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An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem

At "<a href="http://hcrenewal.blogspot.com/2011/01/clinicians-going-for-swim-but-drowning.html">Clinicians Going for a Swim and Drowning in Information</a>" I commented on a NY Times article about how information and cognitive overload can lead to deadly consequences in warfare. My implication was that medical care (e.g., the ED) bears some similarities. I received this reply from a clinician hospitalist I know, who also is well versed in Medical Informatics: <blockquote> Wow, great piece, but a little too close to home for me right now. Eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU. Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.) Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem... PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.</blockquote> This is not atypical of IT's effects on healthcare today. -- SS

An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem

At " Clinicians Going for a Swim and Drowning in Information " I commented on a NY Times article about how information and cogniti...

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Why is Johnson and Johnson "Spinning Out of Control?"

Last week, a New York Times article by Natasha Singer and Reed Abelson <a href="http://www.nytimes.com/2011/01/16/business/16johnson-and-johnson.html">cataloged</a> some of the problems afflicting the giant health care corporation Johnson and Johnson.  <blockquote>Little red flags jut out from the shelves at a CVS drugstore in suburban Boston, alerting shoppers to shortages of nearly a dozen Johnson & Johnson products. Among them are Motrin, Rolaids, children’s Tylenol liquid and adult Tylenol, Mylanta, Pepcid AC and even some Neutrogena skin care products. 'Looking for Tylenol pain relief products?' asks one of the signs. The notices at CVS serve as a stark reproof to Johnson & Johnson, whose brands have for more than a century been synonymous with quality. Some of its products are in short supply at drugstores and supermarkets because the McNeil Consumer Healthcare unit of J.& J. last year recalled about 288 million items, including about 136 million bottles of liquid Tylenol, Motrin, Zyrtec and Benadryl for infants and children. Johnson & Johnson has had to recall such a variety of products because of quality-control problems across product lines, in multiple factories and in several units last year. Some of its consumer products, for instance, may have contained bits of metal. Others came in bottles with a moldy smell. And some products have gone missing from stores with hardly an explanation. All of this has put the company and its manufacturing under the intense scrutiny of lawmakers and officials at the Food and Drug Administration. 'It looks like a plane spinning out of control,' says David Vinjamuri, a former J.& J. marketing employee who now trains brand managers at his company, ThirdWay Brand Trainers. </blockquote> The article noted how the current widespread manufacturing problems at J+J seem to contradict the company's famous credo. <blockquote>dating from 1943, saying that the company owed its first responsibility to the mothers and fathers, doctors, nurses and patients who use its products. </blockquote> The article noted that the company's problems <blockquote>have not been limited to its over-the-counter products, which could suggest that the company may suffer from even broader problems. Last year, its DePuy medical device unit recalled two kinds of hip implants, affecting tens of thousands of patients worldwide. Its vision care unit recalled millions of soft contact lenses sold abroad. </blockquote> In fact, the company also has had major ethics problems. We noted <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>, for example, that last October J&J and Ortho-McNeil Janssen, a Johnson and Johnson subsidiary,were found by a jury to have defrauded the Lousiana Medicaid system by minimizing safety problems with the atypical anti-psychotic drug Respirdal, with a penalty of over $250 million. Moreover, the NY Times summary is already out of date. The Los Angeles Times just <a href="http://www.latimes.com/health/os-tylenol-recalled-again-20110118,0,6893986.story">reported</a> yesterday even more recalls. Why does the company seem to be in a tail-spin? Ms Singer and Mr Abelson listed several possible causes: <blockquote>The reasons for McNeil’s woes remain unclear. Some critics, including former employees, say Johnson & Johnson has lost sight of its credo, while others suggest that the company decentralized its oversight of manufacturing and quality control in error. Others say it was simply a matter of cost-cutting. The December lawsuit, for example, cited two unnamed former employees who contended that the company failed to address the manufacturing problems at McNeil because it was trying to save money. Other former employees who are not involved in the lawsuit say that J.& J. seemed to hesitate in recent years to invest in new manufacturing equipment. 'It takes a lot of money to buy equipment and maintain quality,' says Patrick Bols, who left Johnson & Johnson’s pharmaceutical division in the late 1990s and owns stock in the company. </blockquote> Why, however, would the company lose sight of its sacred credo? Why would it excessively cut costs in a way that would diminish its ability to carry out its most basic function, to produce pure and unadulterated drugs? I submit that one clue can be found in a recent news article in Nature Biotechnology about the march of drug and biotechnology companies forced into <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>. [Ratner M. Crossing the line. Nature Biotech 2010; 12: 1232-1235. Link <a href="http://www.nature.com/nbt/journal/v28/n12/abs/nbt.1726.html">here</a>.] <blockquote>People are rewarded for improving a firm's financial performance - right up the chain to the CEO, [former US Department of Justice and current Vogel, Slade & Goldstein attorney Ms Shelley] Slade says. 'Their concerns are pleasing Wall Street and shareholders, and bonuses are driven by financial performance. There's a real conflict between what the compliance folks want them to do and what's in their immediate financial self-interest. Sometimes the compliance people don't get the full story from the people in operations.</blockquote> So what we have here is another argument for the importance of perverse incentives as drivers of health care dysfunction. It is likely that all the management of nearly all health care organizations are driven, not by mythic credos or high-minded mission statements, but by the impetus for short-term revenues driven by desire to earn big bonuses and keep their total compensation in six- through eight-figures. These sorts of incentives will predictably lead to excess cost-cutting, unethical behavior, and outright crime. So, to repeat like a broken record (if anyone remembers what that means, a broken vinyl audio recording skipping due to surface scratches) - if we really want health care reform, if we really want to lower costs, improve access, and improve quality, we need to abolish the perverse incentives that drive managers of health care organizations.  Somehow we need to make the leadership of health care organizations accountable for fulfilling their credos, mission statements, and really their basic responsibilities.  The patients' interests need to come first.  Drug companies must make pure, unadulterated drugs, and promote them honestly and ethically, and their leaders must first be accountable for doing so.

