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DTC Ad Bans, Limited Genetic Knowledge Spur Industry to Ramp Up MD Marketing

As consumers become familiar with the idea of personalized medicine, diagnostics firms are ramping up efforts to market their tests to doctors, recognizing that physicians stand to be powerful mediators between the genetic testing industry and consumers.
Recently, the American Medical Association, the largest physicians' group in the US, stated its opposition to selling and marketing genetic tests directly to consumers. The AMA now recommends that all genetic tests be performed “under the care of a qualified healthcare professional.” [see PGx Reporter 08-20-2008].
While the AMA’s stance would turn industry's marketing focus toward physicians, most doctors' practices are not equipped with the knowledge or personnel to handle an influx of patients requesting genetic testing. Doctors expressed such reservations when Myriad Genetics kicked off its national DTC advertising campaign for the BRACAnalysis Test [see PGx Reporter 09-12-2007]. 
Still, it seems that genetic testing companies like Decode Genetics, Genomic Health, and Laboratory Corporation of America are combining direct-to-physician marketing with DTC promotions to help get their message across.
And although genetic testing companies don't have the marketing budgets of their pharma counterparts, they appear to be employing many of the strategies drug companies use to convince doctors to prescribe their products, including employing sales reps to target physicians with particular specialties; advertising and publishing in medical journals; and hiring medical pitchmen to speak at conferences.
Even though the pharma industry has received a lot of criticism for its cozy relationships with doctors, direct-to-physician marketing has long remained the bread and butter of drug companies' promotional efforts. According to the US government’s General Accounting Office, although direct-to-consumer advertising for prescription drugs increased at a faster rate than physician marketing and research and development spending between 1997 and 2005, drug companies spent 70 percent more on office- and hospital-based promotion and journal advertising in an effort to convince doctors to prescribe their medicines. These figures do not include pharma industry's promotional activities at scientific meetings and events.
According to Steven Murphy, founder of Helix Health, perhaps the first privately held personalized medicine practice in the US, marketing programs targeting physicians, like DTC promotions, represent “a mixed bag of outcomes” since such strategies can both educate and unduly influence consumer demands or prescribing behavior (see related story, in this issue).
“There is a body of literature showing that detailing by [big] pharma to docs inevitably results in sales of their drugs. The same is very likely to be true of 'big testing,' but even with that there is some benefit to patients who otherwise might have been missed,” Murphy told PGx Reporter. “A physician is in a better place to critically think and assess big testing's claims, unlike the lay public. Geneticist physicians are in the best place to do that.”
What's Up, Doc?
Industry observers, including academics, policy groups, and health regulators in California and New York, have expressed concern over the recent increase in direct-to-consumer marketing in the genetic testing industry in the wake of high-profile launches of personal genomics firms such as 23andMe, Decode Genetics' DecodeMe service, and Navigenics [see PGx Reporter 06-25-2008]. However, many of these personal genomics companies, and also several diagnostic firms, have also announced they are ramping up their marketing efforts to doctors.
For instance, in addition to its DTC campaign for the BRACAnalysis Tests, Myriad Genetics understands that its product will succeed only if physicians prescribe it. And so, docs remain a central marketing focus for the company.
Today, Myriad employs 250 sales representatives that reach out to doctors, and its use of seminars and publications in scientific journals “precedes” its consumer advertising, Myriad spokesperson William Hockett told Pharmacogenomics Reporter last week.
In July, Decode Genetics CEO Kari Stefánsson told investors that in addition to DTC advertising, the company would employ a number of marketing strategies, focused in a large part on physicians. In the third and fourth quarters of this year, the company plans to “expand [its] reach to physicians” through a larger sales force, participation at medical conferences, publications in medical journals, and by hiring medical opinion leaders to speak about its products [see PGx Reporter 07-09-2008]. Decode officials could not speak to Pharmacogenomics Reporter prior to deadline.

“I have not been offered a sports car ... I don't think 'Big Testing's' budget for this sort of marketing has even been created yet.”

