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BLOGSCAN - Medtronic's Multi-Million Dollar Payments to Spine Surgeons

Starting in 2007, we discussed the huge payments made by four medical device companies to orthopedic surgeons and medical organizations related to the use of hip and knee prostheses.  (See post <a href="http://hcrenewal.blogspot.com/2010/06/deferred-prosecution-agreements-end-so.html">here</a> with links backward.)  Payments, in the millions of dollars per year range, went to surgeons including noted academics, and leaders of the main orthopedic physicians' society.  Payments went to medical schools, teaching hospitals, and professional societies.  Many of these financial relationships were not disclosed, and the disclosures that were made rarely indicated the amounts involved. Now <a href="http://online.wsj.com/article/SB10001424052748703395204576024023361023138.html">the Wall Street Journal</a> reports millions being paid to spine surgeons by Medtronic in connection with devices used in spinal fusion.  See Dr Howard Brody's discussion <a href="http://brodyhooked.blogspot.com/2010/12/highest-rolling-spine-surgeons-digging.html">here</a> on the Hooked: Ethics, Medicine, and Pharma blog, and also Felix Salmon's discussion <a href="http://blogs.reuters.com/felix-salmon/2010/12/20/are-surgeons-getting-kickbacks-from-medtronic/">here</a> on the Felix Salmon blog. What seems lacking is a clear rationale for any payments, much less for payments of the sizes listed.  The WSJ article cited a Medtronic spokesperson, "surgeons' device-development work goes beyond mere consulting when the company deems that they are contributing valuable intellectual property to a product. But that intellectual property doesn't necessarily have to be patented."  The reporters found, "search of spine-device patents awarded to the Norton surgeons turned up about a dozen total for Drs. Puno, Johnson, Campbell and Dimar, most owned by companies other than Medtronic. The search turned up no patents for Dr. Glassman."  So what intellectual property that was not or could not be patented could be worth millions a year?

BLOGSCAN - Medtronic's Multi-Million Dollar Payments to Spine Surgeons

Starting in 2007, we discussed the huge payments made by four medical device companies to orthopedic surgeons and medical organizations rela...

