This month Myriad Genetics began marketing BRACAnalysis, its proprietary test for breast cancer genes BRCA1 and BRCA2, directly to consumers (DTC) in several Northeastern states. The campaign stirred controversy even before its launch; some health care providers believe it will lead to inappropriate testing or worse.

Certain mutations in BRCA1 and BRCA2 make carriers more susceptible to breast and ovarian cancer. For women with a family history of these diseases, BRACAnalysis (short for “be ready against cancer”) can reveal whether they’ve inherited such a mutation. If so they can consider preventative actions, such as taking cancer-prevention drugs or having their breasts or ovaries removed.

BRACAnalysis has been available since 1997, but with the exception of a pilot campaign five years ago, it has not been advertised directly to consumers until now. (Although advertised to consumers, the test remains available only through health care professionals.) The new campaign, currently confined to New York, Connecticut, Rhode Island, and Massachusetts, consists of television, print, and radio ads. One television ad advises, “If breast or ovarian cancer runs in your family, BRACAnalysis can help you see the big picture, so you can take steps to reduce your risk. Talk to your doctor, or call 1-866-BRAC-NOW.”

“The BRACAnalysis public awareness campaign is designed to save lives,” says Myriad President Greg Critchfield. Only three percent of people with genetic mutations that increase their risk of breast and ovarian cancer know it, he says, “so the idea is to give these individuals a means to talk to their doctors so that their doctors can focus appropriate medical interventions on those individuals that carry those mutations.”

But Molly Brewer, associate professor of gynecologic oncology at the Carole and Ray Neag Comprehensive Cancer Center in Farmington, Connecticut, believes many doctors are ill-equipped to guide their patients through the decisions surrounding testing. “What I see is most physicians just don’t have a basic understanding of the issues involved: the pros and cons, and what do you do with a positive test, or what do you do with a negative test,” she says. “I spend a lot of time with patients, explaining about genetic testing, about the pros and cons, about assessing their risk, but even I don’t test them. I still send them to the genetic counselors for evaluation because a genetic counselor can really help them interpret the test, and also make sure that they get to the right place for follow-up.”

Luba Djurdjinovic, director of the Ferre Institute – a community- based genetic service that provides professional education to medical providers, genetic counselors, and other human services personnel – also is troubled by what she sees as Myriad’s push to have doctors order BRACAnalysis directly. “Physicians may not appreciate that there are many genes involved in breast cancer,” she says. If not, she says, a negative result can bestow a false sense of security: “A negative result can be a very dangerous result, because we could have picked the wrong gene to test, or may need to test other family members to confirm it. A negative result often means you need to keep looking.”

Critchfield concedes that “there are some patients that would be more appropriate to go see genetic counselors – these would, of course, be individuals that have a more complicated family history.” But, he says, “Our experience shows that there are a large number of physicians that are able to capably order the test, and to talk to patients about the results of the test.” Furthermore, Critchfield says, “There are maybe 400-500 practicing genetic counselors who talk to patients about cancer risk. If there are more than a million people carrying hereditary mutations for cancer, how in the world can 400 people take care of the counseling that’s necessary in identifying patients and making sure they receive the services that they need?”

In fact, notes Center Deputy Director Joan Scott, “while it’s true that a relatively small number of genetic counselors specialize in cancer, any of the approximately 2000 genetic counselors in the United States would be able to counsel patients about BRCA testing.”

Critchfield also notes that the direct-to-consumer BRACAnalysis campaign is the second of two phases; the first, targeting physicians, began in January. “We’ve worked extensively with professional organizations, such as ACOG [the American College of Obstetricians and Gynecologists] and the American Medical Association, and we’ve been working with local health care providers, giving them educational tools to prepare them in advance of the campaign,” he says. Health care providers in the four targeted Northeastern states received direct-mail fliers alerting them to the upcoming ad campaign and listing “red flags” for hereditary breast and ovarian cancer risk among other basic information, and Myriad has also placed ads in medical journals. A Web address and 1-800 number “for more information” are included, as well as a reply postcard physicians can use to request a specimen collection and transportation kit, fliers for patients, and exam room posters.

To critics of the campaign, those activities are part of the problem. The Responsible Genetic Testing group, which includes Brewer, Djurdjinovic, and several other health care professionals in the Northeast, cites this headline from one medical journal ad: “Because 1 out of 10 patients in your practice may be at risk for hereditary breast or ovarian cancer…”

Maureen Killackey, a gynecological oncologist at Memorial Sloan Kettering Cancer Center, explains that “one out of 10 is just not true. We know the chance of having a genetic mutation in the general population is probably about one in 400, and then if you look at some populations, like Ashkenazi Jewish women, it’s one out of 40.”

