We Have Comparative Effectiveness Research—Now It’s Time to Use It

Maggie Mahar and Niko Karvounis

Last week the New York Times published a story about one of the biggest medical trials ever organized by the federal government,  a study that showed that the newest, most expensive drugs used to treat high blood pressure (a.k.a. hypertension) work no better than inexpensive diuretics—water pills that flush excess fluid and salt from the body. Moreover, the research revealed that the pricier drugs increase the risk of heart failure and stroke. 

The trial was completed in 2002. Why is the story running now? Because six years later, the findings still have had little impact on what doctors prescribe for patients suffering from hypertension.

Allhat –which stands for the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial—demonstrated that when, it comes to preventing heart attacks, the diuretics—which have been used since the 1950s and cost only pennies a day—is just as effective as newer calcium channel blockers and ACE inhibitors that cost up to 20 times as  much.

And the diuretic is safer. Patients receiving Pfizer’s calcium channel blocker (Norvasc) had a 38 percent greater chance of heart failure than those on the diuretic. And those receiving AstraZeneca’s ACE inhibitor were exposed to a 15 percent higher risk of strokes and a 19 percent higher risk of heart failure.
Meanwhile, NYT reporter Andrew Pollack noted, the diuretics cost only about $25 a year, compared with $250 for an ACE inhibitor and $500 for a calcium channel blocker.

In a rational world, the results “should have more than doubled” use of the less expensive drugs, says Dr. Curt D. Furberg, a public health sciences professor at Wake Forest University and the former head of the Allhat steering committee.

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Maybe the Jig Is Up

Yesterday Reuters reported that, in comments at a Financial Times conference in London, a top executive at Roche Pharmaceuticals condemned direct-to-consumer advertising as a disaster. “Direct-to-consumer promotion [of drugs] was the single worst decision for the industry," said William Burns, Roche’s head of pharmaceuticals, to conference attendees. "When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility,” he continued.

Burns’ despondency is understandable: if ever there was a time that the prescription drug industry needed credibility, it’s now. For the first time in recent memory, drug companies are facing the prospects of an end to their free ride of unregulated profiteering. There are already rumblings that both the Obama Administration and the Democratic Congress want to stack up a series of clean legislative victories by going for “low-hanging fruit”—bipartisan, popular initiatives that will pass easily—and there are few juicier targets than Big Pharma. 


A few days ago, The Chicago Tribune reported that President Obama will likely push for “cheaper copies of expensive drugs derived from biotechnology,” will let Medicare “negotiate drug prices directly with drug companies,” and will try to make “it legal for pharmaceuticals to be imported into the U.S.” In other words, Obama wants to make drugs cheaper for patients, and thus impact drug companies’ bottom line. According to David Dranove, professor of health industry management for Northwestern University's Kellogg School of Management, these changes have been “hanging there [in Congress] for some time and will be easy sells and easy to get through."

For its part, the industry knows that it’s got a big, fat target on its back. During the presidential election, drug companies were torn over which candidate to support, mostly because they couldn’t decide who hated them less. Even John McCain boasted—not untruthfully—that he repeatedly “took on the drug industry” over the course of his career.

The comparable distastefulness of both candidates led to a development that hasn’t happened in almost twenty years: the prescription drug industry gave to the Democratic and the Republican presidential candidate in almost equal amounts (usually pharma goes for the GOP). “Both [Obama and McCain] blame big drug companies for high prices and reduced innovation,” sighed one industry insider. “In either case, we should expect more price negotiation and re-importation [of drugs].” Translation: the honeymoon is over. 

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Obesity-Part 3; Health Is About More Than Conforming to the Cultural Norm

Whatever happened to the characters in the PBS documentary, “Fat: What No One Is Telling You,” that I wrote about here and here?

