Genome breakthrough may require stronger privacy laws

Genetic testing offers doctors the promise of being able to fight a disease before it starts, but privacy experts worry the information could be used to deny you health insurance or a job

By Raju Chebium
CNN Interactive Correspondent

WASHINGTON (CNN) -- The Human Genome Project will give physicians powerful new tools to fight genetic diseases and scientists the ability to make groundbreaking discoveries about human nature. That is the good news.

The troubling news, experts say, is that unregulated access to genetic information could destroy a person's privacy.

In the absence of legal protections, they say, you and your doctor will not be the only ones with access to your genetic chart. Insurance companies, the government, employers -- virtually anyone -- could get what ought to be private information.

Consider these scenarios:

Insurers deny you health coverage based not only on your "pre-existing condition" -- the current practice in the United States -- but also on the probability that you may contract, say, cancer years down the road.

You lose your job because your boss fears you will become seriously ill when you turn 50.

Drug companies invade your privacy with unsolicited new therapies for diseases they know you could contract based on your genetic profile.

Such situations worry experts such as John Banja, a medical ethicist at Emory University in Atlanta.

"Medical discrimination exists now. Genetic information opens up the field," Banja said. "When I have genetic information on you, I have information on your family ... your lineage."

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said lack of legislation could lead to snooping by unauthorized parties.

"Everybody gushes on about the revelation that 99 percent of the genome in humans is held in common. But there are plenty of people who will be interested in the 1 percent that is different," Caplan said.

Potential for error

Experts caution that a complete genome map does not mean researchers know all there is to know about what makes you tick genetically.

It will take many years for researchers to figure out what the map means, to determine which gene causes which disease, which ones contribute to which physical and emotional traits, and so on.

As science unravels the genetic mysteries at the core of all humans, the non-scientific segments of society will begin to find ways to apply the information in everyday life. Legislation will greatly help prevent the research from being misused inadvertently or abused intentionally, experts say.

Caplan offered a scenario to illustrate this view. Say you go to an office party and have a few drinks. Your employer wants to find out which employees have the genetic potential to become seriously ill -- and drive up the company's health-insurance expenditures. So the employer has the residual saliva on the party glasses tested for flawed genes. You are found to be at risk for heart disease. Soon you get a pink slip.

Such a situation could be avoided, Caplan said, if there were a law requiring employers to get an employee's permission before the gene test. The employee would be able to say no or to demand job safeguards if the tests revealed a gene for any potentially debilitating disease, he said.

Thomas E. Jurgensen, vice president and general counsel at the Salk Institute in La Jolla, California, said the fear is that the corporate world -- without meaning to -- could make poor decisions based on inadequate research soon after the gene mapping is complete.

"Insurers or somebody could make a gross generalization based on your genetic profile," Jurgensen said. "I'd hate to have decisions that are really premature and not based not on analysis of all the data."

"There is an ability to abuse it. I am not saying that people will abuse it, per se," he said. "It may not be malicious intent; it may just be blind ignorance."

Who can see your genome?

Terri Seargent says she was fired last year by a North Carolina insurance broker after the company discovered she was genetically predisposed to a lung and liver disease. Her lawsuit may be the first to decide whether someone genetically prone to a disease is covered by federal anti-discrimination laws.

In addition to laws protecting privacy, experts say laws requiring informed consent and prohibiting "genome discrimination" are also crucial. The three issues are interrelated.

No one except you should know your genetic makeup unless you authorize someone else to have it, experts say. That means you should have the legal power to choose to disclose your genetic information to a third party -- after you learn how and why this information will be used.

Under current U.S. law, third parties could obtain a person's medical information for various purposes. Employers, for example, have the legal right to require applicants to undergo full physical examinations before being hired. Drug tests are also mandatory in many companies.

In the future, with advanced genetic knowledge, the amount of information revealed about a person's physical makeup through a routine examination would be a mountain compared to the molehill of today, experts say.

What many want to see are laws mandating that employees be told that genetic information will be gathered and what will be done with the individual genetic charts.

Will employees' charts be shared with insurance companies? Will direct marketing companies have access to the employer's database? How about the government, pharmaceutical companies, the armed forces?

Are current laws adequate?

