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If gov't officials can't deal with bendy bananas, curvy cucumbers and water for hydration, how can they possibly consider issues with computers?

I present this story with almost no commentary except this post's title, the simple observation that keeping government out of many aspects of out lives is not a bad idea, and a few minor points: <blockquote>The Telegraph <a style="font-weight: bold;" href="http://www.telegraph.co.uk/news/worldnews/europe/eu/8897662/EU-bans-claim-that-water-can-prevent-dehydration.html">EU bans claim that water can prevent dehydration </a> Brussels bureaucrats were ridiculed yesterday after banning drink manufacturers from claiming that water can prevent dehydration. By Victoria Ward and Nick Collins <div>6:20AM GMT 18 Nov 2011 </div> <div class="firstPar"> EU officials concluded that, following a three-year investigation, there was no evidence to prove the previously undisputed fact. </div><div class="secondPar"> Producers of bottled water are now forbidden by law from making the claim and will face a two-year jail sentence if they defy the edict, which comes into force in the UK next month. </div><div class="thirdPar"> Last night, critics claimed the EU was at odds with both science and common sense. Conservative MEP Roger Helmer said: “This is stupidity writ large. </div><div class="fourthPar"> “The euro is burning, the EU is falling apart and yet here they are: highly-paid, highly-pensioned officials worrying about the obvious qualities of water and trying to deny us the right to say what is patently true. </div><div class="fifthPar"> “If ever there were an episode which demonstrates the folly of the great European project then this is it.” <div class="body"> NHS health guidelines state clearly that drinking water helps avoid dehydration, and that Britons should drink at least 1.2 litres per day. The Department for Health disputed the wisdom of the new law. A spokesman said: “Of course water hydrates. While we support the EU in preventing false claims about products, we need to exercise common sense as far as possible." German professors Dr Andreas Hahn and Dr Moritz Hagenmeyer, who advise food manufacturers on how to advertise their products, asked the European Commission if the claim could be made on labels. They compiled what they assumed was an uncontroversial statement in order to test new laws which allow products to claim they can reduce the risk of disease, subject to EU approval. They applied for the right to state that “regular consumption of significant amounts of water can reduce the risk of development of dehydration” as well as preventing a decrease in performance. However, last February, the European Food Standards Authority (EFSA) refused to approve the statement. A meeting of 21 scientists in Parma, Italy, concluded that reduced water content in the body was a symptom of dehydration and not something that drinking water could subsequently control. Now the EFSA verdict has been turned into an EU directive which was issued on Wednesday. Ukip MEP Paul Nuttall said the ruling made the “bendy banana law” look “positively sane”. He said: “I had to read this four or five times before I believed it. It is a perfect example of what Brussels does best. Spend three years, with 20 separate pieces of correspondence before summoning 21 professors to Parma where they decide with great solemnity that drinking water cannot be sold as a way to combat dehydration. “Then they make this judgment law and make it clear that if anybody dares sell water claiming that it is effective against dehydration they could get into serious legal bother. EU regulations, which aim to uphold food standards across member states, are frequently criticised. Rules banning bent bananas and curved cucumbers [what?? - ed.] were scrapped in 2008 after causing international ridicule. Prof Hahn, from the Institute for Food Science and Human Nutrition at Hanover Leibniz University, said the European Commission had made another mistake with its latest ruling. “What is our reaction to the outcome? Let us put it this way: We are neither surprised nor delighted. “The European Commission is wrong; it should have authorised the claim. That should be more than clear to anyone who has consumed water in the past, and who has not? We fear there is something wrong in the state of Europe.” Prof Brian Ratcliffe, spokesman for the Nutrition Society, said dehydration was usually caused by a clinical condition [like hot weather and low fluid intake? - ed.] and that one could remain adequately hydrated without drinking water. [As the study was done in Italy, perhaps they had something else in mind? - ed.] <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjyLZUalU-u6gFdQV7_ahHIuCl5rKWj8ISlHwobBq2rxIG5xST8aJTc3QH-j4-PWZgv0nPRDYLKvmex6boEjJR1FvSSNCexoD0-1iH0Dp966zlA_c25nbKYEBo7svDnBcVjGANMzNZQ_I-1/s1600/wine-bottles.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5676861099366478818" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjyLZUalU-u6gFdQV7_ahHIuCl5rKWj8ISlHwobBq2rxIG5xST8aJTc3QH-j4-PWZgv0nPRDYLKvmex6boEjJR1FvSSNCexoD0-1iH0Dp966zlA_c25nbKYEBo7svDnBcVjGANMzNZQ_I-1/s320/wine-bottles.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 189px; height: 189px;" /></a> Water? Where we're going, we don't need water. He said: “The EU is saying that this does not reduce the risk of dehydration and that is correct. “This claim is trying to imply that there is something special about bottled water which is not a reasonable claim.” </div></div><div class="storyHead"> </div> </blockquote>Hard as this is to believe, the ruling is no April Fool's joke. -- SS

If gov't officials can't deal with bendy bananas, curvy cucumbers and water for hydration, how can they possibly consider issues with computers?

