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Health Care Revolving Door Roundup

Increasingly, the regulatory and law enforcement functions of the US government in the health care sphere seem to be blending with the management of large health care organizations.  One mechanism for this is the "revolving door," the constant interchange of personnel between government agencies and corporate management.  Here is a list of some of this year's interesting cases of people transiting the revolving door between US government agencies that are supposed to regulate health care organizations or enforce the relevant laws and the organizations subject to these regulations and laws.   Note that this list may not be complete.  It is difficult to keep track of these transitions.  Leader of Health Care Fraud Section of Philadelphia US Attorney's Office to Teva Pharmaceuticals <a href="http://www.mainjustice.com/2013/03/03/former-health-care-fraud-chief-in-philly-joins-teva-pharmaceuticals/">Via</a> MainJustice.org in March, 2013, <blockquote class="tr_bq">John Pease, who led the government and health care fraud section in the U.S. Attorney's Office in Philadelphia, has left the Justice Department for a job with a pharmaceutical company. Pease, 45, is a new senior counsel at Teva Pharmaceuticals, where he oversees government investigations of the company for the Americas.  'I was just ready to try something different,' Pease said in an interview.</blockquote>  Leader of US Department of Justice Fraud Section in Charge of Health Care Issues to Law Firm as Defender of Companies and Senior Executives The initial notice again was <a href="http://www.mainjustice.com/2013/03/25/health-care-fraud-unit-chief-sheldon-joins-quinn-emanuel/">via</a> MainJustice.org in March, 2013 <blockquote class="tr_bq">Sam Sheldon, the deputy chief in the Criminal Division's Fraud Section who oversaw health care fraud prosecutions, is leaving the Justice Department to join Quinn Emanuel Urquhart & Sullivan LLP.</blockquote> Mr Sheldon's new job was made clear on the firm's <a href="http://www.quinnemanuel.com/attorneys/sheldon-sam-s.aspx">website</a>, <blockquote class="tr_bq">Sam Sheldon is head of the firm’s Health Care Practice Group.  He is a trial lawyer who represents companies and senior executives in litigation before the United States federal government including Department of Justice and Department of Health and Human Services, and other law enforcement and regulatory agencies.</blockquote> FDA Deputy Commissioner for Global Regulatory Operations and Policy to Mylan This <a href="http://www.reuters.com/article/2013/04/30/us-mylan-fda-idUSBRE93T12D20130430">story,</a> in April, actually made it (briefly) to Reuters, <blockquote class="tr_bq"> n">Generic drugmaker Mylan Inc said on Tuesday it hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.</blockquote> Leader of Health Care Fraud Enforcement of Philadelphia US Attorney's Office to Law Firm as Industry Defender <a href="http://www.bloomberg.com/news/2013-08-07/morrison-foerster-vinson-elkins-cravath-business-of-law.html">From Bloomberg</a>, in August, 2013, <blockquote class="tr_bq">Marilyn May, a False Claims Act litigator at the U.S. Justice Department, joined Arnold & Porter<a href="http://topics.bloomberg.com/arnold-%26-porter/"></a> LLP’s Washington office as litigation counsel with a focus on healthcare, pharmaceutical and medical device industry defense work.  May was the head of healthcare fraud enforcement in the U.S. Attorney’s Office in the Eastern District of Pennsylvania. She coordinated healthcare fraud cases and investigations as well as handled False Claims Act cases involving pharmaceutical and medical device companies, hospitals, nursing homes and other healthcare providers, the firm said. </blockquote> The law firm's <a href="http://www.arnoldporter.com/professionals.cfm?action=view&id=6531">website</a> states, <blockquote class="tr_bq"> Her litigation practice focuses on pharmaceutical, medical device and healthcare defense matters.</blockquote> Summary In each of these cases, a person with responsibility for regulation of and/or law enforcement for health care organizations went through the revolving door to either work for health care corporations subject to such regulation and/or law enforcement, or work for legal firms that specialize in defending such corporations and their leaders in regulatory and law enforcement actions. As far as I know, none of these instances was the least bit illegal.  However, like previous examples of the revolving door, they raise the concern that people in government regulation or law enforcement who think that they may have future lucrative job prospects helping health care organizations attenuate regulation and law enforcement may not be the most enthusiastic, aggressive, or persistent regulators or law enforcers.  Why would one want to upset one's future employer? While these cases of the revolving door are legal, they are clearly conflicts of interest in the sense that the prospect of such future employment likely may increase the risk of compromising a government official's devotion to serving the public and enforcing the law, if not in the legal sense.  In some particular case, the revolving door may actually lead to corruption according to the Transparency International definition, abuse of entrusted power for private gain, if not according to the legal definition.  Thus the continuing occurrence of government officials blithely transiting the revolving door no doubt was a reason that more than 40% of the public consider the US health care sector to be corrupt (see <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">this post</a>.) True health care reform would require curtailing the severe sorts of conflicts of interest created by the revolving door.  This might require both improving pay and working conditions for government regulators and law enforcers, and specific laws to prevent immediate transitions from being a regulator/ law enforcer to handling corporate responses to or defenses of such regulation and enforcement. Of course, I can already hear the protests of those people who decry paying more for government or increasing government regulation.  I can at least hope that the protests are not from those who personally profit from the current seemingly corrupt system.

Health Care Revolving Door Roundup

Increasingly, the regulatory and law enforcement functions of the US government in the health care sphere seem to be blending with the manag...

