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An honest take on screening for lung cancer

Posted by medconsumers on June 26, 2012

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.

Posted in Cancer, hospitals, Lung surgery, Men's Health, radiation exposure, Scans and X-rays, Screening, surgery, testing, Women's Health | Tagged: , , , , , , , , , | 1 Comment »

Breast cancer and radiation

Posted by medconsumers on June 13, 2012

Want to know the best way to reduce your chances of developing breast cancer? Avoid inappropriate CT scans of the chest. This is the refreshingly blunt conclusion of a new study funded by the U.S. National Cancer Institute. The radiation exposure from this imaging procedure is huge,  the damage is cumulative, and the breast is known to be one of the most radiation-sensitive organs of the body. There has been an alarming five-fold increase in the use of CT scans over the last two decades.

CT scans of the chest are ordered for diagnosing diseases of the heart, the lungs, and even screening symptomless people for these diseases. And it is not yet clear whether the improvements in diagnostic accuracy outweigh the cancer-causing harm of radiation exposure.

Among the reasons given for the inappropriate use of CT scans are: financial incentives, especially for hospitals and physicians who own their CT equipment; expanding indications for appropriate use; fear of malpractice lawsuits; and public demand fostered by hospital advertising campaigns. Too often, radiation exposure is unnecessarily high due to poorly trained technicians, the lack of universally agreed-upon standards for minimal exposure, and failure to calibrate the scanning equipment to the size of the patient.

The National Cancer Institute-funded study was conducted by Rebecca Smith-Bindman, MD, a professor of radiology and biomedical imaging, epidemiology and biostatistics at University of California, San Francisco, and published yesterday online in the Journal of the American Medical Association (JAMA).  She has focused on the breast because of an Institute of Medicine report that was published at the end of last year. Commissioned by the high profile foundation called Susan G. Komen for the Cure, this report disappointed many breast cancer advocates who wanted to know which pesticides and toxic substance in consumer products are the most likely to cause breast cancer.

The Institute of Medicine found insufficient evidence for any of these potential health hazards, but singled out “avoidance of medical imaging as one of the most important and concrete steps that women can take to reduce their risk of breast cancer.” Dr. Smith-Bindman used the National Cancer Institute funding to document the rise in CT scanning between 1996 and 2010 based on the care of patients at six U.S. health plans with 1-2 million enrollees altogether. She found a tripling of the number of CT scans, and a doubling of per capita radiation dosage over the study period. It should be noted that this finding could understate the magnitude of the problem because physicians practicing in managed health plans do not have a financial incentive to overdo the ordering of tests.

Acknowledging the media attention given previous studies documenting CT scan overuse, Dr. Smith-Bindman noted in an online video provided by JAMA: “There is a belief that we’ve solved the problem about radiation dose due to increased awareness over the years, but I’m not convinced that we’ve gotten the doses down, particularly in children and young adults, which are much higher than I would like to see.”

People should ask for the radiation dose before agreeing to a CT scan and make sure the dose is listed in their medical records, she advises, hoping that a groundswell of consumers asking pointed questions will improve the current situation. “Many ordering physicians are insufficiently informed about radiation doses and the cancer risks attributable to medical images,   and yet this information is crucial to weigh risks and benefits and provide appropriate justification for the use of CT and other high-dose imaging studies to patients and families.” Testifying before Congress last week about radiation safety, Dr. Smith-Bindman reportedly said, “Some people have worried about the X-rays at our airports to screen passengers, but one CT scan is equal to approximately 200,000 airport screens.”

When this study was reported yesterday by Medpage, an information source for physicians and journalists, one of the first comments came from an anonymous expert who appears to be a medical physicist, which is a specialist in the health effects of radiation on the human body:

“One issue is the variation in image quality caused by differences in expertise and experience amongst equipment operators, maintenance and calibration protocols, and servicing intervals. Another is the variation in image quality caused by the use of older versus newer, mid-range versus high-end equipment. When I researched this area in some depth about ten years ago, I discovered that the top-end equipment was being built by Japanese firms and only being used in Japan. It simply wasn’t available in the USA, in the EU or elsewhere. I have yet to speak to a specialist in medical imaging technology, or a pathologist or oncologist, let alone a typical medical generalist, who has more than an entry level understanding of the medical physics employed in this area. Accurate images, taken from multiple angles, can be a real boon. But the average physician doesn’t know how to interpret them, and most radiologists refuse to discuss medical imaging results directly with patients.