Why is Johnson and Johnson "Spinning Out of Control?"

Last week, a New York Times article by Natasha Singer and Reed Abelson cataloged some of the problems afflicting the giant health care corp...

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BLOGSCAN - Why Problems at Local Marquee Hospitals May be Anechoic

We have often discussed how the shortcomings of leadership of big health care organizations may be anechoic.  (See <a href="http://hcrenewal.blogspot.com/2011/01/who-undermined-these-wonderful.html">this post</a> for a recent example.)  Now, on the HealthBeat blog, Maggie Mahar <a href="http://www.healthbeatblog.com/2011/01/when-a-local-newspaper-investigates-local-hospitals-.html">discussed</a> how journalists often fail to look closely at the actions of large, well-known local hospitals.  She noted some possible causes: - "Hospitals, after all, are major advertisers." - "the marquee hospital’s patrons tend to be powerful local figures." - " most readers really don’t want to hear that their local academic medical center is having problems...." She also summarized just how unhealthy relationships among the news media and marquee hospitals can become, but also provided some examples of incisive investigative reporting.  As they say, read the whole thing.

BLOGSCAN - Why Problems at Local Marquee Hospitals May be Anechoic

We have often discussed how the shortcomings of leadership of big health care organizations may be anechoic. (See this post for a recent e...

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"I'm Not Here to Sell Drugs" - Then Why Use Company Provided "Correct" Slides?

