healthy4u

More Pharmaceutical Misadventures - Actelion Damages Upheld, Genzyme (Sanofi Subsidiary) Settled, Merck Fined

The march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations goes on, albeit with ever more quiet footsteps as the number of journalists available to amplify their sounds declines.  Last week we <a href="http://hcrenewal.blogspot.com/2014/01/pharmalot-sent-down-memory-hole.html">noted</a> the shutdown of PharmaLot, a journalistic blog edited by Ed Silverman that was one of the few that reported fearlessly on the pharmaceutical industry, warts and all. So we dedicate this round up of legal settlements by pharmaceutical companies announced last month, December, 2013, to Ed Silverman, who reported on two of the cases below, and whose reports have been silenced by the shutdown of the PharmaLot web-site by its corporate owner. In alphabetical order by name of the pharmaceutical company, Actelion $40.7 Million Damages for Keeping Possibly Competitive Drug Off the Market Upheld This story was reported by Ed Silverman on Pharmalot, and <a href="http://www.sfgate.com/business/article/Actelion-loses-appeal-in-lung-drug-case-5079481.php">by the San Francisco Chronicle</a>.  The basics, according to the latter article, were: <blockquote class="tr_bq">A state appeals court has upheld $407 million in damages against the Swiss biotechnology giant Actelion and its executives for buying a Bay Area company and using it to thwart another firm's plans to market a competing hypertension drug in the United States. The drug, Fasudil, is manufactured by Ashai Kasei Pharma Corp of  Japan<a href="http://www.sfgate.com/?controllerName=search&action=search&channel=business&search=1&inlineLink=1&query=%22Asahi+Kasei+Pharma+Corp.+of+Japan%22"></a> for treatment of pulmonary arterial hypertension, an often fatal disease of the lung arteries. In June 2006, Asahi signed a licensing agreement with the South San Francisco biotech firm CoTherix, which agreed to develop oral and inhaled versions of Fasudil and seek regulatory approval in the U.S. and Europe. Less than five months later, Actelion bought CoTherix, paying a premium price of more than $400 million, and announced soon afterward that it was dropping plans to develop Fasudil. Actelion's own drug, Tracleer, dominates the U.S. market for treatment of the same disease and generates more than $1 billion in revenue a year.</blockquote> Note that the federal appeals court judge, Terence Bruiniers, found that the actions by Actelion were not only anti-competitive, but may have harmed patients, <blockquote class="tr_bq">'By impeding the development of Fasudil, Actelion not only sabotaged a competitive and foreseeably profitable commercial venture, but prevented a drug with the potential for alleviating the suffering of patients with life-threatening and debilitating diseases from reaching the market,' Bruiniers wrote.</blockquote> Further note that in this civil lawsuit, it appears that the top executives who engineered the anti-competitive actions that may have harmed patients will actually face negative consequences.  The judge also said, <blockquote class="tr_bq">the jury was entitled to conclude that three Actelion executives - CEO Jean Paul Clozel, chief scientific officer Martine Clozel, and Simon Buckingham, director of corporate and business development - had shown a disregard for the rights of Asahi and its customers and were liable for $30 million in punitive damages, about 10 percent of the executives' net worth.</blockquote> Sanofi Subsidiary Genzyme Settled Charges of Encouraging Unapproved Internal Use of SepraFilm for $22 Million The longest version of this story appeared <a href="http://www.tampabay.com/news/courts/civil/boston-biotech-firm-genzyme-agrees-to-pay-22-million-in-tampa/2158332">in the Tampa Bay Times</a>.  The basics were:  <blockquote class="tr_bq"> A Massachusetts-based biotechnology company has agreed to pay $22.28 million to resolve allegations brought by whistle-blowers in Tampa and Miami that it marketed an inappropriate use for a surgery medication, U.S. government attorneys said. Genzyme, a corporation known for its research into drugs for rare genetic diseases, is paying the settlement in a lawsuit over Seprafilm, a material it manufactures for use in the operating room. According to court documents, Genzyme sales representatives encouraged doctors to use the product in a manner not approved by the U.S. Food and Drug Administration, leading to improper claims for reimbursement from hospitals.</blockquote> The details were: <blockquote class="tr_bq"> According to court documents, Seprafilm is intended to be applied during open surgery to prevent organs and muscle tissue from sticking together. However, the whistle-blowers and lawyers for the federal government alleged that Genzyme sales representatives taught doctors to use it in less invasive procedures — such as laparoscopic or 'keyhole' surgeries — by mixing it into a liquidlike 'slurry' that could be injected into the body.</blockquote> Apparently the sales representative who blew the whistle in this case "recognized that this was a potential danger."  It certainly seems possible that the unapproved use of this material modified to be injected within the body might have resulted in harm to patients, and that at least its harmfulness when used in this manner had had never been tested.  However, in this litigation as supported by the US Department of Justice the plaintiffs were "not required to prove ... that patients had been harmed." Note that unlike the civil case above, and as is typical of federal lawsuits against big health care organizations, those company employees who authorized or directed the questionable actions did not suffer any negative consequences. (Added on 19 January, 2013) - Further note that as the article implied, but did not emphasize, since 2011, Genzyme has been owned by Sanofi.  Sanofi's last three major settlements since 2007 were summarized <a href="http://hcrenewal.blogspot.com/2012/12/tis-season-for-legal-settlements.html">here</a>.  Merck Fined 15.3 Million Euros for Smear Campaign Against Generic Competition This case was reported by Ed Silverman on PharmaLot, and briefly <a href="http://www.reuters.com/article/2013/12/19/france-fine-idUSL6N0JY2DE20131219">by Reuters</a>, <blockquote class="tr_bq">The French competition authority said on Thursday it had fined Schering-Plough, now owned by Merck, 15.3 million euros ($21 million) over what it called a smear campaign against generic competition to Subutex, its drug for opioid addiction. It also handed out a fine of 414,000 euros to parent Merck and another of 318,000 euros to British supplier Reckitt Benckiser for anti-competitive behaviour in staging the campaign in late 2005.</blockquote> Note that while this case did not involve any implications of physical harm to patients, it seemed to involve active deception. Summary First, as we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">said for years</a>, legal actions like those listed above may or may not result in huge financial penalties, and rarely result in penalties for individuals who authorized, directed or implemented the actions in question, but do serve as markers of the extent of misbehavior by large health care organizations.  Such misbehavior may have adverse consequences for patients and for public health and the health care system. Second, also as we have said for years, such actions mark the problem, but are unlikely to deter future problems.  In fact, many large health care organizations have settled strings of cases since we started trying to keep track of them (and may not have done so completely).  For example, the Genzyme, hence Sanofi settlement this year is at least the fourth major settlement by this company since 2007.  Settlements resulting in fines imposed on a company as a whole are diffused, paid by stockholders, employees, and patients, and hence are likely to be regarded as a cost of doing business by top  management.  Managers, however, often are given huge financial incentives for all actions that increase short term revenue.  So managers are likely to continue to enable or direct bad behavior as long as it can bring in lots of revenue at no personal risk. Third, while there has been a modest increase in discussion of ill-informed, mission-hostile, self-interested, conflicted, or even criminal or corrupt management since we started Health Care Renewal, the increasing plight of journalism seems to be making these issues more <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  The shutdown of PharmaLot and the silencing of its archives is another reminder of how public relations and marketing are now overwhelming disinterested reporting (see <a href="http://www.propublica.org/article/pr-industry-fills-vacuum-left-by-shrinking-newsrooms">this report</a> by Pro Publica). If we really want to reverse the downward spiral of our ever more expensive, less accessible, and lower quality health care system, we first have to preserve our ability to identify and loudly discuss its problems. Roy M. Poses MD for Health Care Renewal

