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Drowning our Sorrows in Ketchup: Novartis Settles, Appoints Former Heinz Executive CEO

Here's the latest corporate health care marcher in the legal settlement parade, as <a href="http://online.wsj.com/article/SB10001424052748703906204575026963160833710.html">reported in the Wall Street Journal</a>. <blockquote>Swiss drug giant Novartis AG said its U.S. subsidiary struck a plea agreement with U.S. investigators to resolve criminal allegations regarding the company's promotion of the epilepsy drug Trileptal, and agreed to pay a $185 million fine. Federal investigators have been carrying out civil and criminal investigations of Novartis' marketing of the drug, including allegations that it promoted the drug for uses for which it is not approved by the Food and Drug Administration, an illegal practice known as 'off-label' marketing, Novartis said in a statement Tuesday as it announced fourth-quarter results. To resolve criminal allegations, Novartis said it agreed to plead guilty to a violation of the U.S. Food, Drug and Cosmetic Act, and to pay a fine of $185 million.</blockquote> It has become a drearily familiar ritual. We have now <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">discussed</a> numerous instances of large health care corporations pleading guilty to criminal charges and/or settling civil allegations of unethical behavior.  In the current case, like nearly all the others, the corporation will pay what seems to be a huge fine.  However, the amount is a pittance compared to the corporation's revenue, and is likely to be viewed as only a small cost of doing a very lucrative business by corporate executives.  In very few cases does any individual suffer any negative consequence for approving, ordering or implementing the unethical behavior.  Thus, I would argue that these cases remind us how unethical the health care "business" has become, but the way they have been resolved will fail to deter future bad behavior.  A large fine's impact can be spread among share-holders, employees, and clients/ customers/ patients, and hence poses no threat to executives planning the next bit of unethical behavior.  In fact, the most notable aspect of the current case is that the corporation involved in not run out of the US, but rather out of Switzerland, showing that this pattern is not exclusively an American one. There is an interesting juxtaposition to this case, however.  At the same time this settlement was announced, Novartis <a href="http://blogs.wsj.com/health/2010/01/26/new-novartis-ceo-cafepharma-reader-former-heinz-exec/">disclosed</a> its new CEO.  A Wall Street Journal <a href="http://online.wsj.com/article/SB10001424052748703906204575027083891374688.html">commentary</a> opined, that the " New Novartis Chief Needs Surgery Skills."  Ironically, the new CEO is hardly a surgeon.  <a href="http://www.novartis.com/downloads/newsroom/corporate-press-kit/7j_CV_Joe_Jimenez_EN.pdf">Here</a> is a summary of his background. <blockquote>Mr. Jimenez began his career in the United States at The Clorox Company, and later served as president of two operating divisions at ConAgra. In 1998, he joined the H.J. Heinz Company, and was named President and Chief Executive Officer of the North America business. From 2002 to 2006, he served as President and Chief Executive Officer of Heinz in Europe. Before joining Novartis, he was a NonExecutive Director of Astra-Zeneca plc, United Kingdom, from 2002 to 2007; and was an advisor for the private equity organization Blackstone Group, United States. Mr. Jimenez joined Novartis in April 2007 as Head of the Consumer Health Division and was appointed to his present position in October 2007. Mr. Jimenez graduated with a bachelor’s degree from Stanford University in 1982 and with an M.B.A. from the University of California, Berkeley, in 1984.</blockquote> I would guess that all that expertise marketing ketchup will come in handly preventing the need for more settlements of illegal marketing practices.  Seriously, we have <a href="http://hcrenewal.blogspot.com/2009/12/on-automobile-and-health-care-companies.html">discussed</a> the logic and evidence behind the assertion that health care corporations ought to be run by people with relevant experience and values.  We wish Mr Jimenez well, but hope that he realizes that if he is to prevent future events that could throw his company into disrepute, he ought to lean heavily on people who understand medicine and biomedical science, and who support physicians' core values. More broadly, I again suggest that real US health care reform would need to deal with both these issues.  We need to have rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health.  We need to have leaders of health care organizations who actually understand health care and share its values.  Two hat tips to the PharmaGossip blog (<a href="http://pharmagossip.blogspot.com/2010/01/meet-joe-jimenez-new-ceo-at-novartis.html">here</a> and <a href="http://pharmagossip.blogspot.com/2010/01/novartis-says-us-unit-to-pay-fine.html">here</a>).

Drowning our Sorrows in Ketchup: Novartis Settles, Appoints Former Heinz Executive CEO

Here's the latest corporate health care marcher in the legal settlement parade, as reported in the Wall Street Journal . Swiss drug gian...

