Extract
Patients, physicians, and the general public have increasingly greater
access and exposure to orthopaedic information from a wide variety of sources.
Some information is biased or commercial, while other information is
evidence-based and accurate. The dividing lines may not always be clear to
medical professionals or to consumers. This symposium considers the accuracy,
availability, and influence of information that is available to patients on
the Internet and observes the role of direct marketing to the public by the
orthopaedic industry and pharmaceutical companies. Media coverage of
orthopaedic topics, including what the media looks for in press releases, how
the media interprets and presents the material provided to them, and how the
public is impacted by such coverage, is also discussed. Furthermore, the
validity of orthopaedic industry advertisements directed to physicians, as
well as the role of industry in driving the focus of non-peer-reviewed
publications and podium presentations, is considered.
Patients, physicians, and the general public have increasingly greater
access and exposure to orthopaedic information from a wide variety of sources.
Some information is biased or commercial, while other information is
evidence-based and accurate. The dividing lines may not always be clear to
medical professionals or to consumers. This symposium considers the accuracy,
availability, and influence of information that is available to patients on
the Internet and observes the role of direct marketing to the public by the
orthopaedic industry and pharmaceutical companies. Media coverage of
orthopaedic topics, including what the media looks for in press releases, how
the media interprets and presents the material provided to them, and how the
public is impacted by such coverage, is also discussed. Furthermore, the
validity of orthopaedic industry advertisements directed to physicians, as
well as the role of industry in driving the focus of non-peer-reviewed
publications and podium presentations, is considered.
The Internet, radio, television, and print media have overwhelmed the
American public with medical information. When it is incorrect or misleading,
patients become victims of medical misinformation. The consequences can be
considerable and have negatively affected many doctor-patient relationships.
As an example, a patient may read a nonvalidated infomercial in a magazine
while on an airplane flight and develop erroneous opinions about diagnoses or
treatments. A subsequent visit to a qualified physician may then be made
difficult for the patient by conflicting opinions, the need for potentially
awkward re-education, and by considerable skepticism. In contrast, a patient
who has previously obtained accurate and understandable medical information
can be an active participant in shared decision-making with a physician.
A frequent source of medical information, the Internet, may be as likely to
help as it is to hurt. Beredjiklian et al. described the case of carpal tunnel
syndrome1. The
authors looked at 175 unique web sites and rated them with regard to mean
informational value. On a scale of 100, the average score was 28.4, or a
little less than one of three web sites had information that was of use or was
accurate. This is important because, as demonstrated by the results of a
survey by Murray et al., many people are influenced by medical information
found on the
Internet2. Of the
1050 physicians who responded to their survey (a response rate of 53%), 85%
stated that they had experienced an episode in which patients brought in some
information that they had found on the Internet. Thirty-eight percent of the
physicians found that the visit was less efficient because of this
information, 45% said that it did not make a difference, and 16% stated that
the visit was improved. The authors concluded that accurate, relevant
information helped and that inaccurate, irrelevant information harmed the
health care, the outcome, and the relationship as well as wasted the doctor's
time.
Assessing Web-Site Quality
There have been attempts to regulate the quality of medical information on
the Internet. Health on the Net Foundation is a seven-person Geneva-based
panel that evaluates the accuracy of medical web sites. Health on the Net
accredits health-care web sites and allows them to display the Health on the
Net Foundation logo. However, the logo is easily downloadable, and there has
been a proliferation of web sites displaying the logo without accreditation.
Currently, there is no good way for the public to assess web-site quality. As
of 2002, there were ninety-eight instruments that assessed web-site quality.
Forty-seven of them existed in 1998, and fifty-one are
new3. Unfortunately,
only five of them provided information by which they could be evaluated.
Even if there were good tools to assess the quality of medical web sites,
it is doubtful that users would take advantage of them. Eysenbach and Kohler
asked twenty-one people who were unfamiliar with general medicine to look up a
health topic on the
Internet4. They took
an average of five minutes and forty-two seconds to find this information. The
volunteer subjects judged the credibility of the information by the source; by
whether the web site was professionally designed, looked scientific, or had an
official touch; and by the ease of use. None of them checked "about
us" (the disclaimers that were published on the web site) nor did they
look at any of the disclosures. A few minutes afterward, none remembered the
web sites where they had found their information.
