An honest take on screening for lung cancer

This could be an early sign of more honesty where it concerns new screening tests. In the not-so-distant past, screening tests were introduced to physicians and the general public with great enthusiasm but virtually no acknowledgement of harm. Too often that information came 20 to 40 years later (think PSA and mammography), if at all. Now low-dose lung scans have just received the official blessing as a screening test from four major professional organizations, including the American Cancer Society. Here’s what stands out—not only are the known harms acknowledged but so are the uncertainties.

The stamp of approval comes after an in-depth review of all relevant studies that appeared recently in the Journal of the American Medical Association. Here is the conclusion: “Low-dose computed tomography screening may benefit individuals at an increased risk for lung cancer, but uncertainty exists about the potential harms of screening and the generalizability of results.”

Let me translate this less-than-ringing endorsement. The rate of lung cancer deaths avoided by this expensive high-tech procedure is extremely low, despite the fact that it was confined to heavy smokers and former heavy smokers who quit in the last 15 years.  More on deaths-avoided later.

As for the “generalizability of results” this refers to an underappreciated point that applies to most findings from clinical trials. The care delivered in a clinical trial is usually far better than that delivered in the real-world practice of medicine. Yet the single large clinical trial that formed the basis for the new review is an unusual mix of both. The diagnostic workups and treatments of the trial took place in the real world (academic medical centers, community hospitals, or doctor-owned radiology clinics). But all the images were interpreted by radiologists, who had extra training in the interpretation of low-dose CT scans and more experience with this particular technology than the average radiologist.

This government-funded study, called the National Lung Screening Trial, was described in the review as “the most informative.” It is the largest study (52,000 participants) and the only one that randomly assigned high-risk people to undergo either a CT scan or another already-discredited screening test (chest x-ray). All participants had one screening procedure annually for three years and then were followed for three more years.

Attempts were made to assess the harms. For example, the reviewers estimate that one cancer death would be caused by the radiation exposure of three scans “for every 2,500 persons screened, although this death would likely occur many years later.”  Short-term  estimates of false-alarms and unnecessary lung biopsies were mentioned.  Amazingly, so was overdiagnosis (defined as “histologically confirmed lung cancers identified through screening that would not affect the patient’s lifetime if left untreated. This includes patients who are destined to die of another cause.”) Unfortunately, the reviewers say, “The rate of overdiagnosis [and the inevitable overtreatment] cannot yet be estimated.”  Such gaps in information explain why “uncertainties about potential harms” appears in the review’s conclusion.

Lung scanning was introduced over 20 years ago as a diagnostic test, but there is no reliable information about how long or how frequently it has been used as a screening test. The latter use is a money-maker for hospitals, especially those advertising their high-tech equipment directly to the public. It is unlikely that the first wave of screening customers was giving their informed consent since there was no information to provide until 2010. This is the year when the National Lung Screening Trial posted its preliminary results on the National Cancer Institute’s website.

The final results of this trial are central to the newly published review, and here is how its authors describe lung scanning’s lifesaving advantage over chest x-rays: “The chance of dying from lung cancer was 0.33% less over a three-year period.”

Put another way: 99.6% of high-risk smokers and former smokers will risk the adverse effects of this test but gain no lifesaving benefit. Put yet-another way, one lung cancer death avoided out of every 320 people screened.

This review is described as “a collaborative initiative of the American Cancer Society, the American College of Chest Physicians, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network.   Disclosure: I served as consumer representative on one of the committees within this collaborative. It struck me as downright stupid that we were not permitted to look at the most obvious consideration: Is this expensive technology cost-effective?   Unlike countries with high-quality medical care systems, the U.S. has a toxic politial climate that does not allow this question to be explored. The word rationing would be hurled at any conclusion that indicates the answer is no.

Maryann Napoli, Center for Medical Consumers©
Related posts:
Screening scans for smokers and former smokers 2011 post describes heavy smokers and the National Lung Screening Trial in greater detail.
Are you a smoker or former smoker? 2010 post describes an earlier lung scanning trial and why its results are unreliable.

Time to rethink low-dose aspirin therapy?

Here’s a new slant on the daily low-dose aspirin routine followed by millions of Americans: You might want to stop, if you don’t have heart disease or are at low risk for it. Why? The chance of having a rare but serious side effect from aspirin therapy may be higher than the chance of avoiding a heart attack or stroke.   And this goes for people with diabetes.

These new findings, published online first by the Journal of the American Medical Association, call into question the current thinking about the safety of low-dose aspirin therapy. They also brought to mind an interview I did years ago when doctors were telling us—in the media and in person—that statins are safer than aspirin. I was skeptical about the purported safety of statins because these cholesterol-lowering drugs were relatively new at the time. What’s more, the comparison didn’t seem convincing. After all, it took medical science a hundred years to understand the risks of aspirin.

