Examples of
Health Risk Communications Perceived Less Effective
National
Institute of Environmental Health Sciences, NIH—Analgesic Use and Kidney Disease
8.1 Case Description
In May 1989, NIEHS epidemiologists
published in the New England Journal of Medicine a
case-control study that linked chronic use of two
analgesic drugs, phenacetin and acetaminophen, with
kidney disease. (2) On
the day of publication, at least 10 newspapers reported
the study findings. In general, the newspapers reported
the NIEHS findings accurately. However, almost all
newspaper stories also contained a rebuttal of the study
findings by a major manufacturer of acetaminophen. The
mixed nature of the newspaper accounts may have led to
public confusion about the drug's health risk.
8.2 Characterization of Risk
NIEHS wanted to convey the message
that long-term, daily users of phenacetin were five times
more likely to develop kidney disease than those who took
pain medication infrequently. Also, long-term daily users
of acetaminophen were three times more likely than
infrequent users to develop kidney disease.
8.3 Health Risk Communication
Procedures
At the time of the study's
publication, the NIEHS press office issued press releases
and background materials that were sent to all major
newspapers. Despite substantial efforts to communicate
the findings of the study, the NIEHS researchers believe
that their efforts were adversely affected by the
manufacturer's communications and criticisms to the press
and directly to physicians. Although there was some merit
to the manufacturer's criticism, the manufacturer's
conclusion that there was "no basis" for an
association was considered questionable by NIEHS. In
defense of their findings and conclusions, the NIEHS
investigators not only wrote letters to the New England Journal, but they also wrote directly to the manufacturer
and offered to have an independent body evaluate some of
their raw data.
The manufacturer's opposition was not the only obstacle
to NIEHS' effective risk communication. Other qualitative
factors that may have worked to confuse consumers include
(1) the risk of ingesting acetaminophen was voluntary and
controllable; (2) children weren't affected; (3) the
victims were "statistical"; (4) the effects
were not as dreaded as others, such as cancer; and (5)
there were clear benefits to the use of analgesics.
Four major observations can be made about this particular
risk communication event:
- Competing economic interests
may adversely influence risk communication
efforts and may require a more aggressive or
intensive approach to communicating findings to
key audiences such as the media and the
professional medical community.
- If the product generating the
risk is regulated by FDA, then FDA may be helpful
in mitigating possible criticism by the
manufacturer.
- Awareness of the factors
leading to decreased public concern about risk
might improve the effectiveness of risk
communication efforts.
- Statements about the need for
confirmatory studies, although scientifically
justifiable, may lead to decreased public concern
about risk.
8.4 Outcomes and Benefits
Despite some initial public concern
immediately after the release of the NIEHS study, the
long-term effect was to create greater awareness of the
risks associated with regular use of acetaminophen. FDA
staff felt that the over-the-counter analgesic market was
not affected by the NIEHS study, and the market has
probably increased, although consumer preference may have
shifted slightly toward use of ibuprofen-containing
products.
ATSDR—National Priorities List (NPL) Hazardous Waste Site
Status Report (3)
9.1 Case Description
One of the Southern States is the site
of an abandoned chemical manufacturing plant that was
contaminated with several volatile organic compounds
(VOCs). The manufacturing plant produced a wood
preservative by mixing diesel oil and pentachlorophenol.
As a result of a 1984 investigation of the site by EPA,
the site was included on EPA's National Priorities List
of Superfund sites in 1986. In 1988, citizens near the
site requested a study to assess the health of local
residents. The objective of the study was to determine
whether the prevalence of specific diseases or symptoms
for the approximately 5,000 persons living within a
1-mile radius of the site differed from that for a
comparison population not situated near the site.
A preliminary public health assessment was prepared by
ATSDR in 1988 and was completed in 1989. The community
was skeptical of the study's findings because they were
based primarily on environmental information provided to
EPA by the manufacturer of the wood preservative. A
second study attempted by ATSDR in 1989 was met with
similar community distrust, even though the disease-and
symptom-prevalence study was conducted in cooperation
with the state's department of health.
9.2 Characterization of Risk
In the past, contamination has been
detected on site at levels which, if exposure to those
contaminants occurred, could pose a potential concern to
public health. Soils, surface water, sediments, and
groundwater have been contaminated by VOCs, heavy metals,
polynuclear aromatic hydrocarbons (PAHs), and various
other organic compounds. Low levels of chlorinated
dioxins have also been detected on site.
On the basis of the information reviewed to date, ATSDR
concluded that the site is of potential public health
concern. Risk to health could result from possible
exposure to hazardous substances at levels that may cause
adverse human health effects.
9.3 Health Risk Communication
Procedures
ATSDR is faced with challenges in
health risk communication in the subject community on two
major fronts: (1) explaining to local residents the
difficult nature of the health studies of their
community; and (2) changing strongly held assumptions and
attitudes in the community about alleged government
malfeasance, the role of big business and environmental
racism, the right to health and health care, and a host
of related concerns.
