DC Medical Malpractice & Patient Safety Blog

In 2009 the U.S. Preventive Services Task Force recommended against routine mammograms for women in their 40s. That caused a political firestorm then, with ill-informed politicians claiming that bureaucrats were trying to hold back a lifesaving test to save money. The truth was, and is, that mammograms cause more harm than good unless the women being tested are already at significant risk.

Now, Canadian health-care watchdogs have echoed the U.S. opinion, and for the same reasons.

As reported in CMAJ, the Canadian Medical Association journal, the Canadian Task Force on Preventive Health Care says routine mammograms for women 40-49 are not necessary if they are at average risk of contracting the disease. Women with a personal/family history of breast cancer, or who have the BRCA1/BRCA2 gene mutations are at higher risk, and should be screened more often.

The report concludes that although mammography screening can reduce death from breast cancer among women aged 40–74 years, “the absolute benefit is small — especially for younger women — and is partially offset by harms caused by unnecessary intervention.”

Those harms include false positives, which prompt additional screening or tests that usually include more radiation exposure, uncomfortable biopsies and high anxiety. The disease is relatively rare in younger women, and their higher breast density compromises the ability of mammograms to be fully useful. So the Canadian report says that for women at average risk, an interval of two or three years is sufficient for mammography screening.

Like the earlier U.S. task force, the Canadians emphasize that providers and patients consider the benefits-harm trade-off when deciding about having a mammogram.

We have repeatedly covered this topic, as well the often-conflicting opinions always generated when a former standard of care gets called into question.

In addition to questioning the wisdom of screening younger women via mammography and magnetic resonance imaging, this task force also said that there is no evidence that “clinical breast examination or breast self-examination reduces the risk of mortality or other clinically relevant adverse outcomes.”

Here’s what the Canadian task force recommends for mammography screening for women at average risk, by age:

• 40–49 years, no routine screening;


• 50–74 years, routine screening every two to three years.

The relentless campaign to convince every American woman of her imminent risk of fatal breast cancer doesn't measure up to any calm review of the numbers on who dies from what in the United States. And the value of regular mammograms for women is coming under increasingly skeptical scrutiny.

The latest skeptical report on breast cancer screening with mammograms comes this week in the "Well" column in the New York Times. According to the Times, of the 39 million women who undergo mammograms this year, somewhere between 4,000 and 18,000 of those will be helped by getting earlier diagnosis of a cancer that otherwise might have gotten out of control.

Last year at this time in this blog, we reviewed the numbers comparing breast cancer risk to those of other big killers. We showed that the usual statistic that most Americans have heard, that one in eight women will get or die from breast cancer, is wildly wrong. The numbers still are accurate today.

The point is not to pooh-pooh breast cancer. It's a terrible disease, and nobody should die from it. But nobody should be unduly scared of it either, when the odds are that many other ailments will kill you first.

Should you get a regular mammogram? It's a personal decision depending on your own family history and your own risk tolerance. Just don't let anyone tell you that you're being suicidal if you decide to skip it.

Last week the U.S. Preventive Services Task Force (USPSTF), about which we wrote recently, weighed in with another advisory to cut back on what has long been standard gynecological practice.

As Reuters reported, although Pap smear tests are still the best practice for the prevention of cervical cancer, the USPSTF says that many women needn’t have one every year. The task force recommends the test be given every three years for most women.

Pap tests examine cells from the cervix for cancer or precancerous changes. The same cells can be used for HPV testing.

In proposing changes to its 2003 recommendations, the task force said evidence is still lacking to weigh risks and benefits of tests screening for human papilloma virus (HPV). That stance is opposite of most cancer patient advocates, who support such tests.

But the American Cancer Society agreed with the Feds on the new recommendations.

Routine annual Pap tests appear to present the same problems as the routine prostate-specific antigen (PSA) tests the task force addressed a couple of weeks ago, suggesting it be used only for high-risk men. "If you test every year you find a lot of benign infections that would go away on their own. … You end up overscreening, overmanaging and overtreating women who are not actually at risk of getting cervical cancer," Philip Castle of the American Society for Clinical Pathology told Reuters.

