Understanding lab tests

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.

An honest take on screening for lung cancer

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

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

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

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

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

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

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

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

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

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

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

Breast cancer and radiation

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.

Drugs to prevent heart problems

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

45 medical tests or treatments to avoid

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

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

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

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

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

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

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

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

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

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

Inform yourself

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

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

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

What MDs don’t know about cancer screening

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)

A new take on bone density retesting

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)

Breast cancer deaths drop—but not because of mammography

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.

Rethinking aging

New book: Rethinking Aging: Growing old and living well in an overtreated society

Overtreatment—the theme of this website—is getting much more attention in medical journals these days, but does the public understand? After all, we are the recipients (victims?) of overly aggressive or unnecessary medical treatment. In a survey, published recently in the Archives of Internal Medicine, nearly half of U.S. primary care physicians said they thought their patients were overtreated; only 6% thought their patients received too little care.

But who will tell the people? And how will they recognize inappropriate treatment? One answer is the latest book by Notrin M. Hadler, MD, author of Rethinking Aging: Growing old and living well in an overtreated society. An author of several books revealing the inadequate science behind many standard medical treatments, Hadler now trains his informed skeptic’s eye on medical care of the elderly. Aging, you may have noticed, has become a disease in need of drug treatment. I’m with those who say it all started decades ago when—with strong behind-the-scenes drug-industry backing—menopause became a hormone-deficiency disease in need of long-term hormone therapy.

Hadler, professor of medicine and microbiology/immunology at University of North Caroline, Chapel Hill, makes it clear that this is not “a textbook of geriatrics for the lay reader” nor does it provide the latest tips for successful aging (we get enough of that from the AARP Bulletin). He tells why and how we should be cautious about allowing ourselves to be tested, especially when no symptoms are present. Testing healthy low-risk people leads to overdiagnosis which in turn puts them on the proverbial conveyor belt to overtreatment.

Drugs are approved on the basis of what researchers call “surrogate endpoints”, Hadler states, and the research is conducted and spun by the drug companies to make us think that is the goal.  Put another way: Just because a drug makes dramatic improvements in risk factors like high blood pressure, cholesterol or bone loss (surrogate endpoints), don’t assume that these drugs are also making dramatic reductions in your chances of having a heart attack, stroke, or hip fracture. The reality is far more modest, and risks usually go unmentioned, downplayed, or not discovered until years later.

“Treating high cholesterol in older well people is unconscionable,” writes Hadler, who sees this as part of a far larger problem. “So many medicines prescribed for the elderly target long-term risks and hazards rather than active illness.”

There is, of course, a multi-billion-dollar pharmaceutical industry that conducts the studies of its own products; cherry-picks findings that are favorable; routinely withholds serious adverse effects data; “educates” our doctors, defines illness, and cashes in handsomely whenever long-term drug therapy is prescribed to healthy people (sick people have the unfortunate likelihood of dying earlier). No wonder, for example, that the overwhelming majority of Americans taking one of the blockbuster cholesterol-lowering statin drugs are healthy people without heart disease.

Then there are the expanding definitions of “abnormal”. I’ve kept my health form from 1992 when it was required for an Outward Bound whitewater rafting trip. Under the line for blood pressure, the form instructs the examining doctor to repeat the measurement “If BP is over 150/90.” Today, the instruction would be, “Repeat if over 120/80”, currently the latest definition of high BP. Hadler points out that there’s no evidence that drugs given to bring BP below 140/90 will benefit anyone.

I’ve often wondered why I would occasionally read in medical journals that normal aging brings a steady rise in the upper BP number (systolic pressure) until people reach their eighties; yet this is never reflected in the treatment recommendations from influential organizations like the American Heart Association. Hadler takes this on: “It would be abnormal if the systolic-diastolic difference didn’t widen in our Golden Years,” he writes, going on to explain the complexities that should drive the decision to treat BP, rather than a one-size-fits-all approach.

Then there’s diabetes 2, yet-another disease with an expanded definition that has made millions of healthy people into long-term drug customers. Oral hypoglycemic drugs were introduced in the 1950s, which made sense, says Hadler, because they normalized blood sugar metabolism. “But sense did not hold up to scientific testing,” he notes when the practice was finally—in the 1970s—subjected to a randomized controlled trial, compared oral hypoglycemic to diet or insulin therapy.

“The study participants treated with the early version of an oral hypoglycemic did worse than those in the other two groups, including more deaths. I never again prescribed any oral hypoglycemic, and vowed I wouldn’t until there was data that these agents were beneficial to my patients, not just effective in normalizing their glucose metabolism.” In the intervening decades, no studies have produced such evidence, according to Hadler.

I can’t leave you without naming a few other topics addressed in this book: It’ s OK to be overweight. Longevity is not heritable. We’re meant to live only to 85, after that, things will most likely go downhill. Alzheimer’s disease testing is not ready for prime time, most vitamin D and calcium supplementation is a waste of money … and much, much  more.

Maryann Napoli, Center for Medical Consumers©

Related articles:

Overdiagnosed—Making people sick in the pursuit of health
Another doctor-authored book on the the topic published early this year.