But the research physician I was interviewing pointed out that all the aspirin vs. placebo clinical trials showed that—no matter how low the aspirin dose—there were always more cases of brain or gastrointestinal bleeding in the study participants on aspirin.

Naturally, I checked his contention and found that the smallest aspirin dose studied to date was a trial that included healthy postmenopausal women taking 100 mg aspirin every other day. And indeed, there were more cases of serious bleeding in the women on aspirin than in those on a placebo.

That’s my backstory  for the new evidence against low-dose daily aspirin use in people without heart disease. Surprisingly, a new study found that the incidence of major bleeding leading to hospitalization is much higher than has been reported in clinical trials. Significantly, this new finding is not based on people who took part in clinical trials.

The study was conducted in the Puglia region of Italy where researchers had access to the medical records of all its citizens. They singled out 186,425 people, aged 30 to 95 years, on low-dose aspirin therapy and matched them with an equal number of people of similar ages and health who were not on aspirin therapy. Both groups had equal number of diabetics (about 15%).  All were followed for nearly six years.

Here are the results: There were bleeding-related hospitalizations in 3,369 of the people not on aspirin therapy, and in 3,538 of those on aspirin therapy. Put another way, 169 more cases of serious bleeds in those on aspirin.

This study provides a more accurate, real-world assessment of aspirin therapy’s harm than a clinical trial because people who volunteer for research are typically younger and healthier than the general population. And those with multiple chronic conditions are usually excluded.

From the medical records of people hospitalized for severe bleeding incidents, the Italian researchers were able to identify those most likely to be affected. Men, for example, are more likely than women. So are people with previous hospital admissions for gastrointestinal problems, those on other drugs known to cause bleeding (e.g., Coumadin, Plavix), and everyone over age 70.

The editorial that accompanied this study made it clear that aspirin therapy’s benefit outweighs its harms for people with heart disease. “For 6 major vascular events [e.g., stroke, heart attack] prevented, approximately1 major bleeding event would occur; therefore, the value of aspirin for secondary prevention is not disputed.”   (Click here for another estimate)

As for everyone else—the people who don’t have heart disease—the Italian researchers described two noteworthy aspects of their findings:  It has long been known that people with diabetes have a increased risk (36%) of bleeding, but this is the first study to show that aspirin had no effect. Low-dose aspirin therapy neither decreased or increased the bleeding risk in diabetics.

The other important finding involves statins. (Yes, I’ve come full circle to statins and aspirin). About one-fourth of all people in this study were taking statins, which appeared to have a protective effect against aspirin, say the researchers, citing a “substantially lower risk of both gastrointestinal and intracranial hemorrhages associated with the use of statins.”  They cite several previous studies that confirmed this protective effect.

But things are not so clear for brain bleeds. The researchers cite a large, randomized trial published last year that suggested statins may increase the risk of intracranial hemorrhage [emphasis added].”The take-home message:  your risk of stroke or heart attack has to be high enough to warrant the newly identified higher risk of major bleeding. But you might need someone with an advanced degree in biostatsitics, rather than a family doctor, to help you sort things out.

To me, this is a cautionary tale relevant to all “preventive” medicines. If it took this long to understand aspirin, how long will it take to learn the full-story on the harms of newer drugs like Plavix and Fosamax that people are expected to take daily to cut their chances of heart attack or a fracture.

And keep this in mind: Aspirin therapy is for life, but this study (like most clinical trials) lasted less than six years.

Maryann Napoli, Center for Medical Consumers©

Related posts
Drugs to prevent heart problems
Low-dose aspirin and cancer prevention
Most drugs don’t work in most people  Read how doctors, journalists, and consumers are misled by the way drug-effectivess statistics are presented in medical journals.

Lung screening scans for smokers

At the end of last year, the National Cancer Institute announced that it had stopped its lung screening trial earlier than planned. The reason: fewer lung cancer deaths among participants screened with CT lung scans compared with those screened with chest x-rays. This landmark trial is the first to show that screening can reduce lung cancer mortality in people with a history of heavy smoking. Because the National Lung Screening Trial (NLST) is taxpayer-funded, its results were reported directly to the public on the NCI website. But the NCI also made it clear that the harms associated with lung screening would not be known for months. The missing information came in this week’s issue of the New England Journal of Medicine.