What about academic orthopaedic sites? In 2001, Rozental et al. did a
search to determine whether the 154 orthopaedic residency training programs
had web sites5. They
found that 113 had such a site. Fifty-six percent listed the faculty, and 43%
provided telephone numbers and location. Only 12% of them provided good
information on orthopaedic conditions, and only 4% had links to good web sites
for medical information for patients. Thus, academic orthopaedic sites in 2001
were missing a great marketing and educational opportunity for patients.
Patients may also be the victims of medical misinformation pertaining to
homeopathic medicine. Morris and Avorn examined 443 web sites dealing with
eight different herbal
supplements6.
Fifty-five percent claimed to treat, prevent, diagnose, or cure a specific
disease. Fifty-two percent of them were breaking the law. They had health
claims but omitted the required Food and Drug Administration disclaimer.
What Orthopaedists Can Do
To help to combat medical misinformation on the Internet, there are some
simple things that orthopaedic surgeons can do. They can advocate that
patients use only reputable web sites, such as the American Academy of
Orthopaedic Surgeons (AAOS) web site "Your Orthopaedic Connection"
().
Web sites for clinicians and orthopaedists, such as those readily available
through AAOS, can provide reliable medical information or a link to the AAOS
"Your Orthopaedic Connection." Such a web site can be publicized
through business cards, letterheads, and listings in the telephone book.
Appointment receptionists can direct patients to the web site before their
visit. Also available through the AAOS is a prescription pad, "Rx for
Patient Education," that directs patients to the AAOS web site
"Your Orthopaedic Connection."
An immediate concern among all health providers is the impact of
direct-to-consumer advertisements for prescription drugs and, more recently,
medical devices. Pharmaceutical companies and device manufacturers regularly
advertise their products directly to patients on the radio, television, the
Internet, newspapers, and magazines. Some orthopaedic device manufacturers are
now advocating specific surgical procedures directly to consumers. The
patients of orthopaedic surgeons now specifically ask for a particular drug or
device.
The expansion in direct-to-consumer advertising is largely due to a 1997
change in the United States Food and Drug Administration guidelines. Although
direct-to-consumer marketing was actually authorized prior to 1997,
pharmaceutical companies and device manufacturers were not certain of what was
permissible. Following the release of the Food and Drug Administration
guidelines, spending on direct-to-consumer advertising increased from $791
million in 1996 to just under $2.5 billion in
20007. The Food and
Drug Administration guidelines state that truthful descriptions of indications
as well as a major statement of side effects and contraindications are
required. However, the important statement on side effects and
contraindications may be omitted if the patient is referred to a toll-free
number, a web address, a physician or a pharmacist, or a print media
advertisement8.
Unfortunately, the Food and Drug Administration is not empowered, nor does it
have the resources, to conduct prior approval of these direct-to-consumer
advertisements.
In a study by Woloshin et al., the content of advertisements that appeared
in seven issues of each of ten magazines published in the United States
between July 1998 and July 1999 was
reviewed9. These
included advertisements for drugs to ameliorate symptoms, treat disease, or
prevent illness. Despite a variety of promotional techniques, as well as
emotional appeals and encouragement of consumers to consider the medical
causes of their experiences, most of the advertisements were found to describe
the benefit of the medication in very vague qualitative terms with <13%
referring to any data. Although half of the advertisements did use data to
describe side effects, they typically focused on the side effects that
occurred infrequently and, therefore, did not impact negatively on the
product. None of the advertisements mentioned the cost of the medication. In
an effort to derive a useful interpretation from these data, the authors
suggested that the provision of complete information about the benefit of
prescription drugs in advertisements would serve the interests of physicians
and the public.
Rowland reported that 70% of general practitioners surveyed said that
direct-to-consumer marketing confuses the relative risks and
benefits10.
Seventy-five percent of them believed that it causes the patient "to
think drugs work better than they really
do."10 In a
separate study, family practitioners thought that the direct-to-consumer
advertisements pressured them to use the drugs that they would not use
ordinarily7.
