What is genetic testing?

Every person’s unique genetic makeup determines many of his or her individual traits. Some of these traits—like the color of our eyes, hair, and skin—are visible to the naked eye and strongly linked to genes in our DNA. But many genes play a role in determining traits we cannot see, such susceptibility to disease or how our bodies react to various chemicals. Scientists have understood for years the direct link between certain genes and specific diseases, but as our understanding of human genetic variation improves and the cost of genetic testing drops, new possibilities for personalized medicine arise. But along with these opportunities come questions about how to interpret the avalanche of genetic information and how to protect it from improper use.

Genetic testing is not new. Scientists identified the genetic mutation that causes Huntington disease, a progressive and fatal brain disorder, in 1993. In recent years, companies began marketing tests for mutations in the BRCA1 and BRCA2 genes that indicate an increased risk of breast and ovarian cancer. But over the past few years, steep reductions in the cost of gene sequencing technology have allowed companies to offer direct-to-consumer genetic testing. These new companies may help drive the expansion of personalized medicine, but proper oversight is necessary because these new tests raise policy questions about privacy, safety, and their usefulness in clinical decision-making. According to the National Center for Biotechnology Information’s GeneTests website, there are now genetic tests available for over 1,800 diseases.

What are the different uses of genetic tests?

Genetic tests serve a variety purposes. Some diagnose a disease after symptoms have manifested themselves. Some are aimed at predicting the likelihood of a disease. Others predict the likely effectiveness of a drug or treatment based on an individual’s genes—this is known as pharmacogenomics. Tests for carrier status look for disease-related genes that parents may pass on to their children even though the parents do not have the disease. Genetic tests for newborns can determine if they need immediate intervention for a preventable or treatable condition such as phenylketonuria, a metabolic glitch that, if left unaddressed, would result in mental retardation or other serious problems, but that can be completely averted with proper dietary adjustment.

Genetic tests can also be conducted on an embryo created through in vitro fertilization before it is transferred into a uterus. This same process is referred to as preimplantation genetic screening when is used to select embryos that have chromosomal defects that may prevent them from surviving an entire pregnancy. This screening process is referred to as preimplantation genetic diagnosis when it is used to select against an embryo with a disease, condition, or—more controversially—an undesirable physical or mental trait. An IVF clinic in California called the Fertility Institute has even advertised that it can select embryos based on gender, eye color, hair color, and skin tone. But after several weeks of heated reactions to this advertisement, the institute suspended its program.

Direct-to-consumer, or DTC, genetic tests allow patients and consumers to bypass their doctors altogether and obtain a test from a company over the internet. These companies include 23andMe, Navigenics, DeCode (which has recently filed for Chapter 11 bankruptcy), and Pathway Genomics. These companies offer whole-genome scans for a few hundred dollars. Some also offer genetic tests for specific diseases or conditions as well as ancestry testing. Usually, these DTC tests utilize statistical techniques that provide a significant amount of information about a genome by only scanning a few hundred thousand molecular units (or nucleotides) out of the six billion units that comprise the human genome. The company Knome will sequence every nucleotide—or chemical unit of DNA—in an individual’s genome for $100,000. The companies that offer these DTC tests do not consider them medical products. Nevertheless, some have been known to tout their employment of on-staff physicians and genetic counselors to review customer orders.

Some Internet-based companies offer nutrigenomic tests, which purport to determine what kinds of foods you should be eating based on your genome. However, a Government Accountability Office investigation led to a scathing 2006 report on the industry. The report found that many of the tests gave recommendations that were “ambiguous” and “medically unproven.” Some of the tests were also attached to advertisements for ineffective dietary supplements, and some of the supplements had price tags of as much as $1,200 a year.

How will genetic tests change medicine and how are they already changing it?

Many researchers and clinicians anticipate that genetic tests will aid in the development of new drugs and treatments tailored to patients with specific genetic profiles. The government, private industry, and the medical community still have lots of work to do on research, administrative reorganization, and devising new protocols to make personalized medicine a reality and to make the incorporation of genetic information into regular medical decision making safe, meaningful, and effective. The recent report, “Paving the Way for Personalized Medicine,” explains these issues in detail.

According to a recent survey, 15 percent of healthcare providers reported that at least one patient brought them DTC genetic test results in the past year. Of those providers, 75 percent changed some aspect of their patient’s care based on the test results. This reaction by the clinicians demonstrates a disconnect between the clinical community and the research community on the perceived effectiveness of genetic tests. The research community believes that current studies have only found a small fraction of the genetic components of most conditions. Additionally, there is scant evidence that genetic tests lead to changes in treatment that improve health outcomes, also known as clinical utility. At this point, there are multiple views concerning the level of encouragement physicians should be giving their patients about adopting DTC genetic testing as a guide for personal health care. Some feel that physicians should wait until there are more comprehensive studies about the clinical outcomes of genomic medicine. Others argue that physicians should encourage prevention with genetic tests and teach their patients about the science as it develops so that they do not seek information from other and possibly less-reliable sources.