In October, 2010, we <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">discussed</a> a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records.  Since then, news media around the US have looked into interactions among local physicians and academic medical institutions and the seven pharmaceutical companies.  In November, 2010, <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a> we discussed cases that suggested that pharmaceutical companies like physician speakers because they are more "believable" than pharmaceutical representatives, and choose physicians who already are prolific prescribers of the drug to be promoted, and that suggested that some physicians realized that speaking for pharmaceutical companies influenced their own prescribing. Since then, more investigations of local physicians' interactions with pharmaceutical companies have appeared that reinforced contrasts between rationalizations that physicians and drug companies use to support continued payments for "drug talks," and what these talks are really about. "Leaders in Their Field" vs Sanctions and Crimes  Many pharmaceutical (and other health care corporations) have repeated the mantra that the physicians they hire to give talks are the best and the brightest.  The physicians who give the talks sometimes get to believe this.  For example, a ProPublica follow-up report[1] on discrepancies between data the pharmaceutical companies put on the web and gave to state regulators noted: <blockquote>Pfizer, for example, told the state it paid Dr. Randy Schapiro $1,770 last year. But on the firm’s website, it reported spending $43,827 on him in the second half of 2009 alone.</blockquote>It then quoted Dr Schapiro: <blockquote>Schapiro said the doctors paid by pharmaceutical companies are 'leaders in their fields,' and patients should want to see their physician among them. 'If their doctor is not on the list,' he said, 'maybe they should look for a different doctor.'</blockquote> On the other hand, several of the local news articles focused on physicians who were paid drug company speakers despite having chequered backgrounds, shall we say. In the Elmira Star Gazette[2]: <blockquote>Tulio Ortega, a Rochester psychiatrist who made $144,548 from Eli Lilly and AstraZeneca for speaking to groups of peers during the last two years - was put of [sic] probation for two years in 2008 and ordered to pay a $7,500 fine after being sanctioned for negligence and incompetence.</blockquote>Also, <blockquote>Lilly also paid Yonkers physician Ali Sherzoy $4,334 in the first two quarter of this year, even though he had his license suspended in New York and New Jersey earlier this year after pleading guilty to a count of criminal sexual contact in 2008. Sherzoy told ProPublica the incident involted his family's nanny and had nothing to do with his ability to practice medicine. Other New York doctors were sanctioned for incidents ranging from deficiencies in handling controlled substances to being convicted of tax evasion.</blockquote> Another article by the same author[3] noted two more cases: <blockquote>In 1991, Johnson City doctor Louis Mateya was charged with professional misconduct after a 22-year-old woman accused him of unzipping his pants and fondling himself during an examination. Mateya admitted guilt to the charge. The State Board for Professional Medical Conduct suspended his license for two months, followed by a 58-month probationary period, during which he was monitored by a psychiatrist and a health professional selected by the board. During the last nine months of 2009, GlaxoSmithKline paid Mateya, an internist at United Health Services, $1,750 to speak on behalf of Lovaza, Glaxo's prescription omega 3 fish oil, according to an e-mail from a United Health Services spokeswoman.