Genetic Test, Few Need, Marketed to Masses

September 11, 2007

A Genetic Test That Very Few Need, Marketed to the Masses
By ANDREW POLLACK

BREAST cancer runs in my family," one woman says. She is followed in quick succession by other young and middle-aged women, who say in turn: "My mother." "My grandmother." "My dad's sisters."

So opens a television commercial that is starting to run this week in New York and elsewhere in the Northeast. It urges women to consider being tested for certain genetic mutations that can sharply increase the risk of developing breast or ovarian cancer.

But the commercial, sponsored by Myriad Genetics, which sells the test, is stirring protests from some cancer and genetics specialists, and it has brought on an inquiry by Connecticut's attorney general. Critics say that advertising such a complex screening test to the general population might create unnecessary anxiety among women and lead to overuse of the test, which costs $3,120.

"It really preys on the fears of our society, and one of those fears is getting breast cancer," said Ellen T. Matloff, director of cancer genetic counseling at the Yale Cancer Center.

The Connecticut attorney general, Richard Blumenthal, said his office had issued a subpoena for information from the company. "We've determined that there's enough serious and significant doubt about the accuracy of some of their claims that we feel a strong need to investigate," he said in an interview.

Myriad, which said it would cooperate with Mr. Blumenthal's request, defends the commercial and other elements of what it calls a public awareness campaign. The company says that while its test has been given to about 200,000 women since 1996, only 3 percent of the women believed to harbor the harmful mutations that can be detected by the test have been identified so far. Therefore, the company says, there is a need for much more extensive testing.

"What we are doing is raising public awareness so they will have a conversation with their health care providers," said Dr. Gregory C. Critchfield, president of Myriad's genetic testing business. "Those individuals, if they are tested and identified, can avail themselves of means to reduce the risk of cancer."

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The campaign comes at a time when government officials and some health specialists are expressing concern over the direct sales and advertising of genetic tests, some of them of dubious validity, to the public, mainly over the Internet.

Myriad's test is, by all accounts, valid, and the company requires a physician to order it. But one medium through which it is being advertised, television, has raised questions about whether genetic tests will one day be marketed to consumers as vigorously as pharmaceuticals are today.

Myriad executives would not say how much would be spent on the campaign, which is to last six months and reach women 25 to 55. If it succeeds, the campaign might be expanded to other locations.

The 60-second television commercial is to run in New York, Hartford, Boston and Providence, R.I., during shows like "The Oprah Winfrey Show," "Dr. Phil" and "The Today Show." There will also be radio advertisements and a cover wrapper on copies of the October issue of People magazine that is delivered to doctors' offices and some beauty salons in the region.

The commercial tells women to contact their physicians or to call a toll-free number, which connects them with Myriad. But the only mention of the company is in a brief line of text at the end, identifying the ad as "a service from Myriad Genetics." The campaign's slogan is "Be ready against cancer."

Myriad's test, called BRACAnalysis, detects mutations in genes called BRCA1 and BRCA2. Women with a clinically significant mutation in one of those genes have a 35 to 84 percent probability of developing breast cancer by age 70 and a 10 to 50 percent probability of developing ovarian cancer, far higher than for women in general.

Women with the mutations can reduce their risk of cancer by taking certain cancer-prevention drugs or having their breasts or ovaries removed. They can also be screened more frequently for early detection.

But mutations in the genes account for less than 10 percent of all cases of breast cancer. And only 1 in about 400 women has the mutation. (The risk of a mutation is about 10 times as high for women who are Ashkenazi Jews, but they can be tested for three specific mutations, for a cost of $460.)

Testing women in the general population would be a waste of resources, many experts say. Medical societies have guidelines on who might be tested, based on risk factors like having close relatives who got breast cancer at a young age. One set of guidelines, by a government advisory committee, suggests that about 2 percent of women might be good candidates for testing.

Some critics have said the commercial makes it seem as though any woman who has had a relative with cancer should be tested.

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Another question is whether there are enough trained genetic counselors, specialists who advise on genetic tests, to cope with a surge in demand that could follow the commercials. And another is whether doctors, who might now be asked about testing, have enough expertise to discuss the procedure.

Doctors "are going to get caught between the ad and the patient," said Luba Djurdjinovic, executive director of the Ferre Institute in Binghamton, N.Y., a community genetics practice that works with doctors' offices.

Dr. Kenneth Offit, the chief of the clinical genetics service at Memorial Sloan-Kettering Cancer Center in Manhattan, reserved judgment on Myriad's campaign. But he said women might be falsely assured by a negative result or might have unnecessary surgery if a result is misinterpreted by an inexperienced doctor.

Dr. Critchfield of Myriad said the company spent eight months before the campaign urging doctors in the region to learn about the test and providing them with information. He said the tests would not be used inappropriately because doctors would be involved in ordering them and because insurers, which generally pay for proper uses of the test, would not pay for inappropriate ones.

Myriad ran the same commercial in a five-month test in Denver and Atlanta in late 2002 and early 2003. The company said there were 38 times as many calls to its toll-free number in those cities as in control cities. The number of tests being performed also rose in Denver and Atlanta, by about 30 percent compared with other cities.

Studies at the time by outside parties found that testing or referral to genetic counselors increased, but not always for the women most likely to benefit. And a survey by the Centers for Disease Control and Prevention found that many doctors in the pilot cities had an incorrect or incomplete understanding of the genetics involved.

Dr. Critchfield said Myriad waited nearly five years to start the new campaign to give more time for health care providers to learn to handle genetic testing. "We are in a far different place today than we were then," he said.

NYTimes