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Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Records ('MU') with me after reading a number of my EHR posts, and asked if he could share his thoughts via Healthcare Renewal. Dr Monteith is a graduate of the University of Michigan and Michigan State University where he was chief resident. He is a board certified psychiatrist, clinical assistant professor in the departments of psychiatry and family medicine at Michigan State University, and has worked in the same community health center for 20 years serving people suffering from severe and persistent mental illness. His interest in Health Information Technology goes back over 20 years. He has served as a CCHIT Juror, was appointed by Michigan’s Governor Granholm to the Controlled Substances Advisory Commission which has an oversight role for the Michigan Automated Prescription System, and was a member of the Business Operations group of the Michigan Health Information Network. Dr. Monteith writes:  <blockquote>From Medical Economics:“While 85% of physicians were aware of the financial incentives for implementing an electronic health record (EHR) system, more than 35% did not know that they face government-assessed financial penalties for not complying, according to a survey of more than 500 physicians by Physicians' Reciprocal Insurers, a New York-based medical liability insurance company. The penalties are equal to a 1% reduction of the physician's annual Medicare payments per year up to 5%. However, those penalties do not seem to be having the intended effect, as more than 65% of physicians who were unaware of the financial penalties said this would not cause them to implement system."The above Medical Economics article reflects a reality that is consistent with what we are seeing in the clinical ‘trenches.’Eligible Providers (EPs) are realizing that Meaningful Use (MU) incentives are not as simple as…using a certified EHR + being part of Medicare and/or Medicaid + applying for MU + attesting to MU.Receiving $44k (or $64k) in incentives seems not only increasingly elusive, but of questionable benefit even if some or all of the incentives are realized. The ‘carrot & stick’ of Meaningful Use (MU) seems to increasingly be viewed as ‘meaningless and useless’ by at least some clinicians. Some are asking if ‘MU’ will stand for ‘meaningless and useless’ in the future. There seems to be a long list of reasons why MU is so challenging. From what I have gleaned, there appear to be two main issues: 1. the cost to meet MU may be too high (and, said another way, the ROI might be too low); and 2. there are too many uncertainties associated with MU (largely stemming from the risk of burdensome bureaucratic entanglement – an unknown and potentially huge “cost”). As we know, MU reimbursement flows through two streams: Medicare and Medicaid. And one’s incentive dollars and/or penalties are based on Medicare/Medicaid volume. So small Medicare/Medicaid volume means small incentives/penalties. With the perception of inevitable Medicare and Medicaid cuts, these two funding streams become increasingly irrelevant for more and more providers. Another issue stems from the fact that MU and the associated EHR “certification” are losing credibility because they do not address “usability.” My users simply want EHRs that “work,” and “work” well (like their iPhones). Users ultimately want and expect usability. They hoped that certification would help guide them in this important respect, but they are finding that is not the case. To the extent that certification is not meaningfully addressing ‘usability,’ therefore, MU is viewed as ‘useless’ in guiding purchasing decisions. Further, many are simply not confident that they will meet MU. Other challenges I’ve encountered include: <ul style="font-family:arial;"><li>One big problem with MU is that many people believe that wedding one’s self to MU (ARRA) will open a can of bureaucratic worms (and they might be correct)</li></ul> <ul style="font-family:arial;"><li>MU is 864 pages of details. How many users will read all 864 pages of the government’s final rule for MU? (And of those few who do, how many will understand it?). If one doesn’t know the MU rules, how will one prepare for MU? Hire consultants and IT experts? How much will this cost?</li></ul> <ul style="font-family:arial;"><li>How will one establish that one is MU-certified? In year one there will be self-attestation. But who/what will certify users as to whether or not users are meeting MU in the other years? How much will it cost (direct costs to pay above certification organization/entity)?</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">How much will it cost users to become certified (indirect costs to prepare for your certification)? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Currently it appears that one must recertify every year for incentives. But how often will one have to recertify to avoid penalties? What will be the ongoing cost in terms money, time, energy, business flow? Will the ROI be positive or negative (and how positive or negative)?</li></ul> <ul style="font-family:arial;"><li>To what future governmental audits might one be subjected if one gets incentive dollars and/or wants to avoid penalties (especially after the inevitable celebrated cases of abuse)? It is not hard to imagine receiving a letter from the government that says, in essence: “You self attested that you met MU in year one. You are now being audited to substantiate your attestation.”</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">How many people will be audited after receiving ARRA dollars? How much time will the audit take? For how long will you need to keep records? What records? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">What will Congress (and the FBI) do when someone gets ARRA dollars through the “incentives” (or avoids “penalties” in the penalty phase), but they haven’t properly completed the MU certification process, or properly/fully documented it (perhaps no fault of their own)?</li></ul> <ul style="font-family:arial;"><li>What liability does one incur by claiming to meet MU, but then later discovering that someone in the government says that you have not met MU?</li></ul><ul style="font-family:arial;"><li>Given that one needs to do things for MU that establish X percent of a given function (e.g., Rxs) are accomplished through an EHR, one needs both a numerator and denominator to establish the percentage. But how does one capture the data to establish MU percentages for Rxs (and other tasks) that are done on paper?</li></ul> <ul style="font-family:arial;"><li>Are incentive dollars taxable? The answer appears to be “yes.” But many doctors are already “signing over” their dollars to institutions. Unfortunately, neither the doctors nor the institutions are making accommodations for the tax implications. That is, what happens when institutions get the dollars, but because the dollars flow through the clinician, the clinician gets the tax bill?</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">What happens if you change EHRs, for example, due to moving to new practice? Will you have to start all over again? Will you have to reimburse the government? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Today there are over 400 EHR vendors. In five years, it is expected that at least 350 will ‘go under’ (no longer exist). What then? Recertify? Give back ARRA dollars? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Will the goal line (either in terms of criteria or time) for MU be moved? (It might move; some say it definitely will move.) How often will this occur? What are the implications for your MU and any ARRA dollars that you have received? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">The Republican “Pledge” is calling for no incentives be spent (including related to HIT).</li></ul> </blockquote>Of course, my own opinion is that setting standards for "meaningful use" implies that use of EHR's can be meaningful to the doctor & patient (rather than to the government and to payors); the literature is conflicting on this point. Further, doing do at a time when HIT is widely acknowledged to be of poor usability (even by HIMSS itself) is putting the cart before the horse, as I wrote at my post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?</a>" We report; you decide. -- SS

Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Reco...

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"Drug companies are now No. 1 When it Comes to Defrauding the Government"

