U.S. Senator Ken Salazar

Member: Agriculture, Energy, Veterans' Affairs, Ethics and Aging Committees

 

2300 15th Street, Suite 450 Denver, CO 80202 | 702 Hart Senate Building, Washington, D.C. 20510

 

 

For Immediate Release

July 27, 2006

CONTACT:    Cody Wertz – Comm. Director

                        303-455-7600

Andrew Nannis  – Press Secretary

                        202-224-5852


  Statement of Senator Ken Salazar
Special Committee on Aging Hearing
"Direct-to-Consumer (DTC) Genetic Testing"
Thursday, July 27, 2006

“Thank you Chairman Smith and Ranking Member Kohl for holding today’s hearing.

“Throughout its history, the Aging Committee has led the way in calling attention to important public policy issues impacting older Americans and has not been afraid to take on industries that prey on vulnerable seniors.

“As Colorado’s Attorney General, I spent considerable amount of time and energy protecting the elderly in my state from fraud and abuse. I consider the creation of the Medicaid Fraud Unit one of my proudest accomplishments.

“I welcome the witnesses testifying here today. It is my hope that they can shed light on an industry that I have only recently learned existed: the Direct-to-Consumer Genetic Testing Industry. In particular, I thank Ms. Rosalynn Gill-Garrison, who is here representing Sciona Inc., headquartered in Boulder, Colorado.

“Sciona has been very cooperative throughout Aging Committee’s investigation on the practices of companies currently engaged in Direct-to-Consumer Genetic Testing. I appreciate their cooperation.

“While advances in the field of genetic science continue to open doors in the field of healthcare and improving the quality of life for many people, many questions about on this emerging science remain open for discussion and debate.

“I know I have many questions.

“For example, how are these companies marketing their products and services? What are the effects of their products on Americans who receive their “genetic health forecasts”? And finally, how reliable is the science these companies employ?

“There are certainly ground-breaking possibilities that genetic testing and diagnosis could bring to the field of healthcare, but I believe the impact on those using these products must always be of paramount concern.

“Today, someone sitting at home on their couch can go to the drug store or log onto the internet and purchase a mail-in genetic test that purports to tell them whether they are genetically prone to any number of medical conditions, including heart disease, breast cancer, and Alzheimer’s.

“When that person receives the results from these tests in the mail, without the counseling and interpretation of a specialized medical professional, the results of these genetic tests can be confusing, alarming, and easily misinterpreted.

I am very interested in learning more about the GAO’s recent investigation on these genetic and am pleased to see that GAO representatives are on hand to answer questions about their study.

“At first glance, I find GAO’s conclusions very troubling. GAO claims that tests sold by the companies here today frequently mislead individuals by making claims that they are unable to substantiate.

“By submitting volunteer samples to genetic testing companies, they established a disturbing scheme. After being informed that they are susceptible to a number of serious and possibly chronic diseases, companies market and sell costly supplements, medical supplies, and further tests, which are either unnecessary or based on questionable science, to vulnerable Americans.

“We have provided the companies named in this study an opportunity to defend their company practices. I fully anticipate they will detail the practices they are taking to ensure that their services and the representations they make to their customers are honest and accurate.

“If America’s seniors are indeed being sold a bag of goods, I believe it is the responsibility of our government to regulate this industry and to protect consumers.

“I look forward to hearing the testimony of today’s experts from CMS and the FDA to explain what regulations and oversight are these Direct-to-Consumer genetic testing firms currently fall under. In particular, I am interested learning whether CMS and FDA believe they have the authority to regulate these firms under current law. If the answer is no, it may be the case that the members of this Committee need to work together to rectify this.

“Again, I thank the Committee for holding today’s hearing.”

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