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As Records Go Digital, Cultures Clash, Bringing to Life Secrets the Health IT Companies Don't Want You to Know

<div style="text-align: justify;">Yes, as records go digital, cultures clash: the culture of medicine, and the culture of the Barbary pirates. The following story perhaps brings to life much of the advice from a candid HIT vendor (who happens to also be a physician) in my post "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=secrets">10 Secrets the EHR Companies Don't Want You to Know</a>": <blockquote><a href="http://www.healthnewsflorida.org/index.cfm/go/public.articleView/article/15794" style="font-weight: bold;">As Records Go Digital, Cultures Clash</a> By Sammy Mack, Health News Florida Jan 22, 2010 A group of Broward County doctors looking to switch to electronic medical records say the result has been a massive headache: surprise charges, inadequate training and even blocked access to patient files. ... Experts say a culture clash between mid-career physicians and tech-savvy software vendors can translate into mismatched expectations. They tell the buyer to beware. And with federal incentives now in play, they say there is bound to be further conflict. “I get upset just talking about it,” said Dr. Arleen Richards, a Plantation physician and one of the doctors who signed a contract with Castranova. [An IT supplier - ed.] "When you look back in retrospect, you’re like, ‘how did this happen?’"</blockquote> Physicians are too trusting of IT salespeople, that's how. I recommend considering an IT purchase as you would consider purchasing a used car. <blockquote>Richards says Castranova promised a cheap, easy piece of software that would increase efficiency in filing insurance claims. The price tag: $10,000 plus the cost of some new computers. ... After signing up, Richards learned she would have to pay a $2,500 licensing fee for each provider in her office, to qualify for the stimulus funds. In addition, she said Castranova hit her with almost $15,000 in charges to install new computers--charges she didn't authorize. [cf. Secret #5: Determining how much a specific EHR costs is going to be difficult, and you are going to be nickel-and-dimed every step of the way! - ed.] </blockquote> $10,000 for the software, plus previously undisclosed per-user licensing fees and $15,000 to install what are probably commodity computers available at Newegg for a few hundred dollars? If true, the term for this "gotcha" is: ripoff. <blockquote>Castranova said he doesn’t understand how she could think the computer charges were unauthorized. After all, he said, someone had to let him into her office to install the machines. </blockquote> A contract that clearly specifies such "materials and labor costs" is the standard when, say, a plumber fixes your toilet. This is especially true when those costs exceed the cost of the product itself, the software. These IT added costs should always be presented to clients up-front, above board, in writing and in a manner that could not cause misconceptions or buyer's remorse. If this did not occur here, then that is a problem. <blockquote>Another of the doctors in a tiff with Castranova, Fort Lauderdale internist Paul Preste claims Castranova didn't provide adequate training after installing the electronic records system. Preste's office manager, Donna Golden, said there was a day-long training and that Castranova’s employees came to the office on a number of occasions, but she noted some practitioners had to start from scratch after decades of paper records.</blockquote> One day of training on a complex information system? That is a joke. <blockquote>In another complaint against Castranova, Dr. Linda Kaplan said she too was surprised by charges on her invoice. When they first met, Castranova recognized her as a former medical editor at the local NBC television affiliate. She said he offered to waive her software and training fees if she would endorse the product [cf. Secret #3: Even that EHR-using physician you've been referred to may have been paid off! -ed.] Kaplan agreed, but she said she was unimpressed with the system once it was installed in her Hallandale Beach office. She was reluctant to drum up business when she wasn't a satisfied customer. Kaplan said Castranova was displeased with her lackluster endorsement and locked her out of some 600 patient records on his server. He billed for the software system anyway. [cf. Secret #6: Your patient data will be a bargaining chip to prevent you from leaving an EHR company! - ed.] </blockquote> </div><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkkwlG8x41-1_Q97iOZjDPOaNUINunJLrXCtL9GdpLt9OoRxMcwI-EJ1kX1KAUOp0tQMCJ06cISJMrzcui-YIvOUKqzEkqsD5-ufzOMvV5_U2L190VjOwcjpJ0mLtRMd2VK8gMYRU3jCEM/s1600-h/barbary.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5430782036562852914" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkkwlG8x41-1_Q97iOZjDPOaNUINunJLrXCtL9GdpLt9OoRxMcwI-EJ1kX1KAUOp0tQMCJ06cISJMrzcui-YIvOUKqzEkqsD5-ufzOMvV5_U2L190VjOwcjpJ0mLtRMd2VK8gMYRU3jCEM/s320/barbary.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 163px; height: 240px;" /></a>"We are holding your patient information hostage. Pay up." </div><div style="text-align: justify;"> I sincerely hope for this vendor's sake that none of those 600 patients suffers an adverse outcome during the "records blackout." This information is not exactly chopped liver. Here is perhaps the most concerning statement in the article: No agency tracks electronic medical records disputes, but experts said feuds like these are not uncommon ... Linda McMullen of the Florida Medical Association said she's starting to hear similar stories of spats between doctors and software vendors. As the government pushes health IT on to unwary physicians, physicians need to educate themselves on the wiles of the IT profession ... fast. (HC Renewal and my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">academic site</a> on HIT dysfunction are two examples of where to start.) Advice in the article: <blockquote>Maxwell, the software consultant, said doctors can avoid some of the grief by thoroughly researching their options before buying an electronic records system. She encouraged medical offices to shop around and set a five-year budget that includes the cost of scrapping a system if it doesn't work out. Draw up an exit strategy for retrieving data if something goes wrong, she counseled. And get expert help reviewing contracts. [I note that data migration is never cheap, and never easy - ed.] "The people that have had problems just went out and bought one (electronic medical records system)," she said, as opposed to researching the software and the company behind it.</blockquote> Fine advice. However, this reality belays the arguments about health IT being a deterministic convenience, saving money and improving efficiency. IT is often a headache and a <a href="http://en.wikipedia.org/wiki/The_Money_Pit">money pit</a> in and of itself. Physician buyer beware, indeed. -- SS Addendum Jan. 31: Also see <a href="http://hcrenewal.blogspot.com/2010/01/as-records-go-digital-cultures-clash_31.html">my comments on a Huffington Post Investigative Fund story</a> about physician HIT buyer's remorse. </div>

As Records Go Digital, Cultures Clash, Bringing to Life Secrets the Health IT Companies Don't Want You to Know

Yes, as records go digital, cultures clash: the culture of medicine, and the culture of the Barbary pirates. The following story perhaps br...

