GlaxoSmithKline's Marketing Firm Promised "Clinical Trials Could be Your Solution" to Poor Graduate Students

We have frequently raised concerns about the increasing domination of clinical research, particularly clinical trials, by those with vested in interests in the research producing particular results.  In particular, drug, biotechnology and device companies often sponsor trials meant to evaluate their own products.  Often it appears that commercial trial sponsors <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate</a> various aspects of research design, implementation, analysis, and dissemination to increase the likelihood of a result favorable to their interests.  Furthermore, when even such manipulation fails to produce the desired result, particular studies may simply be <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>, that is, hidden.<br /><br /><b>Clinical Trial Participation as "Your Solution" to Graduate Students' Money Woes </b><br /><br />A recent story, first told on the In-Pharma Technologist web site, gave an example of how trial recruitment could be gamed so as to produce more compliant study subjects. Since that web-site does not allow copy and pasting of even a few sentences of its content, I will quote, instead, from a subsequent <a href="http://www.theguardian.com/money/2014/jun/22/glaxosmithkline-gsk-interns-drug-trial-pitch">article in the Guardian</a>.<br /><br /><blockquote class="tr_bq">GlaxoSmithKline  the pharmaceuticals multinational, has apologised after being accused of playing on the hardship of unpaid interns to recruit them to take part in clinical trials.<br /><br /><i>A marketing firm working for the FTSE 100 company sought to place a blog on careers advice websites boasting that involvement in drug trials could help graduates to finance their way through unpaid work placements</i>.<br /><br />In a proposed 'guest blog' for the website <a href="http://graduatefog.co.uk/2014/3433/unpaid-interns-targeted-for-clinical-trials/" title="">Graduate Fog</a>, an employee at TouchPoint Digital, working on behalf of GSK, wrote: 'Clinical trials could be your solution.'</blockquote><br />The "guest blog" proposed that many graduate students "would prefer an immediate income to tide you over for the coming months."  So,<br /><br /><blockquote class="tr_bq"><i>Clinical trials could be your solution. Depending on the length of the study, you could earn up to £2,000 per trial for up to 4 trials a year</i>, plus reasonable travel expenses.</blockquote><br />This was not a one-off,<br /><br /><blockquote class="tr_bq"> Touchpoint provided examples of similar articles previously published on websites targeted at students. In an <a href="http://graduatefog.co.uk/2014/3433/unpaid-interns-targeted-for-clinical-trials/" title="">email to the founder of Graduate Fog, Tanya de Grunwald</a>, it added: 'Your readers would also benefit if there is a small link at the end of the article to the GSK website, which is the biggest pharmaceutical company in the UK, so that if they want to find out more or get answers to more specific questions they can do so.'</blockquote><br /><b>Excessive Inducement </b><br /><br />The story was <a href="http://blogs.wsj.com/pharmalot/2014/06/23/glaxo-dumps-firm-for-praying-on-college-grads-for-clinical-trials/">picked up by Ed Silverman at the PharmaLot blog</a> in the US, who pointed out how TouchPoint Digital appeared to be supplying an excessive inducement to vulnerable subjects,<br /><br /><blockquote class="tr_bq">Tanya de Grunwald, who runs the Graduate Fog website in the U.K., objected to the tone of the overture. 'Some of my readers are feeling very low, vulnerable and desperate for money,' she wrote us in an e-mail after openly questioning the recruiting tactic in <a data-ls-seen="1" href="http://graduatefog.co.uk/2014/3433/unpaid-interns-targeted-for-clinical-trials/">a note to readers</a> on her website last week. 'Many are unemployed. Others are in low-paid graduate jobs or doing unpaid internships.'<br /><br />'Suggesting that participating clinical trials is a great way to earn easy cash is not just crass – I think it’s irresponsible. Surely, <i>the more desperate someone is for money, the more likely they are to be dazzled by the financial benefits and less careful about weighing up the risks</i>.'</blockquote><br />A long time ago, that is, from 2006 - 2008, we published a series of posts about how <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a> running clinical research projects for commercial health care firms often preyed on financially and otherwise vulnerable research subjects by offering what would appear to such people to be dazzling remuneration.  For example, we discussed the trials by SFBC International (later PharmaNet Development Group, and now apparently <a href="http://www.inventivhealthclinical.com/">Inventiv Health Clinical</a>)  in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-sfbc-internationals.html">here</a> and links backward); and the trial by <a href="http://www.parexel.com/">Parexel International </a>in London that put most of its subjects in intensive care (see post <a href="http://hcrenewal.blogspot.com/2006/08/parexel-blues-again.html">here</a>, with links backward). In 2008, as we discussed <a href="http://hcrenewal.blogspot.com/2008/06/clinical-trials-torture-economy.html">here</a>, two articles questioning the ethics of research done under the auspices of CRO appeared in two major medical journals.  Excessively zealous recruiting designed to tempt vulnerable subjects with money appears unethical, and may be dangerous for these subjects.<br /><br /><b>How Excessive Inducement Could Lead to Invalid Trial Results</b><br /><br />Not only is such a practice apparently unethical and dangerous, it could endanger patients outside the research projects in question by producing invalid research.  Subjects who could be dazzled by such inducements might avoid disclosing conditions which would otherwise exclude them from particular research projects, or participate in multiple projects without sufficient or any wash out periods in between, meaning that one treatment's effects could confound another.  (Note that the blog post proposed by the marketer above suggested that subjects could participate in multiple trials during one year.)  Furthermore, subjects desperate to complete studies and earn their fees might avoid reporting adverse effects to avoid the risk of premature termination of their participation, or avoid protesting questionable actions by the researchers.    <br /><br />But now in the modern era of the Internet and social media, overzealous recruitment using monetary lures is still going on.  As per PharmaLot,<br /><br /><br /><blockquote class="tr_bq">One expert believes the flap is not surprising, because <i>drug makers are under pressure to maintain a steady stream of clinical trial recruits.</i><br /><br /> 'Middle class folks just sit back and wait until the drug reaches the market. <i>Poor folks are the guinea pigs in an economy that is more and more uneven, and uncertain by the day</i>,' says Roberto Abadie, a senior researcher at the Social Networks Research Group at John Jay College, City University of New York, and author of ‘The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects.' </blockquote><br /><b>A Belated Response from GSK </b><br /><br />Apparently only after the story broke did GSK notice there was a problem.  Again, per PharmaLot,<br /><br />A Glaxo spokeswoman <i>blamed the outside marketing firm</i> for the episode. In an e-mail, she wrote us that 'we would agree that the tone used in the ads… is wrong. It trivializes the role of clinical trials in developing new medicines and the part that volunteers play in that process. This isn’t acceptable and we’re looking into what happened.'<br /><br />Whether GSK was properly supervising the marketing firm, and whether GSK had provided incentives that might have lead to overzealous recruitment were not addressed. <br /><br /><b>Summary</b><br /><br />This story is yet another reminder that health care professionals, health policy makers, and the public at large should be extremely skeptical of clinical research sponsored (and controlled) by those with vested interests in the research results turning out a certain way, particularly clinical trials run by drug, biotechnology, or biotechnology companies meant to assess those companies' own products. However, note that very rarely do published clinical trial reports provide enough detail about subject recruitment to determine whether overzealous recruitment and undue inducements may have lead to enrollment of subjects who should have been excluded, under reporting of adverse effects, etc.<br /><br />In my humble opinion, we need to reassess current policies that allows organizations with such obvious conflicts of interest to run experiments on human beings (which is what clinical trials are.)<br /><br />By the way, this story is also a reminder that most big drug, device and biotechnology firms seem to be associated again and again with dodgy clinical research.   For example, see what we have previously written about GSK<a href="http://hcrenewal.blogspot.com/search/label/GlaxoSmithKline"> here</a>. <br /><br />

GlaxoSmithKline's Marketing Firm Promised "Clinical Trials Could be Your Solution" to Poor Graduate Students

We have frequently raised concerns about the increasing domination of clinical research, particularly clinical trials, by those with vested in interests in the research producing particular results.  …

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Fool Me Twice? - Boehringer Ingelheim, Medtronic Settle Lawsuits Alleging Deceptive Marketing