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Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are. (Definition of bad health IT is here:  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a>) I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering. <ul><li><a href="http://hcrenewal.blogspot.com/2013/08/another-health-it-glitch-can.html">Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?</a> </li></ul><ul><li><a href="http://hcrenewal.blogspot.com/2013/08/can-digital-disappearing-ink-ehr-glitch.html">Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2</a></li></ul> Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a>), and the others posted at this blog at query link: <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>, the following issue needs serious consideration by policymakers. Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing. The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information.  It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher  - conservatively, I believe, at least two orders of magnitude. Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to  reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals. The workarounds also cause users to: 1)  have to deviate from habits of use acquired in training and active use of the systems in question; 2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology; 3) keep in mind any other extant workarounds that exist waiting for "fixes"; and 4) be constantly on guard for information storage failures. In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety.  If these were more conventional medical devices, they'd be recalled. See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html</a>) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(<a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html">http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html</a>) for examples where health IT defects similar to the Siemens issues were, in fact, recalled. Further, with paper records or tangible images, a page or image can be lost, or it can be illegible.  In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly.  Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions. On the other hand, when electronic systems: 1)  lose modified information en masse as in the Siemens examples but keep the old, or 2)  when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>), or 3)  images are lost (see "Potential Image Loss in GE Centricity PACS" here:  <a href="http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html">http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html</a>) without warning- - There are no "flags" that the obsolete, truncated or missing information is erroneous. What remains is perfectly legible, perfectly convincing and perfectly deceiving. Electronic healthcare information systems on their face create more risk than paper record systems.  Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation.  Every new upgrade or patch is suspect for introducing new bugs. Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ... Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper.  Further, hundreds of billions of dollars can certainly buy: 1)  a lot of Health Information Management professionals to perform continuous QA of paper, 2)  a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and 3)  a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at <a href="http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html">http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html</a>. 4)  a lot of sensible regulation of this industry's product quality. -- SS

Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are. (Definition of bad health IT is here: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ ) I recent...

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Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

At "<a href="http://hcrenewal.blogspot.com/2013/08/another-health-it-glitch-can.html">Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?</a>" just yesterday, on August 5, 2013, I wrote about a Siemens EHR "glitch" worse than any paper records system problem.  Typed order changes in the medication reconciliation process on patient discharge are disappearing into thin air, unknown to the clinicians typing the orders.  This is likely due to an issue such as some programmer forgetting to put in a statement to write the text to disk, complicated by software testing problems that missed the defect. I noted: <blockquote class="tr_bq">... "<a href="http://hcrenewal.blogspot.com/search/label/glitch">Glitch</a>" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm).  The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).</blockquote>  Paper records may have illegible writing that would generally cause the reader to make a phone call or otherwise contact the writer, but those events are one-offs.  EHR defects potentially affect hundreds of installations and thousands of patients, en masse.  (If patients are not dying en masse from such errors, then the whole argument against paper and for IT on the issue of vastly improved safety goes out the windows, but that's an argument for another time.) Siemens has just released another "glitch" announcement, this time with CPOE (computerized order entry): <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/AVvXsEhlf06mny1stnwAAlLHkyNdwsIaVZoVr4Ftj3MJ0gFspDqC1S8mEHtybkYsgnOntpI-v6uI4j8BUP-XAo0YeldipSlCT8MguHKKiDepn-YABtnVzVy9PpNTY5a43jQDrNAqV54fZYw9CAz1/s1600/Siemens_CPOE.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlf06mny1stnwAAlLHkyNdwsIaVZoVr4Ftj3MJ0gFspDqC1S8mEHtybkYsgnOntpI-v6uI4j8BUP-XAo0YeldipSlCT8MguHKKiDepn-YABtnVzVy9PpNTY5a43jQDrNAqV54fZYw9CAz1/s400/Siemens_CPOE.bmp" width="307" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">(Medication orders "glictch" safety complaint.  Click to enlarge, text below)</td></tr></tbody></table> Text is as follows: <blockquote class="tr_bq">August 2, 2013 Safety Advisory Notification Soarian® Clinicals Medication Orders, Safety Complaint ID# EV06643783 Dear Customer: This notification is to inform you that the Soarian Clinicals Medication Orders may not be operating properly in some cases in Soarian Clinicals 3.3 Service Pack 6 and above.</blockquote> I note that "glitches" are not uncommon after software patches and upgrades.  See examples at the query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.   This reflects inadequate vetting of the patches. I also note that "medication orders not operating properly" is a very, very serious matter. <blockquote class="tr_bq">Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.</blockquote> "May only affect some customers?" (I suspect from this double-indefinite that who is affected is not rigorously known).  "Taking a conservative approach?"  I ask:  what would a non-conservative approach entail? <blockquote class="tr_bq">This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.</blockquote> Again, they mean "yet." When does this issue occur and what are the potential risks? <blockquote class="tr_bq">The issue occurs while placing medication orders. In certain cases, when users select orders from predefines or personal favorites and make changes on the order detail forms, the changes are correctly saved and displayed on the forms but the Order As Written (OAW) is not refreshed to reflect the changes. The incorrect OAW is displayed in Siemens Pharmacy in the Order As Written window but the discrete order details are correct. As a result dispensing or administering relying solely on the OAW prior to pharmacy validation may result in error.  [Putting patients directly in harm's way, patients who never consented to the use of these experimental and unvetted medical devices - ed.]  Once the order is validated the OAW in Soarian is updated correctly.</blockquote> This problem - manually changed data apparently not written to disk - seems similar to the "digital disappearing ink" med reconciliation bug in the aforementioned Aug. 5, 2013 post. Immediate steps you should take to avoid the potential risk of this issue: <blockquote class="tr_bq">To prevent this issue from occurring at your facility, dispensing or administering of unvalidated order should rely on the order details displayed. Secondly, any deviations from the predefined or personal favorites should be phoned in to pharmacy as a verbal order. During validation, if the pharmacist sees a discrepancy between the order detail and the OAW, verbal follow up with the ordering physician is required.</blockquote> Again, a workaround.  How many times will this workaround be forgotten, compared to issues of illegibility in a paper record resulting in a phone call to the writer? <blockquote class="tr_bq">Steps that Siemens is taking to correct this complaint: We are diligently working to develop a correction and will test and deliver it as soon as possible.</blockquote> Perhaps they should have been working more diligently to detect the "glitch" before it went live. Also, perhaps the touted power of EHRs to reduce medical errors needs to be re-examined.  Considering bugs like these - creating en-masse problems far worse than possible with paper (another en-masse example at <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>) - then, if the EHRs are so essential to safety, one would expect significant morbidity and mortality from these defects. If one is to believe patients are not being injured by "glitches", then the expenditure of hundreds of billions of dollars for these systems on the basis of "error reduction" compared to paper is likely a waste of money and resources. --  SS

Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

At " Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients? " just yesterday, on August 5, 2013, I wro...

