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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 »

Time to rethink low-dose aspirin therapy?

Posted by medconsumers on June 20, 2012

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Maryann Napoli, Center for Medical Consumers©

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

Posted in Diabetes 2, Doctors, Drugs, Heart, heart disease, hospitals, Men's Health, Type 2 Diabetes, unnecessary treatment, Women's Health | Tagged: , , , , , , , , , | 3 Comments »

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 »

Omega-3 supplements for the heart

Posted by medconsumers on May 17, 2012

Yet another popular dietary supplement hasn’t lived up to expectations. This time it’s omega-3 fatty acid recommended by many cardiologists for people with heart disease. Unfortunately, these supplements did not help them live longer or avoid a heart attack, stroke, or congestive heart failure. The finding came as a surprise because it failed to confirm the upbeat results of earlier, albeit imperfect, studies.

The reversal is based on an analysis of 14 clinical trials that had a combined total of 20,485 adults with heart disease. All were randomly assigned to take either an omega-3 supplement or a placebo daily; neither the researchers nor the participants knew who was taking the real supplements. The analysis was conducted by Sang Mi Kwak, MD and colleagues in the Korean Meta-analysis Study Group and published in the current issue of Archives of Internal Medicine. Dr. Kwak and colleagues noted that almost all of the trials were funded by pharmaceutical companies that make omega-3 supplements.

What made scientists think omega-3 would do wonders for the heart in the first place? It started in the early 1970s when researchers noticed that the Greenland Eskimos have a low incidence of heart disease. This was assumed to be due to their high consumption of fish or marine mammals that are rich in omega-3 fatty acids.  The animal and population studies that followed eventually zeroed in on two components of omega-3 fatty acids that clearly have healthful effects on the heart: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Then came the above-mentioned randomized clinical trials. Unfortunately, there were problems with the earliest trials. For example, two early trials with results that favored omega-3 supplements had a significant bias in their design because they were open-label trials. In other word, they were not double-blind trials because both the study participants and the researchers conducting the study knew who was taking the real supplement and who was taking the fake. Three trials that came later found no benefit to omega-3, but their results were clouded by the fact that many of the participants in both the supplement and placebo groups were also taking heart disease prevention drugs.

These inconsistent results are the reason for the new analysis by the Korean Meta-analysis Study Group. Its task was to eliminate the poorly designed trials in order to combine the results of the best and most reliable remaining trials. That’s how the group came up with the 14 randomized placebo-controlled, double-blind clinical trials. The flaws, even in these 14 trials, were acknowledged. For example, most did not last very long (less than 2-3 years) and did not have a large number of participants. The study group’s conclusion had carefully chosen wording: There is insufficient evidence of a preventive effect of omega-3 supplements among people with heart disease.

In the commentary that accompanied this analysis, Harvard’s Frank B. Hu, MD, and JoAnn E. Mason, MD, underscored the lack of evidence for supplements, but left the door wide open for a diet high in fatty fish (more than 2 servings of marine fish per week) and plant foods rich in omega-3 fatty acids. They also mentioned a large randomized trial in the works that will determine whether vitamin D and omega-3 supplements protect against cardiovascular disease.   In other words,  stick with foods rich in omega-3 fatty acids … until further notice.      click here

Maryann Napoli, Center for Medical Consumers©
Related posts
Lovaza, the prescription-only fish oil capsules

Vitamin E and strokes

Thumbs down on selenium

Vitamins: research shows no benefits and some risks

Posted in Alternative Medicine, Men's Health, vitamins, Women's Health | Tagged: , , , , , , | 1 Comment »

New book about exercise

Posted by medconsumers on May 10, 2012

You may be exercising to improve your health, your memory, your strength, your endurance, or for the pure pleasure of it all. By now, there’s a mountain of research to show the best ways to achieve these goals while minimizing the chance of injuries. Gretchen Reynolds, who writes the “Phys Ed” column for the New York Times Well Blog, has distilled it all for her new book, “The First 20 Minutes.” Many myths were busted along the way.

The book’s title refers to the latest research that shows the greatest health and fitness benefits from exercise are conferred within the first 20 minutes of a routine that combines low- and high-intensity exercise,  alternating at about one-minute intervals.  This type of workout, called “high-intensity fitness training,” can be applied to different forms of aerobic exercise—cycling, walking, etc.

Runners, for example, would start out with a slow jog and then alternate jogging at a normal speed with running at the fastest speed possible. This, says Reynolds, will prolong your life and provide the greatest reductions your chances of developing heart disease, diabetes 2, osteoarthritis. You continue to get benefit with longer workout, but at a slower rate. (You will also get the same benefits from walking, but it will take longer —20 to 30 minutes, five times a week.)

Actually, high-intensity fitness training was the least appealing part of an excellent book that is aimed at everyone from marathon runners to people like me who don’t want to move at high speed.  Each chapter addresses a single topic like endurance, the brain, avoiding injury, nutrition, and ends with a bullet list summary that allows readers to skip whole sections and cut to the chase.