It seems like it has been really quiet on the legal settlement front in the US, but maybe corporate executives wanted to wait until things calmed down after the unofficial start of summer to let out news that some people might not think reflected well on them.  So this week it was time to announce two new legal settlements of allegations of bad behavior by corporate health were announced, as we will list in alphabetical order....<br /><br /><b>Boehringer Ingelheim Settles Suits Alleging it Hid Data About Pradaxa Harms</b><br /><br />As <a href="http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html">per Bloomberg</a>,<br /><br /><blockquote class="tr_bq">Boehringer Ingelheim GmbH, the German family-owned drugmaker,<i> agreed to pay $650 million to settle the majority of lawsuits filed over its blood thinner Pradaxa, which has been linked to more than 500 patient deaths.</i></blockquote><br />The major allegations were about deception,<br /><br /><blockquote class="tr_bq"> Patients and their families alleged<i> Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought it to the U.S. market in October 2010.</i></blockquote><br />In particular, as we <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussed</a> in more detail in February, 2014, <br /><br /><blockquote class="tr_bq">Documents made public as part of patients’ Pradaxa suits showed <i>Boehringer officials didn’t disclose to U.S. regulators a data analysis that indicated the blood-thinning drug may have caused more fatal bleeding</i> after it was cleared for sale than in a study used to win approval.  </blockquote><br /><a href="http://www.nytimes.com/2014/05/29/business/international/german-drug-company-to-pay-650-million-to-settle-blood-thinner-lawsuits.html">Per </a>the New York Times, Boehringer Ingelheim executives continued to maintain<br /><br /><blockquote class="tr_bq">that it stood behind the safety and efficacy of Pradaxa and continued to believe that the lawsuits lacked merit, but that settling the case <i>allowed the company to move on.</i> 'Time and again, the benefits and safety of Pradaxa have been confirmed,' said Desiree Ralls-Morrison, senior vice president and general counsel of Boehringer Ingelheim USA.</blockquote><br />This is typical of most legal settlements involving large health care organizations, whether they end lawsuits brought by private parties or by the US government.  The settlements often allow the parties to continue to disagree, do not establish guilt or innocence, but leave one to wonder why executives would pay so much of admittedly other peoples' money just to "move on" without upholding their or their companies' honor, especially when documents revealed and legal findings made in cases prior to settlement remain unchallenged.<br /><br />So this settlement also comes after December, 2013, as we discussed <a href="http://hcrenewal.blogspot.com/2013/12/a-second-order-cover-up-judge-finds.html">here</a>, December, when a judge<br /><br /><blockquote class="tr_bq">ordered Boehringer to pay a $931,000 fine in December for <i>failing to preserve 'countless' files on Pradaxa’s development and marketing. Patients’ lawyers say Boehringer should have placed an effective 'litigation hold' on the documents</i>, forcing employees to preserve them.</blockquote><br />(The above <a href="http://www.bloomberg.com/news/2014-05-28/boehringer-pays-650-million-to-end-blood-thinner-cases.html">per Bloomberg</a>.)  That finding, which the settlement does not dispute, does not fill one with confidence about the openness and transparency of Boehringer Ingelheim managers.<br /><br />Also the settlement does not refute documents released during this litigation which suggested that Boehringer Ingelheim personnel tried to influence, or manipulate a company sponsored research paper to prevent it from contradicting the company's official marketing message that Pradaxa administration does not require monitoring of patients with blood tests (as we discussed <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">here</a>).     <br /><br />Note further that this case comes only a few years after a case in which Boehringer Ingelheim settled allegations of deceptive marketing of drugs other than Pradaxa, as we discussed <a href="http://hcrenewal.blogspot.com/2012/10/just-another-day-at-office-boehringer.html">here</a>. <br /><br /><b>Medtronic Settles Suit Alleging Kickbacks to Physicians</b><br /><br />The most extensive and colorful <a href="http://www.startribune.com/business/260978651.html">report</a> was in the Minneapolis Star-Tribune, <br /><br /><blockquote class="tr_bq"><i>Medtronic Inc. will pay the U.S. Justice Department $9.9 million to settle a whistleblower lawsuit that accused the company of paying kickbacks to doctors for using its defibrillators and pacemakers.</i><br /><br />The alleged kickbacks, according to the newly unsealed suit, included '<i>gifts of wine and alcohol</i>' and '<i>trips to strip clubs</i>' paid for by the Fridley-based company. The lawsuit also says Medtronic paid to fly doctors to events in San Francisco, Las Vegas, New Orleans, New York, Minneapolis and other cities that some physicians used as 'a free vacation.'</blockquote><br />More colorful details,<br /><br /><blockquote class="tr_bq">The lawsuit, whose details remained secret until Tuesday, describes Medtronic <i>business plans with names such as 'Project Wildfire' that had sales representatives offer 'cash payments, expensive trips and meals, expensive gifts and entertainment to physicians as kickbacks in exchange for the physicians’ agreement to implant Medtronic devices.'</i><br /><br />The lawsuit alleged that Medtronic '<i>funneled millions of dollars in unrestricted grant money to physicians</i>' to get them to encourage the use of Medtronic defibrillators and pacemakers in patients whose 'mild heart failure symptoms did not meet [Food and Drug Administration] criteria for an implantable device.'<br /><br />Those procedures were not only unnecessary, the suit alleged, but potentially dangerous.<br /><br />The suit describes <i>payments of thousands of dollars in speaking fees to doctors for attending dinners at which they spoke for only a few minutes</i>, if at all. In other cases, <i>Medtronic allegedly prepared entire presentations that physicians offered almost verbatim.</i><br /><br />The suit talks of a plan that 'instructed sales representatives to personally review patient charts in friendly doctor’s offices' and to flag those patients the sales representative 'felt should receive an implant.'</blockquote><br />Note that commercially supplied "unrestricted grant money" is now the lifeblood of many ostensibly academic continuing medical education (CME) programs, but this case suggests that corporate executives may believe they are paying such money to get doctors to use their products.  Note further that many physicians defend their receipt of money in payment of talks they have given on behalf of commercial firms as fair payment for providing unbiased education, but this case suggests that corporate executives may believe they are paying such money for marketing, and/or to get the supposedly unbiased physician speakers to use their products.  <br /><br />Once again, the settlement did not resolve the allegations. <br /><br /><blockquote class="tr_bq"> Medtronic said it <i>did not admit that any of its activities were improper or illegal</i> and that the settlement would bring to a close a long-running review of events dating from 2001 to 2009.</blockquote><br />Also,<br /><br /><blockquote class="tr_bq"> Asked to comment specifically on the strip club allegations and the accusation that it financially facilitated unnecessary implantations, Medtronic<i> reiterated that its $9.9 million payment was not an admission that it had done anything illegal or improper.</i></blockquote><br />See my comments above.  Why would executives with even the slightest ability to feel shame not contest such allegations if they were untrue?  But maybe many of today's corporate health care executives are not capable of feeling shame, and of course they get to pay off these lawsuits with other peoples' money.<br /><br />By the way, this is just one of many Medtronic settlements.  As Bloomberg <a href="http://www.bloomberg.com/news/2014-05-28/medtronic-settles-suit-over-heart-device-kickback-claims.html">summarized</a>,<br /><br /><blockquote class="tr_bq"> Medtronic agreed in 2007 to <i>pay about $130 million to settle consumer suits accusing the device maker of hiding defects in its defibrillators</i>. The company agreed to a <i>$268 million settlement of suits in 2010 over allegations that fractured wires in another line of defibrillators caused at least 13 patient deaths.</i></blockquote><br />In fact, Medtronic has provided our blog with <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">lots of material</a>.  We first <a href="http://hcrenewal.blogspot.com/2006/01/medtronics-payments-to-doctors-too.html">discussed</a> detailed and vivid allegations that Medtronic had been paying off doctors starting in 2003 here in 2006.  Medtronic has been involved in other lawsuits alleging various kinds of deception. <br />-  In 2011, it settled for $23.5 million two other federal lawsuits alleging it paid kickbacks to encourage physicians to implant its devices (look <a href="http://hcrenewal.blogspot.com/2011/12/medtronic-settles-yet-again.html">here</a>).   <br />- In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">here</a>)<br />- In 2006, Medtronic subsidiary Sofamor Danek settled for $40 million allegations that it gave kickbacks to doctors in the form of sham consulting fees and lavish trips (look <a href="http://hcrenewal.blogspot.com/2011/12/medtronic-settles-yet-again.html">here</a>). <br /><br />Yet we are now writing at the end of May, 2014, and Medtronic is still settling lawsuits involving vivid allegations of payoffs to physicians, and its executives are still saying nothing to see here, move on.<br /><br /><b>Summary</b><br /><br />These sorts of cases provide evidence that large health care corporations, including not just pharmaceutical companies, but biotechnology and medical device companies, commonly use deceptive and unethical practices to market their products.  Such marketing lets them charge high, even outrageous prices and sometimes results in patients getting expensive treatments that do them no good, or worse, that do more harm than good.  Some of the executives of these companies doubtless got large bonuses, and may have gotten millions in compensation partially because of the sales generated by these practices.  However, they get to walk away from such lawsuits without any personal accountability, just by paying out a few millions, or billions, of the company's, that is, other peoples' money.  They get do pay that money without any other explanation that it eliminates distractions and allows them to move on (with whatever they have already made).<br /><br />The more this goes on, the more health care dysfunction continues, and the more the health care oligarchy prospers.  As we have written many times,<br /><br /><blockquote class="tr_bq">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.  Note that each of the companies discussed above have had their previous ethical lapses discussed in previous Health Care Renewal posts. <br /><br />The continuing march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlements</a>, and sometimes <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal</a> convictions involving major health care organizations should be regarded merely as providing a floor to estimates of the extent of bad behavior by large health care organizations. Bad behavior may not be reported, or lead to legal action, and legal action may not lead to settlements or convictions. However, it is amazing how many organizations that were once regarded as exemplary have had to settle, or plead guilty, or been convicted.<br /><br />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.</blockquote><br />(That version was from 2010, posted <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a> re Medtronic's 2010 settlement. You heard it here first.  Medtronic is still settling, and according to its <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=76126&p=IROL-secToc&TOC=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9vdXRsaW5lLnhtbD9yZXBvPXRlbmsmaXBhZ2U9OTAwMDI5NiZzdWJzaWQ9NTc%3d&ListAll=1">most recent proxy</a>, from 2013, the annual total compensation of its CEO was last reported to be <b><i>$8,975,886</i></b>.) <br /><br /><br />

Fool Me Twice? - Boehringer Ingelheim, Medtronic Settle Lawsuits Alleging Deceptive Marketing

It seems like it has been really quiet on the legal settlement front in the US, but maybe corporate executives wanted to wait until things calmed down after the unofficial start of summer to let out n…

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Is this Any Way to Discuss Health Care Policy? - Television Advertising about US Health Care Reform Cost $445 Million from 2010 -2014

Every now and then, we get an anonymous comment criticizing our "lack of balance" or words to that effect, maybe because we criticized some action by a big, often but not always for-profit, health care organization.  We usually respond that we have no obligation to be balanced, since<br />- We publish opinion, not hard news<br />-  It is questionable that even hard news reporters must report all opinions on an issue, if some of those opinions are demonstrably less credible<br />-  There are far more voices extolling the wonderful "innovations" provided by our current "best health care system in the world," than providing our sorts of criticism.<br /><br />To expand on that last point - a recent news item suggests how much of the health care policy debate is paid marketing and public relations, rather than individual voices of citizens, health care professionals, or even health care policy experts.<br /><br />From the AP, <a href="http://www.seattlepi.com/news/article/Study-Political-TV-ads-on-health-law-total-445M-5483653.php">via the Seattle Post -Intelligencer</a>,<br /><br /><blockquote class="tr_bq">A new analysis finds the nation's health care overhaul deserves a place in advertising history as the focus of extraordinarily high spending on negative political TV ads that have gone largely unanswered by the law's supporters.<br /><br />The report, released Friday by nonpartisan analysts Kantar Media CMAG<a href="http://www.seattlepi.com/?controllerName=search&action=search&channel=news%2Fpolitics&search=1&inlineLink=1&query=%22Kantar+Media+CMAG%22"></a>, estimates <i><b>$445 million</b> was spent on political TV ads mentioning the law since the enactment of the Affordable Care Act in 2010</i>. Spending on negative ads outpaced positive ones by more than 15 to 1.</blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">In the 2014 congressional races, 85 percent of the anti-Obama ads were also anti-'Obamacare' ads, the analysis found. In some competitive races, 100 percent of the pro-Republican TV ads aimed at Democrats contained anti-health law messages.<br /><br />Over the four years,<i> an estimated $418 million was spent on 880,000 negative TV spots focusing on the law, compared to $27 million on 58,000 positive spots</i>, according to the analysis. Nearly all of the spending was on local TV stations, in races ranging from state offices such as treasurer and governor to Congress and the presidential election.</blockquote><br />That is just amazing. <br /><br />My concern is not so much that much of this advertising is against "Obamacare."  We have not often written about the Affordable Care Act (ACA), aka "Obamacare," and what we wrote at best was mild praise.  As I <a href="http://hcrenewal.blogspot.com/2010/03/health-care-reform-bill-and-health-care.html">posted</a> back in 2009, very little of the law had anything to do with the issues we discuss on Health Care Renewal.  In my humble opinion, since the law went into effect, it has increased access to health insurance, especially for certain groups of people that commercial health care insurers previously spurned, e.g., older people and people with pre-existing diseases.  It also contained provisions that might increase disclosure of conflicts of interest, and foster comparative effectiveness research.  On the other hand, the law has done nothing to reduce <a href="http://hcrenewal.blogspot.com/search/label/concentration%20of%20power">concentration of power</a> in health care.  It has done nothing to make health care leaders more <a href="http://hcrenewal.blogspot.com/search/label/accountability">accountable</a>, especially for their organization's unethical or even <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal</a> behavior, decrease their ability to <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">line their pockets</a> regardless of such behavior, and thus reduce their <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity.</a>  It will not obviously decrease <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest </a>affecting those who make decisions about patient care or health policy, lock the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a> between government and the health care industry, end <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a> to serve vested interests, or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research</a> whose results offend such interests, etc, etc.  So there is plenty to discuss about health care reform and related matters of health care policy.<br /><br />Yet a major venue of US public discussion about health care policy, at least having to do with health care reform legislation, appears to be 15 -60 second paid television advertisements.  Often who pays for these ads are obscure, as certainly are the identities of the advertising or public relations firms that actually craft them.  Certainly, the ads do not explain who might profit were what they urge be implemented. The ads may appeal to emotion, or engage in logical fallacies.  And they appear in millions of peoples homes day in and day out.<br /><br />Such advertising, added to all the other billions of dollars worth of <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a> and <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a> that swirl around health care, make any sort of intelligent discussion very difficult.  The advertising frenzy renders the voices of individual citizens, health care professionals, and even health policy experts  whispers in comparison.<br /><br />While there are ostensible free speech advocates who defend these advertisements, and maybe who promote the free speech rights of corporations as the same as those of human citizens (without, of course, many of the responsibilities of citizens), none of these vocal self-proclaimed civil libertarians seem to be doing anything to defend the audibility of the voices of individuals in the health care policy debate.<br /><br />So we will continue to do what we can to bring some healthy skepticism about loud proclamations in health care made by people who stand to gain financially from their effects.  But is it any wonder that our voices create <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">so few echoes</a>? <br /><br />