And another comment from the same Medpage forum:

“For each non-emergency situation, ask your physician or dental  professional, ‘Is this imaging procedure going to change the  treatment plan?’  If they can’t provide an intelligent answer,  then I refuse or delay the test until I speak to someone who can.   Every time my <10 yr old child goes to the Orthodontist, the  assistant immediately says, ‘let’s get some x-rays’ (or even a whole  facial scan) and then gets mad when I question her.  They’ve never  actually recommended any treatment/action taken for my child’s  teeth; she is just being observed yearly so why take x-rays  additional to the ones she has at the regular Dentist?  On the  other hand, my ~40 yr old husband hit his head tubing in the  Smokies.  At the ER, I agreed on a head CT because having a brain  bleed, although highly unlikely, could be fatal.  So, each patient  needs to question the risk to benefit ratio and consider age at the  time of exposure.”

Maryann Napoli,Center for Medical Consumers(c)
Related posts:
Tests to avoid CT scans appear frequently on the specialists’ list of inappropriate tests.
CT scans: lots of radiation, little research Explains why CT Scan radiation dose is so much higher than that of a conventional x-ray. And how to determine when a scan may be inappropriate.
Another way to cut your risk of breast cancer:  Explains how mammography screening  increases your chances of  being  diagnosed with breast cancer and  treated unnecessarily for a cancer that did not need to be detected.

Posted in Advocacy, Cancer, Doctors, Heart, heart disease, Lung surgery, malpractice, radiation exposure, Scans and X-rays, Screening, testing, Unnecessary tests, Women's Health | Tagged: , , , , , , , , , | 2 Comments »

45 medical tests or treatments to avoid

Posted by medconsumers on April 11, 2012

Our medical care system has become a danger, an expensive, wasteful danger at that. So what else is new? You might ask. Now doctors themselves are recognizing the problem and going public with warnings, specifying tests and treatments to avoid under certain circumstances.  The primary care physicians led the way last year when they named the top ten “don’ts” in their field. Now nine specialty organizations have weighed in with their versions.  A momentous move, given the fact that these specialists are putting aside their own economic self-interest and warning their peers as well as the general public about the harm of overtesting and overtreatment.

Altogether 45 tests or treatments made the new list—five for each specialty. Yes, it’s about saving money; an estimated $660 billion is spent annually on unnecessary healthcare in U.S. And no, this is not about rationing; it’s about improving the quality of medical care and using it wisely.

The theme of this project, called Choosing Wisely, is this: Virtually all medical interventions entail some risks both large and small. An example of the former is the huge radiation dose delivered by CT scans; an example of the latter is the small chance of a puncture-related infection from a screening colonoscopy. And some tests that are risk-free can cause false-alarms that lead to more tests that are not. If you have nothing to gain from a test, why take even a small risk?

Here’s a “nothing to gain” example from the oncologists’ list: “Don’t perform PET, CT, and radionuclide bone scans in the staging of early prostate cancer or early breast cancer at low risk for metastasis.” Some reasons: “A lack of evidence to show these tests improve detection of metastatic disease or survival. Unnecessary imaging can lead to harm through unnecessary invasive procedures, overtreatment, unnecessary radiation exposure, and misdiagnosis.”

There’s also a recurring theme within the lists, namely, avoid imaging people without symptoms and people at low risk for the relevant disease. People in one or both of these categories run the risks but have nothing to gain in terms of improved outcomes. Examples: pre-operative chest x-rays, cardiac imaging stress testing for people without symptoms of heart disease.

Some lists warn against imaging even for people with symptoms, such as brain imaging for fainting or for uncomplicated headaches, because there’s no proof it improves outcomes. The cardiologists’ top five is all about inappropriate use of imaging with radionuclide and CT scans.

The strongest warning about reducing radiation exposure came from the American Society of Nuclear Cardiologists:  “Use methods to reduce radiation exposure in cardiac imaging, whenever possible, including not performing such tests when limited benefits are likely.” The word ‘methods’ also refers to calibrating the machinery to produce the best image with the lowest dose.

Sometimes a standard practice is just a waste of the patient’s time and money like this example from the allergists: “Don’t routinely do diagnostic testing in patients with chronic urticaria [hives]. Routine extensive testing is neither cost effective nor associated with improved clinical outcomes.”

Few treatments are addressed in this project, although one tops the gastroenterologists’ list.  It refers to the drugs like Prilosec and Nexium, which are widely prescribed for heartburn, gastroesophageal reflux disease, and gastric ulcers. The gastroenterologists’ advice: Use the lowest effective dose. (Click here for extensive information on this topic from Consumer Reports, which participates in Choosing Wisely.) The gastroenterologists also want their peers to restrain themselves on the repeat colonoscopies even for people who have had small polyps removed.

