At an article today entitled “Medtronic Says Device for Spine Faces Probe” (Wall St. Journal, Nov. 19, 2008, subscription required) the WSJ reports another major medical device manufacturer, Medtronic, faces a probe for promoting unapproved uses of its technologies, which is improper:

Doctors can deploy FDA-approved drugs and products any way they see fit, but companies aren’t permitted to promote off-label applications or to pay doctors inducements to do so.

“While the law establishes that doctors can prescribe any approved treatment, but off-label promotion by manufacturers is not allowed, there’s growing concern that the line is being crossed, and a Justice Department review is the right kind of response to those questions,” said Sen. Charles Grassley (R., Iowa) who has been looking into whether inducements by Medtronic have led doctors to use its products off-label.

This type of story is common at Healthcare Renewal, and the blog leaves quite a rich trail of search engine-available information, since the healthcare blogs are relatively immune to the anechoic effect. I see numerous hits from governmental agencies in the U.S. and overseas, for example, on search engine queries regarding malfeasance or incompetence at specific companies and organizations. I will not comment on the ethics of the Medtronic/nonapproved promotion issue any further here.

I do want to comment, however, on an item in the WSJ article that caught my eye:

Depositions in a malpractice lawsuit brought by Laurie DeNeui, of Rushmore, Minn., focused on off-label Infuse use and Medtronic salesman Curt Messler’s relationship to her spinal surgeon, Bryan J. Wellman of Sioux Falls, S.D. Mr. Messler said in his depositions in the case that he was with Dr. Wellman in the operating room “a lot” when he used Infuse. He also said he considered Dr. Wellman a friend and said the men saw each other socially.

… About four days after her October 2005 operation to fuse cervical vertebrae, Ms. DeNeui said in an interview, her neck swelled up, she had trouble swallowing and she started choking on food. Soon, she said, she started having difficulty breathing. Ms, DeNeui, 46, said the problems prevented her from returning to work as a teacher and baffled several specialists. Steroid treatment helped ease the breathing and gagging problems, but caused her to gain weight and contract diabetes.

Dr. Wellman denies any malpractice. In a deposition, he said Mr. Messler encouraged him to use Infuse in cervical spine operations, and that he has done more than 100 such procedures with the product. Dr. Wellman said he discussed with Mr. Messler the right dosage of the Infuse material to use in the surgeries but determined the dosage on his own.

Mr. Messler, who isn’t a physician, has a degree in criminal justice, and his prior work history included owning a bar and jobs with New York Life Insurance Co. and Procter & Gamble Co. In his depositions, Mr. Messler denied encouraging Dr. Wellman to use Infuse for unapproved applications or discussing how much to use.

This is the typical I said-he said scenario. That issue’s adjudication will also not be discussed here. While the article also states this patient signed a consent to permit Medtronic representatives to be in the operating room, I have several questions of a very fundamental nature.

In background to these questions, when I was fifteen years old I attended the summer NSF-funded Advanced Preceptorship Training Program (ATP) at Hahnemann Medical College and Hospital back in the early 1970’s. It was a program designed to introduce high school students to biomedicine (ironically Hahnemann’s former medical college is now part of Drexel University, where I teach healthcare informatics). I was assigned back then to watch surgery under the surgical team of Drs. Pearce, Ulin and Weinstein, permitted to scrub in and hold retractors, and in one case to actually saw through a femur in a leg amputation for diabetes-related gangrene. I also made rounds with the surgical team. While today this practice would probably not be permitted on privacy and malpractice concerns, I can honesty admit I offered no advice on surgical procedures or other interventions. I simply didn’t have the background.

