Recently in Evidence-based medicine Category

There's a section not to be missed in Christopher Snowbeck's piece, "Medtronic stock jolts upward after strong quarter," in the St. Paul Pioneer Press. That section stated:

"Medtronic officials said they were disappointed by second-quarter sales of devices used to provide a spine treatment called kyphoplasty.


Medtronic spent $3.9 billion in 2007 to acquire a California company that manufactured products used in the procedure. But doctors' perceptions of the technology apparently were hurt by articles this summer in the New England Journal of Medicine that questioned the effectiveness of a similar treatment called vertebroplasty.

"We were negatively impacted by the recent vertebroplasty articles," Hawkins said during the conference call. "While our customers understand the value of (kyphoplasty) ... the negative vertebroplasty news impacted the perception of referring physicians." "

"Negative vertebroplasty news" indeed. Let's be clear: two separate studies in the New England Journal of Medicine reported there was no difference up to six months later for patients who actually had vetebroplasty and those who had a fake or placebo treatment instead. No better than fake.

At the time those studies were published, a physician friend wrote me this:

"The cynical view is that next week's segment will highlight why kyphoplasty (an alternative procedure for pretty much the same condition) is so much better than vertebroplasty and the segment will be based upon little or no evidence but rather a happy patient and "expert" doctor who attests to the great results of this new (and costly) technology."

And what difference does it make if - after all is said and done and the studies are in - a device manufacturer's customers understand the value of kyphoplasty?

Another Washington Post column that misleads readers on mammography

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I would ignore this except that it's in the Washington Post and despite the fact that they're closing bureaus in Chicago, Los Angeles and New York, what's in what remains of the paper is still influential.

So I feel compelled to address Dana Milbank's column in the Post about the US Preventive Services Task Force breast cancer screening recommendations.

He characterized the USPSTF recommendations as a "cruel and clumsy blow" that "wiped out much of the progress" in breast cancer detection.

Huh?

It got worse, as he wrote:.

"With a drumbeat of recommendations raising doubts about various cancer screenings, the public could easily get the mistaken impression that all cancer screening is a waste of time and money."

Stop the foolishness.

The USPSTF said nothing about any cancer screening being a waste of time and money. In fact, it recommends biennial screening mammography for women aged 50 to 74 years. It recommended against routine screening mammography in women aged 40 to 49 years, stating "The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms."

How "cruel" to try to ensure that women are fully informed about benefits and harms, and to state that this should be an individual decision based on individual values.

If the public can get the impression that all cancer screening is a waste of time and money from those statements, then Milbank might better spend his time educating the public on how to read.

It got worse. Much worse. As he continued:

"Luckily, Congress has a simpler solution at hand: It can abolish the task force and turn it into a group that is more accountable to the public. Under the House version of health-care legislation, the task force, whose members need not subject themselves or their opinions to public comment or public hearings, would be reorganized as a federal advisory committee subject to oversight. Their scientific judgments would stay independent, but the group would no longer be able to go rogue with surprise recommendations."

Oh, that would be a grand idea. Make science accountable to the public? Let's make science ignore the evidence and tell us fairy tales that we want to hear. That everything is terrific, risk-free and without a price tag? And let's make the independent task force subject to federal government oversight. Then we can make science ignore the evidence and only spew out what is politically popular at the moment.

Milbank believes his ideas mean that the task force would no longer be able to "go rogue with surprise recommendations." Read your own paper, Dana.

Dan Eggen and Rob Stein reported that "The findings underscore a decades-long debate in the medical community about the benefits and risks of routine breast cancer screening for younger women." So this is not "rogue" and not "surprising" to anyone who has made any attempt to follow the issue.

Why did he choose to give only Nancy Brinker's side of the story? His own paper reported this praise for the USPSTF recommendations:

"It's about time," said Fran Visco, president of the National Breast Cancer Coalition, a Washington-based patient advocacy group. "Women deserve the truth -- and the truth is the evidence says this is not always helpful and can be harmful."

But it's really sick when a columnist suggests that task force members be sent to Gitmo and that they be sent "to the Death Panel for a humane end."

If he thought this was humorous, it wasn't. If he thought his column clarified anything, it didn't. Confusion and rhetoric will reign as long as we continue to get one-sided, vacuous, inaccurate columns like this. If, indeed, anyone is reading it.