More Pharmaceutical Misadventures - Actelion Damages Upheld, Genzyme (Sanofi Subsidiary) Settled, Merck Fined

The march of legal settlements by large health care organizations goes on, albeit with ever more quiet footsteps as the number of journalis...

Đọc thêm »

WaPo: "When treating a patient with dementia, electronic health records fall short"

Which raises the question:  for what patient types do EHRs in 2014 not "fall short" in many of the ways cited by this author? <blockquote class="tr_bq">When treating a patient with dementia, electronic health records fall short By Regina Harrell and Pulse December 23, 2013 <a href="http://www.washingtonpost.com/national/health-science/when-treating-a-patient-with-dementia-electronic-health-records-fall-short/2013/12/20/7bb51b34-416d-11e3-a751-f032898f2dbc_story.html">http://www.washingtonpost.com/national/health-science/when-treating-a-patient-with-dementia-electronic-health-records-fall-short/2013/12/20/7bb51b34-416d-11e3-a751-f032898f2dbc_story.html</a></blockquote><div class="article_body entry-content classic"><blockquote></blockquote> <article><blockquote>I am a primary-care doctor who makes house calls in and around Tuscaloosa, Ala. Today my rounds start at a house located down a dirt road a few miles outside town. ... We chat about the spring garden and the rain, then we move on to Mr. Edgars’s arthritis. Earlier on in his dementia, he wandered the woods, and his wife was afraid he would get lost and die, although the entire family agreed that this was how he would want it. ... We talk about how anxious he grows whenever she’s out of his sight and how one of his children comes to sit with him so that she can run errands. </blockquote> The omitted lines of this physician's encounter are poignant.  Read them at the Wash. Post link above. <blockquote class="tr_bq">... When I get back to the office, I turn on the computer to write a progress note in Mr. Edgars’s electronic health record, or EHR. In addition to recording the details of our visit, I must try to meet the <a data-xslt="_http" href="http://www.healthit.gov/providers-professionals/meaningful-use-definition-objectives">new federal criteria for “meaningful use</a>,” criteria that have been adopted by my office with threats that I won’t get paid for my work if I don’t.</blockquote> The "meaningful use" criteria, I point out, are an unproven experiment, decided upon by committee.   They are not evidence-based.  Physicians are, in effect, being threatened with nonpayment as part of the experiment.  They have become experimental subjects themselves, for free, and without true informed consent. <blockquote class="tr_bq">Under “History of Present Illness” (HPI), I enter “knee pain.” Up pops a check-box menu: injury-related (surely the chronic wear on Mr. Edgars’s knees from his work as a farmer is some sort of injury, but I don’t think that’s what the computer programmer had in mind), worsening factors (I know of none that apply, since he couldn’t give his own history), relieving factors (there’s no check box for a tired, sleep-deprived wife who’s purposely keeping the dose of acetaminophen low) and so on. Nothing fits, so I exit the HPI and type in “follow-up” (f/u), for which my EHR doesn’t have a pop-up menu. It yields only a blank screen.</blockquote> As a medical student, I was forbidden to use paper templates to "remind me" of what I needed to record in an H&P or progress note.  The "table of contents" had to be learned and applied from memory.  The continued patronization of physicians, nurses and other clinicians via templates like this, and the resultant de-skilling, time-wasting and other deleterious effects, is harmful to quality care.  This physician comments later that without EHRs and "meaningful use," she could see twice as many patients. <blockquote class="tr_bq">I type the Edgars’s story in my own words, so different from the computer-speak generated by the check boxes. I move on to the Review of Systems — another pop-up menu.</blockquote> Translation:  handwritten or typed narrative is meaningful; computer-generated prose is largely "legible gibberish", i.e., garbage.  I note that the EHR output in a recent ED visit of my own would have received a failing grade for documentation quality when I was in medical school - and I would have had serious words with a trainee who'd written such sloppy prose when I was a senior resident and attending. <blockquote class="tr_bq">I used to simply write “patient is an unreliable historian” at the beginning of this section, but the computer doesn’t understand that this statement could apply to the entire review.  [Actually, the designers and programmers who believe they are "revolutionizing" the field didn't understand the real world of clinical medicine - ed.] Using a template, it generates a page of 13 sentences, one for each body system, and, under each sentence, the option “Positive: Other: unreliable historian.”  [Which much then be clicked 13 times - ed.] Sometimes I wonder if it is disrespectful to a patient to say 13 times in one progress note how unreliable a historian he or she is, but I remember that this is great data to mine for research, so I plug on.