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Conflicts of Interest or Bribes? - Biomet, Smith & Nephew Settle

More justifications of physicians' and other health care professionals' financial arrangements with industry have been appearing in the media and the medical literature (for recent examples, look <a href="http://hcrenewal.blogspot.com/2012/03/another-cautionary-tale-about-conflicts.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/03/logical-fallacies-in-defense-of.html">here</a>). Most commonly, the relationships they defended could be characterized as health care professionals consulting or sitting on advisory boards for industry, or receiving royalties from industry for their intellectual property. In the last two months, two device manufacturers, Biomet and Smith & Nephew, accepted penalties for less defensible financial relationships with physicians. They entered into deferred prosecution agreement and settled charges that they bribed doctors employed by foreign governments. Some of these relationships, especially those involving Biomet, would have been prospectively indistinguishable from the sorts of conflicts of interest that have been so fervently defended. Background 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 in the US. All companies except Stryker were charged with "criminal conspiracy to violate anti-kickback laws," and all were subject to deferred prosecution agreements.  (Stryker entered into a voluntary compliance agreement.)  According to a US Department of Justice <a href="http://www.justice.gov/usao/nj/Press/files/pdffiles/Older/hips0927.rel.pdf">news release</a>, the agreements required: <blockquote>• A federal monitor will be in place at each company to review compliance with the DPAs and NPA and all new and existing consulting relationships with the companies; • Each company is required to conduct a needs assessment to determine the reasonable needs for educational consulting services, and new product-development consultants. • All new consulting agreements shall require physicians to disclose their financial engagements with any company to their patients and require the companies to disclose the name of each consultant and what they have been paid on the company website.</blockquote> These agreements ended in 2009. The Latest Settlements As we <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">noted</a>, in 2011, Johnson and Johnson admitted its subsidiaries, including DePuy, had been bribing doctors in Europe through 2007, and agreed to yet another deferred prosecution agreement. Smith & Nephew Last month, Bloomberg <a href="http://www.bloomberg.com/news/2012-02-06/smith-nephew-agrees-to-pay-22-million-to-settle-u-s-bribery-allegation.html">reported</a>: <blockquote>Smith & Nephew Plc, Europe’s biggest maker of artificial hips and knees, agreed to pay $22.2 million to settle allegations by the U.S. Justice Department and Securities and Exchange Commission that it engaged in a scheme to pay bribes in Greece. Smith & Nephew admitted in filings today in federal court in Washington that two of its units were involved in a scheme for more than a decade to make 'illicit payments' to doctors employed by government hospitals or agencies in Greece in violation of the Foreign Corrupt Practices Act. The London-based company, which entered into a deferred prosecution agreement with the U.S., agreed to pay a $16.8 million fine to settle the criminal allegations and another $5.4 million to settle a civil suit filed by the SEC. </blockquote> The colorful specifics were: <blockquote>Smith & Nephew admitted that from 1997 until June 2008, its U.S. and German units bribed public doctors in Greece to win business. The bribes were paid through a person described in court documents as a 'Greek distributor.' This person used shell companies that masked bribes as 'marketing services,' according to the statement of facts filed in the criminal case. The document cites a March 2002 e-mail from the Greek distributor to a Smith & Nephew vice president in Memphis, Tennessee, complaining that the 'marketing services' payments weren’t enough, noting that competitors were paying 30 percent to 40 percent more. 'I absolutely need this fund to promote my sales with surgeons,' the distributor said in the e-mail, according to prosecutors. Reforming a corrupt and dysfunctional public health system was one of the conditions of Greece’s acceptance of a European Union and International Monetary Fund bailout package in 2010. Doctors also supplement their income with payments from patients, called 'fakelaki,' small envelopes with cash for prompt treatment. </blockquote>In the <a href="http://www.sec.gov/litigation/complaints/2012/comp22252.pdf">SEC complaint</a>, the payments made to the physicians were described as "commissions." Note that the company made the usual sort of statement, <blockquote>'We have what I believe to be a world-class compliance program, having enhanced it significantly since this investigation began in 2007,' Olivier Bohuon, Smith & Nephew’s chief executive officer, said in a statement. 'These legacy issues do not reflect Smith & Nephew today.' </blockquote> He did not mention why the payments were continuing at a time when the company was already supposedly operating under the previous deferred prosecution agreement that arose out of the charges in the US discussed above. Biomet This week, the Indianapolis Star <a href="http://www.indystar.com/article/20120327/BUSINESS/203270312/Indiana-medical-device-maker-Biomet-settles-bribe-case">reported</a>, <blockquote>To sell its products abroad, medical device maker Biomet at times bribed doctors with cash, travel and meals, the federal government says. The Warsaw, Ind.-based company agreed Monday to pay nearly $23 million to settle allegations that its payments to doctors violated the federal Foreign Corrupt Practices Act. The Securities and Exchange Commission alleges that Biomet, acting through four subsidiaries and its distributors, paid bribes from 2000 to 2008 to doctors in Argentina, Brazil and China in order to win business. The settlement includes a $17.3 million criminal fine and $5.6 million to the SEC, the government and company said in separate news releases.</blockquote> The details were, <blockquote>he SEC accused Biomet of writing phony invoices to cover kickbacks as high as 20 percent of sales to push its products. In other instances, Biomet provided doctors with money and travel in exchange for implanting artificial joints and other Biomet products in their patients, says the SEC complaint, which was filed in federal court in Washington. In China, Biomet vendors gave doctors cash upon completion of surgeries using Biomet implants, the lawsuit says. 'I've got to send him to Switzerland to visit his daughter,' a Biomet distributor wrote in a 2001 email to the company, describing a trip given as a reward to a Chinese doctor who implanted 10 Biomet hips and knees a month in patients. The SEC said Biomet's compliance and internal audit functions failed to stop the practices even after determining they were illegal.</blockquote> Note how Biomet accounted for the payments, <blockquote>The payments were falsely recorded on company books as 'commissions,' 'royalties' and 'scientific incentives,' the Justice Department said.</blockquote> Furthermore, the Fort Wayne Journal-Gazette <a href="http://www.journalgazette.net/article/20120328/BIZ/303289938/1031/BIZ">added</a>, <blockquote>With the settlement announced Monday, the Justice Department found that Biomet and its subsidiaries covered up bribery payments by officially recording them as 'consulting fees' or 'commissions.'</blockquote> Note that Biomet's official response was similar to Smith & Nephew's, as reported in another <a href="http://www.journalgazette.net/article/20120327/BIZ/303279978">article</a> from the Fort Wayne Journal-Gazette, <blockquote>Jeffrey Binder, Biomet’s president and CEO, didn’t address the company’s guilt or innocence in a written statement released Monday. Biomet has 'significantly enhanced' its procedures worldwide in recent years to ensure employees’ conduct is legal and ethical, he said. 'Moving forward, we intend to continue to adhere to our enhanced global compliance procedures, and to promote the company’s commitment to the highest ethical standards in all the markets that we serve,' Binder said. </blockquote> Again, he did not explain why this time the enhanced compliance procedures are likely to work, given that the questionable conduct was still going on after the company had already entered into the 2007 deferred prosecution agreement. Summary Some Apparent Conflicts of Interest are Actually Bribes In these cases, two medical device corporations paid doctors in several countries for implanting their products into patients. The resulting legal proceedings allow us to characterize these actions as bribes. Clearly both the companies' and the physicians' actions were unethical, since they lead to decisions that put the enrichment of the decision makers and those bribing them ahead of the patients' interests. Some of the most common financial arrangements between health care professionals and industry that are thought of as conflicts of interest are paid consulting and payment of royalties for intellectual property. As we have discussed, e.g. <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">here</a>, conflicts of interest in medicine and health care are generally thought to raise the likelihood of corruption, but not necessarily to indicate corruption in specific instances. In the cases above, bribes were sometimes called "consulting payments or royalties." This suggests that some consulting payments and royalties which may commonly be thought of as conflicts of interest are outright bribes, that is, outright <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">health care corruption</a>. Those who fervently defend conflicts of interest as inevitable, and necessary for collaboration and hence innovation (e.g., look <a href="http://hcrenewal.blogspot.com/2012/03/logical-fallacies-in-defense-of.html">here</a>), often minimize the adverse effects of these conflicts (e.g., look <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">here</a>). In fact, any putative benefits of such conflicts ought to be contrasted with their possible harms. These cases make it clear that these harms include outright corruption which may be disguised as mere conflicts of interest. This adds strength to arguments that conflicts of interest ought to be minimized or eliminated, not tolerated and "managed." Current Measures to Enforce Laws Against Bribes and Kickbacks are More Theatre than Deterrent The current cases are just the latest members in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a>. We have noted that misbehavior in large health care organizations rarely leads to any negative consequences for the people who authorized, directed or implemented the offending actions. Instead, the penalties are, at most, fines paid by the organizations, not the people involved, and variants of deferred prosecution and/or corporate integrity agreements. We and <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">others</a> have previously argued without negative consequences affecting the people who authorize, direct or implement unethical actions, such actions will continue. The current cases corroborate this. Corporations that had already paid fines and accepted deferred prosecution agreements for bribes to physicians continued to bribe other physicians. The failure of the offending corporations to admit any wrongdoing, or the need for specific changes of behavior in the future, suggests that the current fines and deferred prosecution agreements will not be any more effective than the previous ones. The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.   As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.

