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Diabetes 2 drug warnings

Posted by medconsumers on September 23, 2012

Type 2 diabetes has reached epidemic proportions in the U.S., we are told. The high blood sugar levels that define this disorder are linked to a higher than normal risk of heart attack, stroke, and many nerve complications. Unfortunately, the drugs prescribed to lower this risk come with complications of their own. Aggressive lowering of blood sugar levels has severe, potentially fatal consequences. A recent study found that — of all medications—insulin and oral diabetes drugs are the second most common cause of emergency department visits and hospitalizations!

That the treatments for diabetes 2 might be worse than the disease has been an issue for years. click here  So has the possibility that the treatments are prescribed too intensively.  click here Then there’s the expanded definition diabetes 2 that, not surprisingly, had drug industry’s behind-the-scenes guidance. click here  Today’s post, however, deals solely with the potential overtreatment of people, aged 65 and older.  It is based on a new online first commentary in Archives of Internal Medicine.

A co-author David Aron, MD, Case Western Reserve University School of Medicine, Cleveland, explained in a telephone interview why a diagnosis of diabetes 2 in old age could be problematic:  “The benefits of better glycemic [blood sugar] control takes roughly up to about ten years to develop, so it’s only beneficial to someone who has a longer life expectancy.”  Put another way, the whole reason for diabetes 2 drug therapy is the lowering the diabetic’s increased risk for a long list of horrors including stroke, amputation, blindness, stroke, heart attack, and others.  But the rate of these complications does not begin to drop until the diabetic has been on drug therapy for about ten years.  Ever heard that before?

Intensive use of drugs to lower blood sugar levels is another problem for diabetics over age 65. The drugs prescribed for diabetes 2 range from metformin alone—thought to be the safest—to the riskier combination of insulin plus an oral drug class of medications called sulfonylurea. Age 65 is the point at which many people begin to develop other serious health problems that make them more likely to experience complications when the drug therapy causes the blood sugar to go down to dangerously low levels (hypoglycemia).  Dr. Aron’s commentary identifies a list of conditions that put older diabetics at risk for hypoglycemia.

Ominously, at the top of the list is: treatment with the combination of insulin plus a sulfonylurea drug (click here for brand names). The list also includes “chronic kidney disease, cognitive impairment or dementia, neurologic conditions that may hamper the ability to speak or respond to a hypoglycemic event, and conditions associated with weight loss, appetite disturbances, or altered medication metabolism.” Yet Dr. Aron has this caution, “I wouldn’t want concerns about hypoglycemia to be seen as a license to avoid appropriate treatment for diabetes 2.”

Now for the test result at which overtreatment and hypoglycemia complications become a possibility: The diagnosis of diabetes 2 is based primarily on the hemoglobin A1C test, which can also measure how well the treatment is working.  The A1C test shows the average blood sugar levels of the past three months. The A1C result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. For people without diabetes, a normal A1C level can range from 4.5 percent to 6 percent.

Dr. Aron and his co-author Leonard Pogach have identified 7 percent as the A1C level as significant for certain people with diabetes 2. Once the patient’s A1C level goes below 7 percent, they say, the potential for overtreatment kicks in for people over the age of 65 who are at high risk for hypoglycemia.  Their commentary is part of the “Less is More” series published regularly by Archives of Internal Medicine, a medical journal with the mission of addressing the problems of unnecessary medical care.

Alarmingly, Drs. Aron and Pogach describe the A1C test as not very accurate (no matter the age of the patient), “There is even greater inaccuracy in many point-of-care A1C tests,” they wrote, referring to blood tests administered in a doctor’s office, as opposed to a free-standing laboratory.

Dr. Aron was asked for more information about how people would know whether their test results could be trusted as the basis for long-term drug therapy “Yes, it’s scary,” he said. When pressed further,  “No test is 100% accurate,” he hedged, “And there is a National Standardization Project currently working on improvements (click here).”

Take-home messages:  Pay attention to your A1C test results and keep copies. If your A1C goes below 7%, talk with your doctor about lowering the dose.   Become an expert on diabetes 2, hypoglycemia and the controversies that dog both topics.  Learn more about the drugs you are taking.   Read the links within this post and “Related posts” below.