I present this story with almost no commentary except this post's title, the simple observation that keeping government out of many aspe...

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Websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with an EMR

Stunning. Two websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with an EMR: <a href="http://kottemann.wordpress.com/" title="In Support of Dr. Steven Kottemann" rel="home"></a><blockquote>In Support of Dr. Steven Kottemann Testimonials submitted by the patients of Dr. Steven Kottemann, Lincoln, Illinois<hgroup></hgroup> <a href="http://kottemann.wordpress.com/">http://kottemann.wordpress.com/</a> </blockquote> And a corresponding Facebook page: <blockquote> Support Dr. Kottemann <a href="http://www.facebook.com/pages/Support-Dr-Kotteman/170060299745403">http://www.facebook.com/pages/Support-Dr-Kotteman/170060299745403</a></blockquote> The posts at these sites are well worth reading. For background, see "<a href="http://www.prairiestatereport.us/2011/10/26/beloved-springfield-doctor-benched-for-not-being-proficient-with-electronic-medical-records-system/">Beloved Springfield Doctor Benched For Not Being Proficient with Electronic Medical Records System</a>", The Prairie State Report, Oct. 26, 2011: <blockquote>... This situation brings into focus the problem of top-down medical solutions, calling into question the efficacy of healthcare by committee, not to mention Obmacare itself. Do we really want to sacrifice good doctors in favor of good followers of top-down rules? Do we want good users of computers or excellent doctors? The doctor, Steven Kottemann, 63, was placed on paid administrative leave in September because they felt he was not properly utilizing the new electronic medical records system that his employer, Family Medical Center, instituted.</blockquote> Which is more important, one needs to ask? A computer, or an excellent clinician? -- SS

Websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with an EMR

Stunning. Two websites dedicated by patients to a physician in Illinois under fire essentially because he's "too slow" with a...

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To Sir Andrew? With a Settlement - GlaxoSmithKline to Settle for $3 Billion, CEO Said to Pursue Knighthood