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The Mystery of the Northwestern Settlement

Watson, quick, the game's afoot.  We have discussed a large number of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations that serve as markers of misbehavior and often lack of leaderships' responsibility for same.  These settlements often follow a common pattern.  Yet this week a settlement appeared that was quite different, and hence raised some important questions. The Basics of the Settlement I will summarize the settlement as <a href="http://online.wsj.com/article/SB10001424127887324170004578638351789022658.html">described</a> by the Wall Street Journal.  The basic points were: <blockquote class="tr_bq">Northwestern University agreed to pay nearly $3 million to settle claims that a former cancer researcher fraudulently used federal grant money for personal expenses, including food, hotels and airfare for family trips between 2003 and 2010. The settlement in the civil suit was unsealed Tuesday by the U.S. Attorney for the Northern District of Illinois, which investigated claims brought by a whistle blower under the False Claims Act.</blockquote> The settlement seemed to be more about the researcher, Dr Charles L Bennett, than Northwestern, <blockquote class="tr_bq">At the time of the alleged fraud, Dr. Bennett was the principal investigator on research funded by the National Institutes of Health, studying adverse drug events, multiple myeloma, a blood disorder known as thrombotic thrombocytopenic purpura, and quality of care for cancer patients. <a href="http://www.blogger.com/null" name="U902207295947GR"></a> According to the settlement agreement, he allegedly billed federal grants for family trips, meals and hotels for himself and friends, and for 'consulting fees' for unqualified friends and family. Northwestern also allegedly improperly subcontracted, at Dr. Bennett's request, with various universities for services that were paid for by the NIH grants. <a href="http://www.blogger.com/null" name="U902207295947OO"></a> 'Allowing researchers to use federal grant money to pay for personal travel, hotels, and meals and to hire unqualified friends and relatives as 'consultants' violates the public trust and federal law,' U.S. Attorney Gary S. Shapiro said in a statement.</blockquote> Meanwhile, <blockquote class="tr_bq"> Northwestern, which is in Evanston, Ill., cooperated with the investigators and didn't admit to any wrongdoing, according to a statement by the university.</blockquote> The settlement was the result of the actions of a purported whistle-blower, <blockquote class="tr_bq">The whistleblower, Melissa Theis, worked as a purchasing coordinator in the Feinberg school's department of hematology and oncology, processing invoices when she 'noticed some red flags,' according to her attorney, Linda Wyetzner, of the Evanston firm Behn & Wyetzner Chartered. <a href="http://www.blogger.com/null" name="U902207295947A3G"></a>The federal False Claims Act allows private citizens who allege government programs are being defrauded to file actions on behalf of the government and receive a portion, usually 15% to 30%, of any recovered damages. Ms. Theis will get $498,100 in settlement proceeds, according to the agreement.</blockquote> The settlement resulted from the efforts of multiple federal agencies, <blockquote class="tr_bq"> The allegations were investigated by the NIH, Federal Bureau of Investigation, U.S. Department of Health and Human Services Office of Inspector General and the U.S. attorney's office.</blockquote> Curious Aspects and the Questions They Raise So here is yet another settlement by a large health care organization, in this case, the prestigious academic medical center of a well known university.  This one, however, does not follow the usual pattern, and includes some quite curious aspects. Media Attention vs Severity The settlement so far has generated articles in the WSJ (above), the Chicago Tribune, the Chicago Sun-Times, Crains Chicago Business, Medscape, Modern Healthcare, UPI, Bloomberg, other local Chicago and university publications, and local outlets in South Carolina, the state in which Dr Bennett currently works.   The amount of the grants that Dr Bennett allegedly misused was $8 million, according to the University Herald. There are no allegations that any activities of Dr Bennett or the university affected the quality of clinical research, clinical teaching, or patient care. Contrast that substantial media attention to that generated by another recent settlement we just discussed, that of Pfizer misbranding of Rapamune (look <a href="http://hcrenewal.blogspot.com/2013/07/pfizers-umpteenth-settlement-for-491.html">here</a>.)  This involved the excess promotion of a relatively dangerous drug that likely resulted in harm to many patients.  The over-promotion may have caused up to 90% of the drug's $200 million yearly sales.  The settlement itself was for $491 million.  Yet while it got more coverage, mainly from local media outlets which covered it because the settlement will result in payments to individual states, only four big national outlets have covered it so far, again the Wall Street Journal, and  the New York Times, Reuters and Businessweek. Why did a relatively small settlement of alleged financial misbehavior without clinical implications get nearly as much attention as a settlement fifty times bigger that involved actions that likely harmed patients? Intensity of the Government Response Dr Bennett's alleged misuse of grant funds required investigation by four different federal agencies, including the FBI.  Pfizer's misbranding of a dangerous drug seemingly was handled only by one, and the FBI was not obviously involved.  In fact, the FBI rarely has rarely been mentioned in the media coverage of most of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> we have discussed. Why did again a case of relatively small alleged financial misbehavior require such massive federal resources when much bigger cases which had implications for clinical care, policy, or research seemed to command lesser resources? Naming and Shaming The settlement did not involve any admission of any wrongdoing by Northwestern. In contrast, nearly all the news coverage of this settlement emphasized the role of Dr Charles L Bennett.  