Non-pharmaceutical steps to take:  Improve your diet by eating real food, as opposed to fast or processed foods (read “Food Rules“).  Don’t forget regular aerobic exercise (read “You can be fat and fit“).  Do both and you might be able to avoid drugs.

Maryann Napoli, Center for Medical Consumers©

Related posts

Risks of diabetes 2 treatment  A meta-analysis of 13 randomized controlled trials  found that drug therapy does not reduce mortality and might, in fact, slightly increase mortality. Study participants were middle-aged and older.  Drug industry’s role in expanded definition of diabetes 2 is described, so there is reason to think that overdiagnosis explains part of the diabetes 2 “epidemic.”

Weight loss and diabetes 2   Former American Diabetes Association official takes issue with the organization’s standard advice about weight loss and the disturbing trend toward labeling people as prediabetics.

Posted in Chronic Conditions, Diabetes 2, Diet & Exercise, Drugs, exercise, Heart, heart disease, Type 2 Diabetes, unnecessary treatment | Tagged: , , , , , , , , , | 1 Comment »

How prescription drug harms can go unnoticed

Posted by medconsumers on July 12, 2012

Twelve years ago, the American public first heard the shocking news that deaths due to medical care constitute the third leading cause of death in the U.S.—after deaths from heart disease and cancer. Sadly, the death of the research physician who introduced this statistic has recently been attributed to her medical care. Implicated is the commonly prescribed and widely advertised drug Plavix.

The circumstances surrounding the death of Barbara Starfield, MD, of the John Hopkins School of Hygiene and Public Health, were described online first at the Archives of Internal Medicine. The story is told by her husband, also a physician, who has raised critical issues about how common but serious harms of prescription drugs can go unreported.  He calls on doctors and the general public to be vigilant about reporting adverse effects to FDA. His wife had published many papers about improving the quality of medical care.

Neil A. Holtzman,MD, got more information than usual because an autopsy was required for his wife. She died while swimming alone in a pool. Although the immediate cause of death was “pool drowning,” Dr. Holtzman wrote that he was stunned by the description of “cerebral hemorrhage” as the underlying condition. “The pathologist attributed the massive hemorrhage to cerebral amyloid angiopathy (CAA), listing “anticoagulation therapy” on the death certificate under “other significant conditions.” CAA is not so rare, says Dr. Holtzman who learned that it is present in about 8% of everyone over age 75, which includes his wife.

Plavix is the “anticoagulation therapy” mentioned in the autopsy report.  Dr. Holtzman explained that his wife had been diagnosed with a heart condition called coronary insufficiency three years before her death.  Initially, she was put on aspirin therapy, but six months later a stent was implanted to open the right main coronary artery.  Plavix is the standard open-ended treatment thereafter.

Unfortunately re the “thereafter” part, only two aspirin vs. Plavix clinical trials had been conducted in people who had stents implanted. (Not incidentally, both trials were industry-sponsored.) Neither lasted more than one year; yet many cardiologists prescribe Plavix beyond one year after stent placement, as did his wife’s cardiologist.

(Forgive me for inserting myself into this story, but my husband and I discovered the same gap in research information after he had a drug-coated stent implanted during a “possible heart attack.”   We too noticed the short duration of the two Plavix vs. aspirin trials.  And we were disturbed by the higher rate of major bleeding shown for Plavix plus aspirin compared to aspirin alone in one study of unstented people post-heart attack.  With his cardiologist’s approval, my husband stopped the Plavix  15 months after his stent was implanted and stayed on the 325 mg dose of aspirin. None of this bad news about Plavix was explained to us by the cardiologists, by the way, we found it on our own.)

Searching the medical literature for current Plavix data, Dr. Holtzman found two trials published after his wife’s death that showed a significant increase in major bleeds.  All but one of the Plavix studies were published before his wife died, but their alarming results seemed to be ignored by most cardiologists, he wrote. “Neither the American Heart Association nor the FDA issued an alert on prolonged use of the drug.”

Dr. Holzman observed that the studies on Plavix following coronary stent placement reflect the focus of the cardiologists who are largely concerned with the short-term effects of a drug following stent implants. The patient, on the other hand, would want to know about bleeding risks throughout entire duration of drug treatment.

