Genetic Cancer Test Stirs Debate

By THE ASSOCIATED PRESS

Filed at 8:13 p.m. ET

NEW YORK (AP) -- The contentious debate over aggressive marketing of prescription drugs and other pharmaceutical products is about to get a new twist.

Myriad Genetics Inc., which makes tests for genetic predisposition to certain kinds of cancers, is starting a big marketing push with doctors this summer. In the fall, it will launch a direct advertising campaign aimed at women to promote the test for breast and ovarian cancers.

As in other ads for prescribed products, viewers are urged to consult their doctors. But these ads apparently are the first of their kind to promote genetic testing directly to the public and a part of a controversial marketing effort to expand distribution of Myriad's products.

The Salt Lake City-based company has developed tests that assess an individual's risk of developing genetic forms of breast, ovarian, colon, uterine and skin cancers, and also can help determine which hypertension drugs are best for a patient.

Until now, they have been marketed only to doctors though an 85-person sales force. This summer, under a market agreement signed in December, the 600 sales agents of Laboratory Corp. of America Holdings will also begin marketing the drug tests to 200,000 doctors.

Gregory Critchfield, president of Myriad Genetic Laboratories Inc., the test subsidiary, said the campaign is designed ``to make these tests for mainstream.''

He said doctors need to be more familiar with the tests, and be more attuned to patients' family histories to detect which groups of people are at risk for genetically based cancer. In the fall, a television, print and radio campaign focusing on tests for breast and ovarian cancer will be test marketed in Atlanta and Denver.

``We think the public needs to know, too,'' he said. ``We think the information needs to come in both directions.''

Some doctors and health advocates contend that, with a relatively small real market for the tests, and with many doctors already aware of them, the entire campaign is too much of a simple push for profits.

They fear that it could cause unnecessary anxiety, increase medical costs and perhaps even create a false sense of security, with a negative result misinterpreted as a clean bill of health for all kinds of cancer.

Doctors estimate that between 5 percent and 10 percent of cancers are genetically based. The tests cost between $745 and $2,760.

``I'm worried about marketing overstating the benefits of these tests and that, despite everyone's best intentions, they won't be used properly,'' said Dr. Richard Roberts, chairman of the American Academy of Family Physicians.

``Mark Twain once said that someone with a new hammer thinks of the world as a nail,'' he said. ``I know where to find these tests, and I've never felt deprived because someone wasn't marketing them to me.''

Most agree these tests are appropriate for a small subset of patients where there is a family history of cancer that suggests a genetic origin.

Breast cancer diagnosed in women before reaching menopause is typically genetically based. Colon cancer in individuals under 50 is also genetically linked. Only patients with close relatives with such histories should receive the test, according to experts.

Critchfield says sales representatives are trained to explain to doctors that only a small group of patients should take the tests and to leave brochures outlining the criteria with physicians. No patient is given the test if counseling hasn't been provided beforehand, he said, and follow-up counseling is also required.

Couselors help patients deal with the emotions the test may raise, such as fears after a positive result or even guilt from a negative outcome when other family members have been stricken with cancer. Medical options are outlined for those who have tested positive.

``This isn't something we take lightly,'' said Critchfield.

Critchfield says Myriad will train doctors to guide patients through the process. Others insist counseling should only come from genetic specialists.

``Genetic specialists go to school for years. It is not something you can train someone to do in an hour,'' says Barbara Brenner, executive director of Breast Cancer Action, a nonprofit advocacy organization.

Brenner opposes direct marketing of the breast cancer test. ``It is not about saving women's lives. It is about increasing market share,'' she said.

In a breast cancer test, a woman who tests positive for a mutation of either of two genes, has an 87 percent chance of developing the cancer in her lifetime. But there is no way to know if she will beat the odds.

Those who have the mutation can choose preventive mastectomy or chemotherapy. Most choose vigilant surveillance through self-exams and mammograms instead of such radical options.

In testing for ovarian cancer, a positive finding means a 40 percent chance. Still, doctors often recommend that women have their ovaries removed if they are past their childbearing years because there are no good tests to diagnose the disease in its early stages of the often fatal disease.

A recent study of 170 women by Memorial Sloan-Kettering found those with the genetic mutations that elected to have their ovaries removed had a 75 percent decreased risk of breast and ovarian cancer.

``We need to prevent cancer and this test can help. It is a good tool,'' said Dr. Barbara Weber, director of the Abramson Family Cancer Research Institute at the University of Pennsylvania.

Weber isn't a big fan of direct to consumer pharmaceutical advertising but she believes women don't know enough about these tests. ``How else are we supposed to get the information out there? It is our responsibility as physicians to make sure the tests are used appropriately,'' Weber said.

Myriad introduced the test for breast and ovarian cancer -- its first -- in 1997. The company is believed to be the only company that manufactures predictive tests. Other firms, such as Genzyme Corp., make tests that can detect actual disease or determine who is a carrier.

Myriad also is developing drugs but, like many genetics companies, has yet to have any big success in that arena. For now, the tests account for about half its revenues, increasing 61 percent to $19.1 million in the nine months ended Mar. 31, compared to the year-ago period.

The new marketing alliance could boost revenues to $100 million by 2006, according to First Albany Corp. analyst David Webber, who applauded the deal.

``This is a really good chance for them to increase revenues, and that is important for all operations,'' he said.

Myriad spokesman Bill Hockett said he sees the company's future in both tests and drugs, and is not attempting to cash in on one activity to bail out the other. ``Both businesses have long-term business potential, `` he said.