the saying goes — you have the makings of a quagmire.
This quagmire has led to problems like those facing Brittany Johnson. In 1988, Diane and Ronald Johnson, a Santa Barbara couple, used California Cryobank sperm from a man known only as “Donor 276” to conceive their daughter Brittany. Between 1984 and 1988, Donor 276 made $11,200 for himself by donating over 300 specimens to the Cryobank.
While there is no way to know for certain, court documents (Diane Johnson v. California Cryobank) suggest that Cryobank sold nearly 1,500 vials of Donor 276 sperm to an unknown number of women in unknown locations before Cryobank restricted the sale of his sperm in 1991.
The problem with 276’s sperm was an exceptionally rare kidney disorder known as autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a late-onset disease, typically not appearing until after 40 years of age but usually requiring a kidney transplant by age 50. It is possible that Donor 276 didn’t know he was a carrier — though this seems unlikely, since his grandmother died from it and his mother and aunt also suffered from it.
Either way, when Brittany got sick in California at age 6, she was well on her way to becoming what the media dubbed “the test case for sperm gone wrong.”
The problem, so the Johnsons alleged, was that California Cryobank knew the truth about Donor 276 — though Rothman strenuously denies this — and that the sperm bank went out of its way to conceal it.
While the facts about this case remain somewhat murky (it was settled out of court in 2003, so some records remain sealed), the resulting hoopla brought other, similar concerns to light. There is the widely reported case of Donor 1084 at Fairfax Cryobank in Virginia, the second largest cryobank in America, whose sperm carries a rare platelet disease and has resulted in a half-dozen sick children up and down the East Coast. Also at Fairfax, Donor 2148 carried a rare genetic immune disorder that has already infected one of 23 of Donor 2148’s known children — and still Fairfax refuses to admit there is a problem. Not too long ago, the Journal of Pediatrics reported that Donor F827, from International Cryogenics in Michigan, fathered somewhere between five and 11 children, all with a rare blood disease that leaves carriers at serious risk for leukemia. And this list goes on and on.
The easy answer that many are pushing for is a ban on donor anonymity. But as other countries can attest, this brings problems of its own. In 1984, Sweden outlawed anonymity, and so severe was the drop in potential donors that Swedish women began traveling to Denmark for sperm, giving rise to what is now known as “reproductive tourism.” The same thing happened in New Zealand.
In 2005, England passed a national amendment outlawing donor anonymity. In the years leading up to the law’s passage, donor numbers dropped by 84 percent. On an island of 22 million men, less than 200 are now willing to bank their sperm. After the law’s passage, Clare Brown, chief executive of the Infertility Network UK, told reporters, “Clinics across the country are having to close because there is a shortage of donor sperm — and that constitutes a crisis.”
In the U.S., that crisis is following an even stranger path. In 2005, while England was banning donor anonymity, a donor-sperm-born teenager named Ryan Kramer decided he wanted to know his father. So he swabbed his cheek and sent the DNA sample to an online genealogy testing service and soon became the first person in history to use Internet DNA services to track down a lost parent.
There were two immediate reactions to Ryan Kramer’s quest — the first by the sperm-banking industry. “We removed a bunch of information from our donor profiles,” says Cappy Rothman, “making it a lot harder for people like Ryan to track down their fathers.”
The second response was the creation of a number of organizations dedicated to chipping away or washing away donor anonymity. In the chipping-away category is the “Donor-Sibling Registry,” founded in 2000 by Ryan Kramer’s mother, Wendy Kramer, of Nederland, Colorado. “I started the Web site as a Yahoo message board,” says Kramer, “to give these donor kids a place to go to try and find their half brothers and half sisters.” For the first two years, the site totaled 37 members, then word spread. By 2003, the registry’s popularity had grown so much that Wendy removed it from Yahoo and created a dedicated site (donorsiblingregistry.com). Today, there are 8,500 members and no end in sight.
In the washing-away category are projects like those started by Dr. Kirk Maxey, a former sperm donor and founder of the “Donor Semen Archive,” the “Donor-X Project” and the “Donor Y Project,” a series of endeavors that uses genetic markers to track both donors and the resulting children, with hopes of forcing the industry to end the practice of donor anonymity.
