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Understanding lab tests

Posted by medconsumers on August 25, 2012

Always request copies of your medical test results. This may be the standard advice to consumers, but can you make sense of the report? There’s a place to go online for free help in understanding the results of a wide range of tests from the standard blood test to a bone marrow aspiration plus biopsy.

Lab Tests Online provides information that is far more in-depth than anything likely to be conveyed by the doctor who ordered the test. This website calls itself, “A public resource on clinical lab testing from the laboratory professionals who do the testing,” adding that its content is “peer reviewed, non-commercial and patient-centered.” This website can be accessed in 14 languages.

There are brief explanations of the diseases (e.g., Alzheimer’s disease) and conditions (e.g.,vitamin K deficiency) that account for most of the testing. You will learn what to expect from the test itself, get answers to frequently asked questions, and see how quality standards are established and maintained.  In some instances, the reliability of the test will get a brief critique, most notably for the relatively new test for prostate cancer, called the complexed PSA (cPSA).

Genetic testing and screening tests for healthy people—newborns to old age—are also part of the roster, along with the often contradictory recommendations from organizations like the National Osteoporosis Foundation and the U.S. Preventive Services Task Force.  If you have a specific question about a test or your own test results, you can submit a question that will be answered by a laboratory scientist.

This website is not without flaws. For example,  the urine test (urinalysis) is described as “often ordered for adults without symptoms as part of a routine health exam,” but the website fails to mention that this test got a thumbs down for men and nonpregnant women from the U.S. Preventive Services Task Force. Reason: “The harms of giving antibiotics to people with evidence of symptomless bacteria in the urine outweigh any benefit.”

There’s a similar lack of warning about the standard blood test, aka, blood chemistry panels, for people without symptoms, which is yet-another component of the routine health exam. Surprisingly, this test made the 2011 primary care physicians’ list of the most useless tests routinely administered by their peers. There are two exceptions: a blood test  for LDL cholesterol and for type 2 diabetes mellitus in symptomless adults with hypertension. This list was put together by working groups established by the National Physicians Alliance.  The list is one of ten developed by the Choosing Wisely campaign in order to improve the quality of medical care.

Still. This is a terrific website that is definitely worth a long visit whenever a test is ordered.

Maryann Napoli, Center for Medical Consumers©

Related posts:

45 tests or treatments to avoid  Nine different specialty organizations list the five most useless tests or treatments commonly administrered by their peers. Hardly any lab tests on the list, but this one’s a gem from the American Academy of Family Physicians:  “Don’t perform a pap test on women younger than 21 or who had a hysterectomy for non-cancer disease.”

When to just say no  This is about the 2011 primary care physicians’ list of useless tests. Unnecessary testing is more than an waste of time and money. False alarms and inconclusive results can escalate to riskier tests that also provide inconclusive results.

Posted in Screening, testing, Unnecessary tests | Tagged: , , , , , , , , , | 3 Comments »

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 »

What MDs don’t know about cancer screening

Posted by medconsumers on March 8, 2012

Most primary care physicians are keen on cancer screening. In fact, sending symptom-free patients for regular tests is central to their practice. Yet an understanding of cancer screening statistics is critical to informed decision-making, whether you’re the doctor sending people for tests or a patient just following orders. A new survey of U.S. primary care physicians shows the majority accept misleading statistics as proof that screening works.

Four hundred and twelve physicians took the online survey, which was designed by an American and German research team with a history of trying to improve understanding of health statistics by health professionals as well as the general public. “Most physicians incorrectly equated improved survival and early detection as evidence of lives saved,” concluded the researchers led by Odette Wegwarth, PhD, Max Planck Institute for Human Development, Berlin, Germany. “Few correctly recognized that only reduced mortality in a randomized trial constitutes evidence of the benefit of screening.” The survey results were published this week in Annals of Internal Medicine.

The survey presented physicians with two ways of expressing the effect of a hypothetical screening test which was described as improved 5-year survival and increased early detection in one scenario and as decreased cancer mortality and increased incidence in the other. Though the type of cancer was not identified, the hypothetical test scenarios were based on real-life data from the European prostate-cancer screening randomized trial. And the 5-year survival statistics and the percentage of stage I prostate cancers came from the U.S. database of cancer statistics collected in 1975. To be safe, that year was chosen because it predates the introduction of any organized screening program for prostate cancer.

The physicians were more impressed with what the survey authors called “irrelevant evidence,” for example, a test with a large 5-year survival rate. Here’s why this is irrelevant: The older we get, the more cancers we have in our bodies; many will never become life-threatening. Prostate cancer, for example, is in the overwhelming majority of cases a slow-growing or non-progressive cancer.