Two weeks ago, reports of the largest legal settlement involving a pharmaceutical company to date in the US appeared.  The $3 Billion Settlement In summary, <a href="http://articles.philly.com/2011-11-04/business/30359814_1_glaxo-diabetes-drug-medicaid-pricing">per the Philadelphia Inquirer</a>, <blockquote>In perhaps the largest penalty ever paid by a pharmaceutical company, GlaxoSmithKline said Thursday it had reached a tentative deal with the U.S. Justice Department to pay $3 billion to settle criminal and civil allegations of illegal marketing practices and pricing under a Medicaid program.</blockquote> Why the deal was announced this month is not clear. Neither are all its provisions: <blockquote>Glaxo said the deal would be made final in 2012, but it was unclear why it was announced now. A spokeswoman declined to say whether Glaxo would have to live by a corporate integrity agreement, which the government sometimes requires in such cases.</blockquote> The Inquirer listed some possible reasons for the settlement, <blockquote>As for Glaxo's latest situation, one investigation, started by the U.S. Attorney's Office in Colorado and later run on a national level by the U.S. Attorney's Office in Boston, looked at Glaxo's marketing practices related to nine of its best-selling drugs, including Paxil, Wellbutrin, and later Advair. In a second investigation, the Justice Department looked at Glaxo's possibly inappropriate use of rules exceptions when reporting prices charged for drugs for different situations in the marketplace. Under part of the Medicaid Rebate Program, drugmakers are supposed to report the lowest price they charge most organizations, which is then used to calculate the price that Medicaid ultimately pays for its drugs. The third investigation, also by the Justice Department, was over how Glaxo promoted the diabetes drug Avandia, which was pulled from European markets and severely restricted last fall by the Food and Drug Administration after it was shown to cause heart attacks.</blockquote> As commonly occurs in such cases, GSK and its CEO averred that all the sorts of conduct that lead to this settlement are old news: <blockquote>The company said in a statement that since 2008 it had 'established a new framework for compliance in the U.S., based on the company's values, policies and established industry codes of practices. It is supported by a larger compliance staff and strengthened training programs that require certification by employees.' The changes included new incentive formulas for sales representatives, eliminating sales targets for bonuses. 'This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,' Glaxo chief executive officer Andrew Witty said in the statement. 'In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.'</blockquote> As is also usual, none of the reports included any acceptance of responsibility for the bad conduct by GSK or any of its leaders, and certainly they did not mention any negative consequences for any persons who might have authorized, directed, or implemented the misbehavior, even giving, as is apparently true in this case, that some of the behavior was at least alleged to be criminal. A Settlement for a Knight? It was not clear why this settlement was announced this early in such a preliminary, and vague manner. However, a <a href="http://www.pharmalot.com/2011/11/your-majesty-may-i-present-sir-andrew/">post</a> on the PharmaLot blog suggested one motivation: <blockquote>As the calendar year draws to a close, the UK government is busy readying the next list of individuals who are to be honored as members of the Order of the British Empire. These honors are bestowed on people from all walks of life who have somehow made a difference in their community. And there are various types of awards, including knighthood, that recognize a different type of contribution. The list, however, is a closely guarded secret. Presumably, even Rupert Murdoch employees would have a hard time hacking into the treasured line up of nominees. But one name that may be under consideration is Andrew Witty, the ceo at GlaxoSmithKline. Our sources say that Glaxo minions have been encouraged to find ways to hone his image in hopes that he becomes Sir Andrew.</blockquote> So one could speculate that being able to clear up these "difficult, long-standing matters," could be touted as a task that only could be accomplished by a knight. That might have been plausible if Mr Witty recently rode into town on a white horse, and then dispatched these old legal demons. Some More History In fact, that is not what happened. Per his <a href="http://www.gsk.com/about/bio-witty-cet.htm">official GSK biography</a>, <blockquote>Andrew Witty became Chief Executive Officer of GlaxoSmithKline plc on 21 May 2008. He is a member of the Board and Corporate Executive Team. Andrew joined Glaxo in 1985 and held a variety of Sales and Marketing roles in the UK business. He has worked in the Company’s International New Products groups, both in the Respiratory and HIV/Infectious disease fields and has been involved in multiple new product development programmes. He has also worked in South Africa, The USA and Singapore where he led the Group’s operations as Senior Vice President, Asia Pacific. While in Singapore Andrew was a Board Member of the Singapore Economic Development Board, the Singapore Land Authority and in 2003 he was awarded the Public Service Medal by the Government of Singapore. In 2003 Andrew was appointed