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Recent Second Opinion: Post-Election Predictions for Obamacare Improving the FDA's REMS Program Are Foreign Clinical Drug Trials Safe? FDA's Bad Ad Program Obesity and Public Health The Route to Reconciliation Conflict of Interest Analyzing the Healthcare Bills President Obama's Plan for Reform The Healthcare Reform Debate Priorities for the New FDA Commissioner PhRMA's New Marketing Code Personal Genetics Testing Where health care policy experts have their say Sources of Medical Research Funding Off-Labeling Marketing |
Second Opinion: July 29, 2008: Personal Genetics Testing This new medical innovation, being offered directly to consumers, allows individuals the opportunity to have their genetic make-up examined by a private firm. However, regulators—most recently in California—have ordered that these firms halt operations until they obtain a clinical laboratory license and require a doctor's order for each genetics test. We sent the following news story, Citizens
Can't Test Their DNA Without a Doctor's Note, California Says to leading
health care scholars and asked them whether consumers have the right to
obtain information about their own DNA in the largely unregulated free
market that currently exists, or are there valid risks posed by providing
consumers with access to such complicated and consequential information. This edition of our expert panel includes:
"I see no compelling social interest in regulating
access of consumers to data about their own genomes. When scientists and
physicians make a lot of commotion about the risks of broad-spectrum genetic
testing, they create the misleading impression that these data contain
more interpretable information than they actually do. Indeed, I am generally
skeptical about the need to protect people from 'informational risks,'
even when the information is scientifically interpretable. Our regulatory
agencies should focus on attempting to enhance the safety, efficacy, and
affordability of drugs, devices, and procedures—a difficult enough
job that yields unequivocal public benefits when done well. When patients
show up at a clinic with test results that they expect their physicians
to interpret, the physicians should just say they don't know what the
results mean and get on with the real challenge of providing enlightened
primary care." —Maynard V. Olson is one of the founders of the Human Genome
Project as well as a professor of genome sciences and medicine at the University of
Washington. He is also specialist in the genetics of cystic fibrosis.
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"Despite complexities associated with interpreting incomplete and probabilistic genomic data, consumer-patients should have the right to know everything about their DNA. Advances in science have given us a remarkable tool that we are using to unlock generations of mysteries about health and disease. In the years to come the sequencing of a patient's entire genome will be an affordable and useful instrument in the analysis of disease predisposition. This will make truly individualized care possible. Yet, as with any new frontier, it is important that we proceed with caution. Personal genetics testing offers consumers an introduction to what is known about their DNA, establishing a new intersection of health information and the consumer. Those who choose to be tested should be protected from the unintended attributions of personal genomic information and assured that the information provided is valid and confidential. Earlier this year, the federal government took a big step in this direction when President Bush signed into federal law protections against discrimination in the workplace and in health care coverage using a person's genetic information. Consumer-based genomic services available today provide consumers with information that is not yet definitive or useful for supplanting medical decision-making. I see a future in which this knowledge can have important personal utility; however, the notion that we will soon derive all the answers from genomic information is exaggerated. As genomic research advances, we must continue to work as a community with scientists from the NIH and around the world to responsibly harvest the potential benefits of genetic information and build the pathway for personal health." —Ben Sasse, is the Assistant Secretary of Planning and Evaluation
for the Department of Health and Human Services. Sasse was chief of staff in the
Office of Legal Policy at the U.S. Department of Justice and is currently on leave
from the University of Texas where he teaches public policy.
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"Given the complexity of the legal, economic and ethical issues, its difficult to occupy a dogmatic position on the matter. I'm rather dazed by the 600,000+ of my single-nucleotide-polymorphisms I recently obtained from the 23andMe genetic testing service. What does it all mean to me? to my children? Is the data accurate? Can I 'game' the insurance industry? Will I experience undue panic if I discover a serious risk factor in there somewhere? As a molecular biologist, I know that we don't yet know what the data is suggesting. The vast nature of the basic science problem 'what is the genome telling us'; in terms of predictive and preventative care, lends itself to business/research models that are 'free and open source', web2.0, crowdsourcing etc. I would encourage our healthcare regulators, providers and lawmakers to appreciate the need to keep all routes of participation open." —John Fossella, is an Assistant Professor Mount Sinai School of Medicine. * * *
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