June 10, 2009

Patients uninformed about potential harms of CT scans

Next time you see an ad promoting CT scans, look for any disclosure of potenial harms. Good luck finding any.

A study in this week's Archives of Internal Medicine (non-subscribers get free access only to an abstract), Medical Decision Making Regarding Computed Tomographic Radiation Dose and Associated Risk: The Patient’s Perspective, suggests that patients are inadequately informed about the potential risks of ionizing radiation form CT scans.

• 47% of patients believed that the decision to undergo CT imaging had been made entirely by their physician.

• Despite the amount of physician involvement in the decision to obtain a CT scan, patients knew little about ionizing radiation and the risks associated with medical imaging, which was demonstrated by the fact that only 6% of respondents knew that the radiation associated with CT increased the lifetime risk of cancer.



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May 14, 2009

More vested interest vilification of virtual colonscopy decision

The Colon Cancer Alliance has distributed a statement of disappointment over Medicare’s decision not to pay for virtual colonoscopy.

Let's do a reality check on what they say in that statement.

"This decision now leaves millions of older Americans exposed to a higher risk of colon cancer.”

• Nope. Not one bit higher than it was the day before the decision was made. The risk is the same. Ridiculous fear-mongering rhetoric.

“It also exacerbates an unequal standard of care between Medicare beneficiaries, who do not have the choice to undergo a virtual colonoscopy, and those with private insurance who do.”

• Euphemism for rationing – battle cry of almost any anti-health care reform movement.

"By denying coverage for virtual colonoscopy, CMS is sending the signal that increased screening amongst the Medicare beneficiary population is unimportant.”
• Hmmm. I didn’t get that signal at all. I heard a signal of “show me the evidence in a Medicare population.” Period. There's no denial of payment for methods WITH solid evidence in a Medicare population.

By the way, the Colon Cancer Alliance is sponsored by a host of drug companies and by GE Healthcare, which makes and sells virtual colonoscopy machines.

Let's be clear: I don't have a dog in this hunt. I have nothing to gain or lose by Medicare's payment decisions - no more than any other taxpayer. But I can't stand the rhetoric. And I'm going to write about it whenever I have the chance.

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March 6, 2009

Terrific WSJ story on FDA device approval

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."


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March 3, 2009

Proton promotions

Journalists can set the agenda for public discussion on health care reform. Or they can simply be led by the nose by special interests down a path of the medical arms race.

The latter was the case with a Columbus Dispatch story last week. It was a shill of a story and it should have done so much more to inform readers.

The story was about one Ohio man having to go to Florida for proton beam therapy for prostate cancer. But the story seemed to promote the plans for two proton beam facilities of their own in the near future right there in central Ohio so no one would have to travel to Florida anymore.

Our HealthNewsReview.org review summarized:

"Cheerleading hometown story, perhaps meant to pave the way for two very expensive proton therapy centers in Central Ohio. No hard questions about whether two are needed, or about the therapy itself.”

Here's a website promotion for the Florida proton center the Ohio man visited.

UFL proton website.png

The story could have asked for evidence on the benefits the website promotes. And for evidence on the "harder on cancer, easier on you" claim.

Indeed, the Boston Globe this week looked for evidence and reported:

"...a study found that though proton beam therapy is at least five times as expensive as other forms of radiation, only a few small, brief studies have examined its effectiveness. There was no evidence that it was better at curing prostate cancer, and insufficient evidence that it was superior at preventing side effects."

The Columbus paper could have asked questions that appeared in a New York Times story about 14 months ago. Excerpt:

“Some experts say the push reflects the best and worst of the nation’s market-based health care system, which tends to pursue the latest, most expensive treatments — without much evidence of improved health — even as soaring costs add to the nation’s economic burden.”

“There are no solid clinical data that protons are better,” said Dr. Theodore S. Lawrence, the chairman of radiation oncology at the University of Michigan. “If you are going to spend a lot more money, you want to make sure the patient can detect an improvement, not just a theoretical improvement.”

Meantime, here’s an ad one medical center is running in local papers in advance of their acquisition of a proton beam facility.

Proton ad.png

Questions consumers might ask:

1. How can you know you’ll treat 2,000 patients a year when it hasn’t even opened yet? How can you know this will be their choice? Or that it will be the best option for 2,000 a year?

2. Why doesn’t the ad mention any evidence of benefits or harms?

3. Why doesn’t the ad mention cost?

The stimulus plan contains more than $1 billion in funding for "comparative effectiveness" research and guidelines. It is predictable that some in the medical arms race industry will scream "rationing" when questions about evidence and cost-effectiveness arise. Rather than "rationing" journalists could start talking about "rational" health policy decisions. And it starts on the local level, questioning whether any one area needs two - or even one - proton beam facility.