</blockquote> Also, <blockquote>A second Southern Tier physician, Robert Douenias, of Corning, was also paid by Glaxo: $20,000 during the same time frame to deliver speeches, even though he received sanctions in 1992. According to the Office for Professional Medical Conduct (OPMC) records, Douenias lied about a previous criminal conviction on his application for a New York medical license. He received a censure and reprimand from the OPMC, was ordered to perform 200 hours of public service and was placed on probation for two years. Douenias said on his application he had never been convicted of a crime in any state or country, even though he had a previous conviction, according to OPMC records.</blockquote> Note that the original ProPublica reporting from their database emphasized cases of physicians paid to speak by pharmaceutical companies who also had been sanctioned by medical boards or the criminal justice system (see post <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>). Although drug marketers like to tell physicians they are selected as "thought leaders" because of their brilliance, it appears that the selection of such "key opinion leaders" is not necessarily based on sterling character. "I'm Not There to Sell a Drug," But Then Why Use the Company's Slides? A number of the reports featured physicians who asserted their independence, at least from marketing goals.  For example, as reported by the Duluth (MN) News Tribune[4], <blockquote>A Duluth psychiatrist has received more than $525,000 since 2002 in payments from pharmaceutical companies, far more than any other Northland doctor, an analysis by the News Tribune shows. Dr. Tracy Tomac of St. Luke’s hospital was paid by the companies to give presentations on health and drug issues.</blockquote> Furthermore, <blockquote>'I’m there as an educator and resource,' she said. 'I’m not in business to do a sales pitch. I’m not a salesperson.'</blockquote> Also, <blockquote>In 2007, [Dr] Tomac said her presentations included content that was screened and approved by the FDA,....</blockquote> However, other reporting suggested that content "screened and approved by the FDA" was content provided by the pharmaceutical companies. For example, The Tennessean noted[5]: <blockquote>Dr. Jan Brandes heads the Nashville Neuroscience Group, a clinic that's now part of Nashville-based Saint Thomas Health Services. She made $111,150 in outside income over the past two years, largely in speaker fees paid by drug company GlaxoSmithKline, which markets a wide array of brand-name drugs, literally from A to Z.</blockquote> Dr Brandes also asserted, <blockquote>'The real point is I'm not there to sell a drug,' Brandes said. 'I'm there to interpret trial results, talk about disease states and help physicians understand where this research might fit in the context of their practice.'</blockquote> However, <blockquote>Most drug companies now require physicians to use the company's slides and presentations if they pay them to speak at an event. The industry says that is to ensure that all U.S. Food and Drug Administration rules are met and that physicians don't wander off into discussing uses for a particular product that haven't been approved by regulators.</blockquote> Also, an article in the Alexandria (VA) Gazette Packet[6] noted: <blockquote>Whistleblower lawsuits filed in recent years have accused firms of using doctors to push pills for unapproved uses during dinnertime talks, prompting at least 10 firms to settle cases for nearly $7 billion in the last three years. Since that time, pharmaceutical companies have tightened control over what happens during presentations given on their dime. Last year, for example, GlaxoSmithKline instituted a new policy prohibiting doctors from using their own slides during presentations. Starting in 2010, all doctors giving speeches sponsored by GlaxoSmithKline must use slides presented by the pharmaceutical company in the order specified. 'We want to make sure that everything is correct,' said Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline. 'The best way to do that is to have our team prepare the slide.'</blockquote>Note that Dr Brandes above was paid mainly by GlaxoSmithKline, who presumably also provided all her slides and made sure that everything she said was "correct," at least in terms of what GlaxoSmithKline thought was correct. And one more example per MyFoxAtlanta[7]: <blockquote>Some of Georgia's highest paid physicians? .... and Roswell psychiatrist Dr. Michael Banov: over $68,000, also from Lilly.