The harm of screening lung scans is primarily, but not limited to, false alarms. That is, of course, the risk of all screening tests. Mammography, for example, has a high rate of false-alarms (false-positives), and studies show that most women accept this as the “price to pay” for what they perceive as the lifesaving benefit for mammography. But unlike a biopsy of the breast, which is, after all, an appendage, a needle biopsy of the lung is much riskier. Complications include death (rare, we are told) and collapsed lung (common for smokers and former smokers). Some NSLT participants went on to more invasive, risky procedures like thoracotomy and mediastinoscopy for abnormalities that turned out not to be cancer.

If you are a smoker or former smoker, your decision to be screened with a CT lung scan should involve weighing the benefit against the harms. The first thing to consider is whether you fit the profile of the people who participated in the NLST. They were male and female smokers and former smokers, age 55 to 74 years*, who were symptom-free at the start of the trial. All had smoked one pack a day for 30 years, or two packs a day for 15 years, or three packs a day for at least 10 years in the previous 15 years. The more than 53,000 participants were randomly assigned to have either a low-dose spiral computer tomography (CT) lung scan or a standard chest x-ray annually. The trial was stopped at 3 years and continued to followed participants for 3 ½ more years.

There were 356 lung cancer deaths among the more than 26,000 participants assigned to receive a spiral CT lung scan, compared to 443 among the 26,000 participants given chest x-rays (either way, a surprisingly low number of deaths for such high-risk people followed over a six-year period). But this benefit came at a huge cost in terms of money, health, and worry to the one in four people, whose scans indicated cancer, leading to more tests, a needle biopsy, and in some cases, an invasive procedure before a false-alarm was ultimately determined in the overwhelming majority of cases. False-alarms occurred in both groups, but scanning found far more abnormalities that looked like cancer before they were ultimately judged to be benign. The scans cost a couple of hundred dollars each; the “cascade” of tests that can follow are costly.

Though “low-dose” is part of its description, CT scans involve a radiation dose far higher than a standard chest x-ray but less than the standard CT scan click here. Whether annual spiral CT lung scanning itself causes lung cancer is yet to be determined. For screening mammography, the NCI estimate is: There are between 10 and 32 radiation-induced breast cancers for every 10,000 women exposed to accumulated doses of radiation received over the years from multiple mammographic examinations.

Although hospitals have already started targeting smokers with advertising for annual screening lung scans, the authors of the NLST, led by Christine Berg, MD, of the NCI’s Early Detection Research Group, do not think the technology is ready for prime time both for cost-effectiveness and safety reasons.  One concern—and it applies to all research projects—is the care delivered in the context of a clinical trial is likely to be far better than that received in the everyday practice of medicine. In the editorial that accompanied this study, Harold C. Sox, MD, Dartmouth Medical School, points out that the NLST took place at 33 academic medical centers, but the diagnostic testing and cancer treatment took place in the community, aka the real world. Dr. Sox is encouraged by the fact that the rate of death associated with diagnostic procedures was low because it indicates that diagnostic care in the community is good. However, where it concerns the radiologists who read the scans for the NLST participants, Dr. Sox suggests their skills were probably far higher than their counterparts practicing in the community. The NLST radiologists “had extensive training in the interpretation of low-dose CT scans and presumably a heavy low-dose CT workload.”

Dr. Sox wrote that he agreed with the authors of this study. “…policy makers should wait for more information before endorsing lung-cancer screening programs.”

*Participants in their seventies were underrepresented in this study (fewer than 3% of all). This means that less is known about the safety and effectiveness of screening people over age 70.

See this August 7, 2011 lung screening addition to TheNNT.com website. 

Maryann Napoli, Center for Medical Consumers©

Improved treatment trumps mammography

Is there any point in writing about the latest mammography screening study? Opinions are entrenched on both sides—people who think the technology is lifesaving and people like me (a much smaller group) who follow the supporting research and see its lifesaving benefit as far outweighed by its well-documented risks. It is, however, worth mentioning a new study conducted in Norway that answers an important question that has nagged cancer researchers for years. Is the declining breast cancer death rate, seen in the U.S. and other Western countries, due to mammography screening or improvements in treatment? The findings, published yesterday in the New England Journal of Medicine, indicate that mammography accounts for only a small percentage of mortality reduction.

Norway did not start its national screening program until 1996 when women between the ages of 50 and 69 years were offered mammography every two years. In anticipation, the country set up what was described as “multidisciplinary breast cancer management teams [surgeons, pathologists, oncologists, radiologists, etc.] to provide comprehensive and integrated optimization of breast-cancer care.” Norway has a population of 6.8 million and a cancer registry that includes nearly 100% of its cancer patients.

The researchers led by Mette Kalager, MD, based their findings on registry data from over 40,000 women with breast cancer. They compared the breast cancer deaths among women diagnosed and treated in the nine-year period prior to, and the nine-period following, the introduction of mammography screening. Because the program had staggered implementation, the researchers were able to include women who lived in areas where mammography was still unavailable.