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March 2, 2009

The scan scam

Gina Kolata raises many questions in her New York Times piece today, "Good or Useless, Medical Scans Cost the Same."
Besides issues of variable scan quality, she writes:

In a recent report, the Government Accountability Office said nearly two-thirds of the money Medicare paid for imaging was for scans in doctors’ offices. And, the report added, doctors were receiving an ever larger part of their income from providing scanning services. Not only were patients more likely to have scans if a doctor did this, but the quality of some of the scans was questioned.

“No comprehensive national standards exist for services delivered in physician offices other than a requirement that imaging services are to be provided under at least general physician supervision,” the G.A.O. wrote.

Private health insurers were concerned, too. “These are alarming patterns that have also been observed in the private sector,” America’s Health Insurance Plans wrote in a response to the G.A.O.

It is clear why self-referral can be tempting, said Dr. Bruce Hillman, a radiology professor at the University of Virginia.

“It’s all profits,” Dr. Hillman said, adding that a group of doctors can make an extra $500,000 to $1 million a year simply by acquiring a scanner.

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January 16, 2009

Is "substantially equivalent" good enough for approval of new medical devices?

I think the American public would be shocked if they knew the guts of what was in the GAO report yesterday, "FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process."

The report suggests that FDA review and approval of new medical devices has been lax, allowing companies to get approval through an easier process whereby they only had to show their idea/product was "substantially equivalent" to an existing product on the market. But that loophole was only meant for the smaller toys of the medical arms race. It wasn't meant for metal hip joints, pacemaker electrodes and pedicle screws for spinal surgery - all of which slipped through the easier review process, according to the GAO.

And journalists and the public should take this into account when they hear or report news of FDA approval of some devices. It's NOT terribly big news, in my view, to trumpet FDA approval of something that's only judged substantially equivalent to something already on the market.

NBC, for one, gave a big chunk of precious airtime to FDA approval of a laser hair comb. Whoopee. Our review on HealthNewsReview.org showed that it was only judged to be substantially equivalent to 10 other products already on the market!!!

Breakthrough? Depends on how you spell hype.

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November 25, 2008

Gotta have a robot to compete

Paul Levy. President and CEO of Beth Israel Deaconess Medical Center in Boston, blogs about keeping up with the Joneses in the medical arms race. He wrote:

"Many months ago, I wrote about the da Vinci Robot Surgical System and expressed doubts about whether there was evidence to support the clinical efficacy of this equipment, as opposed to the marketing efficacy of the company selling it. Well, the time has come to graciously say, "Uncle!"

Without making any representations about the relative clinical value of this robotic system versus manual laparoscopic surgery, I am writing to let you know we have decided to buy one for our hospital.

Why? Well, in simple terms, because virtually all the academic medical centers and many community hospitals in the Boston area have bought one. Patients who are otherwise loyal to our hospital and our doctors are transferring their surgical treatments to other places.

Prospective residents who are trying to decide where to have their surgical training look upon our lack of the robot as a deficit in our education program. Prospective physician recruits feel likewise. And, these factors are now spreading beyond urology into the field of gynecological surgery. So as a matter of good business planning, concern for the quality of our training program, and to continue to attract and retain the best possible doctors, the decision was made for us.

So there you have it. This is an illustrative story of the health care system in which we operate."


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November 14, 2008

Saga of the heart sock continues

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.

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November 6, 2008

Sergeant Scan of the Radiology Police says NO

The Wall Street Journal tracks the boom in "radiology police" or radiology benefit managers to ensure that doctors use scans only when necessary. Excerpts:

Big insurers including Aetna Inc., WellPoint Inc. and Cigna Corp. have hired so-called radiology benefits managers, or RBMs. Health plans say they want to ensure that doctors use high-tech scans only when it is clear that patients will benefit. The RBMs say their guidelines are based on scientific evidence and medical groups' recommendations. Often, the firms require doctors to get permission to do a scan before the insurer will agree to pay for it.

Scans have helped drive up health-care costs in recent years. The number of computed tomography, or CT, scans, and magnetic resonance imaging, or MRIs, increased 43% in five years to a combined 96.2 million procedures in 2007, according to IMV Medical Information Division Inc., a market-research firm. Positron emission tomography, or PET scans, more than tripled from 2001 to 2005 to an estimated 1.1 million.

There is evidence that a significant number of scans ordered by doctors aren't needed. A recent Government Accountability Office report noted that Medicare spending on scans varied sharply by geographic region, suggesting that the procedures weren't all "necessary or appropriate." Other research has shown that a substantial portion of imaging tests are ordered by doctors who have a financial stake in the imaging equipment being used, a potential conflict of interest. Physicians may also order imaging tests that aren't always necessary to protect themselves from liability. Excessive use of scans is a particular worry with CT, because it can expose people to high doses of radiation.