</blockquote>Dr Banov asserted: <blockquote>We don't sell medications. We simply educate physicians about data, and they make their own mind up.</blockquote>However, <blockquote>Banov says, the drug company - not him - creates the materials used in his speeches, and he says there's a reason for that. 'We are only able to present the data. We're not able to present our personal opinions. Our personal preferences, how we use the medication off label. any of that. So we're held to a very tight standard by the FDA,' said Banov.</blockquote>Drug companies may say they make their paid physician speakers use slides provided by the company to prevent them from talking about "off-label" uses.  However, there is no reason for a physician-educator not to talk about "off-label" uses, and physicians can prescribe any legal drug for whatever purpose they see fit, whether or not the drug is on or "off label."  But drug companies are prohibited by law from promoting off-label uses.  Requiring physicians to use drug companies' slides and preventing them from talking about "off-label" uses demonstrates that the physicians are functioning as marketers, not educators.  Summary As local reporters look into more cases, it becomes increasingly clear that up to now, pharmaceutical companies have been none too fussy about which physicians they pay to speak about their products. It is self-serving, but inaccurate for both sets of parties to assert that the companies choose only the "best and the brightest."  Furthermore, it has now become glaringly obvious that the purpose of "drug talks" is, well, to sell drugs.  Some physicians paid by drug companies to speak may bluster about their independence, but if they are using company provided slides, who can deny they are influenced  by the company.  Furthermore, when companies insist not merely on providing slides, but on ensuring that "everything is correct," then it is clear that it is the companies' talks that the physicians are giving.  Physicians giving company talks cannot be speaking independently, and hence must be regarded as company sales personnel, whose disguises as independent doctors or medical academics are now in tatters. Doctors who still choose to go to "drug talks" should have no illusions that they are being exposed to anything other than marketing.  Thus, I urge my colleagues to forgo the nice meals and the company prepared "correct" slides, and spend the time trying to more critically assess the clinical evidence.  References 1.  Ornstein C, Weber T. In Minnesota, drug company reports of payments to doctors arrive riddled with mistakes.  ProPublica, Dec 10, 2010.  Link <a href="http://www.propublica.org/article/in-minnesota-drug-company-reports-of-payments-to-doctors-mistaken">here</a>. 2. Hunter J. Rochester psychiatrist, sanctioned for incompetence, made $144K from drug companies. Elmira Star-Gazette, Dec 4, 2010. 3. Hunter J. Despite sanctions, physicians hired as drug company pitchmen. PressConnects.com, Dec 4, 2010. Link <a href="http://www.pressconnects.com/article/20101204/NEWS01/12040345/Despite-sanctions-physicians-hired-as-drug-company-pitchmen">here</a>. 4. Stahl B. Duluth doctor denies payments from drug companies sway decisions.  Duluth News Tribune, Dec 20, 2010.  Link <a href="http://www.duluthnewstribune.com/event/article/id/186841/">here</a>. 5. Ward G. They say they prescribe based on patients, not Big Pharma. Tennessean, Dec 19, 2010. Link <a href="http://www.tennessean.com/article/20101219/BUSINESS01/12190355/TN-doctors-get-big-bucks-from-drugmakers">here</a>. 6. Pope ML. Conflict of interest? - Alexandria doctors receive thousands of dollars from Big Pharma.  Alexandia Gazette Packet, Jan 13, 2010.  Link <a href="http://www.connectionnewspapers.com/article.asp?article=347442&paper=59&cat=104">here</a>. 7. Galvin B. Health watch: doctors and drug companies. MyFoxAtlanta, Dec 29, 2010. Link <a href="http://www.myfoxatlanta.com/dpp/health/Health-Watch%3A-Doctors-and-Drug-Companies-20101229-gda-sd">here</a>.

