Pre- and posttest counseling is essential for patients who undergo BRACAnalysis, says Georgia L. Wiesner, MD.
Big pharma has been pitching prescription and over-the-counter drugs to consumers since the U.S. Food and Drug Administration loosened the rules on pharmaceutical marketing in 1997. Statins, antidepressants, and erectile dysfunction pills have been sharing the airwaves with cars, cereals, and soaps for more than 11 years.
Now, a direct-to-consumer (DTC) ad campaign is pitching not a drug but a genetic cancer predisposition test, and some people aren’t pleased. Salt Lake City-based Myriad Genetics’ DTC multimedia campaign surrounding its BRACAnalysis test is aimed at physicians and patients and has received coverage, often critical, from The New York Times, The Wall Street Journal, and dozens of other national media outlets.
The test analyzes a blood sample for mutations in the BRCA1 or BRCA2 genes. Women with such mutations have an estimated 56 to 87 percent chance of developing breast cancer by age 70, while the population risk is about 7 percent. The same mutations confer an estimated 27 to 44 percent risk of developing ovarian cancer by age 70, compared with less than 2 percent for women in the general population.
A mutation in either the BRCA1 or BRCA2 gene does not necessarily mean that a woman will develop cancer but it does mean that the likelihood may be higher. Eight risk factors, including a family and personal history of breast and ovarian cancer, are important pieces of the puzzle.
CONFLICT OF INTEREST?
So why all the fuss about a test that is considered an important advance in determining a woman’s chances for developing breast or ovarian cancer? The short answer is that genetic tests are not drugs. The FDA gave its blessing to DTC drug advertising and wrote the rules about what could and couldn’t be said. No such rules exist for genetic tests, and that means companies such as Myriad Genetics can call their advertisements the BRACAnalysis Public Awareness Campaign.
Ellen Matloff, director of cancer genetic counseling at the Yale Cancer Center in New Haven, Conn., thinks that’s misleading.
“Many important things are left out of these advertisements,” says Matloff. “I would even go as far as to say it could be misconstrued as a public service announcement. It’s not clear that it’s an advertisement.”
As for important omissions, Matloff claims the BRAC-Analysis ads: fail to mention that most breast cancer is not associated with heredity; exaggerate the benefits and minimize the risks and complexities of testing; and imply that it is a straightforward tool for assessing risk and planning clinical management and that the test can be appropriately ordered and interpreted by any healthcare provider.
“People are making critical decisions about whether to have parts of their body surgically removed,” she asserts. “This has implications not only for the person taking the test, but for their entire family and for generations to follow.”
The concern surrounding the ads has extended to the legal arena. Connecticut is investigating the BRACAnalysis campaign in response to the concerns of Matloff and others in the medical community.
“My function as the state’s lawyer is to protect consumers against ads or pitches that may be misleading or deceptive,” says Connecticut Attorney General Richard Blumenthal. “The problem here is the potential for exaggerating the benefits of the test. The consumer may be misled by the test if it is not properly interpreted by a scientist, clinician, or healthcare provider who has the training.”
Interpretation of test results and the adverse consequences of inadequate evaluation and counseling are topics Matloff and others return to frequently.
“There are many benefits to having this test,” Matloff says. “It could lead to increased surveillance or to the use of medications like tamoxifen to reduce the risk of cancer. But it can lead to [unneeded] prophylactic breast or ovarian surgery. On the other hand, we don’t want women to think that because their test came back negative, they never need another mammogram. Either of those actions would be inaccurate and very dangerous interpretations of the test.”
Matloff asserts that although Myriad provides training to physicians on how to do pretest counseling and how to order the test and interpret its results, the training is in -adequate and exposes providers to malpractice liability.
“FRIGHTENED PEOPLE”
These concerns are real, according to Georgia L. Wiesner, MD, medical director of the cancer genetics program at Case Western Reserve University, in Cleveland. Wiesner is careful to note that the Cleveland market has not been targeted by the BRACAnalysis Public Awareness Campaign, though she and her team of genetic counselors have ordered the BRACAnalysis test and have interpreted its results often. In fact, about 60 percent of her clients either have breast cancer or a family history of it.