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October 31, 2008

"You can't keep stuffing gizmos into people" to treat them

Interesting tidbit the other day on the Wall Street Journal Health blog. Excerpt:

"Would-be medical-device entrepreneurs got a sobering message Wednesday at a Boston conference of academic researchers and medical-device companies.

“You can’t keep stuffing gizmos into people to treat end-stage disease,? the keynote speaker said. “When biotechnology gets right, we’re finished. Because it’s restorative, not palliative as devices are.?

The seemingly pessimistic speaker? Device giant Medtronic’s senior vice president for medicine and technology, Stephen Oesterle.

Oesterle, an ex-Harvard cardiologist, joked that he was contributing to “the destruction of my own company.? His remarks, clearly containing some hyperbole to drive home a bigger point, were made to a few hundred academic and industry device researchers gathered for a meeting of the Boston-based Center for Integration of Medicine & Innovative Technology. Medtronic, Boston Scientific and General Electric were among the corporate sponsors for the event.

The bottom line? “It’s done. Devices ultimately are done,? Oesterle said.

In his address, he also contended that America’s leadership in medical devices –- including Medtronic’s –- is due less to American ingenuity than it is to the availability of risk capital in the U.S.

The pacemaker, the coronary stent, the dual-chambered pacemaker, the implanted defibrillator, and the implanted cardiac resynchronizer were all originally invented in Europe, South America, or Israel, Oesterle said, then commercialized here."

Now sit back and watch the device industry's spin machine go into high gear.

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September 18, 2008

Medical device ads more troublesome than drug ads?

The US Senate Aging Committee was looking at medical device ads yesterday.

The AP reports:

While spending by the device industry is minuscule by comparison (with drug ads), several of the biggest players are adapting similar high-profile tactics.

Johnson & Johnson currently promotes its orthopedic hips with a TV advertisement featuring Duke University basketball coach Mike Krzyzewski. Biomet has promoted its competing products with spokeswoman Mary Lou Retton, an Olympic gymnastics champion.

Unlike ads from pharmaceutical companies, medical device spots are not required to give equal balance to risks and benefits of their products. Because of that, they can "create unrealistic expectations among patients and lead to overutilization of inappropriate and costly, unproven technologies," said Kevin Bozic, a board director of the American Association of Orthopedic Surgeons.

Consumers Union called for device ads to include information about infections and other complications. a CU news release stated:

A recent FDA report on data collected from fiscal year 2006 found a 25 percent increase in adverse events linked to medical devices over the previous fiscal year, including 2,830 deaths, 116,086 injuries, and 96,485 malfunctions. The CDC's National Nosocomial Infections Surveillance (NNIS) System Report shows knee and hip replacement surgery to be a serious source of infection. In some of the NNIS reporting hospitals, the risk of infection may run as high as five percent or more.
Warnings of side effects associated with implantable medical devices in direct consumer ads are generally non-existent or minimal. A review by Consumers Union found no advertisements that advised consumers of the very real possibility of deadly infections or of the need to seek out surgical centers with low infection rates.

The New York Times reported:

"...some experts maintain that the advertising of a medical device can have more of an impact on a patient’s well-being than a drug, because devices often require surgery to implant and may remain inside the body for years.

'The results are irreversible because you are kind of stuck with a device,' said Dr. Kevin J. Bozic, a professor of orthopedics at the University of California, San Francisco."

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September 13, 2008

Men are more dissatisfied with robotic prostate surgery

Travel around the Web and you’ll see some amazing claims for robotic prostatectomy:
“minimizes blood loss and pain…is the #1 choice for localized prostate cancer…is rapidly being chosen by more men as well as their doctors worldwide….is the most advanced surgical option….faster recovery times…shorter hospital stays.?

But these claims don’t get at a key question: are men more satisfied with robot- assisted prostatectomy?

A Duke University Medical Center Prostate Center survey says NO, they are not.

Duke’s survey of several hundred patients shows that men who got robotic prostatectomy were about four times as likely to be dissatisfied with their treatment decision as men who choose open retropublic surgery.

The authors concluded that those patients “were more likely to be regretful and dissatisfied, possibly because of higher expectation of an ‘innovative’ procedure. We suggest that urologists carefully portray the risks and benefits of new technologies during preoperative counseling to minimize regret and maximize satisfaction.?

In a letter to the editor of that journal, two authors who call them “surgical nihilists? wrote:

“We feel that far too many patients with prostate cancer are treated more definitively than need to be to save the occasional patient from dying.? They suggest, from their our own studies at Henry Ford Hospital, “one needs to perform six radical prostatectomies to prevent one death from prostate cancer. Stated otherwise, five of six radical prostatectomies are either unnecessary or ineffective.?