To meet these challenges, ATSDR has initiated a broad
range of communication strategies and interventions. The
purpose of the communication activities is to work
closely with local residents in assessing community needs
and concerns and then to respond to those needs by
providing timely and accurate information. Many of the
ongoing communications interventions have already been
proven effective in working with the community to
negotiate serious problems and issues and defuse some
potentially volatile situations. Community involvement
has increased through the following types of community
organization, interpersonal contact, and media
strategies:
- Community input into the
design of health studies has been actively
solicited by ATSDR through the Community
Assistance Panel (4) (CAP) process, which allows the
community to participate directly in ATSDR's
evaluation and ensures that community concerns
are addressed in any ATSDR report.
- As part of the public health
assessment review and consultation process, ATSDR
is holding two informal public availability
sessions to learn more about community concerns
related to the site.
- Before each public
availability session, ATSDR staff has
face-to-face discussions with community members
to find out what their immediate information
needs and health concerns are.
- ATSDR has worked often with
the local media to correct scientific
inaccuracies that were being published by some
news media in the area.
- ATSDR involved other
government agencies in its activities to avoid
sending conflicting messages to the community.
9.4 Outcomes and Benefits
ATSDR has learned, and continues to
learn, important lessons about the attitudes and
perceptions of community members toward hazardous
substances as a threat to human health. Some of the
following lessons in the communications process could be
fairly described as common sense or intuitive, yet they
are often overlooked:
- Take the concerns of the
community seriously by responding quickly and
appropriately to questions and problems. Regular
followup is also essential to effective
communication.
- Work closely with initial
contacts in the local system to avoid the
negative image of a meddlesome outsider.
- Emphasize personal approaches
to dialogue, such as meeting people either
one-to-one or by telephone, which may be more
successful than merely holding a public meeting.
- Provide information that is
simple and understandable. Speak in terms that
people can understand and relate to.
- Use creative media sources,
such as videotape, to inform the community about
the purpose and activities of the agency.
Center for Devices and
Radiological Health, FDA—Temporomandibular Jaw
Implants
10.1 Case Description
In April 1991, FDA ordered a
manufacturer of temporomandibular jaw (TMJ) implants to
conduct a patient-notification program for an unknown
number of patients (estimates range from 13,000 to
26,000). Patient notification was necessary because of
clinical studies showing a higher-than-normal incidence
of device failure with serious consequences.
Complicating the risk notification effort was the
company's declared bankruptcy, which prevented the
company from conducting the notification process. FDA
assumed the responsibility to identify, locate, and
notify the patients of the possible device failure. Those
reached were advised to take the following protective
actions: (1) have a professional evaluation by a
physician; (2) if warranted, have implants removed; and
(3) join an implant registry to facilitate future
notifications.
10.2 Characterization of Risk
Clinical case studies indicated a
higher-than-normal incidence of device failure with
serious consequences. If left uncorrected, the TMJ device
has been shown to have severe health side effects.
Typically, a patient may begin to experience clicking,
discomfort, and pain in the jaw. Patients have complained
about their inability to work, sleep, and perform other
normal daily activities.
As the device begins to break apart, patients may have
difficulty opening their mouth. Flaking or delamination
from the device can become embedded in oral tissue,
causing allergic reactions, ultimately resulting in
progressive erosion and disintegration of bone mass.
Numerous surgeries to correct the problem can have the
reverse effect of creating scar tissue that is resistant
to different forms of therapy.
10.3 Health Risk Communication
Procedures
Media outreach efforts by FDA,
including press and video news releases and
journal/magazine advertisements, were designed to
identify implant patients, while letters of notification
were directed to patients and doctors describing the
problems and risks associated with the device failure.
FDA patterned the materials for the company program on a
model developed by the manufacturer of the defective
heart valve (see FDA case study number 7). FDA drafted
three versions of the notification letter. Focus groups
of implantees evaluated the first two letters; their
comments formed the basis of the final letter. Changes to
the letter resulting from the focus tests were (1)
detailing the benefits to the patient for joining the
registry; (2) clarifying the cost of joining the
registry; and (3) providing detailed instructions on
completing the registration form for the registry.
FDA evaluated each of the letters for frightening word
content. The assessment consisted of comparing the total
number of words with the total number of frightening
words per letter. The results showed that there were
fewer frightening words in the first draft than in the
final notification letter sent out by the heart valve
manufacturer. FDA used the heart valve manufacturer's
letter to physicians as a model for the two drafts of the
TMJ letter to medical specialists. The first letter was
tested in a telephone interview of oral maxillofacial
surgeons and radiologists. Suggested changes to the
letter were minimal and were incorporated into the final
letter.
10.4 Outcomes and Benefits
Measurement of the effectiveness of
FDA's risk communication notification program is ongoing.
Efforts are still under way to identify, locate, and
notify patients. Patients who have already been notified
appear motivated to take action in contacting the
registry for information and to see their physician for a
medical evaluation. Less successful has been the overall
identification and location of TMJ patients.
Approximately 4,000 of the estimated 13,000 to 26,000
patients have been identified and located. Public
awareness of the program has come about mainly through
media outreach, interpersonal contact (e.g., friends and
family), or registering of accident complaints with FDA.
ENDNOTES
(2) Sandler DP,
Smith JC, Weinberg CR, et al. Analgesic use and chronic
renal disease. NEJM 1989;320(19): 1238-43.
(3) ATSDR is
conducting an ongoing review (public health assessment)
and investigation (health consultation) of the
information available about contamination at the site.
(4) Community
Assistance Panel is a group of community members
impaneled by ATSDR to advise the Agency on the
community's health concerns and recommended actions.
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