“I think that gamete [egg and sperm] banking is by its very nature a nonprofit activity,” says Maxey. Harshly attacking the industry’s profit motive, Maxey says, “It is only a misguided perversion that has allowed it to become an industry, and that industry should be abolished. That industry is the only strong advocate for donor anonymity. The malfeasance that has already been perpetrated under the guise of donor anonymity is what we are slowly but steadily bringing to light through our genetic testing.”
(Last year, Maxey told ABC News that he began donating his own sperm in the 1980s and guesstimated that over the course of 16 years he may have produced more than 200 children. However, Maxey cannot prove his figures, which he uses to paint disturbing imagery of the sperm banks he now opposes.)
Dr. Rothman defends the industry, saying, “We’ve been trying to create an industrywide donor tracking system, but it’s expensive and we’re trying to get other sperm banks to buy in as well. Either way, we’re hoping to have something in place by the middle of next year.”
But there’s an important caveat in Rothman’s avowed support for a donor tracking system, which would put an end to the destruction of former donors’ records: Their names would remain anonymous to parents. Donor tracking would be used only internally, to allow sperm and egg banks nationwide to keep track of how often and where donors sell their sperm and eggs, and, as they age, to monitor donor health issues that can’t currently be tracked.
As such, donor tracking would be the middle ground between current practice and an outright ban on anonymity, as in Great Britain. Many industry watchdogs feel a tracking system doesn’t go far enough, while others feel Rothman’s sentiments — despite the fact that he publicly applauded Wendy Kramer’s efforts and initiated talks to partner with her enterprise (these talks, as of yet, are inconclusive) — are mere lip service.
Either way, when it comes to donor tracking, California Cryobank may be sailing alone.
Recently, William Jaeger, vice president of Genetics and IVF Institute in Virginia, another of the nation’s biggest banks, told The New York Times that mandatory donor-identity disclosure “would devastate the industry.” Kramer has found similar attitudes elsewhere. “I’ve spoken to the directors of all the major sperm banks and they don’t all think like Cappy,” she says. “Even though my site is based on mutual consent, Northwest Andrology [one of the other major players] is very much against what I do.”
She contends that Northwest Andrology, whose www.beatslabor.com Web site features a photo of a fat wad of $100 bills and touts the news that donors earn up to $16,000, is so opposed to unveiling the donor names that “They’ve threatened donors on my site, making them take down their information. They’re hell-bent on preserving anonymity.”
But Sam Henrichs, owner of Northwest Andrology, disagrees. “I thought—and still do think—the donor-sibling registry is a great idea. We did request that one donor remove his information from the site, but it was part of his contract. We are not able to enforce other parts of that contract if we knowingly let donors breach it whenever they wish.”
Are you using protection? Special gloves in the storage room prevent direct contact with the frozen materials.
Because of the secrecy, an even more insidious problem is brewing just below the surface: a growing concern within industry watchdog groups that it’s only a matter of time until two donor-siblings meet and mate without realizing that they share the same father or, in the case of egg donations, mother.
“No one on the sperm-bank side wants to talk about it,” says Kramer, “but there are over 1 million donor children in the world, and I know of several cases where unknowing siblings have ended up going to college together and having the same groups of friends. The industry says accidental incest is a statistical impossibility, but from what I’ve seen, it’s only a matter of time.”
And indeed, Kirk Maxey told ABC News last year that most of the hundreds of families who allegedly used his sperm came from within a 150-mile radius of his location, prompting him to worry about incest when donors are allowed to remain anonymous.
This is a problem that has long cut to the heart of our fears. Sir James Frazer was the first to demonstrate the universality of the incest taboo, in his 1910 study Totem and Exogamy. But it was the famed anthropologist Claude LÃ©vi-Strauss who elevated the incest taboo from a basic component of our subconscious minds to the “fundamental step because of which, by which, but above all in which, the transition from nature to culture was accomplished.”
He called the incest taboo a deep structure, unvarying and ubiquitous. Simply, incest is bad for the gene pool. Sleep with your brothers and sisters, and pretty soon mutations arise. If that pattern of intimate relations with intimate relations continues for more than a few generations, pregnancy becomes impossible. The line dies out. Incest isn’t just a cultural taboo; it’s a biological taboo. More than that, Levi-Strauss realized that the prohibition forces us to breed outside the nest, and this commingling of families provided society with its most basic building blocks.
