10/16/01
Health Care: Genomics' Final Act
BERKELEY, California -- A slew of new genetic methods, tests, and knowledge promises to revolutionize medicine now that scientists have cracked the human genome map. But those same advances could land health-care providers and insurance companies in a quagmire of sticky issues, including conflicts with patient privacy.
Genetic research experts who convened at the Biotech and Infotech Summit 2000 at the University of California at Berkeley this week agreed that while developments in genetics will profoundly effect medicine for the better, they could also cause a significant bottleneck for health care organizations.
The delay will come as hospitals, insurers, and doctors evolve from today's "rather primitive" way of dealing with disease by reacting to symptoms to catching potential problems before disease starts, said George Poste, CEO of Health Technology Networks and former chief and science and technology officer at SmithKline Beecham.
"I see us having a fairly difficult decade to come," Poste said. "The real promise of genetics is moving medicine from diagnose and treatment to prediction and prevention."
These changes will require a profound change in the education of future doctors, as well as training for those already practicing. "Most of the health care systems of the G7 nations are going to go through some very difficult economic convulsions over the course of the next 10 to 15 years," Poste said.
Insurers also will have to adjust to the wave of change. Some experts have pointed out that if everyone knows exactly what their medical needs are because of genetic testing, insurance companies will be out of the risk business.
"The insurance business depends on the mutual ignorance of what will be my life fate," said Elbert Branscomb, director of the Joint Genome Institute in Walnut Creek, California, one of the labs that contributed to the Human Genome Project.
The most immediate, and probably the largest, effect of genetic research that health-care providers will face is personalized medicine. By studying single nucleotide polymorphisms, or SNPs (pronounced snips), researchers hope to be able to tailor the right drug to the right person, instead of using a one-size-fits-all drug, which in about 100,000 cases per year results in adverse reactions.
SNPs are small gene variations in populations that give people different hair colors, make individuals more prone to certain diseases, or determine how people will react to certain drugs. Companies like Orchid Biocomputer, Millennium Pharmaceuticals, and Nanogen, as well as a government-funded SNP Consortium, are working to discover and catalog SNPs.
One in 500 of the 3.2 billion chemical bases in humans will be different among individuals, said Leroy Hood, director of the Institute for Systems Biology. Many will be insignificant, but many others will lead to diseases or other significant changes among individuals.
Human Genome Project researchers have already discovered 300,000 SNPs, Hood said. A year ago, they hoped they'd be at the 50,000 SNP point, but at this rate, researchers will have discovered more than a million SNPs by the end of 2000.
In addition to adapting to all of the new testing and treatments to ensure that the genomics revolution progresses, health care providers and insurers also will have to walk a fine line on patients' privacy.
"Everybody realizes that patient information should be kept highly confidential," said Carl Feldbaum, president of the Biotechnology Industry Organization. "There's no place for publishing names or clear identifiers of individual patients. That's a bedrock responsibility of all health-care providers."
Yet in order to proceed with SNP research, scientists need to know identifying characteristics of populations, such as whether they smoke, their exposure to chemicals, infectious diseases they may have encountered, and what drugs they take.
"You must have ways to link those very different data sets or the whole thing comes crashing down with very little understanding and very little advancement from all this fabulous genetics," said Gilbert S. Omenn, executive vice president for medical affairs at the University of Michigan and CEO of the University of Michigan Health System.
"The information in the aggregate form of patient databases will probably be one of the most powerful tools for the medical industry in the future," said Randy Scott, president and CEO of Incyte Genomics. "Protecting the freedom of the individual" while using that information stored in patient databases for the good of all is the goal "in terms of value for society."
If the government enacts overly restrictive legislation to protect individual genetic privacy, the potential for understanding disease in a preventive way would be reduced, the experts said.
At the same time, people must be confident that their information is private, so they'll feel free to have tests that could show them the need for a lifestyle or diet change, or that a new treatment would prevent the onset of disease.
"This would be like a genetics civil rights bill, but unlike other civil rights, this will not involve a minority," Feldbaum said. "Every single one of us, 100 percent of the population will have some propensity for disease or some predisposition that we would rather others not know, so I think there will be an enormous consensus around strong safeguards."
Once the health-care industry, doctors, insurers, and legislators weather the early days of the genomics revolution, the long-term benefits will be incalculable.
"The economic implications of (genetic research) are all in the positive direction," Poste said, "as well as the overall impact on the quality of life for all of us."