Is this Any Way to Discuss Health Care Policy? - Television Advertising about US Health Care Reform Cost $445 Million from 2010 -2014

Every now and then, we get an anonymous comment criticizing our "lack of balance" or words to that effect, maybe because we criticized some action by a big, often but not always for-profit, health car…

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The Smarming of Health Care - How to Spin a Minimally Efficacious Variant on an Old Drug as New and Wonderful

A recent announcement of the approval of a new drug showed the latest ways pharmaceutical companies can spin products as new and effective when in reality they are barely either.  <br /><br /><b>Announcing a Drug Approval with a Twist</b><br /><br />United Therapeutics just got US Food and Drug Administration (FDA) approval for their new oral prostacyclin agent for the treatment of pulmonary arterial hypertension. The basics, <a href="http://www.bloomberg.com/news/2013-12-21/united-therapeutics-wins-u-s-approval-for-lung-therapy.html">per Bloomberg</a>, were:<br /><br /><br /><blockquote class="tr_bq">United Therapeutics Corp. (UTHR)’s gained U.S. marketing approval for the oral version of its treatment for high blood pressure in the arteries that supply the lungs. <br /><br />The Food and Drug Administration cleared orenitram, an extended-release tablet, for the treatment of pulmonary arterial hypertension to improve exercise capacity in some types of patients, the Silver Spring, Maryland-based company said today in a statement. <br /><br />The pill’s active ingredient, treprostinil, is the same as in the company’s approved injection and inhalation solution for PAH, a life-threatening disorder, United Therapeutics said. The FDA had rejected the oral version of the therapy in March and in October> <br /><br />'This approval marks the first time that the FDA has approved an orally administered prostacyclin analogue for any disease -– and our fifth approval from the FDA for treatment of PAH -- supporting our mission of providing a wider choice of PAH therapies for physicians and patients,' Roger Jeffs, the company’s president and chief operating officer, said in the statement. 'We are grateful for the FDA’s thorough review and will continue to build clinical support for the use of Orenitram.' </blockquote><br /><br /><br />But the triumphant announcement by the company CEO had some unusual twists.  As<a href="http://www.npr.org/blogs/health/2013/12/24/256839330/orenitram-united-therapeutics-names-pill-after-ceo-who-sought-daughters-cure"> reported</a> on National Public Radio's (NPRs) Shots blog,<br /><br /><blockquote class="tr_bq">'When I started the company 17 years ago, the only option for treating pulmonary hypertension was intravenous ,' Martine Rothblatt, CEO of United Therapeutics told investors in a celebratory conference call Monday. '<i>My young daughter looked at me and said, 'Can't there be a pill?</i>''<br /><br />Now there is </blockquote><br />So,  <br /><br /><blockquote class="tr_bq">'What it has resulted in is<i> something that as the parent of a lovely young lady with pulmonary hypertension, I cannot even put into words, the emotional meaning that it has to have a pill form of prostacyclin,' Rothblatt said.</i></blockquote><br />It appears to be such a warm and happy story.  A mother is so concerned about her daughter's serious illness that she founds a company to develop treatments for it.  Now many years later they have come up with something groundbreaking.<br /><br />How could anyone not shed a tear?  How could anyone not be happy about this triumph of commercial drug development.<br /><br />However, while it may seem snarky to point this out, drug development is usually about issues other than "emotional meaning," and this discussion of emotional meaning took place during the public relations/ marketing blitz put on after the approval of the marketing of a new drug, so maybe closer examination, and some skepticism are warranted. <br /><br /><br /><b>How Well Does Orenitram Work?</b><br /><br />The quote above from the CEO was about "emotional meaning," not efficacy or effectiveness.  In fact, the blog post by Mr Hensley hinted at and a review of the one relevant published article strongly suggested that the drug really had minimal efficacy, and possibly benefits that failed to outweigh its harms.<br /><br />Mr Hensley wrote, <br /><br /><blockquote class="tr_bq"> The FDA approved Orenitram on the basis of a study that gauged its safety and effectiveness as a standalone treatment. The drug helped people <i>walk a little farther in a timed walking test. </i>The <i>most common side effects seen in the study were headache, nausea and diarrhea.</i></blockquote><br />On my review of the evidence....<br /><br />A single randomized controlled trial(1) showed that patients given treprostinil could walk on average 26 meters (less than 100 feet) more in 6 minutes after 12 weeks of treatment than they could at the beginning of the treatment, while those given placebo were only able to walk about as far as they did before.  The treated patients also had some improvement in their shortness of breath.  On the other hand, they were substantially more likely to experience adverse effects, particularly nausea, vomiting, diarrhea, flushing, jaw pain, or pain in the extremities.  <br /><br />Furthermore, the study lasted only 12 weeks, and provided no information about outcomes after that.  Treated patients were not spared overall worsening of their clinical situation compared to untreated patients.  Treated patients were no less likely to be hospitalized or to die.<br /><br />Various aspects of its design may increase doubts about its validity, including emphasis on a "modified intention-to-treat population" which was not clearly defined, a relatively high rate of premature study drug discontinuation, and a complex statistical analysis scheme which seemed unnecessary to assess the main results of a randomized controlled trial.<br /><br />Finally, the generalizability of the study was limited to patients already optimally treated with conventional therapy, and perhaps by ist predominantly Asian female population. <br /><br />So the only apparently positive trial of trepronsinil did not provide good evidence that its benefits outweighed its harms.  At best, some patients might find that the modest increases in exercise capacity and decreases in dyspnea it may produce may be worth nausea, vomiting, diarrhea, flushing, or jaw or extremity pain.   <br /><br />Note that treprostinil is an oral version of a type of compound called a prostacyclin.  As noted above, United Therapeutics markets other forms of prostacyclin.  However, the latest (2005) Cochrane Collaboration systematic review of this class of drugs for pulmonary arterial hypertension only found evidence that the drugs helped when added to first-line drugs to improve symptoms for the short-term, no more than 12 weeks.  It found no evidence that prostacyclin prolongs survival, or lessens complications of the illness(2)  <br /><br />So having an oral prostacyclin treatment for PAH may have emotional meaning, but the pill, while likely more convenient than an injectable prostacyclin, does not seem to have sufficient efficacy to outweigh its harms for many patients.  <br /><br /><b>What Does Orenitram Cost, and Why?</b><br /><br />But United Therapeutics may have been able to make one aspect of this drug superlative, - its price.  Per Scott Hensley in the Shots blog,<br /><br /><blockquote class="tr_bq">Orenitram won't be available for sale for about six months, the company said, and its exact price hasn't been determined either. But<i> it will be very expensive, about<b> $150,000 a year</b>, </i>according to an estimate by Dr. Mark Schoenebaum, an industry analyst with ISI.</blockquote><br />That would be about three times the median US family income.  But the CEO shrugged concerns about the price off,<br /><br /><blockquote class="tr_bq">Rothblatt acknowledged that the cost of the drugs is high but manageable, because pulmonary hypertension remains pretty rare, though the exact prevalence is hard to pin down.</blockquote><br />One explanation for that amazingly high price comes from a <a href="http://www.forbes.com/sites/matthewherper/2013/12/23/this-drug-company-ceo-just-named-her-new-drug-after-herself/">post</a> on Forbes by Matthew Herper,<br /><br /><blockquote class="tr_bq">She commercialized [prostacyclin] ..., and was able to get investors interested because she realized there was<i> no maximum price </i>insurers would pay for an effective drug. United Therapeutics became one of biotech’s great success stories.</blockquote><br />A lack of an upper limit on pricing has other effects of course.  <a href="http://financials.morningstar.com/ratios/r.html?t=UTHR&region=usa&culture=en-US&ownerCountry=USA">According to Morningstar</a>, the company's sky high pricing enabled a net profit margin over 33% in 2012-13.   According to the <a href="http://ir.unither.com/common/download/download.cfm?companyid=UTHR&fileid=660323&filekey=f90b5dc7-52ac-4a2a-9350-8446eaeee34d&filename=UTHR_2013_Proxy_Statement_v2.pdf">United Therapeutics 2013 proxy statement</a>, CEO Martine Rothblatt's total compensation is<b><i> $7,958,328</i></b>.  Three other executives got more than $4.5 million.<br /><br />So I imagine that marketing a drug that may produce so much revenue may have emotional meaning for company executives.  On the other hand, in this era of high insurance deductibles and co-payments it may have considerable negative emotional meaning for patients. <br /><br /><b>Some Off-Key Notes</b><br /><br /><br />The recent publicity about the new oral prostacyclin did not dwell on an issue that appeared earlier in a December, 2013, <a href="http://ir.unither.com/releasedetail.cfm?ReleaseID=812424">press release</a> from United Therapeutics about its other prostacyclin products,<br /><br /><blockquote class="tr_bq"> United Therapeutics Corporation (NASDAQ: UTHR) announced today that it has received a subpoena from the Office of the Inspector General of the Department of Health and Human Services reflecting <i>an investigation by the United States Department of Justice</i>, principally represented by the United States Attorney's Office in Baltimore. The subpoena requests <i>documents regarding Remodulin® (treprostinil) Injection, Tyvaso® (treprostinil) Inhalation Solution and Adcirca® (tadalafil) Tablets, including the company's marketing practices relating to these products.</i></blockquote>Instead, as we discussed above, the CEO of the company that will market this very expensive but not very efficacious drug went out of her way to bring up emotional issues about her own daughter's illness.  Certainly, anyone can believe the CEO was motivated to develop prostacyclins for PAH by concerns about her daughter's own illness.  However, focusing on such emotional issues may also distract from concerns about other aspects of the company's marketing. <br /><br />So maybe it is not a surprise that she decided to name the new drug in a personal way,...  But she did not name it for her daughter.  Again per Scott Hensley,<br /><br /><blockquote class="tr_bq"> Now there is: Orenitram. The<i> name comes from 'Martine Ro,' as in Martine Rothblatt, backward.</i></blockquote><br />Instead, Martine Rothblatt names her company's new drug for.... herself. <br /><br />So what is this very emotional and personal drug marketing/ public relations campaign really about? <br /><br /><br /><b>On Smarm in Health Care </b><br /><br />So it appears that United Therapeutics and its CEO used what may now be called smarm to promote their vested interests and divert attention from uncomfortable facts. <br /><br />In a now widely read and commented upon article in Gawker, Tom Scocca asserted that smarm has become "an omnipresent, unnamed cultural force."  Some aspects of smarm, as discussed in the article,<br /><br /><blockquote class="tr_bq">Smarm is a kind of performance—an assumption of the forms of seriousness, of virtue, of constructiveness, without the substance.</blockquote><br /><blockquote class="tr_bq"> it expresses one agenda, while actually pursuing a different one. It is a kind of moral and ethical misdirection. Its genuine purposes lie beneath the greased-over surface.</blockquote><br /><blockquote class="tr_bq"> Smarm, whether political or literary, insists that the audience accept the priors it has been given. Debate begins where the important parts of the debate have ended.</blockquote><br />So the smarmy element in the public relations about Orenitram was the misdirection created by invoking the CEO's daughter's illness and its emotional ramifications.  By focusing on an emotional issue which apparently only the callous could dismiss, the issues of the drug's minimal efficacy, frequent side effects and very high price were eclipsed.   Yet they, not the emotional connection between a particular parent and chile should be salient to patients, doctors, regulators, and the general public.<br /><br /> (The issues of the investigation of the company's marketing of other prostacyclin products, and the egotism implied by the drug's name were certainly eclipsed as well.) <br /><br />Presumably by raising these truths which might be unpleasant to United Therapeutics executives, I am now guilty of "snark."  As Scocca pointed out, one aspect of smarm is to exile reasonable criticism and skepticism as "snark,"<br /><br /><blockquote class="tr_bq">What is snark reacting to? <br /><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa"><br /></div><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa">It is reacting to smarm. </div></blockquote><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa"><br /></div><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa">So snarky as it may be, I believe that the major considerations for patients and physicians when considering a therapy - like Orenitram - should be the benefits versus harms of the the therapy for the individual patient, and the strength of the evidence supporting both.  The more marketers, public relations functionaries, and executive try to distract from that, and the more smarm they employ to do so, the more skepticism is required.  </div><br /><br /><b>References</b><br /><br />1.  Jing ZC, Parikh K, Pulido T et al.Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial.  Circulation 2013; 127: 624-633. Link <a href="http://circ.ahajournals.org/content/127/5/624.full">here</a>.<br /><br />2. Paramothayan NS, Lasserson TJ, Wells A et al.   Prostacyclin for pulmonary hypertension in adults. Cochrane Review 2005; Link <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002994.pub2/abstract;jsessionid=631C530B905482CD4A1108101CF1D775.f04t04">here</a>.

