Genetic testing for breast cancer: marketing through fear

I wondered the other day when I saw a commercial advertising genetic testing for "breast cancer genes" whether the company that patented the tests for BRCA1 and BRCA2 and controls this segment of the genetic testing market was starting to have declining sales. They haven't advertised before; why now?

Perhaps their advertising is justified by the fact that, according to an article in the New York Times, "only 30,000 of more than 250,000 American women estimated to carry a mutation in BRCA1 or a related gene, BRCA2, have so far been tested."

In any case, the advertisement caught my attention and that of a number of other people--including the Attorney General of Connecticut. According to an article from the phg Foundation,

A US television advertisement for familial breast cancer testing has attracted criticism from oncologists and geneticists, who say that advertising a specialised genetic test to the general population could cause anxiety among women for whom the test is not actually appropriate. Director of cancer genetic counselling at the Yale Cancer Center Ellen T. Matloff said: “It really preys on the fears of our society, and one of those fears is getting breast cancer” (see New York Times article). Inherited mutations in the BRCA1 or BRCA2 genes can confer a lifetime breast cancer risk of up to 85%, and an ovarian cancer risk of up to around 40%; however, only a small proportion of breast cancer cases in a population arise in women with a BRCA mutation. Normally, only women considered to have an increased risk of carrying a mutation based on their family history (such as several affected relatives, and/or early onset cases in relatives) are referred for genetic counselling and the option of genetic testing.

The attorney general of US state Connecticut has ordered an investigation of the claims made by Myriad in the advertisement. However, Myriad president Gregory Critchfield has said: “The purpose of the BRACAnalysis public awareness campaign is to save lives" by identifying BRCA mutation carriers (see press release). He added that: "We are committed to working with healthcare providers around the country to provide useful resources for them to offer hereditary risk assessment, counseling and genetic testing to their patients". However, the key issue is what proportion of the women prompted to ask about genetic testing will be at genuinely increased risk of having a mutation, and whether direct advertising of this genetic test is appropriate.

The ad I saw did not seem to fit with Myriad's contention that the "campaign is being initiated with the hope that women with a family history of breast or ovarian cancer will contact their physicians to learn more about their risk of developing cancer and the actions they can take to reduce their risk." (see press release) I also find it interesting that I am in Portland, OR, but, according to the press release, the "advertising component is being conducted specifically in four areas, namely Boston, Hartford, Providence and New York City." Perhaps The DISH network enabled me to see something being broadcast elsewhere.

According to the New York Times:

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 officials are reported as responding:

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.”

The New York Times summarizes details of the test as follows:

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.)

In an interesting side note, the article claims that only docotrs can order the test. I don't remember that being a requirement when I last checked their website. And, women getting genetic tests from other online sources are, in fact, getting the Myriad test.

Many of the 200,000 women who have had the test since 1996 may have been influenced by Myraids' early marketing (with the same ad) in a five-month test in Denver and Atlanta in late 2002 and early 2003. That campaign, and scientific articles on BRCA1 and 2 have been enough to generate enough business to last over 5 years. According to the New York Times,

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.

Well, at least one thing is probably true: I doubt Myriad will call me again for help in writing documents. By the way, those of you who remember that I do not generally name specific companies should know that Myriad is the sole provider of the BRCA1 and 2 tests; and the ads don't make this very obvious. So, I have referred to them by name.

Marie Godfrey, PhD

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