Special Report: Trends and Forecasts in Medical Ethics
Will we buy genetic profiles with our milk and eggs?
Age of genomic’ medicine magnifies concerns
Over the course of the next decade, genetic technologies are expected to completely reshape the health care landscape, with the availability of new genetic tests and genetic therapies that are almost unimaginable at this point in time.
"I am optimistic that genomic medicine will provide important reclassifications of disease and, at the same time, insights into the pathophysiology of disease that will be useful for disease management and prognosis," predicts Paul Billings, MD, founding fellow of the American College of Medical Genetics and co-founder of the Internet genetic information company GeneSage in San Francisco. Billings also is the former chief medical officer of the Heart of Texas Veterans Health Care System. "From that knowledge, will also be the development of new management strategies and the production of new therapies."
However, whether those promising technologies will be available to all segments of society remains a big question mark in the minds of Billings and many other experts. The issue of genetic medicine highlights issues of equity of access to care more profoundly than almost any other aspect of medicine, says Billings.
"We already have a problem with unfair access to certain technologies — you can get certain things quicker if you are wealthy than if you are not wealthy," he explains. "But when you think about genetics and how it is about all of us. We all have a very basic right to know our own genome if we wish or to be left alone, it magnifies the issue. The dilemma for the health care system is how do we — with a small field and limited number of skilled practitioners — deliver the benefits broadly and equitably."
Already, many currently used genetic diagnostic tests are not covered by government payers, nor by some private payers, says Vivian Weinblatt, MS, president of the National Society of Genetic Counselors (NSGC) in Wallingford, PA. Weinblatt specializes in the area of prenatal genetic counseling and testing for heritable diseases.
"What if I have a Medicaid patient at risk for alpha-thalassemia?" she says. "This is a disorder that can, if the fetus is affected, kill the fetus and also make the mother very, very ill. It is an inheritable disorder that is most common in people of southeast Asian ancestry. There are very routine genetic tests that would indicate if both parents were carriers, but it can cost up to $2,000 for the DNA analysis, and Medicaid doesn’t pay."
Unless there are unforeseen changes, Billings predicts, the use of genetic testing for estimating a person’s risk of developing certain diseases in the future will likely move completely out of the traditional medical setting into a separate consumer industry where those who can afford the testing will be able to receive it.
"We already have single gene tests; we are going to see multigene tests that can establish a person’s risk profile," he says. "This will be mixed with other kinds of data that are predictive of risk. At various stages of our lives, we will have the opportunity to assess the genetic component of our health risk and, hopefully we will have strategies to modulate that risk as well."
But it is not likely that such options will be routinely available in a doctor’s office, he adds. Currently, primary care physicians don’t have the appropriate education or the time to spend with their patients on this service. And insurance plans frequently don’t cover genetic testing. "One of the things that I see happening is that there is going to be this sort of partition in the sense that risk analysis of healthy people and prevention may become more of a consumer business as opposed to an activity of the health care system," he says.
In fact, not all health care systems in the United States will have equal access to genetic technologies because of a scarcity of medical expertise to provide accurate analysis of genomic information, he adds. "Genomics has never been a significant issue for health care until now. The notion that health systems that want to expand in this area can simply hire more expertise doesn’t work because there simply isn’t any."
National societies like the NSGC and the National Coalition for Health Professional Education in Genetics are trying to remedy that situation by encouraging medical societies to offer educational programs in genetics for their members and by encouraging medical schools to make genetics education a requirement for graduation, says Weinblatt. "Right now, I think that the level of knowledge is pretty uneven around the country," she says. "There are some primary care doctors who are extremely sophisticated about genetics; they have an interest in it and are able to provide some of the preliminary information to patients. But, there are also some providers who have a lot less comfort with the area of genetics."
Is it research or clinical consent?
Increased availability of genetic testing and the growth in genetic research will require that hospitals and health providers clarify their procedures for obtaining informed consent from patients. "Are we properly informing people when they are participating in research settings, or is it clinical consent that we are really obtaining?" Billings wonders. "We need to clearly distinguish between clinical consent in episodic care and consent to participate in research."
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Patients who give clinical consent usually are consenting to let a physician perform tests for a particular diagnosis and be treated for a particular illness, he says; whereas, research consent means that the patient has been informed of all of the risks and benefits and has given consent anyway.
With the potential for genetic research protocols to change given different findings and factors of the community studied, research consent should be more dynamic in that setting. "It is increasingly being recognized that the consent process should be ongoing and should involve two-way interaction between participants and researchers," he says.
In the age of genetic medicine, research consent will have to be much more than a "signature on a piece of paper," agrees Weinblatt. "Informed consent is a process that involves communication and discussion." Even obtaining appropriate informed consent for episodic clinical care is more complicated in the arena of genetic information, she adds. "Many genetic tests are not deterministic," she notes. "For example, the BRCA1 test; if it is positive for the mutation, absolutely confers increased risk to the person carrying the mutation. But, it does not say you will definitely get breast cancer. That distinction is really very hard for patients to understand. Informed consent for a test like that is also critical."
Legislative protections needed
In order to enable health care providers to make strong progress in increasing the availability of the benefits of genetic technologies to patients, state legislatures must pass better patient protections, adds Weinblatt. "There are some protections. Kennedy-Kassenbaum [the Health Insurance Portability and Accountability Act of 1996] and the Americans with Disabilities Act provide some," she says. "But there are holes, and there needs to be a better, more universal approach."
Although ensuring the privacy and confidentiality of medical information is important, it does not replace the need to have legislation that prohibits employers and insurers from discriminating against people based on their genetic information. "In case somebody is able to hack into some computer somewhere and get the information, the information then needs to be rendered useless," she says.
Many people who want to take advantage of predictive genetic testing may choose not to because of the fear that the information may one day fall into the wrong hands. "People need to be able to decide to have a test or not, [and] have a test based on the merits of the information alone and not the fear of what is going to happen to them later."
Sources
• American College of Medical Genetics, 9650 Rockville Pike, Bethesda, MD 20814-3998, Telephone: (301) 530-7127. Fax: (301) 571-0677. E-mail: [email protected]. Web: www.faseb.org/genetics/acmg.
• Paul Billings, GeneSage Inc., 589 Howard St., Third Floor, San Francisco, CA 94105. Web: www.genesage.com.
• Vivian Weinblatt, National Society of Genetic Counselors, 233 Canterbury Drive, Wallingford, PA 19086-6617. E-mail: [email protected]. Web: www.nsgc.org.
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