In the Medtronics situation of reps in the O.R., I thus ask the following questions:

• Were patients and others in the O.R. aware of the lack of the Medtronic sales representative’s medical credentials?
• Are such consents sought and signed routinely for allowance of medical device company reps in the operating theater?
• What, exactly, was the purpose of having a nonmedical person in the O.R.? What, exactly, could such a person contribute?
• Why would any patient want a nonmedical person in the O.R. with the potential for that person to give advice or affect the procedure in some manner?
• What were patients told to convince them to sign the consent?
• If advice was given of any kind to any clinician the O.R., would that not constitute the practice of medicine without a license?
• What were the rep’s obligations if they witnessed anything they thought could be misuse of the device, or any other practice they thought improper?
• Did the rep follow the surgical team around in postop care?
• Why couldn’t Medtronic actually hire people with medical backgrounds for such roles, instead of a former bar owner and P&G sales rep? Could such people be afforded?
• Might people with medical credentials actually be better suited to make valid scientific observations in the OR setting?

These are just some of the questions that come to mind in the seemingly inexhaustible cornucopia of nonmedical people either leading healthcare organizations or performing roles perhaps better performed by people who actually have a medical background and actually know at a very granular level what they’re doing.

– SS

[Source : Health Care Renewal]

Starting last year, we posted (here, here, here, here and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves. Our last post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.

This month, the Minneapolis Star-Tribune published a series of reports on its investigation of payments made to orthopedic surgeons by medical device maker Medtronic. Unsealed documents from an ongoing lawsuit suggested that this company also made some strikingly large payments to orthopedic surgeons who perform spine surgery. The Star-Tribune’s first article focused on a single surgeon:

Dr. David Polly’s reputation precedes him and it’s worth a lot. Among spine surgeons, this rather unremarkable-looking 51-year-old is a rock star.

Arrayed before him as he spoke at the annual Design of Medical Devices Conference at the University of Minnesota were two dozen doctors, engineers, students and medical device company representatives, some furiously scribbling notes. In this reverential group, Polly’s mention of a particular surgical technique or medical device would be golden.

They already knew much about this man with a 29-page résumé. The head of orthopedic spine surgery at the university, Polly has led close to 80 research studies and co-written at least 90 scientific papers on repairing aging, injured and contorted spines. In an era of active baby boomers, many with ailing backs, Polly’s specialty is a growth industry.

Polly’s paid consulting relationship with Medtronic Inc., the global leader in medical devices, was not a focus of discussion that muggy April day. The Fridley-based firm makes the plates, screws, cages, neurostimulators and bone grafts that largely comprise the toolbox of spine repair.

A recently unsealed whistleblower lawsuit, and Congressional and Justice Department investigations, are finally bringing into public view the practice of handsomely reimbursing top doctors to consult for medical device companies.

The $344,375 in consulting fees Polly allegedly received from Medtronic in 2006, and similar amounts in 2004 and 2005, are only emerging because of a complaint filed in a whistleblower lawsuit by two former Medtronic employees in U.S. District Court in Massachusetts.

Another article focused on another surgeon:

Dr. Kenneth Burkus is quite confident his eight-year relationship as a paid consultant for Fridley-based medical device maker Medtronic Inc. hasn’t compromised his patients’ care.

The Columbus, Ga., surgeon said he receives royalties for helping to develop the company’s artificial neck disc and other products. A whistle-blower lawsuit filed in Massachusetts federal court alleges that he was paid $416,775 for consulting work in 2006.

I thought it might be useful to examine the extent that these two surgeons have disclosed their relationships with Medtronic in their published work.

Dr Polly is by far the more prolific writer. Most of his recent work is in Spine. So I looked at a 2008 review article on treatment of scoliosis for which he was senior author.(1) This is what was disclosed in the article:

Although one or more of the author(s)has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of the manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other non-profit organization which the author(s) has/have been associated. One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That was really specific, wasn’t it. The disclosure does not identify which author received payments, what company made the payments, how much they were, or what their purpose was.

I found two recent articles authored by Dr Burkus, both again in Spine. The most informative disclosure statement was from an article by Dimar et al(2)

One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That wording seems familiar, and presumably is the boilerplate favored by Spine. Of course, it is no more specific here than it was before.

