Recently in Medical devices Category

There are many stories journalists could report about conflicts of interest and questions about evidence in the treatment of low back pain, perhaps especially with spinal fusion. We talked about many of these with journalists from the American Society of News Editors in a workshop at the Foundation for Informed Medical Decision Making in Boston in May.

John Fauber of the Milwaukee Journal-Sentinel hammers one of these issues, looking at how Medtronic's Infuse product "went from revolutionary advance to public health alert."

Here's his story on MedPageToday.com.

His entire "Side Effects: Money, Medicine and Patients" series is indexed on the Milwaukee Journal-Sentinel website.

The image below is from the Journal-Sentinel's online story.


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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

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."

Did news coverage of Cheney's LVAD minimize risks?

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I was troubled by some of the network TV news coverage I saw about former Vice President Dick Cheney getting a left ventricular assist device. So I turned to a journalist who knows a lot about such issues - Mary Knudson, co-author with Edward K. Kasper M.D. of Living Well with Heart Failure, the Misnamed, Misunderstood Condition. Here are Mary's comments:

The main problems I saw with coverage of former Vice President Dick Cheney getting a device implanted to treat his worsening heart failure was absence of reporting about the huge risks associated with this procedure. Below are some points to include in balanced reporting about an LVAD:


A left ventricular assist device (LVAD) can be an effective means of treating heart failure short term, but is much riskier and more complex than implanting a pacemaker. The LVAD is a pump that does the work for a weak left ventricle, removing blood from the left ventricle and pumping it into the aorta where it then flows to the rest of the body. The newer model smaller pump is implanted in the chest and has tubes leading to the left ventricle and aorta and another that goes outside the body to connect to a computerized controller. The controller can be worn on the waist and operated by batteries. The LVAD is used in people with heart failure that is so severe, medications do not prevent shortness of breath and fatigue. The device is used in someone with end-stage heart failure as a bridge to keep a person alive until he can get a heart transplant or as a final treatment that may prolong his life up to 10 months to two years or sometimes longer.

While the LVAD can dramatically improve the quality of a person's life by relieving the symptoms that prevent activity, it is a procedure that carries a great deal of risk. Death can occur during the procedure, in the first few days after it, or after the person returns home. Risks include infection, blood clots, bleeding, device failure, and quite a few others.

Using the newest model of LVAD, a person can go about daily activities by carrying with him a couple of sets of battery replacements and then at night connecting the LVAD to a laptop computer that is plugged in to an electrical outlet. Or the person might work at an office or at home with the LVAD plugged through the computer to an electrical outlet. The LVAD has come a long way from the noisy large stationary power sources patients were tethered to. Newer units are smaller, portable for hours, and quieter. But the risks are the same and this device is used as a last resort.

The TalkingPointsMemo site did focus on the potential harms and risks. And a TPM reader submitted this comment:

"I'm a surgeon and just read your wire story about Dick Cheney getting a Left Ventricular Assist Device (LVAD) placed. The story downplays the seriousness of that procedures...once you've got an LVAD in place, it means your heart is essentially incapable of working on its own and has no potential to improve. While LVAD outcomes have been improving, and some patients live months or even years with one of these devices in place, this is a HUGE operation with MAJOR associated morbidity and mortality. If he's not listed for a heart transplant, his days are seriously numbered. Life on an LVAD isn't something I'd wish on my worst enemy...an axiom that this situation really tests. He's in for a rough time."

Exaggerating potential benefits and minimizing potential harms is a troublesome trend in health care news - something we've documented on HealthNewsReview.org.

It's ironic that the Cheney LVAD story occurred on the same day the New York Times ran a relatively unquestioning piece about a French artificial heart device. Scrutiny of the evidence for medical devices - big or small - is an important area of improvement for health care journalists.

Here we go again. And believe me, as one who covered the artificial heart experiments of the 1980s, I feel like I've been through this countless times before. But so have news readers.

Another entrepeneurial team announces its hopes for its artificial heart device and some news coverage trumpets the company's announcement.

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But this was in the New York Times! Now, granted, it's in a "Global Business" section. But we don't see why that removes the need for more scrutiny, for independent perspective, for a better discussion of evidence. The story begins:

"It is a long-held dream: an artificial heart to replace one that is damaged or diseased. Now, a French company says that it has the technology to make the implantation of it a standard surgical procedure."

But the story never scrutinizes what the company says - except to say "While the sales pitch may make for a compelling story, as with any start-up, there is no guarantee that the enterprise will succeed." But that's about business prospects. It's not about the science and the evidence.

"The company hopes to start human testing in France by the end of next year and to bring the technology to the market in Europe in 2013."