Geneticist J. Craig Venter recommends in a recent Nature article that companies report the proportion of disease risk attributable to genetic markers, focus on diseases and traits with high-risk predictions, and agree on a set of strong-effect genetic markers for specific conditions.

What are the privacy concerns?

Thanks to the passage Genetic Information Nondiscrimination Act of 2008, employers and health insurance companies cannot obtain an individual’s genetic information without his or her consent and cannot use an individual’s genetic information to deny that individual a job, promotion, or health insurance coverage. Unfortunately, these federal protections do not extend to disability insurance, long-term care insurance, and life insurance. However, 16 states regulate the use of genetic information in life insurance; 16 states regulate its use in disability insurance; and 10 states regulate the its use in long-term care insurance. Of course, these policies all vary from state to state.

Many of the companies offering direct-to-consumer genetic testing also compile databases of genetic information that they gather from their customers. This is the second major component of their business model, as the data is valuable for advancing genetic research. But informed consent process for this information raises new, complex issues.

In an interview with Science Progress, Stanford bioethicist Sandra Lee explained the consent processes that some of these companies have adopted for using or selling their customers’ genetic data for research purposes. Some have adopted policies of “open consent” where a customer agrees to allow research on their genetic data for any studies in the future. This marks a break with the traditional rules of informed consent in clinical trials where all potential uses of the subject’s information must be disclosed. Navigenics has adopted a policy of asking customers to opt-in to research and then provide new consent forms to customers every time a new study arises. 23andMe also has a similar consent policy wherein they provide individual data to their research partners.

Most informed consent forms for genetic research indicate that a subject’s genetic information will be de-identified by separating the genetic information from the subject’s name and other personal information. Of course, some studies focus on the links between genes and other identifying information like ethnicity, family history, or disease status; and the informed consent forms tend to vary from study to study.

One of the most common types of genetic studies is the genome wide association study, commonly referred to as a GWAS. In a this type of study, scientists take a group of people who possess a certain phenotype—an observable characteristic or a trait like height, a condition like hypertension, or a disease like cancer—and compare them with a group of people without that phenotype. The scientists look at hundreds of thousands of single units of DNA known as single nucleotide polymorphisms or SNPs. Whichever SNPs are more likely to be present in the people who possess the phenotype and absent in those without it are considered associated SNPs. An associated SNP is not directly responsible for the phenotype, though it does indicate that the genetic sequence that is responsible may lie somewhere nearby on the genome. Scientists will then examine the relevant section of the genome and attempt to identify the exact sequence that is responsible.

The hope of many researchers is that with the passage and enforcement of GINA, more people will volunteer for genomic research. GINA is needed now more than ever since even though researchers remove subject names and other identifiers from the genetic data they collect, researchers demonstrated in 2008 that it is nonetheless possible to work backward from a common pool of de-identified genetic information and identify individuals in a database. As a result, the National Institutes of Health implemented stronger security controls for their GWAS databases.

How do scientists or regulators assess the reliability of genetic tests?

In order for genetic tests to have a meaningful impact on medicine, they need to be rigorously assessed and held to transparent empirical and clinical standards. Not only do the labs and diagnostic manufacturers need to demonstrate that the tests they conduct can reliably find the genes they purport to look for, researchers also need to show that once the genes are detected by a test, they can reliably predict a phenotype and help to inform treatment decisions in a way that improves health. This is a tall order to say the least, but scientists and regulators assess tests according to three criteria: analytical validity, clinical validity, and clinical utility.

• Analytical validity is the ability of a test to find a specific genetic sequence, broadly referred to as the “analyte.” Genes are different from other analytes like proteins, which can be present in varying amounts, since a gene is either present or absent.
• Clinical validity is the probability that you will get a disease if you test positive and that you will not get the disease if you test negative. The probability that a disease will appear if a disease-related gene is found is called the penetrance of the gene.
• Clinical utility is the ability of a genetic test’s results to lead to a course of action or interventions that result in improved health outcomes.

A coalition of researchers has also proposed a fourth criterion called personal utility. Research on this criterion would assess the patient’s or population subgroup’s perception of the advantages of genetic testing and whether it would affect the patient’s behavior and subsequent clinical utility of the genetic test. The social considerations and metrics for this criterion are still under development.

What are the gaps in the oversight of direct-to-consumer genetic tests?

