In the December 8^th issue of the New England Journal of Medicine in the Perspective section, there appears an article, “Making Sense of the New Cervical Cancer Screening Guidelines,” by Dr. S. Feldman.  Dr. Feldman concedes that Pap smear sensitivity is poor, “roughly 50 to 60% [false negative].  She does not in her article explain the relatively poor sensitivity of the test but we can learn easily from other literature that a major contribution to the poor sensitivity of the test relates to improperly identified or interpreted smears.

While it is true that multiplying the frequency of smears increases the likelihood in spite of negligent readings that a cervical abnormality will be discovered while the disease is pre-invasive.  There is no study randomized and prospective which proves that.  Someone has simply picked out of a hat a frequency that they think is greater than needed and a frequency that is somehow lesser than needed and it comes to kind of a consensus that after age 21 every three years is frequent enough.

Cervical cancer is a very aggressive disease particularly in women who acquire the disease in their 30’s and 40’s.  No intelligent woman knowing she possessed a cervical abnormality would decide to wait three years to do something about it.  Where therefore does the pressure come from to reduce the frequency of looking?  Most women considered healthy to have their gynecologist see them annually and Pap smears are done at this annual exam.  Pap smears are relatively inexpensive.  Of course, even something that is inexpensive becomes expensive when you multiply it by 100,000,000.

On the other hand, if a lab is getting $25.00 to $30.00 for every Pap smear it screens and requires the cytotechnologists (not doctors)  who read the slides to read as many as 100 a day, one can see readily where the money is going.

I recently questioned during a deposition a cytotechnologist who had screened a slide with obvious severe abnormalities on it which she had in fact marked with screening dots.  She doesn’t know why she put the slide back in the box but she did.  She was having difficult times in her personal life which she had shared with her supervisors and others at the organization that was requiring her to perform as many as 96 screenings a day in spite of her obvious distraction.

While 4,000 to 5,000 women are needlessly dying of cervical cancer in the United States every year, cost efficiency is truly in the mind of the beholder.

In her article Dr. Feldman goes on to assert that HPV testing done with Pap smears, though recommended by the American Cancer Society every three years, is not recommended by anyone else including the United States Preventative Services Task Force.

It is well-know that women who are HPV positive are at much higher risk of developing cervical cancer in women who do not have this characteristic.  It is also well recognized that any sexual encounter with a new person, particularly if it is unprotected sex could result in the transmission of HPV.  Therefore, the fact that a person in a committed relationship is negative for ten years doesn’t mean that they are going to be negative for the next ten.

I keep on writing about this even though few hear what I have to say.  It is simply that I am tired of watching my clients die of cervical cancer that was preventable if a person had been allowed to spend more than eight minutes reviewing their slide or were willing to endure the further expense of subjecting the slide to HPV testing.  I wonder which committee of government or the prestigious professional organizations that direct these policies think they are in a position to decide what a woman’s life is worth.  Perhaps if they watched more women die of cervical cancer as has been my unfortunate experience, they would find that testing every year rather than every three and adding HPV testing is cost efficient.

What do you think?

Jerry I. Meyers

January 1, 2010 Journal Watch summarizes a remarkable article entitled “Investigation of incidental findings on cardiac CT.”  The article was based on a study conducted at a Canadian institution where the investigators evaluated the incidence, clinical importance, and costs of these incidental findings.

It’s first important to note that these researchers used the word incidental as  equivalent to the word, occult.  In medical imaging, an occult finding is an unexpected finding that has clinical consequence.  Such findings are made with great frequency and have dramatically improved the lives of many.  For example, a chest x-ray searching for a rib fracture reveals a lung cancer mass which was otherwise completely unexpected.  A CT scan of the abdomen performed because of a complaint abdominal pain reveals a dissection of the thoracic aorta.

The Canadian researchers are strangely troubled by the discovery of   unexpected conditions.  The test they are evaluating is cardiac CT.  Imaging data obtained during a cardiac CT includes imaging information of structures or tissues outside the heart.  in an examination of 966 consecutive patients who underwent cardiac CT during 12 months at a single Canadian institution, incidental findings were noted in 401 patients.  12 of the patients were found to have clinically significant conditions, many of them, life-threatening without treatment.