Between 1996 and 2003, pharmaceutical companies increased spending on
direct-to-consumer advertising from $791 million to $3.2 billion and industry
promotional spending totaled $25 billion. According to a Kaiser Family
Foundation report, prescription drug expenses increased two to five times more
than spending on hospital care and physician services during this same
period11. In light
of Merck's recent recall of Vioxx, direct-to-consumer advertising will likely
come under increased scrutiny by federal agencies, consumer groups,
physicians, and patients.
It is clear that direct-to-consumer advertisements can have a negative
impact on the doctor-patient relationship and that physicians may feel the
"pressure to prescribe," which may lead to inappropriate
medication use or therapy. However, direct-to-consumer advertisements can have
a positive effect too. They can raise the public awareness of a specific
medical condition and may promote an appropriate visit to the doctor.
Recently, the AAOS developed a position statement on direct-to-consumer
advertising, which addresses many of the points
discussed12.
Continued research efforts on the effects of direct-to-consumer advertising on
public health are called for. The statement recognizes the potential value of
direct-to-consumer advertising provided that it is done "in a
responsible and ethical manner" and that it should be
"scientifically substantiated, accurately presented, and free of false
or misleading claims." It acknowledges there may be patient safety
concerns "if it leads patients to seek health care solutions without
consulting a physician." It also states that "advertising that an
individual surgeon has received training to perform a procedure does not imply
the same standards as certification by the American Board of Orthopaedic
Surgery (ABOS)."
It is appropriate for the orthopaedist to remain the premier source of the
patients' orthopaedic information. Although the media, the Internet, and
industry exert influences on patient information, these sources should seek
counsel from orthopaedists to assure the accuracy of information provided to
patients. Orthopaedists must make time to assist them in this joint endeavor.
Questions to consider with regard to the interaction of the orthopaedist with
the media include the following: How should the orthopaedist relate to the
media? What information is appropriate to release to the press? How does the
media handle orthopaedic information? How does the public relate to the
orthopaedic information presented by the media?
There is no doubt about the importance of media-generated information. The
media can increase public awareness of health-related issues, impact political
trends, and influence the allocation of research funds. Examples include
television's educational partnership with the National Dairy Council to
enhance awareness of the benefit of drinking milk on bone health, their
participation with the American Lung Association on the need to cease
cigarette smoking and the dangers of secondhand smoke, and their campaign in
association with the American Academy of Orthopaedic Surgeons to increase
awareness of fall prevention strategies, especially in the elderly.
The media has been influential in the successful campaign to champion a
patient's right to choose his or her physician. The media's emphasis on the
prevalence and devastating effects of breast cancer resulted in increased
funding for breast cancer research by government agencies. Moreover, the
recent highlighting of the substantial physical and emotional cost of
arthritis appears to be resulting in increased funding for research on
cartilage growth and repair.
Who is "the media"? The media are journalists who produce print
and broadcast news. Broadcast media can be taped or live, cover general or
specific topics, and is typically more focused and abbreviated than print.
Print media encompasses both newspapers and magazine articles. Articles in
newspapers can be feature articles, science articles, or general news. General
news articles are usually the briefest. Magazines can be general (e.g.,
Time or Ladies' Home Journal), or they can be focused on a
specific interest (e.g., Golf Digest and Tennis Weekly).
Trade magazines, like Orthopedics Today, report the latest news in
orthopaedics to orthopaedists. Journalists who write for the trade magazines
are usually very knowledgeable about the medical field and are frequently
members of the American Medical Writers Association, the Association of Health
Care Journalists, or the National Association of Science
Writers13. These
writers generally have a story in mind and are looking for a few quotes or
verification of facts when they call a physician for an interview. It is rare
that such an interview is hostile. Although trade magazines are written to
attract a physician audience, journalists of health columns may read them and,
after reviewing the newest information, develop ideas for their own
articles.
Medical writers who script articles for major publications and broadcasts
can be very knowledgeable. However, in some instances, reporters may have very
little medical knowledge and may be looking for an education when they call
the orthopaedist for comments on a particular
topic13. On
political issues, reporters may be friendly or hostile and potentially lead to
a challenging interview for the physician.