Another treatment example comes from the kidney specialists who are concerned about the overuse of a class of anti-anemia drugs.  “Don’t administer erythropoiesis-stimulating agents [Procrit, Aranesp, Epogen, and Eprex] to chronic kidney disease patients with hemoglobin levels greater than or equal to 10 g/dL without symptoms of anemia.” The kidney specialists could have taken a stronger stance with this example, given the fact that these drugs’ effectiveness is in doubt and they have killed an estimated half million people.  Click here for a Whistleblower’s Story.

Inform yourself

We consumers have a role in driving the market for unnecessary testing. Here’s the doctors’ side of the story: 30% of them admit that they order tests they know won’t help their patients but order them anyway because patients come in asking for them.  On the other hand, 80% of all medical care expenditures is driven by physicians.

Read more about Choosing Wisely, an initiative a foundation established by the American Board of Internal Medicine.  Click here for the names of specialty organizations and their respective lists.

Maryann Napoli, Center for Medical Consumers©
Related Posts
The primary care physicians’ list of 2011.
Heart screening tests
CT Scans: Lots of radation, little research

Posted in breast cancer, Cancer, colon cancer, Doctors, Drugs, Heart, heart disease, heartburn, radiation exposure, Scans and X-rays, Screening, unnecessary treatment | Tagged: , , , , , , , | 2 Comments »

New Book: Mammography Screening—truth, lies and controversy

Posted by medconsumers on March 31, 2012

What happens when a popular cancer screening technology is found to be far more harmful than lifesaving? When the finding becomes clear decades after it was oversold to the public? When a lucrative industry, in terms of equipment, breast biopsies, drugs, etc., has already built around it that is now impossible to dismantle?

One might hope that science would win out. After all, mammography has the distinction of being a cancer screening test with extensive research behind it. In his new book Mammography Screening: Truth, Lies and Controversy (Radcliffe Publishing, London/New York: 2012), physician and research scientist, Peter C. Gøtzsche recounts what it was like to take a hard look at that research and find it didn’t match up with mammography’s sterling reputation.

The near-universal reaction? Shoot the messenger. Vicious attacks came from researchers, policymakers, and physicians. Too often aimed at the man himself rather than his critique. Opinions were fixed—mammography is risk-free and lifesaving. Anyone who disagrees publicly is causing deaths in women who might reconsider and stop having mammograms. The book describes the scientist’s 11-year investigation that uncovered mammography’s considerable harms, though they were “hiding” in plain sight—in the original studies that had long ago established mammography screening as a lifesaver.

Dr. Gøtzsche, director of The Nordic Cochrane Centre, Copenhagen, describes himself as someone who knew little about mammography when, in 1999, he was asked by the Danish Research Council to do an in-depth assessment of all mammography-related research. A statistician and expert in clinical trial design and analysis, Dr. Gøtzsche was the right man for the job. Denmark was considering a national screening program, but first wanted to know more. Bad signs were already showing up in Norway where such a program was underway. Screening decreased breast cancer deaths but, ominously, it hadn’t decreased the rate of deaths from all causes. Even more alarming, mammography failed to detect the most aggressive, deadly form of breast cancer.

Central to Dr. Gøtzsche’s conclusions are the nine randomized clinical trials that included a half million women altogether. The first took place in New York City, in the early 1960s; the last two trials were conducted in Canada and Sweden in the 1980s. “We were baffled by what we found,” he wrote. “We had expected them to be more convincing considering how popular mammography screening had become, despite its high cost.”

The results of these nine trials focused narrowly on mammography screening’s role in reducing breast cancer deaths. Dr. Gøtzsche may well be the first to step back and look at the big research picture, assessing the total death rate and the harm to women. His assessment for the Danish National Board of Health described the benefits as uncertain and raised the possibility that screening could cause more harm than good. It was ignored.

Dr. Gøtzsche continued mining the data from the nine trials and publishing frequently over the next decade. The first paper, co-authored with statistician Ole Olsen, appeared in 2000 in the British journal, The Lancet. But it was their second paper for The Lancet in 2001 that set off a furious international reaction. The nine mammography trials emphasize the number of breast cancer deaths among the participants, but Olsen and Gøtzsche contend that deaths from other causes must also be taken into consideration. These trials show that many more women given regular mammograms are treated for breast cancer than the unscreened women, and these treatments themselves may cause fatalities. Furthermore, overtreatment of ductal carcinoma in situ, often with mastectomy, was identified as “a considerable risk of mammography screening because most cases do not become invasive.” (Disclosure: I serve on The Nordic Cochrane Centre’s advisory board, am quoted in this book, and have reported Dr. Gøtzsche’s work ever since I first came across it in 2000.)

