Deborah Peel, founder of Patient Privacy Rights, said the Genetic Information Nondiscrimination Act, approved last week by the Senate Health, Education, Labor and Pensions Committee, would not fully protect people from losing their jobs or health coverage because it allows insurers and employers to hold patients’ electronic health information, Healthcare IT News reports.
The bill would prohibit health insurers from adjusting premiums based on genetic testing, restricting enrollment or requiring genetic testing to qualify for insurance. It also would prevent employers from using genetic information to discriminate in hiring, compensation and other personnel processes, and require employers to confidentially maintain any genetic data they possess.
Peel said the bill “forbids employers or insurers from using our genetic information to discriminate against us, but there is literally no way to stop them from doing that when they hold and possess the sensitive information.” She added that the nondiscrimination legislation underscores the need for a comprehensive federal health privacy bill to give U.S. residents control over their electronic health records.
Since the launch of the Human Genome Project, genetic testing has been adopted increasingly into standard practice for diagnosing and managing disease, expanding on its roles in predicting the risk of future disease and informing decisions about life planning and behavior change.
Since the launch of the Human Genome Project, genetic testing has been adopted increasingly into standard practice for diagnosing and managing disease, expanding on its roles in predicting the risk of future disease and informing decisions about life planning and behavior change. Today, genetic tests use combinations of biochemical, cytogenetic, and molecular methods to analyze deoxyribonucleic acid (DNA), ribonucleic acid (RNA), chromosomes, proteins, and selected metabolites. Advances in genetics research are enabling improved prevention, treatment and disease management for common chronic conditions such as cancer, heart disease, and diabetes.
As genetic testing technology is integrated into health care, increasingly detailed information about individual and population genetic variations becomes available to patients and providers. More and more, health professionals are turning to genetic testing to assess the risk of disease in individuals, families, and populations and using this information to guide healthcare decisions. Yet availability of this information requires significant support for efforts to understand its validity, interpretation, and utility in clinical and personal decisionmaking. Scientific and technological advances in genetic testing present certain challenges to existing frameworks for regulation and oversight. It is critical to anticipate and adapt to the impacts of these advances on individual health care and public health.
The significance of the information that can result from genetic tests, their expanded use of genetic testing in clinical practice and public health, and the pace and extent of technological change in the ways testing is performed, have prompted efforts to examine the current systems of oversight and regulation of genetic tests and test results. The Secretary’s Advisory Committee for Genetics, Health, and Society (SACGHS) first identified oversight of genetic tests as a priority area in 2004. After several years of monitoring the issue, SACGHS began a concentrated effort in 2006 to assess the various systems of oversight that play a role in genetic testing. Like SACGT, the Committee’s overarching concern was the adequacy of the oversight system and whether there were gaps in it that could lead to harms in public health. In March 2007, HHS launched the Personalized Health Care (PHC) Initiative to advance the integration of genomic technologies that are capable of tailoring treatment and prevention strategies to each patient’s unique genetic characteristics and individual needs into general health care.
Minneapolis/Saint Paul The Minnesota Department of Health has suddenly and quietly withdrawn the newborn genetic screening rule which was set to be rolled out at the end of this month, says Citizens’ Council on Health Care (CCHC). “Clearly, the Minnesota Department of Health is not interested in protecting the genetic privacy and property rights of its newest citizens and their families. Instead they hope to use the legislative process to maintain their illegal ownership of baby DNA,” says Twila Brase, president of CCHC.
After CCHC forced the Department to hold a public hearing on the proposed newborn genetic screening rule on January 23, 2007, administrative law judge Barbara Neilsen ruled that portions of the proposed rule had “defects” and required specific changes, including:
- Against the Department’s written wishes, Judge Neilsen required that parents of newborns be given a Tennessen Warning as requested by CCHC at the public hearing. The Warning, which is required for most data collection by government agencies, would fully inform parents of state government’s involvement in the testing program, the parent’s right to refuse government collection of DNA and genetic data, and how the data would be used and who could access the data if the parents permitted their baby to be tested for a list of genetic conditions.
- The judge also required explicit opt-in parent consent for the retention of newborn blood and DNA, and for dissemination of blood and genetic information to genetic researchers. Countering the Department’s executive decision ten years ago to begin retaining and disseminating newborn blood without parent knowledge or consent, Judge Neilsen specifically stated that Minnesota law does not authorize such retention and dissemination, and in fact such activities now specifically violate the 2006 Minnesota genetic privacy law.