In a survey by the National Health Council, 2256 people were asked about
their primary sources for health-care
news14. The results
showed that most look primarily to television as their medical news source,
with doctors as the second most popular source, magazines and journals as the
third most popular, and newspapers as the fourth. Five percent of all local
television shows are about health. Typically, this segment consists of clips
that are forty-two seconds
long15.
Who does the public trust for reliable information? Even though the primary
source that the public uses for health information is television, it is the
doctors, nurses, and pharmacists who are the most trusted source, with books
following closely
behind15,16.
To be able to understand how doctors can influence the public through the
press and to understand how to get the interest of the press, physicians must
first understand what triggers an article or an interview by the press.
Recently published research, a celebrity injury (for example, former President
Clinton's quadriceps rupture), or a catastrophic public occurrence (such as an
increased prevalence of acute cardiac events for patients taking a commonly
prescribed medication) often results in a story. A recent survey revealed that
it is personal relevance, and not sensationalism, that attracts viewers'
attention to medical news
broadcasts17.
During a media interview, orthopaedists should be clear and concise with
their prepared comments, which should be both interesting to the press and
also relevant to the public. Physicians should take care not to talk above the
level of the audience as well as to avoid medical
jargon18,19.
The audience's unspoken question, "What's in it for me?" should be
anticipated and answered. It is important to know the subject matter in
advance and to know the expected audience, so that the message can be tailored
to them. Because the interview may result in only fifteen seconds of air time,
the interview should stay focused. This will be more likely if there is a
"grab 'em" type introductory sentence, three or four points to
stress with supporting statistics, and a summary made by repeating key points.
For example, rather than simply stating, "We should all help to make
playgrounds safe for children," one should say instead, "Increase
the safety of your child's playground by ensuring that (1) the equipment is
properly spaced, (2) the surface is soft and absorbent, and (3) the playground
is protected with barriers." Or, rather than saying, "Injuries can
occur if children do not wear helmets while in-line skating," it is
better to support the statement with facts, such as, "Over 27,000
children were injured last year while in-line skating. Of those, 321 who were
not wearing helmets died from head injuries."
Having props available for broadcast interviews will help to better
illustrate the message. If an interview goes in a different direction than
planned, the technique of bridging to return to the original message can be
used, such as, "I remember that instance, but don't you believe the more
important point is..." Additionally, for accuracy and to help the
reporter to maximize the interview time, it is helpful to provide information
to the reporter prior to the interview.
Even though orthopaedists may try to provide accurate and current
information to the media during an interview, the media may well place their
own slant on an article or video clip. The media often interprets the medical
information as they perceive it or as they feel it will be best received by
their readers or viewers. The orthopaedist's agenda should be to present
truths to foster public welfare. The press's agenda may be an interesting
story, with lifestyle implications, catchy headlines, broad appeal, or
realistic stories, but not necessarily overwhelmingly accurate
ones16. The press
enjoys controversy. In a live broadcast, one can pick the points to stress and
typically be heard. This is harder to do in a taped broadcast or in the print
media, as the physician's words may be taken out of context, abbreviated, or
rearranged either overtly or inadvertently by the journalist.
Newspaper articles are frequently influenced by press releases provided by
medical publications or
organizations20. A
retrospective analysis of newspaper stories and press releases found that, of
the published articles, 84% had been promoted in press releases prior to
publication21. Only
recently have press releases on medical journal articles been made available
by authors or by journal editors prior to the publication date. Dr. Franz J.
Ingelfinger, editor of the New England Journal of Medicine, in 1969,
instituted a rule that stated that a journal article would not be published if
its contents were released in substance prior to the journal's publication
date14,22.
This "Ingelfinger Rule" has been countered with the "Embargo
Rule," which essentially states that if a journal or author provides
journalists with an advance copy of a manuscript or a press release of a
manuscript prior to the publication date, the journalists will not print a
story regarding the material until the day of official publication of the
journal22. In this
way, the journalists can write timely articles on the latest information
without the publication of medical journal articles being preceded by media
releases.
