healthy4u

More "You're Too Negative, And You Don't Provide The Solution To The Problems You Critique", This Time re: Pharma

I think it worth noting that critical writers about both health IT and pharma attract a similar phenomenon: the anonymous attack accusing them of 'negativity' and not providing 'solutions.' One excellent blog I read, as a former director of a pharmaceutical R&D department that supported, among others, medicinal chemists, is Derek Lowe's "<a href="http://pipeline.corante.com/">In the Pipeline</a>." In the comment thread at his 'In the Pipeline' understatement-of-the-year post "Taking the Ax to the Scientists Is Probably a Mistake" (<a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php">link</a>), I posted numerous links to various Healthcare Renewal posts on pharma's current travails related to that theme, and to other forms of pharma mismanagement. The comment thread is below the post itself at the aforementioned link. I post as "MIMD" and frequently link here and to my Drexel academic site, so I am anything but anonymous. Invariably, a response (anonymous, of course!) of the type we've seen here at Healthcare Renewal (such as <a href="http://hcrenewal.blogspot.com/2010/01/electronic-medical-records-and-going.html?showComment=1264052395182#c3086217865260584599">here</a> and in a more extreme example, <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">here</a>) has appeared. Various logical fallacies are used as a form of argument. Emphases and red comments mine: <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885215"></a><blockquote><a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885215">74. </a>Reply to MIMD [how's that for anonymity - a screen name of "Reply to MIMD"? - ed.] on April 4, 2012 3:44 AM writes... MIMD, you have commented at length on this post blaming various parties for the industry's woes [i.e., you're too negative - ed.], dismissing other points of view [that are almost always unsubstantiated; I provide hyperlinks to posts at this blog and others regarding pharma mismanagement and malfeasance to justify my views - ed.] out of hand [well, no, actually - ed.] and offering nothing in the way of new ideas or solutions. [Except for the myriad aforementioned links and clearer identification of the problems - ed.] And then, this: "If I were still in pharma and had kids in college and a mortgage, and a hope for a pension, I'd literally be keeping my head low. And certainly not writing the types of posts I do here and on the blog I often link to!" [Pharma is as retaliatory of its internal critics and "whistleblowers" as is clinical medicine, except doesn't even bother with sham "peer review"; they just send people out the door. I do not believe pharma management understands or cares about the implications to people who are not wealthy. Discreetness and timing are everything for putative internal medchem change agents in this environment - ed.] I'd just like to get your thoughts on the delicious irony of this post in the middle of your long-winded and boring commentary. [Approaching ad hominem - ed.] As far as I understand, you're advocating that pharma scientists blame anything that breathes for the problems whilst [seems to be from UK or related country - ed.] actively avoiding attempting to find a solution. [Classic strawman argument - ed.] Weirdo [another anonymous poster, possibly the same person as this - ed.] commented on this, and you laughably dismissed it out of hand so I expect no more. [I opined that a naïvely idealistic and/or cruel Marie Antoinette-like suggestion that laid-off medicinal chemists simply just set up their own drug discovery shops to show Big Pharma how it 'should be done', as if doing so were a realistic option financially for mostly middle class people strapped by being laid off mid-career, was a useless suggestion - ed.] But if you do fancy dropping a few more 'pearls of wisdom' our way I'd be fascinated to read them! I think it was Homer Simpson that said "It's everybody's fault but mine". Seems apt, no? [No, in fact - ed.] <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885215">Permalink to Comment</a></blockquote> My reply was: <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885615"></a><blockquote><a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885615">75. </a>MIMD on April 4, 2012 9:49 AM writes... Re: #74 Regarding your comments, I offer a hearty "so what?" In your comment I see no meaningful critiques of any of the volumes of writing I've posted links to, other than the hackneyed, quasi-ad hominem, without-merit statement about "dismissing other points of view out of hand and offering nothing in the way of new ideas or solutions." That's disappointing. I also must point out this classic example of the strawman fallacy: you're advocating that pharma scientists blame anything that breathes for the problems whilst actively avoiding attempting to find a solution I do believe they teach better debating skills in the Commonwealth realms. Finally, when you come out from behind your cloak of anonymity, I'll consider answering in more depth. Who are you? What agenda are you hiding? My bio is on the site I often link to, as well as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="nofollow">here</a>. <a href="http://pipeline.corante.com/archives/2012/04/02/taking_the_ax_to_the_scientists_is_probably_a_mistake.php#885615">Permalink to Comment</a></blockquote> Derek Lowe's blog is a serious site for medicinal chemists and like-minded scientists currently being discarded by pharma; a perfect place for anonymous pharma sockpuppets to intersperse their materials. Although I doubt it, it will be interesting to see if the anonymous poster reveals exactly who they are and what their agenda is. I add that in an industry plagued with scientific <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghostwriting</a>, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of negative research</a>, misleading <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a>, an endless parade of "<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>" for various forms of malfeasance, mass <a href="http://hcrenewal.blogspot.com/2008/06/gsk-whacks-its-employees-hard.html">layoffs</a> and other troublesome practices, I find "ghost commenters" who attack the industry's detractors from behind cloaks of anonymity quite suspect. (Unless, of course, and ironically, the writer is afraid of pharma retaliation.) Finally, I can understand how pharma executives might find detailed stories about pharma mismanagement and leadership thought errors profoundly disturbing. They are usually protected from such candid material in their dystopic, highly remunerative cocoons surrounded by ear-pleasing consultants and employee sycophants rightly fearing career termination. -- SS