The Smarming of Health Care - How to Spin a Minimally Efficacious Variant on an Old Drug as New and Wonderful

A recent announcement of the approval of a new drug showed the latest ways pharmaceutical companies can spin products as new and effective when in reality they are barely either.  Announcing a Drug Ap…

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"Emotion, not Information" - the Lucrative Deceptive Marketing of Hospice, and its Potentially Fatal Consequences

One of the real recent advances in health care, in my humble opinion, was the organization of compassionate, palliative care for people at the end of life.  During my training and early career I saw too many patients with terminal illness getting aggressive, sometimes very painful treatments which at best only offered hope of briefly prolonging their lives.  Some patients chose such treatments with full knowledge of the implications, at times with the hope that they might survive until some significant event, for example, the birth of a grandchild.  Many patients, however, seemed to be suffering with no purpose.<br /><br />The hospice and palliative care movement, however, offered true comfort to those with little hope of prolonged survival.  Good hospice care eased the final days of patients with advanced disease for whom no definitive treatments could be found.<br /><br />Hospice seemed like a great alternative for such patients, but its reasonable use depended on physicians' abilities to identify patients who really were at the end of life, and for whom aggressive treatment would be futile.  The Achilles Heel of the hospice movement remained health care professionals' inability to reliably identify such patients.  The big problem is that putting a patient who actually potentially could survive for a long time in hospice will doom that patient were he or she to develop an acute illness for which treatment is available, like a bacterial pneumonia that might respond to antibiotics, because in hospice antibiotics are not given for acute infections.<br /><br />So the development of hospice had a downside which could be fatal for some patients.  I think most physicians hoped, however, that we could minimize the number of such patients by trying hard to make accurate predictions, and that in the future, better technology would lead to better predictions.<br /><br /><b>The Rise of Corporate Hospices </b><br /><br />Back in the 1980s, however, I did not anticipate that hospices might become parts of for-profit corporations, and that such corporations might be able to make more money by admitting more patients, even patients who really were not at the end of life.   Starting in 2011, however, we started to find cases in which that appeared to be what was going on (look <a href="http://hcrenewal.blogspot.com/2011/07/prepare-them-to-die-for-profit-hospices.html">here</a>, then <a href="http://hcrenewal.blogspot.com/2012/03/gentivas-odyssey-healthcare-settles.html">here</a>, <a href="http://hcrenewal.blogspot.com/2012/05/who-cares-if-patients-die-apparently.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2012/09/more-hospices-pretending-patients-are.html">here</a>).<br /><br />In 2013, more cases appeared, listed in chronologic order -<br /><br /><u>Hospice of Arizona LC and American Hospice Management LLC</u> - Per a <a href="http://www.justice.gov/opa/pr/2013/March/13-civ-326.html">news release</a> from the Department of Justice, these entities settled litigation that alleged, among other things, that they "submitted or caused the submission of false Medicare claims between Sept. 1, 2002, and Dec. 31, 2010, for Hospice of Arizona patients who did not need end of life care...."<br /><br /> <u>Hospice Care of Kansas, and parent company Voyager HospiceCare</u> - Per a Topeka (Kansas) Capital-Journal <a href="http://cjonline.com/news/state/2012-06-21/kansas-hospice-firm-pays-61-m-settlement">article</a>, these entities settled to resolve allegations that they "submitted inappropriate claims between January 2004 and December 2008 for patients without a terminal prognosis of six months or less."<br /><br /><u>Hernando-Pasco Hospice</u> - <a href="http://www.tampabay.com/news/health/hernando-pasco-hospice-agrees-to-pay-1-million-to-settle-false-billing/2132592">Per the Tampa Bay Times</a>, " Hernando-Pasco Hospice has agreed to pay $1 million to settle allegations that it billed the Medicare and Medicaid programs for patients who did not need end-of-life care, the U.S. Attorney's Office for the Middle District of Florida announced Monday.  The not-for-profit Hernando-Pasco Hospice, which goes by HPH Hospice, is accused of admitting ineligible patients in order to meet targets imposed by its management team, federal authorities said in a statement."<br /><br />These were all small settlements, that is, less than $15 million, reported in relatively small media outlets. <br /><br />This week the issue was in the media spotlight courtesy the Washington Post, in <a href="http://www.washingtonpost.com/business/economy/medicare-rules-create-a-booming-business-in-hospice-care-for-people-who-arent-dying/2013/12/26/4ff75bbe-68c9-11e3-ae56-22de072140a2_story.html">an article</a> which provided yet more data and vivid examples suggesting that for-profit hospices were putting money ahead of vulnerable patients' well-being.    <br /><br /><br />The Post added to the background we provided above,<br /><br /><br /><blockquote class="tr_bq">Medicare began paying for hospice care in 1983, following a resurgence of interest in end-of-life care, sparked in part by the publication of '<a data-xslt="_http" href="http://www.amazon.com/gp/product/0684839385?ie=UTF8&camp=1789&creativeASIN=0684839385&linkCode=xm2&tag=thewaspos09-20">On Death and Dying</a>' by Elisabeth Kubler-Ross.<br /><br />'We can give families more help with home care and visiting nurses, giving the families and the patients the spiritual, emotional, and financial help in order to facilitate the final care at home,' Kubler-Ross testified to the Senate Special Committee on Aging in 1972.</blockquote><br />After this well-intentioned beginning, there was a rapid increase in the use of hospice, and hence its costs,<br /><br /><br /><blockquote class="tr_bq">The benefit was quickly embraced by Americans and continues to grow, with Medicare paying for hospice care for more than 1.2 million people annually. <i>In 2000, Medicare spent $2.9 billion on the hospice benefit. By 2012, that figure has risen fivefold, to $15.1 billion.</i><br /><br />But as more Americans have taken up hospice care, <i>a profound change has been underway: <b>Big businesses have moved in.</b></i></blockquote><br />In parallel, the nature of hospices changed, going from being predominantly local non-profit organizations to predominantly corporate,<br /><br /><br /><blockquote class="tr_bq">When Medicare paid its first hospice benefit, the vast majority of hospice-care providers were nonprofit groups. Over the past decade, however, the for-profits have come to dominate the industry.<br /><br /><i>In 2000, 70 percent of hospices were run by nonprofit organizations or government agencies. Today, nearly 60 percent are for-profit companies</i>, and they may account for an even larger share of patients.</blockquote><br /><br />They really were for-profit,<br /><br /><br /><blockquote class="tr_bq">The profit margins as measured by MedPAC, the Medicare watchdog, <i>climbed to 8.7 percent in 2011.</i><br /><br /><i>The per-patient operating profit has risen from $353 in 2002 to $1,975 in 2012</i>, according to the analysis of California data.</blockquote><br />Big money lured aggressive players, in particular, private equity,<br /><br /><blockquote class="tr_bq"> The returns have attracted some prominent financial firms, whose analysts have run the numbers and decided to invest. Among the private investment companies that have put down bets on hospices in recent years are <i>Kohlberg Kravis Roberts & Co., KRG Capital Partners and Summit Partners.</i></blockquote><br />As we have discussed <a href="http://hcrenewal.blogspot.com/2012/07/private-equity-vs-patient-care-bainful.html">elsewhere</a>, the private equity model involves not long term management, but trying to make big money in the short term, either by directly extracting it from the companies taken over, of by rapidly selling them, if necessary, piece by piece.  <br /><br /><br /><b>Financial Incentives to Enroll the Wrong Patients</b><br /><br />Keep in mind that the revenue fueling the uber capitalists involved in for-profit hospices came predominantly from the US government, and depended on the rules set by the government to pay for hospice,<br /><br /><blockquote class="tr_bq">The vast majority of those profits flow from the U.S. government and Medicare, which makes an estimated 85 to 90 percent of all payments to hospices.</blockquote><br />The payments provide more profit from patients with the longest stay in hospice,<br /><br /><br /><blockquote class="tr_bq">The reason that longer stays are more profitable is that hospice companies typically spend more on patients at the beginning of their care and then again at the end of their lives.<br /><br />When a patient is first enrolled, the hospice often must diagnose the patient’s illness, set up home equipment and get them stabilized. Then, during the last week of life, a hospice typically must pay for more frequent home visits by the nurse, aides and others.<br /><br />As a result, patients who live a longer time — and for whom there is a long, stable period in the middle — generate more profits.</blockquote><br />There is evidence that for-profit hospice management has reacted to these incentives to enroll patients who would live a long time, despite the fact noted above that hospice was intended for patients who were at the end of life, and were obviously thus expected not to live for a long time,<br /><br /><br /><blockquote class="tr_bq">Indeed, it has been an open secret in the industry that, <i>because of the method of payment, the way to run a hospice profitably is to enroll patients who stay for a long time.</i><br /><br />The <a data-xslt="_http" href="http://www.wikinvest.com/stock/VistaCare_%28VSTA%29/Filing/10-K/2007/F3366157">annual report in 2004 for one large hospice provider, VistaCare</a>, noted that its fortunes depended on its ability to manage costs and '<i>maintain a patient base with a sufficiently long length of stay</i>.'<br /><br />The company also warned that 'cost pressures resulting from shorter patient lengths of stay . . . could negatively impact our profitability.'<br /><br />'It is common knowledge in the industry that <i>a longer length of stay is going to be more lucrative</i>,' said Rachel Mason, who worked in marketing at Delta Hospice in California, where one of the company’s branches had one of the highest discharge rates of living patients in the state last year — 63 percent. 'If they come in very sick and die right away, it’s difficult to run a business that way.'</blockquote><br />So, in the aggregate, stays have gone up, costs have increased, partially because there are more hospice ''urvivors," that is, patients who actually were admitted to hospice not at the end of life, survived much more than the six months which was supposed to have been their expected lifespan, and thus ended up graduating from hospice, a service meant originally for the terminally ill,<br /><br /><blockquote class="tr_bq">over the past decade, the number of 'hospice survivors' in the United States has risen dramatically, in part because hospice companies earn more by recruiting patients who aren’t actually dying, a Washington Post investigation has found. Healthier patients are more profitable because they require fewer visits and stay enrolled longer.<br /><br />The proportion of patients who were discharged alive from hospice care rose about 50 percent between 2002 and 2012, according to a Post analysis of more than 1 million hospice patients’ records over 11 years in California, a state that makes public detailed descriptions and that, by virtue of its size, offers a portrait of the industry.<br /><br />The average length of a stay in hospice care also jumped substantially over that time, in California and nationally, according to the analysis. Profit per patient quintupled, to $1,975, California records show.