Conflicts of Interest or Bribes? - Biomet, Smith & Nephew Settle

More justifications of physicians' and other health care professionals' financial arrangements with industry have been appearing in ...

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Tulane/BRG Resident Sues The Hospital: Former Medical Resident Sues for Abuses

My own medical internship was needlessly abusive in terms of sleep deprivation, treatment of interns as chattel by the Chief and some particularly nasty attendings, and the behaviors of some residents who were determined to return the hazing they'd received to the new intern 'plebes.' The abuses ultimately led to high levels of risk to patients. I wrote about my training experiences in my Sept. 2007 post "<a href="http://hcrenewal.blogspot.com/2007/09/in-on-sleep-deprivation-and-medical.html">Metric myopia: does reducing exploitation of medical trainees have 'little effect' on patients?</a>" [1] However, in those days medical trainees were generally helpless to do anything about it. Most sucked the abuse up without complaining. In some cases they became victims of a form of the <a href="http://en.wikipedia.org/wiki/Stockholm_syndrome">Stockholm Syndrome</a>. (In my case, I picked up and left the hospital after the PGY-1 internship year and went to other hospitals to complete my residency which were, at the time, of better quality and far less abusive. The jarring PGY-1 experience in part informs my writing on healthcare abuses in general at this blog. The original hospital went bankrupt a few years ago; this was no surprise to me.) At HC Renewal, the posts on "physician learned helplessness" such as <a href="http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/02/physician-expected-helplessness.html">here</a> in part focus on the effects of postgraduate medical training abuses. So, whatever the truth and ultimate outcome, you at least have to admire this Resident (or, I should say, ex-Resident), who both sued and put up his own website about the suit, for his tenacity: <blockquote><a href="http://www.brglawsuit.com/" style="font-weight: bold;">Former Tulane/BRG Resident Sues The Hospital</a> A whopping 182 million dollar lawsuit against Tulane/Baton Rouge General Medical Center and various local doctors was filed by former Tulane/Baton Rouge General Internal Medicine Resident, Dr. Eid Amer on March 19, 2012 in the 19th Judicial District Court of Louisiana. Among the counts in this enormous fifty page lawsuit are: breach of contract, fraud, forgery, negligence, defamation, intentional infliction of emotional distress, invasion of privacy, violation of the whistleblower statute and violation of due process. Dr. Amer, a thirty-year old physician was in his first year of a three-year categorical internal medicine residency program when he suffered retaliation from his program superiors after submitting a series of complaints regarding medical negligence, defamation, fraud and forgery that culminated in his retaliatory discharge just over two weeks from his last complaint to the CEO of the hospital William Holman who did nothing about it, the complaint alleges.</blockquote> Details of the issues are at the website. They focus on Dr. Amer's whistleblowing about violations of the 80-hour-per-week rule instituted after the Libby Zion affair (the "<a href="http://en.wikipedia.org/wiki/Libby_Zion_law">Libby Zion law</a>"), retaliation for complaints about the violations, psychological abuses of the trainees that sound all too familiar, and patient care risks (e.g., as detailed in <a href="http://www.brglawsuit.com/duringresidency.htm">this long page</a>). The Complaint docket is available in PDF at <a href="http://www.brglawsuit.com/Lawsuit%20stamped.pdf">this link</a>: Eid Amer, MD vs. Baton Rouge General Medical Center, General Health System, Tulane Univ. School of Medicine, and a host of individual plaintiffs. This is certainly speaking out against the ingrained abuses of the medical training system. I cannot comment on the merits of this case, but can say from my own personal experience, and that of many colleagues, that the claims are certainly plausible. I wish this doctor luck. He will need it. -- SS [1] I could not at first locate that old post. However, I remember so vividly being compelled - at explicit threat of career jeopardy - as a PGY-1 to do pelvic exams in the middle of the night on disabled febrile female patients from the <a href="http://www.inglis.org/nursinghome.jsp">Inglis House</a> nursing home in Philadelphia (for the mentally normal but severely physically handicapped) with UTI's, pneumonia and other problems, that a search on "pelvic exam" brought the post right up. One does not easily forget experiences like that.

Tulane/BRG Resident Sues The Hospital: Former Medical Resident Sues for Abuses

My own medical internship was needlessly abusive in terms of sleep deprivation, treatment of interns as chattel by the Chief and some partic...

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Gartner: Famous Last Words on National Health IT - "Don't Fear Progress"

From time to time I review old articles about health IT via Google and other search engines. Found this analysis/prediction/statement of confidence, by a research analyst at IT consultant company <a href="http://www.gartner.com/technology/home.jsp">Gartner Group</a>. Emphasis mine: <h2><a href="http://blogs.gartner.com/brian_burke/2009/04/17/dont-fear-progress/" rel="bookmark" title="Permanent Link to Don’t Fear Progress"></a></h2><blockquote><h2 style="font-family:arial;"><a href="http://blogs.gartner.com/brian_burke/2009/04/17/dont-fear-progress/" rel="bookmark" title="Permanent Link to Don’t Fear Progress">Don’t Fear Progress</a></h2> by Brian Burke | April 17, 2009 | <a href="http://blogs.gartner.com/brian_burke/2009/04/17/dont-fear-progress/#comments" title="Comment on Don’t Fear Progress">1 Comment</a> In an <a href="http://dmsblog.burtongroup.com/data_management_strategie/2009/04/dear-mr-president-a-data-model-for-my-electronic-health-records-nearly-killed-me.html">open letter blog</a> to President Obama, Burton Group Senior Analyst <a href="http://www.burtongroup.com/AboutUs/Bios/PrintBio.aspx?Id=137">Joe Bugajski</a> opines that President Obama is spewing “delusional visions of a nation-covering, interoperable, secure, private, reliable, accurate, and instantaneous electronic healthcare data network is at best terrifying and at worst pernicious.” OK – I had to look up ‘pernicious’. It’s not good. Mr. Bugajski goes on to relate a horrifying personal experience in which he ended up in a clinic and then a hospital that both used electronic health records. He relates the story of his stay in which electronic health records hindered rather than helped and concludes that most health care professionals “longed for handwritten charts hanging at the foot of every patient’s bed.” While I don’t doubt his experience, and I disagree that building a national health information network is an unsound idea. In fact, the National Health Services (NHS) in the UK is several years into its ‘<a href="http://www.connectingforhealth.nhs.uk/" style="font-weight: bold;">Connecting for Health</a>‘ program and has already built a nation-covering, interoperable, secure, private, reliable, accurate, and instantaneous electronic healthcare data network. The UK is reaping the benefits of improved treatment and cost savings. You can read additional background in my research note, <a href="http://www.gartner.com/DisplayDocument?ref=g_search&id=500076&subref=simplesearch" title="http://www.gartner.com/DisplayDocument?ref=g_search&id=500076&subref=simplesearch">Toolkit: Enterprise Architecture for the U.K.’s National Health Service (Case Study)</a> Mr. Bugajski is correct that the initiative will be large and costly and I also agree that the US government should approach the program with caution. But the benefits are enormous – it’s about saving lives! While I sympathize with Mr. Bugajski’s unfortunate experience, I believe moving forward on this initiative is truly one of the bright spots in President Obama’s stimulus plan.</blockquote> Problem is, the NHS program to build a "nation-covering, interoperable, secure, private, reliable, accurate, and instantaneous electronic healthcare data network" failed, as I wrote at my Sept. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html">NPfIT Programme goes PfffT</a>." The success of this program was long in doubt, as expressed by the UK's own House of Commons public accounts (audit) committee as <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>, published 27 Jan 2009 (four months before the optimistic Gartner piece) entitled "The National Programme for IT in the NHS: Progress since 2006 - Public Accounts Committee." In fact, I had been writing skeptically about that program for years, including <a href="http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html">at this query link</a> and at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=granger_speaks_out">academic site</a>. I don't fear progress. What I fear is cybernetic hyper-enthusiasm masquerading as progress, especially when it wastes money - in this case conservatively estimated at £12.7bn - and harms patients. -- SS

Gartner: Famous Last Words on National Health IT - "Don't Fear Progress"

From time to time I review old articles about health IT via Google and other search engines. Found this analysis/prediction/statement of con...