By the end of the film, the 300-pound 18-year-old who I described in part 1 had his bariatric surgery and, to his delight, lost 147 pounds. “I’m a whole human less in weight,” he exulted.   Indeed, he had lost the equivalent of his skinny twin’s total weight. (It’s worth noting that this surgery is recommended only as a last resort. And even then, a patient should make sure that his physician is an experienced bariatric surgeon who has performed many operations. The risks are real—and harrowing. Nevertheless, for this young man, the procedure was a huge success.)

What about the former tomboy who gained 125 pounds after becoming an executive at Microsoft? Humiliated when she spilled out of her airplane seat—and onto her fellow passengers—and frustrated that she could no longer participate in the sports she loved, she became even more depressed when she had difficulty getting pregnant.  

That’s when she and her over-sized husband signed up for a comprehensive program that includes doctors, nutritionists, and trainers.

They also purchased health cook books, determined to learn how to cook foods that had been foreign to their diet—such as chicken.

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Censorship, the Media and the Blogosphere

I recently attended a conference where bloggers and print journalists talked about the pros and cons of their respective professions

I noted that as a blogger, I am never censored. As a print journalist I was told, on more than one occasion; “Maggie, you can’t say that!” (even though I had evidence to back up my facts.)  Usually, the editor was concerned that I would “scare the readers” or upset the publisher (and advertisers). 

Of course, the downside to not having an editor is that I’m working without a net. If I get something wrong, no one has my back. On the other hand, my readers are knowledgeable, and are likely to question anything that looks peculiar. I count on you to do that, and at the same time, know that if I make serious errors—or too many small mistakes—I would lose my credibility.

But not all bloggers have alert readers. And because of the lack of editing,   the blogosphere is clogged with posts that are silly, just plain nasty, and, all too often, simply not true.

Nevertheless, I think that the best blogs manage to keep the level of public discourse high, while enjoying first amendment freedoms that are difficult to achieve in mediums supported by advertising and owned by corporations.

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What Does Health Care “Reform” Mean? How Quickly Can We Get There? LBJ’s Example (Part 1)

Forces calling for Healthcare Reform Now are gaining momentum. I share their sense of urgency—assuming that they are talking about the “reforms” needed to create an effective, affordable, patient-centered health care system.  But if they simply mean “universal coverage,” I have to disagree.

Giving every American a piece of paper labeled “health insurance” will bail out a health insurance industry desperate for customers. And it will help drug-makers, device-makers, and medical-equipment makers.  But it will not solve patients’ problems.  What Americans need is not health insurance, but rather effective health care.

A stunner of a story in yesterday’s Washington Post makes it clear that today we are pouring money into a health care system that does more for the health care industry than it does for patients.

“We're not getting what we pay for," Denis Cortese, president and chief executive of the Mayo Clinic, told the Post’s Ceci Connolly. "It's just that simple."

"Our health-care system is fraught with waste," added Gary Kaplan, chairman of Seattle's cutting-edge Virginia Mason Medical Center. According to Kaplan: “As much as half of the $2.3 trillion spent today does nothing to improve health.” 

“Not only is American health care inefficient and wasteful,” declared Kaiser Permanente chief executive George Halvorson, “much of it is dangerous.” 

This is a startling indictment, and one that health care reformers should heed.

“There is a broad consensus on what should be done,” writes Connolly, a health care journalist who knows her subject well. The system needs structural reforms which include  “realigning financial incentives, coordinating care, researching what treatments work best…and most daunting but perhaps most important, saying no to expensive, unproven therapies.”

Therapies that have not been fully tested harm tens of thousands of Americans each year. Consider this: 10 percent of all drugs approved by the FDA from 1975 to 1999 were later withdrawn from the market or “black-labeled” to warn of risks.

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Heart Attacks, Strokes and Breast Cancer–The Good News (Part 1)

Assume that you are a 40-year-old man. What do you think the chances are that you will die of a heart attack or stroke in the next 10 years? (Please forgive the morbidity of the question; there is a purpose to this pop-quiz.)  The answer: just 4 out of 10,000 according to Drs. Steve Woloshin and Lisa Schwartz, authors of Know Your Chances. The odds that you will die in an accident before reaching your 50th birthday are 50 percent higher: 6 out of 10,000. 