"I'm Not Here to Sell Drugs" - Then Why Use Company Provided "Correct" Slides?

In October, 2010, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven p...

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Clinicians Going for a Swim and Drowning in Information

Clinicians these days at computerized facilities are often drinking information from a firehose, and even worse. Just to make their tasks more difficult, the firehose is <a href="http://www.tinyurl.com/hostileuserexper">difficult to use</a>, it sputters on occasion due to "glitches" in the water pumps, and sometimes even emits fouled water due to problems at the reservoir or connecting pipes, without frequent "workarounds" and mental gymnastics by the clinicians. I've seen it personally in the care of relatives. This is far from the dream of Medical Informatics, whose specialists viewed IT as a tool to reduce cognitive overload and make healthcare provision more efficient. Why is information overload a bad thing? Here's why: <blockquote>New York Times <a style="font-weight: bold;" href="http://www.nytimes.com/2011/01/17/technology/17brain.html">In New Military, Data Overload Can Be Deadly</a> By THOM SHANKER and MATT RICHTEL January 16, 2011 When military investigators looked into an attack by American helicopters last February that left 23 Afghan civilians dead, they found that the operator of a <a class="meta-classifier" title="More articles about unmanned aerial vehicles." href="http://topics.nytimes.com/top/reference/timestopics/subjects/u/unmanned_aerial_vehicles/index.html?inline=nyt-classifier">Predator drone</a> had failed to pass along crucial information about the makeup of a gathering crowd of villagers.But Air Force and Army officials now say there was also an underlying cause for that mistake: information overload. At an Air Force base in Nevada, the drone operator and his team struggled to work out what was happening in the village, where a convoy was forming. They had to monitor the drone’s video feeds while participating in dozens of instant-message and radio exchanges with intelligence analysts and troops on the ground. There were solid reports that the group included children, but the team did not adequately focus on them amid the swirl of data — much like a cubicle worker who loses track of an important e-mail under the mounting pile. The team was under intense pressure to protect American forces nearby, and in the end it determined, incorrectly, that the villagers’ convoy posed an imminent threat, resulting in one of the worst losses of civilian lives in the war in Afghanistan. “Information overload — an accurate description,” said one senior military officer, who was briefed on the inquiry and spoke on the condition of anonymity because the case might yet result in a court martial. The deaths would have been prevented, he said, “if we had just slowed things down and thought deliberately.” Data is among the most potent weapons of the 21st century. Unprecedented amounts of raw information help the military determine what targets to hit and what to avoid. And drone-based sensors have given rise to a new class of wired warriors who must filter the information sea. But sometimes they are drowning. Research shows that the kind of intense multitasking required in such situations can make it hard to tell good information from bad. The military faces a balancing act: how to help soldiers exploit masses of data without succumbing to overload. </blockquote> Read the entire NY Times piece.I have no other comments to offer, other than (as the military seems to recognize for its own needs through engaging experts in domains such as neuroscience), the time to "accelerate interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering" as recommended in 2009 by the <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">National Research Council</a> is before the attempted national rollout of hundreds of billions of dollars of technology. The time to do so is not during - and certainly not after - the HITECH-led medical re-engineering attempt.Finally, unlike the health IT industry, I don't see the military attributing these issues to "Luddite soldiers." <table id="Table1" width="100%" align="left" border="0" cellpadding="1" cellspacing="1"><tbody><tr></tr></tbody></table>-- SS

