Drugs for mild hypertension

Are you taking drugs for mild hypertension, yet you’ve not had a heart attack, stroke, or a diagnosis of heart disease?  A new review of all studies that followed people who fit this description could not find a benefit to drug treatment. Astounding — when you consider that half the people currently on blood pressure-lowering drugs have only mild hypertension. Not incidentally, the threshold for mild hypertension has been lowered considerably over the years, thus making more and more of us into drug customers.

The review was published this week by the Cochrane Collaboration, an international organization that evaluates medical research.  It’s the first hard look that any independent team of researchers has directed at the evidence for prescribing drug for mild hypertension.  The best of all available research boiled down to four clinical trials with a combined total of nearly 9,000 participants who had mild hypertension.  It should be noted here that these are old studies  …  from an era when mild hypertension was 140-159/ 90-99 mmHg.  All were randomly assigned to take a drug or a placebo every day for five years. While these four studies may be the best available, the reviewers found that they left a lot to be desired. Only one, for example, kept track of the number of participants who dropped out of the study due to adverse effects.

Here’s the Cochrane review conclusion:  “Available data from the limited number of available trials and participants showed no difference between treated and untreated individuals in heart attack, stroke, and death. About 9% of patients treated with drugs discontinued treatment due to adverse effects. Therefore, the benefits and harms of antihypertensive drug therapy in this population need to be investigated by further research.” The reviewers acknowledged that withdrawals may not be this high with today’s lower doses of thiazides and beta-blockers (two most common anti-hypertensive drug classes).

“We just assumed that there must be benefits to treating most people with mild hypertension and that the benefits were greater than the harms,” said James Wright, MD, co-author of the Cochrane review, referring to conventional medical wisdom.  In a telephone interview, Dr. Wright described his own reaction to what he and his co-authors found.  “It was shocking to me, and it changes the way I approach my patients with mild hypertension,” he said.  “I tell them that there is no proven benefit to continuing treatment.  Some say, ‘Fine I’ll go off the drugs.’  Others say, ‘I’ll stay on the drugs anyway.’”    What?  Some of your patients would actually stay on a drug after hearing that it provides no benefit! What about the unanswered questions about harm?   “For sure, there will be harm,” he responded.  “The idea that any drug is without serious adverse effects is just wrong.”

Dr. Wright, who is a professor of Medicine at the University of British Columbia, Vancouver, explained that the four trials in this review looked only for effectiveness and not serious adverse effects, and none were funded by drug companies.  Today, most drug trials are funded by industry, and all are now required to collect information about serious adverse effects.  Unfortunately, he said, many of these industry-funded clinical trials withhold findings that are unfavorable to their products. Too often, only some—-but not all—serious adverse effects are reported.

The conclusion of the Cochrane review calls into question the hypertension guideline recommendations in the US, Canada and Europe. These guideline groups have recommended treatment of all adults with a blood pressure of more than 140/90 mmHg, yet the reviewers found no proven benefit to treating people with blood pressures under 159/99.  The time is right for a rethink, as the reviewers observed, “The decision to treat people with mild hypertension  has important consequences for both the patients (e.g. adverse drug effects, lifetime of drug therapy, cost of treatment, etc.) and any third party payer (e.g. high cost of drugs, physician services, laboratory tests, etc.).”

More:

-Despite the title of the new Cochrane review —  “Benefits of drugs for mild hypertension are unclear” — all the study participants actually had what is considered to be moderate hypertension by today’s definition (140-159/90-99). If this describes you and you are currently taking anti-hypertenisve drugs, print out this abstract and discuss it with your doctor.  Disclosure: I am an unpaid contributor to the Cochrane Collaboration, which describes itself as “an international, independent, not-for-profit organisation of over 28,000 contributors from more than 100 countries, dedicated to making up-to-date, accurate information about the effects of health care readily available worldwide.”

-There are non-drug treatments for hypertension (e.g. diet, exercise, stress management, etc.). The Cochrane reviewers say that many people with mild hypertension might give them a try, if they knew the uncertainties of drug therapy.

-Dr. Wright is a co-author of an earlier Cochrane review that found no benefit for drug treatment that lowers blood pressure below 140/90. Read this 2009 interview with him.

-Here’s a 2009 post that presents a case for taking anti-hypertensive drugs whether or not you have high blood pressure. Small doses are key to minimizing adverse effects.  Learn your chances of having a stroke, heart attack or heart failure, as well as the drug treatment’s reduction of each.

– Read “Treatment guidelines and conflict of interest” which describes the drug industry connections of experts who set treatment standards.

-This is a trip-down-memory-lane historical post “Prehypertension—How real is this new “disease?” from 2003, when 120-139/80-89 was declared prehypertension.  This new information about the lack of proven benefit for treating mild hypertension makes the concept and treatment of prehypertension even more absurd.

Maryann Napoli, Center for Medical Consumers©

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

Protect yourself from overtreatment

Overdiagnosed—Making People Sick in the Pursuit of Health is a new book by three physicians whose work I admire. All are practising physicians, researchers, authors, and professors at the Dartmouth Institute for Health Policy and Clinical Practice. Here is my recent interview with the lead author, H. Gilbert Welch, MD.

Maryann Napoli (MN): You say that overdiagnosis is the biggest problem posed by modern medicine. “It has led millions of people to become patients unnecessarily, to be made anxious about their health, to be treated needlessly, and to bear the inconvenience and financial burdens associated with overdiagnosis. It has added staggering costs to our already overburdened health care system. And all of the forces that helped create and exacerbate the problem — financial gain, true belief, legal concerns, media messages, and self-reinforcing cycles — are powerful obstacles to fixing it.” What exactly is overdiagnosis?