The American College of Physicians - the largest medical specialty organization and the second-largest physician group in the United States - has issued this statement:

The U.S. Preventive Services Task Force (USPSTF) recommendations on mammography, which were published in ACP's flagship journal, the Annals of Internal Medicine, have regrettably been used by some critics of the health reform bills being considered by Congress to make baseless charges that the bills would lead to rationing of care. Other critics have made unfair and unsubstantiated attacks on the expertise, motivations, and independence of the scientists and clinician experts on the USPSTF.

ACP believes that it is essential that clinicians and patients be able to make their own decisions on diagnosis and treatment informed by the best available scientific evidence on the effectiveness of different treatments and diagnostic interventions. The USPSTF is a highly regarded, credible and independent group of experts that performs this role, on a purely advisory basis, to the Department of Health and Human Services, as it relates to interventions to prevent or detect diseases. As is often the case with evidence-based reviews, the USPTF's recommendations will not always be consistent with the guidelines established by other experts in the field, by professional medical societies, and by patient advocacy groups. Such differences of opinion, expressed in a constructive and transparent manner so that patients and their clinicians can make their own best judgment, are important and welcome. It is not constructive to make ill-founded attacks on the integrity, credibility, motivations, and expertise of the clinicians and scientists on the USPSTF.

Some critics have erroneously charged that the USPSTF's recommendations were motivated by a desire to control costs. According to the Agency for Health Care Research and Quality, "the USPSTF does not consider economic costs in making recommendations." The Agency continues, "it realizes that these costs are important in the decision to implement preventive services. Thus, in situations where there is likely to be some effectiveness of the service, the Task Force searches for evidence of the costs and cost-effectiveness of implementation, presenting this information separately from its recommendation" and the "recommendations are not modified to accommodate concerns about insurance coverage of preventive services, medicolegal liability, or legislation, but users of the recommendations may need to do so." [emphasis added in bold]

Under the bills being considered by Congress, the USPSTF will have an important role in making evidence-based recommendations on preventive services that insurers will be required to cover, but the bills do not give the Task Force -- or the federal government itself -- any authority to put limitations on coverage, ration care, or require that insurers deny coverage. Specifically, the House and Senate bills would require health plans to cover preventive services based in large part on the evidence-based reviews by the USPSTF, but no limits are placed on health plans' ability to offer additional preventive benefits, or in considering advice from sources other than the USPSTF in making such coverage determinations. Accordingly, patients will benefit by having a floor - not a limit - on essential preventive services that would be covered by all health insurers, usually with no out-of-pocket cost to them. Patients will also benefit from having independent research on the comparative effectiveness of different treatments, as proposed in the bills before Congress. The bills specifically prohibit use of comparative effectiveness research to limit coverage or deny care based on cost.

The controversy over the mammography guidelines illustrates the importance of communicating information on evidence-based reviews to the public in a way that facilitates an understanding of how such reviews are conducted and how they are intended to support, not supplant, individual decision-making by patients and their clinicians.

ACP urges Congress, the administration, and patient and physician advocacy groups to respect and support the importance of protecting evidence-based research by respected scientists and clinicians from being used to score political points that do not serve the public's interest.

Rochester freelancer criticizes Mayo stance on mammography

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Paul Scott has an opinion piece in the Rochester Post-Bulletin in which he criticizes what he calls the Mayo Clinic's "vague and surprisingly unprepared" response to the US Preventive Services Task Force's mammography recommendations.

"Taking unspecified issue with "the modeling data used in the analysis," it stated "a substantial number of women who receive biopsies because of a screening mammogram are found to have cancer." Mayo's Dr. Sandhya Pruthi added "there are many stories about younger women who have found cancer early as a result of screening."


I'm not sure why she made mention of stories. Dr. Pruthi is surely a talented clinician, but in supporting mammograms for women in their 40s here she is citing anecdotes, not data. It would have been better for her to acknowledge that when it comes to population-wide recommendations about screening and illness, medicine always eventually draws a line in the sand somewhere. People invariably will fall on either side of that line wrongly, but if we don't draw a line somewhere, you have to screen everybody for everything, and screening sets in motion the potential for new harms."