Clinicians Going for a Swim and Drowning in Information

Clinicians these days at computerized facilities are often drinking information from a firehose, and even worse. Just to make their tasks mo...

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Guidant (Boston Scientific) Gets Probation

The latest in the parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by health care corporations involves a new wrinkle.  We have been writing about the case of <a href="http://hcrenewal.blogspot.com/search/label/Guidant">Guidant Corporation's</a> faulty implantable cardiac defibrillators (ICDs) <a href="http://hcrenewal.blogspot.com/2005/05/guideants-short-circuit.html">in 2005</a>, almost since the start of the Health Care Renewal blog.  A quick summary, <a href="http://www.startribune.com/business/113367264.html">via the Minneapolis Star-Tribune</a>, is: <blockquote>In 2005 Minneapolis Heart Institute doctors Barry Maron and Robert Hauser went public with concerns about a Guidant defibrillator called the Ventak Prizm 2 after a 21-year-old patient died when his defibrillator short-circuited and failed to revive him after he went into sudden cardiac arrest. Guidant had known about the short-circuiting issue since 2002 and had made two attempts to fix the device, according to court documents. The company did not alert the FDA -- even though federal law requires manufacturers to report changes that may pose a health risk to patients. In early 2004, Guidant discovered a similar short-circuiting problem in different defibrillator models called Contak Renewal 1 and 2. The company ordered its factory to stop making and shipping the models, but potentially faulty products on hospital shelves continued to be implanted in thousands of patients. Although engineers at Guidant had recommended recalling the Contak Renewal devices, upper management rejected the proposal, court documents state. Instead, Guidant issued the 'least aggressive' form of communication, called a product update, in which sales representatives were told to tell doctors that 'nothing was broken' with the device. Maron and Hauser met with top Guidant officials in May 2005 and urged the company to communicate the problem to doctors, but Guidant refused. The doctors then went to the New York Times, which published an article indicating that the company had known for three years that the Ventak Prizm model could short-circuit, but did not communicate that to doctors. In June 2005, Guidant issued a public missive detailing safety issues with the defibrillators, which were later recalled by the FDA.</blockquote> A longer version from a series of Health Care Renewal posts can be found <a href="http://hcrenewal.blogspot.com/2010/04/who-guards-guardians-case-of-boston.html">here</a>. In 2010, Guidant, now a subsidiary of <a href="http://hcrenewal.blogspot.com/search/label/Boston%20Scientific">Boston Scientific</a>, agreed to a settlement which would involve guilty pleas to misdemeanors and payment of a large ($296 million) fine, but the settlement was rejected by a federal judge who found it to be too lenient (see post <a href="http://hcrenewal.blogspot.com/2010/04/judge-rejects-prosecutors-lenient.html">here</a>). Now the judge has approved a new version, again per the Star-Tribune, <blockquote>In what is believed to be the largest criminal penalty ever imposed in a medical device case, a federal judge on Wednesday approved an agreement calling for Guidant Corp. to pay $296 million for concealing safety information about several of its heart devices. The denouement in U.S. District Court in St. Paul ended a difficult chapter for one of the biggest players in Minnesota's signature medical technology industry. Thirteen patient deaths have been associated with faulty devices made by Arden Hills-based Guidant, which is now part of Boston Scientific Corp. The controversy lingered for almost six years and raised questions about how safety issues involving medical devices are communicated to the Food and Drug Administration, doctors and patients. Last April, U.S. District Judge Donovan Frank rejected a previous $296 million settlement between the Department of Justice and the company. This time that fine remained intact, but Frank also called for Boston Scientific to serve three years' probation. Boston Scientific will be required to make quarterly reports to the U.S. Probation Office regarding safety and compliance issues, as well as submit to regular, unannounced inspections of its records. Frank also called upon Boston Scientific to continue charitable programs intended to raise awareness about heart disease. 'I believe this serves not only the interests of the community and the interests of justice, but respect for the law and corporate responsibility,' Frank said.</blockquote> The new wrinkle is, of course, probation. I have not previously heard of a US health care corporation put on probation in a criminal settlement. Presumably, the idea is that probation will involve court supervision of the company that might be less lenient than US Department of Justice oversight via a <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreements">corporate integrity agreement.</a> So this is a small step forward, but once again, the extent that this settlement will deter future bad behavior seems small. Once again, although the fine imposed seems large, it is small compared to the money to be made by selling these very expensive devices. Moreover, the cost of the fine can be diffused over the entire company, and ultimately over all its employees, its stockholders, and its customers. Since no individual will pay a penalty, and since it is likely some individuals made themselves rich or richer from the company's actions, it is likely that other individuals in the future will authorize, direct, and implement similar bad behavior to fatten their bonuses and total compensation. Last June, we <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">noted</a> that some government officials were starting to talk tough about imposing penalties on individuals for misbehavior by health care corporations. In fact, in 1943, the US Supreme Court found that corporate leaders could be held responsible for corporate bad behavior, the so-called Responsible Corporate Officers doctrine. However, the laissez faire malaise that apparently infected most government officials starting in the 1980s seemed to prevent anyone from invoking this doctrine during the last 30 years of health care dysfunction. That malaise still seems to be rendering US federal law enforcement effete, at least when applied to wrong-doing by big, powerful, rich health care corporations. So like Cassandra, fated to have her predictions always ignored, I repeat: When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards.  Further, expect organizations that did not uphold high standards in one instance to fail to uphold them in other instances.  If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.

Guidant (Boston Scientific) Gets Probation

The latest in the parade of legal settlements by health care corporations involves a new wrinkle. We have been writing about the case of G...

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Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith