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UCI Medical Center Fails Inspection, UCI Executives Get Bonuses

Back in the early days of Health Care Renewal, we had many occasions to write about problems with the leadership of the University of California - Irvine (UCI) medical school.  Starting in late 2005, we posted  about various management problems at the institution, involving its liver transplant service, cardiology division, and bone marrow transplant service, (see posts <a href="http://hcrenewal.blogspot.com/2005/12/more-trouble-in-oc-golden-parachutes.html">here</a> and <a href="http://hcrenewal.blogspot.com/2006/01/even-more-trouble-in-oc-uci-bone.html">here</a>) which lead the new chancellor of the campus to "acknowledge a failure of leadership and accountability" (see post <a href="http://hcrenewal.blogspot.com/2006/04/some-themes-emerge-from-problems-at.html">here</a>.) Slightly more recently, we noted the almost 20 year history of questionable financial relationships that involved one of UCI's "biggest stars" in clinical researach and several pharmaceutical companies (see post <a href="http://hcrenewal.blogspot.com/2006/08/yet-more-trouble-in-oc-psychiatrist.html">here</a>).  Then, in 2007, we wrote about some strange contracting practices involving UCI and a local orthopedic practice (see post <a href="http://hcrenewal.blogspot.com/2007/03/strange-contracting-at-uci.html">here</a>). So it was deja vu all over again when last week the Los Angeles Times <a href="http://www.latimes.com/news/local/la-me-uci22-2010jan22,0,4604550.story">reported</a> about the latest batch of problems at UC Irvine Medical Center: <blockquote>Federal investigators found scores of problems at UC Irvine Medical Center during a fall inspection that again put the troubled hospital's Medicare funding at risk, according to report released Thursday. In an 85-page report on their surprise October inspection, regulators said they observed poor oversight and mistakes by UCI doctors, nurses and pharmacists, leading to inadequate care that in some cases harmed patients. Among the findings: * An 82-year-old man was mistakenly given a narcotic patch by a medical resident, without approval of doctors or pharmacists. The patch led to an overdose that required emergency intervention and may have contributed to his death a week later. * A patient in the neuropsychiatric unit fell twice in three days and despite yelling 'Help me, doctor, help me,' suffered a head injury and had to be taken to intensive care. * An on-call resident did not respond to repeated emergency pages from nurses in the neurological intensive care unit, where a patient with an irregular heartbeat languished for more than an hour. * Pharmacists failed to monitor and store drugs correctly, allowing nurses to carry narcotics in their pockets and inject patients without proper oversight. The report comes a year after investigators from the Centers for Medicare and Medicaid Services documented repeated examples of poor oversight at the hospital and threatened to cut Medicare funding. In July, Medicare officials issued a finding of immediate jeopardy after investigators discovered that five UCI patients had received overdoses because nurses using pain medication pumps were not properly trained. UCI officials immediately began training nurses to use the pumps, the finding was lifted within 24 hours and the hospital submitted a plan of correction. </blockquote>However, the 2010 continuation of the sad tale of UCI adds an interesting contrast. <blockquote>UCI nurses said Thursday that many of the latest problems stem from understaffing and other cost-cutting, even as the facility turned a $54.2-million profit last year and the chief executive earned an $83,250 bonus. 'This is a problem of money. To provide extra training, extra staffing, is money,' said Beth Kean, California Nursing Assn. director for UC nurses, including 1,000 at UCI. Terry A. Belmont, who took over as the hospital's chief executive last year, disputed that the facility was understaffed. </blockquote>The new wrinkle in the UCI saga seems to be that now the leadership of UCI has been raking in bonuses while the mismanagement of the organization apparently continues. Indeed, also last week several California newspapers reported on a series of bonuses granted to the top executives of the University of California system.  For example, <a href="http://www.latimes.com/news/local/la-me-uc22-2010jan22,0,487236.story">per the Los Angeles Times</a>, <blockquote>The University of California regents Thursday approved the controversial payment of $3.1 million in performance bonuses to 38 senior executives at UC's five medical centers. The regents emphasized that the payments were linked to improved patient health and stronger hospital finances and said they were important tools to attract and retain talent. They said the bonuses were part of a 16-year-old plan funded by hospital revenue, not state funds or student fees. An additional $33.7 million is distributed among 22,000 lower-ranking medical employees. However, union activists denounced the executive bonuses as unconscionable as other parts of the university were coping with pay cuts and layoffs. 