More "You're Too Negative, And You Don't Provide The Solution To The Problems You Critique", This Time re: Pharma

I think it worth noting that critical writers about both health IT and pharma attract a similar phenomenon: the anonymous attack accusing t...

Đọc thêm »

Divide by Zero: Weird Math in CMS Clinical Quality Measure (CQM) Criteria

From the CMS "<a href="https://www.cms.gov/EHRIncentivePrograms/Downloads/EP_Attestation_User_Guide.pdf">Medicare Electronic Health Record (EHR) Incentive Program - ATTESTATION USER GUIDE For Eligible Professionals (EPs)</a>" (warning: large PDF), page 41/64: <blockquote>... Step 25 – Core Clinical Quality Measures (CQMs 1 of 3) EPs must report calculated CQMs directly from their certified EHR technology as a requirement of the EHR Incentive Programs. Each EP must report on three core CQMs (or alternate core) and three additional quality measures. If one or more core CQMs is outside your scope of practice, you will have to report on an equal number of alternate core CQM(s). If the denominator value for all three of the core CQMs is zero, an EP must report a zero denominator for all such core measures, and then must also report on all three alternate core CQMs. If the denominator value for all three of the alternate core CQMs is also zero an EP still needs to report on three additional clinical quality measures. Zero is an acceptable denominator provided that this value was produced by certified EHR technology.</blockquote> Now, while I had an "800" in the math section of the SAT, where I believed that a fraction with a denominator of zero had a value of either infinity or 'undefined', that was many moons ago. Perhaps my knowledge of mathematics is now obsolete... Wait - I tried this simple program on an old Microsoft MS-DOS GWBASIC interpreter, ported ca. 1981 to the Intel 8086/88 from Bill Gates' original 8080-based MBASIC, that I have laying around on my PC: <blockquote>10 INPUT X 20 LET Y=X/0 30 PRINT Y 40 END</blockquote> and got this warning/error message, right from Bill Gates: "Division by zero" and the answer: 1.701412E+38 (infinity in the 8/16-bit world from where GWBASIC sprang). So ... allow me to say I find CMS math just a bit puzzling. Wait ... now I understand. Infinite quality! :-) But thank heavens the zero denominator is only accepted when produced by <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">'certified' health IT</a>. Uncertified health IT is liable to produce a denominator of "i" (that is, the square root of -1). -- SS Addendum: since I am not a government math genius, I checked with <a href="http://en.wikipedia.org/wiki/Fraction_%28mathematics%29">Wikipedia</a>: <blockquote> ... A common fraction (also known as a vulgar fraction or simple fraction) is a <a href="http://en.wikipedia.org/wiki/Rational_number" title="Rational number">rational number</a> written as a/b or <img alt="\tfrac{a}{b}" class="tex" src="http://upload.wikimedia.org/wikipedia/en/math/e/c/3/ec3e447b2dcda3eb68860a5cb3780bf7.png" />, where the <a href="http://en.wikipedia.org/wiki/Integer" title="Integer">integers</a> a and b are called the numerator and the denominator, respectively.<a href="http://en.wikipedia.org/wiki/Fraction_%28mathematics%29#cite_note-0">[1]</a> The numerator represents a number of equal parts and the denominator, which cannot be zero, indicates how many of those parts make up a unit or a whole.</blockquote> -- SS Addendum: This post is partly satire. I was a day late for April 1 but... -- SS

