Recently in Medical devices Category

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:

250px-CowPie-JeffVanuga.JPG

• 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:

-1.jpg

"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.

I've reported many times on news organizations hyping medical technologies. But this past week, a medical journal - BMJ - did the same thing in its "news" section, presenting only the fantastic potential of robotic surgery without any evidence - any quantification - of potential benefits and harms and without any discussion of costs.

The BMJ "news" story was entitled, "Robotic prostatectomy transmitted live to engineers to promote collaboration."

Read my letter and that of a British oncologist in response to that article. I wrote:

"...the story was completely devoid of any data.

We learn that robotic radical prostatectomies are much more common in the US than in the UK but we learn nothing about outcomes.

We learn that there are ethical issues but none is specified.

We learn that a urologist believes robotic surgery has several advantages. But those are not quantified. What does "better results" mean?

We learn that "patients recover more quickly" but we're not told how many patients. We learn of "better cancer control" without any definition of that term.

Ditto for reported claims of more precision, "less collateral damage, resulting in less blood loss, faster recovery, and fewer complications." No numbers.

I'm trying to teach my health journalism students, "No numbers? No story." I hope they weren't reading this week's BMJ "news" section."

Wish I had a nickel for every story about vagus nerve stimulation that trumpeted it as a treatment for depression.

This week, Medicare rejected Cyberonics’ implantable nerve stimulator, saying the device, the VNS Therapy System, hasn't been shown to be necessary. The $25,000 device is already approved for epilepsy. Cyberonics wanted to expand its use.

Bloomberg News reports “The Food and Drug Administration approved the device in 2005 to treat depression, overruling 20 agency advisers who urged rejection.��?

On the Cyberonics website the company boasted of dozens of news stories from across the country over the past two years, with headlines such as:

"Implant can relieve depression: VNS Therapy is proving beneficial."

"Omahan says she's proof device zaps depression."

"Emerging from the depths of depression."

"The Pacemaker for the Brain" is Saving Lives."

"Up from hopelessness."

"Implanted device helps fight drug-resistant depression - Giving new hope"

Among the media reporting the potential for the device:

U.S. News & World Report
Saturday Evening Post
Redbook
Reuters Health
Arizona Daily Star
San Antonio Express News
El Paso Times
Corpus Christi Caller Times
Toledo Blade
Omaha World Herald
Chicago Tribune
KSAT, San Antonio
WMUR Manchester, NH
WCCO, Minneapolis
KETV, Omaha
KUTV, Salt Lake City
KSL, Salt Lake City,
WBZ, Boston
WCBV Boston
WISN, Milwaukee
WKYC, Cleveland
KTBS, Shreveport
KOMO, Seattle

Each one of those news organizations owes it to their audience to play up the Medicare rejection of the device as prominently as they promoted the potential in the giddy glory days.

Two years ago, I wrote about how the Minneapolis Star Tribune had acted like a cheerleader on behalf of a local company whose product was a mesh-like sock to go around the heart in hopes of combating heart failure.

Over two straight days, the paper reported on the company's trial results with the sock. The stories did not have one comment from an independent medical source. But they did promote the company's "bullish" attitude about "the future of their unsual device as well as the company's prospects."

When the paper reported on a trial, in which the sock group was compared with a non-sock group of patients, the paper said the sock group scored better in "improvement" (not defined). There was no mention of complication rates. There was no discussion of whether the results were statistically significant, or whether they could have been due to chance.

The Wall Street Journal also reported on the sock study, but pointed out that the "sock didn't lead to a significant improvement in ejection fraction, the percent of blood that is pumped out of the left ventricle during a beat and a widely used measure of the strength of the heart."

The Star Tribune coverage felt naive and pro-local-business.

Last week, the cheerleading ended. The Star Tribune was forced to report, "The future of a New Brighton medical technology company remains unclear after a U.S. Food and Drug Administration panel ruled Friday that it may need to conduct a new clinical trial for the firm's sole product -- a unique device that treats heart failure. ...The company based its initial FDA application on a 300-patient trial. A similar study, if required by the regulatory agency, could cost Acorn an additional $20 million and take about three years to complete."

Journalists should review data and evidence and seek independent analysis of ideas in medicine, not local companies' bullish attitudes about their own products.

Medicine in conflict

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Business Week has an interesting special report on "blurring the lines between objective science and financial gain. "

The magazine profiles a New York heart specialist who is chairman of the Cardiovascular Research Foundation in New York. Excerpt: "The foundation uses donations and fees from medical device companies to stage (an) annual conference, called Transcatheter Cardiovascular Therapeutics (TCT). A professor of medicine at Columbia University, he has helped start a handful of cardiac device companies through a corporate "incubator" he co-founded. He also has served as a paid scientific adviser for several other startups. Over the years, companies to which he has had close ties have been featured prominently at TCT, creating at minimum a perception that the companies' products are favored for reasons other than medical merit. ... Beyond the danger that conflicts may distort individual clinical decisions, some TCT observers worry that the event engenders a general excess of enthusiasm for complicated device-based procedures. From 1986 to 2003 the number of nonsurgical cardiac procedures, such as propping open arteries with wire-mesh stents, rose twelvefold, according to the American Heart Assn. Such procedures "are uncomfortable, relatively expensive, and might be taking the focus away" from less invasive, equally effective treatments, such as taking medicine, says Dr. David D. Waters, chief of cardiology at San Francisco General Hospital."

Read the entire report. It paints a picture that is now being seen more often in medical research - a tangled web of conflicts of interest with big dollars at stake. And where, in all of this, are consumer interests represented?