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BLOGSCAN - Deceptive Pharmaceutical Marketing

Perhaps in honor of the recently concluded <a href="http://www.pharmedout.org/conferenceagenda.htm">meeting</a> organized by Dr Adriene Fugh-Berman and her colleagues at PharmedOut.org on the pharmaceutical industry and its influence on continuing medical education, three significant posts appeared this week about deceptive pharmaceutical marketing practices.  <a href="http://www.healthbusinessblog.com/?p=3548">On the Health Business Blog</a>, David Williams analyzed how a former pharmaceutical and biotechnology executive spun the Vioxx case, blaming it all on the public's risk aversion.  <a href="http://brodyhooked.blogspot.com/2010/06/how-does-drug-industry-exert-power.html">On the Hooked: Ethics, Medicine and Pharma Blog</a>, Dr Howard Brody summarized two significant articles by Kalman Applbaum on complex psychological campaigns, really versions of disinformation campaigns, used to to market pharmaceuticals.  <a href="http://carlatpsychiatry.blogspot.com/2010/06/former-emory-psychiatrist-criticizes.html">On the Carlat Psychiatry Blog</a>, Dr Daniel Carlat published a letter about life at a medical school department lead by Dr Charles Nemeroff, one of the "key opinion leaders" most lavishly paid by pharmaceutical companies to help them market questionable drugs for questionable reasons, and giving observations on Dr Nemeroff's new career.

BLOGSCAN - Deceptive Pharmaceutical Marketing

Perhaps in honor of the recently concluded meeting organized by Dr Adriene Fugh-Berman and her colleagues at PharmedOut.org on the pharmace...

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WellPoint: Don't Know Much About Computer Programming; Aetna: Don't Know Much About Mathematics