</blockquote><br />Yet, while Medicare administrators have been warned about these perverse incentives, they have done nothing to fix them,<br /><br /><blockquote class="tr_bq">For five years, Medicare’s watchdog group has been recommending that the payments to hospice companies be revised to eliminate the financial incentive for improper care, but Medicare has not yet done so. To ensure that patients are appropriately selected for hospice care, Medicare relies on strict medical documentation requirements, a spokesman said. </blockquote><br />Perhaps Medicare administrators are listening harder to for-profit hospice executives than to their own advisory committee,<br /><br /><blockquote class="tr_bq"> The hospice industry is opposed to fundamental changes to the payment system. Jonathan Keyserling, senior vice president of health policy at the <a data-xslt="_http" href="http://www.nhpco.org/">National Hospice and Palliative Care Organization</a>, an industry group, said that the current payment system is sound and that tampering with it could have unintended consequences. </blockquote><br />Furthermore,<br /><br /><blockquote class="tr_bq">because of the large sums of money at stake, <a data-xslt="_http" href="http://www.medpac.gov/documents/Jun13_EntireReport.pdf" target="_blank">MedPAC in June added a sense of urgency</a> to its recommendation.<br /><br />'Given the magnitude of hospice spending devoted to long-stay patients, who are more profitable under the current payment system than other patients, it is important that an initial step toward payment reform be taken as soon as possible,' MedPAC wrote.</blockquote><br />Yet Medicare administrators still seemed to feel no sense of urgency, and are not eager to address the specifics of the MedPac recommendations, <br /><br /><blockquote class="tr_bq">A spokesman for Medicare said the agency is considering hospice payment reform but that no such changes will happen in fiscal 2014.<br /><br />'While the Medicare hospice benefit provides a choice for beneficiaries to seek the care that best meets their care needs and desires, Medicare has and will continue to take actions to safeguard this benefit from inappropriate use,' said <a data-xslt="_http" href="http://www.cms.gov/About-CMS/Leadership/jonathanblum2.html">Jonathan Blum</a>, principal deputy administrator of the Centers for Medicare and Medicaid Services, said in a statement. </blockquote><br />So to recap so far, the hospice movement devolved from one involving non-profit organizations providing care to the terminally ill to ever larger corporations providing care to the less ill, paid largely by the US government under rules from a simpler era.  However, since hospice provides only palliative care, this transition meant that some patients who were not terminally ill may have died from illness that would have been treated in an environment other than hospice.<br /><br /><b>Vivid Anecdotes of the Deceptive Marketing of Hospice</b><br /><br />The Washington Post article summarized allegations from multiple legal actions that provided a disturbing tapestry of deceptive marketing deployed to recruit patients unsuitable to hospice care,<br /><br /><blockquote class="tr_bq">While the lawsuits against the for-profit hospices vary in the details, as a whole they depict an industry in which companies compete for new patients and provide services to patients who are not eligible for them.<br /><br />Hospice 'outreach specialists' and 'community education representatives' seek out patients in a variety of ways: They solicit doctors and hospitals who might regularly deal with the terminally ill; they make connections at nursing homes, assisted-living developments and Meals on Wheels groups. They show up at the 'health fairs' held at senior centers with, for example, machines that test blood pressure. For families struggling to take care of a loved one, they offer the promise of extra help.<br /><br />At AseraCare, officials gave advice to their recruiters on how to close a deal with families who are 'not ready yet' for hospice, according to a company presentation for Alabama employees. It instructed recruiters to 'focus families' by <i>stressing the urgency of a decision, and saying things like, 'We only have 10 minutes left.'</i><br /><br />'<i>Effective communication is the transfer of emotion, not information</i>,' the presentation said.<br /><br />At Odyssey Healthcare, one of the nation’s largest hospice companies, <i>representatives earned bonuses if they met their goals for new patients,</i> according to that complaint. The case led to a $25 million settlement with the company. <br /><br />At <a data-xslt="_http" href="http://www.vitas.com/Aboutus/Newsroom/ParentCompany.aspx">Vitas</a>, a division of Chemed, a company that also owns the Roto-Rooter plumbing service, the <i>corporate culture encouraged staff members to admit as many patients as possible, regardless of whether they were eligible for hospice care</i>, according to the lawsuit. The lawsuit said the <i>company paid bonuses based on the number of patients enrolled.</i> One former manager said that <i>the company philosophy was 'sign everybody up' and that medical staffers felt pressured to admit patients regardless of whether they were appropriate.</i><br /><br />And at Angels of Hope hospice in LaGrange, Ga., audio recordings cited in the complaint described how <i>some salespeople found patients: by cruising neighborhoods, looking for elderly people with disabilities.</i></blockquote><br />The article coned down on specific litigation about AnseraCare,<br /><br /><br /><blockquote class="tr_bq">One of the primary lawsuits against AseraCare was initiated by Dawn Richardson, a clinical manager at the company, and Marsha Brown, the former executive director at the company’s Monroeville, Mobile and Foley, Ala., outlets.<br /><br />There was <i>steady pressure for AseraCare managers to find more patients</i>, the lawsuit said. <br /><br /><i>An executive who did not meet a quota was penalized</i>, according to the lawsuit, and the company offered a massage chair for the person who brought in the most hospice patients.<br /><br />'<i>In order to make our admission goal for the month, we are down to the wire, and need today to be a huge admit day for every region,</i>' a regional vice president wrote in an e-mail, according to the lawsuit. <i>'Mobilize your teams, get them into the game this morning . . . when we call on them, they always respond with referrals and a push to convert those referrals into admits ASAP</i>.'<br /><br />'We had a director who would be like, ‘<i>Get a patient, get a patient, get a patient,</i>’ ' Michael Bonham, a Lutheran minister who worked as a chaplain at the company in Alabama, said in an interview. He is not a party to any of the lawsuits.<br /><br />These demands for patients were sometimes met with people who were sickly but not dying, according to the federal lawsuit, which outlines five examples.<br /><br /><i>One patient was supposed to have had end-stage heart disease</i> and thus would have had trouble breathing and walking, according to the lawsuit. <br /><br /><i>He left the nursing home for his granddaughter’s graduation and for Christmas, had a good time and ate a lot,</i> according to notes from hospice workers cited in the lawsuit.<br /><br />Another, <i>diagnosed with end-stage 'debility,</i>' was not losing weight as is typically the case, according to the legal filing, and instead <i>went out for a trip to Wendy’s and another to go birdwatching</i>.</blockquote><br />Hospice firms' public relations departments provided the usual high minded statements that did not address specific allegations about the marketing of hospice, for example, <br /><br /><blockquote class="tr_bq">'AseraCare provides an important and valuable service to patients and their families facing difficult end-of-life decisions,' the company said in a statement. 'Our policies and programs comply with the Congressional intent of the hospice benefit to reduce the stress and anxiety of the end of life of a loved one,' the company said.<br /><br />'Doctors for each patient in question determined that the patient needed hospice care, and expressed their clinical judgment by signing the required physician certifications. Other independent and well-qualified physicians reviewed the charts of these ­patients, and overwhelmingly agreed with the original conclusions that these patients were entitled to receive the hospice benefit.'<br /><br />The company declined to identify the doctors who certified the patients in Alabama.</blockquote>That seems about as relevant as the <a href="http://www.goldenliving.com/about-us.aspx">mission and values statements of Golden Living,</a> AseraCare's parent corporation,<br /><br /><blockquote class="tr_bq"><h3><span style="font-size: small;">Our Mission</span></h3>To share our passion for improving quality of life through innovative healthcare — one <b>person</b>, one <b>family</b> and one <b>community</b> at a time.<br /><br /><h3><span style="font-size: small;">Our Values</span></h3>Make <b>integrity</b> and <b>accountability</b> your pledge.<br />Share our passion for <b>excellence</b>.<br />Be uncompromising in delivering <b>quality</b> care.</blockquote><br /><br /><b>Summary</b><br /><br /><blockquote class="tr_bq">Yet somehow our society must make it right and possible for old people not to fear the young or be deserted by them, for the test of a civilization is in the way that it cares for its helpless members. </blockquote><br />Pearl S Buck, <i>My Several Worlds</i>, 1954, p 377 (see <a href="http://en.wikiquote.org/wiki/Civilization">Wikiquote</a>) <br /><br />I also was once taught that the true test of a doctor is his or her care of the sickest and most vulnerable patients.  By this token,  how the hospice movement in the US evolved into corporate health care delivery which generates tremendous revenues from the most vulnerable patients, and in some cases may condemn ill but not terminal patients to death from treatable disease marks how badly US health care has failed.<br /><br />The story combines many of the themes we have sounded before -<br /><br /><a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives"><u>Perverse Incentives</u></a> - a reimbursement scheme that made sense when hospices were local community non-profit organizations now provides incentives for commercial hospices to enroll patients who are not terminally ill, putting them at risk of inadequate care should they develop a new serious but treatable problem.<br /><br /><u>Money Before Mission</u> - For-profit hospices which market themselves as equivalent to their community non-profit forerunners, are run, as is suggested above, to maximize revenue no matter the effect on mission. Presumably this is justified by the fallacy of <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">maximizing shareholder value</a>, which really means maximizing apparent short-term revenue in order to maximize executive compensation, no matter what the collateral damage. <br /><br /><a href="http://hcrenewal.blogspot.com/search/label/impunity"><u>Impunity</u></a> - Although hospice enrollment of unsuitable patients not only may defraud the government, but may put such patients at risk of their lives, the only regulatory or law enforcement actions against big corporate hospices so far involve corporate fines that are small in comparison with revenues, but not penalties imposed on any individuals who authorized, directed or implemented such patient enrollment, even when patients wrongly enrolled have died from lack of treatment of potentially treatable problems.<br /><br /><a href="http://hcrenewal.blogspot.com/search/label/corporatism">Corporatism</a> - Government agencies which could seriously challenge corporate hospices' actions have been curiously inert, perhaps because agency leaders feel more sympathetic to their fellow managers within corporate hospices than to the citizens whose interests they are supposed to protect.<br /><br />Because of their potentially severe adverse effects on our most vulnerable patients, reform of hospices should be at the forefront of true health care reform.  At the least, we need vastly tougher regulation of corporate hospices, removal of perverse incentives for them from the government payment system, and vigorous law enforcement when their leaders induce them to misbehave.  Leaders of corporate hospices need to be held accountable for their actions, and must be pushed towards putting their patients' health ahead of all other considerations, including the leaders' personal enrichment.<br /><br />Furthermore, the story of corporate hospices shows that while turning direct health care over to poorly regulated for-profit corporations may have been increased efficiency, been "disruptive" and lead to innovations, the efficiency, disruption and innovation have mainly lined the pockets of corporate insiders, and not improved patients' or the public's health.  We ought to give strong consideration to banning corporate hospices, and banning all forms of the <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate practice of medicine </a>and corporate health care "delivery." <br /><br />Given how many insiders make so much money from the current version of laissez faire capitalism in health care, however, I would expect strong resistance should such apparently "radical," but actually conservative proposals actually get any mainstream attention.     <br /><br /><br /><br />

