Author: Jon Merz
Date: 04-06-04 16:54
Source: Philly Inquirer
URL: http://www.philly.com/mld/inquirer/living/health/8363431.htm?1c
Date published: April 6th 2004
From Haavi Morreim:
Tue, Apr. 06, 2004
Medical testing suffers from a lack of volunteers
The difficulty of finding subjects "is the number-one roadblock to getting
drug trials done."
By Virginia A. Smith
Inquirer Staff Writer
The medical world needs more Phyllis Morellos.
This self-effacing nursery-school teacher from Garfield, N.J., volunteered
for one of the hundreds of clinical trials in this region, agreeing to have
an experimental pacemaker implanted in her stomach to see whether it would
help her digestive problems.
Although millions of other sick people are enrolled in clinical trials to
test new treatments, the number falls far short of the growing demands of
corporations and medical centers that compete in a mad, expensive dash to
market new products.
Hard as it is to attract patient volunteers, it's even harder to keep them.
Three million Americans do complete clinical trials each year, but so many
others drop out that 90 percent of trials never make it to the end,
according to Thomson CenterWatch, a Boston nonprofit that tracks the
clinical trials industry.
"You can't bring drugs through the pipeline if you can't adequately test
them, and the patient recruitment problem has slowed the pipeline to a
crawl," said Dan McDonald, CenterWatch vice president.
There are many possible explanations.
Patients may not know enough about clinical trials. They may be scared off
by the risks, or by revelations of deaths or abuses. They may fear being
given a placebo. They may be too busy.
And then there are the trials themselves - bigger, longer and more complex,
requiring more patients than ever.
"Patient recruitment is the number-one roadblock to getting drug trials
done," said Kathleen Drennan of Iris Global Clinical Trial Solutions in
Chicago.
In true American fashion, the problem has spawned a new growth industry:
private companies such as Drennan's that recruit and retain volunteers, a
growing number of whom now come from India, Eastern Europe and South
America, where patients are often desperate for treatment.
It's a scramble with a potentially grand payoff. The drug giants' future
earnings depend on finding the next breakthrough treatment or blockbuster
drug, which in turn can mean life or death for sick people.
"People have to realize this is serious business," said John I. Gallin,
director of the National Institutes of Health Clinical Center in Bethesda,
Md., where 1,100 clinical trials are going on. "This is what's going to move
us forward in developing better care and prevention of disease."
Clinical trials test potential new drugs, devices or procedures in patient
volunteers over time to see whether they meet standards for general use.
Some trial subjects are paid.
More than 70,000 trials are conducted annually in this country alone, funded
by about $6 billion a year from private drug and biotech companies and the
NIH.
They are carried out by research institutes, medical schools, hospitals and
private trial-management firms, and overseen by local review boards and the
U.S. Food and Drug Administration.
Merck & Co. of Whitehouse Station, N.J., has about 170,000 patients involved
in 300 trials; 120 of the trials are in 58 countries overseas. In September,
for example, Merck launched an HIV vaccine trial in 18 cities in the United
States, Puerto Rico, Brazil, Haiti, Malawi, Peru, South Africa and Thailand.
Jacobo Sabbaj, vice president of clinical research operations worldwide,
said Merck had no problem enrolling patients. "If you know where to look for
those patients, you will find them," he said.
Some trials easily attract volunteers, said Ken Getz, founder of CenterWatch
and now chairman of the Center for Information and Study on Clinical
Research Participation in Boston. He cited male pattern baldness and other
so-called vanity illnesses.
But everyone else in the industry, he said, "is having a terrible time. It's
the biggest problem today."
And the need for patients doesn't go away after a drug wins FDA approval.
GlaxoSmithKline, based in London with U.S. headquarters in Philadelphia and
North Carolina, will invest $300 million in long-term studies of Avandia, a
drug for Type II diabetes that won FDA approval in 1999.
"You have to look at it for years and years, even after the drug is
approved," company spokesman Rick Koenig said.
Getting one new drug tested and approved, drugmakers estimate, takes seven
years and costs $897 million, a figure "Big Pharma" critics say is inflated
to justify high drug prices.
Whatever the true cost, none of this can happen without patients such as
Morello, 46, who was despondent on arrival at Temple University School of
Medicine two years ago.
For years, she had suffered from gastroparesis, a common disorder that
prevents even small amounts of water from being digested. She was throwing
up 24 times a day. "It was depressing," she said.
Morello had never heard of clinical trials but figured if this one failed,
she was no worse off. "If you're sick, you have nothing to lose," she said.
Things slowly began to improve. "I could sit in the car or go to the mall
and have a bottle of water with me," she said. "It's just a normal thing for
everyone else, but I was ecstatic."
Aaron Shostack, 43, of Pottstown, hasn't been so lucky.
Shostack, who is HIV-positive, has volunteered for several Philadelphia drug
trials since 1990. None helped, but he remains committed to volunteering.
"When you have an illness and there's no real light at the end of the
tunnel," he said, "the way I look at it, anything I can do, I'm willing to
do."
The biggest recruiting problem, many believe, is that patients haven't heard
of clinical trials and don't know that a commitment might last only eight to
18 months. "Industry and the medical profession have done a pretty lousy job
of educating the public about clinical trials," said Drennan.
And bad news travels fast: One in 30 patient volunteers experiences a
serious side effect and one in 10,000 dies, according to CenterWatch.
Jesse Gelsinger, 18, died during a gene-therapy trial at the University of
Pennsylvania in 1999. Traci Johnson, 19, of Bensalem, committed suicide Feb.
7 during an Eli Lilly & Co. drug trial in Indiana.
Sometimes, patients are just too busy.
"The patient may say, 'I'm from New York' or 'There's a traffic jam' or 'I
work' or 'Can I come see you on Saturday?' " said Henry P. Parkman, the
Temple gastroenterologist who runs Morello's trial, one of 101 at the
medical school.
Sometimes it's the primary-care physicians who are too busy to refer
patients to trials.
Women are hard to recruit, investigators say, because of family
responsibilities. The underrepresentation of African Americans in studies is
often blamed on the legacy of the government-sponsored Tuskegee syphilis
study in the mid-1900s. Four hundred black Alabama sharecroppers received no
treatment for syphilis so the disease could be studied.
"Tuskegee... is still an important part of the African American relationship
with the health-care establishment," said Vanessa Northington Gamble, a
medical historian and physician at Johns Hopkins School of Public Health.
She cautioned, however, that the black community's distrust of medical
trials did not begin - or end - with Tuskegee.
Jane Shull, executive director of Philadelphia FIGHT, said her AIDS service
organization has enrolled hundreds of minority patients in clinical trials.
She suggested that "provider behavior" is the problem.
"It's prejudice," she said. "They believe people of color either won't
understand the study or will be unreliable. The truth is, they just don't
try to sign them up."
CenterWatch estimates that $500 million will be spent this year on
advertising to recruit patients. And everywhere the talk is about educating
the public and making the trial experience more customer-friendly.
Meanwhile, Morello may never be able to handle a Thanksgiving feast, but she
eats salads and raw vegetables and occasionally goes out for dinner.
She now throws up "only" four or five times a day. "Everybody has
something," she said cheerfully. "This is what I have to deal with."
------------------------------------------------------------------------
Contact staff writer Virginia Smith at 215-854-5720 or
vsmith@phillynews.com.
------------------------------------------------------------------------
© 2004 Philadelphia Inquirer and wire service sources. All Rights Reserved.
http://www.philly.com
|
|