Nevertheless, many men remain convinced that they are at great risk of dying from vascular disease, particularly as they get older. In truth, even at age 60, the odds that a heart attack or stroke will end your life over the next decade are only 37 out of 10,000.  Over that span, you are three times as likely to die of another cause—with the chance of a fatal accident (5 out of 10,000 ) just as high as the chance of a stroke.

Moreover, for reasons we do not fully understand, the incidence of heart attacks is declining. “Fifty hears ago, heart attacks were a scourge. Everyone knew a working-age man who’d dropped dead from one,” writes Dr. Nortin Hadler in his new book, Worried Sick. Today “the decline in mortality from coronary artery disease is well documented.”

There is one exception:  If you are a 60-year-old smoker, the chance of a fatal heart attack or stroke in the next ten years climbs to 67 out of 10,000, and your chance of dying of lung disease rises to 59 out of 10,000.

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Inside the Imaging Boom

Much of the newest issue of Health Affairs is dedicated to putting hard numbers to the rapid proliferation and over-use of diagnostic imaging technology like computed topography (CT) and magnetic resonance imaging (MRI) scans. This research warrants special attention:  quantifying the “imaging boom” provides an important contribution to understanding  America’s health care woes.

The Scope of Growth

The lead article from Health Affairs comes from Laurence Baker and Scott Atlas at Stanford and Christopher Afendulis at Harvard. The research team notes the explosion of imaging machines in recent years, estimating that “the number of CT units [in the United States] grew more than 50 percent between 1995 and 2004” and that “the estimated number of MRI units more than doubled.” As this technology has become more widely available, it’s been used more often: the number of MRI procedures per 1,000 Medicare beneficiaries increased from 0.3 in 1985 to 173 in 2004. Use of CT scans more than doubled from 235 per 1,000 in 1995 to 547 per 1,000 in 2005. Baker et al. crunch the numbers to find that, over the years, each new MRI unit on the market led to 733 additional MRI procedures, adding $550,000 to Medicare spending annually. Each new CT unit on the market prompted 2,224 additional CT scans and tacked on $685,000 to the yearly Medicare bill.

These are striking numbers, and the shock persists when you put diagnostic imaging in the context of other medical services. In another Health Affairs study, Ariel Winter and Nancy Ray from the Medicare Payment Advisory Commission (MedPAC) note that between 2000 and 2005, the volume of services per Medicare beneficiary grew by 31 percent (in other words, the average Medicare patient in 2005 received 31 percent more care than she did in 2000). In contrast, the volume of diagnostic imaging (including MRI and CT scans, x-rays, and ultrasound) grew by 61 percent—twice as fast as broader physician services. More services means more payments, and this increase has been coupled with a doubling of Medicare spending on imaging services, from $6.4 billion in 2000 to $12.3 billion in 2006.

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The Personal Side of Medicine

Below, a story and a poem from Pulse, a very special online magazine that uses stories and poems from patients and health care professionals to talk honestly about giving and receiving care.

Pulse was launched by the Department of Family and Social Medicine at Albert Einstein College of Medicine/Montefiore Medical Center in the Bronx, New York, with help from colleagues and friends around the state and around the country. The magazine’s contributors are doctors, nurses, psychologists, social workers, patients, students, editors and writers.

I count its editor-in-chief, Dr. Paul Gross, as a friend. Here Paul describes how Pulse was born:

“While leafing through a medical journal some years ago, it struck me that the scientific studies that filled its pages bore only a slight resemblance to my experience of the practice of medicine. For one thing, the patients in the studies seemed to enjoy swallowing pills. They remembered to take them and didn’t seem to mind their accompanying side effects…

“For another, the studies assumed that the pills were readily available—and affordable…

“These journals had glossy images of smiling patients who were now leading active lives thanks to antidepressants or anti-inflammatory agents. My experience with these same pills was a little different: many didn’t work nearly as well as advertised…

“The health center where I worked at the time wasn’t making things easier for patients, who complained about doctors (myself included) who made them wait and telephones that rang and rang unanswered.