In July, Commissioner Dianne Mandernach appealed the ruling to the Chief Administrative Law Judge, Raymond R. Krause. The appeal was denied.
According to a Department letter tucked away on the health department’s website—no press release was issued—the Commissioner is now withdrawing the rule to “seek legislative guidance on storage and use of blood spots.”
Ms. Brase provides the following statements:
“The health department has cleverly avoided getting specific consent from parents of newborn babies. They’ve avoided fully informing parents about what’s happening to their children. They’ve withdrawn the rule in hopes of using the political process to sanction 10 years of illegal blood retention and genetic research, and specifically to get approval for state government ownership of the DNA of newborn citizens.
“The department’s decision strips the judge’s genetic privacy and DNA property protections from newborn babies and their families. The Department is clearly disregarding the privacy and property rights of citizens in hopes of eventually dismissing them through the legislative process.
“Obviously these DNA samples have great value, but they belong to parents and their children, and not the State of Minnesota,” Brase adds.
“We again call on the Governor to make the Department follow the rule of law.
“We call on the Governor to protect the genetic privacy and property rights of parents and children by dissembling the health department’s warehouse of DNA wrongly taken from children and their parents, and by requiring the Department to get explicit fully informed consent from parents for newborn genetic testing.
“Minnesota’s children and parents are waiting for the Governor to protect their legal rights.”
MDH Letter to Judge Krause, August 29, 2007
Chief ALJ Raymond R. Krause’s Reconsideration Order, July 3, 2007
MDH Request for Reconsideration, June 27, 2007
The ALJ Report (ALJ Barbara Neilsen), March 27, 2007
CCHC Attachments to Testimony, January 31, 2007
Office of Administrative Hearing Newborn Screening Rule including all letters from the public
Cheers to IBM for its recent pledge to not use genetic information in its hiring practices or in deciding eligibility for health insurance coverage for its 300,000 employees. Yet the fact that IBM felt the need to take such action highlights the gap in federal legislation to adequately protect job candidates and employees from discrimination based on their personal genetic information. And will it be a bellwether for action on a national level?
At least 20 bills have been introduced in Congress to prohibit genetic discrimination in the past 10 years. Only one has passed, providing limited protection against genetic discrimination for the group health insurance market. National legislation to prohibit genetic discrimination by employers and health insurers is way overdue.
A prime example of the abuse of genetic information is a much-publicized $2.2 million settlement between Burlington Northern Santa Fe Railway Co. and the U.S. Equal Employment Opportunity Commission. The railway tested or sought testing for 36 unsuspecting employees in an attempt to establish that injury claims were due to genetic disease and not to work-related activities. The science here was shaky, but the surreptitious misuse was clear-cut.
The recent case involving former Chicago Bulls basketball player Eddy Curry and the team’s request for DNA testing to diagnose a heart arrhythmia also highlights the interest in genetic information in making personnel decisions.
Testimony before a federal advisory committee on genetics, health and society last year revealed that citizens were avoiding or hiding test results because they might lose their health insurance. Do we want women with a family history of breast cancer deciding not to get tested out of fear of discrimination?
As more genetic tests are developed to help prevent disease or enable early detection, protections against the potential misuse of genetic information become ever more important. Employers may decide not to hire someone based on his or her genetic predisposition to diseases such as cancer or heart disease. Or an insurer may raise premiums or decline coverage for individuals with a high risk of disease or disability based on genetic differences. The enactment of national legislation to protect all individuals from genetic discrimination will not just benefit a select few who are affected with a genetic disease. All of us have genetic miscues in our genomes that may one day lead to disease. Given all of the bills introduced over the last 10 years, what is the hang-up in passing this legislation? Most politicians support the legislation, as evidenced by the Senate vote on the most recent bill — 98 to 0. And the president has indicated his willingness to sign such legislation. Ironically, groups that represent employers have voiced concerns that this bill addresses a problem that doesn’t exist and creates a new cause of action against employers. Therefore, the announcement by IBM comes both as a surprise and a welcome vote of confidence that businesses can survive without peering into the genomes of potential and current employees.
