Recently in Evidence-based medicine Category

Why we don't regularly review the Today Show anymore

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Earlier this week, the NBC Today show brought viewers news of robotic heart surgery - from Australia! Our observations:

• The story went out of its way to name the company making the robotic system - making it feel awfully ad-like. Maybe from a video news release?

• The story said this was "one of only two being used in Australia" but nothing about any US experience. Are viewers in Adelaide, Australia now part of the Today Show's key demo?

• Nothing on cost or evidence.

• Nothing with any context - just more gee-whiz, high-tech drooling - especially because it had ROBOT in the title. Way cool.

• It was 50 seconds of "must miss TV" but we bring it to you anyway.

Visit msnbc.com for breaking news, world news, and news about the economy

A well-intentioned ad campaign run by the American Cancer Society is too vague, and, therefore, may leave impressions that are imbalanced, incomplete and unsubstantiated - the kind of common tactic seen in many drug company ads.

That's my opinion based on my analysis of the ad and based on my reading of the text.


A Cancer Society news release states:

The American Cancer Society Cancer Action Network (ACS CAN) is launching a new print and online advertising campaign in congressional districts across the country this week, urging lawmakers to fully fund a lifesaving cancer prevention, early detection and diagnostic program that is celebrating 20 years of screening low income, uninsured, and medically underserved women for breast and cervical cancer. The ads also send the message that when it comes to increasing your odds of surviving cancer, access to evidence-based early detection tools is critical.


The ads reference the Centers for Disease Control and Prevention's (CDC) National Breast and Cervical Cancer Early Detection Program (NBCCEDP), which has a track record of reducing deaths from breast and cervical cancer. The program has provided more than 9 million screening exams to more than 3 million women and diagnosed more than 40,000 cases of breast cancer and more than 2,000 cases of cervical cancer since it launched in 1990. But with limited funding, the program is able to serve fewer than 1 in 5 eligible women.

The accomplishments of the CDC NBCCEDP are noteworthy. So this blog entry is no knock on that program.

It's a criticism of the ad.

We can't fight cancer if we can't see it AD.jpg
jpg

There is no specific mention of the specific goals of the CDC NBCCEDP. The ad doesn't state what the news release states that this is promoting "20 years of screening low income, uninsured, and medically underserved women for breast and cervical cancer."

Instead, the ad promotes unspecified screening - all screening, one could infer. "We can't fight cancer if we can't see it....When it comes to cancer, screening is seeing...It's time to take the blindfolds off and stop cancer before it starts." Catchy phrases from an ad agency or from someone creative at the Cancer Society. But are we talking about prostate cancer screening? Lung cancer CT scan screening? Ovarian cancer screening? Show me where it does NOT say that. And show me where it DOES say this was about breast & pap smear screening for medically underserved women?

But this is a fund raising and political message: "current funding isn't enough...tell your members of Congress (to) increase funding..."

And when you're raising funds, a little vague fear-mongering can't hurt, right?

Wrong.

One other piece of copy from the ad demands scrutiny: "60% of cancer deaths could be prevented." The implication is that's all from screening because screening is the only prevention method mentioned in the ad. Nothing about stop smoking or other lifestyle changes. If the ad meant to imply that 60% of cancer deaths could be prevented just from screening, it should provide the evidence for that. If the ad did not mean to imply that, but was just misleadingly vague, then I call for the ACS to pull this ad. In either case, I think they have a problem.

That unsubstantiated 60% figure is especially ironic since the ACS news release includes this line: "Access to evidence-based prevention is just one component of the fight to defeat cancer." We needed a little more clear evidence here - evidence that would show that screening is just one part of prevention.

Earlier this summer I criticized a federal agency's vague screening promotion ads. I'll end this note in a fashion similar to the way I ended that note:

I know that the folks at the American Cancer Society (or their ad agency) had their hearts in the right place with this campaign. But their heads have to do a better job of learning how to communicate about screening. Or else they'll be guilty of the same disease-mongering techniques that are so prevalent in so many other messages in general circulation these days. The worried well are constantly whipped into a frenzy over the supposed weapons of mass destruction inside all of us. As a physician-colleague reminded me: "All screening tests cause harm; some may do good as well."

You'd never know it from the ACS ad. But then again, it's "only" a fundraising ad, right?

The SHAPE of medical guideline-setting sausage-making

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It's not pretty watching sausage being made. Larry Husten of Cardiobrief.org provides a peek at the process - as seen in new and controversial cardiovascular prevention guidelines:

"The Society for Heart Attack Prevention and Eradication (SHAPE) has announced the formation of a new task force "to refine and update" its earlier published guidelines.
...
The earlier guidelines, when published in a supplement to the American Journal of Cardiology, were not endorsed by the American College of Cardiology, American Heart Association, or the National Heart Lung & Blood Institute, and received a mixed response from the cardiology community. A typical response came from Robert Califf, who told heartwire: "It's an opinion, it's not a guideline that's been vetted through any kind of ecumenical group of people who have any official standing to make clinical-practice guidelines. There's enough evidence to have an opinion about this; I don't think there's enough evidence to have a policy about it. It's an interesting idea and it could be right. Then again, it may not be right."


A further complicating factor is the role of SHAPE's founder and current chairman, Morteza Naghavi, who has numerous financial interests in technologies and devices that stand to benefit from SHAPE policies and the Texas legislation.

On the other hand, the AJC supplement was introduced by a prominent cardiologist, Valentin Fuster, and co-authors of the guidelines included such leading figures as PK Shah, Pam Douglas, Sanjay Kaul, and others. Many cardiologists, though critical of SHAPE and its methods,nevertheless broadly support efforts to identify people at high risk for MI.

The SHAPE press release announcing the new Task Force (see below) takes no note of the controversy and calls the publication "a major breakthrough in preventive cardiology." The press release also refers to a bill passed last year in Texas that requires reimbursement for heart attack screening, but does not mention that the bill was actively supported and promoted by SHAPE, and that SHAPE was widely criticized for its role in promoting the legislation."

Husten also includes links to previous Cardiobrief coverage of SHAPE and the full SHAPE news release. From that news release, perhaps the most controversial section was this:

"...the wider use of atherosclerosis tests has improved the affordability of the procedures. In major U.S. cities patients pay approximately $100 to have their coronary artery calcium score (CACS) measured by CT scan or carotid intima-media thickness (CIMT) and carotid plaque measured by ultrasonography. And progress is being made to persuade insurance companies to cover the costs of such preventive screening tests in the interests of public health and prevention. In 2009, Texas Governor Rick Perry signed the nation's first heart Attack Preventive Screening Bill into law requiring insurance reimbursement for the tests."