In the editorial that accompanied this study, H. Gilbert Welch, MD, Dartmouth Medical School, observed that the Norwegian researchers could separate the mortality reduction effect of mammography from other other factors that may have changed over time, such as treatment improvements and awareness campaigns that now make women react more quickly to a new breast symptom than they would have in an earlier era. Mammography’s benefit was found to be “disappointingly small,” accounting for only a 10% reduction in breast-cancer death among women between the ages of 50 and 69 years. [Note: Hiding in plain sight—in the new study’s abstract—was the fact that this small reduction is not statistically significant, i.e., the finding is due to chance. This was noted by Peter Gotzsche, MD, professor and director of the Nordic Cochrane Centre and the world’s leading authority on the research basis for mammography screening. click here]

This is not the first study to find a marginal benefit to mammography screening. Nor is Norway the first country to use cancer registry data to see what happened after mammography screening was introduced. Denmark, for example, found that the mortality rate declined 1% per year in the screening areas, but—brace yourself for the unexpected—there was a bigger decline (2%) per year in the non-screening areas and breast cancer deaths decreased even in women too young to be screened click here.

Back to the Norwegian study, Kalager and colleagues make the point that mammography screening requires a back-up of good comprehensive care available to all: “Our results support the evidence that screening mammography reduces the rate of death from breast cancer. However, the magnitude of the benefit seems modest in the high-attendance, nationwide screening program we evaluated. Most important, the apparent benefit conveyed by optimized patient care may be missed unless mammography screening is integrated into a well-functioning health care system that is available to the entire population.”

This point was driven home when the researchers looked at women over the age of 70 years who, in Norway and virtually all other countries (except the U.S.), do not undergo mammography screening. The unscreened women in this age group had an 8% reduction in breast cancer deaths which was attributed to the comprehensive-care teams.

So what do these findings have to do with American women? Hard to say. Obviously, we don’t have universal access to medical care, much less to mammography screening. Women treated at academic medical centers might be seen by multidisciplinary teams, but it’s unlikely to be the norm. The breast cancer mortality rate in the U.S. has decreased by roughly 2% a year since the 1990s. This study indicates that the rate could drop further if we too had universal access and a medical care system that offers the same high-quality care for all.

This study gives us something else to think about—Is mammography screening a good use of limited financial resources? This is a technology that causes a high rate of false-alarms, biopsies, and unnecessary treatment of healthy women with breast cancers that would never progress had they been left undetected. With such a small lifesaving benefit in return, mammography screening may have already crowded out other, more promising ways to lower the breast cancer death rate.

Maryann Napoli, Center for Medical Consumer©

For previous articles on this topic, type the word mammography in the search box on our home page.

Best place for cancer death—home

Which is the best place to die of cancer—home or hospital? This crucial question was answered in an unusual study that looked not only at the quality of remaining life for the dying cancer patients but also the impact on their loved ones.

Those who died in the hospital or an intensive care unit fared the worst in terms of physical and emotional distress, compared with those who died at home with hospice care. A hospital death also put the bereaved family members at a higher risk of depression, anxiety, and prolonged grief. Death in an ICU was associated with the highest risk of post-traumatic stress disorder—for the patients as well as the bereaved family members.

This study had an unexpected finding. The people who died at home without hospice care did the best in terms of quality of life and psychological well-being (better than home with hospice by about 1%, respectively). “This may be because they are a particularly well-adjusted group who either did not need additional services, had more family support, and/or received services we did not assess,” according to the researchers. As for the caregivers, the percentage who reported “stressful caregiving experiences” ranged from 5% (ICU)to nearly 8% (home with hospice).

This study was published recently in the Journal of Clinical Oncology and led by Alexi A. Wright, MD, Dana-Farber Cancer Institute, Boston. The researchers followed 342 patients for about 4 ½ months and their bereaved caregivers were assessed within two weeks of death. Caregivers were primarily spouses and adult children.

This type of study is long overdue because more and more people are treated aggressively, even when their cancers are advanced and there is little chance of prolonging life. The new study dovetails nicely with one published last month in the New England Journal of Medicine. It compared people with advanced lung cancer given either early palliative care or the standard aggressive treatment. Those given early palliative care received less aggressive care; reported a better quality of life; and had a longer survival.

When surveyed, most Americans say they want to die at home but most of us now die in hospitals. When faced with a cancer diagnosis, however, many might see the hospital as the better place for pain control. When Dr. Wright and colleagues were planning this new study, they wrote that were influenced by earlier research showing, “55% to 75% of cancer patients in an ICU reported moderate to severe pain, discomfort or anxiety, despite the routine integrations of palliative care services.”

