Gizmo Idolatry --> RE: Needleless Lidocaine (et al) Injector

[Guest guest]

I do love my Gizmo's...and Idols for that matter. ;-)

See below

Locke, MD

http://jama.ama-assn.org/cgi/content/short/299/15/1830

Gizmo Idolatry

Bruce Leff, MD; E. Finucane, MD

JAMA. 2008;299(15):1830-1832.

It seems that "gizmo idolatry" now exists in the practice of medicine. "Gizmo" is defined by the American Heritage Dictionary as "a mechanical device or part whose name is forgotten or unknown; a gadget." In this article, gizmo is used to refer to a mechanical device or procedure for which the clinical benefit in a specific clinical context is not clearly established, and gizmo idolatry refers to the general implicit conviction that a more technological approach is intrinsically better than one that is less technological unless, or perhaps even if, there is strong evidence to the contrary. The credulous acceptance and rapid diffusion of frontal lobotomies in the 1930s and 1940s led to great harm, and to a Nobel Prize for Egas Moniz in 1949 "for his discovery of the therapeutic value of leucotomy in certain psychoses."1 Autologous bone marrow transplantation for breast . . . [Full Text of this Article]

Common Sense AppealAuthor Affiliations: Department of Medicine, s Hopkins University School of Medicine (Drs Leff and Finucane), and s Hopkins University Bloomberg School of Public Health (Dr Leff), s Hopkins Bayview Medical Center, Baltimore, land.

http://www.6minutes.com.au/michael_blog/blogposts.asp?postid=646

Are you prone to gizmo worship?By Woodhead, 6minutes editor The medical profession has fallen into the trap of “gizmo idolatry” to the detriment of patient care, according to two US doctors writing in JAMA this week.Doctors are like other human beings in having a weak spot for gadgets that have all the latest bells and whistles say Dr Bruce Leff and Dr Finucane of s Hopkins University.They say that while some new technologies have a useful place in patient care, many doctors are becoming enthusiastic “early adopters” of new gadgets and technologies simply for the “gizmo quotient”.Gizmos are popular, they say, because their cachet boosts the status of the user, confers more significance on the disease and increases the appeal of an intervention. They cite examples such as coronary CT scans and PET scans for dementia where everyone is dazzled by the technology, but the evidence remains far from convincing. And yet, even without good evidence, the use of gizmos is seen as a sign of competence - especially when they are able to provide “objective” information which may be of little help to the patient.The threat in litigation also encourages the use of gizmos, the doctors argue, because of the pervasive belief that the latest technology represents the highest form of care. And of course profit is a great driver of gizmo use in medicine, they claim, with whole business models built around particular technologies such as the recent “nerve testing device” mentioned in the New York Times.Gizmo use is also driven by tech savvy patients who expect the same approach in medicine as they do in their everyday life surrounded by mobile phones, iPods and DVD players.But often the best medicine is painstaking diligence, “watchful waiting” and lifestyle changes, say Drs Leff and Finucane. These are seen as the menial and low status tasks in medicine, where surgery and interventional approaches are highly prized. There may even be harms from gizmo idolatry when early uncritical adoption of new technologies occurs in the absence of proper evaluation. They cite example such as Swan Ganz catheters, which they say did not improve outcomes and resulted in more complications.“Clinicians should resist the clamour for the new and fancy,” they advise.“Recognition of gizmo idolatry is the first step in educating … both clinicians and patients to be circumspect rather than enthusiastic and to seek evidence of the effectiveness of any medical technology,” they conclude. Comments

Elliott is right that computerised dermoscopy that relies on computer analysis is no better (well, actually inferior) to a trained human with a dermoscope. Where computerized dermoscopy excels is in efficiently monitoring lesions over time (image comparison still requires a human to analyse), which can pick up a large percentage of the 10% of melanomas that are otherwise “featureless” - without resulting in greatly increased biopsy rates.Jeff KeirPosted by Jeff Keir on Monday, 21 April 2008

EditorAgreed - the worship if Gizmo's has reached great heights.One good example is the computerized dermatoscopic machines - not really offering any real diagnostic advantage over the simple dermatascope, but because it's "computerized", it must be betterThanks ElliottPosted by Elliott on Monday, 21 April 2008

================================================

http://www.nytimes.com/2006/10/20/business/20device.html?_r=1 & oref=slogin & pagewanted=all

New Nerve Test, a Moneymaker, Divides Doctors

Dr. D. England says NC-stat is being “utilized by physicians who are not qualified to do these tests.”

