Most women know what a Papanicolaou smear is and what it is intended to do. Cell specimens from a woman's cervix are sampled to look for pre-cancerous changes. For decades women have been encouraged to have this test, commonly known as a pap smear, on an annual basis. Because cervical cancer is generally a slow growing tumor, the death rate from cervical cancer has plumented in this country since this annual testing began. This may be changing.
There have been some studies which suggest that if a woman has three normal pap smears, does not smoke, has only one sex partner (who also has only her as a sex partner), and has no other risk factors, having a pap smear as infrequently as every three years may be statistically safe. Some health maintenance organizations have latched onto these studies and identified the obvious cost saving potential of this concept. These health maintenance organizations have started recommending that pap smears may be done every three years without making clear that this MAY be safe for only a very narrow class of women. For the rest of the population it could be deadly.
Our office has handled a number of cervical cancer cases where Pap smears were not done on an annual basis. In other cases the smears were misread. All of these cases resulted in death. Given some current HMO recommendations for pap smear tests every three years, we fear more of these tragic cases will develop than ever before. We hope we can help spread the word to prevent this from happening.
Reproduced from the Letters to the Editors, Letter from Terry L. Wade, February 1999 American Journal of Obstetrics & Gynecology, Vol. 180, No. 2, Part 1, at 507 with permission from Mosby-Year Book, Inc.
Death of the Papanicolaou smear? Future litigation
To the Editors: I read with interest Dr. Richard C. Boronow's concerns about the current medical/legal climate surrounding Papanicolaou smears (Boronow RC Death of the Papanicolaou smear? A tale of three reasons. Am J Obstet Gynecol 1998; 179:391-6). He perceives there to be a threat to the use of this indisputably excellent screening test because of a variety of factors including substandard laboratories, the greed of many, including patient's lawyers, and a failure of the public and the professions to recognize that some level of error is inescapable. As a patient's lawyer who has handled Pap smear cases, my perspective is undoubtedly a bit different than Dr. Boronow's. Having said that, there is certainly substantial merit to many of the points that Dr. Boronow makes.
According to Dr. Boronow's graph (Fig. 2 in his article), since the Wall Street Journal exposé of dubious laboratory Papanicolaou smear practices, the incidence rate of cervical cancer has increased and the death rate has decreased. Dr. Boronow interprets this observation as evidence that "loss of the inexpensive, widely available Pap smear will undoubtedly lead to increased cervical carcinoma" [quoted in Boronow from: DeMay RM. Common problems in Papanicolaou smear interpretation. Arch Pathol Lab Med 1997; 121; 229-38]. To the contrary, wouldn't these data be better interpreted to suggest that increased laboratory quality (perhaps in part motivated by medical/legal litigation) has resulted in increased frequency of diagnosis at an earlier stage with an associated decreased mortality rate? It would seem that Dr. Boronow fails to recognize the possibility that civil responsibility for substandard laboratory practices may have a laudatory effect on public health.
Dr. Boronow laments the trend of current managed care toward the practice of medicine by the lowest bidder and the potential impact this trend may have on the availability of this important laboratory test. Managed care economic pressure is not isolated to the reimbursement allowed for each test. It also puts pressure on clinicians to decrease the frequency with which the test is recommended, notwithstanding the recommendation of Dr. Boronow and other reputable gynecologists, oncologists, and pathologists who recommended "...annual cervical cytology...."1 There is support in the medical literature for the proposition that certain low-risk categories of women may safely defer annual Papanicolaou smears to up to a 3-year cycle after 3 consecutive normal Papanicolaou smears. Unfortunately, some "managed care" organizations extrapolate these data to the generalized recommendation that Papanicolaou smears every 3 years are adequate.2 This generalization is then applied to women who smoke, have had multiple partners, or are involved in relationships with sexual partners who have had multiple sexual partners – perhaps unknown to the women. As Dr. Boronow so accurately recognizes, "...most women who have cervical cancer develop, who have had a Papanicolaou smear, have not had one in the past 3 to 5 years." Should "managed care" recommendations for 3-year Papanicolaou smears affect a large population of American women, I anticipate Dr. Boronow will observe even great numbers of patients' lawyers bringing ever-increasing numbers of lawsuits on behalf of women suffering unnecessarily delayed diagnosis of cervical cancer and associated premature death.
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