Drug Trials Reach Out for Patients (and Vice Versa) on the Web

February 27, 2001 - It was 1993 when Katherine Russell Rich learned that
her breast cancer had recurred. Tumors were eating away at her spine, and
her doctors told her she was only weeks away from becoming both paralyzed
and incontinent.

As she lay curled in the fetal position in the hospital, groggy on
morphine, a friend suggested that she hire a medical researcher to see
what, if any, options were available. Clinical trials for new breast cancer
treatments were out there — but where? There was no central place to find
them.

A researcher would have to call dozens of hospitals, doctors and academic
institutions to come up with a list of options, and after that there would
be the endless discussions with each trial coordinator to find out if Ms.
Rich was an appropriate candidate.

"Still, hiring a researcher gave me hope I could do something," said Ms.
Rich, 44, who in 1999 chronicled her experience of surviving breast cancer
in "The Red Devil: A Memoir About Beating the Odds."

"It was the sort of thing very few people would even think to do at the
time," she said. "The Internet was still a mystery — and sites that talked
about clinical trials were in the Stone Age."

As it turned out, she did not find an appropriate trial, though she did go
on to have radiation followed eventually by a bone marrow transplant.

Had she undertaken that search today, she would have had many places to
turn. Since October, at least four Web sites have been introduced on the
Internet, with more to come. Largely financed by venture capital firms,
they are generally geared toward helping pharmaceutical and biotech
companies recruit patients for their trials. The four new Web sites are
emergingmed.com, veritasmedicine.com, americasdoctor.com and acurian.com.
Among those taking shape is hopelink.com.

Part matchmakers, part bounty hunters, these services are free to subjects
and promise to cut down the money pharmaceutical and biotech companies pay
to find appropriate subjects. Private industry pays anywhere from a few
dollars for a client reference for a relatively common medical problem —
foot fungus, say — to thousands of dollars for candidates with rare
diseases. Government studies and trials at academic centers also have money
for candidate recruitment, but substantially less; many of these trials are
listed on the new Internet sites as a public service.

Not that the availability of information is an unalloyed good. More choices
can mean more confusion, and because patients may be coming into their
doctors and asking about treatments the doctors themselves have not heard
about, the sites may be perceived as threats to their authority.

"If you say the words `promising new cancer treatment' — well that sounds
like a good deal," Ms. Rich said. "But let's face it, most of the
treatments don't work out. Doctors can get frustrated if they have a
treatment that's working, and the patient is confronting them with the
promise of something new."

Which raises the question of informed consent. Do seriously ill patients
being matched over the Internet fully understand that trials are just that
— trials — and very rarely result in a cure for their diseases?

"Most patients could not state for you exactly what the purpose of the
trial is," said Dr. Paul Helft, an ethicist and professor of medicine at
the University of Chicago, who has been studying how cancer patients find
and select clinical trials. "It's clear they enter primarily for
therapeutic benefit. And the trials are not designed that way."

Indeed, cancer patients are often subject to the riskiest Phase 1 trials,
which test the safety of potentially toxic agents that could not be used on
healthy people.

Government studies like those at the National Cancer Institute, posted on
the Web site cancernet.nci.nih.gov, post clear warnings: "Because all
potentially harmful side effects are not known before a trial is conducted,
dose and schedule modifications may be required for participants if they
develop side effects from the treatment or test. The therapy or test
described in this clinical trial is intended for use by clinical
oncologists in carefully structured settings, and may not prove to be more
effective than standard treatment."

But commercial clinical trial sites on the Web are not subject to
monitoring by institutional review boards, the panels that examine ethical
issues and ensure that the language used to inform potential trial
candidates is not coercive or too hopeful.

"The whole area of monitoring what goes on on the Internet is an uncharted
area," said Dr. Cynthia Dunn, director of the clinical research institute
at the University of Rochester. "And that's troublesome."

While some sites, like emergingmed.com, say the information they present
will be examined by a review board, the Food and Drug Administration does
not require panels to check Web descriptions of trials. But print
advertising for drug trials is subject to F.D.A. rules, which demand that
the language be reviewed and that enough information be given to meet
federal standards of informed consent. The drug trials themselves are
monitored by review boards and subject to the agency's regulations and
standards.

For now, the sites primarily are conduits to link trials with potential
patients. The warnings will come later, say the Web site organizers, when
potential patients actually go to the trial centers and enroll.