Therefore, prostate cancer’s 5-year survival rate will look like a clear justification for early cancer detection because most men will die of something else. Conversely, they  could die six years after a diagnosis of prostate cancer and still be counted as a “survivor”. Furthermore, screening often moves up the time of diagnosis (and treatment) without moving back the time of death.  (By the way, we can thank the American Cancer Society for its long-time use of this extremely misleading measurement of a cancer screening test’s benefit. In the not-so-distant past, the ACS actually used the word ‘cure’ interchangeably with 5-year survival, thus making generations of cancer patients think that making it to five years meant something.)

Now for the other worrisome finding:  The surveyed physicians were less impressed with a test described as having “reduced mortality”. And they were more impressed with a test that finds lots of cancer. But screening for cancer will always increase the number of cancer cases diagnosed, compared with the number of cancers found in people who seek medical attention only after symptoms appear. That’s because screening detects many more cancers that do not progress, which falsely inflates the apparent benefit of a screening tests (a phenomenon that the survey authors describe as overdiagnosis). This is why careful researchers will—after many years of follow-up—-compare the overall death rate of both the screened and unscreened groups. It is the only way to sort out the people who actually achieved a life-saving benefit from those who were treated unnecessarily for a cancer they didn’t need to know about.

This comparison is also a way  for researchers to determine screening’s “cost” in terms of harms. Here’s what the European prostate cancer screening trial found:  For every one prostate cancer death avoided in the PSA screened men, 48 men suffered severe complications from unnecessary treatment of a non-progressive cancer.

What to do

If you are going for any cancer screening test, inform yourself first at the National Cancer Institute’s website.  And be sure to use the “health professional” version which is more honest and in-depth than the patient version. If you get most of your medical information from the media, plan on regular visits to this media fact-checking website (www.Healthnewsreview.org). See its recent excellent critique of the media’s take on the latest colon cancer screening research, particularly The New York Times’ erroneous portrayal of it as definitive proof for colonoscopy as the best screening method. Click here

Maryann Napoli, Center for Medical Consumers©

Related posts:
Most drug don’t work (This is about understanding drug trial statistics.)
PSA screening for prostate cancer
Cancers that do not kill
Reduce your risk of breast cancer: Avoid mammograms (unless you have a breast symptom)

Posted in Cancer, colon cancer, Doctors, Screening, testing | Tagged: , , , , , , , , , | 1 Comment »

A new take on bone density retesting

Posted by medconsumers on January 19, 2012

Screening creates drug customers. Keep this little-known consumer beware maxim in mind when you read the new finding about bone density retesting.  Frequent screening bone scans, starting in early middle-age, have been the norm ever since osteoporosis was discovered in the 1980s. (Believe me, no one ever heard of osteoporosis before then, other than the few health professionals who cared for people of advanced old age.)  The new study shows that women whose first test at age 67 indicates normal bone density can safely delay having a second test for as long as 15 years.  There was a time, not so long ago, when women were advised to start bone density testing right after menopause. But then again, there was also a time when the diagnosis of osteoporosis was not made until a person suffered a fragility fracture.

Before I describe the new study, an historical context is in order. Merck, maker of the first osteoporosis drug, may also have been the first company to establish a winning “formula” for blockbuster drugs: 1) lower the cutoff point for the diagnosis of osteoporosis, better yet, fund a meeting in a beautiful place (like Italy) of high-profile osteoporosis researchers (aka, hired “consultants”) who will do it for you; 2) mount an “osteoporosis awareness” campaign to scare women into thinking the risk of hip fracture starts soon after menopause; 3) expand your market share with frequent mention of a new “disease” called osteopenia, a diagnosis that can be given to anyone who almost has osteoporosis; 4) encourage use of a new screening technology for identifying “at risk” women, and do it with an ad campaign that doesn’t mention your drug so it looks educational; 5) provide financial incentives to doctors who want to purchase screening equipment for their offices; 6) introduce your new drug Fosamax, which received FDA approval in 1995 and soon became a top-selling drug worldwide, despite its minimal effectiveness in reducing the chance of having a hip fracture (1%).  For more, read “The Marketing of Osteoporosis.”

Now for the study that appeared today in The New England Journal of Medicine. It followed nearly 5,000 women, 67 or older, with normal bone density at the hip and no history of hip or spinal fractures, or osteoporosis treatment. The research team led by Margaret L. Gourlay, MD, University of North Carolina, took off from the current advice that women should start having bone-density tests at age 65. This study was designed to determine how long it took for osteoporosis (defined as bone mineral density T score, −2.50 or lower) to develop in women with normal bone density or osteopenia.