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Another Cautionary Tale about Conflicts of Interest: the CEO's Stretch Limousine, Golden Parachute, and Slush Fund

It remains fashionable in academic medicine to tolerate, if not celebrate conflicts of interest as necessary to support the "collaboration" needed for "innovation," while minimizing their risks (e.g., look <a href="http://hcrenewal.blogspot.com/2012/03/logical-fallacies-in-defense-of.html">here</a>).  Recently, another cautionary tale about how conflicts of interest signal the risk of all sorts of unpleasantness has appeared in the media. A Sentinel Event: the First Conflicts Uncovered In 2009, we <a href="http://hcrenewal.blogspot.com/2009/03/some-conflicts-grow-in-brooklyn.html">wrote</a> about some conflicts of interest at Wyckoff Heights Medical Center in my hometown of Brooklyn, NY.  The New York Daily News had reported that Dr. Addagada Rao, the hospital's chief of surgery was simultaneously the president and part-owner of a Caribbean medical school that funneled medical students to clerkships at Wyckoff.  The hospital's CEO, Rajiv Garg, was an investor in the same school.  At the time, I wrote, <blockquote>This story illustrates another twist on conflicts of interest affecting the leaders of not-for-profit health care organizations. Many of the smaller not-for-profit hospitals, of which there are thousands in the US, may have minimal conflict of interest policies, which may be minimally enforced, without much transparency or accountability. The coziness of the leadership culture of such smaller institutions may preclude anyone within the culture from asking tough questions. The results may be total confusion as to whose interests particular leaders are serving. In particular, the interests of each hospital's patients may get lost in the shuffle. In this case, the interests of medical students may also get lost in the shuffle. Although the institutions involved may be small, and hence the conflicts may seem small in terms of their monetary value, they aggregate to contribute to the moral miasma that now is the atmosphere of health care. </blockquote>You heard it here first. The CEO's Golden Parachute Fast forward to 2012. In January, the Daily News again <a href="http://articles.nydailynews.com/2012-01-31/news/31007403_1_brooklyn-hospital-center-state-advisory-panel-severance-payout">reported</a> that CEO Garg had been ousted, but that <blockquote>Trustees at Wyckoff Heights Medical Center asked to consider a whopping $875,000 severance payout for its former CEO are balking at the package....</blockquote> It seems that Garg's attorney claimed <blockquote>They were on the verge of bankruptcy when he arrived. He reduced the debt by tens of millions of dollars.</blockquote>However, <blockquote>the hospital’s financial situation remains grim. According to the work group’s final report, Wyckoff’s liabilities are $91 million greater than its assets and it is saddled with $114 million in long-term debt.</blockquote>So here is yet another example of a CEO personally profiting while his or her organization's finances fester. The Chauffeured Cars, the Stretch Limousine The the Daily News began <a href="http://articles.nydailynews.com/2012-02-10/news/31048142_1_security-guards-limo-beleaguered-hospital">chipping away </a>at the other ways CEO Garg benefited from his leadership of the fiscally troubled hospital. A notable symbol of these benefits was a stretch limousine: <blockquote>The ousted CEO of a debt-riddled Brooklyn hospital had his security guards ferry friends to the U.S. Open and his wife around town in a stretch limo, the Daily News has learned. Rajiv Garg, the disgraced honcho of Wyckoff Heights Medical Center, also enjoyed his own commutes in the hospital-issued ride — a sleek, black $33,000 Lincoln Royale.</blockquote>Garg rolled in style, <blockquote>The beleaguered hospital bought the fancy car — equipped with a mini-bar, four champagne flutes and a fridge for chilling Dom Pérignon — last summer for Garg It also owned two other cars for his use, sources said. Several times a week, the limo was dispatched to take Garg’s wife from her job near the hospital to the couple’s midtown apartment, said an employee. Sometimes, it picked her up and then swung by the hospital to get Garg and whisk them to dinner before dropping them home, sources said. Two or three times a month, the limo picked her up at home and took her shopping. 'I haven’t had a raise in seven years,' said the employee. 'They always tell us they don’t have any money. They spent it on cars.' The limo has comfy leather seats with room to spare for six passengers and a stereo system capable of drowning out highway noise when Garg and his wife were driven in it to Washington.</blockquote>More Conflicts of Interest Discovered Then the Daily News <a href="http://articles.nydailynews.com/2012-02-08/news/31039487_1_trustees-garg-hospital">started to reveal </a>conflicts of interest beyond the ones we discussed in 2009: <blockquote>Then-trustee Frank Chiarello was in a partnership that loaned money to hospital entities, according to a list of board members’ conflicts the Daily News eyeballed. The $2.5 million loan had an 18% interest rate, sources said, costing the hospital hundreds of thousands of dollars. Chiarello, a real estate exec, resigned from the board last week. Another trustee who quit the board last week, attorney John Rucigay, serves as a lawyer for other trustees, owns real estate with other trustees, and rents space to the Polish and Slavic Federal Credit Union — whose head of operations is yet another Wyckoff trustee, Agnieszka Poslednik. Additional trustees on the conflicts list first reported by Crain’s New York Business, include Andrew Boiselle, whose Cebco Check Cashing Corp. does check-cashing business with hospital employees, and attorney Fred Haller, who provides legal services to Wyckoff employees about issues not related to the hospital.</blockquote>Slush Funds and Bribes Last week, the Daily News <a href="http://articles.nydailynews.com/2012-03-19/news/31212038_1_bank-account-upstate-judge-bribes">reported </a>about findings by a judge that the CEO kept slush funds used to pay bribes: <blockquote>Wyckoff Heights Medical Center kept a secret bank account that a former CEO used to bribe a disgraced state assemblyman, an upstate judge said in a court decision. Orange County Supreme Court Judge Elaine Slobod’s decisionk brought to light new details about the Bushwick hospital’s alleged dealings with Tony Seminerio (D-Far Rockaway), who died in a North Carolina prison last year. The bank account used for the Stockholm St. hospital’s payoffs to the corrupt pol belonged to 397 Himrod Corporation. Former Wyckoff board chairman Emil Rucigay originally set up the company to buy real estate for the hospital to turn into a parking lot, the judge’s order said. The bank account was kept active — though the corporation was dissolved in 2001. The bank account still had approximately $130,000 in it in 2008. “[Wyckoff’s] CEO was using monies in the Himrod account to bribe Seminerio,” Slobad wrote in her decision last week, referring to Dominick Gio, who was the hospital’s head honcho at the time. Gio refused to talk a reporter last week. Wcykoff’s interim CEO Ramon Rodriguez also declined to comment. Money from the Himrod account was used to make payments totaling $15,000 to Seminerio, other court filings charge.</blockquote>A Lexus, a Bentley, Oh My Then the story really hit the big time when the New York Times <a href="http://www.nytimes.com/2012/03/26/nyregion/at-ailing-brooklyn-hospital-insider-deals-and-lavish-perks.html">picked it up yesterday</a>. That report added some colorful details about how magnificently the CEO traveled: <blockquote>In August 2009, Mr. Garg said, he fell asleep at the wheel and crashed his Lexus into a truck. He then lost his license. Asked why in the interview, he said he was not certain, though he offered several explanations, including unpaid tickets and previous accidents. He then used the hospital’s cars — a Lincoln Town Car and a Cadillac Escalade — for himself and his family around the clock. They were driven by two security guards on overtime, a hospital official said. He parked his other car, the $160,000 Bentley, at Wyckoff and had the hospital put the vehicle on its own insurance policy. </blockquote> The limo only came later, <blockquote>Mr. Garg said in the interview that he suspected that the drivers of the Town Car and the Escalade were eavesdropping on his conversations. So he had the hospital purchase a used stretch limousine for about $33,000. </blockquote>Yet More Conflicts of Interest Discovered The Times story also found more conflicts of interest. Some involved CEO Garg: <blockquote>Mr. Garg introduced hospital officials to Skyscape, a provider of mobile medical references, in which he had a financial interest. Wyckoff signed a contract with the company worth at least $38,700, hospital records show, though the deal eventually fell through.</blockquote> Others involved hospital trustees. This example might have affected patient care at the hospital: <blockquote>Dr. Theophine Abakporo arrived at Wyckoff in 1996 from Harlem Hospital to work in emergency medicine. Originally from Nigeria, he said he found his way to the top blocked by what he believed was a clique of doctors at Wyckoff. In 2009, according to data provided by MapLight.org, Dr. Abakporo, an American citizen, began donating money to the campaign of Representative Edolphus Towns, the Democrat who represents a nearby area. Mr. Towns, a longtime board member of Wyckoff, had by then been replaced by his chief of staff, Albert Wiltshire, on the board. Dr. Abakporo gave $1,000 to the Towns campaign, then $750, according to election records. With Mr. Wiltshire’s support, Dr. Abakporo became chairman of emergency medical services. </blockquote> This example might also have affected patient care: <blockquote>With his solicitous manner and tailored sport jackets, Gary Goffner, a pharmacist who serves on Wyckoff’s board, has long endeared himself to customers and doctors alike. He inherited his pharmacy, Kraupner, from his father, a prominent Bushwick landlord as well as a pharmacist, who died recently. It is an old-fashioned store, crammed with supplies, the opposite of an orderly Rite Aid. It is also a half-mile walk from Wyckoff, a disadvantage Mr. Goffner overcame through a contract that gave him exclusive access to Wyckoff patients as they were being discharged, and allowed him to keep an employee at the hospital to promote his business. </blockquote> In summary, the Times found, <blockquote>According to internal hospital documents, 13 of the hospital’s 22 board members declared at least one conflict of interest. </blockquote>Summary So, from a single story about conflicts of interest affecting the CEO and a medical leader at the hospital, we have gone to stories about widespread conflicts of interest affecting the hospital's board and leadership, about lavish payments and benefits to the CEO while the hospital's finances suffered, and allegations (by a judge) of bribes and slush funds.  Recall that the Institute of Medicine's <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report on conflicts of interest in medicine and health care</a> defined conflicts of interest as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.” While no particular conflict of interest is guaranteed to cause someone to abuse entrusted power, conflicts of interest create the risk of such abuse. The case of the leadership and governance of Wyckoff Heights Medical Center shows how such risks may manifest. Yet we have noted again and again how leaders of supposedly mission-oriented non-profit medical organizations seem to be ignoring these risks while pursuing ever more money from health care corporations. We <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">noted</a> how the Chancellor of the University of California-San Francisco "has no qualms" about faculty's financial relationships with industry. Just this week at Brown University, my alma mater, while discussing a new conflicts of interest policy, we <a href="http://www.browndailyherald.com/conflict-of-interest-policy-shifts-responsibility-to-u-1.2718709#.T3HWwdnefao">heard</a>, <blockquote>'People do have conflicts of interest, and it’s not the end of the world,' said Janet Blume, associate dean of the faculty. </blockquote>Conflicts of interest may not lead to the apocalypse. However, they certainly may lead to all sorts of unpleasantness. As Joe Collier <a href="http://bmj.bmjjournals.com/cgi/content/full/332/7555/1447">stated</a>, “people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." Conflicts of interest clearly lead to conflicted, and confused thinking, and such thinking may lead to bad decisions, and hence bad outcomes for patients' and the public's health. Worse, as the IOM asserted, conflicts of interest are a risk factor for outright corruption. True health care reform might start with a reasoned discussion, based as much as possible on evidence, about the risks as well as the supposed benefits of conflicts of interest affecting those who make decisions about individual patients' health care, and about public health and health care policy.

