By Turna Ray
Citing reports that test developer Myriad Genetics discourages patients from seeking guidance from genetic counselors, a patient advocacy group urged the HHS Secretary's Advisory Committee on Genetics, Health, and Society last week to recommend that federal agencies monitor the unethical marketing practices of diagnostics companies and encourage patients to seek genetic counseling prior to getting tested.
"We urge the Secretary's committee to recommend federal action to monitor, regulate, and track adverse events resulting from marketing from laboratories to consumers and healthcare professionals," Lisa Schlager, outreach coordinator at Facing Our Risk of Cancer Empowered, said at a meeting in Washington, DC, last week. Schlager also urged SACGHS to recommend that doctors be required to inform patients of genetic counseling options prior to ordering genetic tests.
Schlager made these recommendations based on reports that Myriad Genetics, a company marketing gene mutation testing for hereditary breast and ovarian cancer, was urging physicians to do genetic counseling in house, instead of referring patients to outside genetic counselors [see PGx Reporter 09-23-2009].
Myriad markets BRACAnalysis, a genetic test that detects BRCA mutations, which infer in those who have the gene variations a heightened risk of hereditary breast and ovarian cancer.
"Based on what we have witnessed it is our opinion and belief that Myriad's sales representatives discourage doctors and other healthcare providers from referring patients to genetics experts," Schlager said.
SACGHS committee members responded to Schlager's presentation with concern and said they will invite Myriad to come before the committee to respond to these charges.
An official from the US Food and Drug Administration who sits on SACGHS informed Schlager that FORCE members can report such marketing practices from any company to the agency.
"Even though we're not regulating Myriad at the moment, anyone who has suffered an adverse event may report it to the FDA, may complain about such a laboratory -- I'm not picking on Myriad here -- or any other laboratory marketing a genetic test," said Liz Mansfield, FDA senior genomics advisor and SACGHS ex-officio member. "We have the possibility of taking action."
FORCE Executive Director Sue Friedman told Pharmacogenomics Reporter this week that while the organization is trying to educate and support its members, there needs to be some formal system of reporting adverse events experienced as a result of misinformation from diagnostic firms or laboratories.
Unlike the FDA's Adverse Event Reporting System for monitoring the post-market safety of drugs, there is no such centralized system for diagnostic tests since oversight is split between the FDA and the Centers for Medicare & Medicaid Services. The SACGHS has previously recommended the FDA and CMS work with other federal agencies to create a web-based repository for diagnostic tests. Whether such a system would allow for the reporting and tracking of adverse events is not yet known [see PGx Reporter 02-20-2008].
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The FDA launched last year the Sentinel Initiative, under which the agency plans to implement a proactive, electronic system for tracking adverse events associated with drugs, biologics, and medical devices the agency has approved for marketing. However, since Myriad's BRACAnalysis is a laboratory-developed under CMS' regulatory purview, adverse events associated with this test would not fall under the Sentinel Initiative.
At the meeting Schlager recounted the story of a FORCE member who, based on faulty BRACAnalysis test results and without genetic counseling, had her ovaries removed. "In this instance and undoubtedly in many others, circumventing genetic counseling before testing created additional revenue for the lab, and led to unnecessary cost for the individual and her insurance company," Schlager said.
Furthermore, upon reviewing Myriad's educational materials to doctors, FORCE has determined them to be "misleading," as they focus only on the hereditary syndromes addressed by the company's BRACAnalysis test.
This means that patients who might meet criteria for other hereditary syndromes for which Myriad does not test "are not always receiving comprehensive or accurate information because their health care providers are not genetics experts and are unaware of these other syndromes," Schlager said.
"By encouraging health care providers with limited genetics expertise to provide `in-house counseling' and order testing, it is our opinion that Myriad is establishing a minimum competency for providing genetic information to patients, which falls below published national expert guidelines," she added.
Furthermore, Schlager asserted that Myriad has doctors and patient advocates to "speak out in favor of genetic testing" in various forums. "Unchecked and unregulated, Myriad has unrestricted access to providing consumers both directly and through their healthcare providers with unbalanced, biased information about genetic testing for hereditary cancers," Schlager said.
This is the second time FORCE has brought Myriad's marketing practices to the attention of SACGHS. Last year, Friedman told the committee that a growing number of its members were reporting instances of receiving either too little or the wrong information about their genetic risk for developing cancer from companies marketing the tests [see PGx Reporter 01-07-2009].
"Your experience is not an isolated one," James Evans, director of clinical cancer genetics at the University of North Carolina - Chapel Hill and a SACGHS member, said in response to Schlager's presentation. "We've seen very similar things in our practice."
SACGHS members felt that FORCE should inform its members who have not received genetic counseling and have experienced an adverse event following a genetic test to report it to the FDA. Furthermore, the committee invited Myriad to come before the committee to give its side of the story.
"This is a rather serious discussion," Paul Billings, chief scientific officer at GeneSage and a SACGHS member, said during the meeting. "We are obligated to have Myriad or at least invite Myriad to respond, since these kinds of allegations and representation [are] rather significant. I think we should make them aware of it."
To this, SACGHS Chair and Los Angeles County Department of Health Chief Scientific Officer Steven Teutsch agreed.
When asked about its marketing practices for this article and other articles of the same topic in the past, Myriad has not responded. In attempting to procure the questionnaire the company distributes to doctor's offices to help them determine which patients are right for testing, one doctor said he was instructed by Myriad to not provide the questionnaire for the article.
FORCE has taken its concerns to Myriad in the past, and according to Schlager's presentation, the company's VP of marketing "dismissed them as the work of a few `rogue' sales agents."
At a recent investor conference hosted by UBS, Myriad CEO Peter Meldrum defended its strategy to urge doctors to genetically counsel patients in-house by noting that there is a shortage of genetic counselors in certain areas. Also, Meldrum said that in the oncology setting, doctors and nurses will know the nature of disease more than a genetic counselor, and therefore, will be able to advise the patient better.
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Myriad has made no secret of its extensive marketing strategy for BRACAnalysis, which includes outreach to doctors by its 300-member sales team, television ads in several regions, and physicians who speak at medical conferences.
During an earnings call announcing 2008 financial results, Myriad officials outlined plans to stave off the impact of the recession on the company's business by bolstering sales force visits to OB/GYNs (the hardest hit segment of its BRACAnalysis sales), ramping up its DTC campaigns in the Midwest and the South, and expanding physician-to-physician outreach efforts to spread the word about its products [see PGx Reporter 08-26-2009].
However, at least one large insurer isn't convinced Myriad's hard selling is such a cost-effective strategy.
Lee Newcomer, senior vice president of oncology at United Healthcare, recently cited data suggesting that without precertification and mandatory genetic counseling procedures many patients that should not be tested on BRACAnalysis would be unnecessarily tested. Myriad's BRCA test costs upwards $3000 [see PGx Reporter 08-12-2009].
United Healthcare recently issued a prior notification requirement for Myriad, which means the company must inform the insurer prior to testing enrollees on BRACAnalysis. The insurer simultaneously began covering genetic counseling services for enrollees requesting BRCA testing [see PGx Reporter 08-26-2009].