Read “Americans are overtreated to death” in USA Today.

Maryann Napoli, Center for Medical Consumers©

Hospital-Acquired Infection Report

New York State Releases 2008 Hospital-Acquired Infection Report

June 30, 2009. The long awaited New York State 2008 report on hospital-acquired infections was released today at a press conference held at Roosevelt Hospital. The law requiring the report took effect in mid-2006, but the first report issued in 2007 did not by design provide the names of hospitals. The 2007 report did provide aggregate rates for the state by region and type and size of hospital, thus establishing a baseline for trending purposes. Arthur A. Levin, MPH, Director of the Center for Medical Consumers, was instrumental in writing the law and steering it through the legislative process.

Some important findings from the new report are as follows:

– No one hospital was found to have a high hospital-acquired infection rate across the board.

– Colon surgical-site infection rates decreased significantly in 2008 and were lower than 2006-2007 national rates.

– Coronary Artery Bypass Graft chest infection rates declined from 2007 and were significantly lower than 2006- 2007 national rates.

-Hip replacement surgical-site infections in 2008 were unchanged from the previous year.

-Central line-associated bloodstream infection rates in intensive care units for 2008 were the same or higher than the 2006-2007 national rates. The report breaks down intensive care units into categories, such as surgical, medical, pediatric and newborn.

As a result of including the auditing requirement in the law, New York State likely has the most reliable information of any state hospital infection reporting system. A Department of Health team of infectious disease specialists visited each of the reporting hospitals at least once during the year to review the accuracy of their identification and reporting. The Department of Health teams conducted sample chart reviews as part of their routine audit process. While in 2007, eight hospitals were identified as out of compliance with reporting requirements and eventually cited by the department; by 2008 all hospitals in New York State were in compliance with the law.

Consumers should understand that infection rates alone might not be a sufficient reason to go to or stay away from any one hospital. If the report had found that one or more hospitals with higher rates across all the measures, a prudent consumer would have had reason to avoid that facility. However, that was not the case in 2008.  Furthermore, the results are mixed for each hospital.

The department has said it will work with hospitals with higher than average infection rates on one or more measures to find ways to improve patient safety.

Here are some tips on how to best understand the report. The graphical presentation of results starts on page 55 with the results for colon surgical-site infection rates and the other measures follow. On page 26 of the report you will find an explanation of the tables. A summary of all the results for each hospital begins on page 123 (Table XXIII). The absence of any result in any cell (box) of the table means that the hospital does not provide that service (for example only 40 hospitals perform CABG surgery). Where “NA” appears in the cell, the hospital did less than 20 procedures in 2008, a number too small for statistical significance.

Contact Arthur A. Levin at medconsumer@earthlink.net

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Heartburn Drugs Overused In Hospital Patients Not at Risk for Stress Ulcers

Acid-reflux drugs like Nexium and Zantac, which suppress stomach acid, are among the most widely prescribed in the country. Their use has been steadily increasing among hospital patients, often for indications that have no supporting scientific evidence. Between 40% and 70% now receive some version of these acid-suppressive drugs, also known as proton pump inhibitors (PPIs), during a hospital stay. A new study, published last month in the Journal of the American Medical Association, found that they have a higher incidence of pneumonia than hospital patients not given these drugs.

The study was led by Shoshana J. Herzig, MD and colleagues who analyzed the medical records of all patients who where admitted to a large, urban, academic medical center in Boston from 2004 through 2007. To be included in this study, the patients had to be at least 18 years of age and hospitalized for three or more days, but not admitted to the intensive care unit. The study included nearly 64,000 patients, 52% of whom were given one of two classes of acid-suppressive drugs—PPI (e.g., Nexium, Prevacid, Prilosec) and histamine2 receptor antagonist (e.g., Pepcid, Zantac).

Of the hospital patients who received the acid-suppressive drugs, 4.9% developed pneumonia while in the hospital, compared with 2% of the people not given the drugs. PPIs were more likely than H2 receptor antagonists to be prescribed and to cause an increase in pneumonia. After taking into account that the drug-treated people may have been sicker at the time of hospital admission, the researchers estimated that the people given acid-reflux drugs had a 30% increase in their risk of pneumonia compared with those not given the drugs.

Although hospital patients frequently are given acid-reflux drugs for preventive purposes, Dr. Herzig and colleagues say that the drugs are approved by the FDA only for people at high risk for developing stress ulcers.

This study builds on the results of earlier acid-reflux drug studies that found people on these medicines have a higher incidence of hip fracture, community-acquired pneumonia (i.e., pneumonia that occurred outside of a hospital), and diarrhea associated with Clostridium difficile.