</blockquote> This is not just "disrespectful", but a waste of clinician time. <blockquote class="tr_bq">Under “Physical Exam,” there is a template for geriatric patients. I pretend that the computer-speak it generates creates logical sentences, although I know better. In the check boxes, a person can be oriented to person, place and time, or not. Mr. Edgars is oriented to person and place; he knows that he is with his wife and at home, and is happy nowhere else. He no longer cares what year it is. There isn’t a check box for that.</blockquote> Obviously this "feature" was not even run by medical students, who know that orientation is not "x3" or "none" as the only pertinent options. Technically speaking, this represents inadequate and insufficiently granular data modeling ... a task I wrote years ago that requires the highest levels of clinical and biomedical informatics expertise, not computer or programming expertise.  There are likely many other examples of poor data modeling in this EHR. <blockquote class="tr_bq">I remember that I must go back to “Social History” and document tobacco use. It occurs to me that if you have not tried tobacco products by your 80th birthday, you are unlikely to suddenly change your mind. Especially when you can’t remember where the store is to buy them. So I slog through the series of check boxes for “never smoker,” an extra six mouse clicks.</blockquote> More wasted time. <blockquote class="tr_bq">After 15 minutes, the note is finished. And on goes my day of house calls, five in all.  There aren’t enough physicians to see all the homebound patients in my area, so I try to visit as many as I can safely care for. At day’s end, I review my meaningful use.  I spent more time checking boxes than talking to patients and their families. I could see twice as many patients if I could write their notes at the bedside while visiting with them.</blockquote> In other words, in this underserved area in and around Tuscaloosa, Ala., the "meaningul use" of EHRs deprives homebound patients of care. <blockquote class="tr_bq">I would happily do this on paper or using an EHR that created a logical note within the same amount of time. But that is not an option.</blockquote> Such EHRs are rare, if they exist at all.  Besides, this physician is likely contractually bound to use some larger organization's choice. <blockquote class="tr_bq">The reality is that I spend more time talking to the Information Technology people about Internet connections, firewalls and box-checking than I do answering messages from concerned family members.</blockquote> In other words, computerization is in the way of the best practice of medicine. <blockquote class="tr_bq">As a teaching doctor, my feedback to the residents now consists mainly of explaining how to document their visits so that we will all get paid, instead of teaching them how to take care of frail elders in their homes.</blockquote> I remember my community medicine clerkship in the early 1980s in a relatively underserved region in Maine.   Other classmates at Boston University School of Medicine did similar clerkships in Roxbury, an exceptionally poor and harsh section of Boston near Boston City Hospital.  We were taught patient care...with nothing less than the patient's best interests at heart.  Medicine today is now being financially and cybernetically deprived of its heart and soul. </article><article> </article><article>I believe I can honestly say the EHR here contributed nothing to the care of this patient, and was deleterious to the overall clinical mission for this patient, and for others. <blockquote class="tr_bq">Harrell is a geriatrician and assistant professor of family medicine at the College of Community Health Sciences, University of Alabama. This is an edited version of a story that originally appeared in <a data-xslt="_http" href="http://pulsemagazine.org/archive/stories/310-checking-boxes">Pulse — Voices From the Heart of Medicine</a>, an online magazine of stories and poems from patients and health-care professionals.</blockquote> I hope that patients who are not suffering dementia will increasingly take notice that these systems are depriving them of their clinicians' attention and of providing good documentation for their future care.  </article><article> </article><article>Clinicians themselves, with the exception of some unionized nurses, have grown largely complacent about bad health IT, the "meaningul use" experiment and IT's getting in the way of medical care to feed the bureaucracy. -- SS</article><article> </article><article>Jan. 15, 2014 Addendum: </article><article> </article><article>The reader comments at the original story in "Pulse" magazine are worth reading, and are at the bottom of this page:  <a href="http://pulsemagazine.org/archive/stories/310-checking-boxes">http://pulsemagazine.org/archive/stories/310-checking-boxes</a></article><article> </article><article>-- SS</article></div><div class="article_body entry-content classic"></div>

WaPo: "When treating a patient with dementia, electronic health records fall short"

Which raises the question: for what patient types do EHRs in 2014 not "fall short" in many of the ways cited by this author? When...