The coverage seemed to be following the lead of the Department of Justice <a href="http://www.justice.gov/usao/iln/pr/chicago/2013/pr0730_01.html">press release</a>, which included, <blockquote class="tr_bq"> Northwestern allegedly allowed one of its researchers, Dr. Charles L. Bennett, to submit false claims under research grants from the National Institutes of Health. The settlement covers improper claims that Dr. Bennett submitted for reimbursement from the federal grants for professional and consulting services, subcontracts, food, hotels, travel and other expenses that benefited Dr. Bennett, his friends, and family from Jan. 1, 2003, through Aug. 31, 2010.</blockquote> Yet Dr Bennett appeared not to be a party in this settlement, and it was unclear whether he had a direct opportunity to respond to it.  The Wall Street Journal did note that after it was announced, <blockquote class="tr_bq"> James M. Becker, an attorney for Dr. Bennett, said, 'We deny the allegations.…We are actively engaged in discussions to resolve the allegations.'</blockquote> We have discussed numerous <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations, often involving hundreds of millions or even billions of dollars, sometimes involving guilty pleas by the companies involved or their subsidiaries.  Almost never do these settlements name or involve in any way persons who authorized, directed, or implemented the misbehavior.  In fact, we have commented again and again about the <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> of health care organizational managers and executives.  For example, the recent $491 million Pfizer settlement did not name or punish any individuals.  Furthermore, Pfizer's $2.3 billion settlement for deceptive marketing of a drug later pulled from the market (Bextra) did not name much less penalize any responsible individuals (look <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>.)  Also, GlaxoSmithKline's $3 billion settlement of numerous unethical practices did not name much less penalize any responsible individuals (look <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">here</a>). So why was naming and shaming Dr Charles L Bennett such an important part of the relatively small Northwestern settlement, when much larger settlements, many involving unethical behavior that could have harmed patients or distorted medical research, and some of which involved corporate guilty pleas to criminal charges did not involve naming and shaming any responsible person?       How Accountable was Dr Bennett? As in the Wall Street Journal version, the settlement implies that Dr Bennett was the person most responsible.  The Chicago Sun-Times <a href="http://www.suntimes.com/news/21623742-418/northwestern-to-pay-nearly-3-million-to-settle-cancer-research-fraud-suit.html">put it</a> this way, <blockquote class="tr_bq"> Dr. Charles L. Bennett allegedly took his wife on personal trips, then illegally billed the flights, hotels and meals to the National Institutes of Health, claiming it was part of his cancer-fighting work. And he allegedly submitted phony bills for his work over a seven-year period beginning in 2003.</blockquote> Here I will have to interject a bit of information about how federal grants work.  As I learned when I was a young faculty member, and as I confirmed with several other experienced researchers who have run and reviewed federal grants, these grants are made to institutions.  In the current case, the grant apparently went to Northwestern University.  The institution that receives the grant is responsible for making all payments and disbursements related to that grant.  The grant's Principal Investigator is responsible for the scientific conduct of the grant, but NOT payments, disbursements, business management or accounting.  The Principal Investigator can request that payments be made for various things, including travel expenses and consulting work.  But the Principal Investigator cannot directly authorize or make these payments.  They are authorized, signed, and made by institutional administrators, usually in grants and contracts offices or the equivalent, and usually only after copious paperwork to justify the payments. So Dr Bennett may have requested reimbursement for travel expenses, or requested the university to hire a consultant.  But university managers must have made those payments, unless the university's grants administration mechanism had completely broken down.  Note that given the usual ways grants are administered, it would appear that Ms Theis, the ostensible whistle-blower, who will receive nearly one half of a million dollars from this settlement, actually may have had more direct responsibility for making the payments in question than did Dr Bennett. Presumably, that is why the settlement was made by Northwestern. Why then did the settlement, the DOJ press release, and the media coverage so emphasize Dr Bennett's responsibility, and so minimize the role of the university?   Was Anyone Else Accountable? The DOJ press release, and all the media articles on the case,  save one, mention only Dr Bennett as the person at fault.  Crain's Chicago Healthcare Daily, however, <a href="http://www.chicagobusiness.com/article/20130801/NEWS03/130809990/northwestern-fraud-settlement-includes-key-researcher">suggested</a> someone else was responsible, <blockquote class="tr_bq">Northwestern University's nearly $3 million settlement of fraud claims by the federal government protects the director of the school's cancer center, who allegedly failed to supervise a researcher who used grant money to cover personal expenses over a seven-year period. Dr. Steven Rosen, director of the <a href="http://cancer.northwestern.edu/home/index.cfm" target="new"">Robert H. Lurie Comprehensive Center for Cancer,</a> and Dr. Charles L. Bennett, a researcher who is no longer with the center, were both named in a whistleblower complaint unsealed on Tuesday, <a href="http://www.chicagobusiness.com/article/20130730/NEWS03/130739982/northwestern-to-pay-u-s-3-million-to-settle-fraud-claims">when the settlement was announced.</a> Dr. Bennett used federal grant money for family trips and fraudulent consulting fees for his brother and cousin from 2003-10, the government alleges. Dr. Rosen 'failed to exercise appropriate responsibility,' Randall Samborn, a spokesman for the U.S. Attorney's office said. 'It was a supervisory function that he didn't adequately fulfill.' When the settlement was announced, Mr. Samborn said the agreement did not cover either doctor. On Wednesday, he corrected himself, saying that settlement covered Dr. Rosen, but not Dr. Bennett.