Healthy Skepticism Library item: 7777

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Publication type: news

Johnson S.
Hazy future for genetic drugs, tests
The Mercury News (San Jose, CA) 2007 Jan 2Business
http://www.mercurynews.com/mld/mercurynews/business/16365391.htm

Full text:

Photo: Susanna Frohman / Mercury News
Genomic Health’s Julie Ballard, left, and Heidi Cheng set up test samples in 2003. Today, the company has sold thousands of the test that predicts the likelihood of recurring breast cancer.

INSURANCE FEARS LIMIT TREATMENTS ON MARKET
There may be no better example of the promise and pitfalls of so-called personalized medicine — tailoring treatments to individual genetic traits — than the test Genomic Health developed for breast-cancer patients like Katherine Young.

Since 2004, the Redwood City company has sold more than 17,000 of the tests, designed to help women treated for early forms of the disease determine the risk of their cancer recurring. Young, the first to use it, swears by the product, Oncotype DX.

Having undergone a double mastectomy, the 54-year-old Stockton podiatrist was relieved when the test told her she didn’t need chemotherapy, which can have nasty side effects. So Young took its advice. And today, after treatments with relatively mild tamoxifen, she feels fine.

``I’m great,’‘ Young said. ``I just passed my ski instructor’s license. I’m so happy.’‘

But it took her a year of badgering to persuade her insurance company to pay for the test. Most insurers still balk at its $3,460 price, reflecting a troublesome reality for personalized medicine.

Despite widespread hopes that mapping the human genome this decade would usher in a flood of drugs for genetically similar patients, few such products have hit the market, largely because of fears that insurers won’t cover their cost.

``This is really a sea change in medicine,’‘ said Dr. David Lawrence, former chief executive of Kaiser Foundation Health Plan and Hospitals. ``The whole question of what gets paid for and who pays it is going to take a while to get sorted out.’‘

A change in the norm

Drug manufactures typically make treatments aimed at broad segments of the population. But because of genetic variations among the 130 million Americans who use prescription drugs each month, the medicines don’t always benefit those taking them.

Some patients, for example, require only one-tenth of a typical drug dose because of the way their metabolizing enzymes work. Others require five times the normal amount.

Those and other differences can have serious consequences. More than 700,000 people in the United States each year suffer prescription-drug reactions severe enough to send them to emergency rooms, according to a federal study published in October.

Consequently, many health experts welcome the idea of drugs being specifically engineered for patients with common genetic characteristics.

One such medicine is Gleevec, sold by Swiss drugmaker Novartis, which is designed for leukemia sufferers with a genetic disposition to overproduce white blood cells. Another is Herceptin, a highly successful anti-cancer treatment made by Genentech of South San Francisco. It is aimed at breast-cancer patients who share a genetic inclination to overproduce the so-called HER-2 protein, which can trigger tumorous growths.

Yet Gleevec costs a typical patient at least $2,200 a month and Herceptin $3,195. A sudden flood of such expensive medicines might not sit well with insurers, some experts warn.

If insurers won’t pay for genetically customized drugs, consumers might have to bear the cost themselves, experts predict. Some say that could lead to growing health care inequities between the rich and poor. Others fear it could subject consumers to a marketing blitz from firms misrepresenting personalized medicines.

Some questionable advertisements already have caught the attention of Sandra Soo-Jin Lee of Stanford’s Center for Biomedical Ethics. In the January issue of the Journal of Clinical Pharmacology & Therapeutics, she criticized a Florida company that claims a genetic basis for health products it sells to racial groups.

Diagnostic testing

The future also remains unclear for another key component of personalized medicine: diagnostic tests designed to help patients with similar genetic dispositions get the right medicines. A number of Bay Area companies sell such tests or are developing them.

XDx of South San Francisco makes one called AlloMap for predicting heart transplant rejections. By examining certain genes in a heart recipient, it helps determine whether the patient’s white blood cells are about to attack the organ.

Cholestech of Hayward has a test that among other things can peruse a patient’s blood for signs of a certain protein associated with a high risk of heart attack and stroke.

And Monogram Biosciences of South San Francisco makes genetic tests that helps doctors choose drugs for people with HIV.

That’s just the beginning, said Howard Birndorf, chief executive of Nanogen, a San Diego test company. He envisions a device that one day could instantly perform multiple tests on a person, like the tricorder used on the television series ``Star Trek.’‘

By helping individuals understand their genetic vulnerabilities, some experts say, diagnostic tests might encourage people to take better care of themselves, which ultimately could reduce the nation’s health care expenditures.

Yet others suspect insurers would bridle at paying to test people who aren’t already sick. And determining how many tests a person should reasonably undergo could prove difficult.

Speeding up change

Given such uncertainties, England’s scientific academy, the Royal Society, has concluded it could be 15 to 20 years before the health care system fully embraces personalized medicine. But if anyone is in a position to speed that process along — particularly with insurers — it is Genomic Health, according to an article in the August edition of Nature Biotechnology.

``If Genomic Health can blaze a path for genomic test reimbursement, they will set a precedent that will rapidly be followed by other companies,’‘ the article by two health-care consultants concluded.

Incorporated in 2000, Genomic Health has consistently lost money since going public in October 2005. Nonetheless, the company won a major victory in January when California’s Medicare insurance carrier agreed to cover the cost of the Oncotype DX test.

Other insurers — including Aetna and Kaiser — also have decided to pay for it. And Genomic Health’s Chief Executive Officer, Randy Scott, predicts more will follow.

``We do see over the coming year a significant policy shift toward coverage,’‘ he said. ``Personalized medicine can be successful.’‘

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Contact Steve Johnson at sjohnson@mercurynews.com or (408) 920-5043.

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