According to a LabCorp spokesperson, tests and services sold to physicians comprise approximately 80 percent of the company's sales. LabCorp employs around 1,000 sales reps who target doctors nationwide. The company's recent marketing efforts have targeted oncologists, OB-Gyns, and women's health-and-wellness physicians to promote the ovarian cancer diagnostic OvaSure, the colorectal cancer test ColoSure, and its HPV tests, the spokesperson said. LabCorp reps also promote the firm’s Dianon and USLabs pathology services to doctors.
Another company, Genomic Health, launched a web-based direct-to-consumer education effort in January, but its strategy to drive adoption of its flagship Oncotype DX breast cancer recurrence test has focused on marketing to doctors nationwide through a combination of sales rep visits, peer-review publications, and having the test included in treatment guidelines.
Genomic Health declined to discuss its physician marketing strategies with PGx Reporter, though company officials have consistently attributed the growing sales of Oncotype DX to continued adoption of the test by physicians and insurers.
Most recently, in the quarter ended June 30, the firm delivered more than 9,690 test results compared to more than 5,750 during the same period one year earlier. Since the company launched Oncotype DX in 2004, more than 65,000 Oncotype DX test results have been delivered to patients.
Even 23andMe, which was recently warned by New York and California health regulators for not being licensed in the state to operate a laboratory and for not going through a doctor to order tests for its service, has said it has developed a physician's advisory board. Members include Geoffrey Ginsburg from Duke University and James Lupski from Baylor College and are responsible for advising the company on the best way to work with doctors in its service.
“We think it's very important for physicians to be involved in educating the public about the role of genetics in healthcare,” a 23andMe spokesperson told Pharmacogenomics Reporter.  “Unfortunately, genetics hasn't been stressed very much in medical school, and physicians themselves may not have the resources to keep up with the constant flow of new information coming out of the genetic research world.”
Undue Influence?
Given the controversy surrounding DTC advertising for genetic tests, it's no surprise that genetic testing firms are increasingly focusing their marketing efforts to doctors. However, in doing so, they could face criticism for exerting what some would call undue influence on doctors — a criticism the pharmaceutical industry has had to endure for its own direct-to-physician efforts.
It is no secret that health information companies collect and sell physicians' prescribing profiles to pharmaceutical companies, which in turn enables them to target their marketing efforts. Even though the AMA has said it opposes DTC genetic testing, the organization has historically allowed health information companies to use its membership databases for marketing purposes. Like pharma companies, genetic testing firms can also access such databases for their marketing purposes.
Although in 2006 the AMA initiated the Physician Data Restriction Program, through which doctors can deny pharma reps access to their prescribing data, the initiative is voluntary. According to an article published in the Annals of Internal Medicine last year on physician marketing, Jeremy Greene of Brigham and Women's Hospital wrote that the AMA's “PDRP will continue to allow the sale of prescriber data for marketing purposes.
“It is possible that prescription data sets would no longer be useful to pharmaceutical sales representatives if a substantial proportion of physicians were to choose to opt out,” Greene wrote. However, based on the AMA's statistics, “only 7,000 of roughly 650,000 actively prescribing physicians have enrolled in the PDRP to date [and] only 25 percent of surveyed physicians are even aware that the program exists,” Green reports.
However, Helix Health's Murphy feels that since most doctors lack genetic expertise, relationships with the genetic-testing industry will be critical to advancing personalized medicine.
“This stance by the AMA to be against DTC testing and advertising is likely to direct most efforts towards physicians,” Murphy said. “Although, I must admit, in genetics any sort of education is a step in the right direction, whether being delivered by a Myriad representative or by Helix Health.”
Murphy noted that Helix Health employees meet with genetic-testing sales representatives to coordinate insurance coverage for testing, to engage in educational campaigns to community specialists, and to provide feedback about the company's services.
Many genetic-testing firms Helix Health works with issue “useful” patient handouts, according to Murphy. However, Helix Health takes the company's information, edits it, and creates its own handouts, Murphy added.
He revealed that sales reps for several undisclosed genetic testing companies have offered Helix Health employees lunch, but that's about as far as it has gone. “I have not been offered a sports car. ... I don't think 'big testing's' budget for this sort of marketing has even been created yet,” Murphy said. “Time will tell as their budget gets bigger.” 
A LabCorp spokesperson similarly told Pharmacogenomics Reporter that its marketing budget does not include cash for courting physicians, pharma-style. Rather, LabCorp's marketing efforts to doctors consists of “just our sales people talking to doctors and office managers. We do not sponsor dinners and trips and such,” the spokesperson said. “We, at times, send our own physicians and scientists to speak at symposia, and of course, we do attend various conferences around the country to hear what thought leaders are saying.” LabCorp also sets up informational booths at medical conferences, according to the spokesperson.
Murphy highlighted education as the most important value a physician can glean from close ties with genetic testing companies. “A physician cannot access this expertise if they do not know it exists.”
In a survey of 243 physicians identified as potential referrers to a local cancer genetics program, researchers found that the largest barriers to referral were lack of program awareness, confusion about patient eligibility, and limited knowledge about insurance coverage and anti-discrimination legislation.
“Physician-targeted marketing, education highlighting patient selection and insurance issues, and brochures in exam rooms may improve physician comfort and referrals,” concluded the authors of the study, published in the Journal of Clinical Oncology.
“Overall, I am happy that ‘big testing’ will be working with physicians,” Murphy said. “I see this relationship more like a pharmacist and physician when prescribing drugs. Working together is bound to have beneficial effects as well. I have seen it already.”

California Health Regulators Say MDs’ Role Sufficient to License 23andMe, Navigenics
The California Department of Public Health last month granted Navigenics and 23andMe licenses to operate their DTC genetic-testing services in the state.
The licenses, granted on Aug. 7 to Navigenics and Aug. 15 to 23andMe, suggests that the CDPH has made a decision about the extent to which physicians must become involved under state law to guide consumers about genetic testing.
CDPH's investigation found that Navigenics and 23andMe “provide a physician and genetic counselors to provide counseling pre- and post-testing to meet the requirements of state law for a physician ordering a test on behalf of his/her patient and providing counseling of the test interpretation,” a CDPH spokesperson told Pharmacogenomics Reporter.
Gail Javitt, director of law and policy at Johns Hopkins University's Genetic and Public Policy Center, had previously said that diagnostic companies that deploy in-house physicians to help individuals make genetic-testing decisions are manipulating unclear state laws [see PGx Reporter 08-20-2008].
“The issue turns on the meaning of 'authorized provider,' (or similar terms), found in state laws,” Javitt said in an e-mail to Pharmacogenomics Reporter recently. “It is unlikely that a company-employed physician is what states had in mind when they enacted laws to prevent direct ordering of laboratory tests, but the laws as currently drafted may be sufficiently broad to encompass this situation.”
According to CDPH these laboratories are state licensed under a genetics specialty, which was added to state law in 1996. 
“Genetics is defined broadly to cover testing and interpretations of genetic tests,” the CDPH spokesperson said. “State law defines a clinical lab test to include the interpretation of genetic scans. If the genetic tests are done at one location and the interpretation at another, then both must be licensed and must validate their reports.”
LabCorp, which is licensed in California, performs the genotyping for 23andMe. For Navigenics, Affymetrix provides the genotyping services.

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