'This is appalling to do this when they are telling the lowest-paid workers to stay in poverty,' said Lakesha Harrison, president of the American Federation of State, County and Municipal Employees Local 3299, which represents about 20,000 UC workers, including hospital technicians and campus custodians. Some of the union's members get bonuses of about $300 a year, Harrison said. In contrast, the payments to the 38 senior managers range from about $30,100 to nearly $219,000. The incentives were awarded after the UC medical center system met such targets as reducing catheter-related infections and saving money through group purchases of supplies, officials said. Among the payments approved Thursday by the regents in San Francisco were $218,728 to UCLA Medical Center Chief Executive David Feinberg, on top of his $739,695 base salary; $181,227 to UC San Francisco medical center Chief Executive Mark Laret, on top of $739,700 in pay; and $87,000, in addition to his $580,000 salary, for John Stobo, the UC system's senior vice president for health sciences. </blockquote>Corroborating the assertion that the bonus plan is not new is a <a href="http://www.universityofcalifornia.edu/news/compensation/payroll2008/table3.pdf">document</a> that lists executive compensation at the University of California in 2008. (2009 data does not yet seem to be available on the web.) This document noted the following bonuses paid to University of California - Irvine medical leaders in 2008: - Susan J Rayburn, Executive Director of Clinical Enterprise - Base Salary= $212,700, Bonus=$28,401 - Lisa M Reiser, Chief Patient Care Services Officer - $243,000, $26,507 - Eugene Spiritus, Chief Medical Officer - $310,000, $38,373 - Patricia D Thatcher, Executive Director - HR and Customer Service, Medical Center - $197,547, $17,542 - Cynthia A Winner, Chief Ambulatory Care Officer - $238,200, $24,371 - Maureen L Zehntner, Associate Vice Chancellor/ Chief Executive Officer, Medical Center - $555,000, $74,432 Note that Dr Spiritus, the Chief Medical Officer, did not mention that he was a 2008 bonus recipient when he defended bonuses given to UCI leaders in the LA Times article, <blockquote>'Everybody's fallible. We just have to make sure we have the right processes in place' to catch errors, said Dr. Eugene Spiritus, UCI Medical Center's chief medical officer. Spiritus also defended the compensation for hospital managers, saying they need to stay competitive in order to attract and keep talented managers, especially given the cost of living in California. </blockquote> F Scott Fitzgerald wrote, "the very rich are different from you and me."  These days, it is executives and managers who are very different from you and me.  Physicians are beginning to dread the notion of "pay for performance," which may mean tiny increases in fees paid to physicians who uncritically follow wooden-headed guidelines based on over-simplified notions of disease, poor measurement schemes, and manipulated and suppressed clinical data.  However, for health care organization executives, "pay for performance" seems to mean lavish bonuses only tenuously related to any rational notion of performance.  In the example above, it seems that multiple UCI executives earned bonuses for their management of clinical affairs at the medical center in 2008, and at least the medical center CEO earned a bonus in 2009 for "improved patient health" while outside review of the medical center's performance in 2009 revealed "scores of problems" sufficient to threaten withdrawal of Medicare funding.  One wonders about the basis for all the millions in bonuses that have been paid to University of California executives over the years? In fact, the executive "pay for performance" programs that started in the for-profit corporate world, and now are prevalent in not-for-profit health care organizations, seem to reflect the culture of executive entitlement now so prevalent in the US (and maybe most developed countries.)  First, executives claim credit for any improvements in their organizations, while the workers in the trenches who actually accomplished the improvements get chump change.  Second, when things go wrong, the workers face salary cuts and lay-offs, while the executives' total compensation never seems to go down.  As we <a href="http://hcrenewal.blogspot.com/2009/12/98-million-dollar-man.html">mentioned before</a>, executive compensation in health care seems best described <a href="http://hcrenewal.blogspot.com/2009/12/compensation-madness-insiders-hijacking.html">as Prof Mintzberg described compensation</a> for finance CEOs, "All this compensation madness is not about markets or talents or incentives, but rather about insiders hijacking established institutions for their personal benefit." As it did in finance, compensation madness is likely to keep the health care bubble inflating until it bursts, with the expected adverse consequences. Meanwhile, I say again, if health care reformers really care about improving access and controlling costs, they will have to have the courage to confront the powerful and self-interested leaders who benefit so well from their previously mission-driven organizations.