Divide by Zero: Weird Math in CMS Clinical Quality Measure (CQM) Criteria

From the CMS " Medicare Electronic Health Record (EHR) Incentive Program - ATTESTATION USER GUIDE For Eligible Professionals (EPs) &quo...

Đọc thêm »

University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system

In my Oct. 2006 post "<a href="http://hcrenewal.blogspot.com/2006/10/70-million-for-electronic-medical.html">$70 million for an Electronic Medical Records system?</a>" I wrote: <blockquote> ... healthcare doesn’t have the capital for clinical IT misadventures, and I believe when the issues become more public in this industry sector and information flows about mismanagement and abuses (as is happening in the UK ’s <a href="http://www.manchestereveningnews.co.uk/news/health/s/219/219945_leaked_papers_reveal_nhs_computer_problems.html" target="blank">Connecting for Health </a>project) [now abandoned <a href="http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html">as described here</a> - ed.], the fallout won’t be pretty. </blockquote> Here's an example of an organization in profound ardent technophile-driven <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">Ddulite mode</a>: <blockquote> <a href="http://azstarnet.com/business/local/ua-medical-center-to-spend-m-on-new-records-system/article_a0866af4-9890-502f-8454-530cebf71bcf.html?mode=story">UA Medical Center to spend $100M on new records system</a> Tucson's largest health-care organization expects to spend upward of $100 million on getting its two hospitals talking to each other. Right now, the inpatient medical record systems at the University of Arizona Medical Center's two campuses aren't speaking to each other. The lack of communication is resulting in more work for healthcare providers in the University of Arizona Health Network. [How much more work, exactly, and how much would a non-cybernetic solution cost? These issues seem never to be mentioned - ed.] The $1.2 billion, nonprofit company employs nearly 7,000 people. The network is installing a new, uniform electronic medical records system for all patients at its two hospitals - UA Medical Center - University Campus and UA Medical Center - South Campus - and at outpatient centers as well. ... Project leaders predict it will result in a more efficient organization with fewer medication errors and better patient care. ... The new system's benefits will certainly trickle down to patients, said Clint Hinman, an experienced pharmacy director within the network who is directing the computer upgrade program. [Note once again the absolutist statements of deterministic benefit and beneficence, based on scant supportive evidence and increasing contradictory evidence, that I bolded above - ed.] </blockquote><div style="overflow: hidden; color: rgb(0, 0, 0); background-color: rgb(255, 255, 255); text-align: left; text-decoration: none; border: medium none;">I note that $100 million+ is probably enough to pay for AN ENTIRE NEW HOSPITAL or hospital wing ... or a lot of human medical records professionals. Executives and project leaders have probably never read any of the literature at the reading list <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">here</a> or at my academic site <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a>, or if they have, choose to be blind to it and trusting of literature such as ONC's sloppy-science "should not have been published in its present form" health IT cheerleading <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html">here</a>. Most important of all: It's not advisable to gamble with $100 million in that fashion, especially under these conditions: <blockquote>... BUDGET ISSUES Spending $100-million-plus on electronic medical records is a lot of money for a network that as of mid-January was at $10 million in the red in operations, BUT network spokeswoman Katie Riley said the electronic medical records are not to blame. [Capitalization and emphasis of the "but" mine - ed.] </blockquote> This statement is both representative of a healthcare system gone overboard - you don't spend on luxuries when you're $10 million in the red - and is a non-sequitur. Who cares if the EHR's are not to blame for the system being $10 million in the red? That does not seem like a good reason to go ahead and spend $100 million (which will probably balloon to several times that figure, hence I will use $100 million++) on a very risky gamble. Further, all it will take is a few of <a href="http://hcrenewal.blogspot.com/2012/03/expensive-healthcare-computing-mistake.html">these mishaps</a> to put the system further in the red. I should also ask: will medical and other staff be laid off to afford the new systems, in effect trading people for computers? To spend $100 million++ on HIT when you're already $10 million in the red on operations is, in my view, financially reckless. -- SS </div>

