A genetic test to tailor drug treatment?

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A genetic test to tailor drug treatment?

Biotech company hopes to increase effectiveness of medicine, lower costs

By Elias

ASSOCIATED PRESS

Monday, June 17, 2002

It's a frustrating reality of modern medicine: Doctors know the drugs they

prescribe don't work for all their patients. Given the diversity of our

genes, no single drug will be effective in every human.

Insurance companies are also frustrated with the one-pill-fits-all drug

delivery system, since they have to pay for increasingly expensive drugs

whose effectiveness isn't guaranteed.

Interleukin Genetics Inc., a struggling biotechnology company based in

Waltham, Mass., has proposed a solution: Target drugs to individuals based

on their genetic makeup.

Such personalized medicine isn't new -- scientists in academia, government

and the pharmaceutical industry have worked for years in the

" pharmacogenetics " field to develop the necessary genetic tests.

But these individualized medical responses have been considered

prohibitively expensive. By including the insurance companies in the

equation, scientists hope to overcome the cost barrier.

" This would clearly be good for the payers, " said Oliver Fetzer, a

biotechnology analyst with the Boston Consulting Group. With some drugs, " 60

percent of the medication being prescribed has no effect. "

Interleukin -- in what it bills as " a novel partnership between

biotechnology and managed care " -- launched a 2,000-patient rheumatoid

arthritis study last week with the Center for Health Care Policy and

Evaluation. The center is an independent research site financed entirely by

UnitedHealth Group Inc., the Minnetonka, Minn., managed-care giant.

Researchers at the center said their goal has little to do with improving

UnitedHealth's bottom line and everything to do with helping doctors and

patients avoid nasty side effects or fruitless treatments.

Interleukin said its commercial goal is clear: Design a test that will cut

prescription drug costs.

" It will allow the rheumatologist to pick the right drug, and managed care

won't spend a bunch of money on a drug that doesn't work, " Interleukin chief

executive Philip Reilly said. " If it turns out that we develop such a test,

it will be a sea change in how the pharmaceutical industry operates. "

The study is using volunteers with rheumatoid arthritis culled from

UnitedHealth's 16.5 million members. Rheumatoid arthritis is an often

debilitating inflammation of the joints that afflicts 2.1 million Americans.

The study, which should be completed by the end of the year, will determine

if a simple genetics test can help doctors make better choices, especially

when it comes to prescribing expensive genetically engineered drugs.

Researchers will compare the genes of those who respond positively to the

drugs to those who don't.

Three engineered rheumatoid arthritis drugs are now on the market. Each

costs about $1,000 a month per patient.

Interleukin hopes to spot genetic markers that lead to a simple and

definitive test doctors can use to determine which patients respond best --

if at all -- to Enbrel, Remicade and Kineret.

When making prescriptions, doctors rely largely on their " clinical judgment "

-- a combination of habit, gut instinct, and trial and error. They routinely

prescribe one of the engineered drugs to new patients for three months to

see if it works.

Developing a successful test will do more than save insurance companies

money, doctors time and patients discomfort; it may help save Interleukin

Genetics itself. Last month, the publicly traded and money-losing company

warned it had only enough cash on hand to keep it in business through the

end of August.

" It's not our last best chance, but it's probably our best chance, " said

Reilly, who has been negotiating with potential investors for additional

financing.

Even if the Interleukin test proves successful, other obstacles remain

before personalized medicine can become widespread.

" A pretty high degree of clinical sophistication is needed to make this

work, " Fetzer said. " And most insurance companies are having more basic

problems with things like their billing systems. "

Despite its promise, the area has " some real business and legal

uncertainties, " said Hank Greely, co-director of Stanford University's

Program in Genomics, Ethics and Society.

" People are nervous about the word `genetic' like they are about

`radiation.' It's a word people don't like, " said Greely, a law professor.

Reilly, the Interleukin CEO, said his company will guard against individual

genetic information being used to discriminate against insurance coverage or

employment.

" None of these tests are going to be used to kick anyone out of a plan, "

Reilly said. " No one is going to be punished because they have a certain

genotype. "