And for doing so in the heart of Medtronic country, as the Strib reminds readers:

The state is home to Medtronic Inc., the world's largest maker of devices used in spine surgery, as well as Abbott Northwestern Hospital, which performs more spine fusion surgeries on Medicare patients than any other hospital in the country, according to the industry publication Orthopedic Network News.

We applaud the newspaper for pursuing this story, one that was recommended to them months ago by me and other members of the Minnesota Shared Decision Making Collaborative, including Dr. Craig Christianson, who is quoted in the piece. It's part of an occasional Star Tribune series, "Too much medicine? When less is more in health care."

We do a lot of colonoscopies in this country, looking for colon cancer. And that's a good thing.

But do people realize that the only screening test for colon cancer shown by randomized controlled trials to decrease colon cancer mortality and incidence is fecal occult blood testing (FOBT)? It's an inexpensive (about $20) at-home test kit that often seems to get lost in the enthusiasm for in-office higher-tech procedures like standard colonoscopy - or its new sibling, virtual colonoscopy.

This week, a study in Health Affairs reminds us about the relative benefits of FOBT. And it's about time. Kaiser Permanente in California thinks highly enough about FOBT that it mails test kits to subscribers to use at home. From a public health perspective - trying to reach as many people as possible with a cost-effective approach - it sure seems to make sense.

Katie Hobson writes about this study on the Wall Street Journal health blog and includes links to the Health Affairs study and to a MedPageToday.com story, "Virtual Colonoscopy Misses Mark on Cost." See Katie's story and visit those links if you're interested in learning more.

Meantime, one message for journalists is to include a discussion of FOBT whenever discussing colon cancer screening. It seems incomplete and imbalanced not to do so.

And a possible message for consumers (although we don't give medical advice on this blog), ask your physician about FOBT whenever other colon cancer screening methods (e.g., colonoscopy, flexible sigmoidoscopy) are brought up.

Why NOT talk about the evidence for (or against) FOBT?

Only so much to say about this story.

It's about Senator David Vitter of Louisana.

He says that an FDA advisory committee's vote to revoke the approval of Roche-Genentech's Avastin for treating breast cancer is "essentially government rationing." The WSJ reports:


New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.


"I shudder at the thought of a government panel assigning a value to a day of a person's life," Vitter said in a statement. "It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough." In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee's vote appeared to be based on cost effectiveness, not safety issues.

"I am not suggesting that Avastin is a perfect drug, but it has a proven record of effective treatment for some patients when used along with chemotherapy," he wrote.

This is the same Senator who, as the WSJ reminds us, "slammed the new U.S. Preventive Services Task Force mammogram guidelines that said yearly tests shouldn't be automatic for most women under 50. In May he asked the HHS to take the recommendations off the agency's website."

Summary:


• Scientists find no overall survival benefit and considerable side effects.


• Senator says the drug has proven track record of effective treatment and calls rejection "sickening...rationing."

Questions:

• Who knows better?

• Whose advice to trust?

(There, I've blogged about it without injecting my own opinion. Just the facts and some pertinent questions. Talk amongst yourselves. I'm verklempt.)

What's known about the characteristics of men being treated aggressively for prostate cancer? Up to now, not much. A study published in the Archives of Internal Medicine describes "the first large-scale US population-based study to document the risk profiles and treatment patterns among men with PSA levels of 4.0 ng/mL or lower who were diagnosed as having prostate cancer." Between 2004 and 2006, about 14 percent of prostate cancer diagnoses fell into this category. Such men are considered less likely to have more worrisome, high-grade cancer and more than half were classified as having low risk cancer.

But despite the lower risk, treatment rates for these men were comparable to those of men with PSA scores between 4.0 and 20.0 ng/mL.

The researchers wrote:

"The finding that men in low-risk groups were treated intensively raises the concern of overtreatment, especially among older patients."

It's interesting to now have some idea of how many men get conservative treatment - about 25 percent - receiving neither radical prostatectomy nor radiation therapy as their primary treatment. There wasn't good data on the use of hormone therapy.

The researchers conclude:

Recently publicized results from the European Randomized Study of Screening for Prostate Cancer show that 1410 men would need to be screened and 48 additional cases of prostate cancer would need to be treated to prevent 1 death from prostate cancer. Given that US patients are in general diagnosed at earlier stages and are more likely to receive attempted curative therapy, the number needed to treat to save 1 patient is likely to be higher in the United States than in Europe.
...
Based on the recent update of the Scandinavian Prostate Cancer Group Study Number 4 trial, men 65 years or older treated with RP fared no better than men undergoing conservative management. Our results demonstrate that 66% of men aged between 65 and 74 years with low-risk disease and a PSA value of 4.0 ng/mL or lower received either radical prostatectomy or radiation therapy. These findings suggest that many contemporary men receiving treatment for localized prostate cancer are unlikely to benefit from the intervention. Furthermore, it has been documented that men who receive any treatment have increased risk of treatment-related adverse effects.Therefore, it is critical that patients be counseled about treatment-associated adverse effects and benefits when they are deciding about therapy.


The number of men with "abnormal" PSA levels would double to approximately 6 million if the threshold were decreased from 4.0 to 2.5 ng/mL. Estimates suggest that 32% of men with abnormal PSA levels would be diagnosed as having prostate cancer from their needle biopsy. Based on the results in the present study, 82.5% of these 1.9 million men would receive attempted curative treatments, while only 2.4% would have high-grade cancer. However, no evidence suggests that delaying biopsy until the PSA level reaches 4.0 ng/mL would result in an excessive number of potentially noncurable disease cases. Although abandoning an upper limit of normal for PSA level would allow physicians to detect more cancer, the benefits of diagnosing prostate cancer would likely be offset by treatment complications related to cancers that might never have caused harm.

Our study found that aggressive local therapy was provided to most patients diagnosed as having prostate cancer. These results underscore the fact that PSA level, the current biomarker, is not a sufficient basis for treatment decisions. Without the ability to distinguish indolent from aggressive cancers, lowering the biopsy threshold might increase the risk of overdiagnosis and overtreatment.


Here's a Reuters summary of the article.


WebMD's is here.

Katie Hobson on the WSJ Health Blog offered good perspective.

Former US Senator David Durenberger (R-MN), in his monthly commentary from the National Institute of Health Policy at the University of St. Thomas, writes about an example of a patient and a provider balking at evidence and outcomes data.