"Everybody agrees on almost everything: Let's get rid of regular annual Pap testing, let's get rid of teenage screenings, let's screen women who aren't getting screened," said Debbie Saslow, the American Cancer Society's director of breast and gynecologic cancer.

Side effects of overtesting could include vaginal bleeding, pain, infections, risks of pre-term delivery and psychological issues about facing a possible cancer diagnosis.

Although the task force doubted the effectiveness of the HPV test in preventing cancer, other groups said the combination of regular Pap plus HPV testing was indicated for women older than 30 if done every three to five years.

The HPV virus is common, can cause genital warts and can lead to cervical cancer. As the Reuters story noted, usually, the immune system eradicates HPV, especially in younger women. The task force found HPV screening causing more false positive cancer results than the Pap alone.

Specifically, last week the task force recommended a Pap smear test every three years for women between the ages of 21 and 65 who have had sex and have not had their cervix removed. The panel found "little to no benefit" in screening women older than 65 who had been previously tested and not enough evidence of benefit for women younger than 21.

The scourge of cervical cancer -- a leading cancer killer of women in the third world without access to Pap smears and HPV vaccinations -- is being whipped with an unlikely low-tech, low-cost preventive treatment: Ordinary vinegar plus freezing of the cervical warts before they turn cancerous.

The vinegar is brushed on the cervix by a nurse and any areas of abnormality turn white. It's not perfectly accurate -- sometimes spots turn white and they are totally benign. But the treatment of the white spots is low-pain and cheap -- and highly effective: freezing of the white spots with a metal rod dipped in liquid carbon dioxide (available from the nearest Coca Cola plant).

Read more about this public health innovation that was co-invented by American and Indian doctors, and spread in Thailand, in this New York Times article.

The news that health insurers will be required to cover contraception and related counseling, courtesy of the Affordable Care Act (ACA) passed last year, received a lot of media attention and political blowback.

Because some people find that provision of preventive care for women objectionable, it overshadowed other elements of the new guidelines, which pertain to insurance policies whose plan years begin on or after Aug. 1, 2012. Such policies are referred to as “nongrandfathered” because they represent only new plans; a health plan in effect now cannot be “grandfathered” into this coverage, although some might include it anyway.

As defined by the U.S. Department of Health and Human Services, the mission of the ACA is to promote prevention of health problems in the hope of reducing the need to treat them. It also aims to make care affordable and accessible for everybody by requiring health plans to cover preventive services and eliminating cost sharing.

Although “preventive services” covers a lot of territory that can include marginally appropriate, cost-inflating measures, those required by HHS demonstrate strong scientific evidence of their health benefits, per research conducted by the Institute of Medicine (IOM). Not only must plans cover them, they may not charge a copayment, coinsurance or deductible if the services are delivered by a network provider.

In addition to the birth control measures, from which plans are exempt for certain religious employers, the following preventive services for women are mandatory and must be provided by insurers without cost sharing to policyholders for policies beginning on or after Aug. 1, 2012:

• well-woman visits;


• screening for gestational high blood sugar;


• human papilloma virus (HPV) DNA testing for women 30 and older;


• sexually transmitted disease counseling;


• human immunodeficiency virus (HIV) screening and counseling;


• breastfeeding support, supplies and counseling; and


• family violence screening and counseling.

If your health insurance plan or insurance policy began on or after Sept. 23, 2010, it is also subject to mandatory preventive services for which you are not supposed to be charged a copayment or coinsurance, or for which you must meet your deductible if services are delivered by a network provider. To find out what’s on the list, link here.

Ever since the U.S. Preventive Services Task Force suggested relaxing the rigid schedule for mammography testing in 2009, patients seeking a unified, authoritative voice on the topic have been rewarded with confusion. Probably because the medical community, too, is unresolved about who needs what kind of breast screening and when.