Big US based health care insurance companies have not been covering themselves in glory in the last week. Aetna's Math Errors First, there was the case of Aetna's mathematical prowess, e.g., as <a href="http://www.latimes.com/business/la-fi-aetna-rates-20100625,0,6758148.story">reported</a> by the Los Angeles Times: <blockquote>A second insurance company in California has killed plans for double-digit rate hikes for individual policyholders because of errors in its filing that would have inflated premiums, state regulators said Thursday. Connecticut-based Aetna Inc. had sought an average 19% increase in rates for its 65,000 individual customers, but pulled back after multiple math errors in its paperwork were found by its own staff and by an independent consultant working for the state. Aetna's decision follows a similar move by Anthem Blue Cross, which canceled a rate increase of as much as 39% for many of its 800,000 California policyholders in April after the state consultant found calculation errors in its filing with the California Insurance Department.</blockquote> Of course, Aetna tried to minimize the story: <blockquote>An Aetna spokeswoman said the company found 'a miscalculation not previously detected' when it conducted a third round of internal reviews. 'This was a simple human error,' said spokeswoman Anjanette Coplin, who did not elaborate.</blockquote> However, <blockquote>'There were multiple errors … in the way [Aetna] annualized premiums and in the compounding of the rate increase,' said state Insurance Department spokesman Darrel Ng.</blockquote> Of course, somehow the errors all were in Aetna's favor: <blockquote>Even with the new disclosure requirements, regulators have limited authority to block rate increases. They can do so only if insurers fail to spend at least 70% of their premiums on medical claims. In Aetna's recent rate filing, the insurer said its plan met the 70% minimum. But once the errors were identified, medical-claim spending fell below the 70% requirement. The proposed rates were higher than they should have been, officials said. </blockquote> WellPoint's Computer Errors A few minutes ago, the Associated Press <a href="http://www.google.com/hostednews/ap/article/ALeqM5gyEYsN9IqMS3mmDmnLf8e1TsLhOgD9GL40E02">reported</a>: <blockquote>WellPoint Inc. has notified 470,000 individual insurance customers that medical records, credit card numbers and other sensitive information may have been exposed in the latest security breach of the health insurer's records. The Indianapolis company said the problem stemmed from an online program customers can use to track the progress of their application for coverage. It was fixed in March. Spokeswoman Cynthia Sanders said an outside vendor had upgraded the insurer's application tracker last October and told the insurer all security measures were back in place. But a California customer discovered that she could call up confidential information of other customers by manipulating Web addresses used in the program. Customers use a Web site and password to track their applications.</blockquote> Note that this security breach was potentially serious: <blockquote>WellPoint's security breach doesn't crack the top 10 in terms of number of people who may have had information exposed, said Paul Stephens, the [Privacy Rights Clearinghouse]organization's director of policy and advocacy. Even so, he labeled the breach 'very serious' because it possibly involved both financial and medical information.</blockquote> This is not the first time WellPoint's computers and software have violated the privacy of its applicants or customers: <blockquote>Two years ago, WellPoint offered free credit monitoring after it said personal information for about 128,000 customers in several states had been exposed online. In 2006, backup computer tapes containing the personal information of 200,000 of its members were stolen from a Massachusetts vendor's office.</blockquote> Summary Of course, everyone makes mistakes.  However, one would expect that at least health insurance companies/ managed care organizations ought to be able to do the math necessary to support their rate proposals correctly, and keep their policy-holders' and applicants' personal information confidential.  These would seem to be fundamental competencies that such organizations ought to display.  Of course, one can find other examples of lack the lack of competency (and worse) displayed by both <a href="http://hcrenewal.blogspot.com/search/label/Aetna">Aetna </a>and <a href="http://hcrenewal.blogspot.com/search/label/WellPoint">WellPoint</a>.  Furthermore, anyone can make mistakes, but in the real world, those who preside over such mistake-prone enterprises often do not do too well.  However, in the bizarre world of large health care organizations, the executives who preside over the ongoing bumbling just make more and more money, under the pretense that their continuing brilliant leadership just leads to one triumph after another.  As we noted <a href="http://hcrenewal.blogspot.com/2010/04/what-me-worry-leaders-prosper-despite.html">here</a>, WellPoint CEO Angela Braly's total compensation increased in 2009 to an outsized $13.1 million, with the executives just underneath her paid proportionately well.  Per its <a href="http://ir.wellpoint.com/phoenix.zhtml?c=130104&p=irol-SECText&TEXT=aHR0cDovL2lyLmludC53ZXN0bGF3YnVzaW5lc3MuY29tL2RvY3VtZW50L3YxLzAwMDExOTMxMjUtMTAtMDc1ODk3L3htbA%3d%3d#toc15642_100">2010 proxy statement</a>, WellPoint's <blockquote>Total Rewards compensation program is designed to attract, engage, motivate and retain a talented team of executive officers and to appropriately reward those executive officers for their contributions to our business and our members. We seek to accomplish this goal in a way that is closely aligned with the long-term interests of our shareholders and the expectations of our members and health care providers.</blockquote> I suspect that WellPoint's members' expectations did not include the three computer security breaches noted above. Similarly, according to its <a href="http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9Mzc2MjMxfENoaWxkSUQ9Mzc0NzgyfFR5cGU9MQ==&t=1">2010 proxy statement</a>, Aetna CEO Ronald A Williams' total compensation in 2009 was a mere $18,058,162. Other top executives made proportionate amounts, from more than $1 million to more than $12 million. The rationale underlying executive compensation includes: <blockquote>We seek to implement a pay-for-performance philosophy by tying a significant portion of our executives’ compensation to their achievement of financial and other goals that are linked to the Company’s business strategy and each executive’s contributions towards the achievement of those goals.</blockquote> To me, avoiding mathematical errors in calculating policy premiums ought to be part of the company's goals linked to its business strategy. An old rock song that starts with "don't know much about history," may have a certain charm.  Health insurance companies that cannot accurately calculate premiums or protect the confidentiality of policy-holders' computerized data has none.  As long as "imperial CEOs" can continue to get extremely rich while presiding over incompetence and stupidity, if not worse (see here), we can expect the foolishness to continue.  Meanwhile, the foolishness drives up costs and drives down quality of health care for the poor suffering patients, let alone the physicians and other health care professionals who must deal with it. To really reform health care, we need to provide incentives for competent, honest leadership, and make that leadership accountable for its shortcomings.

WellPoint: Don't Know Much About Computer Programming; Aetna: Don't Know Much About Mathematics

Big US based health care insurance companies have not been covering themselves in glory in the last week. Aetna's Math Errors First, the...