Another Cautionary Tale about Conflicts of Interest: the CEO's Stretch Limousine, Golden Parachute, and Slush Fund

It remains fashionable in academic medicine to tolerate, if not celebrate conflicts of interest as necessary to support the "collaborat...

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Experiments on Top of Experiments: Threats to Patients Safety of Mobile e-Health Devices - No Surprise to Me

As noted by columnist Neil Versel at MobiHealthNews.com in a Mar. 14, 2012 post "<a href="http://mobihealthnews.com/16642/beware-virtual-keyboards-in-mobile-clinical-apps/">Beware virtual keyboards in mobile clinical apps</a>": <blockquote>... Remember the <a href="http://mobihealthnews.com/14752/ipad-setback-at-seattle-childrens-is-but-a-minor-growing-pain/">problems Seattle Children’s Hospital had</a> with trying to run its Cerner EMR, built for full-size PC monitors, on iPads? The hospital tried to use the iPad as a Citrix terminal emulator, so the handful of physicians and nurses involved in the small trial had to do far too much scrolling to make the tablet practical for regular use in this manner. [From that post: As CIO magazine <a href="http://www.cio.com/article/693401/iPad_in_Healthcare_Not_So_Fast?page=1&taxonomyId=3114" style="font-style: italic; font-weight: bold;">reported</a> last week, iPads failed miserably in a test at Seattle Children’s Hospital. “Every one of the clinicians returned the iPad, saying that it wasn’t going to work for day-to-day clinical work,” CTO Wes Wright was quoted as saying. “The EMR apps are unwieldy on the iPad.” - ed.]</blockquote> Thank heaven it was a small trial, instead of a typical forced rollout to an entire clinical community. Someone seems to have grasped the experimental nature of the effort. <blockquote>Well, there may be a greater risk than just inconvenience when tablets and smartphones stand in for desktop computers. According to a <a href="http://www.advisory.com/Research/Applications-and-Technologies-Collaborative/Research-Notes/2012/Desktop-Virtualization-based-Support-for-EMRs">report from the Advisory Board Co.</a>, “[A] significant threat to patient safety is introduced when desktop virtualization is implemented to support interaction with an EMR using a device with materially less display space and significantly different support for user input than the EMR’s user interface was designed to accommodate.” The report actually is a couple months old, but it hasn’t gotten the publicity it probably deserves. We are talking about more than user inconvenience here. There are serious ramifications for patient safety, and that should command people’s attention.</blockquote> Unfortunately, far too little about health IT safety commands people's attention. It's merely assumed that either 1) health IT is inherently beneficent, or 2) the risks are deliberately ignored for - I'm sorry to note - profit and career advancement. <blockquote>How many CIOs or even end users have considered another one of the unintended consequences of running non-native software on a touch-screen device, that the virtual, on-screen keyboard can easily take up half the display? “Pop-up virtual keyboards obscure a large portion of the device’s display, blocking information the application’s designer intended to be visible during data entry,” wrote author Jim Klein, a senior research director at the Washington-based research and consulting firm.</blockquote> How many CIO's have considered unintended consequences of such experiments-on-top-of-experiments (i.e., handheld or other <a href="http://liliputing.com/">lilliputian computing devices</a> on top of the HIT experiment itself)? Probably few to none.The typical hospital CIO, usually of an MIS background and generally lacking meaningful backgrounds in research, computer science, medicine, medical informatics, social informatics, human-computer interaction, and other research domains, are usually "turnkey-shrinkwrapped software implementers." In fact, most have backgrounds woefully inadequate for any type of clinical device leadership role. They may even lack a degree of any kind, as major HIT recruiters over the past decade expressed the following philosophy ca. 2000: <blockquote>I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman. (Healthcare Informatics, "Who's Growing CIO's".) </blockquote> I wonder just how many CIO's "from the school of hard knocks" were put into action by those groups.Back to the MobiHealthNews.com article: <blockquote>... Klein said that users have two choices to deal with a display that’s much smaller than the software was designed for. The first is to zoom out to view the whole window or desktop at once, but then, obviously, users have to squint to see everything, and it becomes easy to make the wrong selection from drop-down menus and radio buttons. Or, users can zoom in on a small part of the screen. “This option largely, if not completely, eliminates the context of interaction from the user’s view, including possible computer decision-support guidance and warnings, a dangerous trade-off to be sure,” Klein wrote. In either case, the virtual keyboard makes it even more difficult to read important data that clinicians need to make informed decisions about people’s health and to execute EMR functions as designed. </blockquote> Good observations. Two points: 1. As far back as the mid 1990's in my teaching of postdoctoral fellows in my role as Yale faculty in Medical Informatics, due to the limited screen real estate I uniformly presented the following 'diagram' regarding my beliefs about handheld devices (then commonly known as PDA's) as tools for significant EHR interaction: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVMVEfJo24MJ3wXp2mGdSG0a6b8-BqYhD_GLkpVQx3mZEIaLzoPbqJfCtuecBWCAcs69jKszwLMr2LTwmG4EQs1N4lTeajI3qz_cuQ2wWPtxTaKptcKVcDh592Jl5DrpcBJPHKf6rx8kAU/s1600/newton1.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5724577116776466994" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVMVEfJo24MJ3wXp2mGdSG0a6b8-BqYhD_GLkpVQx3mZEIaLzoPbqJfCtuecBWCAcs69jKszwLMr2LTwmG4EQs1N4lTeajI3qz_cuQ2wWPtxTaKptcKVcDh592Jl5DrpcBJPHKf6rx8kAU/s320/newton1.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 229px; height: 280px;" /></a>Mid 1990's wisdom: small handhelds as desktop replacements at the bedside - just say "no" </div> This was before today's hi-res screens on small devices, but the limited real estate and its ramifications were obvious to critical thinkers who knew both medicine and medical informatics, even in the mid 1990's. Similarly, experiments with <a href="http://en.wikipedia.org/wiki/HP_95LX">HP95</a> handheld PC's running DOS failed miserably in a similar time frame at the hospital where I later became CMIO. (One benefit: I did get to salvage two of the devices from the trash bin for my obsolete computer collection!): <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVMRrjhASBRH5lRnhwzIxshslXFHRLzCcjmQ0SHaIBLvUmmRBW-yZf9Sq0JR40fEuhoyeP6De6UHtLhpnakM5OjO0VVy6c-IK7_Qi_LuGxGjUi2qK_PDO-_Lbwry6olvL2upAzQZtzm-MH/s1600/hp95.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5724587323294093218" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVMRrjhASBRH5lRnhwzIxshslXFHRLzCcjmQ0SHaIBLvUmmRBW-yZf9Sq0JR40fEuhoyeP6De6UHtLhpnakM5OjO0VVy6c-IK7_Qi_LuGxGjUi2qK_PDO-_Lbwry6olvL2upAzQZtzm-MH/s320/hp95.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 206px; height: 202px;" /></a>HP95LX - full DOS computer equivalent to an IBM PC (except, of course, for screen size). </div> Therefore, IMO the Advisory Report findings of 2012 merely verify what was obvious almost two decades ago. Small devices are adjuncts only, suitable for limited uses (and only after extensive RCT's with informed consent even then, in my view). 2. Another issue that arises is more fundamental. The article notes: <blockquote>“It seems clear that running even a well-designed user interface on a device significantly different than the class of devices it was intended to be run on will lead to additional medical errors,” Advisory’s Klein commented.</blockquote> The critical thinking person's question is: who knows if the "class of device" the app was "intended to run on" is itself appropriate or optimal? Commercial clinical IT (with the exception of devices that require special resolutions, pixel densities, contrast ratios etc., such as PACS imaging systems) is usually designed for commercially available hardware. That means the same size/type of computer monitor you obtain at Best Buy or Wal Mart. Is that sufficient? Is that optimal? As in my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/ehr-workstation-designed-by-amateurs.html">EHR Workstation Designed by Amateurs</a>", who really knows? <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgGjUWJ42opoFiFJ-oGcxn43ThiXoL1qi3xC_ooaqqxhXa4vOfQn1_HVv-NgDxS1vm5Eg4Okwjtj7Jb1cXbhL-KwIT7Q5p4MJ_7zj9XOIdvTLd4eareH_CtREmBTy2sCBAOwlr4XGOxBAZK/s1600/EHR_workstation.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5724589665949685282" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgGjUWJ42opoFiFJ-oGcxn43ThiXoL1qi3xC_ooaqqxhXa4vOfQn1_HVv-NgDxS1vm5Eg4Okwjtj7Jb1cXbhL-KwIT7Q5p4MJ_7zj9XOIdvTLd4eareH_CtREmBTy2sCBAOwlr4XGOxBAZK/s320/EHR_workstation.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 379px; height: 229px;" /></a><div style="text-align: center;">Click to enlarge. A workstation in an actual tertiary-care hospital ICU, 2011. How many things are wrong here besides the limited display size? See aforementioned post "<a href="http://hcrenewal.blogspot.com/2012/02/ehr-workstation-designed-by-amateurs.html">EHR Workstation Designed by Amateurs</a>". </div> These systems are not robustly cross-tested in multiple configurations, such as multiple-large screen environments vs. single screen, for example. In summary, performing an experiment with small devices on top of another experiment - the use of cybernetic intermediaries (HIT) in healthcare that is already known to pose patient risk - is exceptionally unwise. It would be best to decide what the optimal workstation configuration is, as applicable to different clinical environments, in limited RCT's with experts in HCI strongly involved, before putting patients at additional risk with lilliputian information devices that only a health IT <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html">Ddulite</a> could love. <blockquote>Ddulites: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures. </blockquote> -- SS

Experiments on Top of Experiments: Threats to Patients Safety of Mobile e-Health Devices - No Surprise to Me

As noted by columnist Neil Versel at MobiHealthNews.com in a Mar. 14, 2012 post " Beware virtual keyboards in mobile clinical apps ...

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Pseudo-Evidence Based Medicine Should be a Global Health Concern