Maryann Napoli, Center for Medical Consumers© June 2009

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Hospitals Compared

Consumer Reports Provides Comparisons of Aggressive vs. Conservative Hospital Care

The “more is better” approach to American health care has been challenged consistently over the last 15 years by research compiled by two Dartmouth Medical School physicians. As reported in earlier posts, these researchers have studied the care given to Medicare patients in the last two years of life and shown that more tests, more procedures, more specialist care, more days in the hospital do not lead to a longer life or a better quality of life.

Now Consumer Reports has put the Dartmouth findings in a consumer-friendly format that will help Americans determine whether a hospital in their part of the country is likely to deliver aggressive or conservative care. Nearly 3,000 hospitals across the U.S. are included and will be available in the July 2008 issue of Consumer Reports and is freely accessible on the magazine’s Web site. It relies on data from the Medicare claims records of over 4.7 million elderly people treated from 2001 through 2005 for severe illnesses like cancer, congestive heart failure, lung diseases, dementia and coronary heart disease.

The brains behind this research are John E Wennberg, MD, and Elliott S. Fisher, MD, at the Dartmouth Medical School, who have regularly published findings in medical journals as part of a 30-year study of U.S. health care. Entitled the Dartmouth Atlas of Health Care 2008, this research project has also made its findings freely available at its own Web site (www.dartmouthatlas.org).

Contrary to what many Americans believe, aggressive care and consulting many specialists do not improve outcomes or lead to more patient satisfaction. In fact, altogether they slightly increase mortality. The Dartmouth researchers demonstrated years ago that more care often results in more procedures that are painful and unnecessary; more days in the hospital raises the chances of suffering a medication error or getting a fatal hospital-borne infection; and more specialist care leads to uncoordinated care. (Get a good primary care doctor is one of the take-home messages of the Dartmouth researchers.)

At a time when hospitals typically advertise their new high-tech equipment and friendly staff members, Consumer Reports provides an easy way for the public to see just how aggressive their care will be compared to other hospitals in their cities. (Next, we need to know the infection rate of all U.S. hospitals.) It raises a larger question for everyone to consider: Since overly aggressive care is not limited to the elderly, how can people of any age protect themselves when they become hospital patients?

Things aren’t likely to change until consumers make their wishes known and raise questions. Consumer Reports provides many excellent suggestions: Is this treatment likely to extend my life, and if so, for how long? How do its side effects and risks compare with the symptoms and risks of my disease itself? What will happen if I do not have the treatment? Will this test change the way you treat the disease? If not, what is the benefit of doing it? Is this test likely to lead to follow-up tests, biopsies, or other diagnostic procedures? How will this benefit my health?

The Consumer Reports Web site illustrates why New York University Langone Medical Center in Manhattan is #1 in the country in terms of delivering the most aggressive (and expensive) care. The Medicare cost per person in the last two years of life at this hospital was $105,067. This is compared with $44,090 at the country’s #1 hospital in terms of the most conservative care —Scott & White Memorial Hospital in Temple, Texas. (Both are chosen from a subcategory of 93 U.S. hospitals called “integrated medical centers”—that is, hospitals affiliated with medical schools.)

The average patient treated at NYU hospital in the last two years of life spent 54 days in the hospital, 12 days in the ICU, had 34 primary-care visits and 97 specialist visits. The average patient at the Hospital in Temple, Texas spent 16 days in the hospital, four days in the ICU, had 23 primary-care visits and 18 specialist visits. Yet, as Consumer Reports notes, “The Centers for Medicare and Medicaid Services rates care at Scott & White to be at least as good as that at NYU.”

The New York Times reported that the list of New York City hospitals at the Consumer Reports Web site shows a clear division in terms of aggressive care between the private and the public hospitals. As a group, the private hospitals were in the 94th percentile of aggressive care compared with the public hospitals in the 69th percentile. Although the latter is still above the national average, the difference cries out for explanation. The most obvious would be that poor people get inferior (i.e., less) care.

Dr. Eric Manheimer, who is the medical director at Bellevue (a public hospital) and on the faculty at NYU medical school, offered a unique perspective to The New York Times of someone who works for both the public and private systems. “The care at public hospitals was less aggressive because most of their doctors—he estimated 75-85%–were salaried physicians with little financial incentive to order tests or other interventions. At private hospitals, he said, supply can creates its own demand. There is often an abundance of beds and an endless list of specialists who can be called.”

Maryann Napoli, Center for Medical Consumers ©
June 2008

Hospital-Acquired Infection…and What To Do About It

What kills more than five times as many Americans as AIDS? Betsy McCaughey, PhD, chairman and founder of the Committee to Reduce Infection Deaths (RID) wants you to know that it is hospital infections, specifically a bacterium called methicillin-resistant Staphylococcus aureus. MRSA infections are far more difficult to treat than ordinary Staph infections because they are resistant to most types of antibiotics.