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Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to <a href="http://www.dynamicchiropractic.com/mpacms/dc/article.php?id=38545">Frank King, D.C.,</a> many more should be doing just that: <blockquote>Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes. Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system! </blockquote> But that’s not all: <blockquote>Financial Rewards Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits: <ul><li>Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.</li><li>The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness! </li><li>Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy. </li></ul>You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in. </blockquote> This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “<a href="http://www.sciencebasedmedicine.org/?p=3022">subluxation</a>” myth, and the field as a whole has a fine tradition of “<a href="http://www.quackwatch.org/01QuackeryRelatedTopics/chirosell.html">practice building</a>.” Naturopaths, likewise, don’t mind winking at practice ethics in order to <a href="http://www.sciencebasedmedicine.org/?p=146">make an extra buck</a>. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘<a href="http://www.sciencebasedmedicine.org/?p=4768">diagnostic’ sugar</a> that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out <a href="http://www.bio-proinc.com/site/555888/page/131760">this offering</a> from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”: <blockquote>HOWW TOOOO ….The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice. Three day course teaches you: How to relate to the patient, evaluate, test and diagnoseHow to use solutions, mixtures, methods, supplies and equipmentHow to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBIHow to design and organize your officeHow to hire and fire staff and to computerizeHow to use public relations and marketingHow to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies Manuals included…Each attendee receives one set of training materials, including:Protocol ManualPhysicians ManualOffice Procedure ManualForms BookMarketing ManualPatient Results ManualEmployee ManualAudio tapesand other related material. </blockquote>Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “<a href="http://www.sram.org/1101/charlesfarr.html">father of oxidative medicine</a>,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (<a href="http://www.sciencebasedmedicine.org/?p=247">PPO</a>). But none of this is surprising, right? After all, <a href="http://www.quackwatch.org/01QuackeryRelatedTopics/quackdef.html">quacks quack</a>. What may have come as a surprise to beleaguered physicians who still play by the rules was <a href="http://www.medscape.com/viewarticle/720244?src=ptalk&uac=27844PK">this offering</a>, just a few days ago, from Medscape Business of Medicine: <blockquote>Six Ways to Earn Extra Income From Medical Activities You’re chasing after claims but watching reimbursement sink. It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it. We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in. </blockquote>So what are those ‘6 avenues’? Let’s see: <ul><li>Work with Attorneys </li><li>See Nursing Home Patients </li><li>Serve as a Medical Director </li></ul>So far, so not necessarily bad… <ul><li>Team Up with Pharmaceutical Companies </li></ul>What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope: <blockquote>Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.</blockquote> O’course, you gotta watch out for those pesky <a href="http://hcrenewal.blogspot.com/2010/06/when-key-opinion-leader-questions-hand.html">ethics killjoys</a>, warns Medscape: <blockquote>Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position. </blockquote>What it all comes down to is this: <blockquote>Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income… Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies. </blockquote>Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I <a href="http://www.sciencebasedmedicine.org/?p=189">lamented the publication</a> of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor: <blockquote>I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well. </blockquote>True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with <a href="http://hcrenewal.blogspot.com/2008/06/medscapes-cme-ethics-part-ii.html">Bernard Carroll</a> that it seems to have “a right hand – left hand problem.” Oh yeah: what were the other 2 “avenues”? Those would be: <ul><li>Become a Media Personality </li><li>Consult for Wall Street </li></ul>

Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that: Homeopathy is an energetic...

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Slouching, or "Moving Towards ... Oligopoly"