Aside from the federal Clinical Laboratory Improvement Act regulations and limited Food and Drug Administration rules, most lab regulation has been left up to the states. Many policymakers, bioethicists, and representatives from the DTC industry feel that this patchwork of state regulations is not sufficient and that the lack of federal oversight has left a gaping hole in the regulatory framework. Two pieces of legislation that would regulate genetic testing and labs have long been on the Congressional back-burner: the “Genomics and Personalized Medicine Act of 2007” sponsored by then-Senator Obama and the “Laboratory Test Improvement Act of 2007” sponsored by the late Senator Edward Kennedy. Ultimately, whether through legislation or simply new regulatory protocols, this regulatory gap can easily be filled by four measures that will allow for the federal oversight of genetic tests, the labs that conduct them, the transparency of their results, and the advertising of direct-to-consumer genetic tests. The Center for American Progress and the Genetics and Public Policy Center have made these recommendations:

1. Have the Centers for Medicare and Medicaid Services, or CMS, create a “specialty” for genetic testing laboratories.
2. Expand the FDA’s jurisdiction to include the regulation of lab-developed tests in addition to pre-manufactured test “kits” that already fall under its jurisdiction.
3. Create a mandatory genetic test registry so that the clinical validity of all genetic tests is transparent for the public.
4. The FDA and FTC should collaborate on curtailing false or misleading advertising by genetic testing companies in accordance with Section 5 of the FTC Act.

Last year, 23andMe collaborated with Navigenics, de CODE, and the Personalized Medicine Coalition to release a statement outlining the standards they would like to see governing the scientific validity of DTC genetic tests. A recent panel convened by the Centers for Disease Control and Prevention and NIH welcomed their input but also advocated independent assessments from the Depart of Health and Human Services U.S. Preventive Services Task Force or the CDC’s Evaluation of Genomic Applications in Practice and Prevention. Both the governmental and private groups are moving ahead with their standard-setting and assessment efforts, but it remains to be seen rules will materialize.

Michael Rugnetta is a research assistant with the Progressive Bioethics Initiative at the Center for American Progress.

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Although sperm banking is now a vital part of this new frontier of baby making, the industry remains largely unregulated in the United States.

Only now, more than 100 years later, is third-party reproduction beginning to shake off this aura as policy changes roil the field in Europe and new attitudes begin to lap up on American shores. In the United States, the U.S. Food and Drug Administration requires that donors be tested for diseases such as HIV and hepatitis while their sperm are frozen and quarantined, only to be released six months later when certified disease free. But today’s “sperm banks” are under no obligation to report numbers of births, place any limits on births to individual donors, track the health of donors, or make information available to children born of donor insemination.

This poses some serious scientific, medical, and ethical questions. Should individual men be able to procreate perhaps hundreds of children anonymously? Over the long haul, what does this mean for human genetic diversity? What about genetic diseases? And should children “fathered” via sperm banks be allowed to know who their father is? These are questions that are only now being asked—despite the long history of “artificial insemination,” as it was once quaintly called—not just in the United States but also abroad. The answers, as we shall see, are as controversial as the questions.

How We Got Where We Are Today

Dr. Pancoast’s tactic—artificial insemination using another man’s sperm—was for decades the only way to redress male infertility. Doctors most often donated sperm surreptitiously in this manner, but the practice really took off after World War II when soldiers returning with war wounds and sexually transmitted diseases faced infertility.

In the 1950s came the advent of technologies to freeze and store sperm. Still, the sperm was most often secured from impecunious medical students who were paid modest sums to masturbate for posterity. Banked sperm was chosen to match the physical characteristics of the infertile husband, and the sperm of the husband and the donor was sometimes mixed to give the husband plausible deniability. Doctors told patients to lie to their offspring about how they came into the world.

Beginning in the 1960s, individual states began updating laws to recognize that, at least where a doctor or clinic was involved, the third-party sperm donor was not a father in any legal sense. Under such schemes, donors would not have any visitation rights or say in the rearing of their children, nor would they be responsible for any financial contributions. In the early decades of sperm banking, these arrangements were seldom called into question, not surprisingly, given how few donor offspring were told the truth about their conception.

Today, approximately two dozen commercial sperm banks operate in the United States. An untold number are also associated with university fertility clinics, banking sperm for pre-vasectomy and pre-chemotherapy and radiation treatment patients—no one keeps track of how many. Nor can it be said with any certainty how many children are born each year as a result of donor insemination, although the most frequently cited guesstimates range between 30,000 to 50,000.

Lesbian couples and women who are single by choice now comprise, by some rough estimates, two-thirds of sperm banking’s clients. The cost: between $255 to $315 for a vial of regular, unwashed sperm that is implanted through intracervical insemination at home; or slightly more costly for sperm that is washed, which means it was prepared for intrauterine insemination by a health care professional and comes with more information about the donor or the promise of donor identity release.