President of GSK Europe, and joined GSK’s Corporate Executive Team. </blockquote> So he has been with GSK a long time. However, the misbehavior that the current settlement is apparently designed to resolve has been going on for a long time. As we previously <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">posted</a>, Paxil (Seroxat in the UK, or paroxetine), was the anti-depressant whose marketing lead GlaxoSmithKline (GSK) to settle allegations of fraud brought by then New York Attorney General Elliott Spitzer in 2004. That case included allegations of suppression and manipulation of clinical research, and was discussed in great detail in the book <a href="http://www.alison-bass.com/books.html">Side Effects</a> by Alison Bass. We posted about various aspects of this case, e.g., more recently <a href="http://hcrenewal.blogspot.com/2007/01/not-something-we-want-to-publicise-spin.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/british-government-concludes-gsk.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2008/09/brown-university-student-journalists.html">here</a>.  The case continues to echo to this day: see <a href="http://alison-bass.com/blog/2011/11/international-group-seeks-brown-universitys-help-in-getting-controversial-paxil-study-retracted">this post</a> by Alison Bass about attempts to have a questionable journal article that was used to market Paxil retracted.  Then there was Avandia (rosiglitazone), the anti-diabetic drug whose use was just restricted by the US Food and Drug Administration. This GlaxoSmithKline product inspired a <a href="http://hcrenewal.blogspot.com/2010/07/avandia-spin-cycle-continues-even-after.html">"spin cycle"</a> which provided us with endless grist for the Health Care Renewal mill. A good summary of the case appeared in September, 2010, in the British Medical Journal (Cohen D. Rosiglitazone: what went wrong: Brit Med J 2010; 341: 530-534. Link <a href="http://www.bmj.com/content/341/bmj.c4848.fu%20%20ll">here</a>) Once again, it appears that research was suppressed and manipulated (e.g., see <a href="http://hcrenewal.blogspot.com/2010/02/bring-back-dsi-avandia-case-as-spy.html">here</a>), Avandia critics were attacked by "experts" whose financial relationships with GSK were not always obvious (e.g., see <a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">here</a>), and there were allegations that GSK executives tried to intimidate those who disagreed with them (e.g., see <a href="http://hcrenewal.blogspot.com/2010/02/bring-back-dsi-avandia-case-as-spy.html">here</a> and <a href="http://hcrenewal.blogspot.com/2007/11/more-about-who-called-dogs-out-on.html">here</a>).  All this about Avandia came out after Mr Witty became President of GSK Europe and joined the Corporate Executive Team.  While there is no reason to think he was directly responsible for any of it, as a member of this team, he ought to be accountable for the corporation's major actions, and misbehavior.  By the way, we <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">posted</a> last year about another settlement by GSK, in which a GSK subsidiary pleaded guilty to criminal charges for selling adulterated drugs, including a version of Paxil. In the Washington Post <a href="http://www.washingtonpost.com/business/economy/3billion-settlement-expected-in-glaxosmithkline-drug-marketing-probe/2011/11/03/gIQAYf7sjM_story.html">report</a> of the $3 billion settlement, there is this quote from Dr Sidney Wolfe, <blockquote>'The size of the penalties, although large, are not as large as the money [the drug companies] make and so they keep doing it over again,' said Sidney M. Wolfe, director of Public Citizen’s health research group. 'The only way this is going to stop, or get reversed, is to greatly increase the size of the penalties or to start sending some of the executives to jail, if appropriate.'</blockquote>Summary I have no idea whether there is evidence supporting criminal charges for any executives in this case. However, GSK and its leadership have not covered themselves in glory recently as shown by now three major legal settlements. I am just an American and not very knowledgeable about how the UK decides to dub people knights. However, in my humble opinion, it would be grotesque to honor the current CEO of GlaxoSmithKline with a knighthood based how his company has been lead since he became a member of its Executive Team in 2003. I thus will end on my usual, repetitive note for such cases.... penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue. 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. ADDENDUM (18 November, 2011) -  See additional posts on attempts to have Study 329, a particularly questionable study of Paxil, withdrawn on <a href="http://loathingbioethics.blogspot.com/2011/11/fraud-what-fraud-brown-remains-silent.html">the Fear and Loathing in Bioethics blog</a>, <a href="http://brodyhooked.blogspot.com/2011/11/will-brown-university-investigate.html">the Hooked: Ethics, Medicine and Pharma blog</a>, and on <a href="http://www.margaretsoltan.com/?p=33573">the University Diaries blog</a>. ADDENDUM (21 November, 2011) - See also these posts on the call for the withdrawal of Study 329 on the <a href="http://alison-bass.com/blog/2011/11/international-group-seeks-brown-universitys-help-in-getting-controversial-paxil-study-retracted">Alison Bass blog</a>, and the <a href="http://1boringoldman.com/index.php/2011/11/20/a-walk-on-the-wrong-side-side-of-the-street">1BoringOldMan blog</a>.