UCI Medical Center Fails Inspection, UCI Executives Get Bonuses

Back in the early days of Health Care Renewal, we had many occasions to write about problems with the leadership of the University of Califo...

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The Price is What?

Many in the US believe that a free market in health care is a good idea.  Some actually assert that the US health care system amounts to a free market.  More evidence against that assertion was provided this week by an <a href="http://www.projo.com/health/content/HOSPITAL_PAYMENTS_01-20-10_8BH60G0_v16.3a66162.html">article</a> in our local paper, the Providence Journal, by Felice Freyer. For the first time ever, the Rhode Island state health insurance commissioner published a report comparing what insurers pay different hospitals for the same services: <blockquote>If you had surgery at Kent Hospital, your insurer would pay Kent significantly more than if you had the exact same procedure at South County Hospital –– even if the same doctor did the work. On average, Kent is getting paid nearly twice as much as South County for inpatient care, according to a new report from the health insurance commissioner that is causing a stir across the state’s health-care industry. It is well-known that hospitals get paid different amounts for the same services. But the report, for the first time, reveals the winners and losers, and quantifies the disparities –– with numbers showing the differences to be greater than many people thought. The factor determining which hospitals are paid the highest rates, according to the report, is whether the hospital is part of a group. Such hospital systems have the clout to negotiate higher prices than independent hospitals. 'We’ve never had this kind of data [before],' said Christopher F. Koller, state health insurance commissioner. 'The results and analysis show that higher payments to hospitals are associated with system affiliation, and the current contracting method does not appear to encourage the fair treatment of providers.' There is no evidence connecting higher pay to higher quality, he said. </blockquote> What is striking is the reason why such a comparison has never appeared up to now: <blockquote>Koller’s report shines a flashlight beam into the murky world of hospital finance. Hospitals negotiate privately with insurers to establish how much they will be paid for each service. These talks are largely unregulated, and always private, so that no hospital knows exactly what its neighbor is being paid. All are forbidden by contract to reveal their rates. Koller collected data from Blue Cross & Blue Shield of Rhode Island and UnitedHealthcare of New England concerning payments to 11 acute-care hospitals in 2008. He is the first public official to obtain this confidential information, saying he was entitled to it because a 2004 law requires him to promote the affordability of health care and ensure the fair treatment of providers. </blockquote> Thus, the prices of commonly used medical services provided by hospitals were largely secret. On obvious requirement for the function of a free market is price transparency. When making a purchasing decision, one needs to know what prices different sellers charge. In a recent <a href="http://online.wsj.com/article/SB10001424052748703652104574652242436408008.html">commentary</a> in the Wall Street Journal, Alan S Blinder, a Princeton economics professor, and former Vice Chairman of the Federal Reserve Board, described the basic requirements of a free market: <blockquote>When economists first heard [movie character Gordon] Gekko's now-famous dictum, 'Greed is good,' they thought it a crude expression of Adam Smith's 'Invisible Hand' — which is one of history's great ideas. But in Smith's vision, greed is socially beneficial only when properly harnessed and channeled. The necessary conditions include, among other things: appropriate incentives (for risk taking, etc.), effective competition, safeguards against exploitation of what economists call 'asymmetric information' (as when a deceitful seller unloads junk on an unsuspecting buyer), regulators to enforce the rules and keep participants honest, and—when relevant—protection of taxpayers against pilferage or malfeasance by others. When these conditions fail to hold, greed is not good. </blockquote> Clearly, one cannot have appropriate incentives when prices are secret. Secret prices are also a glaring example of "asymmetric information." (Hospitals know what different insurance companies pay them for specific services, but not what the companies pay other hospitals for those services. Insurance companies know what they pay to different hospitals for the same services, but not what other companies pay. Patients, physicians, policy-makers and the public heretofore had no idea what any hospital was paid by any insurance company.) The question begged is why neither hospitals nor health insurance companies wanted to make the prices public. One wonders if it were fears of looking incompetent (by paying to much, or charging to little), or worse, of revealing collusion. One also wonders if it were fears of revealing how anti-competitive is the current way of doing business.  At the time of data collection, Rhode Island had only two health insurers.  As noted above, large hospital networks got the highest prices.  Price differences did not obviously relate to quality of care, or costs of teaching programs.  Note that we previously <a href="http://hcrenewal.blogspot.com/2009/01/scorpions-in-bottle-shook-hands-secret.html">discussed</a> secret agreements between a dominant health care insurance company and the largest hospital system in our northern neighbor, Massachusetts, and how these agreements resulted in payments to that system far greater than those paid to any other hospital.  I suspect that secret deals resulting in wide pricing discrepancies are the rule, rather than the exception in the US, and that such deals overwhelmingly favor the largest organizations, but not the best care.  As we have been saying repeatedly since we started <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, the leadership of the large organizations that now dominate health care lacks accountability and transparency, and often fails to exhibit integrity and honesty.  Deliberately concealing price information obviously is an example of failing to be accountable and transparent.  Now that the events have conspired to slow the US health care reform juggernaut, maybe we can reconsider whether meaningful health care reform can be accomplished without improving accountability, integrity, transparency and honesty of health care oganizations and their leaders.

The Price is What?

Many in the US believe that a free market in health care is a good idea. Some actually assert that the US health care system amounts to a f...

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Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?

<div style="text-align: justify;">In an essay that ties together recent exposés of serious IT security flaws (starting with <a href="http://en.wikipedia.org/wiki/Operation_Aurora">Operation Aurora</a>) and a culture of secrecy that pervades the IT industry and industries who use IT, I ask the question: Is universal healthcare IT really a good idea in 2010? The complete essay is at my academic site <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=aurora">at this link</a>. </div>Operation Aurora was a cyber attack, conducted in mid-December 2009 and apparently originating in China, against Google and more than 20 other companies, including Adobe Systems, Juniper Networks, Rackspace, Yahoo, Symantec, Northrop Grumman and Dow Chemical. <div style="text-align: justify;">The attack used <a href="http://en.wikipedia.org/wiki/Zero_day_attack" title="Zero day attack">"0-day"</a> vulnerabilities (newly discovered and unknown to the software vendor, i.e., "day zero" of the vendor's knowledge of the defect) in Microsoft's Internet Explorer. One target was Google's email service, Gmail. It is not unrealistic to suspect that successful break-ins to that service could have gotten dissidents jailed or killed. <a href="http://blogs.wsj.com/digits/2010/01/19/firefox-soars-on-germany%E2%80%99s-browser-warning/">Entire countries have warned users</a> to switch to other browsers, at least until a vulnerability fix can be found. I find this stunning. I also bring to bear recent reports of a culture of secrecy among IT vendors and users about these defects and vulnerabilities. This culture of secrecy seems prevalent in health IT, with perhaps even higher stakes for people (patients) when systems malfunction. The essay is long-ish and at times technical. The IT issues it addresses, though, are at the root of why I believe the current push in health IT is a bad idea and that we need to "slow down" to a more temperate pace. Again, the full essay is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=aurora">here</a>. -- SS 1/24/2010 Addendum: It appears Microsoft has known about the Internet Explorer bug since <a href="http://threatpost.com/en_us/blogs/microsoft-knew-ie-zero-day-flaw-september-012110">Sept. 2009</a>. <blockquote>The flaw was in the Microsoft Security Response Center's (MSRC) queue to be fixed in the the next batch of patches due in February but the targeted zero-day attacks against U.S. companies forced the company to release an emergency, out-of-band IE update.</blockquote> Actually, this was not a "zero day attack", but a "120 day attack." One wonders if EHR vendors have similar queues. -- SS </div>

Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?

In an essay that ties together recent exposés of serious IT security flaws (starting with Operation Aurora ) and a culture of secrecy that p...

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Senator Grassley asks hospitals about experiences with federal health information technology program

<div style="text-align: justify;">At a brief Oct. 24, 2009 posting "Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors" (<a href="http://hcrenewal.blogspot.com/2009/10/washington-post-emrs-no-cure-all-sen.html">link</a>) I mentioned an Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices. That letter is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/grassley_erecords102409.pdf">here</a> (PDF). A followup investigation has now begun by Sen. Grassley of hospitals themselves. Here is <a href="http://grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=24867">a link to his Senate website and a copy of the new letter</a> dated Jan. 20, 2010. This followup letter is being sent to: Banner Health, Brigham & Women's Hospital Case Western Reserve University Hospital Health System, Catholic Healthcare West, Cedars Sinai Children’s National Medical Center, Geisinger Medical Center, Hackensack Hospital, HCA TriStar, Intermountain Healthcare, Indiana University Hospital, Jefferson Regional Medical Center, Kaiser Permanente System, Marshfield Clinic, Massachusetts General Hospital, Mayo Clinics, Memorial Hermann Healthcare System, Methodist Hospital of Indiana, North Shore-Long Island Jewish Health System, Palo Alto Medical Foundation, Rainbow Babies and Children’s Hospital, Saint Mary Mercy Hospital, Seattle Children’s Hospital, Stony Brook University Medical Center, Trinity Hospital System Tufts Medical Center, University of California San Francisco Medical Center, University of Pennsylvania Health System, University of Pittsburgh Medical Center, University of Virginia Medical Center, and Vanderbilt University Hospital. According to Huffington Post Investigative Fund reporters <a href="http://huffpostfund.org/users/fred-schulte">Fred Schulte</a> and <a href="http://huffpostfund.org/users/emmaschwartz">Emma Schwartz</a> in "<a href="http://huffpostfund.org/stories/2010/01/electronic-health-records-probe-expands-hospitals">Electronic Health Records Probe Expands to Hospitals</a>", these organizations were chosen based on both "positive and negative" press reports, complaints, whistleblowers, and Grassley's own research. The Huffington Post quoted Sen. Grassley's spokesperson Jill Gerber in that regard. The questions are probing: <blockquote>1. Please describe in detail your facility’s process for identifying HIT products for purchase and choosing an HIT vendor(s). a. What is the personnel structure of those involved in the purchase? b. To what extent do physicians and other health care providers within your facility provide input regarding the specific HIT items to be implemented within your facility? c. Who or what department within your facility is responsible for making HIT purchase decisions?</blockquote></div><div style="text-align: justify;"> </div> I have been <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">writing for years</a> on the strategically unsound practice of hospitals leaving these processes up to business IT (MIS) personnel and other non-clinical management, perhaps only then seeking a qualified physician information technology expert - or more typically, appointing a figurehead physician IT amateur - after the acquisition. That person is tasked with "making it all work" and convincing other doctors to use the technology. (I use the term "figurehead" in that the incumbent Clinician Director of HIT or Chief Medical Information Officer/CMIO usually is an "internal consultant" with no direct control over resources or personnel, a Director of Nothing or Chief of Nothing if you will. I use the term "amateur" in the same sense that I am a <a href="http://www.arrl.org/">telecommunications amateur</a>, fine for an avocation but not for a lead role in a mission-critical setting.) <div style="text-align: justify;"> </div> <blockquote>2. Three of the companies that I wrote to in October 2009 informed me that they do not manufacture HIT software or hardware, but instead assist their health care clients, such as hospitals, with the implementation and management of HIT systems. To what extent do you contract with such entities to assist with the purchase, implementation and/or management of HIT products in your facility?</blockquote><div style="text-align: justify;"> </div> I have also written on the huge amount of precious healthcare money wasted on management consulting companies for health IT, when a fraction of that money could pay for in-house, permanent expertise.<div style="text-align: justify;"> </div><div style="text-align: justify;"><blockquote>3. Please describe the training process implemented in your facility to familiarize employees with new technology systems. a. How does your facility budget for HIT training? b. What are the vendors’ roles in helping your facility train in the use of their products? </blockquote></div><div style="text-align: justify;"> </div> I sincerely hope these hospitals have not "shorted" training. On the other hand, that these systems require extensive training to use properly is part of the problem. Finally, no manner of training can compensate adequately for <a href="http://www.tinyurl.com/hostileuserexper">mission hostile health IT</a>. <div style="text-align: justify;"><blockquote> 4. Does your facility have any policies or processes governing the reporting of problems or concerns by your health care employees related to the HIT products or systems implemented in your facility? If so, please provide a description of the policies or processes. If not, please explain why not.</blockquote></div><div style="text-align: justify;"> </div> I would have added "effective policies or procedures" to that question. <div style="text-align: justify;"> </div><div style="text-align: justify;"><blockquote>5. When patient care and/or safety problems related to HIT systems arise, how are these problems reported within the facility and what is the process or mechanism for addressing them?a. Are these problems also reported to the HIT vendor, and if so, what is the process for reporting them? b. If patient care and/or safety problems related to HIT systems are not routinely reported to the HIT vendors, please explain how your facility decides which problems or issues are reported to a vendor and/or addressed by a vendor and which problems are addressed internally by the facility.