The women were followed for 10 to 15 years. The findings were unexpected, according to Dr. Gourlay, who told the New York Times that she and her colleagues were surprised by how slowly osteoporosis progressed. Osteoporosis developed in fewer than 10% of the women who started the study with normal bone density and in fewer than 10% who had either “mild or moderate osteopenia.”  (And I was surprised that the New England Journal of Medicine would allow researchers to use the industry-created term osteopenia.) In summary, women with normal bone density or “mild osteopenia” at age 67 can safely delay having a second bone density test for 15 years.

I hope that word gets out to women about this study because it should cut back on the overuse of bone-density tests, as well as the overuse of Fosamax and other drugs in the same class called bisphosphonates (e.g., Boniva, Actonel, etc.). The test was initially portrayed to women and doctors as predictive of who is likely to suffer a hip fracture.  But Canadian consumer advocate Barbara Mintzes, University of British Columbia, had a more realistic take on this claim over ten years ago: “Bone mineral density testing is a poor predictor of future fractures, but an excellent predictor of start of drug use.” The overwhelming majority of hip fractures, by the way, occur after the age of 70.

Something to think about: Most medical research is now funded by industry, particularly the companies that make drugs, devices, and testing equipment. This study was funded by the U. S. National Institutes of Health.

For information about these serious adverse events associated with these drugs, read “Drugs for bone loss.”   And read this to learn why women should stop taking them after five years.  And here is Dr. Susan Love’s description of how bisphosphonate drugs work and why no one should be surprised that they are causing problems.

This post has been revised to reflect the following correction, added January 21, 2012.

The first version of this article, posted January 19, misstated the conclusion of this study.  The authors did not specify when women should be retested.  The original title of this post and the post itself have been changed accordingly.

Maryann Napoli, Center for Medical Consumers(c)

Posted in Drug ads, Drugs, osteoporosis, Screening, testing, Unnecessary tests, Women's Health | Tagged: , , , , , , , , , | Leave a Comment »

Breast cancer deaths drop—but not because of mammography

Posted by medconsumers on November 25, 2011

Mammography screening is usually credited with the drop in breast cancer deaths recorded in many countries, including the U.S.  But a case is building for improvements in breast cancer treatment as the most likely cause. The decrease in deaths has occurred in many European countries that did not start  mammography screening until the 1990s, which happens to coincide with greater use of long-term adjuvant therapy (e.g., tamoxifen, chemotherapy) given after the initial treatment is over.  Researchers say the case for adjuvant therapy is made stronger by the fact that,  in some of these countries, the greatest decreases in breast cancer deaths were among young women (under 50), the age group that never received mammography screening.

As someone who has followed the “selling” of mammography screening to American women that started in the early 1970s, I offer some background for the new findings from Europe. Thanks to nearly 50 years of research, we know more about mammography than any other cancer screening test. Expert panels with no conflict of interest have concluded that the breast cancer mortality rate among mammography-screened women (in randomized trials) is only 16% lower than that of unscreened women. In the U.S., there was no reduction in breast cancer deaths until the early 1990s and about 2% a year thereafter.

Today, there is a greater understanding of cancer. Some abnormalities that look like cancer under the microscope do not become invasive, if left untreated. Many regress spontaneously, stay put, or grow so slowly they will never make their presence known.  At least as far back as the 1970s, pathologists knew about these non-progressive cancers that can occur in all major organs of the body.  But women weren’t hearing from them.  Instead, radiologists and surgeons dominated the promotion of mammography screening in the early years. Today, it is the radiologists who are often quoted in the media, warning us about the dangers of forgoing mammography screening while downplaying its harms.

Well, it is quite reasonable for women to forgo screening—that is, after becoming well-informed. Here are the highlights of several review articles published in the last few weeks.  See below for my sources.

