The Truth... What is it?





Pap smear: no guarantee against cancer!

As to this file/page, you have been directed to & now @ Dr. Shaw's personal website


DISCLAIMER

The pap smear is generally considered to be the most effective cancer screening system ever devised. Years ago it was credited with dropping the death rate from cervical cancer by over 70%. Yet the courts and the media suggest that it is disreputable.

Since Pap smear screening is not a medical emergency (or even medically urgent), interest in getting a result quickly makes much less sense than does an intense focus on optimizing the detection of cervical cancer. However, many patients are anxious and hyper-demanding. So, turn-around-time (TAT) [check out TAT factors] has become a competitive factor.

***"THE MAJOR BARRIER TO PREVENTION OF CERVICAL CANCER IS NOT THE ACCURACY OF THE PAP TEST, BUT THE FAILURE [of some women] TO BE SCREENED AT ALL" [J.A.M.A. 281 (4):347-355, 27 Jan. 1999].***

Tragically, during the past 30+ years (since 1960), commercial labs sold pap smears as "loss leaders". This falsely depressed the market place valuation of the test at the very time when sexual factors leading to increased cervical cancer are on the increase. And, some providers abused and weakened the testing process in attempts to maintain a profit margin...some patients were hurt.

Plaintiffs and their lawyers and our legal system have created a legal perception that the pap smear should be a perfect test, that women deserve for it to be a perfect test, and that it is therefore required to be a perfect test: a negative report should guarantee absence of cancer or pre-cancer in your cervix. Nothing could be further from the truth!! Worse, attempts have been made in several states to bring criminal manslaughter charges against labs and pathologists who missed a cancer and "failed to diagnose". So-called expert witnesses are being paid large fees to testify in behalf of plaintiffs...many of us have seen examples of the evidence, and the ability of some of these experts to prostitute their opinions is shocking: and the jurors believe them (or simply decide that the plaintiff could use the money)!!! Many labs (including ours) have strongly considered declining to test Pap smears. Some labs try to protect themselves by diagnosing any but the most typical of smears as having "atypical cells"...an "atypia rate" that may approach 30%. The lab can not only protect itself thereby but can spend less professional time on decision making. PLUS, this high rate leads to greater numbers of biopsies...another chargeable procedure. This all then puts a heavy follow-up burden on the primary care doctor and office staff and anxiety on greater numbers of patients. You can help yourself in many ways with a little incomplete review of the "work" involved by all who are involved in your Pap smear.

In our lab (in our group practice), in spite of intensive effort of us doctors personally reviewing and diagnosing between 30-40% of our cases..., we have been unable to reduce our atypia rate to any better than 5-13% as of 2002.

In the best of labs (and we view point-of-service pathology...as in our lab... as the best model for labs to perform in the best interests of patients), studies in the mid 1980's indicated a false-negative rate as high as 25% (due to a great number of sampling and testing imperfections). The 5-year look back now mandated of certified labs is reported to have found the false negative rate in the late 1990's to be improved to between 5-10%. This is why yearly Pap smears under the care of a good doctor were and are your safest bet. If the test is falsely negative this year, there is plenty of time to catch the problem next year or maybe the next.

Our lab's false negative rate starting with 1994 is only <3% as of June 2002. We are unaware of any system...thin-layer processing, computerized screening or rescreening, or other...which is proven to exceed this performance. We believe that our careful, classical process represents an excellent safety and financial value to patients; and, we have added on SurePath (AutoCyte)  thin layer processing.  Never-the-less, we acquired the AutoPap (FocalPoint)  computerized screener which we will use on every case in addition to our cytotechnologists screenings, beginning this summer of 2002. As any physician would do with history, physical exam, and routine screening tests, this computerized sorting or cases helps to progressively form groups of cases with increasing likelihood that the group contains an abnormal case. The most intense professional human energy can then be properly focused.

No matter how you hone, sharpen, and stack the large number of technical and professional factors, there is an inherently irreducible false negative rate; and this can never be a perfect test (nor, for that matter, can any other test known to man be perfect).

AND, if notified that you have an abnormal Pap smear, further diagnostic efforts must be made to determine whether any abnormality is truly significant.

 

 

 

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(posted 16 July 1998; 2nd update 26 February 1999; 3rd update 4 Sept.; 4th, 30 Dec. 2000; 5th, 17 Feb. 2001; 9 June 2002; latest review 4 August 2003)