Then they addressed robotic surgery hype:

"Some opinion leaders have decried the expansion of robotic surgery in the United States, even calling the way it was introduced ‘a black mark on urology’ and attributing this growth to venal marketing techniques. They do not deny the merits of robotic surgery but feel that the hype does not match reality. There is some truth to these observations: Robotic surgeons have increasingly created Web sites, and the information presented there can be uncontrolled, unedited, and unproven."

So let the buyer beware.

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September 9, 2008

Doctors, dollars and devices - Strib series

The Star Tribune today concluded a three-part series on financial conflicts of interest in the spine surgery/medical device industry. Nice job reporting on things all consumers should know more about.

Part 1: Medical device payments to doctors draw scrutiny

Part 2: For companies courting surgeons, how far is too far?

Part 3: Will disclosure affect flow of cash?

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September 4, 2008

WSJ reports new problems in spinal fusion surgery

As if spinal fusion surgery isn't risky enough, with a track record that is questionable enough, now the Wall Street Journal reports on a new wave of issues with a new product.

The story involves doctors with financial ties to Medtronic, maker of the new spine-repair-product. And there are whistleblower lawsuits. And allegations of problems from off-label (unapproved) uses of the product.

Messy.

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July 30, 2008

More MRI & imaging centers - do we ever say "NO"?

A few days ago, the Star Tribune reported on plans for still another diagnostic imaging center in a Minneapolis suburb that has more MRI machines than in many entire countries. Excerpt:

Along a two-mile stretch of France Avenue in Edina, medical providers have installed so many powerful magnetic resonance imaging (MRI) scanners that radiologists joke that anyone driving through with a pacemaker should beware.

Come September, there'll be a new one. ...

Its opening is likely to reignite a debate on whether Minnesota has too many diagnostic imaging facilities, encouraging doctors to order unnecessary procedures and pushing up medical costs. It's also likely to raise the ethically thorny question of whether doctors should refer patients to a facility in which they have a financial stake.

"Imaging has been an area of concern for a long time," said Julie Sonier, director of the Minnesota Department of Health's health economics program, which does reviews of major medical investments. "Issues about the concentration in Edina have also been a concern for some time."

A 2007 Health Department report said there was anecdotal evidence in Minnesota that physician investments in facilities led to financial conflicts of interest and overuse.

Among the reader responses are these:

• As a patient, how do you know that you really need a test that may be uncomfortable, that might have some risk associated, that might have radiation exposure associated, and that you might have to pay for when you know that the person telling you you need it stands to make up to $1000 just for suggesting it? The answer is you can't. This practice is a pox on medicine.

• There are as many MRI scanners in the Twin Cities as in all of Canada. Is the health of Canadians compromised by fewer imaging studies? Obviously not. There is no relationship between the number of tests and procedures performed in medical care and the health outcomes of the patients. More medical care is not better care. The Health Department should carefully examine the merits of this expansion of imaging services.
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July 29, 2008

Insurers say we're wasting $30B a year on scans

Bloomberg reports:

"Insurers, led by WellPoint Inc. and Magellan Health Services Inc., are increasingly rejecting imaging procedures recommended by U.S. doctors as the companies work to trim $30 billion a year they say is wasted on the tests.

CT and MRI scans that allow doctors to peer inside the body can cost as much as $2,000 each. Almost 50 percent of scans for some conditions fail to improve patients' diagnoses or treatment, according to a report issued today by America's Health Insurance Plans, a Washington-based trade group.

With U.S. health costs projected to grow to 25 percent of the economy in 2025 from 16 percent now, insurers are turning to so-called radiology benefit managers who can reject scans determined to be unneeded, said Shay Pratt of the Advisory Board Co., a Washington-based consultant to hospitals. Doctors ordered 115 million of the procedures last year. More than 80 million Americans already must get advance approval for the tests, and that may grow to 120 million in two years, Pratt said. ...

Almost $100 billion a year is spent on imaging in the U.S. and that may double by 2013 unless costs are reined in, according to the report today by America's Health Insurance Plans. ...

The Congressional Budget Office cited the ``widespread diffusion of new medical technologies and services'' as a leading cause of cost increases in its November report forecasting that health care will grow from 16 percent of the U.S. economy to 25 percent by 2025 unless changes are made. Health spending is currently $2.4 trillion, according to U.S. estimates.

Medicare, the U.S. health-care program for the elderly and disabled, has taken an initial step by reducing payments for scanning facilities when they perform more than one procedure on the same patient in the same day. ...

The Government Accountability Office, the investigative arm of Congress, said last month that Medicare should consider requiring pre-authorization for outpatient imaging of its 44 million beneficiaries."