University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system

In my Oct. 2006 post " $70 million for an Electronic Medical Records system? " I wrote: ... healthcare doesn’t have the capital fo...

Đọc thêm »

An Expensive Healthcare Computing Mistake: $1.5 Million

At my June 2011 post "<a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">Babies' deaths spotlight safety risks linked to computerized systems</a>" I reported on a case (case #2) of an infant death in part attributed to HIT (PACS) interference in otherwise simple care processes. In "Allen-Blake vs. Abington Memorial Hospital", a critical x-ray of a PICC (<a href="http://en.wikipedia.org/wiki/Peripherally_inserted_central_catheter">peripherally inserted central catheter</a>) line placement allegedly was never read due to misdating. The Allen-Blake case was settled 2/29/12 for $1.5 million, according to the public docket count 78 (<a href="http://webapp.montcopa.org/PSI/Viewer/Detail.aspx?oq=aWQ9MjAwNzcwODI4JmVudGl0eT1DYXNl">link</a>): <table class="ChamaeleonGrid" rules="all" border="1" cellspacing="0"><tbody><tr class="GridItem"><td>2/29/2012</td><td>Order</td><td>OF 2/28/12 OTT, J PROPOSED SETTLEMENT OF $1,500,000.00 APPROVED CC </td></tr></tbody></table> That $1.5 million might have paid for a lot of other things, such as provision of better medical care through hiring/retention of more staff. The legal fees for defense incurred must also have been substantial, representing yet more precious healthcare capital down the proverbial drain. Add cases like this to the "total cost of ownership" of health IT. -- SS

An Expensive Healthcare Computing Mistake: $1.5 Million

At my June 2011 post " Babies' deaths spotlight safety risks linked to computerized systems " I reported on a case (case #2) o...

Đọc thêm »

Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day

At my Oct. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure</a>" and others in this query link on medical record privacy, <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> I wrote: <blockquote>"Don't worry, your medical data's safe." </blockquote> In Jan 2012 I then posted about Joseph Conn of ModernHealthcare.com's article "<a href="http://hcrenewal.blogspot.com/2012/01/2011-closes-on-note-of-electronic.html">2011 Closes on a Note of Electronic Medical Record Privacy Breach Shame</a>." Don't worry, though; the IT industry's leader, finance, to which medicine is always compared, has gotten closer to getting the situation under control: From MSNBC: <a style="font-weight: bold;" href="http://redtape.msnbc.msn.com/_news/2012/03/30/10940640-mastercard-visa-confirm-credit-card-data-theft-described-as-massive"></a><blockquote><a style="font-weight: bold;" href="http://redtape.msnbc.msn.com/_news/2012/03/30/10940640-mastercard-visa-confirm-credit-card-data-theft-described-as-massive">MasterCard, Visa confirm credit card data theft described as 'massive'</a> March 30, 2012 By Bob Sullivan Law enforcement officials are investigating what appears to be a massive theft of U.S. consumers' credit card data, MasterCard and Visa confirmed Friday. The computer security expert who first reported the theft said it might involve as many as 10 million MasterCard and Visa accounts, making it one of the largest known credit card heists. "MasterCard is currently investigating a potential account data compromise event of a U.S.-based entity and, as a result, we have alerted payment card issuers regarding certain MasterCard accounts that are potentially at risk," that association said in a statement. "Law enforcement has been notified of this matter and the incident is currently the subject of an ongoing forensic review by an independent data security organization." The theft was first reported by well-known computer security journalist Brian Krebs on his blog, KrebsonSecurity.com. Krebs said the crime involves compromise of a credit card payment processor — a "middle man" that handles transactions between retailers and banks [like <a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/2009/10/private-medical-records-offered-for.html">these middlemen</a> in medicine? - ed.] The name of that institution is unknown, but processors have long been a target of identity thieves because of the enormous amounts of data they control. In 2008, Princeton, N.J.,-based Heartland Systems was hacked, exposing tens of millions of credit card account numbers to theft. Krebs reported that hackers had access to the unknown processors data from Jan 21 through Feb 25, and were able to siphon off enough data to easily create counterfeit cards. His sources called the leak "massive." ... Gartner security expert Avivah Litan said she's been told that the stolen data is already being used on the street by identity thieves."I’ve spoken with folks in the card business who are seeing signs of this breach mushroom. Looks like the hackers have started using the stolen card data more recently," she said.</blockquote> Read the whole article at the link. Don't let this trouble you, however. The problem is getting closer to a solution with each mega-break in. They'll have it fixed any day now, so have no fear telling your EHR-equipped doctor all your private and most sensitive medical business. -- SS

Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day

At my Oct. 2011 post " Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your ...

Đọc thêm »

Conflicts of Interest or Bribes? - Biomet, Smith & Nephew Settle

More justifications of physicians' and other health care professionals' financial arrangements with industry have been appearing in the media and the medical literature (for recent examples, look <a href="http://hcrenewal.blogspot.com/2012/03/another-cautionary-tale-about-conflicts.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/03/logical-fallacies-in-defense-of.html">here</a>). Most commonly, the relationships they defended could be characterized as health care professionals consulting or sitting on advisory boards for industry, or receiving royalties from industry for their intellectual property. In the last two months, two device manufacturers, Biomet and Smith & Nephew, accepted penalties for less defensible financial relationships with physicians. They entered into deferred prosecution agreement and settled charges that they bribed doctors employed by foreign governments. Some of these relationships, especially those involving Biomet, would have been prospectively indistinguishable from the sorts of conflicts of interest that have been so fervently defended. Background Starting in 2007, we posted (<a href="http://hcrenewal.blogspot.com/2007/11/orthopedic-device-makers-reveal.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/11/few-answers-and-many-more-questions.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/11/one-more-payment-to-academic-health.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/stories-about-device-manufacturers.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">here</a>) about the payments, often huge, that five manufacturers of prosthetic joints, <a href="http://www.biomet.com/">Biomet</a>, DePuy Orthopaedics,a unit of <a href="http://www.jnj.com/">Johnson & Johnson</a>, Stryker Orthopedics,a unit of <a href="http://www.stryker.com/">Stryker Inc</a>, <a href="http://www.zimmer.com/">Zimmer Holdings</a>, and <a href="http://www.smith-nephew.com/">Smith & Nephew</a>, revealed they made to orthopedic surgeons and various academic and other organizations in the US. All companies except Stryker were charged with "criminal conspiracy to violate anti-kickback laws," and all were subject to deferred prosecution agreements.  (Stryker entered into a voluntary compliance agreement.)  According to a US Department of Justice <a href="http://www.justice.gov/usao/nj/Press/files/pdffiles/Older/hips0927.rel.pdf">news release</a>, the agreements required: <blockquote>• A federal monitor will be in place at each company to review compliance with the DPAs and NPA and all new and existing consulting relationships with the companies; • Each company is required to conduct a needs assessment to determine the reasonable needs for educational consulting services, and new product-development consultants. • All new consulting agreements shall require physicians to disclose their financial engagements with any company to their patients and require the companies to disclose the name of each consultant and what they have been paid on the company website.</blockquote> These agreements ended in 2009. The Latest Settlements As we <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">noted</a>, in 2011, Johnson and Johnson admitted its subsidiaries, including DePuy, had been bribing doctors in Europe through 2007, and agreed to yet another deferred prosecution agreement. Smith & Nephew Last month, Bloomberg <a href="http://www.bloomberg.com/news/2012-02-06/smith-nephew-agrees-to-pay-22-million-to-settle-u-s-bribery-allegation.html">reported</a>: <blockquote>Smith & Nephew Plc, Europe’s biggest maker of artificial hips and knees, agreed to pay $22.2 million to settle allegations by the U.S. Justice Department and Securities and Exchange Commission that it engaged in a scheme to pay bribes in Greece. Smith & Nephew admitted in filings today in federal court in Washington that two of its units were involved in a scheme for more than a decade to make 'illicit payments' to doctors employed by government hospitals or agencies in Greece in violation of the Foreign Corrupt Practices Act. The London-based company, which entered