The commentary is built on the back of a story in the St. Paul Pioneer Press by Jeremy Olson (who is leaving soon to join the Star Tribune across the metro). Durenberger writes:

For many years MN health insurance companies like BCBSMN have been trying to convince members that they can provide more value for the premium prices they charge, because they can give members access to higher value health care services. This is what the HMO has been about for three decades and "data on docs" and the creation and sponsorship of the Institute for Clinical Systems Improvement (ICSI). For example, Health Partners Medical Group reports key clinical outcomes of more than 400,000 patients classified, since 2004, by socio-economic status, race and ethnic group because more than 90% of their patients will trust them with that kind of information.


Jeremy Olson, St Paul Pioneer Press, writes about an interesting new chapter in this effort. A 38-year-old leukemia patient is concerned that BCBSMN requires her to go to the Mayo Clinic for a bone marrow transplant rather than to the University of Minnesota where she has received all her care. "It breaks my heart," the patient says. But BCBSMN has the local and national data to show that Mayo's transplant outcomes for cases like hers are better than the UMN. The response from UMN is: "We treat the toughest cases that others won't." This is the kind of response we've become used to hearing when outcomes research is used to inform and to direct pre-paid patient decisions.

It doesn't hold water. When lives are at stake, and reputations are on the line, research data must be as precise as possible. There are those in the medical industry who love bashing insurers and managed care even more than President Obama does. Traditional insurance plans will tell you that hospitals with less than the best outcomes may be motivated by their finances in taking on cases for which success is less likely. I will always recall the two neurosurgeons involved in the development of the cyber-knife telling me about a Miami colleague who bought two and was making a mint off "hopeless" tumor cases.

When the UMN says their cancer transplant cases are "tougher" than Mayo's and therefore their success rate is lower, they need to be asked first to prove it, and then whether admission decisions can be affected by reimbursement which is unrelated to outcomes. What I would love to know, were I this patient, is which cancer centers, or which oncological surgeons, in this country have even better results for people like me than Mayo. Maybe one is right here in Minneapolis?

This gap - between what evidence shows on outcomes - and individual or institutional resistance to the evidence - is a huge barrier standing in the way of any meaningful health care reform.

Kudos to Jeremy Olson and David Durenberger for writing about it.

Headlines every day in the New York Daily News are luring men in as part of a mass prostate cancer screening campaign which the American Cancer Society not only does not endorse - its chief medical officer recommends against. Yet the paper brags that it is beginning its second decade of this non-evidence-based campaign. Sample headlines:


• Doctors urge New York men to take advantage of free, city-wide PSA testing


• What you don't know can kill you. Get a FREE prostate cancer test. It can save your life

• Bring dad in for FREE prostate cancer test across the city on Father's Day

and

• Don't skip the PSA test! My prostate cancer is treatable because simple test caught it early (written by a Daily News staffer).

Meantime, as I wrote one year ago when the Daily News promoted this campaign:

Either the paper doesn't realize or doesn't care that:


* The American Cancer Society does not support routine testing for prostate cancer at this time and specifically recommends AGAINST such mass screenings.

* The US Preventive Services Task Force and the American Academy of Family Physicians state that "Current evidence is insufficient to assess the balance of benefits and harms of screening for prostate cancer in men younger than age 75 years."

* No major group - except urologists - recommends starting screening as early as this newspaper does - starting at age 40. And that urology group's thinking is the source of major controversy.

That's a huge public responsibility for a newspaper to take on - especially when it conflicts with medical evidence.

Before being screened, what did the newspaper inform men about the tradeoff of harms and benefits? On the American Cancer Society website, its president, Dr. Otis Brawley says:

"There are some proven harms associated with screening. Screening, for example, leads to unnecessary treatment in some men who are diagnosed with localized disease.


It is difficult to comprehend, but there are prostate cancers that are confined to the prostate and never destined to metastasize (spread to other parts of the body). Screening diagnoses a large number of men who would never be bothered by the disease. In one clinical trial, more than 12% of average risk men were diagnosed through screening over 7 years. This group of men is estimated to have a lifetime risk of death of less than 4%. This study suggests that 2 out every 3 men in this study did not need to be diagnosed nor treated. While this study suggests that the proportion of men in the overall population who are diagnosed with cancers that do not need therapy is as high as 67% of men with localized disease, others estimate it to be as low as 30%. We have very poor ways of predicting who needs treatment because their prostate cancer might kill them, and who does not need therapy because their tumor is of no threat to them."

It's not just a simple blood test, as it is so often promoted. That's why Dr. Brawley says:
"Many health care provider organizations and many well-meaning community groups encourage prostate cancer screening and offer mass screening at health fairs and other activities. The American Cancer Society is concerned that so many do not understand that the benefits of screening are still undetermined. The ACS recommends against such mass screening activities because one cannot be assured that the patient has the opportunity to hear a balanced explanation of screening in an environment in which he can feel comfortable to ask questions and make an informed decision."

Even more to the point of the newspaper's promotion and advertising of this mass screening, Brawley wrote in an editorial in the Journal of the National Cancer Institute:

"I heard a radio commercial that brings perspective to the issue. A local celebrity was promoting prostate cancer awareness. He said, "Prostate cancer is 100% curable when caught early." He encouraged all men to get screened and announced that a van was touring the area offering screening in supermarket parking lots. This was a community service project sponsored by the radio station, the supermarket chain, and a radiation oncology practice.


A commercial like this plays to our fears and prejudices. ...

Prostate cancer screening has resulted in substantial overdiagnosis and in unnecessary treatment. It may have saved relatively few lives. ... The benefits of prostate cancer screening are still open to question. This means that informed or shared decision making should be done using the data now available before screening is performed. Some of the confusion of prostate cancer screening can be avoided if we all clearly label what we know, as what we know; what we do not know, as what we do not know; and what we believe, as what we believe. Of course, one must not confuse what is believed with what is known to do this."


Anti-climax: flibanserin flops before FDA

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The AP reports:

"...members of the Food and Drug Administration's reproductive drugs panel voted 11-0 that the drug's benefits did not outweigh side effects, including fatigue, depression and fainting spells.


Flibanserin failed to increase sexual desire, as recorded by women in daily journals, in two company studies.

The FDA will make its own decision on the drug in coming months, though it generally follows the panel's advise."

When will we learn to put evidence before hype?

To wait until all the evidence is in before promoting something as "the female viagra" - as "the pink pill" that women have been waiting for?

Shame on the journalists who hyped this story leading up to the FDA panel's vote. It resembled free advertising, free marketing, free buildup of demand for an unproven product.

And pity the poor consumers who heard about this every day and bought the hype.

When will we learn to be better evaluators of the evidence?


Addendum two hours after original post: many more good details in this story from MedPageToday.com.

Reuters reports on a study in the current Archives of Internal Medicine that shows that:

"...after the U.S. Congress had mandated Medicare coverage of a digital tool to help detect breast cancer, health providers were quick to pick it up even though it hadn't showed clear-cut benefits for the women.


