Pubdate: February 9, 1999
Source: Wisconsin State Journal (WI)
Contact:  http://www.madison.com/
Copyright: 1998, Madison Newspapers,
Author: Patricia Simms, Health reporter

MADISON A MAJOR CENTER OF DRUG-TESTING INDUSTRY

Drug testing is a multi-million-dollar industry in Madison.

Millions of dollars are spent in Madison by the federal government and
pharmaceutical companies to clinically test products for approval by
the Food and Drug Administration.

''It's a tremendous impetus to the economy of Madison,'' says Dr.
William Busse, internationally known UW allergist. ''If the National
Institutes of Health (NIH) dropped off the face of the Earth, the
problems economically in Madison would be immense.''

Every year, the NIH and pharmaceutical companies contract with local
centers and with many others across the nation to test new drugs for
safety and efficacy.

Madison is attractive for drug testing, Busse said, because of the
number of physicians here, the pool of bright, educated subjects and
the ease of getting around town.

In 1996, for example, investigators at the UW General Clinical
Research Center snagged about $46 million in federal and non-federal
funds for the medical school and hospital.

''We are talking millions of dollars coming into Madison,'' said
Dorothy Adams, executive director of the Jackson Foundation. ''There
is so much competition all over this country now, we have to continue
to market and try to get this stuff here. Everybody in the country is
trying to do it now.''

There are four major players in Madison: the University of Wisconsin, the
Jackson Foundation, the Dean Foundation and Covance Inc., an international
drug development company headquartered in Princeton, N.J. A handful of
physicians also operate small testing labs that compete in niche markets.

The local centers agree to round up subjects (if they're healthy) and
patients (if they're sick) to participate in the drug trials, which
are done in four phases and can last three or more years.

Last week, for example, UW advertised for test volunteers with
shingles, urinary incontinence, tennis elbow, depression or spinal
injury.

And again last week, an ad crawled across the bottom of the Weather
Channel, asking women with severe PMS if they wanted to be part of a
Dean Foundation clinical test.

Study coordinator Gemma Warner said the test, led by Dean psychiatrist
Leslie Taylor, has already started, but Warner is still screening for
a total of 16 women. ''We'll have to screen about 100 women to get
that,'' Warner said last week.

Few success stories

The drug testing industry has become far more sophisticated as drug
companies compete for the next pharmaceutical blockbuster.

Gone, said Rhonda Lagoni, director of the UW Center for Clinical
Trials, are the flush, open-ended budgets drug companies used to offer
universities for tests. ''Budgets are tighter,'' she said, forcing
academics to more carefully price their services. ''Years ago, you
just asked for money. Now you don't even get all the money up front.''

Drug companies invest a lot of money to get a new drug, Busse said.
First, it has to be tested in animals. Then, he said, it takes four or
five years from the start of human trials for a drug to work its way
to FDA approval.

Meanwhile, the patent on the drug generally lasts 17 to 20 years,
Lagoni said. After that, the drug becomes generic, and the price is
likely to plummet.

''If the drug is under a protected patent,'' Busse said, ''chances are
that the financial profit will be greater. The more rapidly the study
is done, the greater the financial benefit to the company.''

And the number of drugs that actually make it to the market is
extremely small, he said. About one in 5,000 drugs will eventually
make it to human trials, then there's further dropout. ''The chances
of being a successful product are extremely remote.''

Across the board at the UW, Lagoni estimated, at least four of every
10 human clinical trials may fall through.

The UW typically does about 500 new trials a year, she said. ''That
doesn't count anything already up and running. We could have between
1,000 and 1,500 trials running at any stage.''

Adams said the Jackson Foundation runs about 50 new tests a year. Dean
Foundation runs about 35, according to director Peg Dovi.

Covance's facility on West Washington Avenue conducts between 20 and
40 clinical trials involving about 500 people annually, according to
Deborah Keller, vice president of marketing.

There is a difference, however: Covance is a contract research
organization (CRO), a market-driven phenomenon that has developed in
the last five to 10 years.

While Covance here in Madison only does Phase I trials on healthy
normal subjects, the corporation maintains a network of investigators
worldwide, including some of the doctors in Madison, that may be used
to conduct the later, more extensive trials known as Phase 2, 3 and 4.

Patient benefits

Lagoni said CROs have cut deeply into the traditional dominance of
universities in drug testing. In Madison, she said, the UW has lost a
chunk of market share to private shops.

Keller said the business has grown and changed in the last decade
because of the need to decrease drug development time and cost.

For the subjects or patients, the drug trials can be a source of
additional revenue or not. Many of the trials offer the subject
payment, some offer just free drugs, treatment and expenses.

In 1993 Jan Michaelis, a 59-year-old Oregon grandmother, answered an
announcement her daughter saw in the newspaper. The UW center was
seeking congestive heart failure patients.

Michaelis had been facing the probability of a heart transplant, but
the heart drug she tested from 1993 to 1996 worked for her.

''They shortened the trials up because the results were so good that
the (FDA) Food and Drug Administration approved it early,'' said Michaelis.

Michaelis received free drugs and treatment but no money. Many
subjects, however, do receive some payment.

''We do reimburse patients, most likely,'' Adams said. ''When we are
inconveniencing a patient for the benefit of drug companies, then let
the drug companies reimburse them for their time.''

Adams said reimbursement could be as much as $200 per trial or $20 to
$25 a visit when the patient comes back in.

Busse, however, offered a caution. ''You do not want to use such a
large incentive that it becomes an enticement, that patients would
disregard the risk for the financial benefit. Compensation should not
be an excessive allurement.''

Added the UW allergist, ''There are people who do this repetitively,
but you cannot make a living from this.''

Some people do volunteer for trial after trial.

Lagoni said ill patients may ''follow'' a particular physician in any
trial he or she supervises. Others just appreciate the extra attention.

''I've been with Jackson for 32 years,'' Adams said, ''and there are
some people who have been in one study or another for all those years.
It's a great benefit to the patient because they have access to
these new medications sooner.

''And some people like the little extra hand holding. For the sick
patient, it's nice to have another person you can call when you don't
feel right.''

Lagoni agreed. ''It can be almost like a social connection for them.
They can meet other patients and commiserate. It's very lovely care.
For some, it's really like a little social outing.''

Patients who have a disease may truly just want to help further a
cure. ''It's very clear to me that some of these people are doing it

for altruistic reasons. They've had the disease, and they're
interested in seeing breakthroughs.'' Busse said.

For Michaelis, the decision to participate was driven by her desire to
avoid a heart transplant.

''I had marvelous results,'' Michaelis said. ''Had it been a different
drug, it may not have worked. But this drug worked for me.''

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MAP posted-by: Rich O'Grady