Đọc thêm »

PharmaLot Sent Down the Memory Hole

As noted in blog posts (<a href="http://www.the-scientist.com/?articles.view/articleNo/38780/title/Goodbye--Pharmalot/">The Scientist</a>, the <a href="http://pharmamkting.blogspot.com/2013/12/where-have-all-critical-pharma-bloggers.html">Pharma Marketing Blog</a>, <a href="http://shearlingsplowed.blogspot.com/2014/01/if-you-know-ed-and-like-his-work-please.html">Shearlings got Plowed</a>), and one solitary newspaper article (<a href="http://www.utsandiego.com/news/2014/Jan/02/pharmalot-ubm-canon-silverman/">San Diego Union-Tribune</a>), Ed Silverman's PharmaLot blog is no more. The main page of the blog has been replaced with a simple announcement. <blockquote class="tr_bq">UBM Canon has ceased the production of the following brands: Med Ad News, PharmaLive.com, Pharmalot, eKnowledgeBase and R&D Directions. Thank you for your loyalty and support that has played such an important part over the last thirty years. </blockquote> As others have noted, the shutdown of PharmaLot will remove an important source of news and opinion about the pharmaceutical and biotechnology industry.  Ed Silverman provided unbiased, insightful reporting.  Notably for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> audience, he was not afraid to report on the good, the bad, and the ugly. He was no friend of marketing and public relations smarm.  Often he was first to break stories involving legal settlements, guilty pleas, and miscellaneous misconduct, and in some cases was one of the few to document such stories. For example, in my current file, I note that PharmaLot provided one of the few accounts of a $21 million fine imposed on Merck by French antitrust regulators (here is the brief <a href="http://www.reuters.com/article/2013/12/19/us-france-fine-idUSBRE9BI0Q420131219">Reuters version</a>.)  PharmaLot reported on a judgement against Actelion for anti-competitive practices in support of its drug for pulmonary artery hypertension.  The only other media report on this was <a href="http://www.sfgate.com/business/article/Actelion-loses-appeal-in-lung-drug-case-5079481.php">in the San Francisco Chronicle</a>, and it was less detailed.  As we have noted endlessly, bad behavior by large health care organizations, including pharmaceutical and biotechnology companies and the various organizations with which they interact, like <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communication companies (MECCs)</a>, etc has often been <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  If one likes to get along by going along, it is not a good idea to make too much of a fuss about such issues and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a>, <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a> in  <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a>, and <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> including the creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interests</a>, much less outright <a href="http://hcrenewal.blogspot.com/search/label/crime">crime </a>and <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corruption</a>.  Ed Silverman was known to fuss about such issues. So the loss of his ongoing reporting, and willingness to post controversial interviews and editorials, will be sorely missed. Even more concerning, however, is the loss of his previous work. As noted in <a href="http://www.the-scientist.com/?articles.view/articleNo/38780/title/Goodbye--Pharmalot/">The Scientist's blog</a>, the PharmaLot archives are now inaccessible.  Although there are workarounds for the web-savvy that may allow retrieval of some of his previous work, especially if one knows what one is looking for, straightforward access is now difficult, and may become more difficult as it ages. Since PharmaLot provides an important archive of important problems with ethics, management and governance in the pharmaceutical and biotechnology industry, and since such issues as noted above often go minimally or not reported, permanent loss of previous PharmaLot content would be a big blow to transparency in health care, and a big boost for the anechoic effect. The current owner of PharmaLot is UBM Canon.  This company, as noted by a comment on The Scientist's blog post, easily verified <a href="http://ubmcanon.com/medical/">here</a>, is heavily involved with marketing and promotion for the pharmaceutical industry.  I can only hope that they will not succumb to any temptation to suppress the important documentation of the industry that PharmaLot provided, even if that documentation might have not always made industry honchos happy.  ADDENDUM (17 January, 2014) - the <a href="http://www.outcomes-marketing.com/pharmalot">PharmaLot site </a>is now entirely unavailable, that is, going to it yields a 404 not found error.

PharmaLot Sent Down the Memory Hole

As noted in blog posts ( The Scientist , the Pharma Marketing Blog , Shearlings got Plowed ), and one solitary newspaper article ( San Diego...

Đọc thêm »

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 Approval with a Twist 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: <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. 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. 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> '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> 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, <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. 'My young daughter looked at me and said, 'Can't there be a pill?'' Now there is </blockquote> So,  <blockquote class="tr_bq">'What it has resulted in is 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.</blockquote> 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. How could anyone not shed a tear?  How could anyone not be happy about this triumph of commercial drug development. 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. How Well Does Orenitram Work? 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. Mr Hensley wrote, <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 walk a little farther in a timed walking test. The most common side effects seen in the study were headache, nausea and diarrhea.</blockquote> On my review of the evidence.... 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.  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. 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. Finally, the generalizability of the study was limited to patients already optimally treated with conventional therapy, and perhaps by ist predominantly Asian female population. 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.   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)  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.  What Does Orenitram Cost, and Why? But United Therapeutics may have been able to make one aspect of this drug superlative, - its price.  Per Scott Hensley in the Shots blog, <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 it will be very expensive, about $150,000 a year, according to an estimate by Dr. Mark Schoenebaum, an industry analyst with ISI.</blockquote> That would be about three times the median US family income.  But the CEO shrugged concerns about the price off, <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> 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, <blockquote class="tr_bq">She commercialized [prostacyclin] ..., and was able to get investors interested because she realized there was no maximum price insurers would pay for an effective drug. United Therapeutics became one of biotech’s great success stories.</blockquote> 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 $7,958,328.  Three other executives got more than $4.5 million. 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. Some Off-Key Notes 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, <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 an investigation by the United States Department of Justice, principally represented by the United States Attorney's Office in Baltimore. The subpoena requests documents regarding Remodulin® (treprostinil) Injection, Tyvaso® (treprostinil) Inhalation Solution and Adcirca® (tadalafil) Tablets, including the company's marketing practices relating to these products.</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. 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, <blockquote class="tr_bq"> Now there is: Orenitram. The name comes from 'Martine Ro,' as in Martine Rothblatt, backward.</blockquote> Instead, Martine Rothblatt names her company's new drug for.... herself.  So what is this very emotional and personal drug marketing/ public relations campaign really about? On Smarm in Health Care 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.  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, <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> <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> <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> 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.  (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.) 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," <blockquote class="tr_bq">What is snark reacting to? <div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa"> </div><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa">It is reacting to smarm. </div></blockquote><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa"> </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> References 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>. 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 w...