H. Gilbert Welch (HGW): Overdiagnosis occurs when we doctors make diagnoses in individuals who are not destined to ever develop symptoms or die from the condition being diagnosed. In general, overdiagnosis is a side effect of our relentless desire to try to find early disease and that happens through annual check-ups and screenings.

MN: How can people reduce their chances of being overdiagnosed?

HGW: People are sensitized to think about the side effects of treatment, but they are less sensitized to think about the side effects of looking for things to be wrong—testing and screening. Diagnosis can start a train of events that can be very difficult to stop. My co-authors, Lisa M. Schwartz and Steven Woloshin, and I write about the need for those who are well to develop a bit of healthy skepticism about the process of looking for things to be wrong. We are encouraging people to ask themselves whether they want to be part of this testing process that could start a cascade of more tests and interventions…and anxiety. They may decide that they want to – and that’s fine. Our interest is not to say, “you should or you shouldn’t [have a test if you have no symptoms]”. We just want you to know that there are two sides to the story – harms as well as benefits.

MN: Your book provides quite a service by explaining the benefits and harms of taking drugs for each level of high blood pressure, ranging from very mild to severe.

HGW: I start the book with hypertension because it was the first place that we physicians began to prescribe drugs for people without symptoms – in other words, it was the first place overdiagnosis was possible. We’ve studied hypertension so much that we know that the benefit is a function of how high your blood pressure is. If you have really high blood pressure, the benefit is enormous. Treating these patients is one of the most important things we do.

MN: What about the many people who have only mild or very mild high blood pressure and they are strongly urged by their doctors to take drugs for it?

HGW: As we move to treat lower and lower blood pressures, the benefit of treatment falls. People should know how high their blood pressure is and should ask about size of the benefit because all our treatments have some harms. The harms start with the hassle factors like arranging followup appointments, getting your prescription, dealing with insurance companies, which all add complexities to our lives. Then there are the more serious harms of drug side effects that are more rare. Increasingly, treatment is being encouraged for low-risk persons – people with minimal blood pressure elevation (or minimal blood sugar or cholesterol elevations). In these situations we’re looking at helping about of one out of a hundred. In this book, we’re raising the question: What happens to the other 99? And let’s be clear — the treatment is always the patient’s choice.

MN: There are studies, dating back to the 1970s, showing that the annual physical is not necessary, but the public largely remains keen on it.

HGW: If the annual checkup means complete head-to-toe physical and series of tests, etc., it is not a sensible or an important intervention. If, however, the annual checkup is a “check-in”, then it makes sense. To get a sense of what health risks patient may face, we explore your lifestyle and your family history. We talk about health promotion— eat your fruits and veggies, exercise, don’t smoke, develop meaningful relationships, etc. Most importantly, we learn what’s going on in your life and what matters to you. It should be an exploration, not some concerted effort to look for things that are wrong. You may choose to pursue some forms of early detection, but you should know these efforts are more problematic. The truth is we all have abnormalities.

MN: You write about the expanding definitions of diseases like osteoporosis, diabetes 2, hypertension that overnight make millions of healthy people into patients in need of long-term drug treatment. You point out that the sellers create the demand and exploit buyers to make more profit.

HGW: The pharmaceutical industry is the big whipping boy and it deserves to be. But there are other powerful forces, namely hospitals looking to expand their markets. Hospitals, for example, understand that free cancer screening is a great strategy for recruiting new patients. That was addressed nicely in your 2003 interview with Dr. Otis Brawley then the head of Emory University’s Cancer Center, whose PR people were encouraging prostate cancer screening as a long-term money-maker for the hospital (click here). Lawyers are also part of the story. We doctors are sued for underdiagnosis [i.e., failure to diagnose], but never for overdiagnosis. And then there’s the media, trained to provide powerful anecdotes – typically cancer “survivors” who say they owe their lives to the cancer screening test. These are among the most misleading anecdotes in medicine. I hate to say this, but the typical breast or prostate cancer survivor detected by screening is more likely to be overdiagnosed than truly helped by screening.

MN: Yes, one-third of all mammography-detected breast cancers would never become life-threatening had they gone undiscovered and untreated. click here And Otis Brawly, MD, now the chief medical officer of the American Cancer Society, has said that the PSA screening test for prostate cancer is 50 times more likely to ruin a man’s life (unnecessary cancer treatment) than save a man’s life. click here

HGW: There an incredible paradox here. The more sensitive a test becomes, the more cancers we see, and the more overdiagnosis. That translates into more survivors stories featured in the media, the more likely people actually know a survivor and the more popular the test becomes.

MN: I gather you’re down on the current efforts to hold physicians to performance measures.

HGW: It makes sense to find out how well things are going in medicine. Unfortunately, some of our performance measures are brain dead. They are often based on what we do to well patients—for example, all women should have mammogram, regardless of whether we are telling them both sides of the story—regardless of whether we are coercing them into having this test. The incentive for doctors is to get good grades. To me, this is ridiculous. We should not be measured on persuasion. These decisions belong to individuals.

Maryann Napoli, Center for Medical Consumers(c)

Overtreatment of thyroid cancer

Thyroid cancer incidence has tripled since the 1970s. Most of the increase is attributed to the introduction of diagnostic ultrasound and fine-needle aspiration biopsies. Use of these two procedures escalated once ultrasound machines, initially found only at hospitals, became increasingly available in doctors’ offices. Autopsy studies show cancer is present in the thyroids of most people who died from other causes. Consequently, some researchers suspect that diagnosing thyroid cancer at the earliest stage is causing much more harm than good.

This suspicion was confirmed in a new study that found people with papillary thyroid cancer (the most common type) have an excellent prognosis whether or not they are treated within the first year of diagnosis. And they have an excellent prognosis whether part or all of the thyroid gland is surgically removed. Those who receive the latter treatment must go on thyroid replacement therapy for the rest of their lives.

