MONDAY, Sept. 23, 2002 (HealthDayNews) -- It probably won't go down in the annals of advertising, but this month was a momentous one for consumer health.
On Sept. 12, Myriad Genetics launched the first mass market ad campaign for a genetic test that screens for mutations in two genes -- called BRCA1 and BRCA2 -- that are strongly linked to breast and ovarian cancer. The Utah-based company hopes the media blitz, which began in Atlanta and Denver, will prompt women at high risk of inheriting these cancer genes to consider the blood screening.
The move offers a glimpse of the future of disease testing. As more ailments are tied to gene errors, companies like Myriad will develop tools to look for these faulty instructions.
However, some geneticists and consumer advocates fear the public isn't equipped to understand the meaning of a positive result on a genetic test. They worry that, at least for the time being, preventive measures haven't caught up with the ability to identify people at risk of inherited genetic diseases.
William Hockett, a spokesman for Myriad, which introduced the test in 1996, says the two cities represent about 3 percent of the pool of women eligible for the gene screening. The test costs $325 to probe for a specific mutation, and up to $2,760 for any of the roughly 2,000 known cancer-causing BRCA errors.
An estimated 10 percent of the roughly 190,000 breast cancer cases each year in this country are inherited, as are 10 percent of ovarian cancers. Most are the result of BRCA errors. Jewish women of Eastern European descent are at higher risk of carrying BRCA mutations, which sharply increase their chances of developing tumors.
Hockett says insurance companies usually cover more than 90 percent of the price of the test, though women are required to pay 10 percent up front. They may also be charged for blood work their doctor orders, as well as for office time.
The BRCAnalysis campaign -- "Be Ready Against Cancer" -- will run for five months, targeting print, radio and television outlets. Hockett says the company is spending between $2 million and $3 million on the effort, and will bring it to other markets if it proves successful in Denver and Atlanta. These two cities were also chosen because they host cancer centers familiar with inherited tumors, he adds.
The company is working with another firm that will collect blood samples from doctors who provide the test. The specimens will be shipped to Salt Lake City, where Myriad screens them for cancer mutations. The whole process, from drawing blood to the return of results, takes about two weeks.
Since its introduction, some 20,000 women have taken Myriad's BRCA test. However, because the mutations affect one in 400 women in this country, the company felt it had a much wider pool of potential interest for the technology.
Genetic testing experts and consumer advocates generally praise Myriad's campaign. However, some express reservations that the ads don't explicitly encourage women to seek genetic counseling before getting tested.
Although the ads do suggest talking with a physician, most doctors don't have the one to two hours it takes to thoroughly advise a woman about what it means to be a disease gene carrier, says Robin L. Bennett, a genetic counselor at the University of Washington.
"I do think it's a big oversight," says Bennett, who is president-elect of the National Society of Genetic Counselors. "Many genetic counselors say they do a lot of cleanup after people get tested."
The Myriad test has effectively no false positive rate. Yet, it does return vague results in a small percentage of cases, although that number is falling, Bennett says. Primary-care doctors unschooled in genetics may not understand the ambiguous finding doesn't necessarily signify the presence of a cancer mutation. "I've seen people who aren't trained in genetics assume that it must be a positive result, but that's just not true," Bennett says.
Bennett says doctors are more likely than genetic counselors to advise their patients to get tested -- in fact, counselors aren't supposed to offer an opinion either way, she says. "I see many women who will probably get tested some day, but once they speak with me they may slow that process down because they're thinking through the implications of the test."
"Knowing your risk doesn't mean lowering your risk," explains Sue Friedman, founder of FORCE, a Web site for people with cancer genes. Friedman, who previewed the print portion of Myriad's ad campaign, says her group supports raising awareness of genetic testing. However, "we would like to see heavier emphasis on the genetic counseling part," she says.
"What happens is that physicians are ordering the test for their patients and then, only after [the women] test positive are they worrying about where to send these people," she says. "Most are distraught and don't completely understand the significance of the test unless they have had a thorough pre-test counseling session."
Learning you aren't a cancer gene carrier is a huge relief if your mother died of breast cancer, Friedman says. However, she adds that women who have the gene mutations may find themselves frustrated by their prevention options, or lack thereof.
Some women with BRCA errors, especially those with a strong family history of breast cancer, choose to have both breasts removed to prevent the disease. Even this procedure doesn't completely eliminate their risk, however, since tumors can sprout from the thin layer of cells left behind by the surgeon's knife.
Some also consider the drug tamoxifen, which can reduce the risk of breast cancer by between 30 percent and 50 percent but has not yet been approved in this country for that purpose. Unfortunately, tamoxifen also raises the risk of uterine cancer, stroke and blood clots.
Another potential pitfall experts cited was regulatory oversight -- of not only the Myriad ads but those from other companies that are sure to follow. The Federal Trade Commission has authority over genetic testing claims. A spokesman for the agency declined to say if regulators had decided to review the Myriad advertisements.
Dr. Ben Wilfond, a clinical bioethicist at the National Human Genome Research Institute, says direct marketing to consumers of a genetic test has "some concerns."
"I think that there is educational value in helping people understand what genetic tests are, but it's not clear to me that ads are the best way to do that," Wilfond says. Instead, they encourage people to buy a product. As a result, some women may consider or demand the test even if they're not at high risk of breast or ovarian cancer, and their doctor may not be sufficiently discouraging.
P. Michael Conneally, president of the American Society of Human Genetics, was equally cautious. "In general, I'm concerned about mass marketing," says Conneally, who worries that poor women without health insurance would be denied the test. "The breast cancer gene doesn't know the economic status of its holder."
Myriad has provided the test at no charge to certain women who can't afford it, though Hockett could not say how many.
Hockett also defends the company's ad approach, saying women couldn't get the test without going through a physician and signing a consent form. Their doctor would then provide guidance when the results of the screening come back.
What To Do
To learn about the company's testing, visit Myriad. For more genes and tumors, try PBS or FORCE: Facing Our Risk of Cancer Empowered.