The technology, known as computer-aided detection, costs more than $100,000 to install, according to the researchers...

"It illustrates a bigger problem that exists in our society, where the rails are really greased to get new technologies into practice before we are sure that they are safe," Dr. Joshua J. Fenton, who led the study, told Reuters Health.

"There is no evidence that the use of computer-aided detection reduces breast cancer mortality," he added.

A commentary by Dr. Karla Kerlikowski in the same journal calls for "evidence of benefits outweighing harms before implementing new technologies." Excerpt:

Why do new technologies get disseminated so quickly when evidence is incomplete and/or conflicting? One explanation is that the focus of evaluating new diagnostic tests is on providing evidence to support improved or at least equal benefit of the technology with much less attention to the potential harms of new technologies prior to dissemination. In other words, the benefit of the new technology compared with existing technologies is examined but not necessarily whether the potential benefit of the new technology outweighs the harms of the test. In addition, the designs of comparative studies are often maximized to measure the added benefit of the test to detect disease compared with standard tests rather than assessing effectiveness in community practice on important clinical outcomes. Lastly, there are several forces that may encourage the rapid adoption of new technologies, including investigators with professional interests, technology companies with financial investments, lobbyists with vested interests, and a public convinced that new advanced technology is always better.
...
Health care providers and individuals cannot presume that newer technologies are better than existing ones without actual data to that effect. Health care providers should not adopt new technologies without first demanding scientific evidence beyond that required for FDA approval. They need to ask how strong and consistent is the evidence for new technologies and whether the evidence shows an important clinical benefit, whether there are important harms, and whether the benefits outweigh the harms. To be responsible advocates for high-quality medical care, our enthusiasm for new technologies should not replace strong, consistent evidence that the benefits of the new technology outweigh the harms in a clinically important way.

Finally, in another commentary in the journal, this one by Dr. George Sawaya on the attempt to reduce harms of cervical cancer screening "by setting appropriate lower and upper age limits for screening and avoiding too-frequent testing among average- and low-risk individuals," harms are another key focus:

To move forward, clinicians and patients must first be more cognizant of screening harms in all its forms, and studies must be designed to measure not only the likelihood of benefit with various screening strategies but also the likelihood of harm. Second, comprehensive and integrative methods must be identified and used to determine an appropriate balance between benefits and harms that seems reasonable to a variety of stakeholders. Finally, the rationale behind screening guidelines designed to maximize benefits and minimize harms must be clearly communicated to everyone.


While the "less is more" argument may never be convincing to many stakeholders in cancer screening, its rationale should resonate with many clinicians steeped in the tradition of doing no harm.

E-patient Dave (Dave deBronkart, diagnosed two years ago with stage 4 kidney cancer), blogs today under the headline, "e-Patients and doctors both, wise up. If you haven't already." If you don't know about Dave, you should. He's one of the hottest speakers at health care meetings these days. He begins today's blog:

friendDave.jpg

"I've only been studying healthcare for two years - far less than most people on this blog - and I hesitate to be overly assertive. But I have, finally, reached the point where I feel confident in citing cases where people are simply being unscientific: ignoring evidence. That's always hazardous, and it becomes insidious when it's caused by a blind, unquestioning belief in our institutions."

One of those institutions, he points out, is the peer-review system. He quotes Richard Smith, longtime editor of the British Medical Journal, who wrote in the Journal of Participatory Medicine:

"...evidence on the upside of peer review is sparse, while evidence on the downside is abundant. We struggle to find convincing evidence of its benefit, but we know that it is slow, expensive, largely a lottery, poor at detecting error, ineffective at diagnosing fraud, biased, and prone to abuse. Sadly we also know--from hundreds of systematic reviews of different subjects and from studies of the methodological and statistical standards of published papers--that most of what appears in peer-reviewed journals is scientifically weak."

Finally, Dave plugged our project, which he calls a "wise-up tool."

Read his entire column. I've only given you a few points from it.

Part 2 in AP series on overtreatment: back pain

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AP's six-part series on overtreatment in U.S. health care turns to back pain and spine surgery with a great lead line, "Why did they cut on you?" It was a question a spine surgeon asked a man who came to him still in severe pain after an earlier back operation. Except:

"Even though only a fraction of people with back pain are good candidates for surgery, complicated spine operations are on the rise.


So is the hunt for any relief.

By one recent estimate, Americans are spending a staggering $86 billion a year in care for aching backs -- from MRIs to pain pills to nerve blocks to acupuncture. That research found little evidence that the population got better as the bill soared over the past decade."

The Associated Press, which sometimes may be viewed as only reacting to breaking news of the day, today published a timely and timeless feature explaining:

"Anywhere from one-fifth to nearly one-third of the tests and treatments we get are estimated to be unnecessary, and avoidable care is costly in more ways than the bill: It may lead to dangerous side effects."

It's timely because, on the heels of the New York Times' criticism of Dartmouth Atlas methodology, it refers to Atlas data that shows that:

".. in parts of the country, Medicare pays double or triple the price to treat people with the same illnesses. The differences are not fully explained by big cities' higher cost of living or populations that are poorer, older or sicker. How much care someone gets is a main reason, yet Dartmouth's data shows people in pricier areas don't necessarily fare better."

It's also timely because, on the heels of a study published in Health Affairs that showed that many people surveyed thought more care meant higher-quality, better care, this story led with:

"More medical care won't necessarily make you healthier -- it may make you sicker. It's an idea that technology-loving Americans find hard to believe."

Nice team effort by AP with contributions from Lauran Neergaard, Ricardo Alonso-Zaldivar, Lindsey Tanner and Marilynn Marchione.

(Disclosure: the story quotes Dr. Michael Barry, president of the Foundation for Informed Medical Decision Making, which supports my HealthNewsReview.org project.)

The big ALLHAT study of drug treatments for high blood pressure showed, as Harvard's Jerry Avorn writes, "that for patients with hypertension but no major comorbidities, thiazide-type diuretics were as good as or better than other agents that at the time were considerably more costly, many hoped this "old-fashioned" approach would gain new respect and credibility. Yet, publication of this landmark study resulted in a surprisingly small change in patterns of care."

Today Avorn has an invited commentary in the Archives of Internal Medicine in reaction to a study that MedPageToday.com describes in this way:

"Face-to-face educational presentations by investigator-educators, a practice known as academic detailing, was associated with a small but significant increase in the use of thiazide diuretics for hypertension."