We have frequently advocated for <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> (EBM) , that is, medicine based on judicious use of the best available evidence from clinical research, critically reviewed and derived from systematic search, combined with biomedical knowledge and understanding of patients' values and preferences.  However, EBM risks being turned into <a href="http://hcrenewal.blogspot.com/search/label/pseudo-evidence%20based%20medicine">pseudo-evidence based medicine</a> due to systematic manipulation and distortion of the clinical research evidence base.  Dr Wally Smith wrote about pseudo-evidence based medicine, which he defined as "the practice of medicine based on falsehoods that are disseminated as truth," in the British journal Clinical Governance (Smith WR. Pseudoevidence-based medicine: what it is, and what to do about it. Clinical Governance 2007; 12: 42-52. Also see <a href="http://hcrenewal.blogspot.com/2007/02/threat-of-pseudoevidence-based-medicine.html">this post</a>).   Now it appears that this issue is causing concern in the Cochrane Collaboration, the main voluntary international group promoting EBM.  An article from December, 2011 in the Indian Journal of Medical Ethics outlined why we need to question the trustworthiness of the global clinical evidence base.  (See Tharyan P. Evidence-based medicine: can the evidence be trusted.  Ind J Med Ethics 2011; 8: 201-207.  Link <a href="http://www.issuesinmedicalethics.org/194ed203.html">here</a>.)  It merits further review. The Role of Vested Interests Dr Tharyan, its author, emphasized that a major threat to the integrity of the clinical research data base is the influence on clinical research of those with vested interests in marketing particular products, e.g., drugs, devices, etc. <blockquote>The motives for conducting research are often determined by considerations other than the advancement of science or the promotion of better health outcomes. Many research studies are driven by the pressure to obtain post-graduate qualifications, earn promotions, obtain tenured positions, or additional research funding; many others are conducted for financial motives that benefit shareholders, or lead to lucrative patents. </blockquote> The Importance of Pervasive <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">Conflicts of Interest</a> Early on, the author discussed how the distortion of the clinical research data base arises from the pervasive web of conflicts of interest in medicine and health care: <blockquote>This hijacked research agenda perpetuates further research of a similar nature that draws more researchers into its lucrative embrace, entrenching the academic direction and position statements of scientific societies and academic associations. Funders and researchers are also deterred from pursuing more relevant research, since the enmeshed relationship between academic institutions and industry determines what research is funded (mostly drugs at the expense of other interventions), and even how research is reported; thus hijacking the research agenda even further away from the interests of science and society.</blockquote> The article then goes on to show how the influence of vested interests may distort the design, implementation, analysis, and dissemination of research. <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">Distortion of Research Design and Implementation</a> The Research Question Dr Tharyan noted <blockquote>The majority of clinical trials conducted world-wide are done to obtain regulatory approval and a marketing licence for new drugs. These regulations often require only the demonstration of the superiority of a new drug over placebo and not over other active interventions in use. It is easier and cheaper to conduct these trials in countries with lower wages, lax regulatory requirements, and less than optimal capacity for ethical oversight. It is therefore not surprising that the focus of research does not reflect the actual burden of disease borne by people in the countries that contribute research participants, nor address the leading causes of the global burden of disease. Some 'seeding' trials, conducted purportedly for the purpose of surveillance for adverse effects, are often only a ploy to ensure brand loyalty among participating clinician-researchers.</blockquote> Insufficient Sample Size The article stated, <blockquote>Many trials do not report calculations on which the sample size was estimated, often leading to sample sizes insufficient to detect even important differences between interventions (for primary, let alone secondary outcomes) </blockquote> I would add that such small trials are particularly bad at detecting important adverse effects of the interventions being promoted. Excessively Stringent Enrollment Criteria As Dr Tharyan wrote, <blockquote>Most RCTs funded by industry and academia are designed to demonstrate if a new drug works, for licensing and marketing purposes. In order to maximise the potential to demonstrate a 'true' drug effect, homogenous patient populations; placebo controls; very tight control over experimental variables such as monitoring, drug doses, and compliance; outcomes addressing short term efficacy and safety; and methods to minimise bias required by regulatory agencies are used to demonstrate if, and how, the drug works under ideal conditions. </blockquote> The problem is that very few patients in clinical practice resemble those enrolled in such trials, so the generalizability of the trials' results is actually dubious. Ideally, clinicians practicing evidence-based medicine could refer to trials that include patients similar to those for whom they care. <blockquote>Practical or pragmatic clinical trials are designed to provide evidence for clinicians to treat patients seen in day-to day clinical practice, and evaluate their effectiveness under 'real-world' conditions. These trials use few exclusion criteria and include people with co-morbid conditions, and all grades of severity. They compare active interventions that are standard practice, and in the flexible doses and levels of compliance seen in usual practice. They utilise outcomes that clinicians, patients, and their families consider important, such as satisfaction, adverse events, return to work, and quality of life). Recommendations exist on their design and reporting , but such trials are rare.</blockquote> Comparisons to Placebo, not the Other Interventions Clinicians Might Realistically Consider Per the article, <blockquote>Industry sponsored trials rarely involve head-to head comparisons of active interventions, particularly those from other drug companies, thus limiting our ability to understand the relative merits of different interventions for the same condition. </blockquote> The result may thus be a number of studies showing particular interventions appear to be better than nothing, but few if any studies that would help clinicians decide which intervention would be best for a particular patient. Inappropriate Comparators However,when studies are done comparing the intervention of interest to other active interventions, the details of the choice of comparators are often managed so that the comparators are likely to appear to be worse. <blockquote>Even if active interventions are compared in industry-sponsored trials, the research agenda has devised ways in which the design of such trials is manipulated to ensure superiority of the sponsor’s drug. If one wants to prove better efficacy, then the comparator drug is a drug that is known to be less effective, or used in doses that are too low, or used in non-standard schedules or duration of treatment. If one wants to show greater safety, then the comparator is a drug with more adverse effects, or one that is used in toxic doses. Follow up, also, is typically too short to judge effectiveness over longer periods of time. </blockquote> Meaningless Outcomes A favorite tactic used in the design of trials influenced by vested interests is to choose outcomes that are likely to show results favorable to the product being promoted, but have no meaning for patients or clinicians. There are three ways this is commonly done. The first is to use rating scales that are very sensitive to small perturbations, but not meaningful in terms of how patients feel or function: <blockquote>The choice of outcome measures used often ensures statistically significant results in advance, at the expense of clinically relevant or clinically important results. Outcomes likely to yield clinically meaningless results include the use of rating scales (depression, pain, etc.). These scales yield continuous measures usually summarised by means and standard deviations, rather than the dichotomous measures clinicians use such as: clinically improved versus not improved. These rating scales, however extensively validated, are hardly ever used in routine clinical practice. A difference of a few points on these scales results in statistically significant differences (low p values), that have little clinical significance to patients. </blockquote> Another is to use surrogate outcomes, <blockquote>Other outcomes commonly used are surrogate outcomes; outcomes that are easy to assess but serve only as proxy indicators of what ought to be assessed, since the real outcome of interest may take a long time to develop. These are mostly continuous measures that require smaller sample sizes (blood sugar levels, blood pressure, lipid levels, CD4 counts, etc.). These measures easily achieve statistical significance but do not result in meaningful improvements (reduction in mortality, reduction in complications, improved quality of life) in patients’ lives, when the interventions are used (often extensively) in clinical practice.