A study published this week in the Annals of Internal Medicine, is the latest participant in the discussion. It articulates as well as any previous research the notion that mammograms are situationally useful, and promotes the idea that such testing should be customized to each patient.

For women with a normal genetic profile, the timing and frequency of a mammogram, the researchers say, depend on the patient's:

• breast density;


• age;


• family history; and


• personal preference.

Age, history and, to a lesser degree, density, are not new factors in the tricky equation of when to have a mammogram, but personal preference? Since when does science ever acknowledge, much less respect, that what's preferable might also be good medicine?

Although the study researchers made clear that, apart from genetic mutation, breast density is the single-most important consideration in determining the suitability of relatively frequent screening, mammograms often result in false positives -- the suspicion that you have cancer when you really don't. That feeds a cycle of anxiety, unnecessary exposure to radiation, expensive follow-up procedures including surgery and physical discomfort. The artful conclusion here is that such a tangle of concern can undermine the utility of the procedure.

Because dense breasts (more muscle tissue, less fat) are the strongest risk factor for cancer, women with that anatomical profile should have mammograms more frequently. But after an initial screening at age 40 to establish a baseline reading and determine breast density, women lacking other risk factors--such as the two genetic mutations known to increase cancer risk--who aren't comfortable with such frequency, might be acceptably excused from it.

The American Cancer Society and the Task Force would disagree. The former recommends
that women screen initially at 40, and repeat the procedure every year or two thereafter. The latter recommended that women begin screening sometime between 40 and 49, depending on risk factors, and every two years after 50.

As usual, the best guidance for women seeking clarity is to establish and maintain an open line of communication with their physicians that results in a mutual decision about their treatment.

Many women who went to Dr. Kermit Gosnell to end their pregnancies came away with life-threatening infections and punctured organs; some still had fetal parts inside them when they arrived at the ER of nearby hospitals. Though physicians at the University of Pennsylvania Health System, which operates two hospitals within a mile of the West Philadelphia abortion clinic, saw at least six of these patients — two of whom died – they failed to report their peer's incompetence, according to a grand jury report.

"We are very troubled that almost all of the doctors who treated these women routinely failed to report a fellow physician who was so obviously endangering his patients," wrote the Philadelphia grand jurors, who recommended a slew of charges against Gosnell and his staff in January.

The health system - in apparent contradiction of the grand jury report - released a statement saying that it had "provided reports to the authorities regarding patients of Dr. Gosnell who sought additional care at our hospitals" starting in 1999. However, attorneys for the health system could only produce a single report for the grand jury.

The grand jury also criticized Pennsylvania's health and medical regulators for taking no action against Gosnell, despite reports that he was harming patients. But the panel also said too many local physicians had shirked their professional and legal responsibilities to report him and thus protect the lives of future clinic patients.

Pennsylvania law requires doctors to report abortion complications to the state Health Department. And the American Medical Association says "physicians have an ethical obligation to report impaired, incompetent and unethical colleagues."

Prosecutors described Gosnell's clinic as "a house of horrors," where viable babies were killed with scissors, fetal remains were kept in jars and freezers, and dirty medical equipment was operated by unlicensed, often untrained and unsupervised employees. Gosnell himself was never certified in obstetrics and gynecology, only family practice.

Gosnell, 70, is jailed without bail and charged with eight counts of murder in the deaths of one patient and seven viable babies. Authorities say he also routinely maimed his clients, sometimes leaving them sterile and near death.

Source: Associated Press

Anyone who believes it's inevitable that some babies will get injured during childbirth may have a change of heart after reading how a New York City hospital dramatically cut staff errors and reduced medical malpractice payouts by 99%.

In a report published in the American Journal of Obstetrics & Gynecology, the head of the obstetrics team at New York Weill Cornell Medical Center describes how the safety initiatives they introduced reduced avoidable deaths and serious injuries to zero in 2008-2009, down from five in 2000.

“Any hospital could do it — it's not about money, it's about changing the culture to make it safer to deliver babies,” says team leader Dr. Amos Grunebaum. The new measures introduced by the team reduced errors and helped ward off lawsuits by clearly documenting everything doctors did right in cases where a bad outcome was not their fault.