"Emotion, not Information" - the Lucrative Deceptive Marketing of Hospice, and its Potentially Fatal Consequences

One of the real recent advances in health care, in my humble opinion, was the organization of compassionate, palliative care for people at the end of life.  During my training and early career I saw t…

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A New, and Huge ($2.2 Billion) Settlement for Johnson and Johnson, but "No Individuals were Charged with Wrongdoing"

The march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements </a>made by big health care organizations has resumed with a bang.  As reported in most major media outlets, giant drug/ device/ biotechnology company Johnson and Johnson has made a big settlement with the US Department of Justice.<br /><br /><b>The Basics of the Settlement</b><br /><br />As <a href="http://www.businessweek.com/news/2013-11-04/j-and-j-settlement-over-risperdal-said-to-be-announced-later-today">reported</a> by Bloomberg / Businessweek, <br /><br /><blockquote class="tr_bq"><div class=""><i>Johnson & Johnson agreed to resolve criminal and civil probes into the marketing of Risperdal, an antipsychotic drug, and other medicines by paying more than <b>$2.2 billion</b></i>, one of the largest U.S. health-fraud penalties. </div><div class=""><br /></div><i>J&J’s Janssen unit will plead guilty to a misdemeanor criminal charge over misbranding Risperdal for uses not approved by the Food and Drug Administration, including treating elderly patients with dementia.</i> Under a plea agreement announced today, Janssen will pay a $334 million fine and forfeit $66 million.<br /><br />Janssen also settled civil claims that it marketed Risperdal without approval for the elderly, children and the mentally disabled, and that it paid kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes. The civil accord covered off-label marketing of Risperdal; Invega, another antipsychotic; and Natrecor, a heart drug.</blockquote><br />This settlement covered conduct that health care professionals ought to find particularly disturbing, including marketing Risperdal for elderly people with dementia without an approved indication, despite evidence that it could be particularly harmful to those patients; marketing Risperdal to adolescent boys without an indication, again despite evidence that it could be particularly harmful to those patients; and using kickbacks to market Risperdal. <br /><br /><b>Promoting Risperdal for Dementia Despite Increased Risk of Death</b><br /><br />This issue was best <a href="http://online.wsj.com/news/articles/SB10001424052702303936904579177630737380104">summarized</a> by the Wall Street Journal,<br /><br /><br /><blockquote class="tr_bq">Prosecutors alleged that J&J's Janssen Pharmaceuticals unit <i>promoted Risperdal to elderly patients suffering from dementia, despite no approval for that use. </i>Prosecutors also alleged that J&J's 'ElderCare' sales force <i>pushed Risperdal for use in these elderly patients, and sales representatives' bonus awards failed to distinguish prescriptions for schizophrenia or the unapproved dementia use</i>. <br /><br />In 2005, the FDA required the label warn that elderly patients suffering from dementia-related psychosis were at <i>a higher risk of death.</i></blockquote><br />The New York Times <a href="http://www.nytimes.com/2013/11/05/business/johnson-johnson-to-settle-risperdal-improper-marketing-case.html">added</a>,<br /><br /><blockquote class="tr_bq"><div itemprop="articleBody"> Johnson & Johnson officials <i>tried to expand the market for Risperdal to older dementia patients</i> soon after the drug was approved in 1993 to treat symptoms of psychiatric disorders, <a href="http://www.justice.gov/opa/documents/jj/janssen-info.pdf" title="The Justice Department filing (PDF). ">according to federal court filings</a>. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The drug, whose generic name is risperidone, was primarily tested in schizophrenia patients, and the <i>Federal Drug Administration repeatedly rejected efforts by the company to expand the drug’s use to older dementia patients, </i>according to the filings. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">But Johnson & Johnson, federal officials said, actively pursued the market for geriatric patients. <i>The company created a dedicated sales force, ElderCare, to promote the drug and others to doctors who primarily treated older patients. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>The drug, the company claimed, could address symptoms that made treating these patients a challenge, especially in a nursing home setting</i>, including agitation, confusion, hostility and impulsiveness. The company’s sales brochures highlighted these symptoms and <i>minimized the fact that the drug was approved to treat schizophrenia, </i>according to federal documents.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"> Federal officials said <i>the company knew that Risperdal posed serious health risks for older adults, like an increased risk of strokes, but it played them down.</i> The drug’s label was later updated to warn against the use of the drug in older patients with dementia.</div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the allegations were that the company pursued an elaborate and deceptive strategy to promote the drug for elderly dementia patients despite knowledge that the drug was particularly risky for such patients. </div><br /><b>Promoting Risperdal for Adolescent Boys Despite Increased Risk of Gynecomastia</b><br /><br />Again, per the WSJ,<br /><br /><blockquote class="tr_bq">Prosecutors also alleged that J&J <i>promoted Risperdal for use by boys suffering from mental disabilities despite knowing that use could raise levels of a hormone stimulating breast development.</i></blockquote><br />The NYT added,<br /><br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">Federal prosecutors also say, as part of the civil settlement, that <i>Johnson & Johnson promoted the use of Risperdal in people with mental disabilities and children, even though the company did not receive F.D.A. approval to market to children until 2006.</i> Janssen told its sales representatives to visit child psychologists and mental health facilities that mainly focused on children, promoting the drug as a safe treatment for disorders like attention deficit hyperactivity disorder and obsessive-compulsive disorder, the government said. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>Johnson & Johnson knew that children were susceptible to certain health risks from taking Risperdal, including the possibility that boys could develop breasts</i> through elevated production of the hormone prolactin, federal officials said. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Again, the allegations were that the company pursued an elaborate deceptive strategy to market the drug for children despite knowledge that the drug was particularly risky for such patients.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>No Executives were Discomfited by the Disposition of This Case</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The company took pains to emphasize that the settlement only required a single guilty plea to a misdemeanor by a company subsidiary, and did not involve any other admissions of guilt, or any penalties to specific human beings.  For example, per Bloomberg/ Business Week,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq">'Today we reached closure on complex legal matters spanning almost a decade,' Michael Ullmann, J&J’s general counsel, said in a statement. 'This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world.'<br /><br />While Janssen 'accepts accountability' for the actions described in the misdemeanor plea, <i>the civil settlement 'is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations,' J&J said.</i></blockquote><br />So why give up a perfectly good $2.2 billion (minus $400 million fine and forfeiture by the Janssen subsidiary for the single misdemeanor)?  Was "closure" all that valuable?<br /><br />In addition, in the NY Times we found ,<br /><br /><br /><blockquote class="tr_bq">Ernie Knewitz, a spokesman for Johnson & Johnson, noted that the misdemeanor charge was being entered on behalf of the company and <i>no individuals were charged with wrongdoing</i>. '<i>Mr. Gorsky [current CEO] has been an outstanding Johnson & Johnson leader for more than 20 years</i>,' he said. </blockquote>Would you expect someone who works for Mr Gorsky to say otherwise?  Yet it was on Mr Gorsky's watch that much of the alleged bad conduct actually happened.  <br /><br /><blockquote class="tr_bq">Alex Gorsky was promoted to chief executive officer of J&J in April 2012, in part <i>because of his record of generating sales as leader of Janssen Pharmaceuticals. </i></blockquote><br />Furthermore, the Inquirer noted that Mr Gorsky was deposed in one of the many civil lawsuits filed by patients against Johnson and Johnson. <br /><br /><blockquote class="tr_bq"><i>The 60-page transcript of Gorsky's deposition</i> in one of the Philadelphia suits was part of the publicly available court record. In the transcript, McCormick walks Gorsky through discussions from 2001 with Joseph Biederman, a Harvard medical school professor and a Massachusetts General Hospital pediatric psychiatrist who gained fame - and criticism - for advocating the use of pharmaceuticals to treat children with perceived mental illness. That was before the U.S. Food and Drug Administration approved, in still-limited ways, drugs such as Risperdal for children. <br /><br />In a one-page letter dated Dec. 7, 2001, Biederman requested $500,000 to start what became the Johnson & Johnson Center for the Study of Pediatric Psychopathology. Gorsky said in the deposition that he approved that payment. <br /><br /><i>Gorsky was asked whether he had been hoping Biederman and, by extension, Massachusetts General Hospital and Harvard, would help J&J to get wider diagnosis and treatment for child and adolescent mental disorders. </i><br /><i><br /></i><i>'I think our goal was to, yes, have better diagnostic criteria for children who are in need of treatment and to have better therapeutic options for children who are in need of treatment,' Gorsky said. </i><br /><br />Also in the transcript, McCormick discussed with Gorsky a document called the 'Annual Report 2002: The Johnson & Johnson Center for Pediatric Psychopathology at Massachusetts General Hospital.' Biederman was the director of the center, and <i>one of the goals of its research, according to the report, was that 'it will move forward the commercial goals of J&J.'</i></blockquote><br />Thus this testimony seems to imply that current Johnson and Johnson CEO Gorsky was involved in making large payments to an important key opinion leader (KOL) who was supposed to use his academic gravitas to "move forward the commercial goals" of Johnson and Johnson, specifically by promoting Risperdal for children.<br /><br />Yet, as we discussed above, neither Mr Gorsky nor any other person at Johnson and Johnson who might have authorized, directed, or implemented the alleged conduct which was the subject of the settlement, conduct which Johnson and Johnson of course denies was misconduct, suffered any negative consequences. <br /><br />Mr Gorsky's total compensation as CEO in 2012 was <b><i>$10,977,109</i></b> according too the <a href="http://www.investor.jnj.com/secfiling.cfm?filingID=1193125-13-104341">company's 2013 proxy statement</a>. The retiring CEO, William Weldon, on whose overall watch the alleged events occurred, received <b><i>$29,838,259</i></b> that year.  We last discussed their compensation and its contrast with the company's ethical track record <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">here</a>.<br /><br />These payments also occurred despite all the other settlements Johnson and Johnson has had to make because of allegations about its marketing of Risperdal.  As described by Bloomberg/ Businessweek,<br /><br /><blockquote class="tr_bq">The settlement won’t resolve suits brought by attorneys general in Arkansas, Louisiana and South Carolina, where the company has appealed or has said it will appeal judgments over Risperdal sales. <br /><br />Judges or juries in those states have ordered J&J to pay a total of about $1.8 billion in damages and fines over Risperdal marketing campaigns that were found to have misled doctors and patients about the drug’s health risks and effectiveness. <br /><br />In 2012, a judge in Arkansas ordered the drugmaker to pay $1.2 billion in fines over Risperdal marketing. That verdict came three months after J&J decided to end a trial in Texas over the drug’s sales with a $158 million settlement. The Arkansas judge also awarded the state $180 million in attorney fees, J&J said in an August regulatory filing. The company is appealing the judgment. <br /><br />In June 2011, a judge in South Carolina ordered J&J to pay $327 million in penalties for deceptively marketing the medicine. Ten months earlier, jurors in Louisiana ordered the drugmaker to pay almost $258 million to state officials over J&J’s Risperdal marketing campaign in the state. A Louisiana judge later ordered the drugmaker to pay an additional $73.3 million in attorney fees and costs. </blockquote><br />The payments further occurred despite a previous settlement involving another drug whose marketing was at issue in the current settlement, according to Bloomberg / Businessweek, <br /><br /><blockquote class="tr_bq">In October 2011, J&J’s Scios unit pleaded guilty to a misdemeanor violation over Natrecor and paid an $85 million criminal fine. </blockquote><br />Finally, the compensation was given despite other legal actions not having to do with Risperdal, Invega or Natrecor, as we most recently summarized,<br />- A guilty plea for misbranding Topamax in 2010 (look <a href="http://hcrenewal.blogspot.com/2010/05/sunday-settlement-and-guilty-plea.html">here</a>)<br />- Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary (look <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here</a>)<br /> - Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post <a href="http://hcrenewal.blogspot.com/2011/09/smart-alecs-strange-bedfellows.html">here</a>)<br /><br /><b>Summary</b><br /><br />The latest settlement in the parade is another marker of the sort of conduct that big health care organizations have exhibited to increase revenue, and to use that revenue as a rationale for making their top insiders very rich.  The particular conduct alleged here could have put patients at risk, partly by deceiving health care professionals.  Yet in their wisdom, top US law enforcement saw fit not to try to hold any individuals accountable for this conduct, and allowed the company to deny any misconduct other than a single misdemeanor by a subsidiary.  This occurred despite the company's history of multiple legal settlements and findings of guilt in various courtrooms.<br /><br />Yet none of these actions has resulted in any negative consequences for any individual within the company.  No one who authorized, directed, or implemented bad behavior will pay any penalty, even were the bad behavior to have lead to significant personal enrichment.<br /><br />As we have said ad infinitum, and <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">on the occasion of a previous Johnson and Johnson settlement</a>, many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. <br /><br />These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care.<br /><br />As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.<br /><br /><b>Addendum - Other Comments </b><br /><br />See also similar sentiments <a href="http://1boringoldman.com/index.php/2013/11/04/an-ending/">from 1BoringOldMan</a>,<br /><br /><blockquote class="tr_bq"> J&J closes out the escrow fund set aside for this settlement. Alex Gorsky goes to his West Point Anniversaries and Boy Scout Board meetings an ongoing success story [<a href="http://1boringoldman.com/index.php/2012/09/18/shoveling/" target="_blank">shoveling…</a>]. And what was this all about? </blockquote><div><blockquote><div align="right"><i>This is the way the world ends</i></div><div align="right"><i> This is the way the world ends</i></div><div align="right"><i> This is the way the world ends</i></div><div align="right"><i> Not with a bang but a whimper</i></div></blockquote></div><br />and in a <a href="http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=4012">press release from Public Citizen</a>,<br /><br /><blockquote class="tr_bq">Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become common, companies will continue defrauding the government and putting patients’ lives in danger.</blockquote>