To ensure that this basic building block is not violated, sperm banks have long maintained a policy of limiting the number of women who can receive the sperm of a single donor. Britain has legally set a limit at 10 women; Denmark at 25 women.
In the U.S., the American Association of Reproductive Medicine suggests that an individual man’s sperm produce no more than 25 children within an urban area with a population of around 800,000 — which in California would apply to San Francisco, with 799,263 people, and San Jose, with 944,857. In much smaller cities like Long Beach and Fresno (population 491,564 and 464,727, respectively), this halves the limit of recommended donor offspring to 12. Unfortunately, there is no hard data governing populations like those of the state’s two largest cities, Los Angeles, 4 million, and San Diego, 1.3 million, or governing California’s dozens of small towns and cities, so there’s no way to accurately represent the dangers.
Yet because of sperm-donor anonymity, buyers have no idea if they are among a concentrated group choosing the same donor. Moreover, there is no law backing up these guidelines, which are voluntary. Nobody knows how often these guidelines are violated by sperm banks. Nor is there anything in place that stops a man from donating at California Cryobank and then traveling a few miles down the freeway and making another donation at Pacific Reproductive Services in Pasadena.
Instead, the sperm banks police their own limits (California Cryogenics, for example, draws its line at 20), but there are dozens of examples of this safety measure being boldly ignored.
This happens for a variety of reasons. Only about 40 percent of the women who utilize a cryobank’s services report back with news of a live birth, and nobody knows how many of the remaining 60 percent of women end up having babies thanks to purchased sperm or eggs. So the numbers of resulting children that the banks estimate may be woefully shy of the truth. Plus, sperm banks don’t cap sperm sales from a single donor until those 20 live births are reported. And because certain — think blond-haired, blue-eyed — donors are extremely popular, the banks often sell the same man’s sperm to more than the guidelines’ recommended number at once.
If any of these women fail to report their births, or report them long afterward, then more ampoules of that donor’s sperm may be sold in the interim. Furthermore, because most families order sperm for their immediate pregnancy needs and then pay a storage fee to the cryobanks to hold more in reserve for future use, there’s no way to enforce the limits.
“There’s no accurate record keeping,” says Kramer. “No sperm bank knows how many children are born to specific donors. They don’t know who these kids are or where they are.”
More alarming is the charge that sperm banks have been intentionally underplaying how many kids have been sired by a particular donor’s sperm. The most egregious example of this is the case of Dr. Cecil Jacobson, who ran a reproductive-genetics center in Tysons Corner, Virginia. Instead of using donor sperm, Jacobson substituted his own. When he was caught, investigators found that seven children had been sired by the doctor. Moreover, 75 parents refused the court’s request for a paternity test — many not wanting to know if Jacobson was the dad.
Dr. Jacobson, many suspect, may not be the only one. Because there is no centralized donor registry, there is no way to track those with insider access to the process.
Talking about this problem, San Francisco’s Chloe Ohme, both a midwife and the first person in history to impregnate herself using Internet-found, mail-order sperm, says, “I’ve been at lesbian gatherings of single mothers and people suddenly realize their kids look a little too alike and begin comparing donor numbers and, sure enough, they match.” There’s also Fairfax Cryobank’s Donor 401. Regular viewers of The Colbert Report know that comedian Stephen Colbert pretends to be the nameless donor who, according to the Washington Post article that first outed the real Donor 401, definitely sired 11 children and most likely fathered around 20.
And that’s nothing compared to what Kramer noticed after she opened her donor-sibling registry for business. “Very quickly,” says Kramer, “we found donors on the Web site with 30 and 40 and 50 kids.”
The accusation that the industry ignores incest is not misleading. “We don’t talk about it,” says Cappy Rothman, “because it’s not an issue. Not only is it statistically improbable, but go back 300 years and just about all of us lived in tiny villages. There was no public transit. Everyone was related to everyone else because there was no one else around to marry. We’re all descendants of incest. Secondly, from a medical perspective, you’re talking about the danger of one generation of incest — even if that happens, the chances of something going wrong are minute.”