A new <a href="http://www.citizen.org/hrg1924">report</a> from Public Citizen, as <a href="http://www.npr.org/blogs/health/2010/12/17/132134328/when-it-comes-to-government-fraud-health-care-now-tops-defense">summarized</a> by National Public Radio: <blockquote>Drug companies are now No. 1 when it comes to defrauding the government, leaving defense contractors in the dust. A report from the consumer group Public Citizen says financial penalties against drug companies under the federal False Claims Act far outstripped defense contractors between 2007 and 2010.</blockquote> The problem has been getting worse recently: <blockquote>Documented pharma fraud has been accelerating lately, Public Citizen says. It looked at fines and settlements paid by drug companies over two decades. Since 1991 those penalties totaled $19.8 billion. But three-quarters of those occurred over the past five years.</blockquote> Regarding the biggest offenders: <blockquote>Just four giant drug companies – GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plough – account for more than have the pharma penalties over the past two decades. They belong to the Billion Dollar Club — companies that have paid out settlements of $1 billion or more. Altogether the four have paid $10.5 billion back to the government.</blockquote> Reading the report itself makes the acceleration of drug company fraud settlements even more apparent (p. 12): <blockquote>Data from the Department of Justice shows that annual federal FCA settlement totals for all industries have increased dramatically over the past 20 years, from $341 million in fiscal year (FY) 1991 to $3 billion in FY 2010. The proportion attributed to all Health and Human Services (HHS) cases (i.e., cases that involve pharmaceuticals and other health care industries), increased from 4 percent of the total in FY 1991 to 84 percent in FY 2010.</blockquote> Furthermore, <blockquote>the pharmaceutical industry did not comprise a substantial portion of federal FCA penalties until FY 2002, when it overtook the defense industry for the first time. For every year since and including FY 2007, the pharmaceutical industry total has far exceeded the defense industry total. As stated above, the total healthcare industry (as represented by HHS totals), has been the biggest defrauder of the federal government under the FCA for most of the past decade. Defense industry payments and the combined total for all other (non-defense and non-HHS) sectors each represent an amount smaller than the pharmaceutical industry total alone since FY 2007. In addition, since FY 2008, the pharmaceutical industry’s FCA payments have exceeded the total law-violation payments of each of the other sectors within the health industry.</blockquote> Of course, data about settlements of US False Claims Acts claims is only one, limited measure of unethical and criminal behavior. However, in lieu of better data, it is striking that the vast majority of such settlements are now by the health care sector, and the pharmaceutical industry in particular accounts for the biggest share of such claims within that sector.   In my opinion, these data illustrate just how unethical, if not corrupt, health care in the US has become. It is particularly appalling because health care is not just another "industry," but traditionally was regarded as a calling to relieve suffering, and when possible prevent or cure disease. Traditionally, health care practitioners and health care institutions were held to higher standards than other industries, like the defense industry, or the trash hauling industry. Now, however, it appears that the health industry holds itself to the lowest standards.  Is it any wonder that our health care system is dysfunctional, or that our costs constantly rise, while access and quality decline. This data should prompt massive outrage, and lead to yet more ringing calls (like those we discussed recently <a href="http://hcrenewal.blogspot.com/2010/12/health-professionals-for-new-century.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">here</a>) for reform, at least of specific aspects of health care.  