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Policy statement urges safeguards against misuse of genetic data
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The American Heart Association released a new policy statement recommending new regulations to safeguard the rapid advancements in genetic disease research.
“Genetic testing provides a tremendous opportunity, but also a challenge in being responsible with that information,” Euan A. Ashley, MRCP, DPhil, assistant professor of medicine in the cardiovascular division and director of the Center for Inherited Cardiovascular Disease at Stanford University School of Medicine, said in a press release. “If the information is available, how best do we use it to really improve care for individual patients?”
One recommendation from the writing group is to stop the practice of awarding patents for observing a gene. The writing group cited a controversial case, now before the Supreme Court, of a company that patented the two primary genes linked to increased breast and ovarian cancer risk — BRCA1 and BRCA2. That company has a monopoly on testing related to these genes, and some believe that this monopoly has reduced access to this test for women, according to a press release.
Another recommendation focused on establishing federal oversight of genetic tests. Because some of the newer genetic tests have a moderate to high complexity, they should be regulated for quality, analytic and clinical validity.
Expanding antidiscrimination legislation was another topic, as there are currently no protections against genetic discrimination by long-term care, disability and life insurance providers. To maximize the health benefits of genetic testing, federal laws should ensure that patients can undergo such testing without financial or other penalties, according to the press release.
Other recommendations include:
- Genetic testing and counseling in specialized centers.
- Reimbursement codes for screening of family members of those affected by genetic disease.
- Increased funding for clinical research in genetics.
- More studies on the genetic link to CVD and blood vessel disease risk.
- Genetics education for health care providers and patients.
- In-depth studies of genetically mediated responses to drugs, or pharmacogenomics, accompanied by expert consensus before changing prescription information.
“The safeguards are essential for patients in a new age of medicine. This is an unbelievable time in genetics,” Ashley said. “The pace of change has been astounding. You can imagine a world now where every patient might have their genome in the medical record, and the doctor might be able to simply look it up when prescribing medication.”
The new proposals are the result of an expert panel of geneticists, physicians, nurses, genetic counselors and other medical professionals that analyzed, discussed and reached consensus on genetic research and testing practices during a 2-year period.
For more information:
Ashley E. Circulation. 2012;doi:10.1161/CIR.0b013e31825b07f8.
Disclosure: Dr. Ashley reports ownership interest with Personalis.
Perspective
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Robert Roberts, MD, FRCPC, MACC
This AHA Policy is very timely and a prerequisite for the application of genetic management of patients. Two issues addressed include the need for a privacy protection act of DNA results and the need for widespread genetic education for our physicians, health care providers and, most important of all, the public — the end-user.
The improvement in DNA sequencing has improved 10,000-fold in the past 8 years. It is now highly likely that individual genomes will be sequenced for less than $1,000 and will be available for mass consumption within 2 to 3 years. It is postulated that more than 30,000 individual genomes will be sequenced before the end of this year. While DNA sequencing has improved 10,000-fold, our capacity to store, retrieve and interpret the data has only improved 16-fold. It will require a rapid learning curve for the whole of society.
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