Reactions in the U.S. media were exceptionally virulent and prolonged. It was likely the first time that most physicians as well as the general public heard that some cancers will never cause death or symptoms. But this was not the first high-decibel mammography media controversy. In 1992, when the Canadian trial was published, it was roundly trashed because it came up with an unpopular finding: Mammography screening did not reduce breast cancer deaths, though it increased the number of cancers detected. Dr. Cornelia Baines, co-director of this trial, expected fellow scientists to take a dispassionate look at the finding to see why it differed from that of the earlier trials.  Instead, she became the target of numerous attempts to silence and discredit her.

When the mammography controversy surfaced again in the media in 2001, it was the policymakers, the radiologists, and the breast cancer specialists who came down hardest on Olsen and Gotzsche. To accept their conclusions would mean that hundreds of thousands of women worldwide have been treated for a type of breast cancer that would either regress or remain dormant. Who would “dig deep” into that possibility? Certainly not the doctors who for years have been sending their patients for mammograms. And certainly not the radiologists whose income had increased mightily—less from the screening test itself than from the money-making ancillary activities like stereotactic needle biopsies, continuing education courses, magnetic resonance imaging, and biopsy-related patents (click here for one example).

Most women don’t want to hear about mammography’s harms either. Fear of breast cancer sold them on mammography in the first place—without it, there would be no action to take. In the early 1970s when mammography screening was first introduced in the U.S., most American women were not particularly fearful of breast cancer, largely because it was seen as an old woman’s disease. But a multi-national cancer drug maker took care of that “problem” with annual breast cancer awareness campaigns featuring young breast cancer victims. The fear level is kept high for doctors, too, who are frequently reminded that “failure to diagnose breast cancer” is a leading cause of malpractice lawsuits.

Cancer charities take a well-deserved hit in this book for their refusal to admit that screening has a downside. Their misuse of statistics seems calculated to inflate the benefit of cancer screening. Consider the 30% reduction in deaths bandied about in the early years of mammography promotion. This statistic was downgraded recently to 15% by the U.S. Preventive Services Task Force. But both of these are relative risk statistics, which are typically misunderstood by doctors and consumers alike. Most relevant is the absolute effect of screening, not the relative effect, points out Gøtzsche who provides this explanation: “If 2,000 women are screened regularly for 10 years, 1 woman will avoid dying from breast cancer, and 10 healthy women who would not have been diagnosed without screening, will have breast cancer  diagnosed and be treated unnecessarily.”

At the end of last year, the Canadian Medical Association Journal invited Dr. Gøtzsche to write an editorial entitled, “Time to stop mammography screening?”  The Canandian Task Force on Preventive Health Care had just issued new guidelines,  stating that  “women who do not place a high value on a small reduction in breast cancer mortality, and who are concerned with false-positive results on mammography and overdiagnosis, may decline screening. ”  Dr. Gøtzsche describes this as “an important step in the right direction, away from the prevailing attitude that a woman who does not undergo screening is irresponsible.”

It’s hard to imagine that this could ever happen here in the U.S.

This book can serve as a guide to physicians and women who want to make their own informed decisions about mammograpy screening, who want an honest in-depth assessment of the research—one that should have given to the public before the introduction of mass screening. A similar “promote the test first, learn the harms later” story has unfolded recently about the PSA screening test for prostate cancer. You just might want to sharpen your critical skills and prepare in advance for the next cancer screening disaster.

Maryann Napoli, Center for Medical Consumers©

More about Dr. Gotzsche’s work:
Free mammography screening leaflet from the Nordic Cochrane Centre  It is also available  at The Nordic Cochrane Centre website in 13 languages.
Cut your risk of breast cancer—avoid screening mammograms. One-third of all breast cancers found on a mammogram are the forms of breast cancer that would never cause death or symptoms.
Breast cancer death rate has dropped, but not due to mammography  Improvements in breast cancer treatments are most likely cause. ‘Before and after’ studies conducted in countries that introduced mammography in the 1990s verify what was noticed in Norway in this era: Screening  does not detect the most deadly form of breast cancer; it has not reduced the occurrence of advanced cancers.
Poster for the 2002 Cochrane Colloquium  U.S. media coverage of the 2001 Lancet paper.

Posted in Book Reviews, breast cancer, Cancer, Doctors, Drugs, radiation exposure, Scans and X-rays, Unnecessary tests, Women's Health | Tagged: , , , , , , , , | 6 Comments »

Lung screening scans for smokers

Posted by medconsumers on July 6, 2011

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 website. 