The autopsy showed a bruise on Dr. Starfield’s scalp but no skull fractures. Her husband suspects that a bump against the bend in the side of the pool could have precipitated the cerebral hemorrhage. He knew that she had informed the cardiologist that she bruised more easily while taking Plavix and bled longer following minor cuts. Had cardiologists known to look for cerebral amyloid angiopathy, the “significant condition” listed on Dr. Starfield’s death certificate along with “anticoagulant therapy” perhaps a connection would have been made to the strokelike symptoms she experienced in her last weeks.

Ironically, Dr. Starfield’s death would not have been counted in the third leading cause of death statistic. When she identified the sources for this statistic back in 2000, she was careful to note that it is probably an undercount, given the fact that the studies looked only for iatrogenic deaths in hospitalized patients.  It doesn’t take into account people who die of medical treatment outside of a hospital.

Maryann Napoli, Center for Medical Consumers©

Related info: Report adverse drug reactions to the FDA’s Medwatch Program (for consumers) and (for health professionals).  Sign up for FDA drug alerts and recalls.  Read Dr. Starfield’s 2000 commentary in the July 26, 2000 issue of JAMA (Is US Health Really the Best in the World?).

Related post: Angioplasty overuse and Bill Clinton  2010 post about overuse of stents.

Stents vs drugs from one of our favorite websites.

Read this 2012 article by ProPublica Why can’t medicine fix simple mistakes?

Posted in Aspirin, Conflict of Interest, Doctors, Drugs, Heart, heart disease | Tagged: , , , , , , , , , | 4 Comments »

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 »

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 »

45 medical tests or treatments to avoid

Posted by medconsumers on April 11, 2012

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

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

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

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

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

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

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

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

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

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

Inform yourself

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

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

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

What’s so bad about red meat?

Posted by medconsumers on March 25, 2012

OK.  If you need more reasons to cut back on the red meat in your diet, here they are: You will not only cut your chances of getting heart disease and cancer but you  will also have a shot at living longer. All the better, if you lay off the processed red meat like bacon and hot dogs (yes, pork is red meat). And now for the bonus: All of the above are also good for Mother Earth. The new information here is the living longer part.

The link between red meat consumption and an increased risk of chronic disease is already well documented. Now researchers, led by Dr. An Pan, Harvard School of Public Health, may have cleared up the uncertainties about increased mortality. They drew on data generated by two large diet/lifestyle studies that—together—followed over 122,000 U.S. health professionals who initially did not have cancer or heart disease.

One is the Nurses’ Health Study (1980 to 2008) and the other is the Health Professionals Follow-up Study (1986 to 2008). Both studies have about 28 years of follow-up. All participants answered extensive food frequency questionnaires every four years. They were asked, for example, how often they ate a standard serving of protein, defined as 3 oz (which is the size of a deck of cards).

The researchers documented 23,926 deaths, of which 15,910 were attributed to cardiovascular disease and 9,464 to cancer. The upshot: “Red meat consumption is associated with an increased risk of total, cardiovascular, and cancer mortality.” One standard serving of unprocessed red meat was associated with a 13% increase in the total death rate. One serving of processed red meat like sausage and salami escalates the risk to 20%.  (It should be noted here, that the 13% and 20% increases look worse than they truly are because the annual death rate in the 28-year duration of this study was low. The death rate each year was roughly 1% to 1.5%.)   [Note: For clarifications related to the number of servings, see comments below this post from a co-author of this study.]

In the one study that included both men and women, those with a high intake of red meat were less likely to be physically active and were more likely to smoke, drink alcohol, and have a higher body mass index. What’s more, they ate a larger quantity of food and had lower intakes of whole grains, fruits, and vegetables.

Because high consumption of red meat inevitably displaces other foods, the researchers provided this estimate based on healthy sources of protein like fish, poultry, nuts, legumes, low-fat dairy, and whole grains: A standard 3-oz serving of protein from this list is associated with a 7% to 19% lower risk of death.

Anticipating that many people do not want to give up red meat entirely, the researchers measured the advantage of just cutting back. If a person ate no more than 42 grams of red meat daily (a 6-oz. steak), the researchers estimate that 9% of the deaths in men and nearly 8% in women could be prevented. (And if you’re wondering where grass-fed beef  fits into this picture, it didn’t. Even today, only a small percentage of the U.S. population eats grass-fed beef.)

This study was published recently online in Archives of Internal Medicine. It was supported by grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute.