The new investigations by the Star-Tribune suggest that huge payments to orthopedic surgeons by medical device companies are hardly confined to those related to hip and knee prostheses, and that spine surgeons seem no more eager to disclose these payments in any detail to the readers of their research articles than were surgeons who specialized in hip and knee replacement.

So I get to repeat myself. In my humble opinion, a disclosure that a journal article’s author received some sort of “benefits” from a company does not quite have the impact of a disclosure that the author received hundreds of thousands of dollars in consulting fees. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons’ enthusiasm for spine surgery, especially involving the use of specific products, might just have been a bit influenced by making hundreds of thousands of dollars a year in consulting payments from the manufacturers of those products.

Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from consulting fees almost enough to make a doctor rich? Inquiring minds want to know.

This is another argument for requiring full and detailed disclosure of all payments made to physicians, and to health care academics, and health care decision makers, beyond their usual salaries or fees, and that could have any bearing on their clinical or health care decision making.

References

1. Lenke LG, Kuklo TR, Ondra S, Polly DW. Rationale behind the current state-of-the-art treatment of scoliosis (in the pedicle screw era). Spine 2008; 33: 1051-1054.

2. Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistance matrix versus iliac crest bone graft. Spine 2006; 31: 2534-2539.

[Source : Health Care Renewal]

There are many medical devices used in the health industry to help save lives or to improve the quality of life of millions of individuals. In general, defibrillators are an electrical device used to counteract fibrillation of the heart muscle and restore normal heartbeat by applying a brief electric shock. Implanted cardio-defibrillators ICDs are used to shock the heart into normal rhythm after a patient suffers ventricular tachycardia or fibrillation, which are rapid, life-threatening arrhythmias originating in the lower chambers of the heart.

Guidant Failed to Disclose Known Flaws in its Defibrillators for Three Years

Guidant came under fire in the spring of 2005 after The New York Times reported that it failed to alert physicians and heart patients about a potential problem with the VENTAK PRIZM DR model defibrillator.

Since then, Guidant has admitted to knowing of malfunctions in its ICDs for three years but has continued to sell the defective ICDs, allowing them to be surgically implanted in patients, knowing that these patients were at risk for device failures that could lead to severe complications including death.

The New York Times reported that Guidant knew of the defects in a small number of its defibrillators as early as 2002 and yet continued to sell the old models, even though it had corrected the defect and was manufacturing newer models. In addition Guidant did not inform doctors and patients of the defect until it knew that the New York Times article would be published.

The FDA Recalls 50,000 Guidant ICDs

The Food and Drug Administration FDA oversees the safety of medical devices and on June 17, 2005, issued a nationwide recall of nearly 50,000 Guidant ICDs. These devices may develop an “internal short circuit without warning,” resulting in failure to deliver a shock when needed and are subject to memory errors. Less than a week later, Guidant issued a second safety advisory informing doctors to stop using five of its ICD models because a defective switch could cause them to malfunction.

Presently, Guidant is responding to Department of Justice administrative subpoenas requesting information related to faulty manufacturing, as well as FDA observations regarding manufacturing and quality control processes. New York Attorney General Eliot Spitzer filed suit against Guidant on November 3, 2005, stating, “We wouldnt permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device.”

Devices Subject to FDA Recall

As part of the FDAs oversight of medical devices the Administration has classified three classes of recalls, Class I, II, and III. Class I recalls are the most serious type of recall and indicates that there is a reasonable chance that the product will cause serious health problems or death. The FDA issued a Class I recall of the following Guidant devices:

CONTAK RENEWAL Model H135

CONTAK RENEWAL 2 Model H155

CONTAK RENEWAL 3 AVT Models M150, M155

CONTAK RENEWAL 3 AVT HE Models M157, M159

CONTAK RENEWAL 4 AVT Model M170, M175

CONTAK RENEWAL 4 AVT HE Models M177, M179

VENTAK PRIZM 2 DR Model 1861

VENTAK PRIZM AVT Model 1900

VITALITY AVT Model A135, A155

In a Class II FDA, recall there is a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems. The FDA also issued the following Class II recall of the following Guidant devices:

CONTAK RENEWAL 3 Model H170, H173, H175

CONTAK RENEWAL 3 DS HE Model H177

CONTAK RENEWAL 3 HE Model H177, H179

CONTAK RENEWAL 4 Model H190, H195

CONTAK RENEWAL 4 HE Models H197, H199

PRIZM 2 DR Model 1861

RENEWAL RF Model H230, H235

RENEWAL RF HE Model H239

These recalls have been issued because the products pose very serious health risks or death for patients. The FDA is continuing to investigate other defibrillators on the market. Patients who have experienced health problems or injury related to these devices should seek legal help.

About the Author

To learn more about the medical devices, visit http://guidant.legalview.com/. Also use http://www.LegalView.com to learn about other medical devices that may cause defects including the Zimmer Durom cup or learn about the most recent risks associated with Avandia, as well as how to contact an Avandia attorney.

Article Source: Content for Reprint

[Source : Full text health articles - Content for Reprint]

The role of key opinion leaders (KOLs) in marketing drugs and devices has been frequently discussed on this blog (see posts by Dr Bernard Carroll here and here), and on other blogs, such as the Carlat Psychiatry Blog and the Clinical Psychology and Psychiatry Blog.

The British Medical Journal just published an article providing further documentation about how such KOLs function. [Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? Brit Med J 2008; 336: 1402-3. Link here.] The article was based on a discussions with a long-term pharmaceutical representative who was several times “a top national salesperson,” and articles in several business publications. Some key points were:

• Key opinion leaders are salespeople: “Kimberly Elliott, who was a drug company sales representative for almost two decades in the United States, puts it directly. ‘Key opinion leaders were salespeople for us….’ Also, “Ms Elliott says drug companies desperately need key opinion leaders. ‘There are a lot of physicians who don’t believe what we as drug representatives say. If we have a KOL [key opinion leader] stand in front of them and say the same thing, they believe it.’”
• Key opinion leaders are expected to increase drug or device sales: Kimberly Elliott said “we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations,” she said. “If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back.” Also, “the industry’s Richard Tiner, accepts that drug companies often recruit senior specialists and evaluate the return on investment they may bring. They become an integral part of the company’s marketing, education, and research strategies. ‘When these people are receiving a fee, they are in one sense in the employment of the company,’ he says….”
• Key opinion leaders are meant to parrot their corporate patron’s marketing message: “These people are paid a lot of money to say what they say. I’m not saying the key opinion leaders are bad, but they are salespeople just like the sales representatives are.” Also, an industry publication said, “drug companies are then encouraged to evaluate the performance of their key opinion leaders continuously to avoid ‘wasting money on the wrong people.’” Lectures were “largely based on slides supplied by the company.”
• Key opinion leaders are well-paid: “Ms Elliott says she would pay these respected doctors $2500 (£1280; 1610) for a single lecture….” Also, “A publicly available summary of one report shows that some doctors can earn more than $25 000 a year in advisory fees. A press release promoting the other report suggests that the average fee paid to a doctor for a “scientific speech” is more than $3000.”
• Physicians who show favor to particular products are groomed to be opinion leaders: “Importantly, marketing staff should find doctors who will endorse their products, ‘who may be further down the influence ladder,” and then help “raise their profile, and so develop them into opinion leaders.’”

Although pharmaceutical, biotechnology, and device company spokespeople, and some of the industries’ cheer-leaders continue to insist that key opinion leaders are educators, this article underscores that they are merely high-priced marketers. What is most insidious about the use of KOLs, however, is that many of them do not acknowledge that they are even influenced by the money they are paid.