Even if one accepts the very conservative assessment that only 12 of the patients were found to have clinically significant conditions,  that means that 3% of everyone who had a cardiac CT performed had a condition that might have seriously harmed or killed them if it had not been accidentally seen in this study.

The researchers do not see the benefit derived by the 3% as a bonus.  They don’t question that all the patients benefited from having a cardiac CT.  In fact, no one questions that this method of scanning provides an important and noninvasive method of evaluating patients suffering coronary calcification and arterial disease.  However, 68 patients exhibited incidental findings such as nodules or cysts in the lungs or liver.  There’s the rub.

Confronted with 68 patients of the 401 who had abnormalities deemed to be indeterminate (undetermined significance)  researchers worry that the abnormalities found might lead some to conduct further testing or evaluation.  The solution, as they see it, is to not format the data concerning non-cardiac tissue and structures.  They want to ask patients to consent to keeping the non-cardiac information invisible.  If they see no “evil”, they need speak no “evil.”

I think this is insanity. What do you think?

For a comprehensive review of literature dispelling the myth that there is a big difference between high risk and low risk patients and screening for cervical cancer please read NUNS, VIRGINS, AND SPINSTERS’. RIGONI-STERN AND CERVICAL CANCER REVISITED, MALCOLM GRIFFITHS.

Put simply,  over a long period of time a concept often explained and often repeated, acquires an authoritative stature it may not deserve .  The concept’s very foundation may be faulty but the “test of time”  is no test  if, in all the retellings, the foundation is never reexamined.

In his article, Griffiths examines the much quoted proposition that low risk women do not require rigorous screening for cervical cancer.   Who is at lower risk than a nun?  It turns out this is a trick question because the risk of developing cervical cancer is about the same for a nun as an unmarried women and about half that of married women.

In the debate surrounding screening for cancer advocates of opposing positions tend to pick and believe evidence which agrres with therir respective positions.  This is a debate in which women cannot afford to be driven by bias.  They deserve the truth, their lives depend upon it.

For further information on cervical cancer and the importance of proper cancer screening see Meyersmedmal.com

According to the American Cancer Society’s most recent estimate for 2009, 11,270 new cases of invasive cervical cancer will be diagnosed and 4,070 women will die from the disease.

Prior to 1955 cervical cancer was one of the most common causes of cancer death for American women. As a result of the development of the Pap smear screening test between 1955 and 1992, the cervical cancer death rate declined by 74%.

Since half of the cervical cancer cases arise in patients who have never had a Pap smear or whose last Pap smear preceded diagnosis of invasive cancer by more than five years, the problem is not that too many Pap smears are being done but that not enough Pap smears are being done.

Nevertheless, the guidelines for screening of Pap smears have resulted in fewer Pap smears being done. For a test that is misinterpreted when it shows abnormalities between 20 and 40% of the time, frequent repetition of the test is needed to assure one appropriate interpretation. Even when an appropriate interpretation of Pap smears is made and abnormalities are found which require treatment, the appropriate treatment is not given 10% of the time.

For a test associated with little cost, and which is essentially risk free, the pressure to limit the performance of even this test is clearly present.

Matthew Mintz, M.D. writes at KevinMD.com medical web blog on November 17, 2009, “Why Doctors are Doing So Many Unnecessary Pap Smears.” In his opinion piece, Dr. Mintz asserts that the Pap smear is a symbol of our healthcare system’s problems, yet the only evidence he quotes in support of this proposition is a study from the Annuals of Internal Medicine which demonstrates doctors are doing more frequent Pap smears on women than some guidelines recommend.

The fact that more Pap smears are being done does not mean that they are needless and they certainly are not harmful.

When even well-informed physicians can reach such wrong-headed conclusions it is not surprising that it is so difficult to fix the healthcare system.

Where is the alarm about the high rate at which Pap smears are wrongly interpreted as negative when in fact they show ominous changes?

Not all screening tests have been as successful as the Pap smear. The fact that we could have for example better screening tests for breast cancer than a mammogram does not negate the importance of women having an option to have a mammogram. We should be searching for better screening tests improving the performance of existing texts and not failing to screen with the tests available simply because the tests are imperfect.

With such controversy swirling about healthcare reform it is difficult to hear the truth in the midst of all the noise that is being made. Staying well informed and being skeptical is the safest approach to receiving appropriate medical care.