</blockquote> Finally, there are composite outcomes, <blockquote>The use of composite outcomes, where many outcomes (primary, secondary and surrogate outcomes) are clubbed together (e.g.: mortality, non-fatal stroke, fatal stroke, blood pressure, creatinine values, rates of revascularisation) as a single primary outcome, can also mislead. Such trials also require smaller sample sizes, and increase the likelihood of statistically significant results. However, if the composite outcome includes those of little clinical importance (lowered blood pressure, or creatinine values), the likelihood of real benefit (reduction in mortality, or strokes, or hospitalisation) and the potential for harm (increase in non-fatal strokes or all-cause mortality) are masked.</blockquote> Distortion of Analysis Relative Instead of Absolute Risks A favorite trick is to emphasize relative risks rather than absolute risks. For example if a trial reduces the risk of a bad outcome from 2 of 10,000 patients (0.02%) to 1 of 10,000 patients (0.01%), the relative risk reduction is 50%, but only 1 of 10,000 patients experienced a benefit. <blockquote>The use of estimates of relative effects of interventions, such as relative risks (RR) and odds ratios (OR) with their 95% confidence intervals, provides estimates of relative magnitudes of the differences and whether these exclude chance, as well as if these differences were nominal or likely to be clinically important. However, even relative risks can be misleading since they ignore the baseline risk of developing the event without the intervention. The absolute risk reduction (ARR) is the difference in risk of the event in the intervention group and the control group, and is more informative since it provides an estimate of the magnitude of the risk reduction, as well the baseline risk (the risk without the intervention, or the risk in the control group). Systematic enquiry demonstrates that on average, people perceive risk reductions to be larger and are more persuaded to adopt a health intervention when its effect is presented as relative risks and relative risk reduction (a proportional reduction) rather than as absolute risk reduction; though this may be misleading.</blockquote> Sub-Group Analysis <blockquote>Another statistical trick used to present favourable outcomes for interventions is the use of spurious subgroup analyses, where observed treatment effects are evaluated for differences across baseline characteristics ( such as sex, or age, or in other subpopulations). While they are useful, if limited to a few biologically plausible subgroups, specified in advance, and reported as a hypothesis for confirmation in future trials; they are often used in industry-sponsored trials to present favourable outcomes, when the primary outcome(s) are not statistically significant.</blockquote>A major statistical point is that the more ways one subdivides the study population, the more likely it is to find a difference between those receiving different interventions by chance alone. Distortion of Dissemination Poor Exposition As noted by Dr Tharyan, <blockquote>Evidence also shows that the published reports are not always consistent with their protocols, in terms of outcomes, as well as the analysis plan, and this again is determined by the significance of the results. Harms are very poorly reported in trials compared to results for efficacy; and are also often suppressed or minimised. </blockquote> <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">Ghost-Writing</a> Also, those with vested interests may try to ensure maximally favorable dissemination by employing ghost-writers, <blockquote>Other tactics used to influence evidence-informed decision making include ghost-writing, where pharmaceutical companies hire public-relations firms who 'ghost-write' articles, editorials, and commentaries under the names of eminent clinicians; a strategy that was detected by one survey in 75% of industry-sponsored trials, where the ghost author was not named at all, and in 91% when the ghost author was only mentioned in the acknowledgement section. Detecting such conflicts of interest is difficult, since they are rarely acknowledged due to the secrecy that shrouds the nexus between academia and industry in clinical trials. Industry-sponsored trials often place various constraints on clinical investigators on publication of their results; these publication arrangements are common, allow sponsors control of how, when, and what is published; and are frequently not mentioned in published articles. </blockquote>Ghost-writers under the direct control of those with vested interests could more efficiently bias their writing in favor of their sponsors than could even academics constrained by contractual obligations to sponsors. <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">Suppression of Research</a> When all else fails, the most crude example of distorted dissemination is suppression of studies that despite all the manipulations noted above fail to produce favorable results for the product being promoted: <blockquote>A considerable body of work provides direct empirical evidence that studies that report positive or significant results are more likely to be published; and outcomes that are statistically significant have higher odds of being fully reported, particularly in industry funded trials.</blockquote> By the way, the latest demonstration of suppression of research was a study by Turner et al (Turner EH, Knoepflmacher D, Shapley L. Publication bias in antipsychotic trials: an analysis of efficacy comparing the published literature to the US Food and Drug Administration database. PLoS Medicine 2012; 9(3): e1001189. Link <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001189">here</a>) It showed that of 24 trials of atypical antipsychotics registered in the US FDA database, 15/20 (75%) of the published trials were positive, that is, had results in favor of the sponsors' drugs according to the FDA review, but only 1/4 (25%) of the unpublished trials were positive. In other words, 15/16 of positive trials were published, but only 5/8 non-positive ones were. Summary Thus, Dr Tharyan provided a nice summary of many of the ways that the clinical research data base can be manipulated or distorted to serve vested interests. Such distortions risk the transformation of evidence-based medicine into pseudo-evidence based medicine. We have repeatedly discussed (see links above) most of these issues. Because we are located in the US, and speak mainly English, this blog may have given the impression that the lack of trustworthiness of the clinical research evidence base is primarily a US problem. The article by Tharyan emphasizes, however, that it is a global problem. While this problem now seems to have the attention of the Cochrane Collaboration, it seems to be relatively anechoic in global health circles. It appears to be no more prominent on the agendas of <a href="http://hcrenewal.blogspot.com/search/label/global%20health">global health</a> organizations than is <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">health care corruption</a> (look <a href="http://hcrenewal.blogspot.com/2011/12/corruption-kills-so-why-is-health-care.html">here</a>.) Yet the two issues are highly related. Most of the distortions in the global clinical evidence database may be driven by conflicts of interest. Conflicts of interest are risk factors for corruption. Distortions of the global clinical research data base that lead to use of expensive, but ineffective or dangerous interventions when other options would work as well or better leads to needless suffering and death, and by unnecessarily raising the costs of care, decreases access, especially for the poor. Also note that conflicts of interest may be one reason that all these problems remain so <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> (look <a href="http://hcrenewal.blogspot.com/2011/11/will-freeze-of-global-fund-finally-put.html">here</a>). True global health care reform requires addressing health care corruption, but also conflicts of interest and their role in the distortion and manipulation of the clinical research data base. I still live in hope that that some academic health care institutions, professional societies, health care charities and donors, and patient advocacy groups will gain enough fortitude to stand up for accountability, integrity, transparency, and honesty in health care.

