A perusal of several popular magazines readily available at newsstands across the nation reveals the following advertisements:
“Smoother, slower burning cigarettes…lasts longer…Premium tobacco packed tighter for a longer lasting experience…Pleasure to burn.” At the end of the ad is the fine print: Surgeon General’s Warning: Smoking causes lung cancer, heart disease, and emphysema, and may complicate pregnancy by causing fetal injury, premature birth, and low birth weight…Cigarette smoke contains carbon monoxide…No additives in our tobacco does not mean a safer cigarette…There is no such thing as a safe cigarette.
“If a relaxing moment turns into the right moment, will you be ready?…The first tablet for erectile dysfunction that gives you up to 36 hours to choose the moment that’s right for you and your partner…Don’t miss another moment.” At the end of the ad is the fine print: Side effects include headache, indigestion, back pain, muscle aches, flushing, vision changes, or an erection that won’t go away (priapism).
“I won’t let arthritis pain keep me from teaching…Provides 24-hour relief of arthritis pain, stiffness, and inflammation.” At the end of the ad is the fine print: Side effects include heart attacks and other serious events, such as blood clots, acute kidney failure, hepatitis, and aseptic meningitis.
“To stop heartburn pain of acid reflux disease and allows the esophagus to heal.” At the end of the ad is the fine print: Adverse reactions include carcinoma, myocardial infarction, diabetes mellitus, and convulsions.
“Our fund managers spot global investment opportunities others might miss…One-year average return was 18.34%.” At the end of the ad is the fine print: Investment return and principal value will fluctuate so that your shares, when redeemed, may be worth more or less than their original cost…Performance data quoted include 5.75% initial sales charge and represent past performance, which does not guarantee future results…More recent returns may differ from figures shown.
“People don’t always use common sense; fortunately, there’s a health care company that does…24-hour access to a registered nurse…Doctors don’t need permission to treat you…Fewer co-pays for maintenance drugs online.” At the end of the ad is the fine print: Prior authorization may be required for certain health claims and prescription drugs.
The same consumer magazines contained the following advertisements for mammography:
“A mammogram saved my life.”
“Get a mammogram for life-saving screening.”
“With mammography, radiologists can find a cancer the size of a head of a pin.”
“You may have missed seeing the small dot in this ad, which could be the first sign of breast cancer, but your mammogram will find it.”
“Mammograms can detect a tumor as little as a grain of rice, while physical exam will not find a cancer until it is 1-2 cm.”
“One out of every eight American women will develop breast cancer at some point in her lifetime…A mammogram can detect 90% of cancers.”
At the end of all of these advertisements, there is no fine print.
Each advertisements described above, with the exception of those dealing with mammography, ended with so-called fine print, ie, statements in the form of a disclaimer, warning, admonition, caveat, or list of adverse effects or limitations.
Should we care that the advertisements marketing mammography did not include any of these caveats or limitations? And if so, why? The one-word answer to the first question is “Yes.” The one-word answer to the second question is “Malpractice.”
The allegation of a delay in the diagnosis of breast cancer is the leading cause of medical malpractice litigation in the United States today, and has been for the past decade. 1 Of all medical malpractice lawsuits filed in the United States that allege a delay in the diagnosis of breast cancer, radiologists are the most frequently sued specialists. Of all medical malpractice lawsuits lodged against radiologists, the most frequent cause is the allegation of a missed breast cancer on mammography. Why has “missed breast cancer” risen to first place in the medical malpractice standings? I suggest that it is because we have oversold mammography. We have marketed mammography without informing the American public all that we know about not only the benefits, but more important the limitations and potential harms of mammography.
THE KNOWLEDGE GAP
|Leonard Berlin, MD|
In our well-intentioned and commendable effort to reduce the mortality and morbidity associated with breast cancer, we radiologists, along with the American Cancer Society and other medically related organizations, have through advertising and other marketing campaigns encouraged women to undergo screening mammography. True, the high level of mammographic utilization that we have achieved through these marketing efforts has resulted in overall improvement in the health and welfare of American women, but at the same time, this marketing has resulted in something that can be considered detrimental: an exponential growth in malpractice litigation alleging misinterpretation of mammograms.