A <a href="http://www.businessweek.com/news/2010-06-24/wellpoint-s-kleinman-sees-health-insurer-oligopoly-.html">report</a> by Bloomberg on a prediction that the US attempt at health care reform will lead to more concentration of power among health insurance companies. <blockquote>U.S. health insurers are 'moving towards an oligopoly,' a process that this year’s health-care overhaul will accelerate, the investor-relations chief at WellPoint Inc. said today. New regulations on administrative spending and premium increases will push some independent insurers out of business or into deals with bigger rivals, said Michael Kleinman, vice president for investor relations, at a Wells Fargo & Co. conference in Boston.</blockquote> In addition, <blockquote>The insurance market is becoming an oligopoly, a market where supply and pricing are dominated by a few companies, 'and health-care reform is going to move us in that direction more quickly,' Kleinman said. 'There are going to be smaller insurers that are not going to be able to survive in this marketplace.'</blockquote> Wellpoint is not likely to suffer from a move to fewer, larger insurance companies: <blockquote>Led by WellPoint, 12 health plans cover two-thirds of the enrollment in the U.S. commercial-insurance market, said Ana Gupte, a Sanford C. Bernstein & Co. analyst....</blockquote> So, it is not that Mr Kleinman has any regrets about this. Far from it: <blockquote>Indianapolis-based WellPoint, the country’s biggest health plan with 33.8 million members, has the scale to prosper from the overhaul, which is expected to add another 34 million to the ranks of the insured, he said.</blockquote> Mr Kleinman might argue that WellPoint's increasing size and prospects for market domination are good for society as well as the company, and its top executives.  We have heard endless arguments in the last 30 years that larger hospital systems and larger insurance companies lead to more efficiency and lower costs.  However, the evidence is <a href="http://hcrenewal.blogspot.com/2010/02/noticing-elephant-in-room-bigger.html">in the other direction</a>.  There is plenty of reason to worry that increasingly dominant companies will extract higher prices, and the money they make will benefit their top leaders first, maybe their stockholders second, and patients and ordinary employees a very distant third, if at all.  So look for WellPoint CEO Angela Braly to make even more than <a href="http://hcrenewal.blogspot.com/2010/04/what-me-worry-leaders-prosper-despite.html">$13 million a year</a> in the future. So it would have  been more reassuring if the response from the US executive branch included some opposition to the notion of a more concentrated market.  Instead, <blockquote>Asked to comment today, Nicholas Papas, a spokesman for President Barack Obama, referred in an e-mail to the president’s remarks on June 22 touting the health-care overhaul. The law 'will put an end to some of the worst practices in the insurance industry,' such as canceling policies when patients get sick or imposing lifetime limits on coverage, Obama, a Democrat, said at a White House ceremony. The changes 'will make America’s health-care system more consumer-driven and more cost-effective and give Americans the peace of mind that their insurance will be there when they need it,' Obama said. 'Insurance companies should see this reform as an opportunity to improve care and increase competition.'</blockquote> And rather than worrying about the government's response, <blockquote>Angela Braly, WellPoint’s chairman and chief executive officer, was among a group of insurance chiefs who met Obama June 22. While Democrats have attacked the company for its premium increases, the relationship is improving, Kleinman said. 'The Obama administration understands that we need to work in partnership, that in order to make health-care reform work, the carriers need to be able to charge appropriate rates and make an appropriate margin,' he said. 'Hopefully, a lot of that bad rhetoric is behind us.'</blockquote> If the increasing concentration of power in health insurance does not meet a more effective challenge, we will need a lot more than rhetoric, good or bad, to save health care. <blockquote>Turning and turning in the widening gyre The falcon cannot hear the falconer; Things fall apart; the centre cannot hold; Mere anarchy is loosed upon the world, The blood-dimmed tide is loosed, and everywhere The ceremony of innocence is drowned; The best lack all conviction, while the worst Are full of passionate intensity.</blockquote> <a href="http://en.wikipedia.org/wiki/The_Second_Coming_%28poem%29">The Second Coming (Slouching Towards Bethlehem), </a>by W B Yeats

Slouching, or "Moving Towards ... Oligopoly"

A report by Bloomberg on a prediction that the US attempt at health care reform will lead to more concentration of power among health insur...

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Edwin Lee on the Tiger We Are Now Riding

Some insights about why the leadership of large health care organizations has gone so wrong may be found on a blog I just discovered entitled <a href="http://www.dismountingourtiger.com/">"Dismounting Our Tiger," </a>written by entrepreneur Edwin Lee. In particular, <a href="http://www.dismountingourtiger.com/business-health/oil-executives-produce-vacuous-disaster-response-plans/">this post</a>, triggered by the miserable results produced by BP in response to the gulf oil spill, posits the series of steps by which people become leaders of most big organizations, presumably including health care organizations: <blockquote>1.They always followed orders and met the cultural expectations of their organization. They went along to get along. Early in their careers they were faced with a choice: they could make a difference or get promoted; they chose to get promoted. (Those who attempt to make a difference make waves for senior management and fellow workers who then deal with them as disloyal; troublemakers, heretics, or whistle blowers) 2.They were tapped for greatness (fast-tracked) by more senior persons early in their careers. 3.They carefully accumulated 'status' symbols like degrees, awards, medals, etc. 4.They avoided collecting demerits by taking risks and failing.</blockquote> And here are the outlooks and capabilities they share: <blockquote>1.They are culturally conditioned to administer their organizations as they are, not to deal with major changes either inside the organization or in the outside world. Their sole power structure comes from those who report to them and their boards of directors, who expect behavior consistent with past behavior. Should top executives initiate major changes, control of their companies becomes less certain and more difficult. (More importantly it risks their personal compensations). Leaders can’t operate in isolation, they need loyal power bases. 2.They see the world from the tribal perspective of their organizations. (Even after they go elsewhere as in the case of Larry Summers and Robert Rubin whose pro Goldman Sachs tribalism has helped to undermine real financial reform) 3.They rightly understand that relative size a marketplace is the dominant factor for survival and for growing profits. They focus almost entirely on that aspect of their business. (Much as a beautiful woman might rely solely on her beauty rather than develop her mind or personality) 4.They consider their leadership positions to be appropriate rewards for years of loyal service. 5.Their first order of business (as CEOs) is to gain control of their Boards of Directors. 6.They manipulate their Boards into paying inflated salaries, providing expensive perks, agreeing to golden parachutes and rewarding them with extravagant bonuses for last year’s performance.. (Over the last 50 years entire industries have been thus manipulated so that Boards now justify such parasitic compensation as 'competitive'). </blockquote> Does it all sound familiar? Does it sound like a description of many health care leaders we have discussed? As Edwin Lee summed it up: <blockquote>We, the public, are foolish for relying on these executives to plan for disasters or to care about the 'little people' either inside or outside their organizations, or to expect their boards of directors or stockholders to make essential corrections. </blockquote> But in health care, we have been relying on our imperial CEOs, and woe unto us when the disasters start to occur.