</blockquote> As I noted above, the way federal grants work, it was the university, and its managers and leaders, who were responsible for making all payments on this and other federal grants. Why did the government press release and the media coverage emphasize Dr Bennett's alleged role, while ignoring any possible responsibility of anyone else, especially his supervisor? Backgrounds of the Principles Dr Bennett and Dr Rosen, who seemingly were treated so differently in this settlement, travel in very different circles. Most media articles described Dr Bennett as a prolific researcher and medical academic.  Although some described his areas of interest in hematology and oncology, only Medscape <a href="http://www.medscape.com/viewarticle/808784">described</a> one particular project of his.   <blockquote class="tr_bq">Dr. Bennett's research efforts included a 2008 study on which he was the first author (JAMA. <a href="http://jama.jamanetwork.com/article.aspx?articleid=181533" target="_blank">2008;299:914-924</a>). The study was the first meta-analysis to identify an increased mortality risk in cancer patients associated with erythropoiesis-stimulating agents.(1)</blockquote> In fact, as we discussed <a href="http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html">here,</a>  Dr Bennett was the first author of a meta-analysis that was the first to show that epoetins increased the rates of adverse effects and death for cancer patients.  This evidence lead to reduced use of some very expensive drugs made by Johnson and Johnson and Amgen, and hence reduced revenues for both companies. The JAMA article noted that at the time he wrote it, Dr Bennett had financial relationships with Amgen.  He and a coauthor "reported serving as consultants to AMGEN and Dr Bennett reported he has received grant support from AMGEN previously." Note that Amgen pleaded guilty to misbranding its epoetin, Aranesp, and therefore paid fine and a civil settlement totaling $762 million.  Given the data on this drug class' adverse events, as shown by Dr Bennett and others, it is likely that the misbranding lead to patients being harmed by the drug without receiving any benefits (look <a href="http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html">here</a>.)  After writing that article, Dr Bennett became known as a strong skeptic of the pharmaceutical industry.  Just before the JAMA article was published, he coauthored an editorial which wondered if conflicts of interest would ever prove to be acceptable once sufficient research was done.(2)  In that article, he disclosed consulting for, and receiving honoraria and research grants from Amgen.  In 2010, he published research showing the effects of conflicts of interest on reporting of possible adverse effects based on basic science research about epoetins.(3)  By then he apparently no longer had financial relationships with Amgen.  In 2011, he reported a survey of major cases of pharmaceutical fraud resulting in legal actions.(4) Dr Bennett became known for skepticism about the practices of pharmaceutical companies, and for publishing about the harms of specific drugs, despite his previous financial relationships with Amgen.  However, Dr Rosen apparently has continued to work closely with industry.  His <a href="http://fsmweb.northwestern.edu/faculty/disclosure_profile_display.cfm?xid=15275">faculty disclosure page</a> revealed  the following industry relationships <blockquote class="tr_bq">Consulting / Related Activities Faculty member engaged in activities such as speaking, advising, consulting, or providing educational programs for the following companies or other for-profit entities: <ul><li>Allos Therapeutics, Inc. </li><li>Carden Jennings Publishing Co., Ltd. </li><li>Cerner Corporation </li><li>Dava Oncology, LP </li><li>Elorac, Inc. </li><li>Envision Communications </li><li>Health Practices Consulting - unverified entity </li><li>Plexus Communications </li><li>Prostrakan, Inc. </li><li>Seattle Genetics, Inc. </li><li>Studio ER Congressi (Triumph Group, Inc.) </li><li>The Medal Group Corp. </li></ul>In addition, faculty member received compensation for medical record consultation and/or expert witness testimony. Ownership or Investment Interests Faculty member had an ownership or investment interest in the following companies: <ul><li>AuraSense, LLC </li><li>Nanosphere, Inc. </li></ul>Royalty Payments and Inventor Share Faculty member has the right to receive payments or may receive future financial benefits for inventions or discoveries related to the following companies or other entities:</blockquote><blockquote></blockquote><ul><li><blockquote>Nanosphere, Inc. </blockquote></li></ul>We have seen various important effects of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual</a> and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional</a> conflicts of interest in health care.  We have seen <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a> and <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a> affecting government and its dealings in health care.   Did Dr Bennett's break with a powerful industry make it easier to set him up as the villain in this story? Summary    The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> whose continuation we have frequently discussed. The settlement and its media coverage raised important questions whose answers would be important to the assessment of  our current regulatory and legal response to misbehavior by and within large health care organizations.  Health Care Renewal is about raising such issues by commenting on public information, media reports, and research.  I hope those with capacity to investigate will consider these questions.  Inquiring minds want to know. Roy M. Poses MD in Health Care Renewal  References 1.  Bennett CI, Silver SM, Djulbegovic B et al.  Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin adminstration for the treatment of cancer-associated anemia.  JAMA 2008; 299: 914-924. 2.  Djulbegovic B, Angolotta C, Knox KE, Bennett CI. The sound and the fury: financial conflicts of interest in oncology.  J Clin Oncol 2007; 25:3567-3568.  Link <a href="http://jco.ascopubs.org/content/25/24/3567.full7">here</a>  3.  Bennett CI, Lai SY, Henke M et al.  Association between pharmaceutical support and basic science research on erythropoiesis-stimulating agents.  Arch Intern Med 2010; 170: 1490-1498.  Link <a href="http://archinte.jamanetwork.com/article.aspx?articleid=225937">here</a>. 4.  Qureshi Z, Sartor O, Xirasagar S, Liu Y, Bennett CI.  Pharmaceutical fraud and abuse in the United States, 1996-2010.  Arch Intern Med 2011; 171: 1503-1506.  Link <a href="http://archinte.jamanetwork.com/article.aspx?articleid=1105899">here</a>.