But shipping and storage fees also add up. “A typical bill for conception, which takes roughly six once-a-month inseminations, using IUI, identity-release sperm with a photo match, is between $2,345 and $2,945,” writes Lisa-Jean Moore, medical sociologist and gender studies scholar in her Sperm Counts: Overcome by Man’s Most Precious Fluid (2007).

If sperm donor is a misleading tag, sperm banking is not, at least insofar as it suggests a profit-seeking commercial enterprise.

And who are the sperm donors? Some are young men depositing sperm in anticipation of their own future infertility, including those about to go off to war. But the vast majority of donors—or perhaps more accurately, sperm vendors—are men who sell their semen for $40 to $60 per “donation.” No longer are donors almost exclusively medical men, though doctor semen remains in great demand. Education is still a highly sought-after attribute, with sperm banks seeking donors through advertisements in college newspapers.

If sperm donor is a misleading tag, sperm banking is not, at least insofar as it suggests a profit-seeking commercial enterprise. Market forces shape how the supply of sperm meets the demand. In the early days of sperm banking, race, hair color, and eye color were typically the only traits revealed. Nowadays, buyers still seek sperm of certain ethnicity and physical characteristics; taller men are the rule, no shorties need apply.

But it doesn’t stop there. Some banks offer “premium” sperm, which they maintain comes from donors with doctorates or other graduate degrees. This service is reminiscent of Robert Graham’s notorious “Repository for Germinal Choice,” the California sperm bank that claimed to offer sperm from “geniuses,” including that of a handful of Nobel Prize winners. Graham’s bank operated from 1980 to 1999, creating more than 200 children amid considerable controversy about its explicit eugenic goals and the expectations heaped upon the superbabies, as Slate deputy editor David Plotz recounts in his book, The Genius Factory: The Curious History of the Nobel Prize Sperm Bank (2005).

Today women shop from catalogues of donors in a process that has been called “yuppie genetics.” The banks provide potential buyers with “short form” questionnaires about the desired mix of genetic attributes in the sperm they are purchasing, often supplemented by a “long form” set of answers about the health history of parents and grandparents, interests and education of the sperm donor. Banks claim that questions about health histories are exhaustive, but college-age donors don’t always know all the relevant information about family history and the temptation is great to lie or omit information that might screen them out, in a version of resume fraud.

Increasingly, banks offer pictures of the men as children (and possibly adults) along with audio and even videotaped interviews and poignant and/or cloying “mission statements” about why they’ve chosen to become donors. Here’s one such site, which boasts the tagline Creating Families Through Innovation.

Although sperm banking is now a vital part of this new frontier of baby making, the industry remains largely unregulated in the United States. In other countries, fundamental changes are being wrought in sperm banking practices. Canada and Britain now ban payment to sperm donors. Britain, Sweden, Austria, the Netherlands, and parts of Australia no longer permit anonymous donation, insisting that donors be available to be contacted by their children when the offspring reach adulthood. Some of these countries are establishing registries to help make this possible. These restrictions were put in place despite concerns they could dry up the pool of willing donors.

Do U.S. Sperm Banks Need More Regulation?

Occasional sperm bank scandals have brought episodic attention to the state-wide industry, if not much reform. When Cecil Jacobson, the renowned physician and infertility specialist, was discovered in the early 1980s to have inseminated as many as 75 women coming to his Virginia clinic with his own sperm (unbeknownst to them), prosecutors weren’t sure he had committed any crime. He was eventually convicted of 52 counts of mail fraud, wire fraud, and perjury and served time in federal prison, losing his medical license.

Such occasional scandals are outliers, say the bankers, not cause for further regulation. “More regulation of sperm banking is a solution in search of a problem,” says Sean Tipton, a Washington, D.C.-based spokesperson for the American Society of Reproductive Medicine, which is headquartered in Birmingham, Alabama. “The danger with more regulation, like more genetic testing or changing the rules about anonymity, is that you give up important autonomy and privacy at great economic expense. It is not clear what you gain.”

Wendy Kramer, a Colorado single mother and founder of the Internet-based Donor Sibling Registry, doesn’t agree. She is perhaps sperm banking’s most vocal and visible critic. “Sure, there is some regulation at the front door, screening the men who come in,” she concedes. “But what about afterwards, when the births occur? No one in the industry cares by then.”

Kramer was inspired by her son to found the Donor Sibling Registry as a Yahoo users’ group chat room seven years ago. Her son Ryan, now a handsome 17-year-old in his fourth year of college studying aeronautical engineering at the University of Colorado at Boulder, was eager to find any half-siblings. In fact, Ryan’s curiosity was even more precocious. At age two she recalls him asking, “Is my Dad dead, or what?”