Psychiatrist-medical informaticist Dr. Scott Monteith was a guest blogger on the complications of "Meaningful Use of EHR's" in the Dec. 21, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>." He also testified at the Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup which recently had a meeting, Jan. 10-11, 2010, as I wrote about <a href="http://hcrenewal.blogspot.com/2011/01/onc-workgroup-document.html">here</a>. With his permission I am reproducing his testimony to the Committee (which is supposed to also be posted to the <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1482&&PageID=17128&mode=2">meeting website</a>) without further comment. None is needed. Emphases in the original:  <a name="_GoBack"></a><blockquote>HIT Testimony in DC January 11, 2011 My name is Scott Monteith, a board-certified psychiatrist and Fellow of the APA from Michigan. I work in private practice and with Community Mental Health (CMH). I also teach in MSU’s medical school. My 21 year interest in HIT includes: <ul><li>being a CCHIT Juror; </li></ul> <ul><li>appointed by our Governor to three terms on the Controlled Substances Advisory Commission, which has a role overseeing Michigan’s Automated Prescription System; </li></ul> <ul><li>a member of the Business Operations Workgroup for Michigan’s Health Information Network;</li></ul> <ul><li>working with malpractice insurance companies to manage growing risks from EHRs;</li></ul> <ul><li> and more.</li></ul> I’m “pro-HIT.” For all intents and purposes, I haven’t handwritten a prescription since 1999. That said and with all due respect to the capable people who have worked hard to try to improve health care through HIT, here’s my frank message: ONC’s strategy has put the cart before the horse. HIT is not ready for widespread implementation. The problem isn’t Luddite doctors not adopting; the problem is that HIT isn’t ready, especially if we want safe and efficacious bells and whistles like CDS, interoperability, etc. To describe ONC’s handling of HIT promotion, let me use an analogy: It’s as if policy makers said, “Let’s promote a cure for cancer. By curing cancer, we can save money and improve the quality of people’s lives.” Like our collective fantasy for the benefits of widespread HIT use, which I share, who can argue with the dream of curing cancer, or the good intentions behind it? The problem is that finding a cure for cancer isn’t as simple as declaring a cure, and then merely getting resistant doctors to start using it. Continuing the analogy, ARRA dollars are incenting doctors to use Laetrile, the supposed cancer cure that was not evidence-based and didn’t work. ONC has promoted HIT as if there are clear evidence-based products and processes supporting widespread HIT implementation. But what’s clear is that we are experimenting…with lives, privacy and careers. As a clinician, I’m here to report that certified EHRs are not necessarily producing better documentation or improved care. Yes, EHR-generated documentation is usually more legible, but it’s often “legible gibberish.” And there’s a lot of it, including meaningless data, burying relevant information. Example: A colleague requested records for his mother’s nearly two-week hospital stay; this particular hospital is an early adopter of EHRs. He received almost 2,900 pages. Finding relevant data in the midst of 2,900 pages can be like finding a needle in a haystack. Here’s another example of EHRs degrading documentation: In our CMH, administration inserted language into the doctors' treatment plans. The problem is that the language is patently false and untrue. Unfortunately, administration controls the EHR, and physicians cannot change the untrue language. “Ghost writing” clinical notes – often incorrectly – is increasingly common, whether through fixed fields, no or limited free text, inserted language that cannot be changed, multi-authored documents, or other means. I have documented scores of error types with our certified EHR, and literally hundreds of EHR-generated errors, including consistently incorrect diagnoses, ambiguous eRxs, etc. As a CCHIT Juror, I’ve seen an inadequate process. Don’t get me wrong, the problem is not CCHIT. The problem stems from MU. EHRs are being certified even though they take 20 minutes to do a simple task that should take about 20 seconds to do in the field. Certification is an “open book” test. How can so many do so poorly? For example, our EHR is certified, even though it cannot generate eRxs from within the EHR, as required by MU. To CCHIT’s credit, our EHR vendor did not pass certification. Sadly, our vendor went to another certification body, and now they’re certified. MU does not address many important issues. Usability has received little more than lip-service. What about safety problems and reporting safety problems? What about computer generated alerts, almost all of which are known to be ignored or overridden (usually for good reason)? The concept of “unintended consequences” comes to mind. All that said, the problem really isn’t MU and its gross shortcomings, it is ONC trying to do the impossible: ONC is trying to artificially force a cure for cancer, basically trying to promote one into being, when in fact we need to let one evolve through an evidence-based, disciplined process of scientific discovery and the marketplace. Thank you for the opportunity to be a part of this process.</blockquote> Actually, I will make one comment: In the current climate of "cybernetics over all" in healthcare, this is not the type of testimony that will get the good Dr. any dinner invitations. -- SS

Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith

Psychiatrist-medical informaticist Dr. Scott Monteith was a guest blogger on the complications of " Meaningful Use of EHR's " ...

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