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June 29, 2008

To hell with evidence

Read this terrific piece of journalism in the New York Times - "Weighing the Costs of a CT Scan's Look Inside the Heart."

It analyzes important questions about the lack of evidence for these tests, the costs, the radiation risks, and the conflicts of interest of many who promote them.

The story includes a quote from a physician who is a heart CT scan promoter - "It's incumbent on the community to dispense with the need for evidence-based medicine."

To hell with evidence. To hell with science.

This attitude always reminds of me of the saying, "It ain't what a man don't know that gets him into trouble. It's what he knows for sure that just ain't so."

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June 24, 2008

"If a surgeon recommends this, run away as fast as you can."

Judy Foreman reports on an alternative to hip surgery that, "propelled by aggressive marketing featuring pictures of vigorous, youngish athletes, is sweeping the United States: hip resurfacing."

She reports on one man who had it done, and whose surgeon is among those who "are worried about the rate at which doctors, most of whom are still on a steep learning curve for this technically demanding procedure, are jumping to do it."

She quotes another surgeon who advises that if a surgeon recommends hip resurfacing, "Run away as fast as you can. Or limp out of that office. There is no advantage and many disadvantages. It won't give you anything more than a total hip replacement, and with some significant downsides."

Good article. Good snapshot of medical technology assessment (or lack thereof) - especially when it comes to surgical procedures.

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May 10, 2008

Is ultrasound the stethoscope of the 21st century?

Journalist Jacqui Wise writes from London in the BMJ about the explosion in ultrasound use, some turf war issues over the technology, and concerns about training and proper use. Excerpts:

"Ultrasound machines were once the size of washing machines and used solely by radiologists and sonographers working in radiology departments. But in the past 10 years they have become cheaper, smaller, and more portable—the latest models are even pocket sized.

As a result ultrasound machines are increasingly used by non-radiologists as part of the clinical examination or to assist in practical procedures such as insertion of a central line. The number of general practitioners buying their own ultrasound machines has also gradually increased. So is this good or bad news for patients?

Gill Markham, vice president of the Royal College of Radiologists, says: "The price of an ultrasound machine has come down enormously to £5000-£10 000 [{euro}6000-{euro}12 000; $10 000-$20 000] and as a result they are used much more widely. Ultrasound has a reputation as a simple, easy test. It is easy to do but interpreting the results is not so easy and there are things that could be missed."

Paul Allan, clinical director of radiology for Edinburgh, agrees: "There are people with very little training using ultrasound badly." He says he is aware of surgeons doing ultrasound investigations for acute abdominal pain and mistaking invasive cancers for ruptured spleen.

The key issue is adequate training. As Dr Allan says, "I have no problem with who does ultrasound investigations, but they must be trained. Ultrasound does require experience and expertise. There is no physical risk to the patient but there is a risk of false negatives or false positives."

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April 21, 2008

Drug-and-device-reps-free zone

Psychiatrist Daniel Carlat, whose blog is one of the smartest publications on the Web, recently
wrote:

I've had it. As of today, I am no longer allowing drug reps into my office.

Yes, until today, I was seeing reps a few times a month for 5 minute visits in order to keep up on trends in drug company marketing techniques. But today, an Astra Zeneca rep and his district manager came in to push Seroquel for bipolar depression. They came armed with the two studies that won Seroquel its FDA approval. The studies have their limitations, but somehow these reps didn't bring these up.

Instead, what I got was a ridiculous hard sell: "Dr. Carlat, given this data, would you choose Seroquel over the other atypical antipsychotics for bipolar depression?" I asked them if Astra Zeneca had done any head-to-head studies comparing Seroquel with the others. The rep adopted a pseudo-confused look, and said, "I'm not even sure that kind of study would be ethical--would the FDA even allow you to compare an approved drug with an unapproved drug?" I pointed out that the FDA, in fact, requires that drugs be compared with placebo, the ultimate in "unapproved" drugs, and that they deem this ethical enough.

He tried another tack. "What are the symptoms of bipolar depression that you have the hardest time treating?" I said that all the symptoms are hard to treat--that, in fact, bipolar depression is a very difficult illness to treat. Out came his computer, with a slide showing that Seroquel successfully treated every one of the depressive symptoms in one study. "Now doctor, if you had a patient come into your office with suicidal ideation, and you had an agent that would help those symptoms in a week, wouldn't you want to use that agent?"

Of course I would, and there are many other agents that will work better than placebo in a week. But my rep wasn't interested in talking about the alternatives. The focus, as always, was on his product, and on his bonus.