These conclusions are based on 20-year data collected from 17 cancer registries maintained by the U.S. National Cancer Institute. Of particular interest were the people diagnosed with papillary thyroid cancer that had not progressed beyond the thyroid gland. More than 35,600 thyroid cancer patients, diagnosed between 1973 and 2005, fit this description. The researchers specifically wanted to know what happened to the people whose tumors were not treated for a year or more after diagnosis.

Here’s the bottom line: At six years, less than half a percent of those treated within a year of diagnosis had died. The death rate of the people who did not receive immediate treatment was also low (1.2%). As for those followed for 20 years: 99% of immediate-treatment group and 97% of the no-immediate treatment group were alive at 20 years. In other words, early diagnosis and immediate treatment accounted for a 2% difference.

This study was conducted by Louise Davies, MD, and H. Gilbert Welch, MD, of the Dartmouth Institute for Health Policy and Clinical Practice, and published last month in Archives of Otolaryngology, Head and Neck Surgery. It’s a sequel to their 2006 landmark study that identified ultrasound and fine-needle biopsies as the major reasons for the increase in thyroid cancer incidence. The new study was funded in part by a Research Enhancement Award from the U.S. Department of Veterans Affairs.

Davies and Welch caution doctors that the “outcomes” of patients treated for papillary thyroid cancer “are extremely favorable,” but the risks of treatment must also be taken into account. “Survival is so good that it is appropriate to consider whether the risks of complications outweigh the benefits of treatment during discussions about when and how to treat the disease. The risk of permanent hypoparathyroidism and significant damage to laryngeal function have been reported to range from 3% to 5%…”

In the editorial that accompanied this study, a counter argument was offered by Erich M. Sturgis, MD, and Steven I. Sherman, MD, of the M.D. Anderson Cancer Center, Houston. They agreed that a “wait and see” approach may be appropriate for many patients, particularly those with additional, more serious medical conditions. On the other hand, a person with a large tumor and a history of radiation exposure should be treated immediately. Furthermore, Sturgis and Sherman say that they see many patients with recurrent thyroid cancer “after an inadequate initial evaluation and/or treatment.”

And as for that 2% difference in the 20-year survival rate between the patients who were treated immediately and those who were not. Sturgis and Sherman extrapolate that 2% to the estimated 35,000 Americans diagnosed yearly with papillary thyroid cancer. It might be a tiny statistic, they say, but it represents about 500 to 700 people who will die of papillary thyroid cancer. “Certainly, most of these hypothetical 500 to 700 people would have wished their physicians had offered them the treatment that had ‘statistically’ better survival (i.e., surgery).”

Still, the editorialists do not dismiss the overtreatment concerns of Davies and Welch. “… occult papillary thyroid cancers “might even represent the normal aging process of the thyroid gland.” Davies and Welch are quoted approvingly:

“Because so many of these cancers would likely never have caused symptoms during life, epidemiologists have labeled the phenomenon, ‘overdiagnosis.’ Overdiagnosis is a cause for concern because it makes it hard to identify which patients need treatment…Further studies will be needed to determine if a more cautious diagnostic approach—perhaps simply providing follow-up for symptomatic thyroid nodules—is worthwhile. In addition, papillary cancers smaller than 1 cm could be classified as a normal finding.”

For more information
Read this 2006 article about Davies and Welch initial paper on the rise in thyroid cancer incidence. See the suggestions from Dr. Davies about finding a second opinion, including a second opinion about undergoing an ultrasound of the thyroid in the first place. (Click here for “Cancers that do not kill”)

The thyroid cancer incidence has been rising for three decades, and most Americans are treated immediately. Yet there’s no change in U.S. thyroid cancer death rate, which has always been very low. Click here for the National Cancer Institute’s take on this point.

Maryann Napoli, Center for Medical Consumers©

Share This Article

Treatment for Early Prostate Cancer

Not Better Than “Wait & See” Approach

A common treatment given to men with early-stage prostate cancer—one that has significant harms—was found to be no more effective in extending life than the “wait-and-see” approach. The study, published last summer in the Journal of the American Medical Association, highlights the fact that doctors have been using this treatment for decades without proof of benefit. Its finding became the centerpiece for an unusual article in a recent issue of the Journal of the National Cancer Institute that candidly discussed the many reasons for overuse, chief among them are the financial incentives that encourage treatment…but more on that later.

The treatment in question is called androgen deprivation therapy (ADT), aka drugs that shut off the male hormones known to promote tumor growth. It is given to men whose cancer is confined to the prostate and received no other treatment, such as surgical removal of the prostate. The 2008 study that showed ADT does not increase survival was conducted by Grace L. Lu-Yao, MPH, PhD, University of Medicine and Dentistry of New Jersey, and colleagues who drew their information from Medicare claims.

The men in this study were diagnosed with localized prostate cancer in 1992-2002. They were age 66 years and older at the time of diagnosis with a median age of 77 years. Survival results favored the untreated. During the ten year follow-up period, those given ADT had a lower prostate-cancer survival rate (80%) than those not given ADT (82.6%).

Wide variations were seen in the treatment duration—half of the ADT-treated stayed on the drugs more than 30 months. Such long-term use has been associated with 10% to 50% increases in the risks of fracture, diabetes, coronary artery disease, heart attack and sudden cardiac death, according to Dr. Lu-Yao and colleagues. Hot flashes and swollen breasts are some of the common adverse effects.

This is not the first study to show ADT for early-stage disease did not prolong life, though its use steadily increased over the last 20 years. In a telephone interview Peter C. Albertsen, MD, a co-author of the ADT study, acknowledged a trial that randomly assigned men to ADT or no treatment would be ideal. But that type of trial would have taken too long, he continued, “So we did the best we could by going to the Medicare claims data.”