Dr. McCaughey, former lieutenant governor of New York State, has made it her mission to get hospitals and especially the Centers for Disease Control and Prevention (CDC) to make prevention a high priority. In a recent Wall Street Journal op-ed article, she notes, “These infections are caused largely by unclean hands, inadequately cleaned equipment, and contaminated clothing that allow bacteria to spread from patient to patient. At one time, hospitals routinely tested surfaces for bacteria, but in 1970, the CDC and the American Hospital Association advised them to stop, saying testing was unnecessary. Astoundingly, the CDC still adheres to that position despite a 32-fold increase in MRSA infections.”

Dr. McCaughey is interviewed by Maryann Napoli, Center for Medical Consumers.

MN: The statistic that you use—100,000 deaths due to hospital infections annually in the U.S.—comes from the CDC, doesn’t it?

BM: The CDC is only one source. Their more recent statistic is: One out of every 10 to 20 people contracts an infection [while in the hospital]. The CDC puts the number of deaths at 99,000, but other sources say that is a severe undercount. So I usually say, “At least 100,000 deaths.” In fact it’s probably quite a bit more.

MN: What is your basis for saying that?

BM: Last October the Journal of the American Medical Association published a study about the extent of the MSRA infections in U.S. hospitals that nearly doubled what the CDC had been estimating. The reason is the methodology used. Instead of relying on what hospitals report or tell patients’ families, these new data are based on laboratory results which cannot be diminished or modified.

MN: Explain that.

BM: When the hospitals send all their tests to the labs, the laboratories simply count, “How many MSRA infections do we have here?” This was the first nationwide study using this methodology on the extent of MSRA—85% of which occurred in hospitals. The CDC realized that the extent of MSRA infections is far larger than what hospitals had been reporting. And if that’s true for MSRA infections, then it’s likely true for other types of bacteria. So the previous CDC guesstimates need to be reevaluated, based on this October 17 study in JAMA. It revealed the truth gap in the previous methodology.

MN: Denmark, Finland and the Netherlands reduced their soaring rates of MRSA infections to near eradication with multiple preventive measures (see “15 steps” at Dr. McCaughey’s Web Site). You are very critical of the CDC for not encouraging similar actions.

BM: For 25 years, the CDC has tracked the rapid rise in drug-resistant infections. They have consistently understated the extent and cost of the problem. And they have done too little to prevent it.

MN: How do you explain the CDC inaction?

BM: I can only imagine, but having been in government, I know that often agencies that are created to oversee an industry become co-opted by the industry. They spend so much time with hospital administrators rather than with grieving families and ill patients that they begin to share the hospitals’ concerns about the difficulties of changing procedures, the difficulties of more effective cleaning.

MN: You’ve been known to take cleaning matters into your own hands when friends or relatives are hospitalized.

BM: I’ve often gone into the hospital to visit a patient with a bag of cleaning supplies, including gloves, and cleaned the bed rails, the over-the-bed table, the TV monitor. I do it myself, knowing that otherwise it would not be clean.

MN: What do you use?

BM: Something like Windex [ammonia] because it has to stay on the surface for three minutes to kill the germs. It’s not a quick spray and wipe; it’s a drench and wait. Spray it on, wait three minutes to kill the germs and then wipe it off. The only one that Windex won’t kill is Clostridium difficile [bacterium that attacks the colon]—there you need something with bleach in it generally.

MN: We’ve been told that, when hospitalized, we should tell the hospital staff to wash their hands before touching us, but that’s difficult when you’re the one in the bed.

BM: Generally it’s the families [that should do it] because patients are usually too sick, too scared, too old, or in too much pain to act on their own behalf. Families should not be worried about being too aggressive when their loved one’s life is at stake.

For more information:

See 15 steps you can take to reduce your risk of a hospital-acquired infection at the Web site of Dr. McCaughey’s Committee to Reduce Hospital Infection Deaths (www.hospitalinfection.org).

Consumers Union (www.consumersunion.org/campaigns/stophospitalinfections/learn.html) for ways to take action and articles on the topic.

The Leapfrog Group (www.leapfroggroup.org) is aimed at reducing medical mistakes, including hospital infections. See whether the hospitals in your area have instituted 30 safe practices of which five are related to healthcare associated infections. The hospitals collect and submit their own data. The Leapfrog Group does not independently verify the data.