In his commentary, Avorn writes:

"Many well-documented advances in therapy are not adopted widely or quickly, whereas other, unimpressive new treatments are taken up in epidemic proportions, their use often fueled by marketing campaigns that are far more powerful than the medicines being advertised. As a result, patients are frequently exposed to new therapies that may be less effective or less safe than the older regimens they replace. For example, ezetimibe (Zetia and Vytorin; Merck/Shering-Plough Pharmaceuticals, North Wales, Pennsylvania) may not prevent atherosclerosis as well as the statin-only regimens it displaces for many patients; rosiglitazone maleate (Avandia; GlaxoSmithKline, Philadelphia, Pennsylvania) increases the risk of cardiovascular disease in patients with diabetes mellitus; and rofecoxib (Vioxx; Merck & Co Inc, Whitehouse Station, New Jersey) nearly doubled the occurrence of myocardial infarction or stroke in patients who took it, while offering no greater analgesic efficacy than older nonsteroidal anti-inflammatory drugs, such as naproxen sodium. The lavish promotion that drives such overuse is reserved for the most expensive drugs, because only a high-priced product can provide its manufacturer with the economic benefit to justify a big marketing campaign. Patients are left to bear the burden of the mediocre efficacy or increased risk of these products, while all of us get to pay for their high cost."

He says the study published today wasn't about "real academic detailing" but rather "far less effective group presentations, many of which probably degenerated (in a behavior-change sense) to conventional talk-at-you lectures. It is therefore not surprising that its impact on changing practice was so modest."

The Colorectal Cancer Screening Guidelines Mess

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Before we close out colon cancer awareness month, I want to draw attention to another important paper in the journal Gastroenterology, "Understanding differences in the guidelines for colorectal cancer screening," by Thomas Imperiale and David Ransohoff. (subscription required, published online March 16 ahead of print).

The authors start with the broad message that guideline-setting in general is of such concern that the Institute of Medicine has formed a committee "to develop standards (that) ensure that clinical practice guidelines are unbiased, scientifically valid and trustworthy." They remind readers that:

"The problem of varying quality is highlighted by the fact that there are nearly 300 guidelines-making organizations that have created over 2300 guidelines in a process described as "essentially unregulated."

But their focus was on colorectal cancer screening guidelines, and specifically different updates issued by two major guidelines organizations in 2008:

• The "multi-society" guidelines issued jointly by subspecialists in cancer prevention, gastroenterology and radiology.


• The US Preventive Services Task Force.

The authors focus on the first group's "preference for tests that image the colon" - especially colonoscopy.

The authors say that the USPSTF, on the other hand, "considered several strategies to be similar in terms of years of life saved and reduction in colorectal-specific mortality," including colonoscopy and less expensive blood stool tests. The USPSTF stated no preference among methods. But the USPSTF did not share the multi-society group's endorsement of newer virtual colonoscopy and fecal DNA testing.

These are significant differences, according to the authors:

"The current differences in CRC screening guidelines raise practical questions not only about what doctors and patients should do in the face of disagreement, but also about the larger process by which guidelines are made and how "trustworthy" they may be.
...
Further, the potential for conflict of interest is real when subspecialists support or recommend procedures from which they derive income is real; that conflict should be acknowledged and managed rigorously. Conflict may be not only financial; it may also be intellectual, when professional enthusiasm causes one to favor what one has learned to do and knows best."

I encourage journalists to find and read the full Imperiale/Ransohoff paper.

Gastroenterology. 2010 Mar 16. [Epub ahead of print] Understanding differences in the guidelines for colorectal cancer screening.

Imperiale TF, Ransohoff DF.

Division of Gastroenterology and Hepatology, Department of Medicine,
Indiana University School of Medicine, Indianapolis, IN; Regenstrief
Institute, Inc., Indianapolis, IN.

PMID: 20302867 [PubMed - as supplied by publisher]

And I encourage them to be aware of the Institute of Medicine's review of guideline setting. Many "awareness month" campaigns are far too simplistic and incomplete and may, indeed, mislead consumers in the certainty they seem to convey. This is far from a certain field at this point in time.

Here are some recent posts raising important questions about what we know and don't know about colon cancer screening:

http://www.healthnewsreview.org/blog/2010/03/kaiser-takes-blood-stool-test-kit-campaign-to-youtube.html

http://www.healthnewsreview.org/blog/2010/03/colon-cancer-awareness-month-often-means-claims-but-no-evidence.html

http://www.healthnewsreview.org/blog/2010/03/memo-to-harry-smith-cbs-news-re-colonoscopy-crusading.html

http://www.healthnewsreview.org/blog/2010/03/journal-editor-troubled-by-obamas-ct-scan-for-coronary-calcium-virtual-colonoscopy.html

http://www.healthnewsreview.org/blog/2010/02/the-overselling-and-overpromising-of-colonoscopies.html

http://www.healthnewsreview.org/blog/2010/02/what-reporters-missed-at-the-nih-colon-ca-screening-state-of-the-science-conference.html


There's been surprisingly little coverage of an analysis by the Nordic Cochrane group in this week's BMJ that concludes:

"We were unable to find an effect of the Danish screening programme on breast cancer mortality. The reductions in breast cancer mortality we observed in screening regions were similar or less than those in non-screened areas and in age groups too young to benefit from screening, and are more likely explained by changes in risk factors and improved treatment than by screening mammography."

Of the stories I could find, Andre Picard of The Globe and Mail had one of the better reports, including a quote from one of the researchers:

"We have to start asking unpleasant questions about mammography screening."

The medicalization of life

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That's the title of an op-ed piece by Dr. Gilbert Welch of the Dartmouth Institute of Health Policy & Clinical Practice. Excerpts:

"Here's a question that's not being asked in the healthcare debate: How much medical care do we want in our lives? It's something we should be discussing.


Start with the two life events we all experience, birth and death.

My profession has gotten pretty good at terrifying (and operating on) pregnant women during what should be one of the greatest experiences in life. And we are equally proficient at dragging the elderly through all sorts of misery on the road to death.
...
So the most fundamental life events -- birth and death -- increasingly involve more and more medical care. Why should you care about this increasing medicalization of birth and death?

Simple. Because it exemplifies the medicalization of life. Everyday experiences get turned into diseases, the definitions of what (and who) is normal get narrowed, and our ability to affect the course of normal aging get exaggerated. And we doctors feel increasingly compelled to look hard for things to be wrong in those who feel well.

Medicalization is the process of turning more people into patients. It encourages more of us to be anxious about our health and undermines our confidence in our own bodies. It leads people to have too much treatment -- and some of them are harmed by it.

And it's big part of the reason why medical care costs so much.

There are many areas in which medical care has a great deal to offer. But it has now gone well beyond them. There may have been a time when the words "Do everything possible" were indeed the right approach to medical care. But today, with so many more possibilities for intervention, that's a strategy that is increasingly incompatible with a good life. We all need to be a little more skeptical and -- to really be healthy -- willing to ask "Why?"