To Sir Andrew? With a Settlement - GlaxoSmithKline to Settle for $3 Billion, CEO Said to Pursue Knighthood

Two weeks ago, reports of the largest legal settlement involving a pharmaceutical company to date in the US appeared. The $3 Billion Settle...

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A New Low - A Hospital CEO Got a "Golden Parachute" for A Merger that Never Occurred

We recently <a href="http://hcrenewal.blogspot.com/2011/11/ceos-first-to-benefit-from-for-profit.html">posted</a> about how top hospital managers are often the first to benefit from mergers and acquisitions, which once again have become fashionable in management circles.  Now it appears that top executives can benefit even from failed mergers, as <a href="http://www.news-journalonline.com/news/local/east-volusia/2011/11/12/ideas-run-the-gamut-on-future-of-bert-fish-medical-center.html">reported</a> by the Daytona Beach (Florida) News-Journal, <blockquote>Five months after Bert Fish Medical Center's failed merger, one board member said he was surprised to learn payments are still being made toward the $1 million buyout of the former hospital CEO. Hospital board member Joe Benedict said he didn't know former hospital Chief Executive Officer Bob Williams, who steered the board into the illegal deal with Adventist Health System, is due to receive his $289,000-a-year salary until 2014 –– paid through the publicly owned hospital. At the time the merger was announced, a memorandum of understanding with Williams became public and showed the deal had triggered a three-year buyout clause in Williams' contract. Starting July 1, 2010, the Adventist agreement paid him his salary for three years, as his contract required, plus seven months and eight days –– a deal worth $1 million and benefits. 'That man has got away with a lot more than he should have,' said Benedict, a former County Council member, explaining that he considers Williams as responsible for the failed merger as Jim Heekin, the board's former attorney. </blockquote> These payments were made to the former CEO despite the cost of the failure of the merger: <blockquote>The hospital district incurred $3.4 million in administrative and legal fees as a result. </blockquote> Apparently, there are allegations that the merger failed because former CEO Williams agreed to keep the board meetings of this public hospital secret, which was illegal: <blockquote>The hospital board has voted to pursue a legal malpractice lawsuit against Heekin, of the Orlando firm Lowndes, Drosdick, Doster, Kantor & Reed, for his advice to keep the public out of talks about merging the New Smyrna Beach hospital with a partner. The 21 closed meetings that were held over 16 months were called 'so much darkness for so long' they couldn't be cured, according to a ruling earlier this year from Circuit Judge Richard Graham, who threw out the merger. </blockquote> Also, <blockquote>Williams is quoted in transcripts of the closed meetings telling board members not to tell anyone Adventist had been chosen as Bert Fish's partner</blockquote> Other contractual provisions for golden parachutes exist, but have yet to be activated: <blockquote>Benedict said he's still hopeful he can undo other buyout clauses in hospital contracts he believes obligate the hospital to pay more than is allowed, under state law, for the departure of Bert Fish Medical Center administrators. According to the current contracts, provided to the News-Journal, the hospital's current CEO, chief financial officer and chief of nursing must be paid 24 months' salary should they be dismissed from their positions through no fault of their own. Their departures could be a possibility if Bert Fish were to seek another merger partner who doesn't want to keep them on. The contracts were executed June 30. On July 1, a new state law went into effect that limits the buyout of public employees to 20 months. </blockquote> Summary So, a hospital CEO had a contract that made him eligible to begin receiving "golden parachute" payments just because a merger was in process, and these payments could not be stopped even though the merger was declared illegal, and hence never occurred. We noted recently that CEOs and other top officials of health care organizations are often the first to benefit financially from mergers and acquisitions, even when such transactions to not prove so beneficial to the affected institutions, much less patients' and the public's health in the long run. Here is a case in which a CEO could get extra money just because a merger was contemplated. This is some sort of new record for health care leaders personally profiting from their insider positions. There has been growing public outrage about how ordinary people who play by the rules are disadvantaged in today's economy, while insiders profit from their positions. There ought to be equal outrage in health care over its version of this pheonomenon. As long as health care leaders can continue to put their self-interest ahead of the health care mission in this way, is it any wonder that health care costs continue to rise while access and quality suffer? When will would be health care reformers realize that to truly reform health care, we will have to reform health care leadership? We need health care leaders who understand and uphold the mission, are accountable for how well they do so, and whose incentives depend on how they do so. We do not need leaders who put their self-interest first. Right now, however, that seeems to be the leadership we have.

A New Low - A Hospital CEO Got a "Golden Parachute" for A Merger that Never Occurred

We recently posted about how top hospital managers are often the first to benefit from mergers and acquisitions, which once again have beco...

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George Lundberg, MD: The Promise of Health IT, and a Caveat