The problem with his claim is that, outside of anthropological studies of the ancient Egyptian and Roman cultures, where sibling incest was practiced, there is almost no scientific research on the topic. What is known is that some cultures allow some form of incest — usually cousins marrying cousins.
A normal couple carries a 3 percent to 4 percent risk of abnormal offspring. This percentage rises to 6 percent to 7 percent when cousins interbreed. “What we do know,” says Dr. Robert Friar, professor of reproductive physiology at Ferris State University in Michigan, “from animal and plant research, is that when family members inbreed, you get both the supergood traits and the superbad traits — of course, in this case, it’s those superbad traits you have to worry about.” For example, siblings might be carrying recessive genes that could raise their risk of abnormal children to as high as 50 percent.
When it comes to the dangers of brother and sister blending bloodlines, the statistical improbability that Rothman and the rest of the industry talk about is a rapidly diminishing thing. Sibling interrelations have long been the forgotten child of the field, while there are dozens of papers about the damage done by father-daughter incest.
One of the few times the question of sibling incest has been studied was in 1984, by the Law Reform Commission in New South Wales, Australia. That 23-year-old study found no danger of incest among donor offspring in the U.S., but its research was based on an annual assisted-reproduction birthrate of 10,000 nationwide. These days, some 30,000 women annually use California Cryobank’s services alone. And in 2004, the Centers for Disease Control reported that 49,458 infants were delivered via assisted reproduction. But considering how often such babies go unreported, many see the CDC number as extremely low. Today, the statistics used in the 1984 sibling-incest study are little more than a fairy tale of old.
Not surprisingly, the first organizations to react to this threat are religious in origin. The Catholic Church feels that any form of assisted reproduction threatens the sacred covenant between man and woman. The church has forbidden the entire procedure, often citing both the dangers of incest and a remarkable study done in 2004 by scientists at the University of Western Australia that found the dangers of birth defects rise by 30 percent to 40 percent with any assisted-reproduction technique. (Others have repeated this study and reached different conclusions, but the Catholic Church doesn’t often mention this fact.)
The Southern Baptist Church too has begun looking into the dangers of accidental incest. Dr. Richard Land, president of the Ethics and Religious Liberty Commission for the Southern Baptist Convention and head of the organization’s public-policy arm, says, “We don’t share the Catholic prohibition against AIH (artificial insemination by husband), but forget the religious implications. There are good medical reasons why all states have laws against incest. It produces very real medical dangers. And the more we understand about the human genome, the more we should understand those dangers.”
Referring to the Human Genome Project’s DNA map and its influence on contemporary science, Land says, “In the past 20 years, we’ve learned enough about the tyranny of biology to know that, for the most part, the nature-versus-nurture argument is dead. Nature always wins. Which means incest is a real concern, and the more children who are the product of sperm banks, the more this concern becomes a problem for everyone.”
There are a few distinctive items in Cappy Rothman’s corner office, on the second floor of the California Cryobank. On a pedestal by the window is a small statue of a man with what might be described as “10 tons of testicles.” His balls hang to the floor, his ball sac six times the size of the rest of him. Directly across from that, hanging from the ceiling, is a model of the solar system with the starship Enterprise positioned dead center.
“I’m interested in the frontiers of technology and humanity,” Rothman once said. “I know there are always dangers implicit in the sperm-banking industry — I reread Brave New World once every three years — but I also know that infertility is the kind of problem that ruins lives. I only wish the government would recognize this fact as well.”
What Rothman means is that unless the industry finds a quick way to address donor anonymity and all of its downstream concerns, it’s only a matter of time before the federal government gets even further involved, and that’s exactly what the gamete-banking industry most fears. Earlier this year, at the annual meeting of the Pacific Coast Reproductive Society, the very first slide to appear during the presentations was an 800-pound gorilla — in this case, the gorilla in the room is the Food and Drug Administration.
“They’re the most onerous obstacle involved in reproduction right now,” says Rothman. “They’re unaware of the field and are currently taking orders from an administration that has time and again proved themselves irresponsible with science.”
Rothman cites everything from Bush’s global-warming policies to his administration’s stand on stem cells to back this up. But what really raised the alarm was the FDA’s position on sperm importation from other nations.