Don't just settle for my excerpts. Read the entire article.

Dear Harry,

There's nothing wrong with advocating for more awareness of colon cancer screening - although we don't think that crusading advocacy is a role for journalism, which is supposed to independently vet claims of evidence.

10_-_es_colonresults_310.jpg

So, instead of all the promotion of your live colonoscopy last week, you and CBS could have investigated the evidence about colon cancer screening.

And if you had done that, you might have reported on some of the questions about colonoscopy - instead of cheerleading for it.

In this month's journal, Gastroenterology, is an article "Colorectal Cancer Screening Guidelines: The Importance of Evidence and Transparency," by Dr. James Allison, Clinical Professor of Medicine Emeritus, University of California San Francisco.

As a network news operation, CBS should really be on top of this information, but I'm going to bet no one in the network has read this, so I'll offer some excerpts:

"The only screening test for colon cancer shown by randomized controlled trials to decrease colon cancer mortality and incidence is fecal occult blood testing (FOBT)."

Did you know that? Did you consider doing a live promotion of the stool blood test? Granted, it might have been a little gross, but we did see your colonoscopy. And it appears that this kind of colonoscopy promotion is what helped make it the most popular colon cancer screening test, despite the evidence (or lack thereof).

"Medicare data reveal that the use of sigmoidoscopy fell by 54% from 1993 to 2003 with most of that fall occurring after Congress bypassed the Centers for Medicare and Medicaid Services (CMS) and approved Medicare reimbursement for screening colonoscopy in 2001. The reasons for the decrease are multifactorial, but include gastroenterology thought leaders and the lay press.
...
Katie Couric had her own colonoscopy televised on The Today Show, and shortly after proclaimed: "It's considered the most effective test for detecting colon cancer." ...If all these admonitions and recommendations for colonoscopy screening were not enough to discourage use of flexible sigmoidoscopy, the government decreased reimbursement, thereby making the office cost for doing sigmoidoscopy above that covered by the reimbursement."

Wow, as a journalist, doesn't that sound like a good story? How about the author's questions for "the American Cancer Society, the US gastroenterology societies, and the American College of Radiology" about "to whose benefit are assertions, unsubstantiated by the evidence" that FOBT is a poor second choice to colonoscopy? Doesn't that sound like there might be a story there?

If CBS had covered the recent NIH state of the science conference on colon cancer screening last month, you would have heard some of these issues, wide open in public discussion. But, to the best of my knowledge, you didn't cover that meeting. So the following excerpt of the journal article is probably all new to you.

"Thus, the available evidence suggests that repeated screening with highly sensitive FOBT may be as effective and cost effective at preventing colorectal cancer-related deaths as screening colonoscopy every 10 years.
...
Some now question whether the effectiveness of colonoscopy is "good enough" for population-based screening. The costs of population screening with colonoscopy should be of particular concern at a time when the US federal deficit has been projected to hit a record of >1 trillion dollars. Our health care resources are not unlimited.
...
One recent editorial stated that with regards to guidelines, the public is best served by a relatively structured, comprehensive, transparent approach in which the entire body of evidence drives the recommendations. Another stated that only when likely biases of industry and specialty societies have been either removed or overcome by countervailing interests can impartial recommendations be achieved."

Even if you missed the Gastroenterology article or the NIH conference, you couldn't have missed the recent AP story that discussed the "overselling and overpromising" of colonoscopies.

So, you've now learned that you've used your television platform to promote a screening approach that, while it definitely has its merits, has never been shown to be better than a much easier, cheaper test in a randomized clinical trial. You've learned that special interests and biases may be responsible for making colonoscopy the most popular colon cancer screening approach. And you've learned that you and your media colleagues have done your part as well.

Now what are you going to do about that? A make-good perhaps? A followup? A correction? Has CBS ever reported on the issues above? If not, why not?

Not to be missed in this week's Archives of Internal Medicine is an invited commentary, "The Prostate Cancer Treatment Bazaar," by Dr. Michael Barry. After describing about a dozen different treatment options for prostate cancer, Barry writes:

Michael-Barry.jpg

"Complicating the decision, there is an embarrassing lack of comparative clinical trials among these therapies. In fact, for the majority of men who are 65 years and older when newly diagnosed as having prostate cancer, the only randomized trial suggests that arguably the most aggressive of the treatments, radical prostatectomy, and the least aggressive, watchful waiting, have similar prostate cancer-specific mortality over 12 years of follow-up.
...
Given this knowledge vacuum, the type of a physician a man consults may unduly influence his choice. Since many men with prostate cancer discovered through screening have an excellent outcome for years, even without attempted curative therapy, specialists may then naturally assume, based on personal experience, that their treatment works. But increasingly, there are complex financial motives that may lead to bias as well. Large capital investments in equipment for robotic surgery or proton beam therapy, for example, create an intense need to recoup investments by increasing patient throughput. A recent paradox has been the investment by urology groups in roughly $3 million worth of equipment for intensity-modulated radiotherapy, given very favorable reimbursement for this treatment and despite evidence that its marginal benefit over 3-dimensional conformal therapy is meager relative to its cost.
...
Fully informing men about their prostate cancer treatment options involves honestly telling men what we do not know as well as the little we do. It requires a shared decision-making process, in which patient preferences, not physician specialty and certainly not physician investment, determine the treatment course. It is time to make a real shared decision-making process for prostate cancer and other major health problems a "major appliance" in the patient-centered medical home."

Read the entire commentary.

(Disclosure: Dr. Barry is president of the Foundation for Informed Medical Decision Making, which is the sole supporter of the HealthNewsReview.org project.)

I was struck by the recurring themes in this week's health news and planned to blog about it today. But Lindsey Tanner of AP beat me to it with her story, "Experts say US doctors overtesting, overtreating."

She begins:

"Too much cancer screening, too many heart tests, too many cesarean sections. A spate of recent reports suggest that too many Americans - maybe even President Barack Obama - are being overtreated.


Is it doctors practicing defensive medicine? Or are patients so accustomed to a culture of medical technology that they insist on extensive tests and treatments?

A combination of both is at work, but now new evidence and guidelines are recommending a step back and more thorough doctor-patient conversations about risks and benefits."

I had picked up on that same theme in this week's news:

• An independent panel convened this week by the National Institutes of Health confronted a troubling fact that pregnant women currently have limited access to clinicians and facilities able and willing to offer a trial of labor after previous cesarean delivery.

• A troublingly high number of U.S. patients who are given angiograms to check for heart disease turn out not to have a significant problem, according to the latest study to suggest Americans get an excess of medical tests.