Edwin Lee on the Tiger We Are Now Riding

Some insights about why the leadership of large health care organizations has gone so wrong may be found on a blog I just discovered entitle...

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When a Key Opinion Leader Questions the Hand That Fed Him: from "Master Teacher to Someone Who Didn't Know What He Was Doing"

We just <a href="http://hcrenewal.blogspot.com/2010/06/deferred-prosecution-agreements-end-so.html">posted an update</a> on the ongoing cozy relationship with medical device companies, in particular, those that make prosthetic hip and knee joints, and some orthopedic surgeons.  Some surgeons, including many prominent academic leaders and practitioners, have been paid huge amounts, and have often failed to make more than the most minimal disclosure to their patients, or to the audiences of their talks or the readers of their ostensibly scholarly articles.  Deferred prosecution agreements with device companies shed light on these payments, but did not curtail them.  Yet the surgeons and the companies who paid them defended the payments as legitimate consulting agreements, and royalties for worthy innovations.  Now the New York Times has <a href="http://www.nytimes.com/2010/06/20/business/20knee.html">reported </a>on a dispute between a well-paid consultant and an artificial joint manufacturer that provides new insights into these financial relationships. To summarize, <blockquote>IT was a long, fruitful medical marriage that is fast becoming an angry public divorce, one that offers a rare look at a clash between a top-shelf consultant and his corporate patron over patient safety. For years, Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings, trained hundreds of doctors to use its products and talked it up wherever he went. In return, Zimmer, an orthopedic implant maker, helped enrich Dr. Berger, portraying him as a master surgeon and paying him more than $8 million over a decade. Those days are gone. Dr. Berger started complaining to Zimmer a while back that one of its artificial-knee models was failing prematurely, and he went public recently with a study that he says proves it. Zimmer told him that the problem was not the artificial knee, but his technique, and pointed to data overseas indicating that the knee was safe. Last year, Zimmer did not give Dr. Berger a new contract. The company says it routinely rotates consultants. 'I trained hundreds of doctors for them and made them tens of millions,' Dr. Berger said in interview here, in which he also lambasted Zimmer executives as dissembling, out-of-touch bureaucrats. 'So was this just a coincidence? Maybe it was. Maybe it wasn’t.' </blockquote> In more detail, here is how Dr Berger's relationship with Zimmer began: <blockquote>The surgeon, a tall, balding man with a boyish manner, was finishing his fellowship at the Rush University Medical Center in Chicago at the time, one of the country’s top centers for joint replacement. The center has had long ties to Zimmer, whose headquarters is about two hours away, in Warsaw, Ind., and the young surgeon quickly came to the company’s attention. 'Rich has a very clever set of hands, and because of that he is enabled with the ability to innovate surgical techniques,' said Roy Crowninshield, who was Zimmer’s chief scientific officer. Dr. Berger’s skills matched Zimmer’s marketing strategy. To distinguish itself from competitors, the device maker had started promoting minimally invasive surgery, a technique that uses smaller incisions than traditional surgery. Zimmer trained doctors in the procedure, using its device. Soon, Dr. Berger, who was then pioneering a type of small-incision surgery that allowed patients to leave the hospital on the day of surgery, became a linchpin of Zimmer’s efforts. In 2002, he was prominently featured in a press release about Zimmer’s plans to build a training facility for minimally invasive surgery. 'We are clearly excited about Dr. Berger’s data,' J. Raymond Elliott, the company’s chairman and chief executive at the time, stated in the release. Over the next few years, the physician estimates, he helped train hundreds of surgeons on Zimmer’s behalf.