We – that is, the radiology community – know that in as many as 70% of patients in which a new mammogram discloses a cancer, a finding that probably represented the cancer is visible, in retrospect, on a preceding mammogram that had been interpreted as normal.
We know that mammography does not prevent cancer.
We know that some breast cancers are so virulent and possess such high-grade malignant potential that even if they are detected early by mammography, it will be too late to prevent a woman from dying of the disease.
We know that some breast cancers grow so slowly and possess such low-grade malignant potential that the value of early diagnosis is questionable and in such cases delays in diagnosis will not adversely affect the patient’s chance for cure.
We know that some women in whom breast cancer is diagnosed would never suffer any adverse consequences of the cancer if it were untreated, and yet nevertheless undergo surgical and/or chemotherapeutic treatment that may cause complications.
We know that the percentage of ductal carcinoma in situ (DCIS) cases that will evolve into invasive carcinoma lies between 14% and 60%, 2 and that the death rate within 10 years among patients with DCIS is 1% to 2%.
We know that there are divergent opinions in the scientific community and contradictory interpretations of available data that deal with the question of whether early diagnosis of breast cancer by means of mammography does, or does not, lower the mortality rate from breast cancer; and that while there has been a decrease in the number of deaths attributable to breast cancer, it is not clear whether it has resulted from earlier diagnosis or better treatment, or both.
Although we – the radiologic community- know these facts, the public does not. A recent published survey of women’s perceptions regarding the benefits of mammography screening revealed that 57% of American women believe that mammography prevents or reduces the risk of contracting breast cancer 3 ; 62% of American women believe that periodic mammography will reduce breast cancer deaths by 50% to 75% (researchers say that the generally accepted figure is 25%). Sixty percent of American women believe that mammography will prevent up to 80 deaths from breast cancer among every 1,000 women who undergo mammography (researchers say that the generally accepted figure is five deaths).
According to another published survey, 74% of American adults believe that finding cancer early saves lives “most” or “all” of the time, and 53% believe that screening “usually” reduces the amount of treatment needed when cancer is found. 4 Seventy percent feel that a woman who refuses to undergo screening mammography is “irresponsible.” Another emotion experienced by women who have refused or for other reasons have been unable to undergo mammography is guilt. A 43-year-old woman who had developed breast cancer lamented in a recent Ladies’ Home Journal article 5 that she had not had a mammogram in the previous 3 years. “I honestly believe it could have been caught earlier. I wouldn’t have had to spend a year of my life going through what I did if I’d been more conscientious.”
Clearly, a huge gap separates what we, the radiologic community, know about mammography and what the American public knows about mammography. Who is responsible for this gap? Whose fault is it that this gap exists? I turn to Shakespeare for the answer: “The fault, dear Brutus, is not in our stars, but in ourselves.” 6 The fault does lie with us, the radiologic community, for I contend that we have failed to communicate to the American public all that we know about the pros and cons, and upsides and downsides, of mammography.
In an article entitled “The Arrogance of Preventive Medicine,” 7 a Canadian internist-researcher identified three elements of arrogance that he believes characterize the field of preventive medicine:
First, it is aggressively assertive, pursuing symptomless individuals and telling them what they must do to remain healthy. Second, preventive medicine is presumptuous, confident that the interventions it espouses will, on average, do more good than harm to those who accept and adhere to them. Finally, preventive medicine is overbearing, attacking those who question the value of its recommendations.
The researcher then made the following thought-provoking observation:
When patients sought me out for help with their established, symptomatic diseases, I promised them only to do my best and never guaranteed that my interventions would make them better…[However] the fundamental promise we make when we actively solicit individuals, and exhort them to accept preventive interventions, is that they will be better for it.