I've printed out the National Physicians Alliance's brochure, "Why Doesn't My Doctor See Drug Reps?" and will put it in my waiting room. I'll let you know how my patients respond. For now, I'm still accepting samples (making me the most despised of doctors among drug reps, a "sample-grabber") but that will be the next to go.

Meantime, my local Star Tribune newspaper today published a story cheerleading for a local device manufacturer.

Strib device rep.png

With the story came the photo above, showing a device rep making his pitch to health care professionals. The story and the photo seem to come from a different planet - far away from any controversy or concerns about the coziness of such a reps-in-the-clinical-setting repertoire. Not a word about the kind of concerns that Dr. Carlat and so many others have raised. But as I've noted before, there appears to be an "anything goes" attitude with a different code of ethics for local business news on the business page.

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April 2, 2008

We should expect better from a medical journal

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."

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March 31, 2008

The bandwagon for gastric banding

See "Industry Giants Push Weight Surgery" in the WSJ today.

Excerpts:

Medical-device makers, venture capitalists and surgeons are racing to turn gastric banding, a once-controversial weight-loss procedure, into the next big elective surgery in the U.S.

"There's no question that advertising and the commercialization of the band is what's driving it," says J.K. Champion, a bariatric surgeon in Atlanta.

Unlike the band makers, physicians and clinics can make advertising claims that aren't subject to the strict rules imposed by the Food and Drug Administration.

An end-run around the anatomy. An end-run around regulations. Fat chance this will stop anytime soon.

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December 13, 2007

Heart stent ads during heart-stopping football

In what one physician calls a "deplorable" move that may be "a sign of desperation," Johnson & Johnson's Cordis unit has begun a direct-to-consumer ad campaign to promote its Cypher coronary artery stents.

You can read more in the New York Times, or read some bloggers' reactions here.

So picture one of these scenarios:

• during a televised football game (where the first ad appeared), a guy sorts through all the ad messages about erectile dysfunction, restless leg syndrome, sleep problems, and now coronary artery stents and decides to ask his physician on the next visit if a stent is right for him.

• on the cath lab table, after an arteriogram demonstrates his coronary artery blockage, a guy sits up and says, "OK, then. Go ahead with the stent. But be sure it's a Cypher!"


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December 6, 2007

More on the medical arms race syndrome

In his regular e-mail newsletter and commentary, former U.S. Senator David Durenberger writes:

FDA approval of Abbott Lab's new drug-coated stent called Xience means there will now be four large corporate competitors in a relatively small field selling Taxus from Boston Scientific, Cypher from J and J, Endeavor from Medtronic, and a version of the Xience stent called Promus from Boston Scientific (with a drug coating different from Taxus). Multiply those products by thousands of sales persons in the cardiac market and the answer is a gradual expansion of the now $2 billion a year market for stents in this country. Since insurance payments go to hospitals who have financial incentives to encourage the heart surgery in which the stent is implaced, and surgical fees to surgeons who do them, the definition of "medical necessity" is determined by the surgeon's judgment and by the device supply market, not necessarily by the appropriateness nor by the cost-effectiveness of a particular surgery or stent.
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November 7, 2007

Kickbacks to orthopedic surgeons

From Integrity in Science Watch, a publication of the Center for Science in the Public Interest:

"Nearly 50 orthopedic surgeons, many affiliated with the nation’s top teaching hospitals, each earned over $1 million a year in consulting contracts and royalties from the five companies that make artificial knees and hips. The payment disclosures were posted on the companies’ websites last week as part of a $311 million anti-kickback settlement between four of the firms and the U.S. attorney for northern New Jersey. The complaint had accused the companies of using consulting contracts as an illegal kickback scheme to get surgeons to use a particular company’s artificial joints. ...

With seniors accounting for nearly 70 percent of the knee and hip replacement market, Medicare spent $16 billion on the procedures last year. A typical knee replacement costs $33,000, according to Medicare records. A spokesman for Christopher J. Christie, the U.S. attorney in Newark, said the investigation into the alleged kickback scheme is ongoing."

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May 5, 2007

Medicare rejects depression device the media helped hype

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.

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April 10, 2007

Old concerns about new medical device ads

The Wall Street Journal's "Media & Marketing" section today has a column on "New Medical Device Ads; Old Concerns."

The Journal mentions Medtronic's ad for an implantable defibrillator with the line:

"If you've had a heart attack or have heart failure, inside this little device, you just might find 10,000 more kisses, snow, 200 more football wins..."

And Zimmer Holdings' ad for a knee replacement for women. The ad tells viewers they will be "amazed at what a difference a knee replacement can make."

The column's subhead is "Can a knee implant be sold this way, and should it be?"

Can't wait for next year's Super Bowl ads for penile and hair implants, artificial knees specifically designed for couch potatoes, and defibrillators to shock you back to life in time for the second half.