</blockquote></div><div style="text-align: justify;"> </div> These are questions about fundamental processes of quality control of the IT devices themselves. It would perhaps be a criminal affair if pharmaceutical companies and medical device companies did not have such processes in place regarding their products. <div style="text-align: justify;"><blockquote>6. Please describe in detail any system your facility has in place to document, track, catalogue, and maintain complaints, concerns or issues related to HIT products that may directly or indirectly involve or impact the delivery of care or patient safety. </blockquote></div><div style="text-align: justify;"> </div> One would think there would be a robust database or library of such issues at every hospital deploying HIT. Not having such a resource would in my opinion reflect negligence in both the IT and clinical domains. It will be interesting to see the contents, or if they do not exist, the reasons why. <div style="text-align: justify;"><blockquote>7. Please provide a list of HIT problems or complaints that have been identified by or reported to your facility since January 2008 that directly or indirectly impacted patient safety or the delivery of care, including any complications or adverse events that have occurred as a result of HIT product design and/or usability. Please describe whether and how each of those problems or complaints was resolved and whether these issues have resulted in a change in policy to prevent the problem in the future. </blockquote></div><div style="text-align: justify;"> </div> The answers should prove interesting. Hopefully, "near misses" are accounted for in prior questions. <div style="text-align: justify;"><blockquote>8. Does your facility have policies regarding the discussion of problems in your HIT systems with other health care facilities or with government officials or any individuals or entities outside your facility? If so, please describe those policies. To what extent are these policies driven by contractual agreements with the HIT vendors, and to what extent do they stem from internal processes? Please provide examples of contracts with HIT vendors that include non-disclosure clauses.</blockquote></div><div style="text-align: justify;"> </div> Considering the widespread and uncomfortably similar stories people in my field have been hearing for quite awhile (in my case, for the past fifteen+ years), and as I have written before, there seems to be very little cross-institutional knowledge sharing on HIT pitfalls.It was, in fact, not easy to get <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=hitormiss">a book about HIT problems</a> published for a wide audience - even in a de-identified form - in 2009. Most accounts of health IT consist of what Greenhalgh calls "<a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">sanitized accounts of project success</a>." These accounts are of little didactic value in helping other organizations avoid known deleterious practices (such as talent mismanagement, internal strife, failure to adapt IT to the environment, over-reliance on vendor promises, contract pitfalls, etc.) leading to HIT failure. <div style="text-align: justify;"><blockquote>9. Some of the HIT vendors stated specifically in their responses to me that they do not include language that would hold them harmless for failures of their products or for the company’s own negligence or recklessness. However, they may include provisions that spell out the vendor’s and the health care client’s respective legal responsibilities and obligations in the use of the product. For example, one vendor stated that it is accountable for the performance of its product as long as the client uses the product appropriately. Another vendor stated that it is not liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients. a. Do any of the HIT vendors include language in their contracts with your facility that could be considered “hold harmless” provisions, i.e., the transferring of liability associated with the services or products provided to your facility, or otherwise limit their liability? If so, please provide a copy of sample contracts containing such provisions.</blockquote></div><div style="text-align: justify;"> </div> Denial of inclusion of "hold harmless" provisions on the one hand, and statements about being "accountable for the performance of its product as long as the client uses the product appropriately" (whatever that means) and "not [being] liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients" (what are such systems for, playing <a href="http://en.wikipedia.org/wiki/Pong" style="font-style: italic;">Pong</a>?) on the other hand, seem to be at odds. <div style="text-align: justify;"> </div><div style="text-align: justify;"><blockquote> 10. What is the relationship between your facility and any HIT vendors? a. HIT vendors that manufacture software, hardware and/or other products purchased by health care facilities have stated in their responses to me that they do not offer any financial incentives for purchasing their products, such as shares in the company or financial interests in a particular product. At least one vendor stated, however, that it does offer financial incentives in the form of discounts based on purchase size. Another vendor said that health care clients may receive royalty payments when the clients collaborate with the vendor to develop a product. What financial interest, if any, does your facility have in HIT vendors and/or their products? b. Do the vendors offer your facility and/or any of your health care providers any financial incentives for purchasing the vendors’ products? If so, please describe the types and value of the incentives.</blockquote></div><div style="text-align: justify;"> </div> These are clearly questions about conflict of interest. My best advice to these organizations is "be honest." <div style="text-align: justify;"><blockquote>11. Did your staff, health care providers and/or facility receive any payments, product discounts, or other items of value from any vendor for discussing and/or promoting that vendor’s HIT products? If so, please list the different types of payments and discounts and their value. </blockquote></div> This is a question along the lines of the "Key Opinion Leaders" nurtured by pharmas with a green fertilizer that comes from trees, not cows. One vendor did seem to indicate that this occurs in the "10 secrets the EHR companies don't want you to know" essay <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=secrets">here</a>. While that essay must be taken with a grain of salt, it would not surprise me to find out the HIT industry and the pharma industry share practices in common. Today's B-schools and our current dishonest culture produce the leaders and officers of both, after all. <div style="text-align: justify;">-- SS</div>