It seems that anyone who opposes the USPSTF recommendations trots out personal anecdotes to bolster their argument. Scott countered and concluded with an anecdote of his own:

"I would like nothing more than for our society to prevent the incidence of breast cancer. It took the life of my mom, who identified a tumor on her own at 37, was treated surgically at Mayo in the mid 1970s, and who then lived another 26 years. But my mom believed in science, and in trusting science, and in this case, the science says what it says. I hope that Mayo can do the same, even when doing so runs against that which is popular."

The first online comment posted in response to Scott's opinion piece stated that "there isn't one single oncologist on the US Preventive Services Task Force." I've heard that curious argument before. Evidence is evidence - regardless of whether you're a primary care doc, an oncologist, an epidemiologist, an ob-gyn or a breast surgeon. Evidence-based medicine should be guided by the best evidence, not by the personal experiences or preferences of any specialty group.

People should have known more about USPSTF all along

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For a long time, I've urged health care journalists to refer to the recommendations of the US Preventive Services Task Force and to educate readers/viewers about how the group operates.

Perhaps one of the reasons the task force's recommendations this week caught so many people by surprise is that journalism hasn't done a good enough job of:

• explaining the uncertainties that still exist and always have existed about mammography
• explaining the work of the USPSTF

Gina Kolata of the NYT offers somewhat of a backgrounder/explainer today.

All of their work - how they do it - what they base their recommendations on -who they are - is available online - and has been.

Since they're an independent group of experts from across the country, they have no PR machine like the American Cancer Society does. So it's easy for the ACS to rule the airwaves and the columns when they disagree with something the USPSTF states.

But I think journalists have failed badly in explaining this work. And the harm done to evidence-based medicine this week may be lasting.

Truth squad needed on breast screening quotes

In the stories reported by major news organizations all across the US, there have been countless quotes that make wild, unsubstantiated charges about the motivation behind the US Preventive Services Task Force's breast screening recommendations.

A quote in a New York Times story yesterday:


"Why all of a sudden this change?" said Karen Sun, 41, who was loading her groceries into her car here in Los Angeles. "It feels out of nowhere."

It's not all of a sudden and out of nowhere.


As the Washington Post led with in their story, this has been a decades-long debate. What we have seen in the past 3 days is akin to what happened with the uproar 12 years ago after a NIH Consensus Conference on this issue made a concluding statement that many women - and their politicians - disagreed with.


In an ugly clash between science and politics, confusion reigned.

And now it's happening again.

From the LA Times:

Some Republicans jumped on the report as the kind of government intervention in medical decisions that Obama's healthcare plan would bring.


"This is really the first step toward that business of rationing care based on cost," said Rep. Phil Gingrey (R-Ga.), a physician.

Where is the evidence for that? That is fear-mongering rhetoric.

In the Washington Post:

"We can't allow the insurance industry to continue to drive health-care decisions," said Rep. Debbie Wasserman Schultz (D-Fla.), who said earlier this year that she had undergone treatment for breast cancer.

Wasserman-Schultz, whose legislation promoting breast cancer education in young women was widely criticized by evidence-based experts, should be forced to produce evidence for her claim as well.

And on ABC last night, a physician was allowed to say - unchallenged - that mammograms pick up early cancers when they need less treatment. If anecdotes are going to rule the day, then that physician should have to counter the anecdotes I've heard from women whose early DCIS or ductal carcinoma in situ - often called "pre-malignant" or "pre-cancerous" - was picked up by mammograms. And the range of treatment options then thrown at them - as aggressive as prophylatic bilateral mastectomy - left the DCIS-diagnosed to wish that they had actually received a diagnosis of invasive cancer because the choices were easier and more clear cut. These are real stories I heard from real women. The story - the discussion - isn't complete without taking into account the experiences of women like that.

I watched all three TV networks' lead stories from last night's newscasts - all three on the US Preventive Services Task Force's new breast cancer screening recommendations. Lots of talk about "anger, confusion, concern, fear, outright revolt, disturbing, shocking" reactions from women and doctors all across the country.

First, I'll note a reasonably well-balanced job by CBS' Dr. Jon LaPook and by NBC's Dr. Nancy Snyderman. LaPook included a woman who had experienced a false positive mammogram. Snyderman talked about data versus personal anecdotes.