Đọc thêm »

EHR Go-Lives Are Often Chaotic; One Area To Be Explored Is If This Go-Live Led To This Tragedy

EHR "go-lives" are particularly chaotic as staff adjusts to the new cybernetic governor of care.  Could the distractions have caused or contributed to the following tragedy? <blockquote class="tr_bq"><a href="http://www.cnn.com/2013/12/17/health/california-girl-brain-dead/" target="_blank">http://www.cnn.com/2013/12/17/health/california-girl-brain-dead/</a> Family wants to keep life support for girl brain dead after tonsil surgery By Tom Watkins and Mayra Cuevas, CNN updated 4:32 PM EST, Wed December 18, 2013 The mother of 13-year-old Jahi McMath, who was declared brain dead Thursday, three days after undergoing surgery to remove her tonsils, said Tuesday that the family should make the call. ... The surgery, which occurred December 9 [at Children's Hospital & Research Center in Oakland, California - ed.], initially appeared to have gone well, said Sandy Chatman, Jahi's grandmother who is herself a nurse and saw the girl in the recovery room. "She was alert and talking, and she was asking for a Popsicle because she said her throat hurt," Chatman said. But Jahi was then moved to the intensive-care unit, and her relatives were denied access to the eighth-grader for 30 minutes; when they finally were allowed to see her, they knew something was wrong. "Upon entry, they saw that there was way too much blood," Chatman said. "We kept asking, 'Is this normal?'" Sealey said. "Some nurses said, 'I don't know,' and some said, 'Yes.' There was a lot of uncertainty and a lack of urgency." Sealey said that when Chatman noticed that her granddaughter's oxygen levels were dangerously low, she called for help. But Jahi went into cardiac arrest. The medical staff performed chest compressions to revive her and gave her clotting medications, but nothing worked.</blockquote> The girl's brain was severely injured by lack of oxygen.  I am not commenting on the reported dispute regarding removing life support. I am commenting on my concern about a possible contributory role of a new EHR. At my Jan. 2, 2014 post "Doctors' Dissatisfaction With EHRs May Be Early Warning of Deeper Quality Problems" (<a href="http://hcrenewal.blogspot.com/2014/01/doctors-dissatisfaction-with-ehrs-may.htm">http://hcrenewal.blogspot.com/2014/01/doctors-dissatisfaction-with-ehrs-may.htm</a>l) I wrote of the distractions that physicians reported were caused by EHR systems such as: <blockquote class="tr_bq">... current EHR technology interferes with face-to-face discussions with patients; requires physicians to spend too much time performing clerical work; and degrades the accuracy of medical records by encouraging template-generated doctors' notes. </blockquote> I had also noted nurse's concerns of "inevitable" patient injury due to EHR distractions, such as at: <ul><li> My July 12, 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" (<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>),</li></ul><ul><li>my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients" at <a href="http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html">http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html</a>, </li></ul><ul><li>my June 19, 2013 post "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" (<a href="http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html">http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html</a>),  </li></ul><ul><li>and at other posts citing similar nursing complaints. </li></ul> The cases cited above involve the "EPIC" EHR, but similar issues arise will most of the current EHR sellers' products, which are unregulated.   For instance see the ECRI Institute's Deep Dive study of EHR risk 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>. In a volunteer study (i.e., only a fraction of true incidents reported) of 36 ECRI PSO hospitals, 171 EHR-related "events" serious enough to cause harm were voluntarily reported in just 9 weeks.  8 of the "health IT events" were reported to have resulted in patient harm, and 3 were possibly related to patient deaths.   From a press release from nurses at Affinity Medical Center (Ohio) on the nature of the problems: <blockquote class="tr_bq">... The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.” ... I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”</blockquote> <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/AVvXsEgbLHw1SqBJZglTMVlAh9MtKitlKiiVpouL8TTAbtNJwQqXGHGwRLj6imsuWMcqjMftyUM4ywqBSJV8uZ5i0Tqa1jrpxoC178PC40kaaNQww_88NhLwDu4E7UjBNzO82rJzxoX72tNs8yVZ/s1600/affinity_page1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbLHw1SqBJZglTMVlAh9MtKitlKiiVpouL8TTAbtNJwQqXGHGwRLj6imsuWMcqjMftyUM4ywqBSJV8uZ5i0Tqa1jrpxoC178PC40kaaNQww_88NhLwDu4E7UjBNzO82rJzxoX72tNs8yVZ/s320/affinity_page1.jpg" width="247" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">An open letter from nurses at an Ohio hospital, Affinity, on EHR "threats to patient safety."  Click to enlarge.