Consumer advocates are hailing the report as a breakthrough in patient safety and a better way to curb malpractice costs than so-called tort reform.

Patient safety advocates like me, who represent patients in medical malpractice lawsuits, have said over and over that we would like to see lawyers get less business by making the medical system safer for patients.

The reforms at Weill Cornell resulted in annual medical malpractice payouts dropping from an average of $28 million from 2003 to 2006 to $2.6 million a year from 2007 to 2009. And since there were no sentinel events reported in 2008 and 2009, those numbers are expected to drop even more.

Among the changes were:

* Doing away with the labor and delivery unit's dry-erase whiteboard, which staff used to communicate patients' progress, and replacing it with a new electronic application.

* Not allowing any paper charting.

* Hiring a full-time patient safety nurse to educate staff on new protocols the doctors wanted and to conduct emergency drills.

* Hiring three physician assistants and a “laborist” (an obstetrician who works at the hospital full-time) who works nights and weekends, reducing on-call time for other obstetricians, in order to avoid errors due to sleep deprivation.

Though many aspects of the plan were costly, the authors concluded that the savings in medical malpractice payments "dwarf the incremental cost of the patient safety program.”

Source: Crain’s New York Business.com

You can read the article in the American Journal of Obstetrics and Gynecology here.

That's all that a sick friend needs to hear from you. Two sentences. Nine words. Too often, what they hear instead is silence -- you don't know what to say, you're afraid to say the wrong thing, and so the friend winds up feeling abandoned in a time of need. Or, just as bad, friends will weigh in with unsolicited advice, or insensitive comments.

The best thing to do is to be present. And to listen. And respond.

More thoughtful comments and experiences from patients can be found in the NY Times blog piece on "When friends disappear during a health crisis."

Since the 1970’s, gynecologists would generally advise women who are hysterectomy candidates to also have their ovaries removed, along with the uterus. The idea was to prevent ovarian cancer, which is difficult to detect but often deadly. However, Roni Rabin reports in a New York Times story that a new study finds compelling reasons for women to keep their ovaries.

The study, published in the May issue of the journal Obstetrics & Gynecology, tracked almost 30,000 women over the span of 24 years. It found that women who had their ovaries removed were at a greater risk for heart disease and lung cancer, and were more likely to die of cancer than those who left their ovaries untouched. For women who had their uterus and ovaries removed before they turned 50 and did not take estrogen, these risks were even higher. Scientists believe the continued production of estrogen may be the reason why women who kept their ovaries tended to live longer.

The lead author of the study, Dr. William H. Parker of the John Wayne Cancer Institute in Santa Monica, CA, explained why women should consider keeping their ovaries because although ovarian cancer is difficult to detect and treat, it is much rarer than heart diseases. Every year, heart diseases kill more than 20 times the number of women than ovarian cancer.

Of course, there are women who will benefit from removing their ovaries, especially those who are at high risks of getting ovarian or breast cancer. A patient with strong family history of either cancer should definitely consult with their doctor to decide the best course to take.

If you are pregnant and experiencing fatigue, dry skin, sleep loss, or weight loss, it may be worthwhile to find out whether you are a candidate for a thyroid test – these symptoms, while common in pregnant women, may be caused by underactivity (hypothyroidism) or overactivity (hyperthyroidism) of the thyroid gland.

If untreated during pregnancy, both conditions have been shown to result in higher risks for miscarriage, premature birth, preeclampsia, and even impaired intelligence in the child (in the case of hypothyroidism). But does such risk necessarily warrant a universal recommendation for thyroid tests in pregnant women? Ingfei Chen explores an ongoing debate on this issue in a New York Times article.

The thyroid gland produces hormones that regulate many important aspects of our bodies, including metabolism, body weight and heart rate. When there is too much of this thyroid-stimulating hormone (TSH), the pregnant woman suffers from hyperthyroidism and experience poor sleep, weight loss, and nervousness after giving birth. On the other hand, when the thyroid gland is underactive, the resulting hypothyroidism causes fatigue, weight gain and dry skin. Both conditions are manifested in very subtle symptoms but are risk factors for dangerous pregnancy complications.

