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Is the New Direct-to-Consumer Advertising Campaign for BRCA1 and BRCA2 Testing Really Ready for Prime Time?

Rosenthal, Eric T.

doi: 10.1097/01.COT.0000297236.07141.bc
Eric Rosenthal reports

Last month Myriad Genetics began the public relations phase of marketing a potential Pandora's Box in its effort to educate women about hereditary risks of breast and ovarian cancers with the launching of a self-proclaimed “groundbreaking” advertising awareness campaign in New York City; Boston; Hartford, CT; and Providence, RI.

After having given the New York Times and Wall Street Journal a co-exclusive heads up about the BRACAnalysis Awareness Campaign, the Salt Lake City-based company disseminated its press release to the rest of the news media with a cover e-mail noting that the campaign had already been covered by the Wall Street Journal.

It may be that Myriad failed to mention Andrew Pollack's New York Times piece that appeared the same day in that paper's business section under the heading “Advertising,” because that article was even more less-than-positive than Marilyn Chase's account in the Journal.

The “groundbreaking” campaign was also a repeat of a similar direct-to-consumer advertising campaign by Myriad targeted at women in Denver and Atlanta in September 2002 that sources told OT had stirred some controversy.

In fact both the Times and Journal accounts reported that the current campaign is undergoing the scrutiny of the Connecticut Attorney General's Office, which is investigating whether the claims for the test are being fairly and accurately represented.

The legal action stemmed from the concerns of health care professionals who questioned if mass marketing a complex screening test might cause unnecessary anxiety among women, perhaps leading to overuse of a test that can cost from $300 to more than $3,000, and requires professional pre- and post-counseling



The awareness campaign about hereditary risks of breast and ovarian cancer, and the availability of the blood test, first appeared in a television commercial that began airing in the four above-mentioned cities on September 10.

The commercial features several attractive, mostly younger, women saying “breast cancer runs in my family,” and that they will “Be Ready Against Cancer Now”—a slogan utilizing the initials BRAC.

Individually and in chorus, they say that they wondered if cancer would be inevitable, and found out it didn't have to be by learning their risk through BRACAnalysis, “a blood test that has helped thousands of women find out their risk for hereditary breast and ovarian cancer,” and which made them realize they could choose to do something now—to reduce their risk now with effective medical options.

The commercial conveys a sense of urgency with the continuous repetition and emphasis on “now.”

Viewers are advised to take steps now to reduce risk by discussing their family or personal history with their doctor, and to visit to “be ready to talk and to take action.”

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Primary Care Physicians

The doctors referred to in the ad are primarily primary care physicians, according to Myriad, which said it spent the past eight months educating many of them about the campaign.

In a telephone interview Gregory C. Critchfield, MD, President of Myriad Genetics Laboratory Inc., Myriad's gene-testing company, told OT that the tests for hereditary breast and ovarian cancers have been available for more than a decade, but since only about 3% of the women believed to have inherited BRCA1 or BRCA2 mutations are aware of it, the campaign was devised to increase public aware to save lives.

Although the American Cancer Society estimates that about 2.3 million women have a history of breast cancer, no more than 10% may have a hereditary risk factor predisposing them to develop the disease, and not all of those are a result of a BRCA1 or BRCA2 mutation.

“What we need to do as a medical establishment is find better ways to get information out and identify those individuals who carry mutations so they can take action and lower their risk for cancer in the future,” Dr. Critchfield said.

“This is the way of doing it, through certain channels in the medical system through which patients can access this information. Some involve genetic counselors, some involve other professional heath care professionals, but the important thing is in order to reach all of these individuals we have to have many more people involved in the routine identification and discussion of risk with patients so appropriate patients are identified, and that's what the campaign is about.”



He said the campaign would run for about six months in the Northeast, and that in addition to the 60-second TV commercials that would be shown during such programs as the “Oprah Winfrey Show,” “Dr. Phil,” and the “Today Show,” would also include radio, newspaper and other press materials, and an outer wraparound on October editions of People magazine available in physicians' offices.

Dr. Critchfield said that this region was selected because about 15% of the nation's population is covered in those markets, and because the area has a good concentration of health care professionals from oncology specialists, medical geneticists, genetics counselors, and primary care physicians who can identify women at risk and then give medical options to those individuals that could potentially save their lives.

“It's important to understand there are a lot of educational activities that are sponsored by a number of professional societies—for example, an American Medical Association monograph written with the input of 10 specialty societies, groups like ASCO, the American College of Obstetricians and Gynecologists (ACOG), the American College of Medical Genetics and others,” he said.

“This particular educational piece identifies red flags that a physician can use to identify individuals in his or her practice who are at risk for having mutations for BRCA1 or BRCA2. The criteria are simple red flags that allow physicians to know who is at high risk and who is not. Those individuals are the ones who need to talk to their physician and make sure the assessment is done and then they can make a decision about whether they would like to be tested.”

The AMA's 42-page Risk Assessment for Hereditary Cancer Syndromes: A Physician's Guide to Clinical Genetic Testing and Medical Management continuing medical education monograph for primary care physicians was supported through an independent educational grant from Myriad Genetic Laboratories. Seven of the 16 CME Advisory Board members have ties to Myriad, according to the publication's disclosure information.

To date, some 6,000 physicians in the Northeast have responded and requested information including the guide, he noted.

