September 11th, 2007

Ad Campaign Fuels Debate On Breast-Cancer Gene Test

By Marilyn Chase
Wall Street Journal

Critics Say Calling Attention to a Rare Risk Factor May Create Unnecessary Fear

A new direct-to-consumer ad campaign for a breast-cancer gene test is reigniting a debate over who really needs the test and whether it will induce low-risk women to take drastic measures to prevent the disease.

At issue is a series of ads to promote Myriad Genetics Inc.’s test for so-called BRCA 1 and BRCA 2 gene mutations. The mutations, while rare, signal a high risk of developing breast or ovarian cancer in affected women. Women who find they carry the mutations often take steps to lessen their risk. That can mean more frequent screenings and taking certain preventive drugs, but also can include prophylactic surgical removal of a woman’s breasts or ovaries.

The gene tests aren’t foolproof, however. And some experts worry that a campaign calling attention to a rare condition could create unnecessary fear—sending thousands of healthy women with no family history of cancer into the doctor’s office demanding tests that won’t help them. Or lead others to a false sense of security about their results.

“Marketing has the capacity to raise public awareness—a good thing,” says Alan Guttmacher, deputy director of the National Human Genome Research Institute, a unit of the National Institutes of Health in Bethesda, Md. But “with BRCA 1 and 2, people can get uncertain test results. What do you do with that information?”

In Salt Lake City, Gregory Critchfield, president of Myriad Genetic Laboratories Inc., Myriad’s gene-testing unit, says the company vetted the awareness campaign with insurance companies and shared it with medical experts and government officials at the NIH. “We are confident that our materials represent the highest quality of information,” he says. Dr. Guttmacher said his institute hasn’t taken any official position on the test.

Television commercials hit the airwaves yesterday in New York City; Boston; Hartford, Conn.; and Providence, R.I., as part of a multimedia blitz aimed at promoting awareness and use of Myriad’s test.

The TV ads feature a half-dozen women saying “Breast Cancer runs in my family,” and vowing to “Be ready against cancer.” The slogan captures the trade name of the product—known as “BRACAnalysis.” In the background, feminine touches like flowers or pink teddy bears dot the screen. Women can expect to see newspaper and magazine ads, as well as posters in clinics and spas as part of the campaign. Myriad says it hopes to extend it to a national audience.

“The test is designed to save lives by raising public awareness,” says Dr. Critchfield. The company estimates that only 3% of individuals who carry BRCA 1 and 2 gene mutations have been identified, he adds. “It’s important to find these individuals because there are interventions that can lower their risk.”

The ads will urge women concerned about risk to contact their primary health-care providers about the test—rather than genetic counselors, who are in short supply. The cost can run anywhere from $300 to over $3,000, depending on the level of genetic sequencing performed.

In women with a verified family history strongly suggestive of risk, most insurance companies will cover the test, says Dr. Critchfield. However, fear of insurance or employment discrimination already makes some women hesitate to take the test. The Genetic Information Nondiscrimination Act, or GINA—which would prohibit discrimination by insurers and employers based on a person’s genetic history—recently passed the House of Representatives and is now awaiting Senate action.

The new campaign is drawing the scrutiny of at least one state attorney general in the targeted area. “We are doing an investigation to determine whether Myriad is fairly and accurately representing claims for this test,” Richard Blumenthal, Connecticut’s attorney general, said in an interview.

The attorney general’s office has issued a subpoena for information about the Myriad ads to assist in the inquiry. And Mr. Blumenthal said his office had heard from professional caregivers, clinicians and scientists who believe there is “very high potential for misinterpretation and overreaction.”

Myriad’s Dr. Critchfield said the company is “cooperating fully” with Connecticut officials.

For 2007, the American Cancer Society forecasts there will be 178,480 cases of invasive breast cancer diagnosed and an estimated 40,460 deaths. Estimated ovarian cancer cases in 2007 will reach 22,430, with 15,280 deaths, the society spokesman said.

Researchers believe that only about 10% of women with breast or ovarian cancer develop the diseases because of hereditary risk factors, and not all of those involve the two mutations detected by Myriad’s test. Especially at risk are women from an Ashkenazi Jewish ethnic background and those with a significant family history of breast cancer and ovarian cancer.

Women with certain BRCA 1 or BRCA 2 gene mutations have a 56% to 87% risk of developing breast cancer by age 70, compared with a 7% risk in the general population, Myriad says. Women with BRCA 1 or 2 mutations have a 27% to 44% risk of developing ovarian cancer by age 70, compared with less than a 2% risk in the general population.

Experts in oncology and genetics say the decision about whether a woman is at high-enough risk to justify a test begins with a thorough family history. This should focus not so much on a case of cancer in one elderly relative, but multiple cases of cancer in females before menopause, bilateral (double sided) breast cancer or breast cancer in male relatives.

Then genetic testing should start with a family member who has cancer, who should have a complete sequencing of the BRCA 1 and 2 genes, these experts say. Such sequencing tests can cost over $3,000 per person. Then, once a BRCA mutation is confirmed, other family members can be checked for that mutation—a more limited test that typically costs $300 or more.

Some genetic counselors—who prepare patients for the possible results, emotional fallout and preventive steps involved with such tests—are concerned that the Myriad ads oversimplify the benefits of gene tests. Moreover, primary-care providers who often must squeeze in dozens of patient visits a day lack time and training to prepare patients for the tests, says Ellen Matloff, director of cancer genetic counseling of the Yale Cancer Center.

Myriad says it is developing a program to school primary-care doctors about the test. Dr. Critchfield said the company is focusing on primary-care doctors, oncology specialists and tertiary-care centers, along with genetic counselors, “to get the message out.”

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