But ABC's Dr. Timothy Johnson gave a personal recommendation - perhaps only because he was asked to by anchor Charles Gibson - and recommended "sticking with the current guidelines." He said he understood concerns about costs and quality. But that misses the underpinning of much of the USPSTF's recommendation and rationale. It implies that the USPSTF considered costs, which they have repeatedly reiterated they did not. He never addressed false positives and the harms thereof. So his summary was misleading and incomplete.

And CBS again allowed Dr. Jennifer Ashton to give her own personal medical opinion, saying "I am not telling (women) to deviate from their screening practices."

I have a lot of problems with the networks giving airtime to the opinions of their physician-correspondents. Do they ask political reporters about their voting habits? Do they ask economics reporters what their investments are? Do they ask the White House correspondent if they personally like the President or support his stances?

I don't personally care what Timothy Johnson or Jennifer Ashton recommend - and I don't think there's any reason for anyone in the viewing audience to care. In this venue, they are supposed to be journalists. Not recommenders. Not opinion-promoters.

Instead of promoting their celebrity docs, the networks should use that precious air time to educate people on the evidence behind the USPSTF recommendations.

All three networks - and many other news organizations - are treating this issue as if it's new. There never has been certainty about mammography recommendations for women in their 40s. And it was just 12 years ago that an NIH Consensus Conference on this issue resulted in a great uproar - what one editorialist described as "what took place seemed more akin to the Queen's order in Alice's Adventures in Wonderland: "Off with her head!" Thus began the latest round in the debate over recommendations for breast-cancer screening."

Journalism has to take responsibility for conveying far too much certainty about screening issues. And at times like this, when evidence-based bodies speak up, journalists - and the public they serve - act as if their worlds have been shaken. But, in fact, their world on this issue never was cast in concrete. Anyone who spends anytime following this issue would know that.

In the face of the confusion, journalists can fuel the flames by interviewing endless women about their personal anecdotes. Or they can explain, give context, history, guide readers and viewers through the confusion.

Newer isn't better in treating clogged kidney arteries

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Key quote in the AP story, "Kidney angioplasty brings risks, no benefit."

Yale's Harlan Krumholz:

"What's remarkable is that this procedure got so popular and adopted into widespread use before a study like this was conducted to show us what its value may be."

Have MRI, will do back surgery

From MedPageToday:

Patients with low back pain are more likely to have surgery if they live in an area with more magnetic resonance imaging (MRI) machines, researchers say. ...Yet studies show increased surgery rates don't necessarily improve outcomes, as MRIs may also detect anomalies unrelated to back pain, they said.

Criticism of Congressional breast cancer bill leads to changes

Susan Perry of MinnPost.com has an update:

Paul Goldberg, the intrepid editor of The Cancer Letter, reports that Sen. Amy Klobuchar, D-Minn., and Rep. Debbie Wasserman Schultz, D-Fla., have watered down both the House and Senate versions of their controversial breast-cancer bill in order to get the votes needed for the legislation to pass.


Since the bill -- now apparently renamed as the Young Women's Breast Health (rather than Breast Cancer) Education and Awareness Requires Learning Young, or EARLY, Act -- was introduced last spring, Wasserman has wrangled enough votes in the House to ensure its passage there. Klobuchar, however, experienced no such luck in the Senate. The bill has been stuck in the Senate's Committee on Energy and Commerce.

Why? Largely because of opposition from leading breast-cancer scientists and women's-health advocates, who argued that the bill is based on the mistaken premise that risk factors for breast cancer in young women (those under age 45) are firmly understood and modifiable. ...

So what is different in the amended version of the bill? Most notably, the new version -- including its title -- refers to "breast health awareness" rather than to "breast cancer awareness."

The new version also no longer includes one of its most highly contentious provisions: the promotion of breast self-exams for girls under the age of 15.

Most experts agree that breast self-exams have not been shown to be effective at reducing breast cancer deaths in women of any age -- and may even be harmful by causing unnecessary worry and medical procedures. ...

Not all breast-cancer experts and advocates think that the EARLY Act is the best breast-cancer use of that money.

"As a taxpayer, I don't believe that the amended version of the EARLY Act is a responsible use of $45 million over a 5-year period," wrote Christine Norton, co-founder of the Minnesota Breast Cancer Coalition, in an e-mail to me on Monday. "A lot of money will be spent on surveys, media campaigns, and follow-up surveys to determine if the media campaigns were successful. [And] as a former high school teacher, I strongly object to beginning the public education campaigns with 15-year-old freshman and sophomores."