</blockquote> And in more detail, here is how things went wrong:  <blockquote>As he tells it, his relationship with Zimmer frayed over a version of a widely used Zimmer knee, known as the NexGen. The model at issue, called the NexGen CR-Flex, is designed to provide a greater range of motion than the standard NexGen. Most surgeons implant an artificial knee using a cement-like adhesive to bond the thigh bone to the portion of the device that bends. But some specialists, like Dr. Berger, try to avoid adhesives because the cement can break down and cause device failure. So Zimmer also sells an uncemented version of the CR-Flex that relies instead on the bone naturally fusing with the implant. Dr. Berger says that he gave the device, which is supposed to last about 15 years, to about 125 patients in 2005, the first full year he used it. But by early 2006, some X-rays showed lines where the implant met the thigh bone, an indication that the device was loose and had not fused completely. Patients could walk, but they were reporting pain, apparently a result of the loose joint. He says he soon brought the problem to the attention of Zimmer officials, including the company’s new top scientist, Cheryl R. Blanchard. Zimmer executives pointed to the success of the NexGen, but the company did not have separate test data on the uncemented flexible model because the F.D.A. had not required the company to study it in patients before selling it. Later, as more patients complained about the device and Dr. Berger had to replace some of them, he spoke to Ms. Blanchard again, he said. This time, he said, she and other Zimmer officials suggested that his technique was the problem because no other surgeon had complained. 'Suddenly, I went from someone who was their master teacher to someone who didn’t know what he was doing,' he said. BY 2007, Dr. Berger, although still a Zimmer consultant, had stopped using the device and had learned, he said, that several other surgeons had also experienced problems with it. But unlike Dr. Dorr, the physician who sent out the alert about Zimmer, Dr. Berger said he initially had hoped to avoid a public showdown with the company. So he followed a more traditional route by performing a study with another Rush surgeon, Dr. Craig J. Della Valle, who was also having to replace the Zimmer knee. Dr. Berger and Dr. Della Valle first presented their study at a medical meeting last fall and again this year at a national meeting of the American Association of Orthopedic Surgeons. They found that the uncemented Zimmer knee failed early in about 9 percent of some 100 patients studied. Also, the knee exhibited signs of looseness in about half of all patients and has since been replaced in some of them, Dr. Berger said. But Zimmer was unswayed. In a filing with the Securities and Exchange Commission, Zimmer made note of the study but also pointed to the knee’s very positive results in a large database of orthopedic patients in Australia. Officials there confirmed the low failure rate. The company also said that the cement-free CR Flex accounted for only a small fraction — about 2 percent — of its overall knee sales. </blockquote> The most striking lesson of this case is that Dr Berger was only valued as a consultant as long as his work completely followed the marketing party line.  As soon as he questioned the company's product, or the executives who were promoting it, he became "someone who didn't know what he was doing."  Of course, a truly valued consultant should be respected, if not sought for honest advice, whether or not it fit  preconceived notions or marketing strategies.  Thus, how Dr Berger was finally treated suggested he really was hired to market product.  "Consultant" was just a pretty title..  We  (and many others) have discussed (e.g., <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a>) how pharmaceutical, biotechnology, and device companies cultivate "<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>" who really are nothing more than salespeople with fancy academic titles or well-known practices.  The case of Dr Berger suggests that apparently distinguished academics and practitioners hired as "consultants" by such companies ought to be regarded as salespeople until proven otherwise.  Physicians who are wooed by company marketers to take on such consulting roles, often with praise for their ability to "innovate," "excite," or become a "master teacher," may want to consider whether those flattering them merely want to hire another high-profile part-time salesperson.  They may further may want to think about how they would look should this relationship be revealed for what it really is.  If something goes wrong, they should think about what it would be like to deal with "dissembling, out-of-touch bureaucrats."  Sometimes there is a price to pay for taking all that money. I hope that Dr Berger will consider donating the $8 million he made to the cause of more honest teaching and research about orthopedic devices.  Meanwhile, patients and physicians should be extremely skeptical about the pronouncements of paid consultants and key opinion leaders who work for corporations marketing health care goods and services.  We all should demand at least that those paid by such vested interests reveal such financial arrangements in detail if they expect us to listen to their spiels, take their advice, and particularly be subject to their decisions.