The Mystery of the Northwestern Settlement

Watson, quick, the game's afoot. We have discussed a large number of legal settlements by large health care organizations that serve a...

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Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

Yes, it can. There's been yet another "glitch" in the world of health IT (see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for more examples). "Glitch" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm).  The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated). This from Siemens Healthcare: <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/AVvXsEhae-yXD6c2_12_evEvfXooZahy8chrcA9i-9emaRiiLjhepoqQrXLrAvpylkMci6nKV4xjNzHvIb63yLOJ1KgYfGgmm1iqmvVyTm4207vzFOgE42H-dUEDrRwiF2pmb3tL_wrNDZjAoMeZ/s1600/siemens.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhae-yXD6c2_12_evEvfXooZahy8chrcA9i-9emaRiiLjhepoqQrXLrAvpylkMci6nKV4xjNzHvIb63yLOJ1KgYfGgmm1iqmvVyTm4207vzFOgE42H-dUEDrRwiF2pmb3tL_wrNDZjAoMeZ/s400/siemens.bmp" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge.  Text below.</td></tr></tbody></table> Text of this "Safety Advisory Notification": <blockquote class="tr_bq">August 1, 2013 Safety Advisory Notification Soarian® Clinicals Medication Reconciliation EV06736602 Dear Customer: This notification is to inform you that Soarian Clinicals Medication Reconciliation 3.3 may not be operating properly in some cases. Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.</blockquote><blockquote>This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.</blockquote> They mean "no adverse events reported - yet."  And if such events had been reported, Siemens would most certainly not make them public.  (Why should they, when there are no regulations?) <blockquote class="tr_bq">When does this issue occur and what are the potential risks?</blockquote><blockquote>This issue occurs when a user moves a free text in-house order from the current and home medications side (left side) to the discharge medication side (right side), and then modifies the continued free text in-house order in discharge reconciliation prior to saving the discharge reconciliation list. After the modification of the continued free text medication order, the changes to the free text medication order are not recorded in the saved discharge medication list.  [In other words, the changes to medication orders the user just typed disappear into thin air.  I note that medication reconciliation failures are among the most common causes of medical error - ed.]</blockquote> The health IT extremists would invoke the "Leaned Intermediary" doctrine that lays all blame for errors on the user.  It seems the only way to avoid such liability would be after every "enter" or "save" action (or perhaps every keystroke?), users then verify what was saved or entered... The "fix" to this "glitch" is not too far off from that: <blockquote class="tr_bq">Immediate steps you should take to avoid the potential risk of this issue: To prevent this issue from occurring at your facility, instruct users not to modify continued free text in-house orders on the discharge medication list. Users may be instructed to enter free text in-house orders manually by selecting the add prescription action button and entering the order.</blockquote> This is known as a "workaround."  Anyone who believes this edict can and will be 100% reliably followed in often chaotic medical environments, by users from medical students to nurses to physicians, is truly cavalier. <blockquote class="tr_bq">Steps that Siemens is taking to correct this complaint: We are diligently working to develop a correction and will test and deliver it as soon as possible.</blockquote> Perhaps FDA and Joint Commission need to inquire about exactly what testing and QC was done on the current code, testing that (if actually performed) did not detect this glaring and Siemens-admitted safety-risk "glitch." -- SS

Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

Yes, it can. There's been yet another "glitch" in the world of health IT (see http://hcrenewal.blogspot.com/search/label/glitc...

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Pfizer's Umpteenth Settlement (for $491 Million Plus a Guilty Plea), but No Person Held Responsible

The world's largest research based pharmaceutical company was in court again, as <a href="http://www.nytimes.com/2013/07/31/business/pfizer-settles-a-drug-marketing-case-for-491-million.html">reported</a> by the New York Times, <blockquote class="tr_bq"> The drug maker Pfizer<a class="meta-org" href="http://topics.nytimes.com/top/news/business/companies/pfizer_inc/index.html?inline=nyt-org" title="More information about Pfizer Inc"></a> agreed to pay $491 million to settle criminal and civil charges over the illegal marketing of the kidney-transplant drug Rapamune, the Justice Department <a href="http://www.justice.gov/opa/pr/2013/July/13-civ-860.html" title="The announcement.">announced on Tuesday</a>. </blockquote> In particular, <blockquote class="tr_bq"> The recent case centers on the practices of Wyeth Pharmaceuticals, which Pfizer acquired in 2009. <div itemprop="articleBody">Rapamune, which prevents the body’s immune system from rejecting a transplanted organ, was approved by the Food and Drug Administration in 1999 for use in patients receiving a kidney transplant. However, federal officials said Wyeth aggressively promoted the drug for use in patients receiving other organ transplants, even offering financial incentives to its sales force to do so. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Accusations of Wyeth’s practices became public in 2010 after a whistle-blower lawsuit filed by two former employees was unsealed. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">After lawmakers <a href="http://democrats.oversight.house.gov/index.php?option=com_content&task=view&id=4973&Itemid=49" title="A press release about the inquiry.">announced a Congressional inquiry</a>, the Justice Department <a href="http://www.nytimes.com/2010/09/22/business/22drug.html" title="From the archives.">opted to join the lawsuit</a>. The settlement announced Tuesday, which also resolves a second, similar whistle-blower suit, includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">The case did not get much media coverage.  