In the absence of national protections, most states have passed legislation to prohibit or limit the use of genetic information for risk selection and risk classification for health insurance or employment purposes. However, the scope of protections varies by state. The only other employer known to offer protection from genetic discrimination is the federal government; in 2000, an executive order was signed by President Clinton providing protection for 2.7 million federal employees. If the move by IBM instigates more employers to develop their own policies on the use of genetic information, this will result in a messy patchwork of company policies on top of inconsistent state laws.
Regardless of how widespread genetic discrimination practices are, the fear of discrimination could cripple important genetic-related technologies before they are introduced. Fear drives policy, as evidenced by the anxiety surrounding genetically modified organisms in Europe. Without national protections, individuals may decline to participate in genetic research studies or may compromise their health by refusing testing of their genomes, thereby halting the field and promise of genetics. This is why IBM’s action provides a model for Congress. Let’s not squander the promises of genetics by failing to protect our citizens from discrimination.
Susanne B. Haga is senior policy analyst for the Institute for Genome Sciences and Policy at Duke University. Huntington F. Willard is director of the institute.
Like many children whose mothers used an anonymous sperm donor, the 15-year-old boy longed for any shred of information about his biological father. But, uniquely, this resourceful teenager decided to try exploiting the latest in genetic technology and the sleuthing powers of the Internet in his quest.
By submitting a DNA sample to a commercial genetic database service designed to help people draw their family tree, the youth found a crucial clue that quickly enabled him to track down his long-sought parent.
“I was stunned,” said Wendy Kramer, whose online registry for children trying to find anonymous donors of sperm or egg helped lead the teenager to his father. “This had never been done before. No one knew you could get a DNA test and find your donor.”
While welcomed by advocates of children trying to locate anonymous donors, the case — apparently the first of its kind — has raised alarm among sperm banks and some medical ethicists. They are concerned it might start a trend that could violate the privacy of thousands of sperm donors and discourage future ones.
The case has also underscored how the growing number of genetic databases being established by governments, law enforcement agencies, private companies and research organizations could be used in unintended ways, potentially invading personal privacy and raising a thicket of social, ethical and legal questions.
“When you create these databases, you’re creating something that has a lot of power — far beyond what they were originally designed for,” said David M.J. Lazer, who studies the legal implications of genetic databases at Harvard University’s John F. Kennedy School of Government. “This seems like one of those scenarios.”
The database involved in the sperm donor case was set up by Family Tree DNA of Houston, a private company that has accumulated more than 45,000 DNA samples. For a fee, clients hoping to learn more about their heritage can have their DNA tested to see if it matches anyone in the database.
“We provide services for genealogists. That’s what we do,” company spokesman Max Blankfeld said. “We really didn’t have anything like this in mind.”
In this case, the teenager scraped some cells off the inside of his cheek last year and sent in the sample with $296 to see if his Y chromosome, which is passed down from father to son, matched anyone on file.
“At first he just wanted to get a little more information about his paternal side, like countries or origin. That kind of thing helps people who want to know: ‘Where am I from culturally? Where are my people from?’ Any bit of information is so welcomed,” Kramer said.
The youth has declined to be identified, revealing just the outlines of his case through Kramer’s registry to protect the identity of his newfound biological father. The case was first reported by the British magazine New Scientist.
About nine months after submitting his sample and agreeing to be contacted by other clients, the U.S. youth heard from two men with Y chromosomes that closely matched his, Kramer said. Neither man knew the other, but the analysis indicated there was about a 50 percent chance that all three had the same father, grandfather or great-grandfather, Kramer said. The men also had similar last names, spelled differently.
Because the youth’s mother had obtained the donor’s date of birth and birthplace from the sperm bank, he paid another online service, OmniTrace.com, to buy the name of every person born there on the same day, Kramer said. One man with the same last name appeared on the list, and within 10 days the youth contacted him, said Kramer, who declined to reveal details about the donor’s reaction.
“I think this kid would love to come out with his story, but for the time being those are the wishes of the donor,” Kramer said.
Since word of the case emerged, several other offspring registered on Kramer’s site,http://www.donorsiblingregistry.com/ , have clicked the link to the Family Tree DNA site (http://www.familytreedna.org/ ) in hopes of locating their biological father, she said.
“Given this case, more people will be putting their DNA in the pool so that potential connections can be made,” Kramer said. “Not everyone who puts their DNA in is going to find their biological father, but now we’ve seen this as a distinct possibility. The DNA databases are just going to grow and grow, and this is going to be more and more common.”