Maryann Napoli, Center for Medical Consumers©

Posted in breast cancer, Cancer, hospitals, Men's Health, radiation exposure, Scans and X-rays, Screening, surgery, testing, Women's Health | Tagged: , , , , , , , | Leave a Comment »

More overdiagnosis

Posted by medconsumers on May 17, 2011

Here is another disturbing example of a high-tech procedure finding abnormalities that are better left undetected. U.S. statistics show that the use of computed tomographic pulmonary angiography, a diagnostic test that uses contrast dyes and x-rays to see how blood flows through the lungs, has increased steadily since its introduction in 1998. This has led to a large increase in the detection of pulmonary embolism (PE), but only a minimal reduction in its death rate. Worse, this overdiagnosis of PE exposes more people to the considerable harms of unnecessary anticoagulant (blood-thinning) treatment.

“At first glance, the rapid increase in incidence seems alarming—an apparent epidemic of PE. But the epidemic is unusual because it has only occurred among nonfatal emboli… Moreover, an epidemic is unlikely without a corresponding increase in risk factors,” wrote Renda Soylemez Wiener, MD, and colleagues at the Dartmouth Medical School. “Rather than an epidemic of disease, we think the increased incidence of PE reflects an epidemic of diagnostic testing that has created overdiagnosis. In this scenario, much of the increased incidence in PE consists of cases that are clinically unimportant, cases that would not have been fatal even if left undiagnosed and untreated.”

In 2007, there were 2.6 million chest angiography scans performed in the U.S. Before this technology was introduced in 1998, the incidence of pulmonary embolism was unchanged. But PE diagnosis has since increased substantially, from 62 cases per 100,000 people to 112 cases per 100,000. During the same time period, there was only a slight decrease in mortality from 12.3 deaths to 11.9 deaths per 100,000. The rate of complications associated with anticoagulant treatment, such as brain hemorrhage and gastrointestinal bleeding, was also stable prior to the introduction of CTPA. It has since gone from 3.1 to 5.3 per 100,000.

Dr. Wiener, the lead author of this study, was asked how people can protect themselves from this form of overdiagnosis. “Right now I believe consumers are in a difficult situation,” she answered, explaining that doctors do not know which blood clots will become fatal if left untreated. “It is really up to doctors to think more carefully about reserving CT pulmonary angiography for situations in which there is a high pre-test probability of a pulmonary embolism based on symptoms, clinical presentation, etc.,” continued Dr. Wiener in a telephone interview. “We need a randomized controlled trial of treatment with anticoagulation versus close monitoring without anticoagulation to help sort out whether every small pulmonary embolism requires treatment.”

The study was published in Archives of Internal Medicine as part of this journal’s “Less is More” series, which addresses issues of overdiagnosis and overtreatment. Here’s one about CT scans and this about overtreatment of prostate cancer.

Maryann Napoli, Center for Medical Consumers©

Posted in Scans and X-rays, testing | Tagged: , , , | Leave a Comment »

Were you, or are you, a heavy smoker?

Posted by medconsumers on November 14, 2010

Early this month a federally-funded trial found that screening current or former smokers can reduce their mortality. There were 20% fewer lung cancer deaths among those given low-dose spiral CT lung scans. Consequently, the trial was stopped early, and the results were announced directly to the public on the National Cancer Institute’s (NCIs) website. Until this news broke, no study had proven lung cancer screening can save lives.

The National Lung Screening Trial is sponsored by the NCI and conducted by the American College of Radiology Imaging Network. Participants included more than 53,000 men and women ages 55 to 74 who were heavy smokers. All had smoked at least 30 pack-years—i.e., they 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. All were randomly assigned to receive either annual lung scans or standard chest X-rays. None had symptoms of lung cancer when the trial started recruiting in 2002. At the time the trial was stopped, there were 354 deaths from lung cancer in the CT-scanned group and 442 lung cancer deaths in the group given chest X-rays.

The NCI website provides cautions about the new results. For example, there was a 7% reduction in deaths from causes other than lung cancer. But it should not be seen as a call to arms by radiologists eager to screen all middle-aged and older people. Instead, this 7% reduction in deaths is relevant only to middle-aged and older people who have a smoking history similar to that of the study participants. Another caution involves the risks of false-alarm biopsies and treatment of lung abnormalities mistaken for cancer—both can lead to risky lung surgery. (To see how quickly these cautions were ignored, click here.)

The National Lung Screening Trial is not to be confused with another screening study called the International Early Lung Cancer Action Program, or ELCAP. Published in a 2006 issue of The New England Journal of Medicine ELCAP showed that spiral CT scanning can find more potentially curable lung cancers (i.e., early stage). It did not, however, find a reduction in lung cancer deaths in the ten-year duration of this study. Its lead author Claudia Henschke, M.D, took this promising but not definitive finding and went on to claim that most lung cancer deaths could be prevented in heavy smokers through widespread use of CT scans. Over the years, she has gotten a fair amount of media attention with this message despite the consensus among screening researchers that mortality reduction is the only valid outcome for proving a screening test’s worth.