Dr. Albertsen, who is a professor and chief of urology at University of Connecticut, Farmington, went on to explain, “It was thought that early use of ADT would offer a longevity benefit, but our analysis is convincing that early use of hormone therapy doesn’t make sense. In fact it makes much more sense to wait for the patients to develop symptoms before they are offered this treatment.”

That conclusion also calls into question the current practice of giving the PSA (prostate-specific antigen) blood test to symptom-free men, as part of a routine physical exam, though the test has yet to be proven life-saving. And many experts suspect that it causes far more harm than good, particularly in elderly men, because it leads to unnecessary drastic treatments [e.g., prostatectomy] for cancers that would never produce symptoms or become lethal. Furthermore, there is no accurate way to distinguish the cancers that will progress from those that will remain dormant for a lifetime. These concerns led to new recommendations from the U.S. Preventive Services Task Force.

Last summer, the USPSTF announced that men over the age of 75 years should no longer be screened for prostate cancer and men younger than 75 years should know “the benefits of screening for prostate cancer are uncertain and the balance of benefits and harms cannot be determined.” With this recommendation, the USPSTF parts company with many other medical organizations like the American Urological Association that recommend PSA testing for all men after the age of 50 years.

With the new USPSTF recommendation in mind, Dr. Albertsen was asked whether it is reasonable to see his study’s findings as an example of the harm that results from the aggressive promotion of the PSA test over the last 20 years. “Yes it is,” responded Dr. Albertsen, after a moment’s hesitation, “because you can only have early, localized cancer [diagnosed] if you are screened—otherwise you’d have a tumor that causes symptoms and that’s not what we’re talking about here.” (click here for “Just say no to the PSA test.”)

There are other forces driving the overuse of ADT, according to James Talcott, MD, director of the Center for Outcomes Research at Massachusetts General Hospital Cancer Center. In a telephone interview, Dr. Talcott, who was not involved in the ADT study, said, “Two drugs [used in ADT]—Lupron and Zoladex—have been aggressively promoted by their makers—Tap Pharmaceuticals and AstraZeneca.” Both companies used illegal kickbacks to encourage and reward urologists who were high prescribers of these expensive drugs, although a less expensive drug is widely available.

“Together, these two companies had to pay over a billion dollars to the federal government in fines for kickbacks to urologists [in 2001],” said Dr. Talcott. (The kickbacks included free TVs, VCRs and seminars at resorts.) “Drugs like Lupron and Zoladex—that are given by injection or infusion—are where all the money is made,” he continued, doctors can bill for them which is not the case for drugs given orally. “A great majority of men are treated by a urologist and moved on to an oncologist only after they don’t respond to Lupron or Zoladex.”

Part of the ADT overuse problem is not the physicians’ fault, stressed Dr. Talcott. “It’s also the payment mechanism. Doctors are paid to do something like give an injection, but talking to patients is a money loser.” Dr. Albertsen made a similar point, saying it’s easier to give a drug than to explain the seemingly counterintuitive option of leaving cancer untreated.

Men are bombarded with the message that early detection is best, observed Dr. Talcott, and yes many cancers are found, but “men are at least tenfold more likely to be harmed than helped by treatment of early-stage symptomless cancer.”

Maryann Napoli, Center for Medical Consumers© March 2009

Share This Article

Hospitals Compared

Consumer Reports Provides Comparisons of Aggressive vs. Conservative Hospital Care

The “more is better” approach to American health care has been challenged consistently over the last 15 years by research compiled by two Dartmouth Medical School physicians. As reported in earlier posts, these researchers have studied the care given to Medicare patients in the last two years of life and shown that more tests, more procedures, more specialist care, more days in the hospital do not lead to a longer life or a better quality of life.

Now Consumer Reports has put the Dartmouth findings in a consumer-friendly format that will help Americans determine whether a hospital in their part of the country is likely to deliver aggressive or conservative care. Nearly 3,000 hospitals across the U.S. are included and will be available in the July 2008 issue of Consumer Reports and is freely accessible on the magazine’s Web site. It relies on data from the Medicare claims records of over 4.7 million elderly people treated from 2001 through 2005 for severe illnesses like cancer, congestive heart failure, lung diseases, dementia and coronary heart disease.

The brains behind this research are John E Wennberg, MD, and Elliott S. Fisher, MD, at the Dartmouth Medical School, who have regularly published findings in medical journals as part of a 30-year study of U.S. health care. Entitled the Dartmouth Atlas of Health Care 2008, this research project has also made its findings freely available at its own Web site (www.dartmouthatlas.org).

Contrary to what many Americans believe, aggressive care and consulting many specialists do not improve outcomes or lead to more patient satisfaction. In fact, altogether they slightly increase mortality. The Dartmouth researchers demonstrated years ago that more care often results in more procedures that are painful and unnecessary; more days in the hospital raises the chances of suffering a medication error or getting a fatal hospital-borne infection; and more specialist care leads to uncoordinated care. (Get a good primary care doctor is one of the take-home messages of the Dartmouth researchers.)

At a time when hospitals typically advertise their new high-tech equipment and friendly staff members, Consumer Reports provides an easy way for the public to see just how aggressive their care will be compared to other hospitals in their cities. (Next, we need to know the infection rate of all U.S. hospitals.) It raises a larger question for everyone to consider: Since overly aggressive care is not limited to the elderly, how can people of any age protect themselves when they become hospital patients?

Things aren’t likely to change until consumers make their wishes known and raise questions. Consumer Reports provides many excellent suggestions: Is this treatment likely to extend my life, and if so, for how long? How do its side effects and risks compare with the symptoms and risks of my disease itself? What will happen if I do not have the treatment? Will this test change the way you treat the disease? If not, what is the benefit of doing it? Is this test likely to lead to follow-up tests, biopsies, or other diagnostic procedures? How will this benefit my health?