That scenario is likely to concern thousands of men who have donated sperm anonymously — often college students or other young men who saw it as an easy way to make money — according to sperm bank officials and ethicists. There are no reliable estimates of the number of Americans who have been born using donated sperm, but it could number in the hundreds of thousands.
“A fair number will be quite perturbed,” said R. Alta Charo, a University of Wisconsin bioethicist. “They well may be wondering, ‘Am I next?’ ”
Several experts said the relatively small number of people whose DNA is on file means the approach remains a long shot.
“The sperm bank involved in this case disclosed a lot more information than we do,” said William Jaeger of the Genetics and IVF Institute of Fairfax, one of the nation’s largest sperm banks. “In cases where the donor does not want to be identified, we do everything we can to protect them.”
Nevertheless, Jaeger and officials at several other of the nation’s largest sperm banks said the development is disturbing.
“Protecting the identify of our donors is paramount for us,” Jaeger said. “It would become a problem if it became common. It would really reduce the number of donors available, and I think you would be doing a disservice to people who want to use sperm donors.”
Many sperm banks offer donors the option to donate without anonymity and allow recipients to chose those donors. But those who opt to remain anonymous should be protected, officials said.
“I think it’s unethical. It’s an invasion of the donor’s privacy and a breach of contract,” said Cappy M. Rothman of the California Cryobank of Los Angeles, another large sperm bank. “If we were to expose our donors to being known, we would have many fewer donors.”
Some ethicists said the rights of offspring outweigh those of donors.
“I have no sympathy for someone who wants to have a child but doesn’t want the child to find out who their father is,” said George Annas of Boston University. “If you’re worried about it, you shouldn’t be selling your sperm.”
Other ethicists said the case illustrates the need to find ways to balance both interests.
“The overall issue is the importance of some offspring of donors to learn about their biologic parentage, which is a strong impulse in some children and needs to be taken seriously, with ways to accommodate that that are respectful of the privacy of the donors,” said John A. Robertson of the University of Texas School of Law.
“At the very least, we may now need to inform donors that we may no longer have a foolproof way to protect them,” Robertson said. “If the system is as porous as this case indicates, then at least we need to inform them that someone may track them down.”
Moreover, the case illustrates that when people put their DNA on a database, it provides information about more than themselves, several experts said.
“DNA is the ultimate identifier,” said Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University. “I don’t know to what extent these databanks are taking their responsibility seriously to make sure people are aware of the possibility of these unintended disclosures.”
IBM, the world’s largest computer maker, pledged Monday not to use genetic data to screen employees and applicants in what it said was the first such move by a major corporation to safeguard a new category of privacy.
International Business Machines Corp. (Research) also said it would refrain from using the data in determining eligibility for health care or benefits plans.
The pledge comes as Congress debates a proposed privacy bill that would bar health insurers and employers from discriminating against people with a genetic predisposition to disease.
Four years ago, railroad conglomerate 3Burlington Northern Santa Fe Corp. (Research) agreed to abstain from submitting its employees to genetic testing after it was sued by federal regulators.
“Genetic information comes pretty close to the essence of who you are, it’s something you can’t change,” IBM’s chief privacy officer, Harriet Pearson, told Reuters.
“It has nothing to do with your employment, how good your contributions are, how good of a team member you are, so making a policy statement in this case is the right thing to do,” she said.
IBM, based in Armonk, N.Y., employs more than 300,000 people worldwide.
The Genetic Alliance, a Washington-based patients advocacy group, called IBM’s policy “remarkable” and predicted it would spur other U.S. corporations to follow suit.
IBM shares rose 75 cents, or nearly 1 percent, to $81.25 trading Monday after Citigroup upgraded its rating on the company to “buy” from “hold.” IBM’s share price has dropped more than 17 percent this year.
I.B.M., the world’s largest technology company by revenue, is promising not to use genetic information in hiring or in determining eligibility for its health care or benefits plans. Genetics policy specialists and privacy rights groups say that the I.B.M. pledge to its more than 300,000 employees worldwide appears to be the first such move by a major corporation.
The new policy, which comes as Congress is considering legislation on genetic privacy, is a response to the growing trend in medical research to focus on a person’s genetic propensity for disease in hopes of tailoring treatments to specific medical needs.
Gene tests are not yet widespread, but start-up companies are already intent on developing a market for genetic testing and counseling. I.B.M. has a business stake in promoting genetic data gathering and processing, as a leading information technology company with a growing presence in the medical industry.