By REED ABELSON

Published: October 20, 2006

For many doctors, it’s an irresistible pitch: a $250 profit from a 15-minute test.

Skip to next paragraph

Side EffectsAutomatic DiagnosisArticles in this series are examining how monetary considerations can influence the ways doctors conduct business and practice medicine.

Enlarge This Image

Alison Dinstel for The New York Times

A marketing DVD to physicians shows the NC-stat system in use.

With that lure, some 12,000 of the nation’s physicians have purchased an automated device that checks patients for nerve disease. Such a diagnosis might otherwise require extensive testing by specialists.

Indeed, many neurologists, who stand to lose money and patients from the growing popularity of the device, say that the general practitioners who use it are not always capable of discovering the true cause of a patient’s symptoms. Some insurers and other doctors also have qualms about use of the automated test to diagnose possible nerve damage.

One neurologist cites an extreme case, in which a general practitioner diagnosed arm numbness as carpal tunnel syndrome but missed the main cause: a brain tumor.

The system, made by a company called Neurometrix, “is being marketed to and utilized by physicians who are not qualified to do these tests,” said Dr. D. England, a neurologist at the Billings Clinic in Montana who is also an officer for a national professional society of specialists and was the doctor who discovered the brain tumor.

The popularity of Neurometrix’s nerve-testing system, called the NC-stat, speaks to the zealous sales practices that some makers of medical devices employ to build the largest possible market for their products. The company’s marketing is the subject of an investigation by federal regulators, with which the company says it is cooperating. But the product’s success among general practitioners — the company’s primary customers — also touches on a more fundamental fact of the American health care system. Medicare and other insurers tend to pay doctors much more for performing diagnostic tests and other billable procedures than for spending time talking with patients about their symptoms and figuring out how best to treat them.

“NC-stat is a Billable Procedure,” says one slide in a Neurometrix marketing DVD obtained by The New York Times.

A worksheet prepared by one former Neurometrix salesman, labeled “CONFIDENTIAL OPPORTUNITY,” showed how a doctor could realize an annual profit of $46,588.80 by testing 10 patients a week.

“The doctor’s making margin, the company’s making money,” said the former salesman, who shared the document and spoke only on condition of anonymity.

For physicians, who might be able to bill only $80 or so for a routine 30-minute office visit, Neurometrix’s promise of a profit as high as $250 for 15 minutes, is compelling. So was a customer-referral program in which physicians could receive hundreds of dollars in free products for steering other doctors to Neurometrix.

Dr. Shai N. Gozani, Neurometrix’s founder and chief executive, said he could not comment on the specific marketing materials but said the company was “very ethical.”

And he said the company’s marketing efforts stressed the medical over the monetary. “I think our messaging to physicians is clinical first,” Dr. Gozani said.

Neurometrix says there is no evidence that doctors are using the tests inappropriately and that, on average, they are testing only a handful of patients a month.

“By no means do we believe this is a replacement for neurologists,” said Dr. Gozani, who said the doctors referred patients to specialists whenever necessary.

The company says it plans within the next six months to publish research on how doctors are using the test, based on their experience with thousands of patients.

While Medicare and many insurers are paying for the Neurometrix test, other insurers have rejected it as unproven or are now having second thoughts about covering it.

And a Chicago surgeon, to whom doctors have referred cases based on Neurometrix exams, also says he is wary of the diagnoses.

Whenever carpal tunnel syndrome has been found with a Neurometrix test, “it always makes me more uncomfortable,” said the surgeon, who noted that he sometimes referred such patients to a neurologist to rule out more complex problems. The surgeon insisted on anonymity for fear of offending doctors who refer patients to him.

General practitioners who have purchased the device, which sells for around $5,000, say they are qualified to use it. The test is generally used to check for signs of nerve damage associated with carpal tunnel syndrome, diabetes or low-back pain. The company says the system enables patients to be screened more quickly, and to start treatment sooner, than if they must wait to be seen by specialists.

Since the Food and Drug Administration approved the NC-stat in 1998, the company estimates that more than 500,000 patients have been tested with the system, in which biosensors are attached to the skin to stimulate nerves, and a hand-held device records the results. The doctor can transmit the readings to the company and within minutes receive the findings by a fax or e-mail message.

The device is “a good revenue maker,” said Poole, a manager at the family practice Colstrip Medical Center in Montana, but, he added, “we don’t want to abuse it.”