I was cited yesterday in a <a href="http://www.medpagetoday.com/" style="font-weight: bold;">Medpage TODAY</a> video by medical internet pioneer <a href="http://www.medscape.com/public/bios/bio-georgelundberg" style="font-family: arial;">George Lundberg, MD</a>, also former editor of the Journal of the American Medical Association (<a href="http://jama.ama-assn.org/">JAMA</a>). A link was made to Healthcare Renewal as well.   <div style="font-family: arial;"><div style="color: black; direction: ltr; font-family: Arial; font-size: 13px;"> <h1 dir="ltr" style="color: #003399; font-size: 18px; margin-top: 0px;"> </h1><blockquote>Health IT: Garbage In, Garbage Out By George Lundberg, MD, Editor-at-Large, MedPage Today November 15, 2011 <a href="http://www.medpagetoday.com/Columns/29688">http://www.medpagetoday.com/Columns/29688</a> (video and transcript) <div style="text-align: center;"><a href="http://www.medpagetoday.com/Columns/29688"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5675586219048368530" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhDX_mb_kfYLRA-Yy8d1h1ZIIgjwrZWTev8fCqjRHe0PzceTlZ1rWc0O6m_8LN71p0jSu586pkchWFeq-Ue5hnbguBdwJfghUvZlA9UxQxpaH7g10m-Z06-uEhLLyQzLafRx_o26YRhwrMZ/s320/lundberg.jpg" style="cursor: pointer; display: block; height: 181px; margin: 0px auto 10px; text-align: center; width: 222px;" /></a>Click on picture to link to article/video</div> Transcript: Hello and Welcome. I'm Dr. George Lundberg and this is At Large at MedPage Today. I started working with computers in medicine in 1963. I was a Captain in the United States Army Medical Corps in San Francisco when a Lieutenant Colonel told me to "automate the California Tumor Tissue Registry." I said, "Yes, Sir. How would I do that?" He told me to walk across the Presidio parking lot and go into a building that had a big machine in it that is called a computer. I did that, and for the next three months, I took the information that was on a bunch of 3 by 5 cards and converted that data into punch cards, which were then fed into the computer and out came an automated California Tumor Tissue Registry. I was hooked and, although never a "techie," I never stopped finding ways to use computers in medicine. The goal was always better, faster, cheaper. I remain a strong advocate, and have worked in a string of jobs that strived for that goal. One of the truths I learned early on was "G I G O" -- Garbage In; Garbage Out. That has not changed. There are indeed a huge number of medical tasks that computers can do very well if properly programmed, managed, and utilized. The eminent UCSF academic clinician Dr. Bob Wachter was early in recognizing that there were also significant <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1785161/">downsides in applying computers in practice</a>. Physicians are very smart. They will quickly adopt new technology that helps them get their job done if it does not waste their time. Most American physicians have dragged their feet on implementing computers into their practices, and with good reasons. But now they should get on with it. I write this column as it has been announced that 100,000 U.S. physicians and hospitals have signed up for the <a href="http://www.ihealthbeat.org/articles/2011/10/6/more-than-100000-health-providers-sign-up-for-meaningful-use.aspx">"meaningful use" incentive program</a> and thus been able to take the government's money to help automate their organizations. I think this is good and I praise Dr. David Blumenthal for his major efforts to make this happen. However, there is another harsh critic worth listening to. His name is Dr. Scot Silverstein, and he seems to have made it his life's work to call attention to really <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" style="font-weight: bold;">bad problems</a> that he discovers in this mass move to automation. Heed his cautions. They are real. But also recognize that where there is progress, there is trouble; but it can be worth the price. That's my opinion. I'm Dr. George Lundberg, At Large for MedPage Today. </blockquote><div dir="ltr"> </div></div></div> I thank Dr. Lundberg for his caveat, citing me, and agree with his position. My father died in 2000 due to complications of failure to diagnose bilateral renal adenocarcinomas (malignant tumors of both kidneys) for about two years despite numerous warning signs. This occurred in a hospital without electronic medical records and was in part due to impaired clinician communications. His life could have been longer, and with far less suffering, had there been a safe and effective EHR.   Once discovered -- only due to my insistence on a renal arteriogram -- the doctors told my father he could not be treated and to "get his affairs in order." (They lost the later malpractice case that ensued.) I was able to prolong my father's life for a few years by removing him from that hospital, "hospital A" and taking him to another hospital where he underwent bilateral heminephrectomies and other treatment. Let's call the other hospital "hospital B." On the other hand...a caveat of my own: Ironically and tragically, my mother died in June 2011 from complications of a medical error at "hospital B" that was due to impaired clinician communications -- caused by an EHR that to my observation was itself unsafe and ineffective. Therefore, my caveat is that we must be very mindful of the adage "where there is progress, there is trouble; but it can be worth the price." The price must respect medical ethics. It must not involve using patients, especially patients who have not been given informed consent and opt-out choices, as test subjects for software debugging. As I wrote back to Dr. Lundberg: <blockquote> Many thanks George. I agree with your assessments [on EHRs]. Now we have to work to ensure the pitfalls are habitually avoided. Regards, Scot Silverstein</blockquote> Here is a memorial bench I had erected to my parents at their grave last month, near where they ran a small community pharmacy for almost four decades. My father, a pharmacist, was a go-to source for health information in the <a href="http://articles.philly.com/1986-03-25/business/26081235_1_kelsey-hayes-city-material-manufacturer/2">once-bucolic</a> community of Somerton, in far Northeast Philadelphia, long before chain drugstores appeared in the region. The inscription atop the bench reads "Owners of Lumar Pharmacy. Served This Community 1954 -1991." They, like I, also toiled to safeguard and improve the health of the public. May they rest in peace: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEic0QrFaMJTrHh8lqnr-yXq49hhStOs_KyhL3qpreHoOXjf7sNOjmARDOdsoyHVNb9u5WwTmlVSn_gSp6V4l1950vlGPSOxAkpETxlBgat2RTg1c6Bd3lYYBqi3a6tEBVeFQ7bLvAOvnn24/s1600/Bench.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5675584399345929698" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEic0QrFaMJTrHh8lqnr-yXq49hhStOs_KyhL3qpreHoOXjf7sNOjmARDOdsoyHVNb9u5WwTmlVSn_gSp6V4l1950vlGPSOxAkpETxlBgat2RTg1c6Bd3lYYBqi3a6tEBVeFQ7bLvAOvnn24/s320/Bench.jpg" style="cursor: pointer; display: block; height: 241px; margin: 0px auto 10px; text-align: center; width: 320px;" /></a>Click to enlarge.</div> -- SS

George Lundberg, MD: The Promise of Health IT, and a Caveat

I was cited yesterday in a Medpage TODAY video by medical internet pioneer George Lundberg, MD , also former editor of the Journal of the ...