So far, the only other somewhat detailed <a href="http://www.bloomberg.com/news/2013-07-30/pfizer-unit-pleads-guilty-pays-491-million-over-drug.html">article</a> on it was put out by Bloomberg.   In fact, the lawyer for two of the whistle-blowers who alerted federal authorities to what Wyeth was doing had to say</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">the spate of pharmaceutical settlements in recent years had blunted reaction to what he said were shameful practices. 'Everybody’s been asking me why this case is different than any other,' he said. 'We used to trust these companies. You can’t trust these companies anymore.'</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">However, we should not be too blase.  This case was not only about money.  The over-promotion of a potentially dangerous drug likely lead to patients being harmed in the absence of any benefits.  Rapamune suppresses the immune system and increases risks of serious infections and malignancy.  Specific serious adverse events have been reported when it is used in transplants of organs other than the kidney (e.g., lung and liver transplants).  (See full prescribing information <a href="http://labeling.pfizer.com/showlabeling.aspx?id=139">here</a>.)  Bloomberg reported that 90% of Wyeth's revenues from Rapamune came from off-label uses, suggesting that quite a few people may have been adversely affected by its excess use.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody">As in most other members of the march of legal settlements by big health care organizations, this case involved no negative consequences for anybody who authorized, directed, or implemented the improper marketing practices.  While such people must have existed, they were not even named in the press coverage.  At least this settlement involved a guilty plea to a crime, albeit a misdemeanor (misbranding as reported by Bloomberg), so the company did have to admit some wrongdoing.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody">A Pfizer manager, however, tried to disavow responsibility, as noted by Bloomberg,</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">'Pfizer was not a subject or target of this matter, and cooperated fully with the government from the time it learned of this investigation in October 2009,' Chris Loder, a Pfizer spokesman,...</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">But Pfizer had purchased Wyeth, and in doing so got not only assets and profits, but responsibility for actions.</div><div itemprop="articleBody"> </div><div itemprop="articleBody">Also, neither the settlement nor the criminal plea seemed to take into account Pfizer's amazingly sorry recent track record.  I am losing count of all of Pfizer's settlements and/or guilty plea or convictions since 2000.  (The updated list of previous legal results is in the Appendix.)  </div><div itemprop="articleBody"> </div><div itemprop="articleBody">People found guilty of small-time Medicaid or Medicare fraud often forfeit all their assets and go to jail.  Yet actions by large pharmaceutical companies that may harm patients and cost many millions of dollars almost never result in any individual facing any negative consequences, or even being named and shamed.  Meanwhile, the managers of these companies may make gargantuan amounts of money partially rationalized by the revenues produced by such recurrent misbehavior.  In 2012, according to the company's 2013 proxy filing, Pfizer CEO Ian Reed's total compensation was  $25,634,136, and the four next most highly paid executives all made more than $5,000,000.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody">So the Kabuki play that is regulation of and law enforcement for large health care organizations goes on.  As our society is being increasingly divided into a huge majority in increasingly difficult economic circumstances and a small and  increasingly rich minority, it also seems to be increasingly divided into little people who may be ruined by lawsuits, and imprisoned for even minor infractions, and big people who have impunity.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody">True health care reform would need to start by making leaders of big health care organizations accountable for their organizations' misbehavior.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody">APPENDIX - Pfizer's Settlements </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In the beginning of the 21st century, <a href="http://articles.philly.com/2009-09-03/business/25267571_1_pfizer-employee-pfizer-sales-representatives-zyvox">according to the Philadelphia Inquirer</a>, Pfizer made three major settlements, <blockquote>October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.</blockquote><blockquote>May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000. </blockquote><blockquote>April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.</blockquote> Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>). </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/02/pharmacia-or-maybe-pfizer-settles-only.html">here</a>).   </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see <a href="http://www.bloomberg.com/news/2011-03-22/pfizer-reaches-asbestos-settlement-that-may-end-quigley-unit-s-bankruptcy.html">this story</a> in Bloomberg).  </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this <a href="http://hcrenewal.blogspot.com/2011/10/what-pfizer-v-few-consequences-for-long.html">post</a>). </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this <a href="http://hcrenewal.blogspot.com/2012/08/pfizers-pforeign-pfiasco.html">post</a>).</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this <a href="http://hcrenewal.blogspot.com/2012/12/pfizers-13th-legal-settlement-will-it.html">post</a>).  </div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this <a href="http://hcrenewal.blogspot.com/2013/01/pfizers-pfourteenth-settlement-small.html">post</a>).  </div><div itemprop="articleBody"> </div>