</td></tr></tbody></table> The EPIC EHR apparently had just recently "gone live" at Children's Hospital Oakland. From  "Children's Oakland completes Phase 1 of $89 million electronic records system", Nov 20, 2013 (<a href="http://www.bizjournals.com/sanfrancisco/blog/2013/11/childrens-oakland-89m-emr.html">http://www.bizjournals.com/sanfrancisco/blog/2013/11/childrens-oakland-89m-emr.html</a>): <blockquote class="tr_bq">Children's Hospital & Research Center Oakland has completed the first phase of an $89 million Epic Systems Corp. electronic health records system that links inpatient operations and an oncology/hematology clinic. Other outpatient clinics are expected to come online in March or April, spokeswoman Melinda Krigel told the Business Times. ... The project's overall cost, $89 million, includes hardware, software and other implementation costs, including a separate SoftLab system that interfaces with the main electronic medical records system, Krigel said. The official "go-live" date was Nov. 5. </blockquote> See also the Children's Hospital Oakland Annual Report at <a href="http://www.chofoundation.org/assets/files/2012-annual-report.pdf" target="_blank">http://www.chofoundation.org/assets/files/2012-annual-report.pdf</a>.  On page 21:  <blockquote class="tr_bq">... The Epic system will launch in November 2013 at Children’s inpatient facilities as well as in the Operating Room, the Emergency Department, the Day Hospital, and the Oncology/ Hematology Clinic. </blockquote> I believe the possibility of clinicians being so distracted by computer data entry duties, and/or communications being impaired by the system's outputs, that this patient was left anoxic for a crucial period of time needs to be investigated. In my view, in the differential diagnosis of clinical chaos in 2014, the chaos caused by healthcare IT needs to be a consideration. My concerns may be shown unfounded in this case (I hope they are), and the injuries the result of other factors.  In consideration of the reported complaints from other organizations, however, not conducting an impartial investigating of a role of the new EHR in this tragedy would be, in my opinion, cavalier. -- SS  Jan. 5, 2014 Addendum: From a court document cached here:  <a href="http://www.cci.drexel.edu/faculty/ssilverstein/1230rrr.pdf">http://www.cci.drexel.edu/faculty/ssilverstein/1230rrr.pdf </a>, the following is written at p. 11-12: <blockquote class="tr_bq"> ... Originally the surgery was uneventful and MCMATH awoke from sedation in the recovery room speaking with hermother, Petitioner LATASHA WINKFIELD asking for a popsicle.  MCMATH was taken to the ICU and her mother was told to wait several minutes while they fixed her IV. After being told several times that it would be just another 10 minutes, approximately 25-45 minutes after MCMATH was brought into the ICU, WINKFIELD went back and found her daughter sitting up in bed bleeding from her mouth.  It was evident that this had been transpiring for some time.  The nursing staff said “it was normal” and the mother stayed at the bedside as the bleeding grew increasingly worse.  The nurses gave WINKFIELD a cup/catch basin for MCMATH to bleed from her mouth into.  WINKFIELD asked for assistance and was told that this was normal and was given paper towels to clean the blood off herself and MCMATH. The bleeding intensified to where copious amounts of blood were being expelled from MCMATH’s mouth and then nose.  MCMATH’s stepfather was also present and assisted in the attemps to stem/collect the blood. Again, WINKFIELD asked for assistance, and a doctor, and was only given a bigger container to collect the blood and, later, a suction device to suction the increasing volume of blood.  The stepfather continued to suction while the mother went and got her mother, a nurse, to take over for her.  The grandmother saw what was happening and made multiple requests, and then a loud demand, for a doctor. MCMATH shortly thereafter suffered a heart attack and fell into a comatose state.  She later was pronounced “brain dead”… </blockquote> "Heart attack" (i.e., primary myocardial infarction) in a 13-year-old sounds far less likely than exsanguination to the point of hypovolemic shock, severe hypotension, and cardiac arrest.  That such events transpired in an ICU, with family present and calling for help, suggests there were major clinician distractions of some sort at play. A reader wrote me wondering if a new CPOE component could have caused delays in evaluation and treatment. When someone is dying, you simply cannot waste time 'clicking away', they wrote. A reader also wrote me wondering if an EHR crash occurred at the time this patient was left with family to exsanguinate, causing clinical chaos. That is a particularly interesting thought.  See the multiple posts at <a href="http://hcrenewal.blogspot.com/search?q=ehr+crash">http://hcrenewal.blogspot.com/search?q=ehr+crash</a>.  In my opinion, these issues require investigation. -- SS