On the one hand, we got somewhere with that sentence - human testing hasn't even begun. On the other hand, we let the company get away with projecting widespread marketing within 3 years! What is that based on? Besides a company's hope and a prayer?

It was good that the story reminded readers of other devices either already approved or in development.

It concluded with the company's chief executive estimating the:

"... the potential market at "a minimum" of 100,000 patients a year in the United States and Europe. However, he said cost constraints meant it was unlikely that more than one-tenth of those patients would actually receive an artificial heart."

And that cost was estimated elsewhere in the story:

"When all expenses are considered, including hospital and surgical expenses, it says it will cost just over $315,000, about the same as a transplant."

Let's remember to "Be still, my beating heart" and to scrutinize the enthusiasm of a company - maybe until it has experience with, say, at least one human experiment. I remember some of the breathlessly enthusiastic news coverage of experiments with Barney Clark, Bill Schroeder, Murray Hayden and others with the Jarvik-7 artificial heart in the '80s.

Has journalism learned anything about coverage of artificial hearts in 30 years?

The New York Times had an important story that "highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices. ...Those with the most to lose are the hundreds of thousands of people who receive an orthopedic device each year."

The Wall Street Journal Health Blog wrote that "The FDA is proposing new rules on consumer prescription drug ads aimed at making the information about side effects more understandable. (Off the top of our heads, we'd just suggest they slooooooowwww down when discussing all the rare, but often-horrific sounding side effects of a given medication.)... The comment period ends Monday (June 28)."

Blogger Brian Reid offered one more important followup about news coverage of the big American Society of Clinical Oncology meeting earlier this month. In so doing, he referenced George Carlin's 7 words, as I've been known to do. Excerpt:

"But during the meeting, the national media -- the New York Times, the Wall Street Journal, USA Today, the broadcast networks and the Associated Press -- wrote on only seven studies, a tiny snippet of what was presented. These seven stories, in turn, were pulled from the small number of studies promoted by the ASCO communications department with press briefings."

And, if you missed it, the New York Times reported that the University of Michigan did what its Big 10 counterpart Minnesota couldn't:

"In the latest effort to break up the often cozy relationship between doctors and the medical industry, the University of Michigan Medical School has become the first to decide that it will no longer take any money from drug and device makers to pay for coursework doctors need to renew their medical licenses."

A committee (on which I served) recommended to the Minnesota med school that it eliminate corporate funding of CME within 5 years, but that recommendation was rejected by the administration. Score one big one for the Wolverines over the gutless Gophers on this one.

Small town newspapers and the medical arms race

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OK, it's "only" a small town newspaper.

But a lot of people live in small towns.

And a small town newspaper may be the biggest source of news about your local health care facilities.

So when The Tribune of Ames, Iowa published a story not about the University of Iowa's longterm experience with proton beam therapy, not even about the University's acquisition of a proton beam facility, but merely about the University requesting funding for a proton beam facility, it catches our attention.

And once you get into the story, you see how the locals are being set up to be dazzled by the latest and greatest in cancer treatment. Excerpts:

"The bottom line is that it is absolutely undeniable that protons theoretically are better," said Dr. John Buatti, director of the UIHC Center for Excellence in Radiation Oncology, "therefore, technically, they are preferable."

You don't need to dust off your college logic textbook in order to see the incongruities in that quote. "Absolutely undeniable" it's "theoretically better"??? Followed by, "Therefore, technically, they are preferable."???

Another quote:

"I think this is the proper place to have protons available for the state," Buatti said. "I don't want to be in a position where we do not have that."

I can understand why Dr. Buatti feels that way. Most doctors want to practice in a setting where they have the latest technology. But journalism - even at this hyperlocal level - needs to ask questions such as, "Does every state NEED a proton beam facility? Is Iowa racing to get one before Chicago has its in place? Before Minneapolis gets one?"

Instead, the story seems to try to put any doubts to rest with a concluding sentence:

"The UIHC expects to see a $37 million return on their investment over the first 10 years of the center's operation, Buatti said."

You bet they will. But a good story would crunch the numbers on how they expect to do that. What will the per-patient per-treatment charges be?

We've written about proton beam therapy before.

• We blogged about Merrill Goozner's article in the Journal of the National Cancer Institute, "The Proton Beam Debate: Are Facilities Outstripping the Evidence?"


• We blogged about Dr. Michael Barry's editorial in the Archives of Internal Medicine,
"The Prostate Cancer Treatment Bazaar."

• We blogged about a MedPageToday.com story on some staggering numbers that show how "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."

This is the kind of scrutiny, the kind of analysis, the kind of perspective that the citizens of the state of Iowa, the Board of Regents of the University, and that journalists must apply to these claims.