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Novel Idea on Healthcare IT: Worth a Billion Dollars!

From an <a href="http://www.amia.org/">AMIA</a> announcement: <blockquote>CMS Innovation Center Announces $1 Billion Funding Opportunity: CMS announced a new initiative, the Health Care Innovation Challenge, which will provide grants for new ideas to improve care and lower costs for those in Medicare, Medicaid and CHIP. CMS will award up to $1 billion in grants for a 3 year period and is encouraging providers, payers, local government, public-private partnerships and multi-payer collaboratives to develop new and innovative ways to improve care. To learn more about the grants and application process, check out the CMS Innovation Center website and be sure to register for the CMS webinar on Thursday.</blockquote> CMS, I have an idea! It's a really, really novel idea! "Let's regulate HIT to improve its safety, usability, usefulness, fitness for purpose, effectiveness, etc." ™ That will lower healthcare costs! Save lives, too! ---------------------------------- Can I have my Billion Dollars now? <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhhinLWA0LEqtIx0hVUJ7BPLp62RwF2t6YjMjk5lObwSrXxX4ixGktTylUJpX3p3Fs1ty_pliiW-F7mrn6m4CFH1GqwZ4cfVYxz-97Vv0EJUIKBKGhfWEZr2hwI8k42p1RGUSDY2Q-L4TEW/s1600/Billion_Front.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5675578351849844338" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhhinLWA0LEqtIx0hVUJ7BPLp62RwF2t6YjMjk5lObwSrXxX4ixGktTylUJpX3p3Fs1ty_pliiW-F7mrn6m4CFH1GqwZ4cfVYxz-97Vv0EJUIKBKGhfWEZr2hwI8k42p1RGUSDY2Q-L4TEW/s320/Billion_Front.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 310px; height: 134px;" /></a>You can do a lot in health IT with a billion dollars - if you're not the HIT industry, that is, that has squandered a large wad of these over the past several decades. </div> -- SS

Novel Idea on Healthcare IT: Worth a Billion Dollars!

From an AMIA announcement: CMS Innovation Center Announces $1 Billion Funding Opportunity: CMS announced a new initiative, the Health Care ...

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Abbott Laboratories to Settle for $1.3 Billion Allegations Including Giving Doctors Kick-Backs and Training Them to Make False Diagnoses