EHR Go-Lives Are Often Chaotic; One Area To Be Explored Is If This Go-Live Led To This Tragedy

EHR "go-lives" are particularly chaotic as staff adjusts to the new cybernetic governor of care. Could the distractions have caus...

Đọc thêm »

"Doctors' Dissatisfaction With EHRs May Be Early Warning of Deeper Quality Problems" - And Some Common Sense on EHRs and Clinician Distraction and Time-Wasting

The following article was published regarding physician dissatisfaction with EHRs, referencing a RAND study on EHRs commissioned by the American Medical Association: <a href="http://cnsnews.com/news/article/susan-jones/doctors-dissatisfaction-ehrs-may-be-early-warning-deeper-quality-problems-0">http://cnsnews.com/news/article/susan-jones/doctors-dissatisfaction-ehrs-may-be-early-warning-deeper-quality-problems-0</a> <blockquote class="tr_bq">Doctors' Dissatisfaction With EHRs May Be 'Early Warning of Deeper Quality Problems' October 18, 2013 - 10:17 AM By Susan Jones</blockquote><blockquote> Electronic health records (EHRs) are a source of frustration to many physicians, says a new study conducted by the RAND corporation and commissioned by the American Medical Association. Electronic health records are a source of frustration to many physicians, according to a study on physician satisfaction sponsored by the American Medical Association. The findings could serve as an "early warning of deeper quality problems developing in the health care system," the AMA said. The <a href="http://www.rand.org/pubs/research_reports/RR439.html" target="_blank">study</a>, conducted for AMA by the RAND Corporation, found that doctors who perceived themselves or their practices as providing high-quality care reported better professional satisfaction. Electronic health records (EHRs) were a source of both promise and frustration, the Rand study found. Although physicians tend to like the concept of EHRs, those surveyed said that current EHR technology interferes with face-to-face discussions with patients; requires physicians to spend too much time performing clerical work; and degrades the accuracy of medical records by encouraging template-generated doctors' notes.</blockquote> I believe the title should have been "Doctors' Dissatisfaction With EHRs Is A Warning of Deeper Quality Problems".  The academic-style fudge words "may be" and "early" are disposable. <blockquote class="tr_bq">"Physicians [i.e., all of them - ed.] believe in the benefits of electronic health records, and most do not want to go back to paper charts," said Dr. Mark Friedberg, the study's lead author and a RAND scientist. "But at the same time, they report that electronic systems are deeply problematic in several ways. Physicians are frustrated by systems that force them to do clerical work or distract them from paying close attention to their patients." </blockquote> Dr. Friedberg commits a faux pax symptomatic of an amateur scientist (or of a politician).  That is, making a statement that seems to speak for all physicians, and then for "most" physicians.  Clearly he didn't interview "most" physicians.  I know many who see the EHR as bureaucratic invasion of little clinical utility, and would gladly dump the poorly-engineered EHRs foisted on them that "interfere with face-to-face discussions with patients; require physicians to spend too much time performing clerical work; and degrade the accuracy of medical records" for good old-fashioned paper, supplemented perhaps with document imaging systems that make the notes available anywhere, anytime. <blockquote>... Health and Human Services Secretary Kathleen Sebelius has said that EHRs will lead to "more coordination of patient care, reduced medical errors, elimination of duplicate screenings and tests, and greater patient engagement in their own care."</blockquote> Sebelius is parroting others; there is little or no robust evidence supporting such a grandiose assertion (or, typical of today's politicians, she's simply lying; the reader can decide which). For 2014, some commonsense observations and recommendations on EHRs: 1) The pioneers in the 1950's and 1960's developed systems and experimented with their use in an environment far freer of the bureaucratic need for massive amounts of ultra-taxonomized data than today, where visits were not forced to be time-limited for "productivity", and where clinical notes were pithy and terse, as they were for patient care, not bureaucratic satiation.  The pioneers likely could not have conceived of what clinicians are being called on to enter manually, in 2014.  (I was taught Medical Informatics by some of those pioneers.) 2) The pioneers never intended to add uncompensated burdens onto clinicians.  They intended to help clinicians practice medicine more smoothly, not in a time-starved and robotic, slave-to-the-machine fashion. 3) The health IT industry and its health IT designers, and the largely medically-incompetent data processing/merchant computing personnel in hospital IT departments, appear to have not cared less about these real-world HIT issues - as evidenced by their products - until the pressure was put on by users, resulting in studies of IT safety by the Institute of Medicine (<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html</a>) and of IT usability by NIST (<a href="http://hcrenewal.blogspot.com/2010/12/nist-provides-healthcare-it-industry.html">http://hcrenewal.blogspot.com/2010/12/nist-provides-healthcare-it-industry.html</a>) in just the past few years. With these factors in mind: <blockquote class="tr_bq">... AMA noted that some medical practices are experimenting with ways to reduce physician frustration by hiring additional staff members to perform many of the tasks involved in using electronic records, such as data entry. </blockquote> Actually, the use of clinicians as computer data-entry clerks was the real experiment, an experiment whose failure is becoming increasingly apparent.  The "experiments" with hiring of data entry clerks should be made official healthcare policy as follows:  1)  Physicians and nurses should be relieved of the burden of data entry into computer interfaces (as opposed to merely viewing) nearly entirely.  Data entry cannot be done under the real-world conditions of patient care in 2014, for most specialties, without compromising the focus on patient care (let alone clinician morale).   2) Considering the hundreds of millions per organizations spent on theses systems, a pool of data entry clerical staff can well be afforded, hired and trained to transcribe data into computers from clinicians' paper notes, using specialized forms where necessary.   3) Those same paper notes can be rapidly imaged into a document management system (e.g., Documentum, <a href="http://www.emc.com/enterprise-content-management/documentum-platform.htm">http://www.emc.com/enterprise-content-management/documentum-platform.htm</a>; I managed a pharmaceutical department of ~55 people and a $13 million budget using such a system) and made available before transcription.  The note images can also serve as a supplement to data viewing screens in the EHR, which at least in 2014 are themselves poorly engineered from the perspective of optimal presentation of information. 4) The workflows for such arrangement are known to me; I created such an environment in a busy invasive cardiology department, a critical care area performing more than 6000 procedures/year and responsible for 25% of the organization's revenues - fortunately having been able to neutralize and marginalize an IT department seemingly hellbent, perhaps through ignorance, on sabotaging the effort.  See "Essential Value of Medical Informatics Expertise in High-Risk Areas: an Invasive Cardiology Example" at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story</a>.  The offloading of data entry by clinicians into the computer, and the use of special paper forms for the clinicians, worked exceptionally well in allowing the clinicians to focus on what really matters most - patient care. 5) If healthcare organizations insist on direct clinician data entry, then clinicians' time doing so should be fairly compensated.  Lawyers generally earn from $250/hr and up for profession-related clerical work, like creating legal briefs and letters.  I think physicians should do at least as well.  (If readers believe clinicians should take on this considerable burden and not be fairly compensated, I'd like to hear why.) 6) If healthcare organization leaders truly believe the EHR hyper-enthusiasts, the expense of the clericals will be far offset by the "billions and billions" saved by these systems.        a) If they don't believe the EHR hyper-enthusiasts, they should be far more skeptical of implementing such systems and imposing the mission-robbing burdens on their clinicians in the first place. 7) These measures will free industry resources for doing what really matters most in clinical care, namely, health IT robustness (freedom from error, security, etc.) and optimal presentation of information customized for the needs of the many different clinical specialties and subspecialties. -- SS

"Doctors' Dissatisfaction With EHRs May Be Early Warning of Deeper Quality Problems" - And Some Common Sense on EHRs and Clinician Distraction and Time-Wasting

The following article was published regarding physician dissatisfaction with EHRs, referencing a RAND study on EHRs commissioned by the Amer...