There are reasons why we spend a greater percentage of the GDP on health care than any other country, without the outcomes to match that spending, and we don't have enough of a public discussion often enough about what those reasons might be. Starting with "the medical arms race" might not be a bad place to start.

Addendum 3 hours after original post: For a better perspective on this story, see what the Des Moines Register reported - better largely because they got the cautious perspective of Dr. Len Lichtenfeld of the American Cancer Society. Excerpt:

"This is one more escalation in a medical arms race," said Dr. Len Lichtenfeld, an Atlanta oncologist who is deputy chief medical officer for the American Cancer Society.

Lichtenfeld said prostate cancers account for a large portion of the cases being treated with proton-beam therapy. He said there's no proof that the new, expensive machines are better at treating prostate cancer.

But he said patients too often insist on treatment with "gee-whiz technology."

Lichtenfeld said the new devices probably are better than standard treatments for a few, rarer kinds of tumors, including some types affecting brains and spines.

"I think what you need to do with these technologies is prove them safe, effective and useful," which has not been done, he said. He said if a university decides to install one, it should pledge to use it mainly for research.


There has been so much hype of proton beam therapy - especially for prostate cancer - much of it dismissing any discussion of lack of evidence and soaring costs. Given that backdrop, it was refreshing to see a Sanjay Gupta piece on CBS last night that exercised some restraint in reporting on proton beam therapy for pediatric brain tumors.

Strong points:

• CBS had one sound bite with an independent expert stressing the need for evidence, especially given the approach's high cost.
• The high cost was emphasized three times in the piece - $100,000 per treatment.
• It was emphasized that it may take a decade to have sufficient evidence.

Weaker points:

• Gupta showed off the technology's "gantry, cyclotron and snout" but this was just high-tech gobbledygook that wasn't necessary. Rather, he could have mentioned the $125-225 million investment medical centers must make in such technology.
• Too much emphasis and time on the little girl's "cuteness." Is it less of a story if she weren't "cute"?

Nonetheless, I somehow feel the hand of CBS producers in the restraint and context in this piece, especially when Katie Couric followed up by asking Gupta, "As exciting as this is, it's very new and very expensive, right?"




ABC's coronary camera hype

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ABC's George Stephanopoulos, with excitement in his voice, announced a "brand new technology approved just 3 weeks ago by the FDA." It was a story about a tiny camera inside the coronary arteries - a technology called Optical Coherence Tomography. ABC called it:

• a new "cutting edge device."

• a "new technology that could save your life"
• a technique providing a "much clearer picture than ever before."

ABC's Dr. Richard Besser said it "could help treat people with heart disease." This had to be a momentary lapse in his medical knowledge since this is not a treatment device but a diagnostic device.

No evidence, no data, was provided in the ABC report.

Finally, at the very end of the piece, after about 3 minutes of breathless awe over the tiny camera and its pretty pictures, Besser addressed the most important question heretofore ignored - "Are outcomes better than with older technology?" And that answer isn't known.

Meantime, blogger Dr. Wes Fisher, who knows a thing or two about the heart as a cardiac electrophysiologist, wrote:

"Please note that this technology has been around since at least 2002. Is it really new? Or is it really that the company's news of FDA approval is "new?" More importantly, the million dollar question is not if it makes pretty pictures, but rather what does it add to the cost of the procedure and will it improve outcomes?"

Superficial health news coverage in flyover country

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An example of cheerleading journalism for local medical centers appeared in the Rapid City (SD) Journal recently. The story was headlined, "Cholesterol machine pulls out LDL."

If only the paper had pulled out a few vital facts. But it didn't.

The story describes a local medical center's "new machine" called the Liposorber, to "strain out the bad cholesterol known as LDL."

The story goes on to explain that the machine itself is not new - stating that it's been on the market for 24 years!

Hmmm. If it's so great, what took the medical center so long to get it?

But we never learn how great it is - except through the glowing anecdote of one patient supplied by the medical center. No data about 24 years of use was included. No cost information.

The company website says "Approximately 300,000 treatments with the LIPOSORBER System have been performed worldwide on over 2,500 patients." Wouldn't it be good journalism to reflect just a little bit on what's been learned in that vast experience?

Across all levels of journalism - and of consumer decision-making - we need to get a lot better and a lot smarter about evaluating evidence.

In any talk I give to journalists, I encourage them to look into the proliferation of proton beam facilities for cancer therapy. Few have done so with any zeal.

The New York Times did a good job.

The Columbus Dispatch did not.