Neurometrix, a small medical device maker with billion-dollar ambitions, says that its system has removed much of the complexity inherent in traditional neurology exams.

“We’ve put that technology in the hands of all physicians, allowing them to replicate the diagnostic accuracy of the specialist,” Dr. Gozani told financial analysts and others at a recent meeting.

Dr. Gozani, a medical doctor with advanced degrees in biomedical engineering and neurobiology, said the company’s device represented “a new standard of care.”

Still, some former employees and Neurometrix’s own sales materials portray a company willing to go to great lengths to sell its device.

In May, Neurometrix said the Department of Health and Human Services had issued a subpoena for documents from the company in connection with potential kickbacks and possible fraud against the federal government. The company offered no further details, and federal regulators declined to comment.

Several former employees and Neurometrix documents also describe a program to reward physicians who are already customers, if they find other doctors who will purchase the system. The company gave away boxes of the disposable biosensors that are used with the system — which Neurometrix typically sells to the doctor for around $200 a box.

“Allow us to thank you for your loyalty,” reads a document from this year. If a prospective customer agreed to meet with a sales representative, the referring doctor got one box of sensors — and a second if the prospect became a customer.

Giving doctors something of value for referrals is an industry practice that can potentially violate federal antikickback laws, said Bruce A. Levy, a lawyer in Newark who used to work for the United States attorney there.

Dr. Gozani said the giveaway program had been “extremely small,” involving a tiny fraction of the sensors the company sells. He said Neurometrix had recently stopped it, but declined to comment further.

Neurometrix, based in Waltham, Mass., is eager to please Wall Street and investors with fast growth. The company went public in 2004. Sales last year doubled, to $34 million, and are expected to be $55 million or so this year.

Neurometrix cites numerous studies, written up in medical journals, that compared its nerve tests with traditional methods and found them just as accurate.

Medicare and many other insurers, including some Blue Cross/Blue Shield plans, have paid for many of the tests. But some large insurers, including Aetna and Cigna, say they do not generally cover the Neurometrix test because there is inadequate clinical evidence to support it. Cigna says it is reluctant to cover a new test when there are existing methods that have proven reliable in making a diagnosis.

The federal Medicare program leaves the coverage decision to the nearly 20 regional insurers that oversee payments to physicians. Some of these regional Medicare offices are currently reviewing their coverage policies on the Neurometrix test.

Physicians using the device have not told the company they are having trouble getting reimbursed for the tests, Dr. Gozani said. But doubts about insurance coverage have contributed to the volatility of Neurometrix’s stock price in recent months. Short-sellers — investors who bet that a stock’s price will fall — have a large position in the stock.

The debate within the medical community has been muted in part by letters from Neurometrix threatening legal action against some doctors who criticized its technology.

One target was the Arizona Neurological Society, after its Web site posted a sharp critique, according to the society’s president, Dr. Terry D. Fife. The critique claimed that the Neurometrix system produced “results that may be misleading or even wrong” and suggested doctors “are likely to use it excessively for the sole purpose of generating income.”

Dr. Fife said he received a threatening letter in August from the company’s lawyers, saying questions about the test’s accuracy were “unsubstantiated innuendo.” If the Web site continued to post the commentary, the letter said, the society would risk “legal claims both for violations of the antitrust laws and for defamation and for miscellaneous other intentional torts.”

Dr. Fife said that he removed the critique and that the society did not plan to publicly comment on the technology again, because it did not want to risk a lawsuit.

The company says it has sent letters only in isolated cases. “We are by no means trying to limit the discussion,” Dr. Gozani said.

For some health policy analysts, the popularity of such procedures illustrates why primary care doctors should be paid more for basic office visits and less for money-making procedures. Earning $250 from a diagnostic test “is obviously out of line with what physicians can earn from office visits,” said Ginsburg, the president of the Center for Studying Health System Change, a Washington research group.

But many primary care doctors, including family physicians, defend their adoption of the Neurometrix test and say they are not overusing it.

“Family physicians can safely and reliably administer the tests,” said Dr. Lehman, an official with the Ohio Academy of Family Physicians, which has been fighting efforts by the Medicare administrator in that state to curtail use of the tests. “It’s more convenient for the patients,” he said, “and it’s quicker.”

From: [mailto: ] On Behalf Of Sent: Monday, April 21, 2008 5:53 AMTo: Subject: Re: Needleless Lidocaine (et al) Injector

kelley-JAMA this past week article titled "gizmo Idolatry"for you.