Wendy Kramer conceived her son Ryan with sperm from a local bank in Colorado. “The lady at the bank just suggested a sample from someone who looked like my husband.” (She’s now divorced.) “I suppose I got the ‘high octane,’” she joked, proudly sharing stories about her bright young son’s college career.

DSR has grown from a chat room into a thriving website. At last count, the registry had more than 9,000 registered members, including parents of donor-inseminated children, some children themselves and donors who post their donor numbers and profiles to facilitate matches with families of their offspring. More than 3,800 matches have been made with half siblings or donor fathers.

After six and a half years of searching, Ryan Kramer found a half sister and was match number 2,910. “This little 13-year-old girl was just beside herself to have an older brother,” says Ms. Kramer. “I don’t try to define their relationship. They’re teenagers. They ‘IM’ [instant message] each other,” says Ms. Kramer.

The sperm-banking industry tends to dismiss the yearning to find genetic heritage and the worrying stories from DSR match ups as “anecdotal.” Says ASRM spokesperson Sean Tipton: “I don’t draw any conclusions from the Donor Sibling Registry. I don’t know if there is any counterpart organization for happy children of sperm donors.”

But even if data is not the plural of anecdotes, some of the anecdotes are enough to give one pause. Medical concerns in particular are a frequent topic of discussion when families get together on the Donor Sibling Registry. As will be detailed further below, one set of families discovered that five different children born of the same donor were all autistic. Other parents of donor children suffering from genetic diseases have found half siblings sharing the same illness.

Yet sperm banks have frequently refused to contact other potentially affected children, track down the donor, or even pull the sperm from the shelf. Most of these discoveries have come from Internet-abetted detective work, but some are even more serendipitous.

Case in point is Laurence A. Boxer, a University of Michigan pediatric hematologist and an expert on severe congenital neutropenia, a disease of white blood cells affecting only one in 5 million children. Yet Dr. Boxer had four families show up in his office with children suffering from the disease. As Dr. Boxer and his colleagues reported in the Journal of Pediatrics last year, the culprit is almost certainly a sperm donor the children shared, donor #827 from International Cryogenics in Birmingham, Mich. The donor has moved and the sperm bank cannot locate him. The bank had supplied the donor’s sample to a university laboratory for testing, but the lab would not complete the tests because it could not secure the consent of the donor.

Such cautionary tales have inspired some Internet-age consumer activists. Kirk M. Maxey is a physician who was a paid sperm donor while working in Kalamazoo, Mich. and attending medical school in nearby Ann Arbor. He stopped donating after a worker at the sperm bank where he made his deposits claimed she had purloined his sperm to impregnate herself.

While still in medical school, Maxey had founded a company to produce biochemicals and assays for use in biomedical research. Three years ago, Dr. Maxey added a non-profit arm known as the Cayman Biomedical Research Institute. It operates the Donor Semen Archive. Says Maxey of his efforts:

“I come from a background of extreme mistrust of the banks. I don’t think they tell the truth. I don’t think they are careful because they have no real accountability. They hide all their records and no one can catch them unless they blunder over their own mistakes.”

Maxey’s Donor Semen Archive stores donor-related DNA samples retrieved from the vials and syringes used in insemination and from the children themselves, logging genetic sequences to make it easier when questions come up about genetic health and identity. “The Donor Semen Archive is just a molecular version of the Donor Sibling Registry,” explains Dr. Maxey. “If a bunch of Moms think their donor was ‘Donor No. 65,’ for example, we can tell whether it was really the same guy.” The Donor Semen Archive is poised to join forces and offer its services through the Donor Sibling Registry.

Ben now uses an Excel spreadsheet to manage relationships with the families of his 28—count ‘em, 28—donor offspring.

Concern about unwitting transmission of genetic disorders from sperm donors to many more children than would be possible in conventional families is one factor driving calls for more disclosure, traceability, and limits on the numbers of children born to a particular donor. Consider Ben, a 29-year-old practicing lawyer who masturbated his way through a Washington, D.C.,-area law school, earning about $30,000 to help pay for tuition.

Ben asked that we not publish his last name because he’s not ready for the whole world, including his professional colleagues, to know about his donor career. He explains that he saw the anguish two cousins endured trying to get pregnant, struggling through many expensive cycles of in vitro fertilization. He figured his sperm donations could help people experience the joy of parenthood, while helping to finance law school.

“It wasn’t exactly hard work,” Ben quipped in a recent phone interview. Yet as a frequent depositor at his local sperm bank, he may have spread more joy than he reckoned.

Ben, explains Wendy Kramer, is one of her “brave donors,” who posted his story with his donor number on the Donor Sibling Registry and permits contact from families who have purchased his sperm. Ben now uses an Excel spreadsheet to manage relationships with the families of his 28—count ‘em, 28—donor offspring.