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February 15, 2007

How many high-priced robots and scanners can we afford?

The cover story of Minnesota Medicine is “The Medical Arms race: how many high-priced robots and scanners can we afford??

Excerpt: “How many children’s hospitals, heart centers, bariatric centers, robotic surgery systems, PET scanners, MRI scanners, and so on does a given population area need to serve its genuine health care requirements, as opposed to the maximum convenience of patients or the economic interests of physicians and hospitals?

Former U.S. Sen. David Durenberger, chair of the National Institute of Health Policy (NIHP) at the University of St. Thomas in Minneapolis, is one of the more vocal critics. …

As an example, he points to the CyberKnife, a radiosurgery system that enables treatment of intracranial and extracranial tumors previously considered inoperable. According to news reports, a CyberKnife lists for more than $3.5 million. In 2003, St. Joseph’s Hospital in St. Paul was the only center in the Upper Midwest that had one. Now there is another CyberKnife at Miller-Dwan Hospital in Duluth. ‘Where did all the extra patients come from?’ Durenberger asks. ‘Was there a long waiting line at St. Joseph’s? I suspect not.’

Another case in point: the da Vinci robot, a $1 million-plus system used for laparoscopic surgeries such as gallbladder removals, prostatectomies, and bariatric surgery. In 2004, three Minnesota hospitals (the University of Minnesota Medical Center, HealthEast St. John’s, and Mayo Clinic in Rochester) had da Vinci systems. By 2006, the robots were in six hospitals, including facilities in Duluth and St. Cloud, according to manufacturer Intuitive Surgical Systems of Sunnyvale, California. Surgeons report a number of benefits these systems provide, such as an improved view of the surgical field and the elimination of tremor in movement. But a study of the 202 initial robotic abdominal surgery cases performed at Johns Hopkins University Hospital in Baltimore found that ‘clinical data demonstrating improved [patient] outcomes are lacking.’

The concern is that the proliferation of CyberKnifes and da Vincis and free-standing $2-million MRI scanners and $1-million CT scanners may be driven less by patient need than by market share or providers’ desire to use the latest technology to attract specialists who do procedures that pay well: gastroenterologists, cardiologists, and neurosurgeons, for example. A claim on the Web site of Sunnyvale, California-based Accuray, CyberKnife’s maker, is that buyers say the device ‘attracts new patients and increases their practice volumes.’

But the issue of cost-effectiveness is nowhere addressed, he says.

‘In any other industry,’ Durenberger says, ‘when someone invents something new, market mechanisms determine whether it catches on and to what extent.’ For instance, if someone invents a video game, ‘there is a market that tells you this is something that X number of people want and are willing to pay X dollars for. That analogy applies practically everywhere except in health care.’ “

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February 2, 2007

Doctors decry scan approval oversight

The explosion in the use of diagnostic imaging - particularly high-tech, high cost scans such as CT, MRI and PET scans - has led to many questons about appropriateness of all these scans. I've blogged about some of these concerns as recently as last week.

In Minnesota, the Medica health plan claims that 15 to 20 percent of the scans it pays for are not appropriate for the condition being treated, according to a story in the Star Tribune.

But the real news the paper reports is that three insurers have begun (or will soon) to require third-party review by an outside evaluator of all requests for such high tech scans. And doctors don't like it.

The paper reports: "In a letter obtained by the Star Tribune, the 11,000-member Minnesota Medical Association (MMA) asserts that the new third-party consultation places a burden on patients and clinics alike and will 'interfere with the patient-physician relationship. Physicians throughout Minnesota, whether practicing in urban or rural, primary care or specialty, large or small group practices, along with health care leaders in the community, agree this is the wrong direction to take,' said the letter."

This is an important issue.

Why, for example are there something like 20 CT or MRI machines within a two-mile radius of one medical center in metropolitan Minneapolis?

Who says all of those machines are needed? Who knows if all the scans are warranted? And who pays when those machines go unused?

Some may claim that insurers are denying appropriate care, but I think they're asking legitimate questions that may answer some of the questions above.

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January 25, 2007

MRI kickbacks

On this blog, we've followed stories that show how doctors' referral arrangements to MRI and CT scanning centers may make them rich while possibly violating the law. And we advised: "Think about that the next time you see a news story or an ad promoting the latest CT, MRI or PET scanner in your community. Follow the money. And then start to question whether all the scans are necessary."

Last week, the Wall Stree Journal (subscription required) reported on a whistleblower lawsuit that "details a widespread scheme among Chicago-area MRI operators to win referrals from doctors by allegedly signing the doctors to phony equipment lease deals that result in the physicians getting a kickback when they order scans for patients. ... The lawsuit strikes at an increasingly common arrangement between magnetic-resonance-imaging centers and doctors that is blamed for helping to fuel a staggering increase in the number of medical imaging tests done each year in the U.S."