“We talk to patients about this on a weekly basis,” says Wiesner, who is board certified in internal medicine and medical genetics. “I’m familiar with what people understand about it. We have had several instances of women getting test results the physician was not able to interpret.”
One woman had actually cashed in stock, because she didn’t think that insurance would cover the prophylactic surgeries she thought she needed. Her physician was unable to explain her risk and what she needed to do.
“This woman had no pretest counseling at all,” Wiesner recalls. “Somebody ordered the test for her, and she made decisions with a lot of concern about cancer risk, but with no understanding as to how she should proceed. If patients are getting the test without having somebody counsel them about the pluses and minuses, then this is what happens. You get very frightened people.”
Understanding the results, assessing risk, and consulting with an oncologist to devise an appropriate medical management strategy are what Wiesner and the genetic counselors do. Patients spend at least an hour with a counselor and then a half hour with Wiesner. Even if they had the skills, primary care physicians don’t have that kind of time. Wiesner is more concerned that practitioners may not recognize when a high-risk patient needs to be referred.
In Wiesner’s experience, many people believe the BRACAnalysis test will give them a yes or no answer, but that is rarely the case.
“I just am concerned about women who might see an ad and say, ‘Okay, this is the test I need to have,’ and that’s it. That may or may not be true.”
“A POSITIVE IMPACT”
Myriad’s first ad campaign focused on the Boston, Hartford, Providence, and New York metro areas. The public awareness component included physician education and outreach, consumer education, and public relations.
“We were pleased with the response because it generated greater awareness among individuals with a strong personal and family history of hereditary breast and ovarian cancer,” says Myriad Genetics President Gregory Critchfield, MD. “We found that the return on investment was sufficiently high that it was worthwhile to go to the next region to extend the benefits of testing to those individuals.”
In October, the second BRACAnalysis Public Awareness Campaign was launched in Florida and Texas. Critchfield says these states were chosen because they account for 18 percent of the nation’s population and have a good clinical infrastructure.
Critchfield acknowledges that “life-changing decisions” may be made as a consequence of the test, and maintains that “a number of people are trained” to counsel patients, including physicians, genetic counselors, and advanced practice nurses. Only an “authorized healthcare professional” can order the BRACAnalysis test.
“We absolutely require it,” Critchfield says, referring to pre- and posttest counseling. “The clinician and patients both sign forms that require that counseling takes place before the test is ordered. It’s very important that the patient evaluation includes a discussion of what the benefits and limitations of genetic testing are, and that the clinician, with the patient, make an informed decision on whether the patient is an appropriate candidate. When the test result comes back, it’s equally important for the patients to discuss the results with their physicians, and then they decide on a management plan.”
What if a busy Ob/Gyn simply isn’t qualified to render the appropriate counseling and test interpretation?
“Ob/Gyns receive extensive training in genetics. Their practice of medicine gives them a lot of experience with genetic disease,” Critchfield responds, adding that medical professional societies have issued guidelines that say their members are qualified to identify and test patients for genetic conditions. “Whenever there’s a new technology introduced in medicine, there’s an initial period where very few people understand how to use it, but over time, the number grows,” he continues.
Critchfield is upbeat about the BRACAnalysis campaigns, applauding their “tone of empowerment.”
“The benefit of the campaign is that it saves lives,” he says. “It makes women aware of what their risks for cancer are and gives them more tools to reduce their risks.”
For her part, Matloff wants to see regulations for drug advertising applied to Myriad’s ads so they would be forced to include the pros and cons of BRACAnalysis testing.
“I’d also like to see these advertisements identified as such so that it’s clear to patients and physicians that this is a for-profit company trying to make money,” says Matloff.
Myriad is cooperating with Connecticut’s investigation, which Blumenthal describes as “active and ongoing.” The AG adds that “We’re in discussions with the company, and hopeful that perhaps there can be some agreement.”
As more molecular diagnostics such as BRACAnalysis become available, other companies will likely go down the DTC advertising path. New regulations similar to what exist for DTC drug ads might be helpful, but there’s no telling when such rules may arrive and how they would look.