“It is just easier not to mix them up that way,” he says. Ben is only a few years out of law school. His dozens of kids are still of pre-school age. Most of the contact from parents involves email questions about his health status and genetic history.

But Ben is not the bravest donor on Wendy and Ryan Kramer’s site. “I think our record is 64,” says Ms. Kramer of the number of offspring discovered by a donor registered with the Donor Sibling Registry. “We have other donors with children numbering in the 20s, 30s or 40s, says Kramer. “Some pull back after hearing about a few children, they just can’t take it emotionally.”

Other donors, however, are “lurkers,” she says, who visit the site to read the discussion threads but do not officially register, not sure whether they want to commit to being contacted. Official members pay DSR a $40 fee to be able to post information such as donor numbers or sperm bank and donor characteristics data to facilitate matching up with relatives. See how to use the site at www.donorsiblingregistry.com/howDoI.php

What To Do?

When told about Britain’s recent limit on donors to creating 10 families, Ben wasn’t sure about importing such restrictions to the United States. “Why not nine or 11,” he asked. “Any limit would have to be incredibly arbitrary.” Moreover, Ben is not sure that mandating donor identity release is warranted—even after opening up to contact from families who relied on his sperm for one or more of their children.

The question of whether to require identity release—that is, to allow children to contact their donor father when they come of age—is perhaps the hottest topic in sperm banking.

Ellen Singer, a social worker and adoption program specialist with The Center for Adoption Support and Education, Inc., a non-profit organization with three offices in Maryland, says that sperm banking lags far behind the adoption field in terms of regulation and oversight. “There are still professionals who advise parents not to tell their children that they were a result of donor insemination or donor eggs,” she says.

But views are evolving. Singer sees disclosure as a human rights issue. “Kids need to know the truth about their conception,” she argues. “That doesn’t mean the whole world has to know, but the kids should.”

Who knows what is in the best interest of children born to sperm donors? Clinicians? Regulators? Parents? What about the children themselves?

But Singer empathizes with parents who worry about stigma. “The secrecy can be well-meaning and intended to protect the children,” she says. “But children don’t need protection, they need the truth and ways to cope with the challenges that come with it.” The American Society for Reproductive Medicine now advises parents to disclose to their children the details of their conception, even though it opposes more regulation of the industry.

Some sperm banks have been factoring in those privacy vs. disclosure issues for some time now. The Sperm Bank of California, a non-profit outfit established in Berkeley to cater to a largely lesbian clientèle, has offered identity-release semen for more than 20 years. That means the first children born with the option to contact their donor when they turn 18 are now coming of age—and some are beginning to do so.

U.S. sperm banks are increasingly offering donor identity-release sperm as an option. “It goes faster and costs more,” says Lisa Jean Moore, who teaches at Purchase College, State University of New York. Moore is a former board president of The Sperm Bank of California. She is also the parent of two daughters, one born with sperm supplied by a friend, the other with sperm purchased from a bank.

But not everyone thinks imposing more regulations is a good idea. Gays and lesbians, as well as single mothers by choice, may have some misgivings about how sperm banking operates, but many are nevertheless wary of opening the door to regulators who may have much more cramped notions of what should constitute a family. A lesbian couple from Colorado who found out on DSR that their daughter has more than two dozen half siblings emailed the author to say:

We would not support government regulation at any level. The government has a history of discrimination against LGBT [lesbian, gay, bisexual and transgendered] families and individuals, and we would not want to open the door to the government prohibiting sales or contributions from LGBT people.

As journalist Liza Mundy writes in her wide-ranging Everything Conceivable: How Assisted Reproduction is Changing Men, Women and the World (2007), crafting progressive policies is a challenge in this field. “[I]n this area of reproductive science, ‘progressive’ is a hard concept to pin down.” Indeed, almost everyone connected in any way to the field of assisted reproduction gives lip service to the “best interests of the children,” even though sperm banks are set up to meet the needs of doctors, patients and parents.

But, in practice, children’s best interests can be notoriously difficult to pin down. Who knows what is in the best interest of children born to sperm donors? Clinicians? Regulators? Parents? What about the children themselves?

Deborah Spar, a professor at the Harvard Business School, has examined sperm banking as part of a larger look at the reproductive marketplace, including the practices of buying and selling sperm and eggs, renting wombs, and brokering adoptions. Spar, the author of The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception (2006), says she attributes the lack of political interest in regulating sperm banks to the relatively small size of the industry, politicians’ reluctance to enter the fray of reproductive decision making, and a general squeamishness about semen.

“No one likes saying the word sperm,” she explains. “Plus, the egg extraction process is surgical, but the sperm extraction process is sexual.”