Perhaps the “arrogance of preventive medicine” as described by our Canadian colleague is a cause of why the radiologic community has not informed the American public everything it knows about mammography. I believe there is a simpler explanation, however. Many radiologists believe so strongly that every woman will benefit from mammography that they fear that merely discussing potential negatives regarding mammography will dissuade women from undergoing the examination. To illustrate, one prominent American radiologist specializing in mammography has written 8 :
Some may argue that reexamination and discussion of the value of screening mammography is healthy; however, considerable damage has been done, since women and their health care providers are confused with the regard to the need for mammographic screening.
Another radiology expert commented 9 :
The American College of Radiology is deeply concerned about contradictory reports [regarding the efficacy of screening mammography in saving women’s lives] and the result they will have on women’s health…Everyone is now all too aware of the recent controversies raised about mammograms, however, the further public discussion and the ensuing media coverage only heighten the apprehension of women caught in the middle of an unnecessary tug of war. The only victims in this needless controversy are the women who may choose to ignore this life-saving procedure because of a conflicting message from the healthcare profession.
An open letter from 10 medical organizations published in the New York Times in 2002 echoed similar sentiments 10 :
We…are responding to coverage in the media and the resulting public discussion questioning the value of mammography…We have grave concerns that these public debates have already begun to erode the confidence in mammography that has been built up over the past two decades.
In a front page article published in the Washington Post in early January 2004, a leading radiologist specializing in mammography was reported as saying that deluging women with too much information about all the possible outcomes and uncertainties about mammography would unnecessarily confuse and alarm them and “would scare women away from getting mammography.” 11
These concerns expressed above (characterized by some as attitudes of paternalism) may not only be unrealistic, but may in fact be inappropriate. The United States Preventive Services Task Force has called for disclosure of all aspects of mammography 12 :
Clinicians should inform women about the potential benefits, potential harms (eg, false-positive results, unnecessary biopsies), and limitations of the test that apply to women.
The American Medical Association has taken this position 13 :
The recent debate concerning mammography is healthy…injects a new dimension…in making evidence based-medicine a part of our regular routine and in deciding how much uncertainty to share with our patients…We must encourage our patients to examine sources of information critically…As physicians advising the community at large, we …need to talk about additional strategies to deal with the uncertainties those studies sometimes produce. Such discussions will help facilitate shared decision-making real time.
Various physicians and laypersons have voiced support of more open discussion. One Ohio oncologist has written 14 :
We doctors need to do a better job of reminding ourselves and informing women about the limitations of mammography…I am insulted by the medical community’s attempt to distill the issue to a single message: Don’t worry about controversy, just get a mammogram. As a woman it frustrates me. The attitude is that women are too stupid to sort it out, so they need simple straightforward answers. I have a lot more faith in women than that.
Two internists at the University of Washington have added the following thoughts 15 :
During busy office visits, it is difficult to thoroughly discuss with women the benefits and harms of mammography…Nevertheless, we should strive to correct misperceptions whenever possible. Many women overestimate the protective benefits of mammography and underestimate its possible risks, including the evaluation of false-positive mammograms and overdiagnosis leading to unnecessary mastectomy, radiation, or chemotherapy. Clinicians should describe potential benefits of mammography without candy-coating its plausible harms.
Internist-author H. Gilbert Welch has commented as follows: 16,17
Ideally, the “right” reason [for women to undergo mammography] would be that each woman had made an informed choice, or in other words, had made her own decision after being fully informed of the likely benefits and harms of screening experienced by women just like her. While such ideal conditions for decision making may exist somewhere, I don’t foresee them on our planet any time soon…Perhaps if we used less alarming language about cancer risk when we introduce patients to screening, they would have less need for reassurance…We [should talk about screening] in the context of choice instead of obligation.
A woman, who is not a physician, has been quoted as saying 11 :
After 30 years of selling mammography to us, women are still not fully informed about the risks. It’s been oversold. They’re afraid they can’t be fully honest because a lot of us would stop going for screening.
Finally, a woman recently wrote the following to the editor of the Wall Street Journal18 :
You cannot truly have “informed consent” to any procedure unless the patient has been advised about all available alternatives…Doctors seem to feel that they got a lease on women’s bodies…I feel that it’s my body, the decisions should be made by me. I cannot make an informed decision without knowing what all the options truly are. No [physician] owns my [body]. No medical specialty has exclusive rights to treating it. I own it. I get to decide who treats it and how.