¶ 8:47 PM
BERKELEY, California -- A slew of new genetic methods, tests, and knowledge promises to revolutionize medicine now that scientists have cracked the human genome map. But those same advances could land health-care providers and insurance companies in a quagmire of sticky issues, including conflicts with patient privacy.
Genetic research experts who convened at the Biotech and Infotech Summit 2000 at the University of California at Berkeley this week agreed that while developments in genetics will profoundly effect medicine for the better, they could also cause a significant bottleneck for health care organizations.
The delay will come as hospitals, insurers, and doctors evolve from today's "rather primitive" way of dealing with disease by reacting to symptoms to catching potential problems before disease starts, said George Poste, CEO of Health Technology Networks and former chief and science and technology officer at SmithKline Beecham.
"I see us having a fairly difficult decade to come," Poste said. "The real promise of genetics is moving medicine from diagnose and treatment to prediction and prevention."
These changes will require a profound change in the education of future doctors, as well as training for those already practicing. "Most of the health care systems of the G7 nations are going to go through some very difficult economic convulsions over the course of the next 10 to 15 years," Poste said.
Insurers also will have to adjust to the wave of change. Some experts have pointed out that if everyone knows exactly what their medical needs are because of genetic testing, insurance companies will be out of the risk business.
"The insurance business depends on the mutual ignorance of what will be my life fate," said Elbert Branscomb, director of the Joint Genome Institute in Walnut Creek, California, one of the labs that contributed to the Human Genome Project.
The most immediate, and probably the largest, effect of genetic research that health-care providers will face is personalized medicine. By studying single nucleotide polymorphisms, or SNPs (pronounced snips), researchers hope to be able to tailor the right drug to the right person, instead of using a one-size-fits-all drug, which in about 100,000 cases per year results in adverse reactions.
SNPs are small gene variations in populations that give people different hair colors, make individuals more prone to certain diseases, or determine how people will react to certain drugs. Companies like Orchid Biocomputer, Millennium Pharmaceuticals, and Nanogen, as well as a government-funded SNP Consortium, are working to discover and catalog SNPs.
One in 500 of the 3.2 billion chemical bases in humans will be different among individuals, said Leroy Hood, director of the Institute for Systems Biology. Many will be insignificant, but many others will lead to diseases or other significant changes among individuals.
Human Genome Project researchers have already discovered 300,000 SNPs, Hood said. A year ago, they hoped they'd be at the 50,000 SNP point, but at this rate, researchers will have discovered more than a million SNPs by the end of 2000.
In addition to adapting to all of the new testing and treatments to ensure that the genomics revolution progresses, health care providers and insurers also will have to walk a fine line on patients' privacy.
"Everybody realizes that patient information should be kept highly confidential," said Carl Feldbaum, president of the Biotechnology Industry Organization. "There's no place for publishing names or clear identifiers of individual patients. That's a bedrock responsibility of all health-care providers."
Yet in order to proceed with SNP research, scientists need to know identifying characteristics of populations, such as whether they smoke, their exposure to chemicals, infectious diseases they may have encountered, and what drugs they take.
"You must have ways to link those very different data sets or the whole thing comes crashing down with very little understanding and very little advancement from all this fabulous genetics," said Gilbert S. Omenn, executive vice president for medical affairs at the University of Michigan and CEO of the University of Michigan Health System.
"The information in the aggregate form of patient databases will probably be one of the most powerful tools for the medical industry in the future," said Randy Scott, president and CEO of Incyte Genomics. "Protecting the freedom of the individual" while using that information stored in patient databases for the good of all is the goal "in terms of value for society."
If the government enacts overly restrictive legislation to protect individual genetic privacy, the potential for understanding disease in a preventive way would be reduced, the experts said.
At the same time, people must be confident that their information is private, so they'll feel free to have tests that could show them the need for a lifestyle or diet change, or that a new treatment would prevent the onset of disease.
"This would be like a genetics civil rights bill, but unlike other civil rights, this will not involve a minority," Feldbaum said. "Every single one of us, 100 percent of the population will have some propensity for disease or some predisposition that we would rather others not know, so I think there will be an enormous consensus around strong safeguards."
Once the health-care industry, doctors, insurers, and legislators weather the early days of the genomics revolution, the long-term benefits will be incalculable.
"The economic implications of (genetic research) are all in the positive direction," Poste said, "as well as the overall impact on the quality of life for all of us."
¶ 8:47 PM