Two years after publication, ELCAP’s results were tarnished by the conflicts of interest associated with its co-authors, Drs. Henschke and David F. Yankelevitz who receive royalties from patents related to screening scans. What’s more, their study was partially funded by $3 million from a cigarette company, as reported in The New York Times (click here).

The newly announced National Lung Screening Trial may have settled the question of whether screening lung scans can save lives, but another controversy has only just begun. Does the benefit of saving one in every 300 heavy smokers outweigh the risks of false-alarms affecting one in four? Because this trial was stopped early, a complete analysis of the harms will not be ready for months.

Maryann Napoli, Center for Medical Consumers©

Posted in Cancer, Men's Health, Scans and X-rays, Screening, Women's Health | Tagged: , , , | Leave a Comment »

Bone drugs’ adverse effect found to be very rare

Posted by medconsumers on May 28, 2010

Remember those scary reports of spontaneous thighbone fractures that occurred in some women who were taking fracture-prevention drugs like Fosamax? The bone breaks for no apparent reason. (In one memorable case, a woman said her thighbone broke while standing in a stalled subway train that lurched suddenly.) Such fractures are described as very rare (0.03%), according to a new analysis of the data generated by three large trials. These are the same clinical trials that proved bone drugs like Fosamax and Zometa are more effective than no treatment (placebo) in reducing hip fracture—the most serious complication of osteoporosis. Now the results of these trials were searched solely for the rate of spontaneous thighbone fracture.

It’s a relief to know that this is “a very rare” side effect of osteoporosis drugs. But looking at these trial results again reminds me that their hip fracture prevention benefit is also pretty rare. The first to win FDA approval was Fosamax (generic name: alendronate), produced by Merck. After three years, only 1% fewer drug-treated women suffered a hip fracture, compared to untreated women. The drugs’ effectiveness looks much better when the company-sponsored researchers throw in fractures in other sites—spine, wrist, and forearm. In one osteoporosis research sleight of hand that’s always bothered me, it is common to count a reduction in spinal fractures that are symptomless and can be seen only on X-ray.

But I digress. Back to the spontaneous thighbone fractures and how we now know they are very rare. The three major trials that provided the data for this conclusion had a combined total of 14,195 women randomly assigned to take either a placebo or a bone drug (Fosamax in two trials, Zometa in one). Keep in mind that most of what are called hip fractures are actually breaks in the “neck” of the femur, or thighbone, where it meets the pelvis in the ball and socket joint.

So here’s final count: Of the 284 women who had hip or femur fractures, only 10 had what’s called atypical thighbone fractures. It’s interesting to note how few hip or femur fractures—atypical or not—occurred, considering that the 14,195 study participants were considered to be at high risk for fracture and between the ages of 65 and 80 years when they entered the study. Could it be that this isn’t the biggest health threat we face in old age? Or could it be that the study participants weren’t followed long enough?

This analysis appeared in The New England Journal of Medicine and was funded by Merk and Novartis (maker of Zometa). How long can people safely take this drug is not answered by this analysis. It’s a question that lingers over all bone drugs called bisphosphonates (other brand names: Boniva, Actonel, Reclast). The authors of this analysis conclude that the risk of spontanous thighbone fracture remains rare “even among women treated with bisphosphonates for as long as ten years.” Buried deep in this paper, however, is the fact that few women were followed this long. The majority were followed only three to four years. Women on long-term bisphosphonate therapy are advised to report thighbone pain immediately to their doctors as this was the telling symptom that preceded a spontaneous fracture.

For more information

To determine whether you can benefit from Fosamax or any other bisphophonate drug, see this chart from the Cochrane Collaboration, which is based on the results of the above-mentioned three clinical trials. You will see that women who have been diagnosed with low bone density or who have broken bones in their spines are more likely to benefit than those whose bone density is near normal (osteopenia) or who do not have spinal fractures. click here

Update added April 2011: Read the latest article called “Bisphosphonate drugs—more harm than good?” click here

Visit the Web site of Susan Ott, MD, an expert in bone physiology at the University of Washington, Seattle. Everything from osteoporosis prevention to summaries of the latest bisphosphonate studies.

For background on how osteoporosis became a much-feared disease, read this 2009 article for the American Journal of Nursing, The Marketing of Osteoporosis.

Osteonecrosis of the jaw, another rare side effect of bisphosphonate drugs, was not addressed in the new analysis. For more information, click here.