Reynolds is at her most enjoyable when debunking the myths that surround exercise, nutrition, and injury prevention.  By now, most of us have probably heard that stretching before vigorous exercise is useless and perhaps even counterproductive. It lives on, of course, because it takes time for the word to get out.  And regular exercise will not result in much weight loss. Many of us can’t let go of that one, either. “Why exercise doesn’t inevitably make people skinny is one of the more intriguing and vexing issues in physiology,” writes Gretchen Reynolds.

Here’s a sampling of gems from “The First 20 Minutes:”

-Unless you have a congenital defect, running is not bad for your knees.  What’s more, the incidence of knee arthritis in “not necessarily high,” according to a study of longtime runners who were followed for two decades when most were in their fifties or sixties.

-The squat is extremely effective as a body strengthener. It activates the body’s biggest muscles, those in the buttocks, back, and legs. And doesn’t require a gym, a coach or equipment.

-Running for a half-hour doubles the number of brain cells involved in memory, but running has an extremely high injury rate.

-Any kind of movement can improve memory, even everyday activities—cooking, gardening, cleaning, walking around the block—performed by sedentary elderly people showed improvements in memory compared to elderly people who were completely sedentary.

-The importance of improving the body’s core strength has been disproven.

-Healthy people who eat eggs for breakfast consume fewer calories the rest of the day than people who eat bagels or other high-carbohydrate foods.

-Despite the popular notion that slow exercise burns more fat than longer, more rigorous exercise, it doesn’t.

-If you need an alternative to stretching before vigorous exercise (and many people don’t), warm up for a few minutes with an easy version of your planned exercise.

-Massage after strenuous exercise may feel good, but it impairs removal of lactic acid from tired muscles following exercise and interferes temporarily with blood flow to the sore muscles.

-Forget the sugary sports drinks and water. Low-fat chocolate milk provides the ideal ratio of carbohydrates and protein to boost fuel replenishment after a hard workout.

The book ends with a description of a term coined by exercise physiologists, “active couch potatoes,” which probably describes most people who exercise regularly.  Their day might include an hour at the gym or a run in the park, but most of the other waking hours are spent sitting—in front of a computer, watching TV, driving, etc. The body is not meant to be so physically inert. Reynolds’s final message is call to arms: Just “Move it!” Stand up from the computer every now and then; pace around the room while talking on the phone. Simply standing up for two minutes every 20 minutes will counter the negative health effects of sitting for prolonged periods.

Maryann Napoli, Center for Medical Consumers©
Related post:
You can be fat and fit

Posted in Alzheimer's disease, Book Reviews, Diabetes 2, Diet & Exercise, Heart, heart disease, Men's Health, Women's Health | Tagged: , , , , , , , | Leave a Comment »

Drugs to prevent heart problems

Posted by medconsumers on April 26, 2012

Congratulations to the two cardiologists who went public with crucial information rarely explained to the public. Their target: Heart drugs prescribed to healthy people who are expected take them every day for the rest of their lives. Guess what? These drugs can be great at improving your blood test results but not so great at helping you live longer or delaying the symptoms of heart disease. (And isn’t that the point, after all?) Billions of dollars were spent annually on drugs that, initially, showed promise that didn’t hold up with long-term scientific scrutiny.  And too often, failure to prove any benefit does not dull the prescribing enthusiasm.

Vinay Prasad, MD, Northwestern University, Chicago, and Andrae Vandross, MD, Yale University, cite examples of widely prescribed drugs that were ultimately proven useless (Tricor),  dangerous (extended-release niacin), or their advantage is uncertain (Zetia, Vytorin).  In the current issue of Archives of Internal Medicine, the two cardiologists propose “setting the bar” higher for drugs prescribed to healthy people. This means clinical trials with a large number of healthy adults who are randomly assigned to take either the new drug or a placebo and are followed for many years. In other words, drug makers should prove their products can cut the rate of death, heart attack, stroke before the drugs are approved for healthy people.

As things stand now, drugs are usually approved after a few months of study on the basis of short-term results.  For example, a drug must be better than a placebo at lowering cholesterol, or blood pressure, etc.  It has long been assumed that this, in turn, will ultimately lower the rate of deaths from heart attack, stroke, etc.  This assumption hasn’t always panned out. This was shown in 2006, when a much-anticipated drug called torcetrapib was in the process of getting FDA approval for its ability to greatly increase the so-called good cholesterol. But the clinical trial had to be stopped because the drug also increased the number of deaths and heart problems.