I doubt that will happen, however, because these data, like so much of the cases and data we discuss on Health Care Renewal, probably will be muffled by the anechoic effect. Despite its striking results, this report has not been covered in print by any major market newspaper. (Duff Wilson did <a href="http://prescriptions.blogs.nytimes.com/2010/12/16/drug-makers-are-paying-big-settlements">blog</a> about it for the New York Times.) The only US newspaper coverage so far appears to be in <a href="http://www.theday.com/article/20101218/BIZ02/312189912/-1/BIZ">the New London (CT) Day</a>. There has been no coverage on US television. The Public Citizen report noted that the largest settlement for clinically related reasons was by Pfizer of $2.3 billion for unlawful promotion and kickbacks (see blog posts <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">here</a>). Despite the apparently staggering size of this settlement, a Google Scholar search revealed only one mention of it, and that rather tangential, in a large circulation US medical journal, the New England Journal of Medicine.(1) It was mentioned in the news sections of two major journals outside of the US, the British Medical Journal(2) and the Canadian Medical Association Journal.(3) So unless US health care is about to change drastically, I do not expect any discussion of this data in the medical and health care literature. The likelihood that this report will be noticed by most physicians, health care researchers, or health care policy makers is almost nil. Why does such striking information create so few ripples?  It has never been formally studied, to may knowledge. However, I suspect it has to do first with the vast web of conflicts of interest that now drapes over health care.  As we have mentioned before, the majority of US medical school faculty,(4) and the majority of US medical schools' department chairs(5) have significant financial relationships with industry, often the pharmaceutical industry.   Some leaders of US academic mission are simultaneous members of boards of directors of for-profit health care corporations (e.g., see <a href="http://hcrenewal.blogspot.com/2010/12/duke-divinity-students-protest-pay-of.html">this example</a>), and thus have fiduciary responsibilities towards those corporations.  Thus, how many academics are going to want to offend their employers, or their colleagues' and supevisors' employers, by writing about such recent unpleasantness as billion dollar pharmaceutical settlements for fraud?  Second, it probably has to do with the power derived from the wealth of the leaders of pharmaceutical corporations, wealth they seem to amass no matter what ethical violations their companies pile up.  For example, according to the <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMTE5MzEyNS0xMC0wNTc5NDkvZG9jLzAwMDExOTMxMjUxMDA1Nzk0OS5wZGYmdHlwZT0yJmZuPTAwMDExOTMxMjUxMDA1Nzk0OS5wZGY=">2010 Pfizer Proxy Statement</a>, Mr Jeffry Kindler, the CEO of Pfizer through this year, currently owns the equivalent of  1,084,212 shares of Pfizer stock (worth $18,615,920 at <a href="http://www.google.com/finance?q=pfizer">today's price</a> of $17.17/ share), has the rights to 1,996,000 stock options, and received $5,534,285 total compensation in 2009, $7,553,015 in 2008, and $4,469,760 in 2007.   I can only hope that the anechoic effect eventually breaks down, and a movement to truly reform US health care eventually develops.  True reform will require holding health care organizations to higher, not lower standards than trash haulers and gambling casinos, and regarding working in health care as a calling, rather than a means to satisfy one's greed.   Hat tip <a href="http://www.margaretsoltan.com/?p=28337">to Prof Margaret Soltan</a> on the University Diaries blog. ADDENDUM (21 December, 2010) - See also <a href="http://www.margaretsoltan.com/?p=28381">this comment</a> by Prof Margaret Soltan on the University Diaries blog, and comments (<a href="http://shearlingsplowed.blogspot.com/2010/12/astonishing-or-not-so-198-billion.html">here</a> and <a href="http://shearlingsplowed.blogspot.com/2010/12/meet-pharma-new-fraud-kings-path-to.html">here</a>) by "Condor" on the Shearlings Got Plowed blog. References 1. Kesselheim AS, Studdart DM, Mello MM. Whistle-Blowers' experiences in fraud litigation against pharmaceutical companies. N Engl J Med 2010; 362:1832-1839. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsr0912039">here</a>. 2. Tanne JH. Pfizer pays record fine for off-label promotion of four drugs. Br Med J 2009; 339:b3657. Link <a href="http://www.bmj.com/content/339/bmj.b3657.full">here</a>. 3. Anonymous. Federal committee to review Pfizer v-p appointment to CIHR council. Link <a href="http://www.cmaj.ca/cgi/rapidpdf/cmaj.109-3113v1.pdf">here</a>. 4. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa064508">here</a>. 5. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. Link <a href="http://jama.ama-assn.org/content/298/15/1779.full">here</a>.