Maryann Napoli, Center for Medical Consumers ©
February 2008

Yogurt Drink Prevents Antibiotic-Induced Diarrhea

A yogurt drink sold in many supermarkets has been shown to reduce the risk of severe diarrhea that can occur after taking antibiotics. The study, published last month in the British Medical Journal Online First, was conducted at several hospitals, a setting where people are most likely to be exposed to drug-resistant strains of bacteria.

Of particular concern in most industrialized countries is the emergence of Clostridium difficile, an increasingly common, sometimes fatal, complication of antibiotic treatment, which occurs in about 5-25% of all hospitalized patients, usually two or three weeks after finishing antibiotic treatment.

Eating yogurt is now a standard way for people to protect themselves while on antibiotics. And to serve this expanding market, more and more yogurt products now feature the word probiotics on the label, claiming that they contain live cultures. Probiotics are defined as “live micro-organisms which when administered in adequate amounts confer a health benefit on the host.” Most probiotic products contain bacteria that help to balance the hundreds of different species of bacteria found in the human body.

Probiotics are gaining some research attention because of the overuse of antibiotics and the resulting increase in drug resistance. Probiotic-containing foods and capsules are consumed to overcome the tendency of antibiotics to kill the normal as well as the harmful bacteria. The problem with products claiming to contain probiotics or “live active cultures” is that they are unregulated, so it’s impossible to know whether they actually contain adequate amounts of live bacteria and the right strains of live bacteria.

British Hospital Study

The probiotic drink used in the newly published British hospital study was Actimel, sold as DanActive in the U.S. This study was partly funded by Danone, a French company that makes both products, which contain Lactobacillus casei, L bulgaricus and Streptococcus thermophilus. All three strains had already been evaluated for the prevention or treatment of diarrhea associated with antibiotic use and found to be safe, according to the British researchers led by Mary Hickson, Imperial College, London, England.

The researchers recruited patients from three London hospitals. All were asked to participate within 48 hours of taking their first dose of antibiotics prescribed for a variety of infections unrelated to any gastrointestinal ailments. The 113 patients (mean age, 74 years) who decided to participate were randomly assigned to drink either four ounces of Actimel or a placebo drink (milkshake).

All agreed beforehand to take the assigned drink twice a day during the course of antibiotics and for one week after completing the regimen. Neither the patients nor the hospital staff knew who was in the probiotics group and who was in the placebo (milkshake) group. When participants developed diarrhea, stool samples were analyzed for the potentially fatal Clostridium difficile toxin.

The hospital patients in the probiotics group fared much better than those in the placebo group. Hickson and colleagues concluded, “Consumption of a probiotic drink containing L casei, L bulgaricus and S thermophilus can reduce the incidence of antibiotic-associated diarrhea and C difficile-associated diarrhea. This has the potential to decrease morbidity, heath care costs, and mortality if used routinely in patients over age 50.”

Here are the results of the study: 12% of the hospital patients in the probiotic group developed diarrhea associated with antibiotic use, compared with 34% of the patients in the placebo group. No one in the probiotics group developed C difficile, but 9% of the patients in the placebo group developed this serious complication.

Cost Effective, Too

Hickson and colleagues provided this estimate of the cost savings in U.S. dollars. The average cost of the probiotics regimen in this study was $20 per patient. The cost of preventing one case of C difficile-associated diarrhea with probiotics was estimated to be $120, excluding dispensing and nursing costs. This is due to that fact that six patients were treated with probiotics for each case of C difficile prevented.

The $120 was then compared with the $3,669 it would cost in the U.S. to provide the standard medical treatment for one person with C difficile. The high cost is mainly due to the increased length of hospital stay required for people with C difficile and the use of a costly intravenous antibiotic called vancomycin, according to Hickson and colleagues.

Vaginal Infections

Something important to women was not addressed in the British study. Many eat yogurt while on antibiotics in order to avert another nasty side effect—vaginal infections. Will the yogurt drink used in this study have any preventive benefit for this infection? The answer is no, according to a leading probiotics expert not associated with the British study: Gregor Reid, PhD, Canadian Research and Development Centre for Probiotics in London, Ontario. “The product [Actimel/DanActive] is designed for intestinal benefits and not for the type of bacteria strains needed to promotevaginal health.”

There is, however, another product proven to reduce the risk of vaginal infections, called Fem-Dophilus (www.jarrowprobiotics.com), said Dr. Reid, who owns patents to the strains present in these capsules. As for the probiotic claims on numerous products sold in supermarkets and pharmacies: “It’s only a probiotic if the product formulation has been clinically tested. Many of them have not. At least, if they have the strains of probiotic in a suitable viable count as found in studies with other formulations, it is promising, but the real test is a human study with the formulation.”

Maryann Napoli, Center for Medical Consumers ©
July 2007