A New, and Huge ($2.2 Billion) Settlement for Johnson and Johnson, but "No Individuals were Charged with Wrongdoing"

The march of legal settlements made by big health care organizations has resumed with a bang.  As reported in most major media outlets, giant drug/ device/ biotechnology company Johnson and Johnson ha…

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Use of Psychological Manipulation of Physicians to Sell Pharmaceuticals: The Drug Representative as "Den Mother"

We have discussed, most recently <a href="http://hcrenewal.blogspot.com/2013/09/vested-interests-and-their-influence-on.html">here</a>, how marketers of health care goods and services use <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a> and psychological manipulation to sell their goods.  Physicians, of course, are particular targets of marketers of drugs and devices. <br /><br />A vivid anecdote showing how this works just <a href="http://well.blogs.nytimes.com/2013/10/03/for-med-students-love-from-the-drug-rep/">appeared</a> on a New York Times blog.  It may be easier to recall that psychological theories:<br /><br /><blockquote class="tr_bq">In the social and culinary wasteland that was residency training, it had been easy for Cheryl, a bubbly brunette in her mid-30s, to <i>become our den mother</i>. She <i>never tired of listening to our grousing,</i> had unerring taste in take-out, made it a point to come to our parties when invited and every so often <i>brought in a plate of her homemade brownies</i>.<br /><br /> But Cheryl was no den mother. She was a pharmaceutical rep.<br /><br /> That she managed to <i>slip a plug for her wares into every conversation</i> or <i>tuck copies of studies promoting her product into our white coat pockets </i>as we polished off her brownies <em>was</em> awkward. But we always overlooked the salesmanship because it was such a familiar part of our residency routine. As trainees in a large teaching hospital, we knew numerous sales reps by name and the products they peddled; and it was odd, even disappointing, to go to an educational conference where one of them was <em>not</em> standing next to a table laden with tchotchkes, information brochures and free take-out.<br /><br /> But in retrospect, such docile acceptance was problematic. In an environment where no one, including senior doctors, ever questioned the presence of sales reps, <i>we didn’t think too hard about why they might have been as friendly and helpful as they were.</i> We didn’t ask where the money for all these giveaways was coming from and we were rarely curious about who these reps actually were (I only ever knew their first names).<br /><br />It wasn’t that I or the other residents preferentially prescribed their products. But I do know that more than once <i>when faced with a decision about what to prescribe, the first thought that came to mind was <b>not what I needed to do to find the latest evidence-based recommendation, but what Cheryl had just told us over lunch. </b></i><br /><br /> All of this became painfully clear after Cheryl suddenly disappeared. At first, the other trainees and I thought she had been fired, so we avoided bringing her absence up with the rep who replaced her. But when I ran into someone from her company at a national medical conference a year later, I learned otherwise.<br /><br /> 'Oh, she got promoted,' the rep said, smiling broadly. 'Now <i>she’s an executive in the central office</i>.' </blockquote><br />Since Ahari and Fugh-Berman wrote and testified about the cynical tactics used in the marketing of drugs and other medical products years ago (look <a href="http://hcrenewal.blogspot.com/2007/05/fool-me-once-shame-on-you-fool-me-twice.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/what-drug-reps-really-care-about.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2008/04/more-about-cynical-world-of-drug-reps.html">here</a>), it is now inexcusably naive for doctors to believe that drug (or device) representatives are their friends, no matter how friendly they appear.  Drug and device reps are trained to appear to be likable.  They may look like sympathetic friends, glamorous companions, or in this case, den mothers.  But as Sah and Fugh-Berman noted (look <a href="http://hcrenewal.blogspot.com/2013/09/vested-interests-and-their-influence-on.html">here</a>), likability is a ruse to sell products.  Brownies are supplied to give the appearance of warmth and comfort, and to generate feelings of reciprocity. <br /><br />How well it works appears above: "the first thought that came to mind was not what I needed to do to find the latest evidence-based recommendation, but what Cheryl had told us over lunch."  That it works well is demonstrated by Cheryl's promotion to an executive office.<br /><br />As long as physicians remain trusting, naive, or foolish in their approach to deceptive marketing, there will be more use of needlessly expensive, and sometimes needlessly toxic drugs, and more drug reps made into well-paid executives. 