DNA from saliva left on a cup of coffee could be used to determine your genetic profile

People should also have the weight of the law behind them in fighting discrimination stemming from their genetic profiles, experts say. What they want to see are anti-genome discrimination statutes similar to U.S. laws barring discrimination based on a person's age, race, gender or national origin.

Larry Gostin, a professor of law and public health at Georgetown University in Washington, D.C., said the 1990 Americans with Disabilities Act provides the primary legislative shield against health-related discrimination.

He said, however, that "it is not at all clear if all genetic conditions would be covered under the act. We need to close those loopholes."

Another relevant U.S. law that some experts point to is the Health Insurance Portability and Accountability Act. That law protects consumers from losing health insurance if they change jobs and forbids discrimination based on "health status."

Experts worry that HIPAA would be woefully inadequate in protecting people against genome discrimination because it is narrowly written and would apply to only one type of discrimination.

Too little, too late?

U.S. District Judge Gladys Kessler said she worries whether "the law will be able to [respond] fast enough and knowledgeably enough to keep pace with the incredibly swift scientific progress due to the Human Genome Project."

Kessler works with the Einstein Institute for Science, Health and the Courts and the American Bar Association's Bioethics & The Law group.

The number of medical discrimination cases is on the rise, and the prevalent view is that genetic discrimination will become an important factor in these cases.

The pace at which legal doctrine specific to genome discrimination will evolve will depend on the number of cases filed, how quickly they are resolved and whether the U.S. Supreme Court weighs in on the issue, Kessler said.

Virtually no one disputes the need for legislation. The debate is whether the laws must exclusively address genome discrimination or be "omnibus" measures covering all medical information, said Jean McEwen, who directs Ethical, Legal and Social Programs at the National Human Genome Research Institute in Bethesda, Maryland.

She said a genome is roughly the total of all the genes a person has. Though scientists disagree over what that number is, the widely held estimate is about 100,000.

Insurers not assured

DNA taken from a fetus may soon allow doctors to read a person's genetic profile before they are born

For its part, the insurance industry is taking a wait-and-see approach to assess the impact of genetic research, noting that researchers will need years to figure out what the genome map means.

"It is difficult to predict what impact advances in genetic technology will have on the insurance system, because the technology is not yet mature," the American Academy of Actuaries said in an issue paper.

The industry is worried that expensive genetic tests could drive up medical and insurance costs, the paper said.

But, the paper said, people need not worry about losing coverage based on damaging information in their genetic charts. They will not be denied entry into employer-sponsored plans or lose existing group and individual coverage based on damaging genetic information, the paper said.

Herb Perone, spokesman for the American Council of Life Insurers, said speculation about what the industry would do in an era of advanced genetic understanding "has the effect of frightening people into thinking the insurance industry will use [genetic information] against them."

"You're asking us to say what if, what if this, what if that. We can't play that game," Perone said. "We will care about genetic tests when and if genetic tests become part of routine, clinical, medical practice where any doctor you go to ... orders those tests as a matter of course."

Perone continued: "We care about accurate, reliable information. ... We make our decisions and our assessments based on what we know through historical experience to be true -- not what might be."

With more than 1,500 life insurance companies in the United States, Perone said, it would be counterproductive for companies to deny coverage to potential customers, or increase the premiums of existing customers based on genetic information, because competitors would be glad to get the business.

"We know of no life insurance company that has ever required anybody to take a genetic test as a condition for getting an insurance," Perone said, adding that insurers could want access to genetic test results if available and relevant.

Even then, he said, genetic information would be one piece of information actuaries would use to determine whether to cover someone.

Lawmakers hear concerns

As genetic researchers continue to make discoveries, some legal experts worry that changes in protective laws may not come quickly enough

Some lawmakers in the West, especially in the United States, are cognizant about the legal implications of the genome project.

U.S. President Bill Clinton and British Prime Minister Tony Blair have said no one should be able to patent the human genome because it is too valuable for all of humankind to allow anyone to "own" it.

Clinton issued an executive order in February that barred federal agencies from discriminating against employees on the basis of genetic tests.

Anti-genome discrimination bills also have been introduced in the U.S. Congress, with Democrats urging Republicans to reassure those people who fear losing their jobs or health insurance.

"In a sense, the genetic code is the key to who we are," said Sen. Chris Dodd, a Connecticut Democrat. "No one ought to have a right to pick that lock."

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