While both an overactive and an underactive thyroid spell trouble for pregnant women, hypothyroidism is the more common and worrisome condition. Hypothyroidism, affecting 10 to 20% of women of childbearing age, is often undiagnosed but hampers fetal brain development. A study done 10 years ago reports that 19% of children born to women with untreated hypothyroidism had an IQ of 85 or lower, whereas the same measure was only 5% for those born to mothers with a healthy thyroid.

Although risks of an imbalanced level of TSH are known, the medical field is currently split on whether there is sufficient existing evidence for the benefits of treating the condition, and subsequently, of recommending universal screening. Studies are underway to track pregnant women with healthy and underactive thyroids, and their children will be tested for IQ. Until scientists arrive at conclusive results, the general clinical policy is to recommend a thyroid test to high-risk women (for example, a woman with family history of thyroid problems). However, more doctors have begun recommending the test to normal-risk expecting mothers, and many think that evidence for universal screening will soon be available, according to Dr. Stagnaro-Green, an endocrinologist at Touro University College of Medicine in New Jersey.

A new LabCorp blood test called OvaSure is aimed at early detection of ovarian cancer, but OB-GYNs doubt its efficacy and safety, as false positives might lead to unnecessary surgery and extreme anxiety. Ovarian cancer often goes undetected until later stages, by which point it can be too late to treat it effectively. A test that makes early detection more feasible would therefore be a wonderful thing.

From the article:

The need for such a test is immense. When ovarian cancer is detected at its earliest stage, when it is still confined to the ovaries, more than 90 percent of women will live at least five years, according to the American Cancer Society. But only about 20 percent of cases are detected that early. If the cancer is detected in its latest stages, after it has spread, only about 30 percent of women survive five years.

But far from greeting the new test with elation, many experts are saying it might do more harm than good, leading women to unnecessary surgeries. The Society of Gynecologic Oncologists almost immediately issued a statement saying it did not believe the test had been validated enough for routine use.

“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”

The test is good news if it is indeed valid, but raising false hopes and causing unnecessary procedures and stress is an adverse consequence of all this hype.

Tara Parker-Pope has a blog post about how doctors will treat women of childbearing age as "pre-pregnant," focusing on their reproductive capacities to the detriment of their overall health. Obviously reproductive matters are an important part of overall health and can influence many other medical conditions. But so can a lot of other common issues: neurological and psychological problems, drug-related issues, alcohol and tobacco habits, gastrointestinal issues, and so on all have a huge effect on a person's overall health. Yet these issues do not command the same attention from many doctors, who focus on the potential for a pregnancy rather than on the woman as a whole patient. As a consequence, the woman's health suffers.

The comments section of the post is enlightening and makes it clear that this is an issue many women face and are extremely angry about. There are also a few dismissive comments telling women to "get over it," displaying the ignorance and foolishness that enable these attitudes in the first place.

A Spanish study, conducted on 250 participants of varied nationalities, shows that 24% of pregnant women feel poorly informed by their gynecologists and that nearly half do not take any pre-natal course.

Considering the medical, social and emotional importance of pregnancy and childbirth, it is especially vital for pregnant patients to be informed and in control of their health care during gestation and birth.

From the article:

The Head of the Obstetrics and Gynaecology Department at the Hospital Clínico San Carlos, Miguel Ángel Herráiz, who presented the results of the survey...explained that the aim of the study is to find out pregnant women's preferences during birth, with there currently being a tendency in administrations and the media in favour of a more natural birth. With regard to the high number of women who believe their gynaecologist does not inform them properly, the expert recognises that "we need to provide a birth plan and explain well and at all times how the process is going to be".

The survey asked about questions that have become more pressing in recent years, such as whether or not Cesarean sections and other medical interventions ought to be done as commonly as they are at present.