Journalist Merrill Goozner gives ample food for thought in an article in the Journal of the National Cancer Institute, "The Proton Beam Debate: Are Facilities Outstripping the Evidence?" (subscription required for full access). Excerpt:

"A recent report from the Agency for Healthcare Research and Quality (AHRQ) found no evidence to support claims that cancer patients undergoing pricey proton beam radiation therapy (PRT) achieve better outcomes or experience fewer side effects than patients receiving traditional photon radiation.


In the report's wake, proton therapy practitioners are pushing for the first trial comparing the two approaches for prostate cancer, which is the fastest growing use of PRT. The hope for PRT is that it will cause less collateral damage to surrounding nerves and tissue than intensity-modulated radiation therapy (IMRT), the most advanced form of traditional photon radiation.

"It hasn't proven itself to be superior," said Anthony L. Zietman, M.D., professor of radiation oncology at Harvard Medical School in Boston, whose affiliated Massachusetts General Hospital runs one of seven operating proton beam cancer treatment centers in the U.S. "We've applied for a comparative-effectiveness grant to do a head-to-head trial with IMRT with the same radiation dose," he said. The primary endpoint is quality of life.

Even if funded, it will be years before the results of such a trial are known. With dozens of facilities already built or in development worldwide, use of the technology and the controversy surrounding it are bound to grow. In the U.S., where at least three new $100 million-plus proton beam facilities are either under construction or in the planning stage, the costly treatment could dramatically increase Medicare spending on prostate cancer care alone."


Regardless the shape and impact of health care reform legislation, how new health care technologies are communicated to the American public is a major issue. And today a reader sent me a new example of how journalism must improve.

The Asbury Park (NJ) Press reports on a local medical center trumpeting its use of two technologies to treat lung cancer - Cyberknife and Super D. The story reads like a hospital news release, using phrases such as:

• "puts hospital on the cutting edge"

• "The intrusive ways of the past to diagnose and treat cancer -- by using the needle and scalpel -- are being replaced by the electronic hum of computers and the whir of robots."

• "Riverview is the only medical center in the state with Super D and the latest Cyberknife technology"

• "We have the newest technology in the state"

• "It also means treatment can begin sooner and have a better outcome"

Well, wait just a minute about outcomes. The story contains no data, no evidence, no proof of better outcomes.

In fact, hidden away at the very end of the story is this:

"Academic studies are now underway comparing the effectiveness of Cyberknife cancer treatment to conventional surgery."

Usually, we want to wait until the studies are done and until the evidence is in before we proclaim that something is "curing the cancer" or that it's "the wave of the future." Otherwise that wave can become a tsunami of overuse and runaway costs - before we even know if what's newer is better.

MedPageToday.com reports some staggering numbers that show how "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." For example:

Robotic and laparoscopic procedures jumped from 1.5% to 28.7% of radical prostatectomies in the Medicare population between 2002 and 2005. MedPageToday reports:

This exponential growth appears to have run ahead of the evidence, which includes a prior analysis by a Brigham and Women's team showing that minimally invasive prostate surgery doubles risk of genitourinary complications despite shorter hospital stays, and another study suggesting neither benefit nor harm.

Among external beam radiation treatments, intensity-modulated radiation therapy jumped from 28.7% in 2002 to 81.7% in 2005 and perhaps 100% by now.

Within brachytherapy, the addition of intensity-modulated radiation therapy jumped from 8.5% to 31.1% over the same period.

Any evidence of benefit is only coming in now after the fact. But the high-tech train has already left the station. It's not known how much these technologies are costing Medicare.

And the prediction is that proton beam therapy will dwarf all of these technologies in cost.

The news love affair with robotic surgery - even simulators

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We've written before about some of the headlines praising robotic surgery:

• Robot doctor - surgery of tomorrow

• Da Vinci puts magical touch on the prostate

• Cancer survivors meet lifesaving surgical robot

• Robotic surgeon's hands never tremble

• Da Vinci is code for faster recovery

• Surgical Maestro

• DA VINCI ROBOT IS SURGERY WORK OF ART

e67cf064-e7e3-4997-bd49-2d127b463a00_mn.jpg Now even the news that a company is testing a couple of robotic-surgery-training-simulators "and expects the units to go on sale for about $100,000 by early 2011" makes news.

The AP reported it
(this is their photo at left of the news conference) and the story was picked up by ABC News.com, CNBC, the Los Angeles Times and elsewhere.

Granted, a simulator that might help train docs in what seems to be the inevitable spread of this technology might be an important quality/safety improvement.

But the AP story that spread across the country didn't mention any concerns about the medical arms race involving robotic devices, nor any questions about evidence.


• Hold news conference.

• Demonstrate gizmo.

• Get nationwide news.

How easy it can be to get free publicity, without ever having people focus on some of the important policy questions at stake. But after this week, who cares about health care policy, anyway?