Still, Spar believes such squeamishness will give way to calls for more regulation, and does not buy the argument that “as soon as you let the government in they’ll be saying that only heterosexuals can have children.” She says “there are lots and lots of places to stop along the spectrum between no government regulation and the government telling me when I should have my child and what I should name him.”

Besides, a new vocal constituency for reform is about to come of age. “It is going to be the sperm babies who are going to push for donor identification and recordkeeping,” Spar predicts. “That is what is going to spur a political debate and wake people up to the medical issues involved.”

She may be on to something. As Wendy Kramer explained, “My son Ryan is 17 and he is the tip of the iceberg. Ryan can’t even be on the Board of Directors of the Donor Sibling Registry, even though he helped found it and he’s in his fourth year of college. At least until he turns 18, that is.”

Ryan Kramer turns 18 next spring. Watch out.

Jeff Stryker is a Connecticut writer specializing in health policy and bioethics.

Here is a list of the books mentioned in the article, with links to their pages on Amazon.com:

Lisa Jean Moore, Sperm Counts: Overcome by Man’s Most Precious Fluid (New York: New York University Press, 2007).

Liza Mundy, Everything Conceivable: How Assisted Reproduction is Changing Men, Women, and the World (New York: Alfred A. Knopf, 2007).

David Plotz, The Genius Factory: The Curious History of the Nobel Prize Sperm Bank (New York: Random House, 2005).

Debora L. Spar, The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception (Boston: Harvard Business School Press, 2006).

Dr. Orr does not have a medical degree and has no direct experience in family planning. Her public statements indicate a lack of experience and an ideologically-based commitment to extreme points of view that bring into question her qualifications for the job and her ability to objectively assess and apply accepted best practices in health care to Federal policy.

Americans value their right to decide when and whether to have children, and sound public policy supports their ability to make those decisions.

What’s worse, this is the second time in a year that the administration has appointed an anti-contraception activist to the position. In November 2006, the administration appointed Dr. Eric Keroack, a non-board certified gynecologist, who received “two formal warnings from the Massachusetts board of medicine ordering him to refrain from prescribing drugs to people who are not his patients and from providing mental health counseling without proper training,” just before he resigned in March amid Medicaid fraud allegations.

Dr. Orr’s appointment is only the most recent example of a trend that will take years to repair. The administration’s unapologetic long-term political strategy of diminishing the value of scientific integrity to create doubt and achieve ideologically-driven political goals is becoming more widely recognized. Unfortunately this appointment is another clear-cut example of an administration appointee whose background and ideology are at odds with the majority of reproductive health professionals.

In Title Only

Dr. Orr’s appointment highlights some particularly difficult challenges that will likely have negative implications for people in America who don’t have full access to health care. Her position oversees Title X, the federal family planning program that serves more than 5 million low-income Americans annually through more than 4,400 community-based clinics. Seventy-five percent of U.S. counties have at least one clinic that receives Title X funds, and it is estimated that over 1 million unintended pregnancies are prevented each year through contraceptives made available for low income Americans by Title X services each year.

Application of Dr. Orr’s position on family planning places undo hardship on those least able to pay for contraception.

But the controversy of her appointment is about more than the possible subversion of policies that have proven effective for preventing unintended pregnancies and abortions. Few would question that the person filling this position should have a commitment to evidence-based science and to all aspects of reproductive health care including disease prevention and family planning. Title X-supported clinics provide patient education and counseling; breast and pelvic examinations; breast and cervical cancer screening; sexually transmitted disease (STD) and Human Immunodeficiency Virus (HIV) prevention education, counseling, testing and referral; and pregnancy diagnosis and counseling.

Steering the ship responsible for funding such services requires respect for the value of providing people with informed options for their health care. Americans value their right to decide when and whether to have children, and sound public policy supports their ability to make those decisions. The Centers for Disease Control and Prevention included family planning in its list of the “Ten Great Public Health Achievements in the 20th Century,” yet Title X funding has declined by 60 percent since 1980, when adjusted for inflation, even though 17 million U.S. women rely on public funding to obtain contraception.

With almost half of all pregnancies in the United States being unintended—80 percent of teen pregnancies fall in this category—any neglect of basic services can be directly linked to failures in education and public policy. The American public will benefit from a significant increase in funding to make all methods of contraception available to all who want and need them, to research new approaches to family planning, and to provide comprehensive, evidence-based reproductive health and sexuality education in schools and communities.

Steering the ship responsible for funding such services requires respect for the value of providing people with informed options for their health care.

Application of Dr. Orr’s position on family planning places undo hardship on those least able to pay for contraception. Further restriction on these funds will inevitably result in more unintended pregnancies and more abortions, an outcome that runs directly counter to the stated goals of the program she is supposed to be directing.