  • There are usually dramatic increases in the discoveries of new breast cancers after mammography screening takes off. Tomorrow’s cancers are found today is the standard explanation.  This  ignores the fact that in every major randomized trial, some of the regularly screened women—who have had many previous “all-clear” mammograms—are nonetheless diagnosed with  invasive tumors that are fatal despite prompt treatment.  Recent studies conducted in many countries, including the U.S., show that mammography screening has not reduced the occurrence of large invasive cancers.
  • The aforementioned large increase in new cases of breast cancer without a large decrease in the rate of new cases of advanced cancer (over time) indicates that much of the increase is due to detection of non-progressive cancers (i.e., overdiagnosis). Here’s how the Cochrane review on mammography screening assessed the damage: “For every 2,000 women who are screened throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily.”
  • Women are often told that mammography-detected breast cancers require less drastic treatment.  The opposite is true. Mastectomy rates were going down in some European countries in the years prior to the introduction of mammography screening but went up afterwards. Many countries, including the U.S., show 20% more mastectomies in the screened women compared to the unscreened women. One factor is the large increase in the detection of ductal carcinoma in situ, or stage 0 breast cancer, which was rare in all countries prior to the introduction of mammography but is now a common diagnosis.  DCIS  is treated increasingly with mastectomy, though it has long been known that only about 20% to 30% of DCIS will go on to become invasive breast cancer if left undetected, according to Susan Love, MD, author of Dr. Susan Love’s Breast Book.
  • Physicians at the Dartmouth Institute of Health Policy addressed a common misconception about mammography in a paper published online in Archives of Internal Medicine (see below). “The presumption often is that anyone who has had cancer detected has survived because of the test, but that’s not true,” according to co-author H. Gilbert Welch. “In fact, and I hate to have to say this, in screen-detected breast and prostate cancers, survivors are more likely to have been overdiagnosed than actually helped by the test …  It’s important to remember that of the 138,000 women found to have breast cancer each year as a result of mammography screening, 120,000 to 134,000 are not helped by the test.”

Maryann Napoli, Center for Medical Consumers©

Related post
There is aid for breast cancer patients who must decide about adjuvant therapy.  read more

Sources for above post
“Why mammography screening has not lived up to expectations from randomized trials.” Cancer Causes Control, published online November 10, 2011.  This is the source for virtually of the above.  Click here

Cochrane review that assessed the harms as well as benefit of mammography screening.  Click here   Want to know more about the Cochrane Collaboration?   Click here

“Likelihood that a woman with screen-detected breast cancer had her ‘life saved’ by that screening” Archives of Internal Medicine, published online October 24, 2011.  This is the source for the last bullet point.  click here    Better yet, Click here for an easier to read New York Times article about this study.  Added December 4, 2012:  YouTube vide0 explaining a new study that found mammograpy screening accounts for overdiagnosis and overtreatment of 1.3 million American women over the four decades since it was first introduced.

Posted in breast cancer, Cancer, Screening, testing, Women's Health | Tagged: , , , , , , , , , , | 9 Comments »

The overuse of screening colonoscopy

Posted by medconsumers on August 24, 2011

After an all-clear, no-polyps screening colonoscopy, there is no need to undergo another one for at least ten years. This is the standard recommendation for all people over age 50 from organizations like the American Cancer Society. A new study, however, found a large portion of the Medicare enrollees with no sign of colon cancer on the screening colonoscopy are coming back too soon for another one. The perils of doing so include the risk of perforated colon, biopsy-related infection and other serious complications thought to occur more often in older people. That the repeat procedure is unnecessary means symptom-free elderly people are putting themselves at risk for no apparent benefit.

Virtually all colon cancer screening research concentrates on the underuse of colonoscopy, specifically by the uninsured and the minority populations who do not undergo screening colonoscopies in large numbers. The new study, led by James S. Goodwin, MD, and colleagues at the University of Texas, made the rare decision to look at overuse.

It is based on a random sample (5%) of over 24,000 Medicare beneficiaries whose records showed they had a negative screening colonoscopy. The Medicare claims database showed that a sizable minority underwent a repeat procedure prematurely. In people, aged 75 to 79 years, or 80 years or older at the time of the initial negative screening colonoscopy result, 47% and 33%, respectively, received a repeated examination within 7 years. This study was published recently in Archives of Internal Medicine as part of its excellent ongoing “Less is more” series.

Keep in mind that people over the age of 75 are underrepresented in screening studies so the risk of complications cannot be quantified with accuracy. This is part of the reason why the U.S. Preventive Services Task Force advises people to stop screening colonoscopy entirely at age 75 click here.

Dr. Goodwin and colleagues explained the implications of overuse: “First, screening colonoscopy can have adverse effects, including hospitalization and death. Too frequent performance of the examination may shift the benefit to risk ratio by increasing complications without additional benefit. Second, colonoscopy screening is costly; it is important to restrain expenditures for unnecessary procedures. Third, colonoscopy is a limited resource, in terms of facilities and practitioners. Identifying and decreasing overuse of screening colonoscopy should free up resources to increase appropriate colonoscopy in inadequately screened populations.”

In an e-mail message, Dr. Goodwin was asked to elaborate. “The point about screening is that you have to look at the effect on a population. If you harm more people in a population than you help, then screening is a bad idea. Almost all authorities think that to be the case with early repeat colonoscopies,” he wrote, in response.  “You also have to remember that the overwhelming majority of people are neither helped nor harmed. Since your lifetime chance of getting colon cancer is only about 5%, then for 95% of the population screening colonoscopies were unnecessary. It would be nice if we could identify that 5%, but we can’t. But we can certainly work harder to restrict colonoscopy to those who at least MIGHT benefit (i.e., not those with a normal one in past 10 years).”