WBBM in Chicago last week asked, "Is Medicare Ignoring Cheaper Lung Cancer Test?"

Screen shot 2010-02-23 at 1.55.03 PM.png In its report, the TV station's "investigator" team promoted a company president's complaints against Medicare for much of the piece. They let him get away with saying:

"This is a potentially very powerful tool in the toolbox against lung cancer. You can zap the cancer and potentially be cured of early-stage lung cancer without ever having the surgery."

Should we be hearing that from a company president worried about his bottom line while he "wows" the audience with blown-up images like the one at left that appeared in the story? Or should we hear about evidence and data from an independent investigator whose research could speak to efficacy? The story never provided any data to back up the company president's self-interested claims.

They also let him get away with saying, "I think it has the potential to save Medicare millions of dollars."

We're not getting much smarter from stories like this. We're sure not getting a better understanding that in health care, "more is not always better and newer is not always better." We're also not being shown how often special interests - Pharma, device makers, specialty physician groups, etc. - are digging in against health care reform.

Recently, Trudy Lieberman wrote in the Columbia Journalism Review about how cardiologists were using journalists to complain about their reimbursement levels being cut by Medicare. She wrote:

"The doctors' letter warned that they "will be either forced out of business or forced to drastically increase the number of patients seen, most likely with physician assistants or nurse practitioners." Oh, oh. The specter of rationing and inferior care--"

See the similar themes in what she wrote about and in what we saw in the Chicago WBBM story?

Lieberman praised a Miami Herald story for how it handled the issue but said that:

"..a bunch of news articles for the most part passed along the cardiologists' complaints, threats, and warnings without any hint that there was another side to the story. Between the slanted newspaper articles and audio news releases from the American College of Cardiology, millions of Americans learned that the incomes of heart doctors, which can be upwards of $400,000, could take a hit. As an example of the kinds of cuts Medicare envisioned under the new rule, the administrator of one Florida heart practice explained that the reimbursement for a nuclear stress test could drop from $850 to $600. Presumably he said it with a straight face."

News stories that foster rhetoric and fear-mongering aren't making us any smarter. As Lieberman wrote:

"Containing the runaway cost of medical care is the thorniest of all the thorny issues in the health-reform debate. It is a complicated, charged, and crucial issue; the press needs to dig in and own it."

This is the second business section health news story we've questioned today. But we're not the only ones.

A Star Tribune headline screamed, "Blockage Breakthrough" on behalf of a local company's hopes for its coronary artery intervention product.

Problem: We never learn what the product really is or how it works.

We only hear the praise from one - just one happy patient - and the pronouncement from the lead investigator (perhaps a bit conflicted?) that this is the closest they can come to the Holy Grail for treating blocked coronary arteries.

Readers are not dumb. Online, some commented as follows:

• "I don't get it...exactly what is the breakthrough? It sounds like a normal angioplasty,"

• "Please define what (these devices) actually do."

• "There is no description of what it is, what it does."

• "Seems like the main point is not in the article? So how does the thing work? I kept reading it over thinking I missed it in there."

No matter where you live - think twice about health stories on the business page that make things sound too good to be true. And if the story doesn't deliver what you need to understand, take a moment to write in as these folks did. Maybe someone will listen.

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."


Nerves seem to have been rubbed a bit raw at a couple of medical device companies, according to an interesting story by Christopher Snowbeck of the St. Paul Pioneer Press.

I'll only tell you that the story touches on:

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• cow pies
(Photo by Jeff Vanuga, USDA Natural Resources Conservation Service, found on Wikipedia. Ed. note: This photo is provided for the education of users who have never been on a farm. It is not necessarily the "mud" referred to in the headline's reference to "mudslinging." This may be the only time I'll ever have the chance to discuss cowpies on this blog, so this is a rare teaching moment.)


• divorce

• Senator Chuck Grassley

• disciplining sales reps for repeatedly breaching code of conduct for interactions with health care professionals.

You'll have to read Snowbeck's piece to get the details.

CBS News ran a segment last night on a little girl who apparently benefited from the use of a left ventricular assist device called "The Berlin Heart" - a device that supported her heart for a few days while she waited for a heart transplant. The girl was the daughter of Chicago Bears football player Charles Tillman.

Sanjay Gupta - on loan to CBS for this story from CNN - said the technology "saved her life." But no one can say that with any certainty. She was on the pump for a few days. No one can say if she would have survived those few days without the use of the device.

There was no mention of how much the device and its implantation cost. The cost of the device alone is $115,500, not counting the costs of hospitalization, surgery, etc. (Publisher's update of 12/16/09: This cost figure came from a document that was publicly available to anyone on the Berlin Heart corporate website on the day we posted this. The document has now apparently been removed from the Berlin Heart website, so we have removed the link that was once part of this story.) Pro football players are paid very well. How would others in the audience pay for the device or have access to it? These were questions the story didn't address.