Pfizer's Umpteenth Settlement (for $491 Million Plus a Guilty Plea), but No Person Held Responsible

The world's largest research based pharmaceutical company was in court again, as reported by the New York Times, The drug maker Pfizer...

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Patients as lab rats for beta software: have sancrosanct patient's rights been trivialized, while poor software of non-trivial risk been sanctified?

I have noted a class action lawsuit vs. Allscripts and Eclipsys, EHR producers, regarding a merger: <blockquote class="tr_bq">UNITED STATES DISTRICT COURT, NORTHERN DISTRICT OF ILLINOIS, EASTERN DIVISION; BRISTOL COUNTY RETIREMENT SYSTEM, Individually and on Behalf of All Others Similarly Situated, Plaintiff, vs. ALLSCRIPTS HEALTHCARE SOLUTIONS, INC., GLEN E. TULLMAN, WILLIAM J. DAVIS AND LEE SHAPIRO, Defendants.</blockquote> The Lead Plaintiffs' Amended Complaint is available here in PDF:  <a href="http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf">http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf</a>.  It is worth reading, if just to understand the inner workings of an unregulated healthcare device industry on which your well-being and that of your family increasingly depends. <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/AVvXsEg1cK5yyoDM6yOgVXbQe8obtivZXKs4P0bhgybYTqaLqcrIAcNQHA60KrvtaiZ1MkP-oc-xwMGeVPmp5B_Dzai8C7AIWw0zTPqUKRQmNZT2hcXC5KFwbIS8yCPHSIHIZbMFJ4dQQK_3OHNa/s1600/lawsuit.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg1cK5yyoDM6yOgVXbQe8obtivZXKs4P0bhgybYTqaLqcrIAcNQHA60KrvtaiZ1MkP-oc-xwMGeVPmp5B_Dzai8C7AIWw0zTPqUKRQmNZT2hcXC5KFwbIS8yCPHSIHIZbMFJ4dQQK_3OHNa/s400/lawsuit.jpg" width="336" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Lead Plaintiffs' Amended Complaint, available here in PDF:  <a href="http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf">http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf</a></td></tr></tbody></table><div class="separator" style="clear: both; text-align: center;"> </div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgn0vbjsdzy92KT_OQ3oiAgj6Vsw5PiejEBHKRHYl3BDKpCbLCCaygcaFG0nrLWisAae9GOggcC-opFPePZBo1U6_nnWoJpdYoxAcJHXvle_v3nLYQSgbO7T0YbKz32ajWzvgUGpKgpFFKl/s1600/lawsuit.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"></a> The lawsuit is primarily about alleged misrepresentations made to investors by Allscripts and Eclipsys in a merger regarding inability to integrate products, leadership chaos, and materially false and misleading statements and omissions made during the Class period by these companies about their progress. I note that in a chaotic environment such as alleged, product safety is not likely a big concern. However, even more ominous are the allegations of deliberate use of beta software on patients without informed consent or any knowledge by patients whatsoever of its use, which apparently did not work out well.  Not indicated is if patient harm occurred.  If the allegations are true, considering the ECRI Deep Dive health IT risk study results of nearly 200 health IT "incidents" in 36 hospitals over 9 weeks voluntarily reported, including 8 harm incidents and 3 possible deaths - see <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> it would not be surprising. From the Complaint, allegations on software beta testing are as follows.  Emphases mine: <blockquote class="tr_bq">41. CW1 [coded person's name - ed.] explained the different interface integration systems as native integration, disparate integration, and High Level 7 “HL7” interface. The goal of native integration was to have the ability to update patient information throughout the Allscripts’ software offerings. This would allow Allscripts’ Sunrise products to seamlessly integrate with Allscripts’ Enterprise, Professional and MyWay products and allow the products to update patient health records without the use of industry standardized codes. Allscripts branded its native software as ADX. [see Complaint footnote 2.] CW1 described disparate integration as allowing Allscripts software to interface with non-Allscripts software which he described as a Health Information Exchange (“HIE”) software that allowed data to be read and updated from different software vendors. 42. CW1 said ADX 1.0 was designed to pull and update patient electronic health records automatically and was Allscripts’ native integration software. In approximately July 2011, he learned that Allscripts began a complete reworking of ADX 1.0 because customers were complaining about the lack of functionality and integration, and that it did not allow the user to review and approve changes made in other healthcare settings before being accepted by the hospital or physician practice systems. [If the allegations are true, these problems would be creating on its face significant risk of oversights, confusion and medical errors  - ed.] The upgrade was going to be known as ADX 1.5, but the method and interface for data integration changed. In particular, the interface was changed to allow clinicians to approve changes before they were entered into the system. He also learned from other Allscripts employees that ADX 1.0 was being beta tested [see Complaint footnote 3] at Blessing Hospital in Quincy, Illinois and another place he could not recall, but it was suspended in approximately the middle of 2011 because it failed to perform to expectations. [see Complaint footnote 4] [Remarkable - if the allegations are true, experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations" - and what of the unconsenting meatbags a.k.a. patients it was purportedly tested on? - ed.] Complaint footnotes: [2] CW1 described the HL7 interface as using industry standardized codes or language to allow users of disparate software systems to update patients electronic health records. [3] In software development, “beta testing” generally refers to a testing phase in which a subset of the intended user population tries the product out, in order to see how the product works in real-world conditions.  [What sane patient would consent to such testing of medical IT involved in their care, to 'see how it works in real-world conditions'? - ed.] [4] See also ¶158 (Defendant Davis’ May 8, 2012 statement “our initial release of our integrated capability...was launched in the middle of last year”); ¶189; cf. ¶76 (CW11’s statement that beta testing at Blessing occurred in late 2011 and was halted in Spring 2012);</blockquote> Again, I find the allegations of great concern - that experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations."  If true, what of the unconsenting meatbags a.k.a. patients?  They would not have counted for much. More from the Complaint in Count 50: <blockquote class="tr_bq">50. Consistent with CW2, CW3 said the Helios system was never taken to production while he worked at Allscripts. After he left to join Medicity he had heard that Allscripts delivered a Helios type product for beta testing in the fall of 2011 at the New York Presbyterian Hospitals and it did not go well and that the beta testing of the Helios product at the North Shore Long Island Jewish Community Hospital was scratched prior to implementation.</blockquote> If the allegations are true, New York Presbyterian Hospitals in the fall of 2011 were performing beta testing of software so bad it was deemed unacceptable for LIJ Community Hospital.  Again, if true, what about the risks patients were subjected to, and ... were any harmed? Still more in Count 76: <blockquote class="tr_bq">76. CW11 said that Blessing Hospital in Quincy, Illinois was beta testing ADX 1.0 sometime in late 2011, but could not recall specifically when it began. CW11 said he was told that the testing was stopped in early 2012 because the product was not working properly and Allscripts deployed a product development team to Blessing Hospital to develop a workflow which lead to ADX 1.5. As far as CW11 knew, no one went live on ADX 1.0. Blessing Hospital began testing ADX 1.5 in late Spring 2012, and was the first to go live using ADX 1.5 in July 2012 which allowed the integration of patient information seamlessly between Sunrise and Enterprise applications. Components of Helios went into ADX 1.5. ADX 1.5 allowed for integration of patient data relating to PAMI (problems, allergies, medications, and immunizations) but some competitor products allow for significantly more types of data to be seamlessly exchanged and Allscripts was working to increase the types of data that could be seamlessly exchanged between acute care and ambulatory applications.</blockquote> In effect, if the allegations are true, sancrosanct patient's rights have been trivialized, while poor software of non-trivial risk has been sanctified. This would be, needless to say, deranged.  Software can be debugged in test environments without putting patients at risk - if one is willing to invest the resources to do so. The Class Action lawsuit Plaintiffs should perhaps seek to discover if there were patient harms or deaths as a result of the alleged software beta testing - assuming that information was not thoroughly "cleansed" by now. I also note that even small NIH SBIR/STTR grant proposals involving use of new or modified IT on patients, on whose study sections I am an invited reviewer in the domain of Medical Informatics, are subject to human subjects protection evaluation: <blockquote class="tr_bq"><a href="http://grants.nih.gov/grants/peer/critiques/sbir-sttr.htm">http://grants.nih.gov/grants/peer/critiques/sbir-sttr.htm</a> ... Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 [see <a href="http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf">http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf</a> - ed.], the [grant review] committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.</blockquote> In health IT tests in hospital settings, which is most certainly experimentation, there are simply no human subjects protections whatsoever.  Hospital IT deserves no special accommodation regarding Protections for Human Subjects.  There are no justifiable reasons I can think of.  -- SS Addendum:  Perhaps I'm wrong about people's generosity and altruism.  I would like to hear from people who would gladly submit, say, their newborns as test subjects for the beta testing of experimental health IT software.

Patients as lab rats for beta software: have sancrosanct patient's rights been trivialized, while poor software of non-trivial risk been sanctified?

I have noted a class action lawsuit vs. Allscripts and Eclipsys, EHR producers, regarding a merger: UNITED STATES DISTRICT COURT, NORTHERN D...

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