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Genetic Testing, Public Policy and You

Posted Nov 19 2009 10:02pm

I was in DC at the NIH this week and spoke in front of the Secretary’s Advisory Counsel on Genetics, Health, and Society ( SACGHS ) about direct-to-consumer genetic testing and DNA Direct. My goal was to make three main points:

  1. There’s definitely a need for direct-to-consumer genetic testing.
  2. Direct-to-consumer genetic testing can be done responsibly.
  3. Currently, there’s a spectrum of companies that offer tests to consumers, and it’s important to distinguish the “good” and the “bad” so that consumers can make informed decisions.

The committee is a consortium of diverse experts in the field of genetics, from lab directors to researchers, physicians, ethicists, and advocacy organizations. This group formulates recommendations that Secretary Leavitt (Health and Human Services) will address with Congress. I was encouraged that some members of the advisory committee recognized that DNA Direct covers many of the issues raised in previous recommendations to the Secretary on direct-to-consumer genetic testing. They further expressed concern that efforts have not yet been made to distinguish direct-to-consumer companies.

Here’s my full presentation…

Good afternoon. To briefly introduce myself, my name is Elissa Levin. I am a board-certified genetic counselor and the clinical director of DNA Direct. DNA Direct is a web-based company that has been offering direct-to-consumer genetic testing and genetic counseling services since February 2005.

Having worked at two major academic medical centers, I recognized that the current model of delivering genetic services was not meeting the needs of all patients. As a representative of DNA Direct and as a genetics professional, I strongly believe that genetic testing services can be offered responsibly and reliably with a DTC approach. In no way will DTC services ever replace the traditional delivery models, but if DTC is offered responsibly by appropriately trained professionals, these services can be a valuable and viable complement to current model.

I would like to highlight a few critical reasons behind why some consumers choose to utilize DTC genetics services. To name a few:

• Limited access to genetics services by qualified professionals. This may be due to regional limitations, the overall paucity of trained genetics professionals, or current healthcare networks or referral patterns that make it difficult for people to obtain genetics services.

• Concerns about privacy, confidentiality, and genetic discrimination. Again no matter how legitimate the risk of discrimination is based on genetic test results, public fears exist and represent a major barrier to some who could significantly benefit from testing. Anecdotally, I can say that the majority of consumers who have tested using DNA Direct have done so for reasons other than privacy.

• Genetic interpretation and support services. We have had patients come to us because they received incorrect or incomplete information and no follow-up or referral support services through their physician. In addition, we have had physicians refer their patients to us. For example, when a physician does not feel comfortable ordering and interpreting for CF testing for patients.

• Cost of testing and services. Testing through a physician’s office or academic center may be more expensive than DTC channels. And there are many more examples that I will not go into today.

DTC companies need to be responsible for developing and maintaining standards of practice. By setting the bar for reliable and comprehensive services provided by qualified professionals, the industry will hopefully move in a direction that will ultimately benefits consumers.

In doing so it is critical that healthcare providers and policy makers acknowledge that a spectrum of DTC services has emerged. Consumers must be able to distinguish between these companies, and it would be a disservice to consumers if policy were to lump together all DTC genetics services. There are three key factors that distinguish the current market:

1) Selection of tests offered
2) Laboratories utilized
3) Level of services provided and who provides those services

First, all genetic testing is not equal. Under the rubric of “genetic tests” is a significant range from – nutrigenomics and fitness profiles – to paternity and ancestry to clinically validated tests under medical guidelines and a dozen or so that have been approved by the FDA. At DNA Direct we only offer clinical genetic tests that are routinely offered at most genetic centers. We evaluate each test option in light of its clinical validity and utility, and we utilize renowned experts in the medical and genetics fields as well as relevant guidelines to help us convey this to consumers.

Second, it is not up to the DTC industry to defend the validity of lab testing – that is an issue that needs to be resolved through CLIA, the FDA, and other relevant agencies. [CLIA = Clinical Laboratory Improvement Amendment] Critics have suggested that “FDA approval” would be a safeguard for consumers. But since the FDA is not currently regulating genetic tests, consumers should be made aware that reliable testing can still be obtained, often using the same lab that their primary physician would use. Until this issue is clarified, providers of any tests need to be more transparent about where lab tests are done – not just DTC. DNA Direct addresses this by partnering with large, reputable, CLIA-certified reference labs.

The third point relates to the level of services provided. Some DTC companies enable consumers to order a test online, providing no human contact or support by genetics professionals (often referred to as DAT). Pre-test education may be unavailable or incomplete. Informed consent may not be required. Post-test results may be disclosed without access to genetics professionals and without interpretation.

I can speak to the fact that DNA Direct has gone to great lengths to address these issues. We have developed a website that offers patient-oriented information. All of the materials on our site have been developed to reflect the same core information conveyed in genetic counseling sessions – including the limitations of testing. We all know that people learn differently. The web enables people to seek information in ways that make sense to them, and in a timeframe that suits them. The web is dynamic, and enables us to easily adapt to consumer feedback, updated standards and guidelines, and add new interactive tools to help people work through the decision-making process.

Further, all test orders are reviewed and authorized by a board-certified medical geneticist. Signed informed consent is required. Test results are conveyed via personalized reports, with results interpretation based on the individual’s personal and family history. All interpretation is reviewed by both genetic counselors and a medical geneticist. Our disclosure protocols are test-specific. For some tests, reports are only released once results have been disclosed by a board-certified genetic counselor in a post-test phone discussion. Genetic counselors are available to patients at any point before, during and after testing. All of our clinical interactions are HIPAA-compliant.

One last point I would like to raise is that as a genetic counselor, I feel that it is my professional duty to provide consumers with accurate information. I receive no economic incentives to direct people to test, though I acknowledge that providing services is our business. However, DTC is certainly not the only example of conflict of interest in the workplace, but other scenarios have proven that genetic counselors can maintain their professional standards even if their salary is paid by the company offering testing. Why is DTC any different? It is the responsibility of DTC companies to hire and maintain staff who are competent, qualified, and who are morally and ethically dedicated to the patient’s best interest.

When testing is offered responsibly in these ways, consumers can benefit. Indeed, we are finding that people are appropriately selecting whether or not to test. We know this because currently 38 percent of patients who have tested with us have had a positive test result. This trend is consistent. This number is significantly higher than is seen in academic centers, and is significantly higher than would be expected in the general population.

In summary, whether or not genetic testing is offered DTC or through other avenues has become irrelevant. Currently genetic testing can be obtained not only through academic medical centers, physicians’ offices, and internet-based DTC companies, but also through wellness centers, spas, and drive-through clinics. Our society is moving towards more virtual services. Almost 32 million adults in the U.S. go to the web first for healthcare information. The media continues to bring genetic testing into the spotlight. Isn’t it critical that consumers be able to distinguish valid testing services?

The DTC industry, healthcare providers and policy makers should be collaborating to “set the bar.” We should be asking questions like, does the current model of regional medical services meet the public’s needs? Is it effective? Can the traditional system keep up with the advent of new clinical tests? Is it morally and ethically responsible to withhold newly validated testing that may reduce morbidity and mortality due to issues of dissemination and access? In these areas DTC testing is a viable alternative.

We do have common goals, and we need to work together to ensure that testing is provided safely and effectively to consumers.

Technorati Tags: genetic testing, direct to consumer, DTC, CLIA, clinical laboratory improvement amendments, healthcare policy, healthcare legislation

This entry was posted on Thursday, June 29th, 2006 at 2:15 pm and is filed under Privacy, Legislation & Policy. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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