Once the little girl went on the pump, did that automatically move her up higher on the transplant waiting list? If so, is that appropriate? And if so, how did the parents of other children on the waiting list feel about that? There was no discussion of the issue of how some people move up on transplant waiting lists, either.

The story did mention that the device is not approved by the FDA. Why not? The story didn't explain. It didn't explain whether the company had applied for approval and was rejected, whether it had applied but the FDA hadn't decided yet, or whether it simply hadn't applied yet. Regardless, there was no discussion of the evidence behind the device - and evidence is what matters.

Harry Demonaco photo.jpg Harold DeMonaco tracks innovation in medicine in his job as Director of the Innovation Support Center at the Massachusetts General Hospital. He's also one of our medical editors. He wrote to me:

"Unfortunately, in my view, the story strays from a purely human interest story to one that could be taken as a swipe at the FDA. I am particularly troubled by the statement, "Each time, doctors have to get permission from the FDA, and have it flown in from Germany." The obvious implication is that once again government is needlessly impeding delivery of vital care. But the story neglects to point out costs, that the Berlin Heart is not without problems, and that there is an alternative option (extracorporeal membrane oxygenation or ECMO) that has been used successfully for years and is a common approach in most academic medical centers."

So while this was a warm and touching human interest story, it did not educate viewers very well about the technology that the story claimed saved the girl's life, when, indeed, we don't know that. Stories about new medical technologies - even those with such an emotional personal anecdote - should deal with evidence, not hyperbole about one anecdote.

Indeed, another anecdote reported to the FDA tells quite a different story about the Berlin Heart. It describes another child who had the device implanted. Repeated problems with clots forming on the pump's outflow valve led to one, then two pump replacements. A crack developed in the device. The child had to have emergency resuscitation. Another crack developed, which led to bleeding and probable brain damage. The report concludes: "After a long discussion with the family, their wish was to withdraw further support, and to make the child's organs available for donation."

That's quite a different story than the one CBS chose to tell last night. The failure to scrutinize evidence - on harms as well as benefits - and to discuss costs and other options rendered the CBS piece incomplete and imbalanced.

Great piece of local health policy journalism by the Dallas Morning News. Excerpts:

"There's a lot of money to be made in owning imaging machines," said Dr. Richard Strax, president of the Texas Radiological Society. "You can buy a relatively inexpensive second- or third-hand MRI machine for a few hundred thousand dollars and make millions on it."


"Today we can't even tell you how many MRI machines are in Texas, who owns them, what condition they're in and what quality of scans they're turning out," Ron Luke, health policy chairman of the Texas Association of Business, told state lawmakers this year. "That doesn't sound like we're very bright, does it?"

For three sessions, radiologists and doctors have fought in the Texas Legislature over the issue of self-referral. This year's legislation, backed by radiologists and business lobbyists, would have required licensing and accreditation of imaging machines, along with a year-long state study of the extent of self-referral by physicians. But it failed.

Proponents of the legislation say opponents are driven by financial motives. Imaging has become a "lifeline" for many doctors, said Dr. Cynthia Sherry, past president of the Texas Radiological Society.

"It's all about the money, OK? Those very doctors opposed to this are the ones participating in it," Sherry said.

An 1,800-word story on a vital health policy topic. Wow, do we need more like this. Ten gallon hats off to the Dallas Morning News.

I feel a promotional campaign underway for the trials of an implantable device to control high blood pressure that is resistant to drug therapy.

NBC did a breathless story on the device a few weeks ago.

And now the Des Moines Register published one that is strikingly similar to the NBC piece.

* No data on harms or benefits
* The closest thing to evidence was a single positive anecdote of patient success
* No independent perspective, only an interview with a single conflicted source
* No estimate of costs of this approach which could be considerable.

In another fine example of its dedication to important health care journalism, the Milwaukee Journal-Sentinel published a piece, "Debate on MRI payments just one hurdle for reform."

Gems in this piece include:

  • Information on the Access to Medical Imaging Coalition, a group backed by the major manufacturers of imaging equipment, including GE Healthcare. The paper reports: "That industry backing goes unmentioned by the innocuously named group. The Access to Medical Imaging Coalition, which includes cardiologists and radiologists, is just one of the myriad special interest groups that often oppose cuts in what Medicare pays for medical services."
  • "The reality is the status quo puts a lot of money in a lot of people's pockets," said Alwyn Cassil, a spokeswoman for the Center for Studying Health System Change, a policy research organization in Washington, D.C.