Dr. Critchfield said that Myriad did not seek and was not implying endorsement from any society or organization, but the company did work closely with ACOG in helping them build awareness for their members, and “we had conversations with individuals from a number of societies and cancer charities in advance of the campaign rolling out,” he said.

Among those organizations cited were the AMA, ACS, American College of Medical Genetics (ACMG), and ASCO, in addition to ACOG.

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Not Endorsed by ASCO

OT learned that an ASCO staff member had been contacted by Myriad during the summer about setting up a meeting, but nothing was scheduled.

ASCO President Nancy E. Davidson, MD, Professor and Breast Cancer Research Chair in Oncology and Director of the Breast Cancer Research Program at Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center, said during a phone interview that “ASCO did not endorse this campaign in any way, shape, or form.”

“As a general rule,” Dr. Davidson explained, “we are not excited about direct-to-consumer ad campaigns. We think the place for patients to get advice is from their doctors, or well-vetted sources and Web sites, such as the ACS, NCI, or ASCO's People Living with Cancer. Those are the sources I think people should be consulting. I do not believe that television or radio ads about these kinds of things are appropriate places to get medical advice.”

Dr. Critchfield said the ad campaign selectively motivates individuals who have breast or ovarian cancer running in their families.

“They are motivated to take the next step, which is to talk to their physician. The physician receives through professional societies, guidelines and ways of identifying individuals at risk for heredity breast or ovarian cancer, and those are the individuals who are submitted for testing.

“The insurance companies generally reimburse according to those guidelines so there's a great deal of selectivity in who can have access to the tests, and they usually reimburse more than 90% of the cost of the tests.

“Myriad's role is to provide the materials to the physicians to help them best assess the risk of patients.”

He said counseling is typically done by the health care professional who orders the test and then sits down and discusses the results with the patient, and the most important part of the whole process is the management plan based on what the physician and patient decide they want to do with the information.

“There are a number of options that are available to reduce the risk of cancer in the future for an individual who carries the mutations for BRCA1 or BRCA2, and the physician discusses the strategies with the patient and then decides on a management plan, which is a very important part of the assessment and the follow-up so the patient can realize the benefits from having that information.”

Medical options include increased surveillance, chemopreventive drugs, and prophylactic surgery.

Dr. Critchfield said that medical society guidelines help physicians both identify patients for testing and determine how they are managed after the information comes back.

“The societies have determined that their physicians can perform these kinds of services,” he said. “And in fact the great majority of tests ordered in the United States today are done by physicians who have come up to speed on these technologies and offer these services in their practices.

“As with any medical technology, a physician who has information and is well trained to use that information will often do it him or herself. If a situation were complex and they felt they wanted additional help, then they would refer to someone who is more specialized. This is the way that medicine has always been practiced, and in this area it is no different than any other area in that regard.”

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Simple but Complicated

Dr. Davidson said that “obviously I'm happy about anything that raises breast cancer awareness, but I'm unhappy about things that make women worry unnecessarily and fuel anxiety, and I'm obviously unhappy about things that are going to throw them into a health care system that may or may not be prepared for them.

“The testing for BRCA1 and BRCA2 is extremely simple on the surface. It's a single blood test, it's very straightforward. The complicated part of it is that individuals who are contemplating this testing first should be evaluated to see whether it even appears to be a worthwhile test. If it might be, then they need to be counseled about the pros and cons about what they will and won't learn from the test, and also the ambiguities that might emerge. And then after the tests, they may have to be re-counseled about what the test results are and what they mean for them.

“It's all the counseling and thought processes wrapped around it that is really the backbone, so I think primary care practitioners who are on the front lines are going to have to be well counseled about who is actually a candidate for this because only a minority of individuals who have breast cancer in their family actually are likely to be in these kind of families.”

She said figuring out who is appropriate for testing is really important because only a relatively small number of women will be positive, and “it's sorting out with women how this information will help them and what they'll do with it that takes a very long thought process.”

She also acknowledged that oncologists see patients who've had cancer and that it is their family members who are potentially at risk for carrying one of the mutated genes.

“So we have a strong in with family members of someone who has cancer, but what we don't see is the reverse—that is, someone who had a family history of cancer but may not have come in contact with the patient's oncologist, which is when we would need to rely on our fellow practitioners in primary care.

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‘Fear Will Raise Far More Unhappiness & Anxiety’

“I am very concerned about this as an ad campaign,” Dr. Davidson said. “It doesn't strike me as the sort of thing that is appropriate on the airwaves in a direct-to-consumer campaign, and I fear that we will raise far more unhappiness and anxiety than serve women who might be at risk for breast cancer.”

Dr. Critchfield said Myriad had extensively tested these consumer awareness ads on hundreds of patients and that the data show that patients who are motivated to take the next step and talk with their doctor are those with appropriate risk—“so the ads themselves have a selectivity in who they motivate to take the next step.

“The important part of this is the discussion with the health care professional and these tests can only be ordered by a physician, and because patients have to talk to their health care professional, who will assess their risks according to published guidelines by societies, and the reimbursement for the tests are reimbursed according to those guidelines, there is a lot of protection in the system,” Dr. Critchfield said.

“All of those things ensure that the right patients can gain access and have access to the information that is available from testing. The real problem right now is that there are not enough people talking to their doctors about hereditary cancer risks.”

Dr. Davidson added that it is important for consumers to remember that being tested for hereditary risk for breast and ovarian cancers is not emergency medicine, and they should not be rushed to seek testing and make medical decisions.

© 2007 Lippincott Williams & Wilkins, Inc.
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