"Drug companies are now No. 1 When it Comes to Defrauding the Government"

A new report from Public Citizen, as summarized by National Public Radio: Drug companies are now No. 1 when it comes to defrauding the gov...

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Elan, Eisai Settle for Related Reasons

The <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of legal settlements</a> of bad behavior by major health care organizations marches on. The latest to shuffle by are Elan Corp, based in Ireland, and Eisai Inc, based in Japan, for actions taken in the US.  According to <a href="http://www.businessweek.com/news/2010-12-16/elan-to-pay-203-million-unit-to-plead-guilty-in-zonegran-probe.html">Bloomberg</a>: <blockquote>Elan Corp. will pay $203 million and a U.S. unit of the Irish drugmaker will plead guilty to a misdemeanor charge to resolve an investigation of its marketing of the epilepsy medicine Zonegran. Elan will pay $102.9 million to resolve civil claims and $100 million in criminal fines and forfeitures, according to the U.S. Justice Department. Japanese drugmaker Eisai Inc., which bought the drug from Elan in 2004 for $128.5 million, also will pay $11 million to settle civil claims. The Elan Pharmaceuticals unit will plead guilty in federal court in Boston to a charge of misbranding Zonegran, which was approved by U.S. regulators for treatment of epileptic seizures in adults over age 16, the Justice Department said yesterday in a statement. Dublin-based Elan promoted Zonegran for uses including mood stabilization, bipolar disorder, migraine headaches, weight loss and seizures in children. 'Elan’s off-label marketing efforts targeted non-epilepsy prescribers and the company paid illegal kickbacks to physicians in an effort to persuade them to prescribe Zonegran for these off-label uses,' according to the statement.</blockquote> The details were: <blockquote>In 2002, EPI [Elan Pharmaceuticals Inc] 'came under significant financial pressure' because of an investigation of its financial practices by the U.S. Securities and Exchange Commission that caused shares to drop to $2 from $65 in six months, according to the criminal charge. In evaluating its options, EPI 'decided to retain Zonegran because of its large potential for growth, particularly in unapproved areas,' prosecutors said. EPI then trained its sales staff to promote Zonegran for off-label uses, including for children, pain, psychiatric disorders, migraines and movement disorders, prosecutors said. Letters sent to pediatricians described how to administer Zonegran to a child by putting a capsule’s contents into applesauce, according to the document, which EPI will admit to in its guilty plea. Doctors with the potential to write many prescriptions were invited on expense-paid trips to Bermuda, Key Largo, Florida, Banff in Alberta and Tucson, Arizona, to hear speeches on off- label uses, according to the charge. Sales 'increased dramatically,' rising 80 percent from August 2001 to August 2002, while 2003 revenue increased 87 percent over the previous year, prosecutors said.</blockquote> So here we ago again, another week, another multi-hundred million dollar settlement. Once again, the settlement is of charges of deceptive marketing practices and kick-backs to physicians. Once again, the settlement involves criminal charges and a corporate integrity agreement, but does not involve any negative consequences for any individual who authorized, directed, or implemented the unethical practices. We have noted recent cases, <a href="http://hcrenewal.blogspot.com/2010/11/former-kv-pharmaceutical-ceo-and.html">one</a> in which a corporate executive was banned from doing business with the federal government, <a href="http://hcrenewal.blogspot.com/2010/11/this-is-really-going-to-set-peoples.html">another </a>in which a corporate executive was indicted, but not yet tried on criminal charges.  However, in most cases, the parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> made by health care organizations has just marched on, sometimes including guilty pleas to criminal charges, often involving charges of kickbacks, fraud, conspiracy, and other colorful offenses. Most of these settlements entailed fines or other payments by the organizations that may seem huge, but were fractions of the amounts made by the practices that lead to the charges that were settled.  With the few exceptions above, (plus one other known exception, the disbarment from federal business of three former executives of Purdue Pharma, story <a href="http://www.nytimes.com/2010/12/16/business/16purdue.html">here</a>), almost never have the cases involved penalties for any individuals who authorized, directed, or implemented the misbehavior.  We have also been saying (seemingly <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">endlessly</a>, but most recently <a href="http://hcrenewal.blogspot.com/2010/12/abbott-laboratories-and-pig-roasts.html">here</a>) that such settlements may be viewed by organizations as merely the costs of doing business, and so until the actual people who were involved in the bad behavior suffer some negative incentive or penalty, expect the behavior to continue.  Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.) If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy. (FULL DISCLOSURE - I own 3200 shares of Elan.  This is the only health care stock I own.  I have held it a long time, not bothering to sell since the shares have been worth little for years.  This has provided a lesson about how the share-holders of big health care corporations rarely profit from the executives' risk taking.)

Elan, Eisai Settle for Related Reasons

The parade of legal settlements of bad behavior by major health care organizations marches on. The latest to shuffle by are Elan Corp, base...

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Why I Shouldn't Read Non-Systematic Review Articles: Special Pleadings and Undercover Authors