The invited commentary was written by Dean Ornish, MD, whose life’s work has concentrated on researching and promoting non-pharmacological approaches to the prevention of chronic disease. Dr. Ornish praised the study as, “The first large-scale prospective longitudinal study showing that consumption of both processed and unprocessed red meat is associated with an increased risk of premature mortality from all causes as well as from cardiovascular disease and cancer.”

Click here for Dr. Ornish’s healthy way of eating, based on an emerging consensus among nutrition experts.

Now for the environmental costs of eating red meat.  Dr. Ornish points out that animal agribusiness generates more greenhouse gases than all forms of transportation combined.. And that quarter-pound cheeseburger Americans love so much: It takes 26 oz of petroleum and leaves a 13-lb carbon footprint.

“In addition to their health benefits, the food choices we make each day affect other important areas as well. What is personally sustainable is globally sustainable. What is good for you is good for our planet,” he concludes.

Maryann Napoli, Center for Medical Consumers©

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Posted in Cancer, Chronic Conditions, Diet & Exercise, Heart, heart disease | Tagged: , , , , , , , , , | 7 Comments »

Fried foods are not bad for the heart, if…

Posted by medconsumers on February 1, 2012

Regularly eating fried foods is not bad for the heart—if they are fried in olive oil or sunflower oil.  This from a new study conducted in Spain where these two oils are used most often for frying —both at home and restaurants. Unfortunately, this good news may not be relevant to Americans whose fried food consumption most likely takes place at fast food chains where olive and sunflower oils are as rare as a side order of kale.

At the start of this study, reported last week in the British Medical Journal, the 40, 757 participants, aged 29-69, did not have heart disease. All had filled out extensive questionnaires about their usual diet and food preparation. The average daily intake was nearly 5 ounces of fried foods, including about 1 tablespoon of oil for frying. About 7% of the total amount of food consumed was fried. The study started in 1992.  Eleven years later, there were 606 heart-related “events” like heart attack and stroke and 1,134 deaths from all causes.

One might have expected the heart attacks and strokes to be clustered among the study participants who regularly ate the highest amount of fried foods. But this was not the case. In fact, there was no relationship between the amount of fried foods and the rate of death from any cause or the rate of heart-related “events” (i.e., from heart attacks to the need for angioplasty).

These findings should be understood in the context of the Mediterranean diet and the characteristics of the study participants: Two-thirds were women who as a group reported eating a lower amount of fried foods than the men, thus bringing down the average intake of fried foods. The participants lived in five regions of Spain that traditionally have widely varying diets. Sixty two percent were using olive oil for frying and the rest used sunflower oil or other (2%) vegetable oils.

Fried foods make up a large percentage of the diet of all Mediterranean countries.  Here’s the breakdown according to the types of foods the Spanish study participants were most likely to be frying: 24% fish, 22% meat, 21% potatoes, and 11% eggs.  The research team, led by Pilar Guallar-Castillón, University of Madrid, pointed out that consumption of fried foods in Spain is not a proxy for fast food intake. “Fast foods are generally prepared by deep frying with oils used several times, and are consumed mostly away from home. In Spain, fried foods are consumed both at and away from home, and both deep frying and pan frying are used. Moreover, we can assume that oil is not reused many times for foods consumed at home; however, the cardiovascular effects of food fried with overly reused oils merit further research. Finally, consumption of fried snacks high in salt is fairly low in Spain, whereas in other countries such as the United States they provide an important percentage of energy intake.”

This study was based on the Spanish people who had volunteered to participate in a much larger project called the European Prospective Investigation into Cancer and Nutrition.  It was described in the accompanying editorial as the most “comprehensively investigated” study of a potential link between heart disease and fried foods.  An earlier study, also conducted in Spain, had found a link between hypertension and the consumption of foods fried in reused oil. But hypertension is one of many factors that put people at risk for heart disease.  This is the first study to show no link between between intake of fried food and important outcomes like death, stroke, and heart attack.

Want to know more about frying and how it changes the nutritional content of food?  Here’s how the Spanish researchers described the motivation for their study:

“When food is fried its nutritional content changes—the food loses water and takes up fat, increasing its energy density. Frying modifies both the foods and the frying medium because oils deteriorate during frying, especially when reused, through the processes of oxidation and hydrogenation, leading to a loss of unsaturated fats and an increase in trans fats. Thus fried food absorbs degradation products of the frying oil. At the same time, frying may also improve palatability by making food crunchy.”