Use of Psychological Manipulation of Physicians to Sell Pharmaceuticals: The Drug Representative as "Den Mother"

We have discussed, most recently here, how marketers of health care goods and services use deception and psychological manipulation to sell their goods.  Physicians, of course, are particular targets …

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Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As "Advised" At The University Of Arizona Health Network

When clinicians are told to promote a technology in no uncertain terms, that puts a chilling effect on critical thinking and discourse.  In effect, when under orders to only speak positively about a hospital or its technology, saying anything bad could very likely get clinicians labeled as 'troublemakers' or 'disruptive clinicians.'  Sometimes - in a sadly real example at Affinity Health - it may even get threats of having complaints plastered to one's forehead (see <a href="http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html">http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html</a>), a threat answered to by a judge.<br /><br />The 'disruptive' label usually does not have a good effect on one's evaluations and job (or, for doctors, even career) longevity.  See, for example, the resources at <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/</a> on <b>sham peer review.</b><br /><br />At <a href="http://www.uahealth.com/">University of Arizona Health Network (UAHN)</a>, clinicians are being told to promote the EPIC EHR.<br /><br />The campaign is under the aegis of executives who know, should know, or should have made it their business to know the mayhem caused at other medical centers by EPIC and other major clinical IT systems (see for example query links <a href="http://hcrenewal.blogspot.com/search/label/EPIC">http://hcrenewal.blogspot.com/search/label/EPIC</a> and <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20difficulties">http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20difficulties</a>).<br /><br />Here's what clinicians are bring told in the Oct. 3, 2013 "Weekly update for UAHN employees":<br /><blockquote class="tr_bq"><br /><h1 style="color: #606060 !important; display: block; font-family: Helvetica; font-size: 40px; font-style: normal; font-weight: bold; letter-spacing: -1px; line-height: 125%; margin: 0; text-align: left;"> <span style="font-size: 18px;"><span style="color: #1c3e71; font-family: verdana, 'helvetica neue', helvetica, sans-serif; line-height: 18px;">Words that Work </span></span></h1><div style="color: #505050; line-height: 13px;"><br />Talking positively to our patients about our new Electronic Health Record system is important! Here are some key words and phrases you can use to emphasize the many benefits of the new system:</div><ul><li style="color: #505050; line-height: 13px;"> Electronic health record (not ‘Epic’ or ‘EHR’)</li><li style="color: #505050; line-height: 13px;"> One comprehensive record</li><li style="color: #505050; line-height: 13px;"> Coordinated care</li><li style="color: #505050; line-height: 13px;"> Improves patient safety & quality</li><li style="color: #505050; line-height: 13px;"> Convenient, easy patient portal </li><li style="color: #505050; line-height: 13px;"> Private and secure</li></ul><div style="color: #505050; line-height: 13px;"><a href="https://www.uahealth.com/pdf/Epic_Words_That_Work.pdf" style="color: #1c3e71; font-weight: normal; text-decoration: underline; word-wrap: break-word !important;" target="_self"><b>Click here</b></a> for more words and behaviors to inspire confidence in our patients (and ourselves) as we transition to this new system.</div></blockquote><br />The link to "more words" produced this PDF:<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj_OOVivF_6D2GEFgUm6ujfKdJjMf4UMwoxX7ZECU7351gCph46CpKY7tryUY2qq63Q7Snl9fy1SNKk9QOxUyXfhgON7lm2W2MO_Sgin5pPxl4Rf6OR78MIdzjuQrxPDCBQ4ri6BeN3YxKn/s1600/words+that+work.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj_OOVivF_6D2GEFgUm6ujfKdJjMf4UMwoxX7ZECU7351gCph46CpKY7tryUY2qq63Q7Snl9fy1SNKk9QOxUyXfhgON7lm2W2MO_Sgin5pPxl4Rf6OR78MIdzjuQrxPDCBQ4ri6BeN3YxKn/s400/words+that+work.jpg" width="311" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><b>"Words that Work"</b> - If I worked there, I would be concerned that that using "words that don't work" about a project that probably cost hundreds of millions of dollars would likely injure my career. <b> Click to enlarge.</b></td></tr></tbody></table><br />This is shameless.  Many of these claims are unsubstantiated or in significant doubt in the literature.<br /><br />First:<br /><br />They left out issues such as these:<br /><br /><blockquote class="tr_bq">• The software is tested and validated for safety by nobody, including traditional medical device safety testers.<br /><br />• No postmarket surveillance for problems, either.<br /><br />• Transparency about problems that can cause patient harm is severely impeded by systematic impediments to information flow (as per <b>IOM's 2012 study of health IT safety</b> at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>, <b>FDA via their leaked Internal Memo</b> on HIT safety as at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>, the <b>Joint Commission in their Sentinel Events Alert on Health IT </b>as at <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html</a>, and others.)<br /><br />• Problems known are only the <b>"tip of the iceberg"</b> (FDA, ECRI Institute), as at <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html</a> and <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> </blockquote><blockquote class="tr_bq"><b>(Mar. 2014 addendum:</b> add to that list the revelations of med mal insurer CRICO, that EHR technology has contributed to a substantial fraction of the medical malpractice suits in Massachusetts: <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>)</blockquote><br />Of the claims they do make:<br /><br /><blockquote class="tr_bq">• <span style="color: red;"><b><i>Efficient</i></b></span> - see aforementioned links as well as "Common Examples of Healthcare IT Difficulties" at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a><br /><br />• <span style="color: red;"><b><i>Convenient</i></b></span> - as above.  According to whom?  Compared to what?  Pen and paper?<br /><br />• <span style="color: red;"><b><i>Improves patient safety and quality</i></b></span> - see IOM report post at <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> .  We as a nation <b>are only now studying safety of this technology</b>, and the results are not looking entirely convincing, e.g.<b> ECRI Deep Dive Study</b> of health IT safety at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.  171 health IT mishaps in 36 hospitals, voluntarily reported over 9 weeks, with 8 reported injuries and 3 reported possible deaths is not what I would call something that "improves patient safety and quality" without qualifications.<br /><br />• <i><span style="color: red;"><b>The Cadillac of its kind</b></span></i> - according to whom?<br /><br />• <i><span style="color: red;"><b>Patients at hospitals using this system love it</b></span> </i>-  Do most patients even know what it, or any EHR, looks like?  Have they provided informed consent to its use?<br /><br />• <span style="color: red;"><i><b>Exciting </b></i></span>- clinician surveys such as by physicians at <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> and by nurses at <a href="http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html">http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html</a> shed doubt on that assertion.  </blockquote><blockquote class="tr_bq">(<b>Addendum:</b> also see what nurses think about these systems at "<b>Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications Only a Matter of Time in Open Letter</b>", <a href="http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html">http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html</a>)<br /><br />• <span style="color: red;"><i><b>The best thing for our patients</b></i></span> - again, according to whom?<br /><br />• <b><span style="color: red;"><i>Sophisticated new system</i></span></b> - "New"?  Not so much, just new for U. Arizona Health.  "Sophisticated", as if that's a virtue?  Too much "sophistication" is in part what causes clinician stress and burnout, raising risk; see this summary of a new, not-free JAMIA article "<b>Electronic medical records and physician stress in primary care: results from the MEMO Study</b>", J Am Med Inform Assoc amiajnl-2013-001875 at <a href="http://www.beckershospitalreview.com/healthcare-information-technology/the-relationship-between-emrs-and-physician-stress.html">http://www.beckershospitalreview.com/healthcare-information-technology/the-relationship-between-emrs-and-physician-stress.html</a>.   From that summary:<br /><br /><blockquote class="tr_bq">... Compared with physicians at clinics with low-function EMRs,<b> physicians at clinics with moderate-function EMRs experienced significantly more stress and had a higher rate of burnout. </b>Additionally, physicians at clinics with moderate- or high-function EMRs felt less satisfied with their current position overall. </blockquote>and:<br /><blockquote class="tr_bq">... Results also showed a significant relationship between time pressure and physician stress in the cohort with high-function EMRs, and only in this cohort, <b>suggesting physicians at these clinics may be particularly pressured for time during patient encounters in the face of a large number of EMR functions</b>. "This 'made sense' to us in thinking about the possibility that those in the high-use group had more to do in the EMR" [say the authors].<b> </b></blockquote><br />• <span style="color: red;"><b><i>Smartest program out there</i></b></span> - "Smartest" meaning what, exactly?  According to whom?  Who performed the comparison?<br /><br />• <i><b><span style="color: red;">Streamlined</span></b> </i>- compared to what?<br /><br />• <b><span style="color: red;"><i>Thank you for your patience</i></span></b> - even if the effects on clinicians gets you or your loved ones maimed or killed?<br /><br />• <span style="color: red;"><b><i>Safe and secure network</i></b></span> - really?  No break ins, ever, considering multiple breach stories like those at <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>?<br /><br />• <span style="color: red;"><b><i>Keeping you informed is our priority</i></b></span> - informed of what?<br /><br />• <span style="color: red;"><b><i>Specially trained staff</i></b></span> - like these:  <a href="http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html">http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html</a>?</blockquote><br />and this:<br /><br /><blockquote class="tr_bq">• <span style="color: red;"><i><b>Take Responsibility</b></i></span> - I ask, should clinicians "take responsibility" for IT-related disruptions that impair care such as "use error" (as opposed to user error), i.e., what the National Institute of Standards and Technology has called operator error due to poor usability and other features of bad health IT?  (See "<b>NIST on the EHR Mission Hostile User Experience</b>" at <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a>.)  What about <b>"glitches"</b> and bugs that corrupt or lose data?  Should clinicians also 'take responsibility' for those?  (See for example the posts on the wild things that happen when IT malpractice leads to clinical mayhem at <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.)</blockquote><br />It appears to me that this vendor is using its client hospitals' management to enforce an "acceptable point of view" clinicians must proffer to patients about EHRs (which they must call "health" records), despite well-known contradictory findings.  This is, in effect, forced marketing of a device.<br /><br />Trying that for a drug or a conventional medical device (e.g., a particular stent) would be on its face unethical and likely illegal.<br /><br />Finally, critical thinking is what keeps patients alive and safe.  Marketing measures like this (some might call it "propaganda"), espousing and enforcing 'EHR exceptionalism', in my opinion, damage critical thinking and expression, and are thus unacceptable to push on clinicians and on patients.<br /><br />I add that requiring clinicians to promote deceptive propaganda the clinicians themselves know is untrue, from painful experience, is degrading, intimidating and destroys morale.  It is axiomatic that clinicians (or anyone) operating under such conditions cannot perform at their best.<br /><br />Thus the management geniuses who came up with these instructions (if not outright vendor-ghostwritten as at the Aug. 2012 "<b>Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists</b>", <a href="http://www.tinyurl.com/epic-stealth">http://www.tinyurl.com/epic-stealth</a>) are by their actions increasing risk of patient harm. <br /><br />The nurses' unions at at <a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html</a> have it right, in my view:  complain about the disruptions this technology causes, and complain loudly, if at the very least to make sure the problems are out in the open.<br /><br />-- SS<br /><br /><b>Note: </b>also see the followup Nov. 2013 post "<b>We’ve resolved 6,036 issues and have 3,517 open issues: extolling EPIC EHR virtues at University of Arizona Health System</b>" at <a href="http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html">http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html</a><br /><br />

Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As "Advised" At The University Of Arizona Health Network

When clinicians are told to promote a technology in no uncertain terms, that puts a chilling effect on critical thinking and discourse.  In effect, when under orders to only speak positively about a h…

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