Tuesday, December 17, 2013

Should Genetic Testing Services be Regulated?

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Today, we feature a post from ePharma Summit Media Partner PharmaVoice.


If you have a gene that predisposes you for a specific disease, would you like to know? If yes, do you want those types of services regulated by the FDA, or left to innovative companies to develop unhampered? It’s a very personal question, and currently under much scrutiny.

The FDA recently clamped down on 23andMe, a genetic testing service, because of a lack of access to the company’s data. The FDA’s concern is that the testing may not be accurate, and/or may influence people to undertake unnecessary medical procedures knowing they may be at risk for specific medical conditions. If a consumer finds out she has a gene that predisposes her for breast cancer, she may demand a surgical procedure as a preventive measure. Other patients may demand specific medications as a prophylactic against potential health risks.

It’s no surprise that doctors, in general, do not favor the consumer-based mail order genetic testing approach to health care. Physicians are used to patients coming into a consultation with reams of information from the patient’s web research. A visit to WebMD may cause a patient to believe they have the symptoms of a serious disease, however anecdotal the diagnosis may be. Genetic testing services adds a whole new mountain of personal information that patients can lose sleep over. Test results from services such as 23andMe provide specific information about the patient’s genetic predispositions. The data becomes personal. However, being predisposed for something does not mean that condition will arise in one’s lifetime.

Conclusion
Is it good for patients to know their genetic makeup and their possible health risks, or does it cause more problems than it solves? Does it create an open dialog between patients and HCPs, or does it clog up the system with unnecessary office visits and phone calls? Should the FDA regulate genetic testing services such as 23andMe, or call it an educational tool consumers can use or ignore at their discretion?

Genetic testing services could be a boon to Pharma, because the more health information available to patients, the more likely they are to schedule visits with their doctor and address their health concerns.

What’s your opinion? Tweet your thoughts using hashtag #DNAdiscussion.

References:
http://www.economist.com/news/business/21590941-regulator-brings-genetics-company-halt-and-fda
http://www.bloomberg.com/news/2013-12-11/personal-gene-tests-face-stricter-oversight-after-23andme.html
http://www.forbes.com/sites/quora/2013/12/11/what-do-doctors-think-about-23andme/
https://www.23andme.com/ancestry-only-notice/


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