The issues are complex, Dr. Helft said. Are desperate patients, many of
whom spend much time surfing the Web for help, more informed, or more full
of false hopes? Or are their hopes grounded in realism?

Traditionally, pharmaceutical companies recruit trial candidates through
print, radio and television advertisements. While the companies may be
inundated with calls, the vast majority of potential candidates do not fit
the trial criteria.

Matching candidates on the Web will make recruiting more efficient and
cost- effective, said Courtney Hudson, the chief executive of
emergingmed.com, which like most of the sites is financed by a consortium
of private investors and venture capital.

"Not that everybody will be a perfect match," Ms. Hudson said. "But they'll
have a better shot of being placed in a study that's right for them."

About five years ago, Ken Getz founded the first clinical trial site,
Centerwatch.com. The privately financed site, an outgrowth of a newsletter
marketed to physicians and pharmaceutical companies, is simply a listing of
trials that is categorized by disease, and the language describing the
trials is geared toward medical professionals.

The new sites seek to simplify the language. Both veritasmedicine.com and
emergingmed.com use software to match patients to specific trials. On
emergingmed, a potential patient clicks on the disease in which he is
interested and answers questions designed to figure which trials are
suitable for him. Then, the appropriate trials pop up on screen.

Most companies say they maintain confidentiality. But at least one,
Acurian, captures patient data and builds physician databases, acting as a
liaison between companies and patients.

For instance, patients who have indicated stomach troubles and have given
their consent may be receiving notices for new stomach-related drugs by
e-mail.

Veritasmedicine.com, which is affiliated with Harvard and Tufts physicians
and plans to license its health-information content to other sites, also
has an "opt in" program for capturing medical data, which means a patient
checks a box to receive product information.

Joshua Schultz, vice president of Veritas, said, "The site does not require
patients to identify themselves in order to receive information, and will
not sell information without a patient's specific O.K."

Emergingmed.com officials say they have no plans to capture potentially
private patient information, and patients answering questions in order to
be matched need only reveal their identities after they have been through
prescreening and are talking to the clinical trial investigators on the
phone. Ms. Hudson also said the site would not carry banner ads, based in
part on her own experience after her husband had a second heart attack.

. "I'd be on a site looking at cardiology information," she added, "and
someone was trying to sell me margarine."

Still, a thorny question remains regarding many of the sites: what happens
to the health data a site collects if the service suffers financial
setbacks or fails completely?

In 1996, the Health Insurance Portability and Accountability Act set
standards to secure patient confidentiality on the Internet by addressing
encryption of patient health records filed and stored electronically. It
does not deal with standards for the clinical trials industry or with the
information if a site ceases to exist.

Still, many in health care, including Mr. Getz of Centerwatch, believe that
the information trade-off these sites require may well be worth it,
particularly for patients with life- threatening health problems.

"Look at the statistics," said Donna Doneski, director of Communications
for the National Coalition for Cancer Survivorship, a patient advocacy
group. "Right now, only 2 to 3 percent of adults with cancer are involved
in clinical trials. At that rate, you're not going to be finding answers to
questions that quickly."

Then, he added, compare those statistics with the percentage of children
with cancer who are in clinical trials. "It's somewhere from 60 to 70
percent — because they have parents as advocates," Ms. Doneski said. "We've
made a lot of progress in childhood cancer, and part of that progress, we
believe, is because so many are involved in trials."

Ms. Rich, the author, expresses the same sentiment. Since her battle with
cancer, she has biked her way through Tuscany and Turkey and feels
healthier than at any time since her diagnosis. A drug called Cytodrin has
kept her disease in check.

Still, she knows her struggle is not over. She stays informed of the latest
advancements and clinical trials that may pertain to her.

"Too often people become timid about asking their doctors about clinical
trials," Ms. Rich said. "They worry their doctor will think they're
questioning his/her judgment. For them, these sites may be a godsend."


By JUDITH NEWMAN
Copyright 2001 The New York Times Company
http://www.nytimes.com/2001/02/27/health/27CLIN.html?pagewanted=all

janet paterson, an akinetic rigid subtype parkie
53 now / 44 dx cd / 43 onset cd / 41 dx pd / 37 onset pd
TEL: 613 256 8340 SMAIL: PO Box 171 Almonte Ontario K0A 1A0 Canada
EMAIL: [log in to unmask] URL: http://www.geocities.com/janet313/