The Consumer Reports Web site illustrates why New York University Langone Medical Center in Manhattan is #1 in the country in terms of delivering the most aggressive (and expensive) care. The Medicare cost per person in the last two years of life at this hospital was $105,067. This is compared with $44,090 at the country’s #1 hospital in terms of the most conservative care —Scott & White Memorial Hospital in Temple, Texas. (Both are chosen from a subcategory of 93 U.S. hospitals called “integrated medical centers”—that is, hospitals affiliated with medical schools.)

The average patient treated at NYU hospital in the last two years of life spent 54 days in the hospital, 12 days in the ICU, had 34 primary-care visits and 97 specialist visits. The average patient at the Hospital in Temple, Texas spent 16 days in the hospital, four days in the ICU, had 23 primary-care visits and 18 specialist visits. Yet, as Consumer Reports notes, “The Centers for Medicare and Medicaid Services rates care at Scott & White to be at least as good as that at NYU.”

The New York Times reported that the list of New York City hospitals at the Consumer Reports Web site shows a clear division in terms of aggressive care between the private and the public hospitals. As a group, the private hospitals were in the 94th percentile of aggressive care compared with the public hospitals in the 69th percentile. Although the latter is still above the national average, the difference cries out for explanation. The most obvious would be that poor people get inferior (i.e., less) care.

Dr. Eric Manheimer, who is the medical director at Bellevue (a public hospital) and on the faculty at NYU medical school, offered a unique perspective to The New York Times of someone who works for both the public and private systems. “The care at public hospitals was less aggressive because most of their doctors—he estimated 75-85%–were salaried physicians with little financial incentive to order tests or other interventions. At private hospitals, he said, supply can creates its own demand. There is often an abundance of beds and an endless list of specialists who can be called.”

Maryann Napoli, Center for Medical Consumers ©
June 2008

Overtreated—Why too much medicine is making us sicker and poorer

New Book:  Overtreated  by Shannon Brownlee (NY: Bloomsbury, 2007)

In a nutshell, overtreatment is unnecessary treatment. It’s treatment that has no positive impact on health or longevity, and in many cases, causes harm. It’s the coronary-artery opening procedures given yearly to more than one million Americans for whom drug therapy has been proven to be the better choice. It’s the long-term drug regimens recommended to people at low-risk for hip fracture, heart attack or stroke. It’s the PSA blood test for finding prostate cancer at its earliest stage, despite the fact that studies have yet to prove immediate treatment is better than no treatment at all. Just to name a few.

About one-third of the medicine we receive is unnecessary, according to “Overtreated” by journalist Shannon Brownlee. “We spend between one fifth and one third of our health care dollars, between $500 and $700 billion, on care that does nothing to improve our health.” Central to this excellent book is the work of John Wennberg, MD, whose pioneering research spans four decades.

Wennberg was the first to detect wide geographic variations in medical care, first within his home state of Vermont and later in the country at large. Wennberg recalls that he embarked on this research project in the late 1960s with a notion shared by many doctors of that era: The most serious problem in American health care was that many citizens were not getting enough of it. Still, it was startling to find, for example, that in Middlebury, VT, 7% of children under the age of 16 had their tonsils removed, and in Stowe, VT, 70% of children had the operation. Similar variations were shown for other procedures like hysterectomy, hernia operations and hospitalizations for heart attacks.

Extensive interviews of 4,000 people living in this most homogeneous of states ruled out the obvious explanations like patient demand and the possibility that people were sicker in some areas of Vermont. The high rates of surgery were, in fact, driven by doctors not patients. Findings like these ultimately led Wennberg to conclude, “Medicine had wrapped itself in the mantle of science, yet much of what doctors were doing was based more on hunches than good research.” Wennberg’s work drew hostile reactions from fellow physicians, and medical journals turned down publication of his findings. When they were finally published in Science magazine in 1973, they drew no attention. More medical care was still considered to be better care.

Cost Becomes an Issue

In time Medicare provided Wennberg, who had moved on to Dartmouth Medical School, with a treasure trove of patient records to learn not only about regional variations in care for everyone over age 65 but also the cost of treatment. Cost had become a major issue for Medicare by 1995 due to the huge 6000% increase in spending over the 30 years following its launch. With Dartmouth colleagues, Wennberg spent the next three years combing through the Medicare data. One example of what they found: Medicare spent an average of $8,414 for an enrollee living in Miami compared with $3,341 for an enrollee in Minneapolis.

The price of major treatments, as it turns out, played an insignificant role in explaining the differences. The cost of a hip replacement, for example, was only slightly more in Miami than in Minneapolis. Another obvious possibility—elderly people are sicker in some areas of the country than in others—also accounted for only a small difference in cost.

Findings like these began to get national media attention, but the Dartmouth researchers still had to determine whether more care means better care. In 2000 Wennberg’s colleague Elliott Fisher, MD, conducted another study that showed Medicare recipients living in high-cost regions were no healthier and no less disabled than those in regions that got less medical care. The big shocker, however, was this: More care sometimes led to more deaths.

Ultimately, Fisher showed that the people in high-spending regions were not getting more major surgery. Rather they were getting more tests, drugs and procedures that were likely to be done even when it didn’t make sense in frail elderly people with a short life expectancy. An excess of specialists was a major part of the problem. “Patients with heart attack, hip fracture or colon cancer got more care—but not better care—in hospitals where there were more specialists,” concluded Fisher.

Eventually Fisher determined that the 2-6% increase in deaths among Medicare recipients living in high-cost regions was due to the fact that they spent more time in the hospital. Patients are exposed to all the risks that include hospital-borne infections, medical errors and the complications and side effects that come with any treatment.