Added June 28, 2012: Want to make a truly informed decision prior to a screening colonoscopy?  Read this excellent article from Salon.com.  Its anonymous author provides an insider’s look at the downsides of screening colonoscopy, rarely explained to the people about to undergo this procedure.

Maryann Napoli, Center for Medical Consumers©

Related articles: “How accurate are colonoscopies?” and “Best way to screen for colon cancer?”  and this (apparently, you’re never too old or too debilitated for a screening test) “Screening right to the grave”.

Posted in Cancer, colon cancer, Screening, testing, Unnecessary tests | Tagged: , , , | 7 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 TheNNT.com 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 »

Treatment guidelines and conflict of interest

Posted by medconsumers on April 13, 2011

More than half of the cardiologists, cardiovascular surgeons and other experts who produce treatment guidelines have financial ties to companies that make heart drugs or surgically implanted devices. A new study takes a hard look at the conflicts of interest among experts who serve on panels that set the treatment standards for prestigious organizations like the American College of Cardiology and the American Heart Association. While many of us would like to think our physicians and surgeons keep up by reading medical journals. In fact, many physicians rely on these guidelines panels to guide their practice decisions.

I used to think that the main task of these influential panels was to distill the best scientific evidence for practicing physicians who do not have the time or skills to do it themselves. But then I learned from an in-depth review presented at a 2004 Cochrane Collaboration conference that treatment guidelines are largely based on opinion rather than scientific evidence. That’s the first problem, and one not confined to cardiovascular medicine. The second problem is that the panels are supposed to be independent, but in fact, the individuals chosen to join them often have major conflicts of interest.

The new study appears to be the first to determine the scope of the second problem by taking a broad look at the experts who served on heart treatment panels from 2002 to 2008. It found that 56% of them have major conflicts of interest, most commonly a paid consultant to a drug or device company or a member of a company advisory board. Even more troubling was the finding that the physicians who chair the panels are most likely to have conflicts of interest (80%).

The study was led by Todd B. Mendelson, MD, University of Pennsylvania’s Center for Bioethics and Cardiovascular Medicine, and published last month in Archives of Internal Medicine.

In stating their conclusion, Mendelson and colleagues went the glass-is-half-full route, pointing out the bright side of their results. “Conflicts of interest are prevalent in cardiology guidelines, but there seems to be a significant number of experienced experts without conflicts of interest [44%].” In other words, the 44% refute the standard argument that almost all knowledgeable heart specialists take industry money and setting stringent rules about conflicts of interest would leave no one to serve on panels.

There has been a fair amount of media attention given to conflicts of interest over the last decade, and the solution always seems to be disclosure. But in a related commentary entitled, “Can we trust cardiovascular practice guidelines?,” Steven E. Nissan, MD, chairman of cardiovascular medicine at the Cleveland Clinic, dismisses disclosure as a solution and called for banning anyone with conflicts of interest from serving on these panels. “While sunlight is a good disinfectant, there is nothing about disclosure that inherently guarantees scientific independence.” (At the end of his commentary, Dr. Nissen writes that he has consulted for a number of pharmaceutical companies without financial compensation. “All honoraria, consulting fees, or any other payments from any for-profit entity are paid directly to charity, so he receives neither income or tax deduction.”)

These panels are extremely influential, writes Nissan, citing their influence on government and insurance company decisions about which procedures and drugs should receive reimbursement. “Hospitals and clinics use [the guidelines] to decide when innovative, but expensive, therapies are sufficiently mature to warrant a major investment.”

Dr. Nissan comes down hard on professional medical association, stating that any proposed reforms must include them because many receive extensive funding from pharmaceutical and device companies for continuing education for physicians and for advocacy. Although they went unnamed, Dr. Nissan was referring to organizations like the American College of Cardiology. For more on this from ProPublica, click here.

What can you trust? I wish I had an answer. Last February, as I stood outside the cardiac care unit waiting for my husband who just had an emergency angioplasty, I was handed a folder about the drug-emitting stents inserted during the procedure. Not until the surgeon was halfway down the hall did I notice that all the information he gave me came from the company that makes the stents. I’m still looking for independent, long-term safety not only about drug-emitting stents but also the multiple drugs my husband will stay on for the rest of his life.

Maryann Napoli, Center for Medical Consumers©

Posted in Drugs, Heart, testing | Tagged: , , , , | Leave a Comment »

 
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