Just say no
Primary care physicians name the most useless tests and treatments frequently administered by their peers.
 
No benefit to reducing blood pressure below 140/90
A review of all relevant studies from the Cochrane Collaboration.

Overtreated—Why too much medicine is making us sicker and poorer
Earliest book on the topic. This one by an investigative journalist.

Cancer screening tests right to the grave

The PSA debacle

So now it’s official.  The PSA screening test leads to a cascade of more tests and drastic treatments that cause serious harm AND saves no lives.  But there were plenty of warning signs 20 years ago, when the PSA test began to be aggressively promoted to men and their physicians. The demand for PSA screening was created by the companies that make the test, the equipment to diagnose prostate cancer, and the drugs to treat it. These companies also fueled consumer advocacy—but only the groups of cancer survivors who encouraged other men to undergo PSA testing. Now a panel of independent experts has announced its recommendation against PSA screening for healthy men at any age. In the meantime, a multibillion-dollar industry has grown up around PSA screening that’s not likely to disappear any time soon.

I became interested in the selling of prostate cancer screening somewhere around 1989, when prostate cancer went from obscurity to a widely feared disease.  It didn’t generate much interest because the average age at diagnosis was 75.  Autopsy studies of men who died of causes unrelated to cancer had already shown that the incidence of prostate cancer increases with age, 30% of men in their forties have prostate cancer, and by the time they reach their eighties, 70% have it.  Yet only 3% died of prostate cancer. The deaths were due to an aggressive form of prostate cancer, but it was not clear whether whether early detection and prompt treatment would make a difference. To this day, no test can accurately distinguish the aggressive form of prostate cancer from the type that’s slow-growing and not life-threatening.

What set prostate cancer apart from other cancers was the uncertainty about whether no treatment was superior to the drastic treatments like radical prostatectomy.  All this could be found in the 1989 version of cancer information from the database of the U.S. National Cancer Institute.  Of course, the NCI never put it that way.  Instead, “watchful waiting” (aka no treatment) was listed along with treatment options.  Severe treatment complications like impotence and incontinence were mentioned in the doctors’ version of this database, but not in the patients’ version. (Today, this database can be accessed directly at http://www.cancer.gov)

Screening creates customers, but first the public must be made to fear the disease and believe it can be treated successfully if found early. (Note how often your local hospital offers free cancer screenings.) Next, there must be easy access to the screening test. There was a time—around 1990—-when Merck thought its new drug Proscar had the potential for prostate cancer prevention. (It didn’t.) What was memorable about Merck’s early “prostate awareness” ads was the fact that some were aimed at women. They had a “get your man to the doctor” theme with no mention of Proscar, making them appear like public service announcements. Just one of many ways that set the path to a PSA.

By 1993 Gina Kolata would report in The New York Times that an astounding 92% of all American men had had a PSA screening test.  How did this test with no data to show it improves outcomes and a high rate of false alarms become so widely and quickly accepted by physicians and patients, she asked rhetorically.  Answer:  The demand had been created by the drug and device companies who sponsored the annual “Prostate Awareness Week”. (For the women’s version of this story read, “The Marketing of Osteoporosis”.)

In time, the PSA test would be included in the routine blood test with the result that men could now be given the test without their knowledge. Studies would show that most of the men who chose “watchful waiting” after a prostate cancer diagnosis could not live with the idea that they were living with an untreated cancer. The majority would go on to be treated.

In 2009 the results of two large clinical trials were published in the same issue of the New England Journal of Medicine.  Both compared men randomly assigned to receive either regular PSA screening test s or no screening. The results were devastating in terms of exposing  the high incidence of severe complications suffered by the men treated for prostate cancer as a result of PSA testing.  Only one study found screening reduced the rate of prostate cancer deaths, and it was minimal. The bad news about the PSA received plenty of media attention complete with quotes from urologists challenging the findings. click here

These two trials form the basis of the “new” recommendation against PSA screening by a 16-member panel of independent experts, sponsored by the U.S. Preventive Services Task Force.  This recommendation was actually decided back in 2009 after an in-depth review of all PSA-related studies, but not made public—that is, until October 7.  The New York Times (Sunday) magazine was about to print a hard-hitting article about PSA screening that would reveal that the task force recommendation had been withheld for nearly two years. Worse, the delay was due to fears that this unpopular conclusion would jeopardize the task force’s funding.

The predictable backlash came immediately—from doctor groups, especially the urologists, patient groups whose members believe their lives were saved by the PSA, and politicians against healthcare reform quick to charge “rationing”. In 2009, this charge was leveled at another task force that raised questions about the value of starting screening mammograms at age 40.

PSA screening has been called “the largest iatrogenic public health disaster of our time”.  It’s not over until men make it clear to their doctors that they do not want this test and make sure that it is not included in a routine blood test.

Maryann Napoli, Center for Medical Consumers©

Related articles

Drastic treatment of early prostate cancer

Just say no to the PSA test

Overtreatment of early prostate cancer