into a deferred prosecution agreement with the U.S., agreed to pay a $16.8 million fine to settle the criminal allegations and another $5.4 million to settle a civil suit filed by the SEC. </blockquote> The colorful specifics were: <blockquote>Smith & Nephew admitted that from 1997 until June 2008, its U.S. and German units bribed public doctors in Greece to win business. The bribes were paid through a person described in court documents as a 'Greek distributor.' This person used shell companies that masked bribes as 'marketing services,' according to the statement of facts filed in the criminal case. The document cites a March 2002 e-mail from the Greek distributor to a Smith & Nephew vice president in Memphis, Tennessee, complaining that the 'marketing services' payments weren’t enough, noting that competitors were paying 30 percent to 40 percent more. 'I absolutely need this fund to promote my sales with surgeons,' the distributor said in the e-mail, according to prosecutors. Reforming a corrupt and dysfunctional public health system was one of the conditions of Greece’s acceptance of a European Union and International Monetary Fund bailout package in 2010. Doctors also supplement their income with payments from patients, called 'fakelaki,' small envelopes with cash for prompt treatment. </blockquote>In the <a href="http://www.sec.gov/litigation/complaints/2012/comp22252.pdf">SEC complaint</a>, the payments made to the physicians were described as "commissions." Note that the company made the usual sort of statement, <blockquote>'We have what I believe to be a world-class compliance program, having enhanced it significantly since this investigation began in 2007,' Olivier Bohuon, Smith & Nephew’s chief executive officer, said in a statement. 'These legacy issues do not reflect Smith & Nephew today.' </blockquote> He did not mention why the payments were continuing at a time when the company was already supposedly operating under the previous deferred prosecution agreement that arose out of the charges in the US discussed above. Biomet This week, the Indianapolis Star <a href="http://www.indystar.com/article/20120327/BUSINESS/203270312/Indiana-medical-device-maker-Biomet-settles-bribe-case">reported</a>, <blockquote>To sell its products abroad, medical device maker Biomet at times bribed doctors with cash, travel and meals, the federal government says. The Warsaw, Ind.-based company agreed Monday to pay nearly $23 million to settle allegations that its payments to doctors violated the federal Foreign Corrupt Practices Act. The Securities and Exchange Commission alleges that Biomet, acting through four subsidiaries and its distributors, paid bribes from 2000 to 2008 to doctors in Argentina, Brazil and China in order to win business. The settlement includes a $17.3 million criminal fine and $5.6 million to the SEC, the government and company said in separate news releases.</blockquote> The details were, <blockquote>he SEC accused Biomet of writing phony invoices to cover kickbacks as high as 20 percent of sales to push its products. In other instances, Biomet provided doctors with money and travel in exchange for implanting artificial joints and other Biomet products in their patients, says the SEC complaint, which was filed in federal court in Washington. In China, Biomet vendors gave doctors cash upon completion of surgeries using Biomet implants, the lawsuit says. 'I've got to send him to Switzerland to visit his daughter,' a Biomet distributor wrote in a 2001 email to the company, describing a trip given as a reward to a Chinese doctor who implanted 10 Biomet hips and knees a month in patients. The SEC said Biomet's compliance and internal audit functions failed to stop the practices even after determining they were illegal.</blockquote> Note how Biomet accounted for the payments, <blockquote>The payments were falsely recorded on company books as 'commissions,' 'royalties' and 'scientific incentives,' the Justice Department said.</blockquote> Furthermore, the Fort Wayne Journal-Gazette <a href="http://www.journalgazette.net/article/20120328/BIZ/303289938/1031/BIZ">added</a>, <blockquote>With the settlement announced Monday, the Justice Department found that Biomet and its subsidiaries covered up bribery payments by officially recording them as 'consulting fees' or 'commissions.'