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The Front Lines of Primary Care, Part 2

In my previous post, I discussed how the realities of primary care—the “hamster wheel” of 15-minute visits with sometimes-difficult patients suffering from complex, chronic conditions—can burn out idealistic primary care physicians (PCPs). Increasingly, disillusioned PCPs are leaving the field. A recent survey from the Physicians’ Foundation reports that one-half of PCPs would leave medicine if they thought they could do so. 


Well-intentioned doctors choose primary care because they love the idea of working closely with patients and building lasting relationships over time. But the low reimbursement rates force them to see as many patients as possible in a given day, and the frantic pace of their work often de-humanizes their practice. They are pushed to practice “assembly line” medicine.  Understandably unhappy with this state of affairs, many think to themselves, “this is not why I wanted to become a doctor.”

Ideally, as Thomas Lee, an associate editor of the New England Journal of Medicine, recently put it, PCPs should go home every night thinking “this is what I was meant to do.” This seems like a high bar to reach, but we’d be a lot closer to it if our system recognized one simple fact: no physician is an island.

The Importance of Teamwork

Primary care can’t be a one-man (or a one-woman) show. There’s simply too much to do. In a recent commentary for the New England Journal of Medicine¸ Dr. Thomas Bodenheimer of the University of California-San Francisco notes that “it would  take a primary care physician 18 hours per day to provide all recommended preventive and chronic care services to a typical” cohort of patients.

Making the time-crunch even worse is the fact that PCPs often take on duties that have little to do with the actual practice of medicine. In a recent comment over at Theresa Chan’s Rural Doctoring blog, a PCP named “Doctor Jen” describes the diversity of responsibilities that she faces over the course of a day. “Today,” she begins, “I saw a young woman who brought a list with 17 issues to be addressed…I also saw a newly diagnosed cirrhotic gentleman who is really struggling emotionally with his diagnosis, an 88 yr old lovely woman who needed medical clearance to take a driver's test, and a poorly controlled bipolar client who can't get a psych appt for 3 [months] because he's not suicidal.”


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“Fat” – Part 2 Understanding Obesity – Reasons for Hope

“Fat prejudice is the primary impediment to understanding—or wanting to understand what obesity is all about,” says a public health nurse who appears in “Fat: What No One Is Telling You,” a 2007 PBS home video documentary.

In the first installment of this post, I explained how little physicians know about what causes obesity—in part because, as this nurse points out, “blaming the victim has stood in the way of understanding.” Here, I am reminded of how, in the past, we blamed patients suffering from depression and other forms of mental illness. For centuries, this prejudice stood in the way of understanding that mood disorders are caused by a flaw in chemistry, not character

In “Fat,” patients describe how even some doctors treat them with contempt. “When I went to get a Pap smear, the doctor said, ‘You’re too fat; come back when you’ve lost weight,’” one woman recalls. 
The documentary also points out that “while everyone dies . . . it should perhaps come as no surprise that in our society, obese people are blamed for dying. If a thin patient comes into the hospital, has a heart attack, and dies, cause of death is labeled ‘heart disease’, a public health nurse who appears in the film tells the filmmakers. “If an obese patient has a heart attack and dies, cause of death is ‘obesity’.”

Nevertheless, despite the bias, today scientists have begun to look past the old-fashioned notion that obesity is merely a matter of gluttony, and have made real progress in beginning to understand a terribly complicated chronic disease.

Granted, obesity doesn’t look like “a subtle disease,” acknowledges Harvard’s Dr. Lee Kaplan, who heads the Weight Reduction Program at Mass General Hospital. Conventional wisdom says that if you put too much food in your mouth, and don’t exercise enough, you’ll wind up fat. Period.

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