Press releases have come to be regarded by science writers as an easy
source of current scientific
information20. They
are highly credible if obtained from peer-reviewed journals, and they have
generally been screened for human interest. Realizing that journalists are now
relying on press releases for stories, orthopaedists and journal editors
should ensure that press releases contain accurate and complete information.
The media looks to press releases to learn the latest scientific discovery.
They wish to know: Is it safe? Is it successful? What does it cost? Is it
available? What are the alternatives? The press wants new and dramatic
information, as they must tell their story. At issue is the potential conflict
that scientists want true research, with results becoming more reliable upon
repetition. It should be remembered that journalists are foremost reporters
and not
educators23,24.
Physicians should remember that the public considers them the most trusted
source of medical information. Eighty percent of the people surveyed responded
that they sought further information from their own doctor after reading an
article14.
Orthopaedists must take care not to lose this premier position in patients'
minds. Press releases, therefore, should be a very reliable source of current
information and should highlight the study's limitations and sources of
funding. Moreover, orthopaedists should consider whether press releases should
be limited to refereed articles only or whether they should also include
nonrefereed presentations on new technology or treatments. One option to help
to avoid the release of misinformation and to expand accuracy in press
releases has been suggested by Jane Brody, a medical writer for The New
York
Times19.
Such a protocol would include the information listed in
Table I.
Research has shown that to be most effective, press releases should be
e-mailed to journalists directly rather than merely distributed to the wire
services19.
Orthopaedists who are knowledgeable regarding the topic should be available
for questions after release.
In summary, orthopaedists need to stay on top of the media food chain. They
should be aware that lay readers want personal relevance, not sensationalism.
Orthopaedists should ensure accuracy, express limitations, and detail any
biases in the scientific orthopaedic information released to the press and, as
a result, should not jeopardize their position as a trusted authority.
The role of advertising in medicine has undergone substantial evolution
over the past three decades. At one time, advertising to influence patient
decision-making or physician behavior was considered inappropriate at best and
unethical at worst. Now, not only has industry ramped up its advertising
efforts but hospitals, health-care organizations, and physicians themselves
have begun to advertise. Indeed, allocations of dollars for marketing occupy
substantial portions of these organizations' budgets. With regard to the
regulation of advertising in the medical market-place, Capozzi and Rhodes, in
a recent "Ethics in Practice" article in this journal, stated,
"Democratic societies are committed to liberty and, in particular, to
freedom of expression and trade. In that light, the position of the United
States courts on medical advertising is perfectly understandable. Advertising
is essentially speech in the promotion of trade, so government should not
restrict it unless it can be shown to cause great
harm."25
Most would agree that industry plays a role in influencing physician
behavior. However, the impact of that influence is unknown, and the validity
of the information provided to physicians has not been well studied. In order
to investigate the validity of claims made in orthopaedic print advertisements
in journals, Bhattacharyya et al. identified fifty statements from fifty
advertisements randomly selected from six peer-reviewed orthopaedic journals
(The Journal of Bone and Joint Surgery [American volume],
Orthopedics, the American Journal of Orthopedics, the
Journal of Orthopaedic Trauma, the American Journal of Sports
Medicine, and the Journal of the American Academy of Orthopaedic
Surgeons)26.
The companies were then contacted to provide supporting data, and three senior
orthopaedic surgeons, blinded to product and company, evaluated the data for
quality and support. Twenty-three advertisements (46%) focused on adult
reconstructive orthopaedic surgery, while ten (20%) related to trauma, nine
(18%) focused on sports medicine, and eight (16%) concerned basic science
(bone-graft substitutes). A reference was cited to support the claim in only
twelve advertisements (24%).
The supporting data provided by the companies showed that only eighteen
advertisements (36%) were supported by a published source, twelve (24%) were
supported by presentations at scientific meetings, and an additional twelve
were described by the companies as being "data-on-file" (in other
words, supporting data had neither been published nor presented but the
company asserted it had information to support the
claim)26. Only four
companies did not respond after three attempts to solicit supporting data. The
analysis of these data for quality and support showed that only seven data
sets were considered "well supported," seventeen were considered
"possibly supported," and twenty-two were considered
"unsupported." Interobserver agreement among the three senior
orthopaedic surgeons was good (intraclass correlation coefficient, 0.72). The
authors concluded that industry is generally responsive to this type of
inquiry but more than half of the claims are not supported by good scientific
data.