Occasionally, the large clinical trial proposed by the two cardiologists is, in fact, conducted—-but the results aren’t in for a decade or two after the drug was approved.  Worse, prescriptions continue to rise for a drug found to be useless.  One widely prescribed drug called fenofibrate (some brand names: Tricor, Lipofen, Antara) was approved by the FDA in 1993 for the treatment of very high triglycerides in the blood. Tricor became a blockbuster four years after a 2005 meta-analysis cast doubt on the benefits of all drugs in this class known as fibrates. There were no improvements in overall survival, and this was confirmed in a landmark clinical trial. “Although it was prescribed for more than a decade to further improve lipid profiles [standard test for fats in the blood] for patients already prescribed a statin, we now know the error of this practice.”

Cost is no small matter, as noted in this paper. “Annual spending on statins exceeded $19 million in 2005, ezetimibe (in the form of Vytorin and Zetia) costs over $5 billion in 2007, and fenofibrate costs passed $1 billion in 2009.”

Another improvement suggested by Drs. Prasad and Vandross:  Drugs given to healthy people must be shown to lower the rate of deaths from all causes before they are approved.  Too often a drug will lower the rate of heart-related deaths but not the total rate of deaths. If the drug succeeds with the former but not the latter, this raises the possibility that the drug itself is killing some people.  The only way to rule this out is to demand that the clinical trials not only keep track of heart-related deaths but also total deaths.

If this sounds familiar, it is the same argument that has emerged over how to prove the lifesaving value of screening tests (also “prescribed” for healthy people). “While screening for breast, prostate, and colon cancer decreases cancer-specific death, none [emphasis added] have shown an overall mortality benefit in prospective trials,” wrote the two cardiologists.  Screening can lead to potentially fatal, unnecessary, aggressive cancer treatments.  click here for breast cancer screening,  here for prostate cancer screening, and here for colorectal cancer.

Whether these excellent proposals ever see the light of day remains to be seen.  After all, the current system of short-term pre-approval trials serves drug industry interests, and healthy people in early middle age are its favorite “market share.” (Unlike the sick and the elderly, healthy people have a longer lifespan ahead in which to take drugs.)  It’s a good idea to think long and hard before accepting “preventive” drug therapy if you don’t have heart disease.  Drs. Prasad and Vandross have given us the blueprint for the issues to be raised with the prescribing doctor.

Maryann Napoli, Center for Medical Consumers©

Related posts

Drug to prevent heart attacks and strokes

Posted in Alternative Medicine, breast cancer, Cancer, colon cancer, Doctors, Drugs, Heart, heart disease, Men's Health, Screening, statins, unnecessary treatment, Women's Health | 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 »

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 treatment decision aid

Posted by medconsumers on December 14, 2011

You have breast cancer and the initial surgical treatment is over. Now there is help with another decision that just about all breast cancer patients must make:  Should I go on adjuvant therapy, which can mean months of chemotherapy and/or years of hormone therapy? A terrific easy-to-use decision aid freely available on the Web has just been brought to my attention. It is set up to help both breast cancer patients and physicians make informed decisions about adjuvant therapy.

First, a reminder about the role of adjuvant therapy, which refers to postoperative treatments given to reduce the chance of a cancer recurrence. My recent post shows that adjuvant therapy is the main reason for the 2% annual drop in breast cancer deaths since the 1990s.  Click here  This drop, observed in many countries, coincides with the introduction of adjuvant drugs like tamoxifen and more recently Herceptin.

The decision aid is called PREDICT because it predicts a woman’s survival without and with adjuvant treatment.  Put another way, PREDICT shows how much (or how little) the additional treatment improves the chances of having a cancer recurrence.

Here’s how the website describes the basis for its predictions:  “Breast cancer comes in different types and several different factors affect the response to treatment. From research and studies involving many thousands of women we know that the response to treatment is affected by the size and type of the cancer at diagnosis, whether the cancer has spread to involve lymph nodes and whether there are estrogen or HER-2 receptors on the surface of the cells.”

To use this website you must be able to answer a few questions about your diagnosis such as tumor grade and estrogen receptor status. The predictions are presented in two easy-to-understand formats: a color chart and frequencies statistics. Here’s an example of the latter for an estrogen-positive, tumor grade 2 breast cancer in a 68-year-old woman:

“Five-year survival—90 out of 100 women are alive at 5 years with no adjuvant therapy after surgery.   An extra 1 out of 100 women treated are alive because of hormone therapy.

Ten-year survival—78 out of 100 women are alive at 10 years with no adjuvant therapy after surgery.
An extra 3 out of 100 women treated are alive because of hormone therapy.”

Unfortunately, this website does not address quality-of-life issues such as the rates of serious harm associated with each adjuvant treatment choice. Still, this is a great decision aid that deserves replication for other life-threatening diseases.

PREDICT has been developed by a partnership between the Breast cancer Unit at Cambridge University NHS Hospital, the University of Cambridge Department of Oncology and the NHS Eastern Cancer Registry and Information Centre, UK.

Maryann Napoli,Center for Medical Consumers(c)

Posted in breast cancer, Cancer, Drugs, 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 »

 
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