Senator Grassley asks hospitals about experiences with federal health information technology program

At a brief Oct. 24, 2009 posting " Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors ...

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Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported <a href="http://www.masslive.com/chicopeeholyoke/republican/index.ssf?/base/news-25/1263545132168150.xml&coll=1">by the Springfield, MA, Republican</a>: <blockquote>A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsifying medical research and must pay $420,000 in restitution to pharmaceutical companies, federal court records show. Dr. Scott S. Reuben, of Longmeadow, was charged on Thursday with health care fraud. He signed a plea agreement with prosecutors a week earlier. Reuben prompted a furor in the medical community in March, when he was accused of making up research results in at least 21 published studies and inventing patients in certain instances. </blockquote> In one notable instance, <blockquote>In 2005, Reuben received a $74,000 research grant from pharmaceutical giant Pfizer, agreeing to test Celebrex as a component of the multimodal therapy. He claimed to have treated 200 patients, 100 with Pfizer's product and 100 with a placebo. 'In fact, Reuben had not enrolled any patients into that study and the results reported both to Pfizer and to the Anesthesia and Analgesia Journal and in turn to the public were wholly made up by Reuben,' the charge states. Albert said the fabrications were discovered by medical staff within the hospital during a routine review at the hospital's 'research week,' when clinicians design poster displays of their studies. </blockquote> A <a href="http://www.theday.com/article/20100116/BIZ02/301169909/1044">report </a>in the New London, CT, Day indicated the scope of Reuben's fake research: <blockquote>Anesthesia & Analgesia later had to retract 10 papers authored by Reuben, and medical experts at the time said at least 21 journal articles by the anesthesiologist appeared to have been fabricated. The agreement calls for Reuben to pay restitution of $296,557 to Pfizer and $16,000 to Wyeth Pharmaceuticals, two companies that merged last fall. Merck & Co. would receive $49,375 from the agreement, according to documents. In addition to his fabricated Celebrex studies, Reuben had pretended to do research that backed the effectiveness of other pain drugs, including Pfizer's Bextra and Merck's Vioxx, according to prosecutors. Bextra and Vioxx later were pulled from the market because studies showed they increased the risk of death from heart attacks and strokes. In addition, Reuben published data showing that Pfizer's antidepressant Effexor had exhibited painkilling properties. Reuben's studies had been considered pioneering at the time they were published. His data had supported the use of two of Pfizer's major products - Celebrex and Lyrica - in combination to treat certain types of post-operative pain. Reuben 'was a regular on the medical lecturing circuit,' according to court documents, and 'had become a well known figure in the anesthesia and pain management medical communities.' Pfizer said previously that it had supported five of Reuben's research initiatives. Pfizer, which declined at the time to reveal how much it paid Reuben over the years to be part of its speakers' bureau, said the company played no part in the fraud. Asked for a comment Friday, Pfizer was not able to provide a timely response. </blockquote> Note that we usually do not post about stories of individual's clinical research misconduct, not because it is unimportant, but because individual misconduct may be related more to an individual's motives and character than to concentration and abuse of power in health care. However, in this case it appears that Dr Reubens was enabled, at least in the psychological and logistical senses, by pharmaceutical companies happy to sponsor research which suggested the effectiveness of their products.  Since Dr Reubens apparently fabricated most of his data, notice that he apparently deliberately fabricated data that made Pfizer's Celebrex, Bextra, Lyrica, and Effexor, and Merck's Vioxx look good.  Perhaps there was careerism here.  Positive studies about "innovative" effective drugs are more likely to get published than negative studies or studies of old drugs.  However, we have <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">noted before</a> that pharmaceutical (and biotechnology and device) companies like to sponsor studies with results that make their products look good.  One bit of good news in this story is that Reuben's colleagues at the hospital apparently were able to uncover the fabrications when they had an opportunity to critically look at data from several of his studies. Certainly some Pfizer employees had easy access to the same data.  But perhaps they would not have thought to look at it critically as long as it was so unrelentingly positive about their company's products.  As we have said before, health care professionals, policy makers and patients ought to be extremely skeptical of clinical studies sponsored (and often deeply influenced) by those with vested interests in the studies' turning out in certain ways.  We ought to reconsider national research policies that have turned over sponsorship of the majority of clinical research to those with such vested interests. Hat tip to Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=20778">on the University Diaries blog</a>. ADDENDUM (19 January, 2010) - see also <a href="http://alison-bass.blogspot.com/2010/01/why-fda-is-more-pro-business-than-ever.html">comments</a> on the Alison Bass Blog.

Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported by the Springfield, MA, Republican : A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsi...

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