</blockquote> Note that Biomet's official response was similar to Smith & Nephew's, as reported in another <a href="http://www.journalgazette.net/article/20120327/BIZ/303279978">article</a> from the Fort Wayne Journal-Gazette, <blockquote>Jeffrey Binder, Biomet’s president and CEO, didn’t address the company’s guilt or innocence in a written statement released Monday. Biomet has 'significantly enhanced' its procedures worldwide in recent years to ensure employees’ conduct is legal and ethical, he said. 'Moving forward, we intend to continue to adhere to our enhanced global compliance procedures, and to promote the company’s commitment to the highest ethical standards in all the markets that we serve,' Binder said. </blockquote> Again, he did not explain why this time the enhanced compliance procedures are likely to work, given that the questionable conduct was still going on after the company had already entered into the 2007 deferred prosecution agreement. Summary Some Apparent Conflicts of Interest are Actually Bribes In these cases, two medical device corporations paid doctors in several countries for implanting their products into patients. The resulting legal proceedings allow us to characterize these actions as bribes. Clearly both the companies' and the physicians' actions were unethical, since they lead to decisions that put the enrichment of the decision makers and those bribing them ahead of the patients' interests. Some of the most common financial arrangements between health care professionals and industry that are thought of as conflicts of interest are paid consulting and payment of royalties for intellectual property. As we have discussed, e.g. <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">here</a>, conflicts of interest in medicine and health care are generally thought to raise the likelihood of corruption, but not necessarily to indicate corruption in specific instances. In the cases above, bribes were sometimes called "consulting payments or royalties." This suggests that some consulting payments and royalties which may commonly be thought of as conflicts of interest are outright bribes, that is, outright <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">health care corruption</a>. Those who fervently defend conflicts of interest as inevitable, and necessary for collaboration and hence innovation (e.g., look <a href="http://hcrenewal.blogspot.com/2012/03/logical-fallacies-in-defense-of.html">here</a>), often minimize the adverse effects of these conflicts (e.g., look <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">here</a>). In fact, any putative benefits of such conflicts ought to be contrasted with their possible harms. These cases make it clear that these harms include outright corruption which may be disguised as mere conflicts of interest. This adds strength to arguments that conflicts of interest ought to be minimized or eliminated, not tolerated and "managed." Current Measures to Enforce Laws Against Bribes and Kickbacks are More Theatre than Deterrent The current cases are just the latest members in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a>. We have noted that misbehavior in large health care organizations rarely leads to any negative consequences for the people who authorized, directed or implemented the offending actions. Instead, the penalties are, at most, fines paid by the organizations, not the people involved, and variants of deferred prosecution and/or corporate integrity agreements. We and <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">others</a> have previously argued without negative consequences affecting the people who authorize, direct or implement unethical actions, such actions will continue. The current cases corroborate this. Corporations that had already paid fines and accepted deferred prosecution agreements for bribes to physicians continued to bribe other physicians. The failure of the offending corporations to admit any wrongdoing, or the need for specific changes of behavior in the future, suggests that the current fines and deferred prosecution agreements will not be any more effective than the previous ones. The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.   As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.