The train has left the station but questions about robotic surgery remain

AP story on a new study in JAMA:

A new study suggests less-invasive keyhole surgery for prostate cancer may mean a higher risk for lasting incontinence and impotence when compared with traditional surgery.


Laparoscopic, or keyhole, surgery is increasingly chosen by men having a cancerous prostate removed. And often it involves the highly marketed da Vinci robotics system. Da Vinci's popularity has been rising even though there's never been a rigorous head-to-head comparison between it and standard surgery.

"There's been a rapid adoption of this relatively new technique," said the study's lead author Dr. Jim Hu of Brigham and Women's Hospital in Boston. The results add to confusion around prostate cancer treatment. It's not clear that either surgery is superior to radiation alone or watchful waiting, which means simply monitoring the prostate for changes.



I love the photo of the billboard attached to the linked story.

As I predicted yesterday, there has been nary a story on the US Preventive Services Task Force's new statement that the evidence isn't in yet on nine ways to look for signs of coronary heart disease in people without symptoms.

Journalists - many of whom sang the praises of at least two of those methods (the CRP test and coronary artery calcium CT scans) - either aren't aware or don't care about cautious, evidence-based recommendations from the USPSTF.

The only stories I've seen were by the Wall Street Journal health blog and by MedPage Today which did a
story and a blog posting.

On the MedPageToday blog, Peggy Peck wrote:

This is a setback for CRP believers, a group whose numbers swelled significantly when Paul Ridker reported last November that giving "healthy" adults who had hs-CRP of 2.0 mg/L or higher a potent statin for less than 2 years reduced "the rate of MI stroke, arterial revascularization, or cardiovascular death was 44% (P<0.00001)."


Those findings came from the JUPITER trial and when they were announced there were lots of pundits predicting that hs-CRP would become everyone's favorite test and that maybe it really was time to consider putting statins in the water.

Since last November churning out additional analyses from JUPITER has become something of a cottage industry and some weeks it is difficult to pick up a heart journal or attend a cardiology meeting without being confronted with yet another JUPITER result.

In my opinion it had gotten out-of-hand, so about a month ago I started telling every PR person so sent me the latest breathless JUPITER press release that "I am done with JUPITER."

But here I am, once again, strumming the JUPITER tune. There's no escaping it.

Well, there may no escaping it for journalists like Peck.

But almost every other journalist and news organization - so far - has found such news very easy to escape.

It seems to me that when previously highly-promoted approaches are judged to be not ready for prime time by an independent panel with no axe to grind, that's news.

In a new statement, the US Preventive Services Task Force analyzed the evidence for nine nontraditional ways to screen people with no history of coronary artery disease. And the panel concluded that the evidence isn't strong enough yet to be able to judge the balance of benefits and harms with the following:

• high-sensitivity C-reactive protein (hs-CRP)
• ankle-brachial index (ABI)
• leukocyte count
• fasting blood glucose level
• periodontal disease
• carotid intima-media thickness (carotid IMT)
• coronary artery calcification (CAC) score on electron-beam computed tomography
• homocysteine level
• lipoprotein(a) level.

We'll see how widely this is reported by mainstream news organizations - many of whom have already sung the praises of some of these, especially the C-reactive protein test and coronary calcium CT scans.

The USPSTF states:

Little evidence is available to determine the harms of using nontraditional risk factors in screening. Potential harms include lifelong use of medications without proven benefit and psychological and other harms from being misclassified in a higher risk category. ... Adding nontraditional risk factors to coronary heart disease assessment would require additional patient and clinical staff time and effort. Routinely screening with nontraditional risk factors could result in lost opportunities to provide other important health services of proven benefit.

Not enough talk about evidence-based medicine in current "debate"

In an editorial in the Sacramento Bee today, Shannon Brownlee and Michael Wilkes write:

"Why isn't the issue of medical evidence front and center in the health care debate? Maybe because doctors have not always been truthful in telling people what they know and don't know. Many physicians are either unwilling or unable to take the time needed to fully explain where uncertainty exists. As a result, 65 percent of California voters are under the mistaken impression that most or nearly all of the health care they receive is backed up by scientific studies."

About this Archive

This page is an archive of recent entries in the Evidence-based medicine category.

Drug industry is the previous category.

FDA is the next category.

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