I usually resist looking at non-systematic review articles in medical journals, but because the title interested me, and things seem to be getting slow this holiday season, prompted by an update email from the American Journal of Medicine, I looked at Ram CVS. Beta-blockers in hypertension. Am J Cardiol 2010: 106: 1819-1825. (Link <a href="http://www.ajconline.org/article/S0002-9149%2810%2901631-0/abstract">here</a>.) The Ram Article in Praise of Vasodilating Beta-Blockers The article focused on the results of meta-analyses: <blockquote>Concerns have also been raised by meta-analyses in which β blockers were reported to have a suboptimal effect on reducing stroke risk and increasing the risk for new-onset diabetes compared with other antihypertensive agents.</blockquote> The article discussed several meta-analyses in which beta-blockers, [a specific class of blood pressure lowering drugs] but mostly atenolol (mostly sold generically), usually combined with a diuretic, were compared with other antihypertensive drugs, usually including angiotensin converting enzyme inhibitors (ACEIs) and calcium channel blockers. But after discussing these comparative results, the author jumped to descriptions of another group of drugs which were not included in any of these comparative studies. This was the category of vasodilating beta-blockers, consisting of labetolol (mostly sold generically), carvedilol (Coreg, GlaxoSmithKline [GSK]), and nebivolol (Bystolic, Forest Laboratories. Based on physiologic studies of these drugs and trials in which they were compared with placebo, but not on studies which directly compared clinical outcomes of patients given these drugs or other kinds of antihypertensives, Dr Ram reached conclusions that they were a better alternative: <blockquote>The review of the evidence provided herein confirms that there are valid reasons to question the utility of certain β blockers in treating hypertension. However, many of the perceptions about β blockers are derived from data obtained from studies of traditional agents or combinations of diuretics and β blockers. Evidence suggests, and the guidelines concur, that there are intrinsic differences among members of the β-blocker class. Indeed, the vasodilatory β-blockers, which have generally not been included in comparative meta-analyses, lower blood pressure to a similar degree as other antihypertensive drugs, may provide better central aortic pressure reductions than traditional β blockers, and are associated with neutral or favorable metabolic effects.</blockquote>Special Pleading Dr Ram's questioned the old-fashioned beta-blocker atenolol (perhaps only when added to a diuretic)  based on the results of meta-analyses which attempted to compare it to other drugs. Such meta-analyses could suggest that atentolol (again, perhaps only in combination with a diuretic) might be in some way less preferable than the other drugs to which it was compared. However, the meta-analyses did not address the vasodilating beta-blockers at all. Dr Ram concluded that they were preferable based on different kinds of and probably less definitive evidence. He did not seek to compare such studies done on the vasodilating beta-blockers to similar studies done on the conventional beta-blockers.  Thus it seems his conclusions were based on a double standard. In the vocabulary of logical fallacies, this was an example of a <a href="http://www.nizkor.org/features/fallacies/special-pleading.html">special pleading</a>: <blockquote>Special Pleading is a fallacy in which a person applies standards, principles, rules, etc. to others while taking herself (or those she has a special interest in) to be exempt, without providing adequate justification for the exemption. </blockquote> Here was more reason not to bother reading a narrative review articles to learn how to better practice clinical medicine.  They often are based on idiosyncratic, if not biased evidence used to support illogical arguments. But having read so far, I wondered why the authors of this article were so happy to use a double standard as the basis of their arguments. Undercover Author Those paying attention may also now be wondering why I referred to the authors in plural, when the citation lists only one author. The clue is at the end of the article: <blockquote>Acknowledgment I would like to thank Tamalette Loh, ProEd Communications, Inc. (Beachwood, Ohio), for her editorial assistance and literature validation in the preparation of this report.</blockquote> Sensitized as I have been to the many recent discussions of ghost-writing, I immediately wondered who Ms Loh is, and what sort of "editorial assistance and literature validation" she provided. So first I looked at what her company, ProEd Communications does, wondering if its business is to help syntactically challenged academics and professionals write better sentences and more organized papers. The ProEd Communications <a href="http://www.proedcom.com/">web-site </a>states: <blockquote>ProEd Communications balances diverse perspectives—clinical, regulatory, marketing, and customer—to create compelling messaging to maximize a product's potential. </blockquote> So it appears that ProEd Communications does not provide independent editorial services. Instead, it is a <a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communications company</a> (MECC) which works mainly to market its clients' products, and further, its <a href="http://www.proedcom.com/ExperienceAndClientList.aspx">clients</a> are essentially only pharmaceutical companies: <blockquote>Of the world's 50 largest pharmaceutical companies, ProEd has worked with 18 in the past 3 years and currently supports projects for 7 of the top 10 largest pharmaceutical companies, as ranked by MedAdNews (2008).