Maryann Napoli, Center for Medical Consumers(c)

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CT scan misuse and Obama’s physical

Posted by medconsumers on April 14, 2010

It could become a regular feature on this Web site….we’d call it, “Inappropriate medical care of the rich and powerful.”  In February, it was “Angioplasty overuse and Bill Clinton.” And the latest example could be titled, “Too many CT scans for our healthy young president.” Barack Obama had his first presidential physical recently and at least one academic physician has already written a critique of two tests he received.  There was the CT scan of his coronary arteries, a test with no proven value in reducing the risk of heart attack in a symptomless person.  “Indeed the most powerful way for President Obama to reduce his cardiac risk is to stop smoking—a step that will reduce by 72% his chance of a cardiac event in the next ten years,” wrote cardiologist Rita F. Redberg, MD, editor of Archives of Internal Medicine.

The president also underwent a virtual colonoscopy, which has no proven benefit as a screening test for anyone without symptoms. It wasn’t just the excessive cost of these inappropriate tests that alarmed Dr. Redberg. Each CT scans exposed the president unnecessarily to a large radiation dose from each procedure that increased his risk of developing cancer later in life.  The more immediate harm is the detection and unnecessary treatment of small cancers that would never become life-threatening.

In an earlier editorial for her journal, Dr. Redberg warned about the ever-increasing number of CT scans done on Americans yearly (one-third of them unnecessary) and how the radiation exposure from these scans is far higher than previously thought. But that’s not all that bothers Dr. Redberg about the presidential physical. President Obama has—unwittingly, no doubt—set a bad example for health care reform.  He fed that typically American misperception that more testing equals better care.

How can we hope to protect ourselves from unnecessary CT scans when a sitting president just gets on the proverbial conveyor belt going from one questionable test to another? Dr. Redberg gave one example of a situation where a patient might object to a CT scan: “More and more patients go from the emergency department to the CT scanner even before they are seen by a physician or brought to their hospital room.”  

For more information about limiting radiation exposure and when to “just say no” to CT scans, read this 2010 article from the Associated Press and our 2009 article “CT Scans—lots of radiation, little research.”  For more about the risks of finding cancers that do not progress, read this review of a book entitled, “Should I be tested for cancer” by H. Gilbert Welch, MD.

Maryann Napoli, Center for Medical Consumers(c)

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Back Pain and the herniated disc

Posted by medconsumers on February 25, 2010

Back pain and the herniated disc:
An interview with Richard Deyo, back-pain researcher and primary care physician

By Maryann Napoli

Low back pain has generated thousands of published studies, so it was surprising to read that so little has been proven about the best way to diagnose something as common as a herniated disc. That was my first thought when I saw the new Cochrane review of all studies that had assessed the diagnostic accuracy of the various components of the physical exam. Sixteen studies in all, most of them old and only one conducted in primary care practice where most people start looking for help. The combined total of 2,504 study participants had back pain with leg pain, aka sciatica. The conclusion: no single test can accurately diagnose a herniated disc, so doctors should use all of them to do the initial physical exam.

To clarify a few things, I turned to one of the co-authors of the new Cochrane review, Richard A. Deyo MD, MPH, Kaiser Permanente Professor of Evidence-Based Family Medicine, Oregon Health and Science University, Portland. Dr. Deyo, arguably the country’s leading back pain expert who has co-authored over a 100 published studies about the treatment of back pain.

MN: You didn’t have much to work with in this Cochrane review. All but one of the studies weren’t that great, but it gave me an excuse to call you so I can interview you again (click here for 2007 interview with Dr. Deyo).

RD: Yes, like most Cochrane reviews about diagnostic tests, it focuses one-by-one on physical examination signs and of course, doctors never do just one physical exam test. We do several tests and combine it with a history and it all forms a picture that is more reliable than just one test. For back problems, this might include tests of strength in the lower extremities (such as flexing the foot up or down), Achilles reflexes, the straight-leg raising test, and sensory testing (touch).

How important is it to determine whether a herniated disc is the source of back pain, especially now that we know, in most cases, it will go away in time? Two landmark randomized clinical trials showed that 75% of people with the severe back and leg pain of a herniated disk got better without surgery by three months.

RD: That’s a fair question, and it is fair to say that there is usually no urgency in finding out whether the disc is the problem. But it is helpful in giving the patient a prognosis. If it’s a herniated disc we know what to expect with and without surgery.

MN: You’re referring to the two landmark studies.

RD: Yes, if the patient appears to have a herniated disc I would follow the patient a little more closely than I would the person with run-of-the mill back pain. Beyond that, if it looks like the person isn’t getting better, he or she might consider surgery. Then, using data from the studies you just cited, [I would let] the patient know that the surgery might speed up recovery but after a year or two, [he or she will] probably be in the same place with or without surgery. [And the patient] would then have to consider: how do I feel about the risks of the surgery and the urgency of resolving my symptoms?