The same men and women who read the printed media with its advertisements, and who watch television, are the same men and women who become jurors, attorneys, lower court judges, and appeals court justices. As such, any misperceptions regarding mammography and breast cancer that the general public may hold are also held by juries and the judiciary. Unreasonably high expectations of the accuracy and benefits of mammography result in the public’s demanding a standard of care from radiologists who interpret mammograms that is considerably higher than radiologists can deliver. Unless the public is appropriately educated as to realistic expectations of mammography, mammography will descend further into the morass of malpractice litigation.
The radiology community must better inform and better educate the public. Radiologists, radiologic societies, and other medical organizations such as the American Cancer Society should continue to market mammography through public awareness announcements including advertisements. However, advertisements that expound the benefits of mammography must also include the potential risks and downsides of mammography, ie, the “fine print.”
For a show entitled Paris , produced on New York’s Broadway in 1928, famed songwriter Cole Porter wrote “Let’s Do It, Let’s Fall in Love,” a well-known tune whose first verse goes like this:
Birds do it, bees do it,
Even educated fleas do it,
Let’s do it, let’s fall in love.
Borrowing that format, I would like to add:
Makers of tobacco and drugs that fight germs do it,
Even HMOs and Wall Street firms do it,
Let’s do it, let’s put the fine print into the ads.
Leonard Berlin, MD, FACR, is chairman, Department of Radiology, Rush North Shore Medical Center, Skokie, Ill, and professor of radiology, Rush Medical College, Chicago.
- Berlin L. Fear of cancer. AJR. 2004;183:267-272.
- Burstein HJ, Kornelia P, Wong JS, Lester SC, Kaelin CM. Ductal carcinoma in situ of the breast. N Engl J Med. 2004;350:1430-1434.
- Domenighetti G, D’Avanzo B, Efer M, et al. Women’s perception of the benefits of mammography screening; population-based survey in four countries. Int J Epidemiol. 2003;32:816-821.
- Schwartz LM, Woloshin S, Fowler FJ Jr, Welch HG. Enthusiasm for cancer screening in the United States. JAMA. 2004;292:71-78.
- Laurence L. The breast cancer crisis. Ladies’ Home Journal. October 2004:166-172,176-182.
- Shakespeare W. Julius Caesar. Act 1, scene 2, lines 133-134.
- Sackett DL. The arrogance of preventive medicine [commentary]. CMAJ. 2002;167:363-364.
- Jackson VP. Screening mammography: controversies and headlines [editorial]. Radiology. 2002;225:323-326.
- Neiman HL. Many questions, but only one answer. ACR Bulletin. 2002;58(3):3.
- An open letter to women and their physicians [advertisement]. New York Times. January 31, 2002:A19.
- Stein R. Some fear women lack facts about mammograms. Washington Post. January 6, 2004:A1, A8.
- US Preventive Services Task Force Recommendations and Rationale: Screening for Breast Cancer. Rockville, Md: Agency for Healthcare Research and Quality, Center for Practice and Technology Assessment. Available at: Http://www.ahrq.gov/clinic/3rduspstf/breastcancer /brcanwh.htm. Accessed September 14, 2004.
- Clancy C. Addressing concerns about medical studies, privacy: what should you tell patients about conflicting research? [ethics forum]. American Medical News. 2002;45(21):17.
- Aschwanden C. Real life decisions about mammograms. Health. October 2002:104-108.
- Fenton JJ, Elmore JG. Balancing mammography’s benefits and harms: are we overdiagnosing breast cancer? BMJ USA. 2004;4:E301-E302.
- Welch HG. Right and wrong reasons to be screened. Ann Intern Med. 2004;140:754-755.
- Welch HG. Should I Be Tested for Cancer? Maybe Not and Here’s Why. Berkeley, Calif: University of California Press; 2004:82-89.
- Mackay R. Letters. Wall Street Journal. September 3, 2004:A11