• CT scans may pose cancer risk, new research indicates: Doctors, patients should weigh risks vs. rewards of medical imaging. (Chicago Tribune story.)

• Controversy over "value-based insurance design" that tries to address the problem of underuse of proven treatments and overuse of certain surgeries and diagnostic tests that may be less valuable. (Kaiser Health News story.)

• Expensive prostate cancer treatments are winning out over the old standards, driving up the cost of treatment before there's clear evidence that they improve outcomes. (MedPageToday.com story.)

• Dr. Richard Ablin's op-ed in the New York Times, "The Great Prostate Mistake." Excerpt:

"Testing should absolutely not be deployed to screen the entire population of men over the age of 50, the outcome pushed by those who stand to profit."

• And the letter to the editor that followed:

To the Editor:

I can only wish that Richard J. Ablin's article had appeared years ago and spared me and probably many others needless pain and anxiety.

In 1997, at the urging of a couple of friends, I walked into a clinic feeling great and a bit foolish. P.S.A., 9-plus. Biopsy, of course (ouch), and I was told of a "little suspicious gray area" on a film. Lab test result, positive. Doctor recommendation: surgery or radiation.
I decided against both and never looked back, and have lived happily and healthfully ever after.

By the way, the 10 or 15 percent chance of bad side effects (I asked) from surgery is really far higher, from what I've read and heard. Watchful waiting is still the best suggestion any doctor can offer.

Robert S. Corya
Indianapolis, March 10, 2010

• CBS' Harry Smith's live colonoscopy coverage that never touched on any questions about evidence for colonoscopy and some of the questions that have been raised about the overselling of colonoscopy - perhaps resulting in the decline in use of a $20 blood stool slide test.

While Smith's colonoscopy was being televised, I was attending a meeting entitled, "First, Do No Harm," hosted by the US Agency for Healthcare Research & Quality. The purpose of the meeting was to guide future AHRQ research on how to get doctors and patients to stop pursuing approaches for which there is net harm - not benefit. Clearly, health care in the US struggles even with the clearcut issues of cutting back in the face of net harm - much less in grey areas where there is uncertainty about harms vs. benefits.

But kudos to Lindsey Tanner of AP for trying to tie together the week's news in the way she did. We could have stories like that every week. And if we did, we'd have a lot smarter health care consumer population.

Archives of Internal Medicie editor Rita Redberg writes:

"I was troubled to read that the President's physical examination included an electron beam computed tomographic (CT) scan for coronary calcium. This screening test likely exposed Mr Obama to significant radiation unnecessarily, increasing his risk of future cancer. ...In light of this radiation risk, and the lack of proven benefit in low-risk persons, the US Preventive Services Task Force (USPSTF) recommends against this test in men such as Mr Obama. In addition, the leading professional cardiology societies do not recommend coronary calcium screening for such men. ...According to news reports, Mr Obama also underwent colon cancer screening, even though this screening is not recommended in his age group. Moreover, even when he reaches age 50 next year, the recommended colon cancer screening tests are either fecal occult blood test or colonoscopy. The USPSTF does not recommend virtual colonoscopy for screening, as performed on Mr Obama, owing to the lack of supporting evidence. This CT colonography test, like the electron beam CT scan, increased his radiation exposure and subsequent cancer risk.


Inadvertently, but perhaps fittingly, the reports of Mr Obama's physical examination reflect some of the key challenges facing health care reform today--Mr Obama appears to have been administered 2 cutting edge, expensive diagnostic tests that exposed him to a radiation risk while likely providing no benefit to his care. Some might defend these tests on the grounds that the President, of all people, deserves the very best our health care system can provide, but that would miss the point: more care is not necessarily better care. If the tests have no proven benefit for patients like Mr Obama, then they have no benefit for Mr Obama himself. Worse, evidence shows that the performance of unnecessary tests is not limited to Mr Obama or some select few patients. On the contrary, Mr Obama's case is multiplied many times over at extraordinary cumulative financial cost to society and personal cost to the individuals who receive tests with known adverse effects and potential harms but without benefits.


It is unlikely that Mr Obama will have a dispute with his insurance company over the costs of the tests performed at his physical examination, whether or not they were necessary, but it is a certainty that we all will have great disputes over the spiraling costs of health care for the rest of us."

A UK parliamentary panel this week recommended against public funding of homeopathy, as Susan Perry of MinnPost.com wrote.

"[E]xplanations for why homeopathy would work are scientifically implausible," the panel said.

She cited one estimate that Americans spend $830 million on homeopathic products each year.

Meantime, British physician and writer Ben Goldacre wrote that the BBC had hit rock bottom by giving more than five minutes of airtime to a woman who claimed her cancer was cured by homeopathy. Here's the clip:



For a bit of background, go to this link to see an interesting video featuring BBC health correspondent Branwen Jeffreys explaining homeopathy.


Some websites, predictably, have pulled out the following BBC comedy spoof of homeopathy.

That's the title of an editorial in this week's Annals of Internal Medicine (subscription required - even though the article is marked as "free" on the Annals home page.)

It's a reflection on the US Preventive Service Task Force's recommendations on breast cancer screening from last fall. The Annals editors remind readers:

"Although some subspecialty organizations advocate more aggressive routine breast cancer screening, the update actually aligned the USPSTF recommendations more closely with guidelines from the American College of Physicians, the World Health Organization, and the United Kingdom's National Health Service."

Other excerpts:

"Annals posted a survey on our Web site to solicit readers' impressions. The responses suggest that clinicians are more inclined to change what they do in light of the new recommendations than are members of the general public. ...


Clinicians who offer advice compatible with the new USPSTF recommendations are likely to meet resistance. Most women who responded to the survey resolved to continue as routine the practices that the USPSTF advises against being routine. ...

The Task Force's charge is to provide evidence-based, population-level guidance. Only rarely does evidence unequivocally support a single, definite "one-size-fits-all" recommendation. As the breast cancer recommendations so vividly illustrate, clinicians must often invoke the art of medicine to apply available evidence to an individual patient. Before these most recent guidelines, many clinical encounters about breast cancer screening probably involved little more than the physician handing the patient a mammography referral. Going forward, these interactions will surely involve more discussion about risks, harms, benefits, and preference. The Task Force's intent was to motivate such rational discussion, not to ration care. ...

Because the USPSTF issued recommendations that were politically unpopular among some constituents, there have been calls to curtail this independent body's work. If the USPSTF sinks in turbulent waters whipped up by emotion, anecdotes, and politics, Americans should mourn its loss."