Đọc thêm »

"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. 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. 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. 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. The Rise of Corporate Hospices 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>). In 2013, more cases appeared, listed in chronologic order - Hospice of Arizona LC and American Hospice Management LLC - 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...."  Hospice Care of Kansas, and parent company Voyager HospiceCare - 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." Hernando-Pasco Hospice - <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." These were all small settlements, that is, less than $15 million, reported in relatively small media outlets. 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.    The Post added to the background we provided above, <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. '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> After this well-intentioned beginning, there was a rapid increase in the use of hospice, and hence its costs, <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. In 2000, Medicare spent $2.9 billion on the hospice benefit. By 2012, that figure has risen fivefold, to $15.1 billion. But as more Americans have taken up hospice care, a profound change has been underway: Big businesses have moved in.</blockquote> In parallel, the nature of hospices changed, going from being predominantly local non-profit organizations to predominantly corporate, <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. In 2000, 70 percent of hospices were run by nonprofit organizations or government agencies. Today, nearly 60 percent are for-profit companies, and they may account for an even larger share of patients.</blockquote> They really were for-profit, <blockquote class="tr_bq">The profit margins as measured by MedPAC, the Medicare watchdog, climbed to 8.7 percent in 2011. The per-patient operating profit has risen from $353 in 2002 to $1,975 in 2012, according to the analysis of California data.</blockquote> Big money lured aggressive players, in particular, private equity, <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 Kohlberg Kravis Roberts & Co., KRG Capital Partners and Summit Partners.</blockquote> 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.  Financial Incentives to Enroll the Wrong Patients 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, <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> The payments provide more profit from patients with the longest stay in hospice, <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. 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. 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> 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, <blockquote class="tr_bq">Indeed, it has been an open secret in the industry that, because of the method of payment, the way to run a hospice profitably is to enroll patients who stay for a long time. 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 'maintain a patient base with a sufficiently long length of stay.' The company also warned that 'cost pressures resulting from shorter patient lengths of stay . . . could negatively impact our profitability.' 'It is common knowledge in the industry that a longer length of stay is going to be more lucrative,' 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> 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, <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. 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. 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> Yet, while Medicare administrators have been warned about these perverse incentives, they have done nothing to fix them, <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> Perhaps Medicare administrators are listening harder to for-profit hospice executives than to their own advisory committee, <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> Furthermore, <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. '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> Yet Medicare administrators still seemed to feel no sense of urgency, and are not eager to address the specifics of the MedPac recommendations, <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. '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> 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. Vivid Anecdotes of the Deceptive Marketing of Hospice 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, <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. 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. 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 stressing the urgency of a decision, and saying things like, 'We only have 10 minutes left.' 'Effective communication is the transfer of emotion, not information,' the presentation said. At Odyssey Healthcare, one of the nation’s largest hospice companies, representatives earned bonuses if they met their goals for new patients, according to that complaint. The case led to a $25 million settlement with the company. 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 corporate culture encouraged staff members to admit as many patients as possible, regardless of whether they were eligible for hospice care, according to the lawsuit. The lawsuit said the company paid bonuses based on the number of patients enrolled. One former manager said that the company philosophy was 'sign everybody up' and that medical staffers felt pressured to admit patients regardless of whether they were appropriate. And at Angels of Hope hospice in LaGrange, Ga., audio recordings cited in the complaint described how some salespeople found patients: by cruising neighborhoods, looking for elderly people with disabilities.</blockquote> The article coned down on specific litigation about AnseraCare, <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. There was steady pressure for AseraCare managers to find more patients, the lawsuit said. An executive who did not meet a quota was penalized, according to the lawsuit, and the company offered a massage chair for the person who brought in the most hospice patients. '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,' a regional vice president wrote in an e-mail, according to the lawsuit. '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.' 'We had a director who would be like, ‘Get a patient, get a patient, get a patient,’ ' 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. These demands for patients were sometimes met with people who were sickly but not dying, according to the federal lawsuit, which outlines five examples. One patient was supposed to have had end-stage heart disease and thus would have had trouble breathing and walking, according to the lawsuit. He left the nursing home for his granddaughter’s graduation and for Christmas, had a good time and ate a lot, according to notes from hospice workers cited in the lawsuit. Another, diagnosed with end-stage 'debility,' was not losing weight as is typically the case, according to the legal filing, and instead went out for a trip to Wendy’s and another to go birdwatching.</blockquote> Hospice firms' public relations departments provided the usual high minded statements that did not address specific allegations about the marketing of hospice, for example, <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. '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.' 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, <blockquote class="tr_bq"><h3>Our Mission</h3>To share our passion for improving quality of life through innovative healthcare — one person, one family and one community at a time. <h3>Our Values</h3>Make integrity and accountability your pledge. Share our passion for excellence. Be uncompromising in delivering quality care.</blockquote> Summary <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> Pearl S Buck, My Several Worlds, 1954, p 377 (see <a href="http://en.wikiquote.org/wiki/Civilization">Wikiquote</a>) 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. The story combines many of the themes we have sounded before - <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">Perverse Incentives</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. Money Before Mission - 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. <a href="http://hcrenewal.blogspot.com/search/label/impunity">Impunity</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. <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. 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. 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." 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.

"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 t...

Đọc thêm »