It looks like the march of billion dollar <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by health care organizations is on its way again.  The Proposed Abbott Laboratories Settlement Last month Bloomberg <a href="http://www.bloomberg.com/news/2011-10-21/abbott-said-to-agree-to-pay-1-3-billion-to-end-depakote-suits.html">reported</a>: <blockquote>Abbott Laboratories (ABT) agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said. Abbott executives, federal prosecutors and state officials reached a tentative agreement calling for the drugmaker to pay about $800 million to resolve civil claims over Depakote and about $500 million in criminal penalties for marketing the epilepsy medicine for unapproved uses, said three people familiar with the settlement who declined to be identified because the agreement hasn’t been made public. Abbott said earlier this week it was reserving $1.5 billion to cover costs of the potential settlement. </blockquote> A billion here, and billion there, it begins to add up: <blockquote>The settlement would be the third-largest illegal pharmaceutical marketing accord in U.S. history, behind the $2.3 billion Pfizer paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine. </blockquote> Encouraging Dishonesty, Giving Kick-Backs The Bloomberg report only briefly discussed the behavior by Abbott that lead to the settlement: <blockquote>In February, the government joined cases brought by former Abbott employees alleging the company engaged in so-called off-label marketing starting in the late 1990s. The suits contend the illegal sales practices resulted in false claims being submitted to government health programs. The whistle-blowers claim the drugmaker marketed Depakote for unapproved uses including agitation and aggression in patients with dementia, autism, sexual compulsion and other disorders. </blockquote> However, an <a href="http://articles.chicagotribune.com/2011-11-13/business/ct-biz-1113-abbott-20111113_1_whistle-blower-epilepsy-drug-illegal-marketing">article</a> published last week in the Chicago Tribune further described the allegations made by the whistle-blowers. In summary, <blockquote>The lawsuits against Abbott allege that the company encouraged and trained sales reps to market Depakote off-label to nursing home directors, geriatric doctors and other long-term care facilities. The company also gave doctors illegal kickbacks to talk about off-label uses of the drug in an effort to boost sales, according to the lawsuits, which were filed in federal courts in Virginia, Illinois and the District of Columbia. The FDA approved Depakote in 1983 to treat certain seizures in adults and children over 10. Since then, the drug has received approval for the treatment of other types of seizures, manic episodes of bipolar disorder and the prevention of migraine headaches. However, Depakote was never approved to treat Alzheimer's disease or other types of dementia or for general treatment of bipolar disorder. According to the whistle-blower lawsuits, though, Abbott sales reps specifically marketed Depakote to treat agitation and aggression associated with dementia.</blockquote> One whistle-blower alleged that Abbott encouraged doctors to make false diagnoses that would enable the government to pay for the use of Depakote: <blockquote>During a nationwide conference call in 2007, an Abbott trainer allegedly coached sales reps on how to explain to doctors that they could miscode a patient's illness in order to bypass federal regulations. For example, a physician could code a patient as having 'late onset of bipolar' or 'underlying seizure disorder' instead of 'agitation associated with dementia,' according to her complaint. Abbott held training sessions focused on off-label promotion but brought in outside consultants and held the training away from its North Chicago headquarters. At one training event, McCoyd and another sales representative allegedly were asked to share their techniques for off-label marketing but were forbidden from preparing or distributing any written materials about the topic. Upper-level management who attended the sales training purposely left the room when the off-label training sessions began, according to the complaint.</blockquote> The whistle-blowers also alleged that Abbott gave kick-backs (presumably the same idea as bribes) to doctors for prescribing Depakote: <blockquote>The complaints also allege that doctors were given kickbacks to talk about off-label uses of Depakote. According to McCoyd's filing, Abbott salespeople were given about $20,000 to $30,000 each year to 'educate' physicians and other heath care providers about off-label use of Depakote. Abbott paid doctors who promoted the drug between $500 and $2000 per speech, the complaint states. The money allegedly was funneled through intermediaries and associations, including the Alzheimer's Association, although the association told the Tribune it has 'no knowledge' of such activities. Using the organizations to pay doctors was done to 'disguise the direct payments to doctors and Abbott's substantial and direct involvement' in the events, the complaint alleges.</blockquote> Summary So it appears that Abbott is about to settle a case involving some very serious allegations, including training physicians to make false diagnoses, and giving physicians kick-backs. These sort of actions seriously subvert physicians' core values (and any physicians who made such false diagnoses or accepted such kick-backs would have seriously violated core ethical principles.) These actions also may have directly harmed patients. There appears to be no good evidence that Depakote has benefits that exceed its harms for patients with dementia, autism, etc. So encouraging doctors to prescribe the medicine for these patients was likely to have subjected some patients to side-effects without providing them any benefit. That would contradict the physicians' obligations to put the interests of individual patients first, and to avoid harming them. As the Tribune article noted, <blockquote>[Dr Adriane} Fugh-Berman, with PharmedOut, said companies put patients at risk when they promote drugs that haven't gone through the FDA's regulatory process. 'These drugs are being promoted for conditions they have not been shown to be effective, and they might be dangerous,' she said.</blockquote> So a $1.3 billion penalty would actually be a cheap price to pay for such ethical offenses. Note that the Bloomberg report did mention "criminal penalties," so this may be one of the infrequent cases in which a big health care organization actually would plead guilty to some crime. Note however that neither article mentioned anything about any individual who authorized, directed, or implemented the conduct in question suffering any negative consequence or paying any penalty. These reports are preliminary, so it may be that such penalties are part of the final settlement. But it is also possible that this settlement becomes another, and particularly flagrant example of health care corporate executive impunity. If no one turns out to have to pay a penalty for training physicians to lie to the government, and giving them kick-backs to prescribe a possibly useless and likely harmful medicine, what will deter other executives from authorizing and directing such actions again to make more money? Note in the Bloomberg article: <blockquote>Sales of Depakote 'rocketed to over $1.4 billion per year' as a result of improper marketing, according to a complaint filed in February by ex-Abbott sales representative Meredith McCoyd. 'Compensation for senior executives soared as well.' </blockquote> Furthermore, if no one turns out to have to pay a penalty for these actions, this case will just contribute to the ongoing demoralization of health care professionals. It will be another example of how insiders take advantage of the system for their personal gain, to the disadvantage of patients, and at further cost to an already overly expensive health care system that fails to provide adequate access and quality care. So I repeat, repeat, repeat... to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Abbott Laboratories to Settle for $1.3 Billion Allegations Including Giving Doctors Kick-Backs and Training Them to Make False Diagnoses

It looks like the march of billion dollar legal settlements by health care organizations is on its way again. The Proposed Abbott Laborato...

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