When a Key Opinion Leader Questions the Hand That Fed Him: from "Master Teacher to Someone Who Didn't Know What He Was Doing"

We just posted an update on the ongoing cozy relationship with medical device companies, in particular, those that make prosthetic hip and ...

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Deferred Prosecution Agreements End, So Let the Payments Grow

Starting in 2007, we posted (<a href="http://hcrenewal.blogspot.com/2007/11/orthopedic-device-makers-reveal.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/11/few-answers-and-many-more-questions.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/11/one-more-payment-to-academic-health.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/stories-about-device-manufacturers.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">here</a>) about the payments, often huge, that five manufacturers of prosthetic joints (<a href="http://www.biomet.com/">Biomet</a>, DePuy Orthopaedics (a unit of <a href="http://www.jnj.com/">Johnson & Johnson</a>), Stryker Orthopedics,a unit of <a href="http://www.stryker.com/">Stryker Inc</a>, <a href="http://www.zimmer.com/">Zimmer Holdings</a>, and <a href="http://www.smith-nephew.com/">Smith & Nephew</a>) revealed they made to orthopedic surgeons and various academic and other organizations. These revelations were the results of deferred prosecution agreements made in 2007 between four of the companies and the US Department of Justice after the latter charged Biomet, DePuy, Zimmer, and Smith and Nephew with giving surgeons kickbacks, disguised as consulting fees, to promote their products.  Stryker entered into a voluntary compliance agreement (see post <a href="http://hcrenewal.blogspot.com/2007/11/orthopedic-device-makers-reveal.html">here</a>).  We also <a href="http://hcrenewal.blogspot.com/2007/11/aaos-responds-to-disclosure-of-payments.html">noted</a> that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as <a href="http://hcrenewal.blogspot.com/2007/11/aaos-patient-discussion-guide-regarding.html">have the societies themselves</a>. A <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">2008 post </a>on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics. Now in 2010, Bloomberg News <a href="http://www.businessweek.com/news/2010-06-11/new-hips-gone-awry-expose-u-s-kickbacks-in-doctors-conflicts.html">reported</a> on the results, such as they were, of these ballyhooed agreements: <blockquote>The government declared last year that it had overhauled the financial relationships between surgeons and the biggest makers of knees and hips, saying the threat of criminal prosecution for 'kickbacks' had forced them to slash payments to physicians. Results of the crackdown were 'truly extraordinary,' said Christopher Christie, a former U.S. attorney for New Jersey who is now governor, in testimony to Congress in June 2009. It was too good to be true. Compensation ended up being higher after the September 2007 deferred prosecution agreement because payments were postponed, according to data compiled by Bloomberg and interviews with seven surgeons. 'It’s back to business as usual' says Charles D. Rosen, president of the Association for Medical Ethics, who is a spine surgeon in Irvine, California. 'Nothing will change until someone goes to jail. It’s a big game.'</blockquote> Apparently, while during the course of the agreements the companies decreased payments to surgeons, they made up for it later: <blockquote>Prosecutors in the New Jersey U.S. Attorney’s Office, which headed the case, reported a 'satisfactory completion' in March 2009 of the probe of Biomet Corp., Johnson & Johnson’s DePuy unit, Smith & Nephew PLC, Zimmer Holdings Inc. and Stryker Corp. Payments in 2008 fell to $105 million from $272 million the year before, the Justice Department lawyers said. The companies increased doctor compensation for 2008 to about $300 million, according to the data compiled by Bloomberg from reports posted on the device makers’ websites. Fees for 2008 were delivered in 2009, the surgeons say. Payment delays were 'a common happenstance,' says Teresa Ford, a Seattle attorney who represents 150 doctors who have consulting or royalty agreements with orthopedic device makers. “None of them had significant changes in their relationships.”</blockquote> Also, <blockquote>A month after the government closed its case, Zimmer CEO David Dvorak told analysts on a conference call that the action didn’t result in a 'material change' to what it pays surgeons.</blockquote> Attempts by Bloomberg reporters to find out more did not reveal much: <blockquote>Since the agreement, payments to surgeons have been appropriate and for legitimate purposes, according to spokespeople for the five companies. Wright says on its website that it adheres to industry ethical standards in its dealings with consultants. As for 2008 fees that weren’t delivered until 2009, three of the companies say they froze payments while monitors were reviewing contracts with surgeons to ensure they were proper. Spokesmen for Stryker and Smith & Nephew declined to comment. Three of the court-appointed monitors say they’re barred from talking about the details of their work. The two others, including former U.S. Attorney General John Ashcroft, didn’t return telephone calls. The department declined to release reports the monitors filed.