healthy4u

Healthcare IT Delirium

The delirium surrounding healthcare IT seems to be worsening. In an Aug. 2010 post "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html">EPIC's outrageous recommendations on healthcare IT project staffing</a>" I wrote that health IT company <a href="http://www.blogger.com/www.epic.com/">Epic</a>, one of the largest, seemed to not care about healthcare or IT education or experience in its recommendations to hospitals on staffing of safety critical projects (i.e., the implementation of safety critical clinical cybernetic devices): <blockquote style="font-family:arial;">Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say. The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores. </blockquote>Based on a presentation by the company at my university, they apparently they mean it: <blockquote style="font-family:arial;">Career Presentation: Epic Systems Corporation - TONIGHTThe Drexel Women in Computing Society (WiCS) will organize a career presentation by Epic Systems Corporation tonight, January 19, 2011, from 6 to 7 p.m. at University Crossings, room 149 (32nd and Market Streets).Epic Systems Corporation, located in Madison, Wisc., creates software for the healthcare industry and is hiring for many positions. They are recognized nationally as a leader in moving healthcare organizations from paper medical records to completely electronic ones. Epic hires from all majors, all degrees and all experience levels, and requires no software experience. [Or, as is obvious from this solicitation, healthcare experience - ed.] The presentation will include an overview of Epic's industry work, corporate philosophy and role-specific expectations.This presentation is open to all graduate and undergraduate students at Drexel University. Pizza will be provided and resumes will be accepted after the presentation.</blockquote> Other health IT merchants will probably soon follow suit. As I also wrote at the aforementioned post: <blockquote style="font-family:arial;">Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be, and these practices as described, in my view, represent faulty and dangerous advice.The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>."</blockquote> This talent management ideology is also alien to medicine (at least since the Flexner Report of 1910), and at odds with critical thinking and common sense. Then there's this, an attempt by Medical Informatics researchers of the American Medical Informatics Association (AMIA) to ex post facto put a scientific veneer on the troublesome and extremely costly "Meaningful Use of health IT" criteria mandated by the US Government. Those criteria were largely arrived at through "off-the-top-of-their heads" committee meetings (see "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>" on this blog and "<a style="font-family: arial;" href="http://histalk2.com/2011/01/18/the-mu-hearings-drlyle-goes-to-washington-11811/" rel="bookmark" title="Article about: The MU Hearings: DrLyle Goes to Washington 1/18/11">The MU Hearings: DrLyle Goes to Washington 1/18/11"</a> at the HIStalk site): <blockquote style="font-family: arial;">On behalf of the CISWG Leadership Team [AMIA Clinical Information Systems work group - ed.] In light of the HITECH Act and subsequent Meaningful Use objectives, it is imperative for the informatics community to consider the current science behind clinical information systems and to identify areas requiring further research. In keeping with this, the CISWG leadership is interested in developing a white paper, “The Science Behind the Meaningful Use Criteria”. The purpose of this paper will be to synthesize the existing literature regarding each of the meaningful use criteria and develop recommendations for future research. We are requesting your assistance in this work. We ask you, as experts in the field, to help identify current literature and subject matter experts for EACH of the meaningful use criteria. In addition, please state if you (1) believe there is evidence for the objective, and (2) if the evidence is supporting of the objective. Please do not delete other’s input but rather add your comments directly to the document (even if in conflict with others). The document should result in a great asynchronous discussion. Please provide your input by the 7th of February. We appreciate any input you are able to provide. Thank you for your assistance and we look forward to sharing the results of this work in the future</blockquote> My contribution will probably be that it's probably better to examine the science in a domain before putting it into national policy, not after ... I'd also observed at "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html">Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?</a>" and at the followup post "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">Cart before the horse, again: IOM to study HIT patient safety for ONC</a>" that a focus on "meaningful use" before a focus on health IT "meaningful usability" and health IT safety was putting the cart before the horse. Recklessly so, in fact. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyR04XtQiwxZH-TTsZEalW0xlRbKsjUUOL6btjzNUcrdKzoibZQDecVGvhWr9gY0uuvx66BxBBAOlKKZwzP6O4ZGEWL7mNdGLaLq0YTLuFf3Aizl0KsGKGMBU-SaOaUcEARLjquiAJXqLP/s1600/horse-cart.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5564282328497907874" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyR04XtQiwxZH-TTsZEalW0xlRbKsjUUOL6btjzNUcrdKzoibZQDecVGvhWr9gY0uuvx66BxBBAOlKKZwzP6O4ZGEWL7mNdGLaLq0YTLuFf3Aizl0KsGKGMBU-SaOaUcEARLjquiAJXqLP/s320/horse-cart.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 252px; height: 156px;" /></a>How not to do health IT: by putting the cart before the horse on usability and safety </div> Finally, in light of the recent experiences of a medical informatics-skilled hospitalist as I posted at "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2011/01/md-on-ehrs-i-might-have-inadvertently.html">An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem</a>" ... <blockquote style="font-family: arial;"> [The NY Times article on information overload in the military causing deaths] was eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU. Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.) Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem... PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.</blockquote> ... and the injury of my relative in 2010 due to interference of healthcare IT in clinician-clinician communications (including, but not limited to, me communicating with those caring for my relative, and them communicating among themselves and <a href="http://www.tinyurl.com/hostileuserexper">with the technology itself</a>), all I can say is: The field of health IT has become delirious. On top of an irrational exuberance (see <a href="http://hcrenewal.blogspot.com/search?q=irrational+exuberance">this blog query</a>) largely unsupported by the literature (e.g. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>), the technology is <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment">experimental</a>, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">informed consent</a>, nobody is in control, and <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">nobody is taking responsibility for regulating the domain</a> despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant. This is crazy stuff. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhA-qrjYybZPlz2HBlFu5FpGVOgsaHi26r5Og_73CNBiQT7S8iMkSjk2pzI2RhPrlrHus59lt09nEB3X2xy2a3eirUS3mewe3eC-r0OzTIkGC3Vp6XSIZDWto7HgalSUwNf19n-xF6Rhn5Z/s1600/trainwreck.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5564284191038181458" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhA-qrjYybZPlz2HBlFu5FpGVOgsaHi26r5Og_73CNBiQT7S8iMkSjk2pzI2RhPrlrHus59lt09nEB3X2xy2a3eirUS3mewe3eC-r0OzTIkGC3Vp6XSIZDWto7HgalSUwNf19n-xF6Rhn5Z/s320/trainwreck.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 205px; height: 247px;" /></a>Running off the rails. We seem to be going out of our way looking for this with HIT, sending it out full speed ahead on far too short a track ... </div> There's very little else I can do about it at this point, having tried writing, speaking, and political venues. This will affect your healthcare, not just mine (at least I know what to look out for). I suggest litigators stay closely attuned to hospital morbidity and mortality incidence (and incidents). -- SS

Healthcare IT Delirium

The delirium surrounding healthcare IT seems to be worsening. In an Aug. 2010 post " EPIC's outrageous recommendations on healthcar...

Đọc thêm »

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

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

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

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

Đọc thêm »

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

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

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

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

Đọc thêm »

BLOGSCAN - Why Problems at Local Marquee Hospitals May be Anechoic

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

BLOGSCAN - Why Problems at Local Marquee Hospitals May be Anechoic

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

Đọc thêm »

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

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

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

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

Đọc thêm »

Clinicians Going for a Swim and Drowning in Information

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

Clinicians Going for a Swim and Drowning in Information

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

Đọc thêm »

Guidant (Boston Scientific) Gets Probation

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

Guidant (Boston Scientific) Gets Probation

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

Đọc thêm »