Pseudo-Evidence Based Medicine Should be a Global Health Concern

We have frequently advocated for evidence-based medicine (EBM) , that is, medicine based on judicious use of the best available evidence fr...

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An Example of How the Complex Takes Control - A Board Dominated by Hired Managers Levitates Its Hired CEO's Pay

The Indianapolis Star <a href="http://www.indystar.com/article/20120320/BUSINESS03/303180001/Big-raises-those-who-lead-area-s-large-hospital-groups">published</a> the latest story about anti-gravity health care <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a>.  The report emphasized how the largest hospital systems in the metropolitan area raised CEO pay faster than any reasonable metric: <blockquote>CEO pay is up, sharply in some cases, at Indianapolis' four large hospital groups, as the systems have grown and dumped more responsibilities on their top leaders. Total pay for those CEOs rose anywhere from 15 percent to 53 percent from 2008 to 2010. While experts say the pay is in line with executive compensation at other large hospital groups, the rate of the increases far outpaces the minimal wage gains that area health-care workers (1.7 percent) and hourly workers (3.1 percent) have seen over the same time. The rising CEO pay comes at one of the shakiest financial periods ever for hospitals, as they struggle with cuts in reimbursements for care from federal Medicare and Medicaid programs and private insurers.</blockquote> CEO Pay Up More than Revenue Pay at specific health care systems also rose faster than revenue. At the Indiana University Health System: <blockquote>At the top of the best-paid list: IU Health's President and Chief Executive Daniel F. Evans Jr., who pulled down $2.08 million in compensation in 2010, up 17 percent from 2008. Subtracting Evans' retirement payouts, which vary year to year, his base pay jumped 19 percent since 2008.</blockquote> However, <blockquote>From 2008 to 2010, IU Health has seen revenue grow 10 percent to $2.46 billion,...</blockquote> At St Vincent Hospital and Health Care <blockquote>Close behind comes Vincent Caponi, CEO of St. Vincent Hospital and Health Care Center, who took in $1.86 million in 2009-10, a two-year jump of 44 percent, or 64 percent when retirement is removed.</blockquote> However, <blockquote>Revenue over the two years rose 28 percent at St. Vincent,...</blockquote> At Franciscan Alliance, <blockquote>Robert Brody of Franciscan Alliance earned $1.27 million in 2010 (53 percent more than in 2008),...</blockquote> However, over that period revenue only rose 17%. At Community Health Network, <blockquote>Bryan A. Mills, the relatively new CEO of Community Health Network, received $1.35 million, or 15 percent more than his predecessor, William Corley, collected in 2008. (Corley retired in 2009.)</blockquote>while revenue only rose 4%. The Usual Talking Points At this point, it should come as no surprise that hospital leadership trotted out the same old talking points to account for the ever upward trajectory of CEO pay as used in other areas and to account for the pay of leaders of other kinds of health care organizations (look <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">here</a>). These included... We Pay What Everyone Else Pays It was easy to find a professional compensation consultant to repeat this one: <blockquote>Jim Otto, senior principal in Atlanta for the Hay Group, a consultant on executive benefits, said pay to top hospital CEOs in Indianapolis appears in line with rising compensation, including retirement benefits and bonuses, being paid nationally to most large-system hospital executives.</blockquote> CEOs Work Hard and Are Brilliant So we read: <blockquote>At IU Health, formerly Clarian Health Partners, where Evans has been CEO since 2002, 'The system's grown significantly. It makes us think twice about the difficulty of running such a system. We literally cover the entire state of Indiana. And much of that has been under Dan's oversight,' said Charles Golden, an IU Health board member and chair of its compensation committee.</blockquote> Also, <blockquote>Golden says Evans 'has done a really superb job. Almost everything favorable to our system has been positive in his time.'</blockquote> Here is the version pertaining to St Vincent's <blockquote>Caponi 'is on an airplane and out of town a good bit, running a much bigger area' for Ascension, said Bill Estes, chairman of St. Vincent's board. 'That's the way we justify (higher CEO pay) and feel comfortable with that.'</blockquote> High Pay is Needed to Attract Competent, if not Brilliant People From Mr Otto, the compensation consultant: <blockquote>Large hospital groups make certain they pay similar to their peers to remain competitive. One reason for rising pay, Otto says: 'These aren't easy jobs. They are not easy to fill. The candidate pool isn't terribly large.'</blockquote> Furthermore, Mr Golden, from the IU Board, added, <blockquote>'Unless you want to default to mediocrity, I suppose you can do that (cut CEO pay),' he said. 'But I don't think that's where we are going. I don't think these (hospital) systems will get any easier to manage.'</blockquote> Talking Points Sans Justification As in previous cases, no one that reporter Jeff Swiatek could find provided any specifics to back up these talking points. It is striking that those who stewarded all the major hospital systems in this one area felt the need to raise executive pay substantially faster than the rate of rise of revenue, that is from 1.7 times to 3.75 times the rate of revenue rise. Why Are Hospital Boards So Nice to CEOs? In the interests of full disclosure, I noticed this article because reporter Jeff Swiatek chose yours truly, plus fellow blogger Dr Howard Brody (look <a href="http://brodyhooked.blogspot.com/">here</a>) to comment for it. <blockquote>'Whenever the nonprofit sector starts acting more like the for-profit sector, I start to get worried,' said Dr. Howard Brody, director of the Institute for the Medical Humanities. 'It just becomes crony capitalism. If one executive gets paid $3 million instead of $1 million, then every executive wants $3 million. It just becomes a vicious cycle of inflation of CEO benefits.'</blockquote> Also, I suggested: <blockquote>Put more noncorporate members on hospital boards because they'd be less inclined to endorse large compensation packages that are more typical of for-profit companies. 'Boards are populated by wealthy executives, who themselves are getting increasing compensation, rather than by community representatives or patient representatives,' Poses said.</blockquote>Could the Composition of the Board Explain Excess Deference to the CEO? I made the above comments after hearing approximations of the compensation given out by the hospital systems, but without any knowledge of the composition of the boards that approved that compensation. I am guessing that Dr Brody also was not told anything about board composition when he suggested the possibility of crony capitalism. However, now that the article is out, I think it makes sense to look at the composition of at least one of the boards involved. I chose IU Health, since it is the largest of the systems, paid the most to its CEO, and was kind enough to list board members' brief biographies on a <a href="http://iuhealth.org/about-iu-health/board-of-directors/">web-page</a>.  