MN: Back pain is an area rife with overtreatment. To protect yourself from overtreatment, what kind of a physician should you see first?

RD: I’m biased because I’m a primary care physician. I think the first stop should be the primary care physician, as opposed to referring yourself right off the bat to an orthopedic surgeon.

MN: Why?

RD: The primary care physician should be able to do good examination to be sure you don’t have a serious underlying problem like cancer or an infection and be able to explain a range of options without having any vested interest in any particular approach. I make a distinction between back pain alone and back pain with leg pain. If the patient has back pain alone, that suggests surgery isn’t going to help much and [steroid] injections aren’t going to help much. In most cases, the best approach is self-care and exercise after acute pain subsides and it’s probably unwise to think about the more invasive treatment. People with back and leg pain are also likely to get better without any invasive treatment, and if they don’t, they should understand what the options are.

MN: There’s a lot of evidence that MRIs and CT scans are overused and concern about the high-dose radiation exposure from CT scans. (Click here for information about radiation exposure from CT scans.)

RD: Yes, part of the problem is patients often want these tests. They say, “I want to know what’s wrong.” And the fallacy is these tests so often show abnormalities that have nothing to do with the back pain. And they might lead you down a garden path to treatments that may not help. Most people don’t realize that about a quarter of us under the age of 60 have a herniated disc, but no back pain, no leg pain, no nothing. So when a doctor sees that on a CT scan by itself, it may not mean much unless it matches up with leg pain down the same side as the disc and in the same level as the disc, etc. The history and the physical exam have to match up with findings on the scan for it to mean anything. Another thing people don’t realize is that bulging discs are normal. Bulging discs and degenerated discs are in just about everyone over the age of 60 and in people under 60, probably half of them.

MN: What are the latest fads in the overtreatment that you may want to warn us about?

RD: It seems like there’s a new one every day. Are you familiar with vertebroplasty?

MN: Yes, the injection of a cement-like substance into spinal fractures due to osteoporosis.

RD: Two studies, published in the same issue of the New England Journal of Medicine, indicate that this treatment is no more effective than a local anesthetic injection, yet it had become very popular. This is just one example of something that often happens—new technologies that are introduced and become widespread before they are carefully evaluated.

MN: What else gets your hackles up?

RD: Latest thing is artificial discs, which are now touted for patients with degenerative disc disease. It’s like a sandwich with metallic plates—it’s a sandwich with polyethyene plastic material in between to form sort of a cushion. It is inserted between the vertebrae after [the surgeons] shell out the natural material. It’s being touted for people who just have degenerated, or worn-out, discs and back pain—not necessarily a herniated disc. It’s touted for anyone with back pain and a degenerated disc, which describes just about everyone over the age of 50.

MN: And I assume this, too, has not been evaluated.

RD: In my view, it is not adequately studied. The FDA approval was based on the finding that artificial discs are “not inferior” to spinal fusion surgery. The companies did two randomized trials comparing artificial discs with spinal fusion. The problem is we don’t know how long these artificial discs last or what the long-term complications may be. And even more fundamentally, they were compared with spinal fusion, but it’s not clear that fusion is effective.

MN: What about epidural steroid injections?

There’s been an explosion in their use over the last decade. But when you look at the randomized controlled trials that compared epidural steroid injections with placebo injections [just saline], here’s what the research shows: half the trials show no difference, and half the trials show a small advantage for the steroid injections. None of these trials show that these injections help people avoid surgery. A fair conclusion is they offer some people with sciatica temporary relief, but they have no role in the treatment of back pain alone, that is without leg pain, although they are commonly used in that situation.

What have you published recently?

RD: I co-authored an acupuncture and back pain study that was published last year in Archives of Internal Medicine. All the patients were “blinded,” so they couldn’t see which of three treatments they were receiving for back pain. One group got real acupuncture; another group was poked with a toothpick [sham acupuncture]; and another group received usual care from their primary care physicians. The real acupuncture and the sham acupuncture were identical in terms of results. Both groups did better than the group that got usual care from their usual primary care physicians. One interpretation of our results could be: it’s all placebo effect. Another interpretation could be that stimulating acupuncture points stimulates some physiological response whether the skin is penetrated or not. Our results are similar to that of several German studies that also showed sham and real acupuncture are better than the usual care.


Hope or Hype: The obsession with medical advances and the high cost of false promises by Richard A. Deyo, MD, MPH, and Donald L. Patrick, PhD, MSPH

Stabbed in the Back–confronting back pain in an overtreated society by Nortin M. Hadler, MD.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in osteoporosis, Pain, Scans and X-rays, surgery, testing | Tagged: , , , , , , , , | 2 Comments »