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MedicalProgressToday is a web magazine devoted to chronicling how market-friendly public policies drive life-saving medical innovations and make health care more affordable and accessible for all Americans.

 

Recent Second Opinion:

Post-Election Predictions for Obamacare
November 11, 2010

Improving the FDA's REMS Program
August 05, 2010

Are Foreign Clinical Drug Trials Safe?
July 08, 2010

FDA's Bad Ad Program
June 03, 2010

Obesity and Public Health
May 05, 2010

The Route to Reconciliation
March 05, 2010

Conflict of Interest
January 28, 2010

Analyzing the Healthcare Bills
November 18, 2009

President Obama's Plan for Reform
August 24, 2009

The Healthcare Reform Debate
July 23, 2009

Priorities for the New FDA Commissioner
December 19, 2008

PhRMA's New Marketing Code
August 28, 2008

Personal Genetics Testing
July 29, 2008

Where health care policy experts have their say
June 13, 2008

Sources of Medical Research Funding
April 24, 2008

Off-Labeling Marketing
March 17, 2008

Second Opinion:
Where health care policy experts have their say

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:

  • 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. (Read Olson's Second Opinion.)
  • 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. (Read Sasse's Second Opinion.)
  • John Fossella, PhD MBA, is an Assistant Professor Mount Sinai School of Medicine. (Read Fossella's Second Opinion.)

"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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