Here they are, listed with their primary affiliations, and some notable other affiliations. - Judge Sarah Evans Barker, former federal district court judge. - Dr D Craig Brater, "dean of the Indiana University School of Medicine and director of IU Medical Center." Also on  the <a href="http://www.springmillvp.com/people/advisors.html">Board of Advisors</a> of <a href="http://www.springmillvp.com/">Spring Mill Venture Partners</a>, "an early stage venture capital firm focused on investing in high-growth information technology and life sciences companies;" recipient of consulting and travel money from Pfizer (<a href="http://projects.propublica.org/docdollars/">per ProPublica</a>); and who was listed as having "a financial interest/relationship or affiliation in the form of: Consultant for AstraZeneca Pharmaceuticals; BioGen, Inc.; Forest Laboratories; Merck & Co., Inc.; Pfizer Inc.; and Pharmacia and Upjohn Company" <a href="http://www.cmecorner.com/programs_printer.asp?ProductID=178&audience=">per CMECorner</a>. - William R Cast, "CEO of NoMore Clipboard, an online, patient-controlled personal health record management system." - Thomas W Chapman, "president and CEO of The HSC Foundation in Washington, DC, the parent corporation for two subsidiaries, The HSC Pediatric Center and Health Services for Children with Special Needs. He was previously senior associate vice president for Network Development and Professor of Health Services Management and Policy at George Washington University Medical Center in Washington, DC." - Bishop Michael J Coyner, "Bishop of the Indiana Area United Methodist Church" - J Scott Davison, "chief financial officer for OneAmerica and its affiliated companies," and member of the board of directors for Indiana Bond Bank." - Daniel F Evans Jr - CEO of IU Health, also member of the board of Lakeland Financial Corp, (<a href="http://www.bloomberg.com/apps/news?pid=conewsstory&tkr=1000L:US&sid=aunsp4S2I2z0">per Bloomberg</a>) - Charles E Golden, "retired from Eli Lilly and Company in 2006 as executive vice president and CFO and a member of the board of directors. He was previously a corporate vice president of General Motors...." He is also currently on the boards of <a href="http://www.unilever.com/aboutus/companystructure/nonexecutivedirectors/">Unilever</a>, which makes health care related products, and <a href="http://ir.hill-rom.com/directors.cfm">Hill-Rom</a>, which makes medical devices and supplies. - David W Goodrich, "retired in 2005 as president and CEO of Central Indiana Corporate Partnership, Inc." - V William Hunt, "chairman of Hunt Capital Partners, LLC, a venture capital and consulting firm based in Indianapolis. Until August 2001, he was the vice chairman and president of ArvinMeritor Inc...." - Dr James E Lingeman, "long-standing member of the IU Health Methodist Hospital medical staff," but also according to a 2009 American Urologic Association Education and Research <a href="http://www.auanet.org/content/media/whitepaper.pdf">paper</a>, Consultant or Advisor to, and Meeting Participant or Lecturer for Boston Scientific Corp and Lumenis, scientific investigator for Boston Scientific and Olympus, investor in Beck Analytical Laboratories and Midstate Mobile Lithotripsy, and having "Other" financial relationships with Beck and Midstate. - Angela Barron McBride, " distinguished professor and university dean emerita at Indiana University School of Nursing" - Michael A McRobbie, "Indiana University President," also on the board of OneAmerica (look <a href="http://www.oneamerica.com/wps/wcm/connect/oa/oneamerica/home/news+center/press+releases/michael+a.+mcrobbie+elected+to+oneamerica+board+of+directors">here</a>). - Anne Nobles, "senior vice president for Enterprise Risk Management and chief ethics and compliance officer for Eli Lilly and Company." When considering the composition of this board, note that members of non-profit organizations' boards generally are said to have three duties, as <a href="http://www.boardsource.org/Knowledge.asp?ID=3.364">per BoardSource</a>: - The Duty of Care: "a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization." - The Duty of Loyalty: "a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization." - The Duty of Obedience: "The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization." The Duties of Care and Obedience require board members to exercise prudent and reasonable supervision over hired managers, and provide these managers reasonable pay and incentives.  However, boards dominated by hired managers may put the interests of such managers ahead of their organizations' missions.  So of the 14 members of the IU Health board, 8 are current or retired top level corporate executives or corporate board members, 4 of which have such leadership positions at financial service companies, (two at OneAmerica). In addition, 5, including 4 apparently ex-officio members, had or have top leadership positions in academic institutions. The board also included one Methodist Bishop and one federal judge. All but two board members are thus current or former top level hired managers of for-profit corporations or non-profit organizations. Thus this board is largely populated by executives who are likely to be wealthy. Thus it is similar to many other <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of health care corporations</a> (e.g., look <a href="http://hcrenewal.blogspot.com/2010/12/on-interconnectedness-of-leadership-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/12/boards-who-ought-to-be-accountable-for.html">here</a>) and <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20trustees">non-profit organizations</a>  (e.g., look <a href="http://hcrenewal.blogspot.com/2010/04/failed-leaders-of-citigroup-as-leaders.html">here</a>,  <a href="http://hcrenewal.blogspot.com/2009/10/board-of-trustees-or-social-club-for.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/04/hedge-fund-u.html">here</a>) which we have discussed.  It stands to reason that boards dominated by hired managers will feel comfortable with and look kindly on the hired managers whom they are supposed to supervise, and view their compensation sympathetically.  Thus such boards may not exercise the Duties of Care and Obedience. Furthermore, the Duty of Loyalty requires boards not to be affected by conflicts of interest.    However, many of the IU Health board members have financial relationships that could be considered conflicts of interest. Two have or had executive positions at the same pharmaceutical company, Eli Lilly, one of whom also was on the board of medical device and supply company. In addition, both of the doctors on the board have or had significant disclosed financial relationships with drug, device, or biotechnology firms.  Again, it is like other boards affected by such conflicts that we have discussed.  Again, such boards may not exercise the Duty of Loyalty.   Summary   Combined with other examples of the composition of boards of for-profit health care corporations, and non-profit health care organizations, the latest example suggests the complex has taken control.  Nearly every board we have scrutinized is dominated by hired managers of other companies, and salted with conflicts of interest.  It seems likely that such boards will put the interests of hired managers ahead of those of the shareholders of for-profit corporations, and ahead of the missions of non-profit organizations.    The complex that has taken control looks like a confederation of hired managers.  In 2003, five years before the fall of Lehman Brothers ushered in the global financial collapse, John C Bogle <a href="http://www.vanguard.com/bogle_site/sp20030611.html">warned</a> of the "grotesque transformation" of capitalism into an oligarchy of hired managers: <blockquote>The root causes of the disease in our system are deep, and the remedies that are required to cure it will not be easy to come by. For what we have witnessed in the failure of corporate governance in America has been, as journalist William Pfaff described it, 'a pathological mutation in capitalism.' He was right on the mark. The classic system—owners capitalism—had been based on a dedication to serving the interests of the corporation’s owners, maximizing the return on their capital investment. But a new system developed—managers capitalism—in which 'the corporation came to be run to profit its managers, in complicity if not conspiracy with accountants and the managers of other corporations.' Why did it happen? 'Because,' in Mr. Pfaff’s words, 'the markets had so diffused corporate ownership that no responsible owner exists. This is morally unacceptable, but also a corruption of capitalism itself.'</blockquote>This plague of managers' capitalism seems not to have spared health care, and to have infected the non-profit as well as public for-profit sphere. To stave off the coming dystopia, we must return the control of for-profit corporations, including health care corporations, to their owners, and stewardship of non-profit organizations to those who will put their missions ahead of self-interest.

An Example of How the Complex Takes Control - A Board Dominated by Hired Managers Levitates Its Hired CEO's Pay

The Indianapolis Star published the latest story about anti-gravity health care executive compensation . The report emphasized how the lar...

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