Recently in Medical devices Category

Warm, touching, but inadequate story of a pro football player's daughter and her path to a heart transplant.

The story claims that a heart pump saved the girl's life - when that can't be proven. It also didn't discuss costs, didn't discuss evidence, didn't discuss some of the known problems with the heart pump - follow the link to see what it did and didn't do.


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

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


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

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

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

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

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

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

Stents for sex

Yep, we want to stent for that now, too. Medtronic plans a study of whether stents in pelvic arteries can help men with erectile dysfunction, according to the St. Paul Pioneer Press.

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

AP story on a new study in JAMA:

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


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

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



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

Reforming FDA medical device approval

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I don't think the American public would be thrilled with the FDA's device approval system - if they knew more about it. But this week the issue is in the news.

Questions about the booming medical imaging business in Texas

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.

No way to cover new medical devices

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.

Escalating cost of questionable medical technology

Earlier this year, I wrote about how an Ohio newspaper dropped the ball in failing to ask tough questions about expanding use of proton beam therapy.

Now blogger Merrill Goozner - as he often does - asks some of those questions I would look for in such a story. Excerpt:

Anyone worried about the escalating cost of questionable medical technology might want to take a close look at proton beam radiation therapy for cancer. There are now six centers in the U.S. that can deliver the precision radiation ion beams. At least five more are either under construction or in development. Pricetag: anywhere from $100 to $225 million each.


And what's the evidence that proton beams are a superior alternative for tumors located in highly sensitive areas where the risk of collateral damage from radiation is high? "No study found that charged particle radiotherapy is significantly better than alternative treatments with respect to patient-relevant clinical outcomes," a new Agency for Healthcare Quality and Research technical brief reports.

Still, that hasn't stopped leading academic medical centers and even some suburban hospitals from plunging ahead and investing in the high-tech facilities.

Important story by Reuters. Excerpt:

"The more you do, the better you're going to get. The question is at what point are you doing safe surgery," said , said Dr. Kevin Zorn, chief of urology at Weiss Memorial Hospital at the University of Chicago.


Zorn was lead author of an article in the September issue of the Journal of Urology that proposed instituting training standards for surgeons using the equipment. Currently, there is no credentialing system to evaluate a surgeon's competency and surgeons cannot practice on simulators before taking on live patients. Zorn believes such machines ought to exist.

He recounted one case of a surgeon who was using the system for the fourth time. After eight hours of surgery, the proctor -- an experienced surgeon who supervises the operation -- told the surgeon that progress was too slow. He recommended the surgeon switch to conventional surgery, where an incision is made from the navel to the pubic bone to access the prostate.

After the proctor left the operating room, the surgeon continued using the robot. The patient later died from complications.

That's a question the ECRI Institute asks in a story reported by the St. Paul Pioneer Press. Excerpts:

The ECRI report argues that physicians develop preferences for certain medical device brands as they gain familiarity with the product. Other factors might also inform brand loyalties, said the nonprofit group's president, including the influence of sales representatives as well as paid consulting relationships between manufacturers and doctors.


The ties become so strong that when hospitals recruit orthopedic surgeons and heart specialists to their medical staffs, they find they also have "generally 'recruited' the vendors those MDs favored," the report states. "Exacerbating the situation are device manufacturers' sales representative inside the surgical suite during procedures 'assisting' the physicians as they learn how to use new products."

For hospitals trying to negotiate discounts with suppliers, physician preference items can be a problem when doctors' allegiances limit a medical center's ability to shop around for the best price. Hospitals have been reluctant to push back against doctors on these decisions, the report says, because unhappy doctors can threaten to move their practice to another hospital and take their patients with them.

The solution, according to ECRI Institute, is for hospitals to work cooperatively with physicians to make purchasing decisions that incorporate scientific evidence about the relative merits of devices as well as the value a particular product delivers.


More on reining in medical imaging costs in health care reform

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Radiologist Pat Basu of Stanford has an important column on the Kaiser Health News Service, "Medical Imaging: The Good, The Bad and The Ugly."

MRI imaging payments - a case study in the health care reform struggle

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.

Cyberknife insurance coverage in question - a health policy case study

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."

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

Health care/research ethics is the previous category.

Medicare is the next category.

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