The most popular donors in most cryobank catalogs — the books used by hopeful parents to choose the biological father — are described as white, blond, blue-eyed, over 6 feet tall and college-educated. “Danes are what people want, so we opened a branch in Copenhagen,” recalls Rothman. But in 2001, the FDA established guidelines banning the importation of sperm on the grounds that such sperm might be contaminated with mad cow disease. The difficulty with this particular ruling is that Creutzfeldt-Jakob disease is a prion disease, meaning it is not sexually transmittable, Rothman says.
The only danger could come from actually eating frozen sperm containing mad cow. In truth, the ban on importation had more to do with placating the American consumer. Rothman closed the Copenhagen branch as quickly as he’d opened it.
Dr. Barry Behr, Stanford University associate professor of obstetrics and gynecology, and director of Stanford’s in vitro fertilization lab, explains that the inept actions by the FDA are not isolated incidents. Fifteen years ago, recalls Behr, people were getting HIV from blood transfusions. In 2005, the FDA finally decided to react — creating so-called Donor Eligibility and Determination Labeling “to govern all transference of biological material from one person to the next.”
Sperm banking and in vitro fertilization labs must now adhere to these complex rules, Behr says, but “there has never been a case of anyone getting HIV from the transfer of reproductive material. They’ve also put unreasonable and nonsensical demands on reproductive clinics.”
In addition, by California law, all couples considering assisted childbirth must be screened for diseases like HIV, HDLV, syphilis, hepatitis and rubella. Save HIV and HDLV, all of these results can be ignored or waived — meaning one partner can sign a form saying they understand the dangers and want to go ahead anyway. This means that infected material is occasionally stored at the clinics and cryobanks. “The FDA demands that this material be held in a completely separate “biohazard” location in the cryotank,” says Behr. “This means we need more cryotanks, a separate labeling system and a ton more paperwork — and all of it is unnecessary. What they don’t seem to get is that every sample in the tank is still sharing the same liquid nitrogen. It’s like making people with a cough live on the same street, but using only one school bus to pick up the entire neighborhood.”
There is also further consternation at the FDA’s insistence that donors be rechecked every three months for sexually transmitted diseases during the period their gametes are for sale. While this may seem like common sense, cryobanks feel this is overkill whose only real consequence is to increase the cost of already costly sperm. Since the law went into effect, California Cryobank has raised its sperm sales prices by a minimum of $125 per ampoule (average purchase is seven to 10 ampoules).
“Every time the FDA passes another law,” says Rothman, “all they’re doing is restricting women’s reproductive freedom.” On May 5, 2005, the FDA banned sperm banks from using the sperm of any man who has had “gay sex” in the past five years — even though, again, there is no instance of AIDS being passed via purchased sperm. Considering Bush’s position on gay marriage and his administration’s history of meddling in scientific issues such as FDA drug approvals, the gay sperm ban left many in the industry uneasy. (Some critics even pointed out that eight days after the anti-gay-sex prohibition was implemented, Dr. W. David Hager, the Bush-appointed FDA adviser, vocal opponent of emergency contraception, abortion and premarital sex, and author of As Jesus Cared for Women, was accused by his ex-wife of repeated sodomy — a crime in his home state of Kentucky.)
Rothman says, “I don’t think the government belongs in our bedrooms. I understand that if the industry doesn’t establish a donor registry, pretty soon this is what’s coming. But I think the American public should rise up against it. By letting the FDA tell you whose sperm you can’t use, they’re in essence telling you whose sperm you have to use. And I don’t think we want the federal government deciding what kinds of kids the American public should be allowed to have.”
Unfortunately, since few in the industry share Rothman’s position on donor tracking — and almost no one on the cryobank side wants to see donor anonymity revoked — without some sort of governmental intervention, the dangers of accidental incest and hidden genetic disease will grow.
The truth of the matter is, as the famed physicist Freeman Dyson once pointed out, “If we had a reliable way to label our toys good and bad, it would be easy to regulate technology wisely. But we can rarely see far enough ahead to know which road leads to damnation. Whoever concerns himself with big technology, either to push it forward or to stop it, is gambling in human lives.”