While most private insurers cover contraception, it is ethically and fiscally sound public policy to ensure that all Americans have equal ability to decide what is best for them and their families. Dr. Orr’s position as senior director for marriage and family care at the Family Research Council, an organization that advocates restricting access to family planning, makes her entirely unsuitable to run the agency whose mandate is to provide access to needed family planning care for our nation’s men and women.

One Tired Finger

Americans deserve a deputy assistant secretary for population affairs who will advocate for increased access to contraception for all who need and want it, and for the full range of reproductive health services that enhance quality of life. We believe that we must communicate the value of reproductive health services to individuals first and, second, to society as a whole.

Simply put, we are advocating for reproductive health professionals to compensate for the inability of Dr. Orr, her predecessors, and this administration to achieve those goals. As scientists, we must learn to appeal to the positive aspects of belief systems outside of our experience to communicate scientific values, to change minds and to affect public policies.

But it is insufficient to simply point our finger at the administration and Dr. Orr. We also must accept responsibility for failing to effectively communicate with the public and policymakers.

It isn’t completely clear why it’s been so easy to take anti-science policy positions in the United States in the last decade. One answer lies in the U.S. public’s ambiguity about science and the role it plays in their lives. In the most recent survey of public perceptions about science by the National Science Foundation, 55 percent of the respondents agreed that “we depend too much on science and not enough on faith,” and 70 percent agreed that “scientific research these days doesn’t pay enough attention to the moral values of society” and that “scientific research has created as many problems for society as it has solutions.”

These findings indicate that the anti-science faction that has taken root in Washington of late has reason to cheer. This unfortunate trend is not merely the result of overzealous ideologues; there seems to be a level of indifference among much of the lay public to the importance of science and the policies that directly affect them. For many, “science” is a necessary but somewhat remote, dusty, and godless venture that has no direct impact on their everyday lives. These findings should also serve as a warning that regime change in Washington 15 months from now will not be enough to turn the tide of public sentiment.

We also know that lecturing the public about scientific principles and research outcomes in the desire to convince them about our correctness is oftentimes a wasted effort; our intended audiences often consider this approach condescending and patriarchal, despite our opposite intention. If our goal is to change minds, this approach just does not work and should be abandoned as a primary course of action.

Behavioral science theory tells us that most people operate from the screens of their own interests and beliefs; they are not going to listen to or be swayed by data that contradict their belief systems, regardless of accuracy. Without getting overly academic (we tried that), we have to reinvent the way we communicate the value of applying science to health policy in the context of the values that we share with an angry and doubting but concerned public.

The scientific community and the general public have a lot more in common than not. That’s why we as scientists must be prepared to channel the public’s skepticism of science toward a broader understanding of the progressive values that should always underpin scientific inquiry and public policymaking.

Wayne C. Shields is the President and CEO, Association of Reproductive Health Professionals. Rivka Gordon is the Director of Strategic Initiatives, Association of Reproductive Health Professionals.

“People are either thinking about civil rights or they are thinking about climate change. Rarely are they thinking about both.” The two issues are inextricably linked, argued Majora Carter at a panel on “green collar jobs” at the Center for American Progress this Monday.

Carter, the Executive Director of Sustainable South Bronx, and other panelists discussed efforts in the Bronx, Oakland, CA, Chicago, and Washington D.C. to create new jobs in green industries in areas that need the most economic stimulation. Billions of investment dollars will soon flow into green technologies as more businesses work to transform the United States into a low-carbon economy. That investment has the potential to create a new “green collar” workforce that translates new energy technologies into practical commercial, industrial, and residential infrastructure.

Van Jones, President and Founder of the Ella Baker Center for Human Rights, described programs in Oakland that provide job training for workers to learn how to install solar paneling and how to weatherize and improve the energy efficiency of homes. These job skills create opportunities for people low income communities—and the green technologies these workers implement reduce energy costs for consumers and mitigate carbon emissions. “How can we create a linkage between the people who most need work and the work that most needs doing?” Jones asked. For him, training a green workforce is the perfect answer.

The discussion highlighted the importance of ensuring that green investments that can energize the U.S. economy do not simply benefit the middle and upper classes. Scientific and technology policy decisions must do more than dictate emissions and energy efficiency standards and open markets for Wall Street traders and solar startups. These policy decisions can connect the energy future of the United States with the cause of social justice through the creation of a new workforce of quality jobs that companies cannot outsource. Sound policy can improve the environment, spur economic growth, and lift people out of poverty on a tide of new jobs. As Carter explained, “environmental justice is civil rights in the 21st century.”

For more:
Green Collar Jobs Event
Time For Green Collar Jobs