</blockquote> Furthermore, a few minutes on Google reveals that Ms Loh seems to specialize in papers on anti-hypertensives, particularly Coreg (carvedilol), one of the three drugs in the vasodilating beta-blocker group favored by Dr Ram. In fact, two other papers whose authors she assisted sounded hauntingly familiar. Let me first display the quote above from the Ram paper: <blockquote>Concerns have also been raised by meta-analyses in which β blockers were reported to have a suboptimal effect on reducing stroke risk and increasing the risk for new-onset diabetes compared with other antihypertensive agents.</blockquote> Now see this quote from Frishman WH, Henderson LS, Lukas MA. Controlled-release carvedilol in the management of systemic hypertension and myocardial dysfucntion. Vasc Health Risk Management 2008; 4: 1387-1400.  (Link <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2663448/">here</a>): <blockquote>However, concerns have been raised recently from hypertension meta-analyses regarding suboptimal outcomes with use of beta-blockers, specifically atenolol, compared with outcomes for other antihypertensive drug classes.</blockquote> Also see this relatively similar quote from McGill JB. Optimal use of beta-blockers in high-risk hypertension: a guide to dosing equivalence. Vasc Health Risk Management 2010; 6: 363-372. (Link <a href="http://amec.glp.net/c/document_library/get_file?p_l_id=843157&folderId=754745&name=DLFE-19217.pdf">here</a>): <blockquote>Concerns about the use of β-blockers as first-line agents for hypertension have been raised because of a 2005 metaanalysis that found β-blockers do not significantly reduce cardiovascular events, especially stroke, compared with other antihypertensive drug classes</blockquote> Furthermore, read this discussion of Coreg by Ram: <blockquote>Carvedilol is a nonselective β blocker with α1 receptor–blocking activity and no intrinsic sympathomimetic activity. Clinical data suggest that carvedilol reduces systemic vascular resistance in patients with hypertension.</blockquote> Here is Frishman et al: <blockquote>Carvedilol is a third-generation, vasodilatory beta-blocker that nonselectively blocks both the beta 1- and beta 2-adrenergic receptors.... vasodilatory beta-blockers can lower blood pressure by reducing systemic vascular resistance (SVR) </blockquote> Both Frishman et al and McGill are very positive about Coreg.  Although the emphases of the three articles are different, they have organizational similarities.  Again, all three were written with the assistance of Ms Loh. At the end of the Frishman article we again find: <blockquote>The authors would like to thank Tamalette Loh, PhD, ProEd Communications, Inc.®, for her medical editorial assistance with this manuscript.</blockquote> At the end of the McGill article we find: <blockquote>Editorial assistance, specifically revisions to the final draft, was provided by Tamalette Loh, PhD, at ProEd Communications, Inc.®, whose services were also funded by GlaxoSmithKline. Dr Loh’s revisions were reviewed and approved by Dr McGill.</blockquote>Note that now it seems that Ms Loh has a doctoral degree, of unclear kind. Note also that now it seems that GSK, the manufacturer of Coreg, funded Dr Loh's work on the McGill article. Dr McGill further disclosed: <blockquote>Dr McGill is a consultant for GlaxoSmithKline and a speaker for AstraZeneca and Forest Pharmaceuticals. Financial support for medical editorial assistance was provided by GlaxoSmithKline, Philadelphia, Pennsylvania.</blockquote> Finally, in another article, about angiotensin converting enzyme blockers combined with diuretics to treat hypertension (Egras AM, Ram CVS. Reduced cardiovascular risk and healthcare expenditures with angiotensin receptor blocker/ hydrochlorthiazide. Am J Pharmacy Benefits 2010; 2: 127-135. Lin <a href="http://ajpblive.com/media/pdf/Ergas_2-2.pdf">here</a>. ), Dr Ram acknowledged: <blockquote>Dr Ram is in the speakers’ bureau pool of Cogenix, ProCom, and Genesis, which manage medical education programs for Bristol-Myers Squibb, GlaxoSmithKline, and Novartis.</blockquote> The series of articles above demonstrated a phenomenon I have not seen explored before. All articles were written with some sort of assistance from an employee of a MECC, perhaps partly funded by a company which marketed a drug which was the subject of all the articles. The assistance was openly acknowledged.  The three articles had some remarkable similarities not explained by an overlap among their listed authors.  This suggested that the ostensible editorial assistant they had in common was substantively involved in the content of the papers, that is, was truly an author. Her presence was not ghost-like. However, the substance of her contribution may have been downplayed.  So let's call her an "undercover author."  (If someone has a better term, please leave a comment to that effect.) Summary So the reasons I rarely read narrative review articles except to make teaching points about health care dysfunction are: - They often are based on idiosyncratic, if not biased selections of data - They may employ logical fallacies to make their points - They may be written by people with conflicts of interest, that is, with financial arrangements with companies seeking to market products, particularly drugs and devices. My conclusions for health care professionals are: be very skeptical of non-systematic review articles, look for evidence that they are parts of stealth marketing campaigns, and do not assume all conflicts of interest are disclosed and all authorship roles revealed. My conclusions for journal editors are: strictly demand more complete disclosure of conflicts of interest, or risk losing the trust of your readers. My conclusions in general: until we start to sweep away the pervasive web of conflicts of interest that is draped over medicine and health care, expect further discombobulation.