November 16, 2009 the Washington Post reports new screening guideline issued by the U.S. Preventative Services Task Force now recommending against women receiving routine screening with mammograms for breast cancer prior to age 50.

Petitti, Chairman of the Task Force, asserts that the new recommendation will result in “just” 0.7 deaths for every thousand women who now will not be screened. His justification for this remarkable statement is that allowing these 0.7 women per thousand to die will prevent many from suffering the anxiety of a false-positive result. He goes on to say that 33 more women per thousand would be spared unnecessary biopsies. I wonder how many women would be willing to take a 3.5% risk of an unnecessary biopsy to avoid a .7 in 1000 chance of dying.

It is incredible that this Task Force apparently values a women’s life so cheaply.

I guess 0.7 deaths are hard to give a name. Perhaps they should have put it differently. For every 1,429 women who now will probably not be screened, one woman will die.

What do you think?

Gardasil is a HPV vaccine produced by Merck.  HPV, Human Papilloma Virus, has clearly been demonstrated to increase the risk of a woman developing cervical cancer so it would seem to be a good idea to provide young woman, even as teenagers, with a vaccine that would guard against the virus and prevent the development of  invasive cervical cancers which would otherwise be produced by the virus.

In 2006 Merck Pharmaceuticals received the go ahead.  The FDA approved the distribution of Gardasil, a Human Papilloma Virus vaccine manufactured by Merck Pharmaceuticals and Merck promptly began the distribution of the vaccine.

Later in the same month the distribution began, the advisory committee on immunization practices recommended routine vaccination of girls 11 to 12 years old.  Remarkably, these recommendations were issued before completion of the so-called phase III trials demonstrating whether advanced pre-cancerous lesions of the cervix are prevented by the use of the vaccine.

In fact, only two of the fifteen types of HPV known to have a cancer-producing potential have been shown to be affected by the vaccine.

Merck has seen to it that the public has been provided with a favorable view of the vaccine.  In a report by Rothman and Rothman published in the Journal of the American Medical Association this year, Marketing HPV vaccine: implications for adolescent health and medical professionalism, JAMA 2009 Aug 19; 302(7):781-786  the author shows how Merck employed the assistance of various important medical associations by providing the associations with ready-made presentation slide sets, emails and letters to promote the product.  All this publicity in favor of the use of the vaccine began before important trials had even been concluded.

Now, in the same issue of the Journal of the American Medical Association in which the report of Rothman and Rothman appears, there is an article from the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration reporting adverse events occurring in the two and a half years following administration of Gardasil, Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine,  Slade, B.A., Leidel, L.,Vellozzi, C.; et al. JAMA 2009 Aug 19; 302(7): 750-757.    There were 752 adverse reports.  6.2% of the adverse reports involved serious adverse effects, including 32 reports of death but the system of depending on voluntary reports of adverse events risks underreporting and there is no real evidence that the adverse events reported resulted from the vaccine.  Such adverse events reports are based solely on an event occurring after the administration of the vaccine and not because of any other evidence proving the vaccine caused the event.

So, we don’t really know the extent of any benefit a young woman will receive as a consequence of being vaccinated and we also don’t know the risk.

What a nightmare for a parent with a decision to make about a teenager receiving Gardasil.  Cervical cancer continues to kill thousands of women every year. If the leading cause of the cancer is a virus that can be prevented by vaccination, how does one decide to not offer the vaccination?  If, as some have suggested, the chances are less than six adverse events per thousand doses distributed and only 6.2% of those represent serious adverse effects, that means that one serious adverse event would be associated with every three thousand doses distributed.  But even with a risk this small, has there been a sufficient benefit demonstrated to justify that risk?

In a completely different context, many years ago Jonas Salk pointed out to me the importance of focusing on the numerator.  If the chance is 1 in 10,000,000 and you are the one, it is little comfort that 9,999,999 other doses were administered safely.

Perhaps it was easier long ago when we knew little and simply did what we were told.  If not better, perhaps it was just a lot simpler.  What do you think?

In a previous post I briefly discussed how communication failures in the transmission of test results are common.  Many people think that widespread use of electronic medical records systems throughout all of our health systems will improve medical care.