    Another reality is groups such as the Access to Medical Imaging Coalition often succeed in persuading Congress to protect their interests.


Read the entire piece. It includes local angles on local industry affected and about Wisconsin legislators' activities in this area. A fine example of local journalism on a national issue.

A story on an implanted pacemaker to control previously uncontrolled high blood pressure called it a "breakthrough," a "game-changer," and said it has "proven highly effective" and could help millions.



HealthNewsReview.org analyzed the NBC effort as follows:

Strip away the hyperbole and the story failed to:

* Give any evidence - any data - on how well it worked;

* Include any independent expert perspective (the only interviews were with sources with a vested interest);

* Include any cost estimate.

The medical editor who reviewed this piece for us said it was one of the worst he's reviewed in three years.

We salute the Philadelphia Inquirer and reporter Stacey Burling for a terrific piece, "Debate surrounds new prostate cancer treatment."

It got a rare five-star (top score) rating on HealthNewsReview.org. Excerpts of the review:

This was an excellent, provocative exploration of some of the critical issues involving the tension between treatment options, payment responsibility, patient choice, and evidence on risks and benefits. There are a great number of uncertainties about prostate cancer itself, whether active treatment is called for and if so, which is the most appropriate choice for individual patients. Combining this with financial interests of those providing treatment adds another layer of difficulty in making good individual choices.


High marks for a terrific enterprise piece that helps readers understand an important health policy and health care reform topic.

One standout quote from a physician in the story:


"There's a lot of politics involved in this. There's a lot of self-interest. There's a lot of greed."

Another example of fawning coverage of medical technology.

Another example of obsequious news on the DaVinci robotic surgical system, about which I've written earlier. (In fact, an earlier post just this week about the President playing with a robot at the Cleveland Clinic.)

A story in The Oklahoman reports on a university medical center's new DaVinci robotic surgical system for prostate cancer.

It failed to report on the limited evidence to support this approach. The U.S. Agency for Healthcare Research & Quality states that there hasn't been enough research to know how this approach compares with others.

It also failed to look at the apparent burgeoning medical arms race in Oklahoma City - just for prostate cancer much less anything else. One center is bragging about its latest generation robot. Another center is bragging about its even more expensive proton beam therapy.

Wouldn't that be a good story?

How local newspapers deal with issues of medical technology assessment, of community ascertainment of need, of resource allocation. of costs, of evidence is vital to public understanding of why we spend more than any other country on health care without the outcomes to show for it. Stories can educate or they can advertise. This one falls in the latter category.

(Hat tip to Craig Stoltz, from whom I borrowed the "wide-eyed new-technology-in-town" phrase, and who helped with the review of the story in question.)

The New York Times headline: "Bone-Growth Proteins Show Risk in New Study." Excerpt:

"Patients who received a bioengineered protein during spinal fusion procedures to correct neck pain had far more complications than patients who did not get it, according to a study released Tuesday.

The study, published Tuesday in The Journal of the American Medical Association, reinforces previous concerns about the use of the proteins in fusion procedures to treat upper spine, or cervical, pain. The substances studied, sold by either Medtronic or Stryker, are not federally approved for cervical procedures, although surgeons are free to use them for that purpose."


The Wall Street Journal headline
: "Bone Proteins Costly In Surgery, Study Says." Excerpt:

"The findings contrast with previous studies, written by Medtronic consultants, in which authors concluded that cost savings over time could offset the initial cost of Infuse.

For instance, an article in 2002 by former Army surgeon David W. Polly Jr., now of the University of Minnesota, and colleagues said, "Preliminary results suggest that from a payer perspective, the upfront price of bone morphogenetic protein is likely to be entirely offset by reductions in the use of other medical resources. That is, bone morphogenetic protein appears to be cost neutral."

Dr. Polly, who last year received substantial consulting and speaking fees from Medtronic, didn't immediately respond to requests for comment."

The Star Tribune, serving the community where Medtronic and Dr. Polly are based, had what sounded like a local-business cheerleading headline, "Medtronic's Infuse a hit in growth of spine fusion."

But the story itself offered much more beef than the headline suggested.

Still, the Strib story seemed to swing back to what good news this could mean for Medtronic. Excerpt:

"JAMA's findings loom large for Medtronic, which sells the bioengineered product called Infuse used in spine fusion procedures. Since it was approved by the FDA in 2002, Infuse has proven to be a blockbuster device for the medical technology giant. Michigan-based Stryker Corp. makes a similar product, but Medtronic is by far the market leader.

While Medtronic doesn't break out figures for individual products, sales of biologics (including Infuse) have topped $3.6 billion in the past five years. Its spine division, which also markets devices used in spine surgery, is its second-largest with $3.4 billion in annual revenue."

