Letter to Editor: Advance Release
Applied Clinical Trials: September 1999
Countering bad news – a call to action
Recent reports surrounding clinical trial research
practices are drawing negative attention from the
public and congressional leaders. With the release
of the 1998 Office of Inspector General’s report on
IRB’s in June of 1998, the Office for Protection from
Research Risks (OPRR) has closely scrutinized
clinical trial research practices and institutional
review board compliance. In the last 10 months, the
OPRR has suspended research activities at a
number of prestigious academic medical centers
around the country. Now, a second DHHS
investigation has been initiated to specifically focus
on aggressive patient recruitment practices utilized
by investigator sites and recruiting firms to enter
patients into clinical trials. Pharmaceutical
companies will be held accountable for the actions
of study trial sites, regardless of whether a contract
services vendor is involved or not. The negativity
surrounding these reports has an affect on everyone
involved in clinical trials -- subjects, investigators,
sponsors, and contract vendors. The perceptions
and risks that are created are shared equally among
those with vested interests in clinical research.
Recent media stories, such as those published in
the May 16th and 17th editions of the New York
Times paint a picture of greed and patient
exploitation by physician investigators and the
companies with which they collude to conduct
clinical research. In April, the CBS television public
affairs program, 48 Hours aired an hour-long
segment depicting unethical research practices as
the norm for clinical trials involving patient
volunteers. Negative press reports serve to
profoundly affect our business: unnecessarily
frightening potential study subject volunteers, driving
up the costs of conducting research and creating an
exploitative perception of our industry.
In the mid to late1980’s aggressive pharmaceutical
sales and marketing tactics prompted hearings in
the U.S. Congress that lead to substantial reform on
promotional practices that could be akin to what lies
ahead for clinical trials only worse. During this
period, I served as chairperson of PhRMA’s Public
Affairs Section (then PMA), and was instrumental in
being part of the team that shaped the
communications strategy to address the
congressional inquiry.
It is my opinion that the industry should leverage its
experience from the scrutiny of its marketing
practices. Only this time the industry must be
prepared for the worse. In marketing practices the
issues centered on gifts, trips and “boondoggles.”
The patient focus was absent. In clinical trials
journalists and politicians and others will delight in
painting the picture of vulnerable and frail patients
preyed upon by the monetarily greedy industry. We
must develop a proactive campaign that provides a
“fair-balance” perspective. Our industry has been
under examination before. The lessons learned
from the previous experience should be mobilized
for the controversy now being generated by the
media.
My experience in subject recruitment programs has
shown that patient’s trust, understanding and belief
in the importance of clinical research and safety are
paramount to their participation as study subjects -and to efficient trial execution. Enrollment of study
subjects into clinical trials is often the overriding
factor for timeline delays and budget overruns.
As additional negative press unfolds, such as an
upcoming story in USA Today, we call upon the
readers of Applied Clinical Trials and everyone in
the business of discovering, developing, and
marketing pharmaceutical products -- to act.
Preserve the dignity, integrity and value of the
research and development efforts conducted by our
industry. Embark upon a proactive informationadvertising campaign such as PhRMA’s public
affairs campaign profiling the advancements
pharmaceutical research and development
companies have contributed to society. Perhaps the
industry should develop a code of practices
specifying the way study patients should be treated
by sites. We should explore more self-regulation as
a way to prevent a congressional mandate.
Essentially we need interventions aimed at
reassuring patients and ensuring public confidence.
Clinical investigators, companies and sponsors and
satisfied study participants must work together
nationally and locally to highlight the contributions of
clinical research. My colleagues and I are ready,
willing and able to support the industry and help
develop strategies that prepare for the mounting
criticism surrounding clinical trials. We hope you
feel the need to proactively respond.
Liz Moench
President, MediciGroup®
Wayne, PA
MediciGroup® 655 E. Swedesford Rd., Suite 205, Wayne, PA 19087
Tel: 610.995.2025 Fax: 610.995.2303 Email: MediciGrp@aol;.com