Interesante iniciativa procedente de EEUU que puede ayudar a clarificar el uso de los test genéticos y que con toda seguridad tendrá relación con el proceso de suscripción de un seguro de vida o de salud.
José Miguel Rodríguez-Pardo del Castillo.
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Article Date: 09 Mar 2011
An advisory panel to the US Food and Drug Administration said genetic tests should only be marketed direct to consumers under the supervision of doctors, because without this the results can be open to interpretation: for instance a negative result does not necessarily mean that all the markers of a disease have been checked, although this is what the consumer might conclude.
The 21-member Molecular and Clinical Genetics Advisory Committee comprising mainly doctors and academics, is holding a hearing on 8th and 9th March in Gaithersburg, Maryland, to discuss and make recommendations on scientific issues concerning direct to consumer genetic tests that make medical claims.
They did not vote on specific questions on Tuesday, but according to a report in the Los Angeles Times, members generally agreed that doctors should supervise ordering and interpreting the tests.
For several years, companies have been marketing genetic tests that claim to predict an individual's risk of developing diseases.
According to the American Society of Human Genetics (ASHG), these tests currently cover over 150 different conditions, and although doctors have offered tests for many of these diseases, companies are establishing themselves as direct to consumer providers, with some even selling tests that have not been adopted for routine medical practice.
The FDA panel meeting is addressing the following issues:
1. The risks and benefits of genetic tests being available direct to consumers without a prescription, including for instance testing for hereditary disease, development of disease, or how a person might respond to a particular drug.
2. The risk of consumers misunderstanding or receiving incorrect or misleading results from tests that might otherwise be beneficial.
3. The scientific evidence behind claims made in consumer marketing of genetic tests, and whether this should be different to that required for similar claims in prescription-use tests.
One of the panelists, Dr Joann Boughman, Executive Vice President of the ASHG, told the press:
"I would suggest that we are not ready yet to put this completely in the consumer's hands."
"Each test is complex, and when you have each provider doing slightly different tests, it complicates it even more," said Boughman, as reported in the Los Angeles Times.
One example that causes concern is that the consumer may take a test to find out if they are a carrier of cystic fibrosis, get a negative result, and not realize that the test did not cover all the genetic markers of the disease. Cystic fibrosis is a debilitating hereditary disease that affects the whole body and often results in early death.
Panelist Dr George Netto, Associate Professor of Pathology, Urology and Oncology at Johns Hopkins University School of Medicine, said it could be dangerous to receive false reassurance when you have no knowledge of other risk factors.
http://www.medicalnewstoday.com/articles/218601.php