The results of the Wennberg and Fisher studies have been known for years and have long been available to all in the Dartmouth Atlas of Health Care (www.dartmouthatlas.org). The author of the new book “Overtreated,” Shannon Brownlee, a senior fellow at the New America Foundation, provides a public service by calling attention to this important research which is even more relevant today when the newest costliest imaging, cardiac and other high-tech procedures receive almost instant uncritical acceptance.

Brownlee brings us up to speed on the few surgical procedures and drugs that are well studied and proven to be of value…but to a much smaller proportion of current recipients. One outstanding example is the coronary-artery-opening procedure called angioplasty, which, by the way, was shown to have wide regional variations by West coast researchers building on the Dartmouth researchers’ work.

Each year two million Americans receive an angioplasty, but studies show that only 800,000 of them who are in the midst of a heart attack are likely to benefit. The majority have other cardiac-related conditions like stable angina or shortness of breath, which can be more safely and effectively treated with the same drugs that will be given after an angioplasty. In a 2006 federally funded trial, the rate of death and heart attack was lower in those treated with multiple-drug therapy alone than in those given angioplasty plus multiple-drug therapy. Angioplasty with a stent costs insurers $10-15,000.

While angioplasty is an example of doctors ignoring scientific evidence that clearly shows who should get this treatment and who should not, there is no definitive information one way or another about the vast majority of tests and treatments. The Institute of Medicine estimates that only 4% are backed up by strong scientific evidence, more than half have very weak evidence or none.

Malpractice fears cause doctors to order more tests, but to Brownlee the more powerful reason doctors and hospitals overtreat is they are paid more for doing more. She calls for an overhaul of malpractice laws because they fail to punish and weed out incompetent doctors and to compensate patients for injuries that result from medical errors.

Brownlee takes consumers to task for contributing to overtreatment by making irrational demands for drugs advertised on TV or over-the-top diagnostic tests like an MRI for a sprained ankle. She calls for more independent sources of information like the federal Agency for Healthcare Policy and Research so that consumers can be better informed. Studies show that when they are given high-quality decision aids describing the benefits, risks and unknowns about treatment options, many will make an informed decision not to be treated.

The last chapter called “Less is More” presents solutions that will go a long way toward fixing our dysfunctional system. The ideal medical care system Brownlee envisions is one that rewards doctors for using evidence to improve quality; keeps specialist care to a minimum; coordinates care in ways that will reduce errors and overtreatment—among other ideas. Pie in the sky? Brownlee says that several U.S. health care systems have already implemented these ideas—Kaiser Permanente, Veterans Health Administration (VHA), Group Health of Puget Sound and the Mayo Clinic where doctors are on salary.

The VHA is especially interesting because it managed to turn around a failed medical care delivery system in less than a decade. The VHA decentralized its health care; put doctors on salary; makes sure every veteran has a primary care doctor at a local VHA clinic; rewards hospitals that hit performance measures set by Washington; negotiates discounts for drugs; and computerizes patient records to reduce medical errors and repeat testing. In 2003 The New England Journal of Medicine published a study that compared veterans’ health facilities with traditional Medicare. The quality of the care delivered at VHA health facilities proved to be significantly better on nearly all 11 performance measures.

Yet-another kudo for the VHA came from the independent National Committee for Quality Assurance which ranks health-care plans according to 17 performance measures, such as prescribing beta blockers for patients after a heart attack. By every measure, the VHA system outperformed the highest rated non-VHA hospitals, including those widely perceived to be the best in the country.

If the VHA can do it….

Maryann Napoli, Center for Medical Consumers©March 2008

Failed Vytorin Study Raises Questions About Cholesterol

A firestorm of bad publicity erupted over cholesterol drugs last month when an expensive combination drug proved to be no better than an older drug alone. This finding was suppressed for 20 months by Merck and Schering-Plough, the two companies that make Vytorin, which is a one-pill combination of Zetia and Zocor. Their two-year trial failed to prove that Vytorin is better than Zocor alone for slowing plaque accumulation; instead atherosclerosis worsened in those taking Vytorin.

But the study results were not revealed until the two drug companies were pressured into doing so by an article in The New York Times and a Congressional inquiry. Worldwide, about one million prescriptions for Vytorin and Zetia are written each week, and they generated about $5 billion in sales last year. Zocor can be purchased under its generic name simvastatin for less than $6 for a month’s supply; whereas an equivalent amount of Vytorin costs about $100. It was obviously in the two companies’ interest to withhold the negative results for as long as they could get away with it.

When Vytorin came on the market two years ago, it was impossible not to be cynical about its purpose. Merck’s patent for Zocor was running out, and its blockbuster status would soon be diminished with generic competition. The company joined forces with Schering-Plough, maker of Zetia, and sought FDA approval for Vytorin. Their FDA-required trials showed a 17% greater reduction in LDL, the so-called bad cholesterol, than Zocor alone.

Making this 17% reduction in LDL look like an amazing achievement was not much of a stretch. Merck and the makers of other statin drugs like Lipitor and Pravachol had already paved the way. Their respective marketing machines had long ago misled most of us (doctors included) into thinking that cholesterol reductions equal heart attack reductions. One consistently overlooked fact about statins: They are far better at lowering cholesterol than preventing heart attacks or strokes. And those small reductions in heart attacks and strokes shown in clinical trials are largely confined to high-risk middle-aged men and those with heart disease or diabetes. Vytorin, on the other hand, has not been proven to reduce heart attacks or strokes in anyone.