And the Strib story never mentioned Dr. Polly right in their own backyard.

It's an important study and topic. Read all three stories if you get the chance.

A CBS Early Show segment on "three heart tests all women should know about" actually claimed that heart CT scans involved no radiation! And this involved a physician-correspondent!


Excerpts of the story review on HealthNewsReview.org:

This was classic morning show health news garbage.


"Three heart tests that all women should know about"? "All" suggests that even women without symptoms should be thinking about these tests. But the segment later says that the tests are only for women with symptoms, but then never gives a detailed description of these symptoms.

So viewers are left with another high-tech showcase: stress echocardiograms, screening ultrasounds, and CT scans looking for calcium in the coronary arteries - the menu for the morning news-viewing woman.

Does CBS and its physician-correspondent realize that the term "screening" (which they used in reference to ultrasounds) does not apply to those with symptoms?

So which women - precisely - should think about or pursue these tests? Those with symptoms - or those without symptoms?

On top of everything else, the segment included a glaring, unforgivable error. It said that the three tests involved no radiation - implying that they are harm-free. But a cardiac CT scan has an average radiation dose equivalent to 600 chest x-rays!!! In addition, according to a 2007 study in JAMA, there is an increased risk of breast cancer in women having the test due to the radiation dose. And this segment was all about women having these tests.

Who is responsible for this content?

Is this news? Is this public education? Or is it just another meaningless medical marvel morning show segment that fails to quantify benefits or talk about harms or acknowledge costs?

The Oklahoman is another newspaper that must love new, expensive, unproven medical technologies.

The story, "Tulsa company hopes device can ease cancer screenings," may just as well have been headlined, "Tulsa company can't write a better promotional news release than this."

It's a local business story, cheerleading for local business, and to hell with the evidence. And for that matter, the story thumbs its nose at women who need better information than this about breast cancer screening.

Former Washington Post health section editor Craig Stoltz wrote this summary on HealthNewsReview.org:

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"This story on a new ultrasound imaging device stands out from other zero-star stories we've reviewed. This piece doesn't merely fail to be accurate, balanced and complete. It fails to even try.

* It draws on only one source, a company executive whose job it is to sell machines
* It doesn't present any data to justify the source's claims of efficacy and superiority
* It doesn't provide any context about similar devices and other diagnostic techniques
* By implying the device can detect cancers mammograms cannot, it could provoke unjustified fear
* It fails to distinguish between screening and diagnosis

Looking over the story, it's not clear the reporter even asked a question. It is not mean or hyperbolic to say that most press releases are more informative."

Consider the impact on consumers of this kind of daily drumbeat of such stories by news organizations all across the country while you listen to all of the mounting opposition to health care reform proposals in Washington. (Today I've blogged about just two - albeit egregious - examples in South Dakota and Oklahoma.)

Until we educate health care consumers better than this, health care reform is going to be a really tough sell.

Front page. More than 2,000 words. The kind of story Americans need to understand. We're fortunate to have the WSJ on days like this with stories like this. - "FDA Backs Knee Device After Long Lobby Effort."

I've been tracking news coverage of a Minnesota company's heart "sock" device for heart failure for four years. Four years ago, I questioned Star Tribune coverage.

Two years ago, questions of evidence started to surface.

Today the Star Tribune reports:

"The high-profile consumer advocacy group Public Citizen expressed "deep concern" this week about whether the company's experimental device has been sufficiently reviewed by federal regulators. ...

Two advisory panels for the FDA have recommended against approval of the Acorn device after reviewing the company's application and holding public hearings. The agency itself has rejected the company's application three times. Acorn has even taken its case to a dispute resolution panel, a highly unusual move in the device world, which also voted against approval of its device.

Normally, a company in this situation would have abandoned the rather-expensive effort, especially a start-up like Acorn, which has no other products on the market.

But Acorn has been encouraged along the way by Dr. Daniel Schultz, a surgeon who is head of the FDA's device division, and the company subsequently reached an agreement with the agency to conduct a second, albeit smaller, clinical trial involving 50 patients. If that study is successful, the device could be approved by the agency without being first reviewed by an advisory committee and without a public hearing, according to Public Citizen.

In a Nov. 12 letter to Schultz, Public Citizen said the design of the new study "is so poor that it is unlikely to provide reliable data that would contradict the negative findings of the data so far submitted to the FDA." The number of patients enrolled in the study is too small, and they will not be followed for a sufficient amount of time, Lurie said."

I never would have picked up on the scent of this story had not the Star Tribune given such favorable coverage to the company and its product four years ago.

About this Archive

This page is an archive of recent entries in the Medical devices category.

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