This is a story worth following - in Illinois and across the country.

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January 16, 2007

$100 million defib device ad campaign

The assault on our senses from drug ads will now be a bit greater with new ads pushing heart-shocking defibrillator devices.

The Minneapolis Star Tribune reports:

"Medical technology giant Medtronic Inc. will launch a $100 million marketing campaign today to raise awareness about the dangers of sudden cardiac arrest -- and the role of heart defibrillators in saving lives.

Some of the advertising in newspapers and on TV will be aimed at consumers, in addition to doctors. That's common practice in the drug industry but rare for medical device companies.

That could be changing as aging baby boomers take a more active role in their health care. Consumer advertising of medical devices reached the $50 million mark in 2005, an increase from "almost nothing" in 1996, according to a report by Cutting Edge Information, a Raleigh, N.C., market research firm."

But the Star Tribune takes the bait when it writes, "Part of the problem is that patients who need the devices aren't necessarily getting them -- Medtronic estimates roughly 850,000 Americans are in this category. Put another way, less than 35 percent of patients who need an ICD have one -- yet the therapy is effective 98 percent of the time, the company said."

Who says who needs the devices? That should be a matter between patients and their doctors. Any such campaign has one goal: to increase the market share. You can wrap it in all the euphemism about "educating patients" that you wish. But I'm not going to walk into my doctor and say, "Gee, doc, I think I need a Medtronic defibrillator!"

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December 22, 2006

Lump of coal for heart stocking story

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.

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November 22, 2006

Egregious spinning of lung cancer screening news

In the latest edition of The Cancer Letter (Nov. 22, 2006, Vol. 32 No. 42), Editor & Publisher Kirsten Boyd Goldberg and Editor Paul Goldberg, publish an extremely important and troubling followup to the lung cancer CT scanning study published in the New England Journal of Medicine several weeks ago. They obtained documents distributed by the the International Early Lung Cancer Action Program – or I-ELCAP - the organization that conducted the study published in the NEJM. The documents give “talking points? to be used in media interviews about the study. Physicians who put patients on the study were urged to repeatedly use the word “compelling? to describe the results being published, refrain from mentioning ongoing randomized trials, and urge people to get screened. The “talking points? also urged interviewees to avoid using the terms “observational or noncomparative? to describe the design of the trial – even though those are accurate terms for the study design, seen as a limitation by some critics.

In the article, ethicist Heidi Malm says “Why instruct other researchers not to state factual claims? This limits informed consent by suggesting that this kind of study has the same merit as other studies. [Claudia Henschke, I-ELCAP principal investigator and lead author of the study] is blocking the terms that would make it clear that it isn’t the same kind of study, so people might just assume that it has the same evidentiary quality as a randomized clinical trial. This limits informed consent from the public. They are assuming this has been shown to be effective in terms of saving lives and not just in terms of finding new cancers. It feeds into the misassumption by the public that finding more cancers is the same as saving more lives and that’s what we need the randomized trial to show.?

I am also quoted in the article: “I consider myself well-informed on the latest methods of ‘managing the media’ by different sources in the dissemination of health, medical and science information. I consider myself quite skeptical. Yet I am shocked by what is written in these I-ELCAP ‘soundbites.’ The admonition to ‘stay on the high ground’ begs the question of ‘what is the low ground?’ To me, the low ground is the deception that is recommended in these talking points. The advice is to avoid discussing the trial design. Here are scientists urging each other to mislead journalists into doing an inferior job. The observational nature of the trial is critical to consumer understanding. But the I-ELCAP PR machine advises spokespersons to run from the truth.?

A copy of the "talking points" spin document is included in The Cancer Letter article. While the Letter is a subscription-only publication, Editor & Publisher Kirsten Boyd Goldberg says she will send a free copy to anyone who writes to her at: kirsten@cancerletter.com.

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November 17, 2006

Why evidence-based medicine is important

The New York Times published an important story, "When Blind Faith In A Medical Fix Is Broken." Excerpt:

"A major study, presented Tuesday at a medical conference in Chicago, challenged the widespread use of tiny balloons and metal stents in people who had suffered heart attacks days or weeks before.

Although such treatment can be lifesaving in the early stages of a heart attack, the study found that opening the artery later did no good at all. It merely exposed patients to the discomfort, risk and $10,000 expense of an invasive procedure.

The new report is the latest example of a rigorous experiment turning medical practice on its head by proving that a widely accepted treatment is not the great boon it was thought to be (except maybe to the bank accounts of doctors, drug companies and makers of medical devices). "

Read the rest of the story for other examples.

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October 30, 2006

Medicine in conflict

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?

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