You cannot improve a physician’s standard of practice simply by altering the means by which records are kept and transmitted.  In fact, many communication errors are institutionalized.  For example, one of our clients visited a University medical center for the purpose of evaluating his spinal fracture that seemed to have occurred in the absence of any trauma.  An appropriate array of imaging studies and laboratory tests were ordered.  At this medical center, the electronic medical records system was designed to assume that any lab report issued on the date of the patient’s discharge was reported to the patient’s floor before the patient was discharged.  Though a report of results issued after 12:01 a.m. the day following discharge was regularly made to each ordering and attending physician as a matter of policy, any results issued after discharge but before midnight were reported to no one except the medical records.

A two-year delay in the diagnosis of cancer and an associated death sentence for our client was the basis for a lawsuit being filed.  We knew a lab report existed indicating the need for prompt follow-up and that such follow-up would have diagnosed the cancer more than two years earlier with the expected benefits of an earlier diagnosis.  We didn’t know why it happened.  Through intensive investigation we uncovered the flaw in the electronic medical records system and brought this system delay flaw to the hospital’s attention.  The flaw had been present since the system’s inception years earlier.  This is but one of many similar cases we have handled where, as a result of defective policies or procedures, catastrophic injuries have occurred.

The Archives of Internal Medicine, June 22, 2009, published results of a retrospective medical record review involving nineteen community based and four academic medical center primary care practices.  The researchers were intent upon examining how frequently patients were not informed of clinically significant abnormal outpatient test results.  The researcher’s conclusion was that it is common for patients to be uninformed of significant abnormal outpatient test results and they suggest a simple process currently not being followed by most primary caregivers to correct what the researchers see as a problem.

Remarkably, they fail to comment on an additional meaningful conclusion that can be arrived at from examining the same data.  The doctors who didn’t inform their patients must not have done anything about the abnormal lab results.  Surely, it is not possible that physicians failed to inform patients of significant abnormal lab results only in cases where the lab results, though abnormal, suggested no need for a different course of medical treatment.  Perhaps a more important issue for these researchers to have examined is whether the results were communicated to the doctor and whether the doctor incorporated those results in the formulation of each patient’s continued and future course of care.

In these circumstances, a patient’s safeguard of last resort is their own interest in their medical care.  Patients need to be attentive not just in the outpatient setting but also in the hospital setting.  A patient should not assume that because there are a number of people who seem involved in their care, doctors, nurses, etc., that someone in fact is aware of all clinical events and test results and is thoughtfully guiding the patient’s care with a professional interest in the best possible outcome.

Learn more about abnormal pap smears.

The April 2, 2009 Issue of the New England Journal of Medicine includes a report of a study recently concluded concerning the value of HPV screening for cervical cancer in rural India.

HPV stands for Human Papilloma Virus. The current standard of practice in the United States requires that all women be tested for the presence of this virus in cells removed from the cervix.

When such testing is positive in an individual that individual is at a much higher risk of going on to develop cervical cancer over time than an individual whose HPV testing is negative.

In rural parts of India where the standard of practice is no screening of any kind for cervical cancer, a single HPV test followed by treatment of all persons whose tests are positive for the virus, resulted in a 60% reduction in persons developing advanced cervical cancer compared to women not benefiting from the test.

All women need to be vigilant and informed about appropriate screening for cervical cancer as death from the disease can be virtually eliminated by receiving appropriate screening, Pap smears, HPV testing and proper management of those women whose screening shows the presence of cervical abnormalities.

According to Alan Mozes’ report, Monday October 10 in Health Day Reporter, a new study suggests more than 12 percent of cancer patients in the U.S. are undiagnosed initially. Apparently this leads to treatment delays and lost opportunities for better outcomes.

The study was conducted by a team of researchers from Canada, China and the United States but based upon the experience of four American medical centers.

Study author Dr. Stephen S. Raab, a professor of pathology at the University of Pittsburgh School of Medicine said “I want to make clear that the major consequence is not that patients unnecessarily have organs removed or have a false diagnosis of cancer, but rather that they have cancer and it is not diagnosed.”

This study provides insight concerning the accuracy of cancer diagnosis nationwide. The researchers estimate by extrapolation that about 150,000 cancer patients who undergo Pap tests annually may be subject to such mistakes. If the probability of error in cancer testing applies, as these researchers suspect, across the broad spectrum of cancer diagnosis, then surely many patients needlessly suffer from delay.

For more information abnormal pap smears