Finally, the Annals editors referred to "a media cacophony" - a phrase I've used in reference to coverage of this episode. They wrote that "the media and politicians presented the breast cancer screening recommendations as a major departure from existing guidelines that heralded an age of rationed care in the United States. Confusion, politics, conflicted experts, anecdote, and emotion ruled front pages, airwaves, the Internet, and dinner-table conversations."

This episode was - and still can be - a golden opportunity for informing people about evidence - and for shared decision-making. This won't be last collision between evidence and anedote/politics/emotion. Will we be any smarter next time?

Robotic prostatectomy love affair driven by marketing

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Gina Kolata's NYT piece, "Results Unproven, Robotic Surgery Wins Converts," looks at how "robot-assisted prostate surgery has grown at a nearly unprecedented rate."

Excerpts from the story:

• "..robot-assisted prostate surgery costs more -- about $1,500 to $2,000 more per patient. And it is not clear whether its outcomes are better, worse or the same."


• "Meanwhile, marketing has moved into the breach, with hospitals and surgeons advertising their services with claims that make critics raise their eyebrows."

• "Medical researchers say the robot situation is emblematic of a more general issue. New technology has sometimes led to big advances, which can justify extra costs. But often, technology spreads long before investigators know whether it is worthwhile."

• "...a situation like robot-assisted surgery illustrates how patients may end up making what can be life-changing decisions based on little more than assertive marketing or the personal prejudices of their surgeon.

"There is no question there is a lot of marketing hype," said Dr. Gerald L. Andriole Jr., chief of urologic surgery at Washington University. Dr. Andriole does laparoscopic prostate surgery, and although he tried the robot, he went back to the old ways.

"I just think that in this particular instance, with this particular robot," he said, "there hasn't been a quantum leap in anything."


"COURAGE" Not Enough: A Million Stents A Year

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Terrific piece in the Wall Street Journal headlined, "A Simple Health Care Fix Fizzles Out."

It documents how the "blockbuster" COURAGE trial three years ago that questioned the effectiveness of "the most common heart surgery" - coronary artery stent placement - had a brief impact on clinical practice but "as the headlines faded," stentings soon began to rise again.

P1-AT764_COMPAR_NS_20100210211756-1.gifThe graph at left is from the WSJ piece, showing that stenting "is now back at peak levels of about one million a year." Excerpts from the article:

"Sanjay Kaul, a prominent cardiologist and researcher at Cedars-Sinai Heart Institute in Los Angeles, estimates that the U.S. could save $5 billion of the $15 billion it spends on stent procedures each year if all doctors followed Courage's guidance--that is, putting certain heart patients on generic drugs and turning to stents only if the pains persists. ...


Ajay Kirtane, a cardiologist at Columbia University, believes that American expectations about medical "fixes" makes it hard to follow recommendations such as Courage's. If a doctor attempted to persuade a patient to delay stenting in order to see whether drug treatment would work by itself, he says, the patient would likely drop him and see another cardiologist instead."

Read the entire piece. And thanks to the WSJ for still allowing reporters to write 2,000-word articles like this.

This week the National Institutes of Health convened an "NIH State-of-the-Science Conference on Enhancing Use and Quality of Colorectal Cancer Screening."

The only story I could find on it was in the Columbus Dispatch.

But I've seen no news coverage about what a friend who attended the conference reported to me.

I've now verified with various attendees that there were clear new signs of the turf war between gastroenterologists - keepers of the traditional colonoscopy approach - and radiologists - who are more inclined to favor the new kid "virtual colonoscopy."

More than just "inside baseball" about "inside your colon," this is another war over evidence in health care.

The NIH panel was not charged with judging the relative value of different colon cancer screening methods.

But it sounds like some of the parties who attended had a different expectation and so the conference they got was not the conference they wanted.

I'm told that radiologists were upset - demanding at least more recognition of the benefits of virtual colonoscopy (or CT colonography) if not a downright endorsement. Some stated their disapproval of the U.S. Preventive Services Task Force statement that "the evidence is insufficient to assess the benefits and harms of computed tomographic colonography (ed. note: and fecal DNA testing, for that matter)." And they're upset about the subsequent decision by the Center for Medicare & Medicaid Services not to cover the newer test.

Radiologists wanted more recognition of the large American College of Radiology Imaging Network trial.

I'm told that there were several radiologists who got up and basically screamed at the panel members for being in the "dark ages". They cited the American Cancer Society recommendations that conflict with the USPSTF on the virtual colonoscopy and also evoked what they called the "mammography disaster," referring to the USPSTF mammography recommendations released last November - another time the USPSTF and Cancer Society disagreed.

One of the speakers at the NIH conference said that the Cancer Society does not use a formal process for evaluating the evidence, does not provide details about how they come to their conclusions and includes only sub-specialists on their panel - raising questions about conflict of interest in their recommendations.

So even though that's not what the meeting was about, there was scuffling over screening method vs. screening method, turf wars, and conflict of interest in the setting of guidelines or recommendations.

So this one isn't over.

And it's difficult to understand why this didn't get news coverage. It sure sounded newsworthy to me.

Hines Ward PRP therapy.png For some time many news organizations have trumpeted, as ABC's Good Morning America did, the "cutting-edge" healing powers of platelet-rich plasma therapy or PRP. As is often the case in stories about wonderful new therapies, evidence is cast aside in favor of sparkling anecdotes such as that of pro football player Hines Ward.

Well today evidence gets its turn. Stories by the Wall Street Journal and by the New York Times point out, as the Times put it, "the first rigorous study asking whether the platelet injections actually work finds they are no more effective than saltwater."

This study was in people with injured Achilles tendons. But as the Times explains, PRP has already been extended to so many uses - "treating muscle sprains and tendon pulls and tears, arthritis, bone fractures and surgical wounds -- that Dr. Bruce Reider, editor of The American Journal of Sports Medicine, said in a recent editorial that perhaps it should be called "platelet-rich panacea."

The lead investigator was even quoted saying, "We are sorry for the patients"

Supposedly a forthcoming study will tout PRP's benefits in elbow problems, but the Times reports that:

"Dr. Freddie H. Fu, an orthopedist at the University of Pittsburgh Medical Center, said the study stacked the deck in favor of platelet injections. ...


Although 73 percent of patients given platelet injections improved after a year, compared with 54 percent for steroid injections, Dr. Fu said that was not much success. "Any time you touch a patient, you get 70 percent success," he said, adding that even placebos give that rate over time.

... Fu said he was keeping an open mind but still did not offer platelet injections. "I just do not have the heart to ask patients to pay for an unproven therapy," he said.

Guarantee: this won't be the last you hear of PRP as it is being looked at to treat injured shoulders, knees, elbows, heels - you name it. The old medical maxim applies - to a man with a new hammer, everything looks like a nail.

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.

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.

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