In my humble opinion, any physician or other health care professional paid as a key opinion leader should acknowledge that pay, its amount, its source, and its purpose in detail any time they express an opinion relevant to their corporate sponsor’s products or services. If disclosing “I was paid $2,000 by company x to give this talk, using slides the company provided. Company x makes drug y. The purpose of this talk is to market drug y” might make some KOLs uncomfortable, then maybe they should reconsider the compromises they have made by accepting this role.

Any physician or health care professional, however, who does not make disclosures at least this detailed when speaking or writing on a topic relevant to the marketing of his or her corporate sponsor’s products or services is being deceptive and dishonest.

[Source : Health Care Renewal]

Another day, another “corporate integrity agreement.” Last week, there were multiple news reports of a settlement of a civil lawsuit against medical device manufacturer Medtronic. According to the New York Times, some of the key points were:

A unit of Medtronic defrauded Medicare of hundreds of millions of dollars, according to a civil lawsuit that was unsealed Thursday and simultaneously settled with the Justice Department.

Two insiders had said Kyphon, which Medtronic acquired in 2007, improperly persuaded hospitals to keep people overnight for a simple outpatient procedure to repair small fissures of the spine. Medicare then reimbursed the hospitals much more generously than it otherwise would have for the procedure, which was developed as a noninvasive approach that could usually be done in about an hour.

By marketing its products this way, Kyphon was able to artificially drive up demand among hospitals, bolstering its revenue and driving up its stock price. Medtronic subsequently bought the company, its competitor, for $3.9 billion, greatly enriching Kyphon’s senior executives.

The settlement requires Medtronic to pay the federal government $75 million plus interest, and to enter into a ‘corporate integrity agreement’ with the Office of Inspector General of the Department of Health and Human Services. The agreement will require the company to give correct advice to customers about how to apply for Medicare reimbursements. The company will also have to set up internal procedures to make sure it complies with the law.

Bloomberg’s report (via the Boston Globe) also noted:

One former worker, Craig Patrick, said bosses ignored his warnings in 2005 that the practice amounted to fraud.

‘It’s my opinion that this was a very organized strategy from the beginning to make these inpatient cases, so facilities could afford the expensive kits and Kyphon could be very profitable,’ he said in an interview.

After he warned supervisors at Kyphon, he was denied a promotion and told he ‘wasn’t a team player,’ Patrick said. He left the company in 2005, after filing the suit, and now works for another medical device maker.

‘The whole thing played out like a cliched movie you’d see about a whistle-blower,’ he said.

This is becoming all too drearily familiar. We have all the usual elements: a clever, but deceptive plan by a health care organization to increase its profits, while incidentally driving excess medical care; an internal skeptic who is derided as “not a team player,” and thus forced to become a whistle-blower; and eventually, an investigation and then a settlement that probably failed to recover all the costs incurred by the health care system, certainly did not reverse the excess care provided; and may not be sufficient to deter some clever but dishonest health care executive from coming up with the next version of this scenario.

I did find it interesting that the The New York Times article summarized the context of the case thus:

The medical device business is filled with small start-up companies trying to generate excitement about their new products and technologies, hoping to build market share and to attract deep-pocketed buyout offers. It has been fraught with allegations of bribes, exaggerated claims, and other unethical behavior.

One would think that were a segment of the health care industry to be “fraught with allegations of bribes, exaggerated claims, and other unethical behavior,” the result would be not only outrage but some systematic efforts to combat these abuses. Instead, this particular case so far has inspired not a single pundit to view it with alarm, and there still seems to be no systematic efforts ongoing to combat “bribes, exaggerated claims, and other unethical behavior.” It’s the anechoic effect, as usual.

But politician and policy makers keep scratching their heads when confronted with ever increasing health care costs, ever declining access, and stagnant quality. And as we have noted before, the usual approach to these problems seems to focus on cutting physicians’ payments, and imposing new guidelines and quality standards, usually starting with primary care. What’s wrong with this picture?

[Source : Health Care Renewal]