Maryann Napoli, Center for Medical Consumers(c)

Posted in Heart, hypertension | Tagged: , , , , , | 1 Comment »

Niacin and the heart

Posted by medconsumers on December 11, 2011

Niacin, in very high doses, has long bridged the gap between mainstream and alternative medicine.  Many people with heart disease regularly take this form of vitamin B to prevent a first heart attack or avoid having another one.  Though niacin is available over the counter, the more expensive  branded product called Niaspan is often prescribed by cardiologists as the better way to raise blood levels of  “good cholesterol” (high-density lipoprotein).  The assumption that raising HDL cholesterol with niacin will spare anyone a heart-related disaster, however, had never been put to a good scientific test.  That is, until now.

In May, the first large clinical trial designed to determine whether high-dose niacin can benefit people with heart disease had to be stopped 18 months earlier than planned.  Reason:  The addition of Niaspan to the usual statin drug therapy given to heart patients did not lower the chances of having a heart attack or a stroke.   All 3,414 study participants, whose average age was 64 years, had been randomly assigned to take either Niaspan (extended release niacin, 1500-2000 mg daily) or a placebo.

Another, more alarming, reason why this trial was stopped early can be found in the press release issued on May 26, 2011 by its funding source, the National Heart, Lung, and Blood Institute, “…a small and unexplained increase in ischemic stroke rates” was noted in the participants taking Niaspan. This might come as a surprise to many people.  After all, niacin is a vitamin—vitamin B3 to be exact.

Now, the final results of this halted trial, known by the acronym AIM-HIGH, were published recently in The New England Journal of Medicine:  “Among patients with atherosclerotic cardiovascular disease, … there was no incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period, despite significant improvements in HDL cholesterol and triglyceride levels.”  In other words, the heart patients taking Niaspan had greater improvements in their blood test results, compared to the heart patients who were not taking niacin.  But there was no difference between the Niaspan group and the placebo group in terms of outcomes such as heart attack, stroke, and the need for heart surgery.

As for the increased rate of ischemic stroke shown in the study participants taking Niaspan, this was acknowledged by the authors of the AIM-HIGH trial as unexpected but possibly due to chance.  “Although the number of ischemic strokes was higher in the niacin group, the overall rate was low, and we cannot be certain whether this observation reflects a causal association or possibly the statistical ‘play of chance’.”

The AIM-HIGH trial’s additional funding support was described this way in The New England Journal of Medicine: “Abbott Laboratories [maker of Niaspan] provided additional support from an unrestricted research grant.  Merck donated the simvastatin [taken by all the study participants].  The companies that provided financial support or products had no role in the oversight or design of the study or in the analysis or interpretation of the data.”

You might wonder what made cardiologists so enthusiastic about niacin in the first place.  A 2009 Forbes magazine article reported their reactions in response to a small clinical trial (only 208 heart patients) announced at the annual meeting of the American Heart Association.  Using ultrasound in this trial funded by Abbott Laboratories, researchers showed that Niaspan was better than statins alone at clearing coronary arteries.  (Niaspan, by the way, hit $254 million in annual sales in 2009. And Abbott is a “funding partner” of the American Heart Association, as noted on its website.)

Unlike the newly published AIM-HIGH trial, the statins vs. Niaspan/ultrasound trial did not look at outcomes that were meaningful to heart patients.  Cleared arteries or increased HDL levels may be promising, but it is heart attack, stroke, or a heart-related early death that people are trying to avoid.  The AIM-HIGH trial looked for these and other outcomes but found none; the ultrasound study did not even look at outcomes.  The latter is a more common scenario.

When told to go on long-term drug or vitamin therapy, it’s a good idea ask the prescribing doctor about proven outcomes.  The AIM-HIGH trial showed that raising the HDL cholesterol can only improve a lab test result.  Too often doctors give their patients the impression that this is the goal.  It isn’t.

Maryann Napoli, Center for Medical Consumers©

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Lower salt intake will reduce blood pressure but not heart attack risk:  read more

Low fat diet: Whatever happened to that advice?    read more

Sunscreens can protect against sunburn, but they have yet to be proven to prevent cancer.   read more

Posted in Heart, statins, vitamins | Tagged: , , , , , , , , , | 4 Comments »

 
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