LDL Reduction Irrelevant

Though doctors tend to focus their statin-taking patients on the size of their LDL reductions, heart disease researchers have long ago noted that this is likely irrelevant. Statin trials often show that the size of the cholesterol reductions are not consistent with reductions in heart attacks. Such observations led researchers to suspect that the ability of statins to reduce heart attacks and strokes has less to do with cholesterol reduction and more to do with other biological effects like plaque stability and anti-inflammatory effects. Another important but overlooked observation: “Elevated LDL identify less than one half of individuals who will die from coronary heart disease” (Rosenson et al. Antithrombotic Properties of Statins, JAMA, May 27, 1998).

The fall-out from the Vytorin debacle continues to reverberate. At this writing, Merck and Schering-Plough are running full-page ads daily in the Times and Wall Street Journal, warning people not to be confused by a single study and to continue taking Vytorin. The advice was backed by the American Heart Association, which appeared to be an independent source until The Times reported that the AHA receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals.

One of the unintended consequences of two drug companies withholding their negative trial results is that it led some in the media, notably Alex Berenson, an investigative reporter for the Times, to look back at another important failed cholesterol drug trial and question the very foundation of heart disease prevention. In his heretically titled article “Cholesterol as a Danger Has Skeptics,” Berenson cites Pfizer’s trial of its much-anticipated drug torcetrapib that raised HDL, the good cholesterol, and lowered LDL. The trial had to be stopped in 2006 because the drug caused heart attacks and strokes. (Sound familiar? Postmenopausal hormones were widely prescribed because they were so good at improving cholesterol levels but they also increased the risk of heart attack, stroke and blood clots.) “Torcetrapib’s failure shows that lowering cholesterol does not prove a drug will benefit patients,” said a skeptical Walter Reed cardiologist quoted in Berenson’s article.

Many researchers, physicians and scientists around the world have long questioned the import of high cholesterol for anyone other than middle-aged men. In fact there is an International Network of Cholesterol Skeptics (disclosure: we belong), but the skeptics have been marginalized over the years. Now some mainstream media like Business Week and the cardiology Web site, TheHeart.org are willing to give them voice.

Could the house of cards be falling? Would the house of cards be allowed to fall when a worldwide $40 billion-a-year industry is at stake?

For More Information

The International Network of Cholesterol Skeptics www.thincs.org

Business Week magazine (www.businessweek.com) click into past issues, January 17, 2008 Lipitor cover story: “Do Cholesterol Drugs do any Good?”

TheHeart.org from Web MD www.theheart.org, see video blog of Eric J. Topol, MD, who questions the import of LDL reduction in “Temple of the LDL Cholesterol.”

Maryann Napoli, Center for Medical Consumers ©
February 2008

Screening for Prostate Cancer: The More They Test, The More They Find

It’s a controversy that has been roiling among research physicians for two decades: Does the prostate-specific antigen, or PSA, blood test for prostate cancer cause more harm than good? Does the early detection of prostate cancer—that is, before symptoms appear—actually save lives? These questions still haven’t been answered, though many physicians automatically test their middle-aged and elderly male patients as if they have.

A new study conducted in Europe was initiated to see whether PSA screening symptom-free men every two years has any advantage over screening at four-year intervals. The short answer is no, but this study, published in the September 5 issue of the Journal of the National Cancer Institute, suggests that the PSA test is more likely to find non-life threatening cancers without reducing the number of advanced and potentially lethal cancers.

Monique J. Roobol, PhD, and colleagues at medical centers in Holland and Sweden based their findings on data from a large trial called the European Randomized Study of Screening for Prostate Cancer. Initiated in 1993, this trial will answer the question of whether early detection of prostate cancer reduces mortality from this disease.

The reason that this trial and its American equivalent, the Prostate, Lung, Colorectal and Ovarian Cancer trial ongoing since 1992, will take so long to provide answers is the fact that most prostate cancers found on the basis of PSA screening are either non-progressive or so slow-growing that they will never become life threatening or symptomatic. A minority of the prostate cancers diagnosed during the course of this trial will be the deadly aggressive version, and it is unclear whether early detection and prompt treatment of these fast-growing cancers will result in prolonged lives. About 17% of U.S. men contract prostate cancer and 3% of them will die of the disease.

Context Needed

Any discussion of the new study about screening intervals requires some background information on prostate cancer itself. Pathologists have long known that many of the cancers that show up in the prostate will never become lethal had they remained undetected for a lifetime. Autopsy studies of men who died in accidents show that the older they are, the more likely they will have cancer in the prostate.

That’s why the measure of a screening test’s value is not how many cancers it can find; instead it is a reduction in prostate cancer deaths. But that’s not all. Harm must also be taken into account. The detection of prostate cancers that would never progress or become lethal clearly results in a high rate of biopsies and unnecessary treatment. The latter—irradiation or surgical removal of the prostate—is associated with an increased risk of urinary incontinence, bowel dysfunction and impotence.

The diagnosis of new cases of prostate cancer increased substantially in all countries after PSA screening was introduced. In the U.S., for example, PSA screening began in the late 1980s. But contrary to expectations, the prostate cancer death rate has decreased only modestly. And it is not known whether the drop in prostate cancer mortality is due to early detection or improvements in treatment, or both. Such uncertainties can be resolved by a long-term clinical trial that randomly assigns men to be screened (with a PSA test and a digital rectal examination) or not. This describes the European and the American ongoing trials.

“Interval Cancers” Studied

The new study by Roobol and colleagues takes on yet-another unanswered question about prostate cancer screening: What is the appropriate interval for screening? In the U.S. trial, men are usually screened annually.

Not so in Europe. Some medical centers participating in the European trial screen participants every four years, and others screen every two years. This difference in intervals provided the opportunity for Roobol and colleagues to see whether one has any advantage over the other. Of particular interest was the number of prostate cancers detected in men between screening tests. These are what researchers call “interval cancers.” And they are worrisome because they are likely to be the potentially fatal, advanced cancers. A reduction in their detection would be a good sign that screening might eventually reduce the number of prostate cancer deaths.