Research on genetics is already beginning to lead to improvements in health care. But polls have shown that Americans worry that gene tests and genetic profiling could be used to keep people deemed at genetic risk of certain diseases or conditions from getting jobs and health insurance. And there have already been instances of employers trying to use genetic data to workers’ detriment.
“What I.B.M. is doing is significant because you have a big, leadership company that is saying to its workers, ‘We aren’t going to use genetic testing against you,’ ” said Arthur L. Caplan, director of the Center for Bioethics at the University of Pennsylvania medical school.
“If you want a genomic revolution,” Mr. Caplan added, “then you better have policies, practices and safeguards that give people comfort and trust.”
In a handful of publicly disclosed cases, genetic data has been used without workers’ knowledge. Perhaps the best known involved a $2.2 million settlement in 2002 that the United States Equal Employment Opportunity Commission reached with the Burlington Northern and Santa Fe Railway Company. The government had sued, saying the railroad tested, or sought to test, 36 of its employees, using blood samples, without their knowledge or consent. According to testimony, the company performed the tests in the hopes of claiming that the workers’ arm injuries stemmed from a rare genetic condition instead of from work-related stress on muscles and nerves. The railroad denied that it violated the law, but agreed not to use genetic tests in future medical examinations.
The Genetic Alliance, a Washington coalition of patient advocacy groups, receives a few inquiries a week, said Sharon F. Terry, president and chief executive of the alliance. Some are complaints from people who have had trouble getting health insurance after they disclosed a genetic condition, while others come from people concerned about how employers might use any genetic information they might reveal in health forms.
“It is a problem already, and the prospect is that the problem will only grow,” Ms. Terry said. “That is why we need rules and practices from government and the private sector to prevent abuses.”
Congress has certainly taken notice of the issue. This year, the Senate passed a genetic information nondiscrimination bill, by a vote of 98 to 0, and the House is now considering similar legislation. Two years ago, after the Senate passed a genetic privacy act, the House never voted on the legislation. But House sponsors are more optimistic this time. Also, about 40 states have laws that address some aspect of genetic privacy and discrimination.
To some extent, the privacy provisions in existing statutes like the Health Insurance Portability and Accountability Act and disability and civil rights laws already address the issue. They include prohibitions against using personal medical information to discriminate against people in hiring and in providing health insurance. But the current laws tend to deal with the diseases or disabilities that people already have.
Some critics say the genetic privacy bill would deny insurers a means of measuring risk that would be available to the people they insure, allowing some people to take advantage of that information. For example, there is a strong genetic marker for the early onset of Alzheimer’s disease. A person could test for it privately, and then take out long-term care insurance.
Health insurers have expressed skepticism about the need for federal legislation to protect genetic privacy. They say that current federal and state laws are adequate, and that a new law could have the unintended effect of, say, preventing insurers from providing disease management programs to people who have tested positive for a genetic risk. But the industry’s big trade association, America’s Health Insurance Plans, has not lobbied against the Senate bill, according to Congressional staff members.
I.B.M. has become a big player in what is called information-based medicine, which relies on genetic information. The company’s involvement goes beyond the hardware and software often employed in such work. I.B.M. scientists and technology consultants are engaged in projects including research at the Mayo Clinic and a venture with the National Geographic Society to trace the genealogy of the world’s population.
“The time is right,” explained Harriet Pearson, I.B.M.’s chief privacy officer. “The market and medical practice is moving in this direction – to gather and use genetic information.”
In an e-mail message to be sent to all I.B.M. employees today, Samuel J. Palmisano, I.B.M.’s chief executive, writes that the spread of gene-testing and genomic research is “enormously promising – but it also raises very significant issues, especially in the areas of privacy and security.”
Opinion polls have repeatedly showed that workers are leery of companies using genetic test information against them. For example, a poll in 2000 by the National Center for Genome Resources, a research group, found that 63 percent of workers would not take genetic tests if employers could get access to the results.
Genetic specialists regard I.B.M.’s move as a positive step and one that could help prod policy forward. But many also insist that a federal law would be the best protection.
In an article last month in The Journal of the American Medical Association, Dr. Francis S. Collins, director of the National Human Genome Research Institute, and Dr. Alan E. Guttmacher, the deputy director, wrote that “potential discrimination in health insurance or employment based on the results of genetic testing has been apparent for years and requires a national legislative solution.”