</blockquote> We have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">repeated</a> often (e.g.,<a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html"> here</a>) the argument that limiting punishments of health care organizations for wrong-doing to corporate fines and deferred prosecution agreements has not deterred further wrong-doing.  Most of the cases which we have discussed involved pharmaceutical and biotechnology companies, and sometimes health insurers.  It seems that the argument also applies to device manufacturers.  To underline the lack of a deterrence effect, others payments by other device companies to other surgeons have also recently come to light. In 2008, we <a href="http://hcrenewal.blogspot.com/2008/09/more-lucrative-payments-to-orthopedic.html">discussed</a> payments made by Medtronic revealed in various court filings. Medtronic just started voluntarily revealing more information. For example, as <a href="http://stlouis.bizjournals.com/stlouis/stories/2010/06/14/story4.html">reported</a> by the St. Louis Business Journal, Dr Larry Lenke helped Medtronic develop a spinal surgery system, so <blockquote>In the first three months of 2010, Lenke earned $832,000 in royalties from Medtronic, putting him on track to top $3 million in royalties this year. Lenke received between .5 percent and 1 percent of sales of the system in royalties. 'The royalties are very small, but the sales are large,' he said. Lenke is cho-chief of adult and pediatric spinal, scoliosis and reconstructive surgery and the Jerome J. Gliden professor of orthopedic surgery at the Washington University School of Medicine, the director of spinal surgery at Shriners Hospital for Children, and a spine consultant to the St. Louis Rams and Blues. </blockquote>Like the surgeons we <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">discussed in 2008</a>, neither Dr Lenke nor Washington University seemed to make an effort to reveal his multi-million dollar relationship with Medtronic. Dr Lenke's <a href="http://www.ortho.wustl.edu/FindaPhysician/Spine/lenkel/bio.aspx">official web-page </a>at Washington University does not reveal financial ties to, much less multi-million dollar royalties from Medtronic. A quick review of a few of Dr Lenke's published articles reveal such vague disclosures as: <blockquote>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 this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.</blockquote>[Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, et al. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lubmar scoliosis: a prospective multicenter evidence-based study. Spine 2009; 34: 2171-78.] The most specific disclosure I could find was: <blockquote>Dr Lenke was a consultant for Medtronic until January, 2009, and is a patent holder with Medtronic.</blockquote>[Silva FE, Lenke LG. Adult degenerative scoliosis: evaluation and management. Neurosurg Focus 2010; 28: 1-10.] So the more things change, the more they stay the same. Device companies are still paying royalties, sometimes enormous sums, to the surgeons who helped them develop lucrative devices. Many of these surgeons are in practice, and some are prominent academics. The surgeons, and their academic institutions when applicable, do not seem to be going out of their way to reveal these sometimes massive financial relationships to patients, many of whom end up implanted with the very devices that generate these enormous payments. While some of the surgeons and influential academicians and prolific authors, they do not seem to go out of their way to reveal these sometimes massive financial relationships to their audiences and readers, even while touting aggressive, procedure-oriented, device-centric approaches to manage orthopedic problems. So although the "Sunshine Act" was made part of the US health reform legislation, there is not yet much sunshine out there.  In my humble opinion, at a minimum, physicians should reveal, in detail, all financial relationships that might appear to have a probability of influencing their clinical decision making to the patients for whom such decisions are made.  Physicians should also reveal, in detail, all financial relationships that might appear to have a probability of influencing any related teaching or research.  Furthermore, as <a href="http://www.iom.edu/~/media/Files/Report%20Files/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice/COI%20report%20brief%20for%20web.ashx">an Institute of Medicine's report on conflicts of interest</a>, which as received strikingly little attention, recommended: <blockquote>researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial.</blockquote> Also, the report said we need <blockquote>to develop a new system for funding high-quality accredited continuing medical education that is free of industry influence.</blockquote> These idealistic recommendations seem a long way from the reality of our currently money-focused system of medical education and research.

Deferred Prosecution Agreements End, So Let the Payments Grow

Starting in 2007, we posted ( here , here , here , here and here ) about the payments, often huge, that five manufacturers of prosthetic jo...

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