Conflicts of Interest or Bribes? - Biomet, Smith & Nephew Settle

More justifications of physicians' and other health care professionals' financial arrangements with industry have been appearing in ...

Đọc thêm »

Tulane/BRG Resident Sues The Hospital: Former Medical Resident Sues for Abuses

My own medical internship was needlessly abusive in terms of sleep deprivation, treatment of interns as chattel by the Chief and some particularly nasty attendings, and the behaviors of some residents who were determined to return the hazing they'd received to the new intern 'plebes.' The abuses ultimately led to high levels of risk to patients. I wrote about my training experiences in my Sept. 2007 post "<a href="http://hcrenewal.blogspot.com/2007/09/in-on-sleep-deprivation-and-medical.html">Metric myopia: does reducing exploitation of medical trainees have 'little effect' on patients?</a>" [1] However, in those days medical trainees were generally helpless to do anything about it. Most sucked the abuse up without complaining. In some cases they became victims of a form of the <a href="http://en.wikipedia.org/wiki/Stockholm_syndrome">Stockholm Syndrome</a>. (In my case, I picked up and left the hospital after the PGY-1 internship year and went to other hospitals to complete my residency which were, at the time, of better quality and far less abusive. The jarring PGY-1 experience in part informs my writing on healthcare abuses in general at this blog. The original hospital went bankrupt a few years ago; this was no surprise to me.) At HC Renewal, the posts on "physician learned helplessness" such as <a href="http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/02/physician-expected-helplessness.html">here</a> in part focus on the effects of postgraduate medical training abuses. So, whatever the truth and ultimate outcome, you at least have to admire this Resident (or, I should say, ex-Resident), who both sued and put up his own website about the suit, for his tenacity: <blockquote><a style="font-weight: bold;" href="http://www.brglawsuit.com/">Former Tulane/BRG Resident Sues The Hospital</a> A whopping 182 million dollar lawsuit against Tulane/Baton Rouge General Medical Center and various local doctors was filed by former Tulane/Baton Rouge General Internal Medicine Resident, Dr. Eid Amer on March 19, 2012 in the 19th Judicial District Court of Louisiana. Among the counts in this enormous fifty page lawsuit are: breach of contract, fraud, forgery, negligence, defamation, intentional infliction of emotional distress, invasion of privacy, violation of the whistleblower statute and violation of due process. Dr. Amer, a thirty-year old physician was in his first year of a three-year categorical internal medicine residency program when he suffered retaliation from his program superiors after submitting a series of complaints regarding medical negligence, defamation, fraud and forgery that culminated in his retaliatory discharge just over two weeks from his last complaint to the CEO of the hospital William Holman who did nothing about it, the complaint alleges.</blockquote> Details of the issues are at the website. They focus on Dr. Amer's whistleblowing about violations of the 80-hour-per-week rule instituted after the Libby Zion affair (the "<a href="http://en.wikipedia.org/wiki/Libby_Zion_law">Libby Zion law</a>"), retaliation for complaints about the violations, psychological abuses of the trainees that sound all too familiar, and patient care risks (e.g., as detailed in <a href="http://www.brglawsuit.com/duringresidency.htm">this long page</a>). The Complaint docket is available in PDF at <a href="http://www.brglawsuit.com/Lawsuit%20stamped.pdf">this link</a>: Eid Amer, MD vs. Baton Rouge General Medical Center, General Health System, Tulane Univ. School of Medicine, and a host of individual plaintiffs. This is certainly speaking out against the ingrained abuses of the medical training system. I cannot comment on the merits of this case, but can say from my own personal experience, and that of many colleagues, that the claims are certainly plausible. I wish this doctor luck. He will need it. -- SS [1] I could not at first locate that old post. However, I remember so vividly being compelled - at explicit threat of career jeopardy - as a PGY-1 to do pelvic exams in the middle of the night on disabled febrile female patients from the <a href="http://www.inglis.org/nursinghome.jsp">Inglis House</a> nursing home in Philadelphia (for the mentally normal but severely physically handicapped) with UTI's, pneumonia and other problems, that a search on "pelvic exam" brought the post right up. One does not easily forget experiences like that.

Tulane/BRG Resident Sues The Hospital: Former Medical Resident Sues for Abuses

My own medical internship was needlessly abusive in terms of sleep deprivation, treatment of interns as chattel by the Chief and some partic...

Đọc thêm »