7/25/2000 – Clinical trial revenue streams lead to more scandals

This article might explain why your doctor’s interest has shifted away from
you as a patient. He may be looking at you with $$$$ signs stamped all over
you as he envision another guenia pig for yet another clinical trial funded
by a large drug company.

Most of you are aware, or certainly should be aware, of the scandal involving
the two researchers in Georgia that are now in prison for their fraudulent
research over a ten year period on drugs such as Paxil, Celexa, Zyprexa and
others. They were out spending their millions that was coming in on the
research while their secretaries conducted the research for them.

Now breaking news out of Oklahoma reminds us once again of the dangers
involved when research is conducted in this way. Can you guess yet where the
old family doc who used to make house calls went? Thanks to the
pharmaceutical industry, medicine in America has become nothing more than
just another big business.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://neurology.medscape.com/LWW/NP/2000/v07.n06/np0706.01.html

Clinical Trials – Drug Studies Provide Benefits for Patients, Knowledge and
Revenue for Neurologists

[Neuro Practice 7(6):41,43, 2000. © 2000 Lippincott Williams & Wilkins]

——————————————————————————

Introduction

A growing number of neurologists are discovering a gold mine in their
clinical practices: Their patient population. Pharmaceutical companies and
contract research organizations (CROs) are looking for patients with a
variety of neurological conditions to participate in clinical studies,
generally for Phase III and Phase IV post-marketing drug studies.
Participating in clinical trials is a worthwhile way to keep current with
medical developments, assure patients access to the latest technology, and
not incidentally, provide a substantial revenue stream for the clinical
practice.

“There are many opportunities for neurologists,” says Matthew D. Heller, MD,
co-author with James A. Boyle, MD, of The Physicians Guide to Clinical
Research Opportunities (Los Angeles: Practice Management Information Corp.;
1996). “You’re going to learn about new drugs way before they’re out on the
market. And when physicians come under the crunch financially, it’s a
wonderful way to earn alternative income.”

Physicians in private practice play a key role in the drug development and
monitoring process. While Phase I and Phase II clinical trials involve
healthy volunteers, primarily males, post-marketing studies and many Phase
III clinical trials require large numbers of patients with the conditions
being studied. The pharmaceutical industry depends on physicians with access
to patient populations to participate in post-marketing studies. Clinical
study subjects are needed in the areas of stroke, Alzheimer and Parkinson
diseases, and movement disorders.

“Phase IV post-marketing studies are very good for the general neurologist,”
says Bill Nikolov, MD, neurologist at New York Hospital Cornell Medical
Center, who is a study coordinator for a 21-site clinical trial of topiramate
(Topamax, Ortho-McNeil Pharmaceutical) for the treatment of amyotrophic
lateral sclerosis. “Being involved in clinical research is very good for
professional development, and you learn about new drugs years before the
papers are published.”

Community Setting

In February, the National Library of Medicine launched a website
(clinicaltrials.gov) to provide physicians and patients easy access to
information about the location of clinical trials. There are presently more
than 440 clinical studies involving diseases of the nervous system,
everything from abetalipoproteinemia to Zellweger syndrome, including 115
studies of nervous system neoplasm, 16 studies of Alzheimer disease, and
eight studies of tremor.

Far greater opportunities for clinical research are found in the private
sector, particularly since accelerated drug-approval processes have placed
greater importance on post-marketing studies to identify potential untoward
effects and interactions of prescription medication.

In 1997, the pharmaceutical and biotech industry spent more than $3.5 billion
on grants to physicians who provide investigator services, and the grants
went to fewer than 10% of U.S. physicians, according to consultant Tracy
Blumenfeld, chief executive officer of Wayne, PA-based Physicians Clinical
Research Solutions.

“The demand for productive, high-quality sites [for clinical research] is
increasing rapidly,” says Blumenfeld, whose company markets the clinical
trial capabilities of physician groups to commercial research sponsors.

While demand for physician investigators is rising, so is competition for
private-sector clinical trial dollars. Heller says that the number of
private-practice physicians participating in drug studies has increased 60%
in the last five years. “It’s tougher to get a study these days than it used
to be,” he says. “There are many more investigators. Everybody wants to get
into it.”

Still, opportunities abound for physicians willing to accept the burdens of
clinical research, even for those without a university affiliation. “Often,
drug companies prefer that you don’t have a university affiliation,” says
Heller. “The patients at tertiary medical centers are quite different than
the populations found in the private practice.”

Revenue Stream

Community-based physicians have something that drug makers desperately need
patients. Post-marketing studies require a broad cross-section of patients,
representing a range of ages and illness severity. “It’s the patients they’re
looking for,” confirms Blumenfeld.

Participating in clinical studies can provide a substantial revenue stream
for medical practices. Blumenfeld says that physicians can expect
compensation ranging from $5000 to $10,000 per patient. One stroke study
presently under way pays $8500 per patient, she says.

The seemingly lucrative money in clinical trials has caused the activity to
come under fire in the popular press, suggesting that pharmaceutical
companies are bribing physicians to change prescription habits. However, the
compensation provided to participating physicians includes reimbursement for
office visits and diagnostic testing, typically leaving about 20% after
expenses.

“Nobody makes a lot of money from post-marketing studies,” says Nikolov. The
most common error made by physicians is underestimating the amount of time
and labor demanded by clinical trials. “It’s important that physicians
realize the time commitment that’s required,” says Blumenfeld. “Physicians
who look at clinical trials as selling data don’t have a clear idea of what’s
involved. It’s not like the pharmaceutical company hands the doctor $5000. He
or she has to work for it.”

U. of Okla. Scandal Leads to Exodus

.c The Associated Press

By KELLY KURT

TULSA, Okla. (AP) – A research scandal that led to the shutdown of 75 human
experiments at the University of Oklahoma medical school in Tulsa has brought
the departure of three top university officials and dismissal proceedings
against a scientist.

“I think we have no choice but to demonstrate we’re making a fresh start,”
university President David Boren said Friday. “We simply have to send a very
strong signal for the sake of all our research programs.”

The scandal broke earlier this month over a skin cancer study. An outside
audit found flaws in the manufacturing the study’s vaccine and lapses in the
monitoring of its participants, all of whom were seriously ill with melanoma.

Twenty-six of the 94 participants who received the vaccine over the three
years of the study died, though officials found no evidence the study
contributed to the deaths.

In the wake of the discovery, the university suspended 70 clinical trials at
the university and the government suspended five others.

Boren said that the university has started termination proceedings against
the study’s lead researcher, Dr. Michael McGee, and that three officials had
either resigned or retired: Harold Brooks, dean of the college of medicine in
Tulsa; Edward Wortham Jr., director of the Office of Research at the Health
Science Center; and Daniel Plunket, chairman of the school’s research
oversight board.

Boren also announced stringent new procedures, including the establishment of
a research compliance office with a hot line for anonymous callers to report
violations.

07-21-00

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