This information raises several questions. First, should industry be held
to some standards regarding the validity of the claims they make in print
advertisements? Should those standards be equivalent to, or in any way related
to, the types of standards to which published articles are held when they are
considered for publication in the medical literature? At one extreme, some
journals currently rate the quality of the evidence associated with the
articles that they publish. This journal began doing this in January 2003 and
uses a five-tiered rating system to place a clinical study into its context
for the reader27.
However, most journals in medicine have no systematic procedure for addressing
this issue.
To investigate the question of evidence-based advertising by industry,
Gutknecht performed a study to determine how research results are presented in
pharmaceutical
advertisements28.
After reviewing a consecutive, six-month sample of advertisements in four
general medical journals, he found 186 distinctive advertisements, of which
only forty-three presented results with quantitative data. References to
randomization and blinding were found in less than half of these, and,
although p values were frequently provided, confidence intervals and
references to power and number were not. He concluded that "descriptions
of research in pharmaceutical advertisements were brief and incomplete, and
they inconsistently provided the basic design and statistical information
needed to judge the results reported."
Another question raised in relation to this general topic is whether media
coverage of scientific meetings is appropriate. Schwartz et al. performed a
search of LexisNexis to identify news stories printed in the two months
following five scientific meetings held in 1998 (Twelfth World AIDS Conference
and the meetings of the American Heart Association, Society for Neuroscience,
American Society of Clinical Oncology, and the Radiological Society of North
America)29. They
also searched MEDLINE and contacted authors to determine subsequent
publication of articles in the medical literature within three to 3.5 years
after the meeting presentation. They identified a total of 252 articles
reporting on 147 meeting abstracts. They found that, in the three years after
the meetings, 50% of the abstracts had been published in high-impact journals,
25% had been published in low-impact journals, and 25% had not been published.
The publication record of the thirty-nine abstracts receiving front-page
newspaper coverage was almost identical to the overall rate. The authors
concluded that a substantial number of studies from scientific meetings remain
unpublished and preclude evaluation in the scientific community. Similar
findings have been confirmed for orthopaedic scientific meetings, including
the Annual Meeting of the American Academy of Orthopaedic Surgeons as reported
by Hamlet et al. in a 1997
article30.
The way by which industry, the medical media, and even health-care
organizations and physician practices present the quality of their product to
their peers or the public is inconsistently reviewed, validated, or judged. As
a result, the impact on patient care is unknown. This raises several
questions: Should published statements by industry be held to the same
standards as scientific articles by clinicians and scientists? Can or should
industry be held accountable for the information they publish? Should medical
journals "referee" or reject advertisements if they are not
supported by data or make unreasonable claims? The American Academy of
Orthopaedic Surgeons and other professional associations are grappling with
these and related questions right now.
Information about orthopaedic conditions, treatments, and associated
products is widely available to the general public, patients, and health-care
providers. The reliability of the source and the validity of such information
may not always be accurately identified. Orthopaedists should be aware that
their patients may receive misinformation from the Internet or other sources.
They are encouraged to refer their patients specifically to reputable sources
of orthopaedic information such as the AAOS web site for patients
().
They are invited to develop personal interviewing skills and to be available
to report as an accurate media source. Full disclosure of funding sources,
potential conflicts of interest, and the study's level of evidence should
accompany orthopaedic media releases. It is hoped that the impact of
advertisements in the medical literature, and the way by which advances in
medical sciences are covered by the press, will improve communication and
knowledge so that physicians and patients can make informed choices regarding
disease treatment and maintenance of health.
The authors did not receive grants or outside funding in support of their
research or preparation of this manuscript. They did not receive payments or
other benefits or a commitment or agreement to provide such benefits from a
commercial entity. No commercial entity paid or directed, or agreed to pay or
direct, any benefits to any research fund, foundation, educational
institution, or other charitable or nonprofit organization with which the
authors are affiliated or associated.
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