Why I Shouldn't Read Non-Systematic Review Articles: Special Pleadings and Undercover Authors

I usually resist looking at non-systematic review articles in medical journals, but because the title interested me, and things seem to be g...

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"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this letter in today’s WSJ that I think says it all about complex technological projects, including (perhaps especially) healthcare IT.Emphases mine:<a href="http://topics.wsj.com/article/SB20001424052748704694004576019311025319804.html" rel="nofollow"></a><blockquote><a href="http://topics.wsj.com/article/SB20001424052748704694004576019311025319804.html" rel="nofollow"> </a>Wall St. Journal Letter to the Editor Dec. 16, 2010 <a href="http://topics.wsj.com/article/SB20001424052748704694004576019311025319804.html" style="font-style: italic;"> Manhattan Spirit for Cyber Defense </a> In “How to Fight and Win the Cyberwar” (op-ed, Dec. 6), Mortimer Zuckerman uses the analogy of the Manhattan Project to build the atomic bomb in World War II and suggests forming a “Cyber Defense Administration” (CDA). We need to keep in mind how the Manhattan Project managed to succeed in achieving its objectives. The direction and top management of the project was by scientists like Robert Oppenheimer, who understood the scientific details of the project, and project director Gen. Leslie Groves, who made sure the scientists got what they wanted. This is not like any bureaucracy in the U.S. government today. I would visualize a CDA more as a TSA- or EPA-type bureaucracy with a politically sensitive lawyer or bureaucrat at the top, and having to go down two or more administrative levels before you find the first Ph.D.-level computer scientists with a history of serious research and publications in computer/network security. The head of the CDA would probably be clueless about the computer science details and would have no basis for making rational decisions. This is a field where the devil is in the details, and to truly understand those details requires much more than bureaucratic and political skills. Whoever created the Stuxnet worm that attacked Iran’s nuclear program’s computers probably was not managed by a bureaucrat, but by a team of very high-level scientists who clearly understood the details. Countries like China often have real experts running their organizations, not just politically smooth bureaucrats who go from job to job with a false theory that a “good manager can manage anything.” In reality, especially in a field like cyber security, a good manager can only manage what he understands. Our bureaucrats will lose the cyberwar against scientists who understand the details. Dallas Weaver Huntington Beach, Calif.</blockquote> It is a bureaucratic conceit to think that a "good manager" can manage major healthcare IT projects - or pharmaceutical companies - or anything else outside their core competencies. This holds true even assuming, at best, that one of their "core competencies" is <a href="http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.64.2655&rep=rep1&type=pdf">competency itself</a> (warning: PDF on the <a href="http://en.wikipedia.org/wiki/Dunning%E2%80%93Kruger_effect">Dunning-Kruger effect</a> on illusory superiority). -- SS

"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this ...

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New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT: <blockquote>"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, <a href="http://www.nytimes.com/2010/12/14/business/14records.html?_r=1&hpw" style="font-weight: bold;">link</a>) </blockquote> In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (<a href="http://www.iom.edu/">IOM</a>) Committee on Healthcare IT safety. In general, the expressed viewpoints reported upon are consistent with the position in the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">Healthcare IT Ecosystem</a> of those quoted. I wish to add some commentary to a number of those stated positions. Mr. Freudenheim observes: <blockquote>Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington. </blockquote> (This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "<a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">Current Approaches to U.S. Health Care Information Technology are Insufficient</a>", which has largely been invisible. The IOM is the health arm of the National Academies.) I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care. I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose relative was injured as a result of HIT interference with care continuity, will I be allowed to testify?) Mr. Freudenheim then relates the points of view of stakeholders. <blockquote>In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals. “Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official. </blockquote> I'd written about this at "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=FDA_iceberg">FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg</a>" where I noted: <blockquote>This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters. Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this: “We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - <a href="http://www.himss.org/ASP/ContentRedirector.asp?ContentId=65039&type=HIMSSNewsItem">2005 HIMSS Summit</a></blockquote> I also opined at "<a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a>" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment: <blockquote>[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events. In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.</blockquote> Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon. The NYT article then reports on a statement made by ONC Chair David Blumenthal: <blockquote>“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology. </blockquote>Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records</a>" I wrote: <blockquote><div class="PlainText" style="font-family:arial;">... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available <a href="http://healthcarereform.nejm.org/?p=3732&query=home">at this link</a>, the opening statement is (emphases mine): </div><blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"><div class="PlainText">The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</div></blockquote><div class="PlainText" style="font-family:arial;"> I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;"> Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">I note the lack of footnotes showing the source(s) of these statements. I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.] </div></blockquote> Dr. Blumenthal then appeals to authority: <blockquote> Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.” </blockquote> I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise. (Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.) Freudenheim then quotes Blumenthal as stating: <blockquote>“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend. </blockquote> This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine. <blockquote>“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”</blockquote> Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right: As I'd written about HIMSS admissions of health IT unsuitability to task at "<a href="http://hcrenewal.blogspot.com/2010/12/nist-provides-healthcare-it-industry.html">NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education</a>": <blockquote>... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/national-program-for-health-it-in-us.html">The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room</a>".)</blockquote> Further, from the NYT article: <blockquote>He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.” </blockquote> That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit: <blockquote>“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups. </blockquote> There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “<a href="http://hcrenewal.blogspot.com/2010/12/nist-provides-healthcare-it-industry.html" rel="nofollow">NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records</a>” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’ In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned. Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle. Per the NYT, the industry trade group HIMSS has gone mum: <blockquote>The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.” </blockquote> They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products. The NYT article goes on: <blockquote>Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse. “We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety. </blockquote> It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=workshop">here</a>). Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC. I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.In summary, I welcome the New York Times bringing these issues to the public.I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify. But their effects on people's behaviors can - and should - be regulated.-- SS

New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT: " Panel Set to Study Safety of Electronic Pat...

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