Roobol and colleagues found that, after 10 years, more cancers were diagnosed in the men (12%) screened at the shorter (two-year) intervals than in the men (8%) screened at longer (four-year) intervals. Contrary to expectations, the number of potentially life-threatening prostate cancers was the same in both groups. The downside of too frequent screening is overdiagnosis, i.e., the increased detection of cancers that do not progress, resulting in more unnecessary biopsies and treatments.

Asked by e-mail for the bottom line message from her study, Dr. Roobol wrote, “Screening should not be done at fixed intervals but through a more personal approach. Men with very low PSA levels (<1.0 ng/ml) can, depending on their age, be screened at much longer intervals. Screening every year for me looks [like] too much for the majority of men in the age group 55 or higher.”

E. David Crawford, MD, University of Colorado Health Sciences Center, author of the editorial that accompanied this study, had this observation: “Although many of us believe that early detection is saving lives, definitive evidence is lacking.”

This uncertainty is reflected in the treatment options listed for all stages of prostate cancer on the National Cancer Institute Web site (www.cancer.gov). Whether prostate cancer is diagnosed at stage I (early) or stage IV (advanced)—no treatment is as reasonable a choice as having the prostate surgically removed or irradiated.

That raises the obvious question: Why test symptomless men when—once cancer is found—no treatment is a valid option? We still don’t know whether the man whose cancer was detected after symptoms appeared is any worse off than the symptom-less man whose cancer was detected with a screening PSA test.

More Needle Biopsies, More Prostate Cancers Detected

“Despite the considerable attention given to the prostate-specific antigen (PSA) as a screening test for prostate cancer, it is needle biopsy—and the PSA test result—that actually establishes the diagnosis of prostate cancer.”

With that as background, H. Gilbert Welch and colleagues at Dartmouth and other Medical Centers studied Medicare claims to determine the proportion of men, aged 65 years and older, who have prostate cancer after a needle biopsy (removal of prostatic tissue by inserting a thin needle through the rectum and into several sections of the prostate). Their study was published in the September 19 issue of the Journal of the National Cancer Institute

The researchers found: Over 10,000 needle biopsies were performed in 1993 through 2001 in 8,273 men, age 65 and older. The overall proportion of needle biopsies found to contain cancer was 32%, and it increased with age—35% for men in their late 70s and 41% for men over age 80.

The risk of finding prostate cancer increased with repeat biopsies in those initially found to be cancer-free, with 50% of the men diagnosed with prostate cancer after two biopsies, 62% after three biopsies and 68% after four biopsies.

The odds of finding cancer go up not only with the age of the man undergoing a needle biopsy but also the number of tissue samples taken. Over the years, the needle biopsy has become more and more aggressive. Initially, needle biopsies consisted of jabs for prostate tissue in six different sites. Now many urologists advocate 12 or more and some even advocate “saturation biopsy,” which involves 32 to 38 jabs, say Welch and colleagues, “the more biopsies taken, the more cancer is found.” The incidence of biopsy-induced infection was not recorded in this study.

Maryann Napoli, Center for Medical Consumers ©
November 2007

Restless Legs Syndrome: Two Heavily Promoted Drugs

Very likely you never heard of restless leg syndrome (RLS) before 2003. That’s when Glaxo-SmithKline launched a media campaign to promote awareness of this condition that the company described as “underdiagnosed.” Not incidentally, two years later Glaxo’s drug Requip received FDA approval for the treatment of RLS. The drug was already on the market as a treatment for Parkinson’s disease.

Within a year of its RLS approval, Requip was on track to post sales of $500 million, making it one of the fastest-growing drugs in Glaxo’s portfolio, according to the Wall Street Journal. Predictably, another company Boehringer Ingelheim got in on the action with its Parkinson’s drug, Mirapex.

Though RLS invites the usual suspicions that this is yet another illness made up by drug companies intent on expanding their markets, it appears to be real. For some people it can be disabling enough to interfere with sleep on a regular basis. But it is also likely, thanks to Glaxo’s ongoing promotional campaign with its ads aimed at doctors and the general public, that RLS is now overdiagnosed. And many people may be taking a serious drug indefinitely for a minor annoyance that could be treated non-pharmacologically or not at all.

How do you know you have it? These four criteria must be met for a diagnosis of RLS:

• An urge to move the legs due to an unpleasant feeling in the legs;
• Onset or worsening of symptoms when at rest or not moving around frequently;
• Partial or complete relief by movement (e.g., walking) for as long as the movement continues;
• Symptoms that occur primarily at night and that can interfere with sleep or rest.

Several things to keep in mind if you are taking Requip or Mirapex:

• According to company-sponsored trials, about 70% of the people on Mirapex or Requip reported a reduction in symptoms; so did more than 50% of those on placebo.
• These FDA required pre-approval trials lasted only 3 to 36 weeks; therefore the safety and effectiveness of taking a RLS drug longer is unknown.
• The precise mechanism of action of Requip and Mirapex as a treatment for RLS is unknown, according to company-generated label information.
• Because the FDA-required pre-approval studies have a relatively small number of participants and are short-term, information about a drug’s serious adverse effects usually comes out years after it comes on the market (if at all). Here is what is known to date: Both drugs can cause some people to fall asleep during everyday activities like driving, eating or talking to someone.

Have all non-pharmacological alternatives been explored?

• Try doing without any drug that can precipitate RLS, such as antihistamines, caffeine, alcohol, nicotine, as well as numerous prescription drugs, including antidepressants, anti-nausea, neuroleptics (e.g., antipsychotic drugs, major tranquilizers).
• Engage in moderate exercise, for example, a brief walk before bedtime. Avoid unusual and excessive exercise, which may precipitate RLS.

Maryann Napoli, Center for Medical Consumers ©
September 2007