However, Critchfield says the flier was not intended to imply that one in 10 patients in a typical ob/gyn practice will have a BRCA1 or BRCA2 mutation. “This is saying that as many as one in 10 would have a family or personal history that needs to be investigated, and it would be appropriate to have a conversation with those individuals about their personal and family history risk,” he says, citing a 2003 study as support. “Of those individuals, the doctor and patient can decide together whether they will do the testing or not.”

To Killackey, this explanation doesn’t ring true. “That’s a very high number… I would have a very hard time saying that one in 10 of my patients had a family history suggestive of that,” she says.

Connecticut’s attorney general is investigating the accuracy of the campaign’s claims, and recently issued a subpoena for information from Myriad.

The Responsible Genetic Testing group also takes issue with the tone of the campaign materials, whether directed at consumers or providers. The consumer campaign “exaggerates and oversimplifies the benefits (e.g. ‘be ready against cancer risk’, ‘reduce my cancer risk now’) and does not mention any of the possible risks (e.g. uncertain test results, result misinterpretation, emotional/psychosocial concerns, discrimination, etc.) of the test,” the group states. “I think the bottom line is that it really only focuses on the potential benefits – it makes it sound like anyone with a family history of breast or ovarian cancer is a candidate, but that’s not the case,” says Ellen Matloff, a Responsible Genetic Testing group member who directs cancer genetic counseling at the Yale Cancer Center.

Critchfield says, “It is in the counseling session with the health care professional that detailed questions about risks and benefits are weighed by the patient and the doctor. That is not what an ad does; the ad merely stimulates people to have that conversation if they have the appropriate family history.”

Myriad piloted a similar ad campaign in Denver and Atlanta for five months beginning in 2002. A team of researchers studied the effects of the campaign on demand for genetic services and tests in the Kaiser Permanente Colorado managed care organization (KPCO), whose guidelines direct physicians to refer all patients to genetic counselors before genetic testing. The researchers found that “the number of referred women at KPCO with a high pretest probability for a BRCA1/2 mutation increased during the [DTC advertising campaign],” but that the proportion of genetic counseling referrals with a high probability of mutation declined from 69 percent to 48 percent, indicating that women with low pretest probability of a BRCA1/2 mutation were also seeking counseling. However, they found “no increase of testing among women with a low mutation probability during the [DTC advertising campaign].” It is unclear whether this pattern holds for physicians operating outside of managed care organizations.

A Centers for Disease Control study on the same campaign found that “consumer and provider awareness of BRCA1/2 testing increased in the pilot cities and that providers in these cities perceived an impact on their practice (e.g., more questions asked about testing, more BRCA1/2 tests requested, and more tests ordered). However, in all four cities [pilot and comparison], providers often lacked knowledge to advise patients about inherited [breast or ovarian cancer] and testing.” Despite physicians’ low knowledge level (just over half knew that a BRCA1/2 mutation can be inherited from either parent; just under half knew that a woman whose sister has a mutation has a 50 percent chance of carrying it herself), the study found that “Providers in the pilot cities also reported ordering more tests but not more referrals to genetics or oncology centers.”

“The knowledge about these kinds of tests is increasing, and when a new technology is introduced, it takes time for that to happen,” Critchfield argues. “Today we are far more advanced in our knowledge of how to use this information clinically.” He says insurers’ guidelines provide an additional safeguard against unnecessary testing: “insurance coverage [for the test] is not available to people that lack sufficient family risk or personal risk for hereditary breast or ovarian cancer.”

Rebecca Fisher, a medical librarian, patient advocate, and breast cancer survivor, writes that she felt relief and gratitude on seeing the television ad for BRACAnalysis. “I felt relief that someone is actually, finally talking about this problem, bringing it into the forum of common discourse (which happens to be, for us, television),” she explains. “And I felt gratitude that other women may be spared what I (and many others) have gone through – all because they saw an ad on TV.”

Critics of the campaign readily concede that its potential benefits include raising awareness of hereditary breast and ovarian cancer, and of genetic testing. But they suspect that Myriad is taking advantage of patient fears and lack of provider knowledge to sell more tests. “I think that if this is handled in the right way, that it actually has a chance of improving patients’ access to care. I’m not anti-Myriad at all, I’m just very concerned about the format they’re doing it in,” Brewer says of the ad campaign.

Djurdjinovic worries that, without regulatory action, the Myriad campaign may be a sign of things to come. “I can’t believe that as we move toward the $1000 genome, what we get is endless DTC advertising,” she says. “We should begin to think about oversight.” – Shawna Williams

Myriad’s press release about the new advertising campaign

Study on the impact of BRACAnalysis ad campaign at Kaiser Permanente Colorado

Centers for Disease Control study on the impact of BRACAnalysis ad campaign in Denver and Atlanta

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