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It Was the Best of Times, It Was the Worst of Times ... for Synthes Executives

The latest news about the Synthes Norian XL bone cement case shows just how bizarre incentives for health care leaders can be.  The Synthes Case Synthes USA, the American branch of a Swiss based device company, first settled charges that it had been paying surgeons with company stock to use its products in its clinical trials in 2009 (see <a href="http://hcrenewal.blogspot.com/2009/05/synthes-settles-agrees-to-stop-giving.html">this post</a>).  Then prosecutors alleged that these were not really rigorous trials. Instead, for marketing purposes, executives of Synthes subsidiary Norian persuaded surgeons to use its Norian XR product in a case series of spine surgery patients and then publish the results.  Three patients who received the product for this "off-label" use died.  This scheme was alleged to have been directed by "person no. 7," whom journalists identified as the company CEO, Hansjorg Wyss (see post <a href="http://hcrenewal.blogspot.com/2009/06/synthes-indicted.html">here</a>.)   In an unusual move, the prosecutors indicted four company executives, who then pleaded guilty.  They did not take any further action against Wyss, who turns out to be one of the world's richest men (see post <a href="http://hcrenewal.blogspot.com/2009/12/person-no-7-also-known-as-83rd-richest.html">here</a>).  Executives Sentenced In late November, three of the executives were sentenced, as <a href="http://www.philly.com/philly/business/134297618.html">per the Philadelphia Inquirer</a>: <blockquote>Three former executives of medical-device manufacturer Synthes Inc. were sentenced to prison Monday. A fourth might have been if his attorney hadn't collapsed while standing at a lectern moments after saying that Synthes' unindicted board chairman was the ultimate authority and responsible for the illegal, sometimes fatal, bone-cement trial at the center of the proceedings. Michael Huggins, 54, of West Chester, the former president of Synthes USA, was sentenced to nine months in prison and taken into custody immediately. Thomas Higgins, 55, of Berwyn, former leader of Synthes' spine division, got the same sentence. John Walsh, 48, of Coatesville, who was in charge of regulatory affairs, got five months. U.S. District Judge Legrome D. Davis gave Higgins two weeks to report to prison so he could arrange for extra medical care for his wife. Davis gave Walsh until next Monday to report because Tuesday is his young daughter's birthday. The three will pay $100,000 each in fines and be on supervised release after prison. All pleaded guilty to a single misdemeanor count under the responsible-corporate-officer doctrine. Richard Bohner, 56, of Malvern, former vice president for operations, was the third of four defendants on Davis' docket Monday and might have gotten a sentence similar to those received by Huggins and Higgins.</blockquote> No Penalty for the Former CEO However, there were no penalties for the company CEO who was allegedly "person no. 7": <blockquote>Hansjorg Wyss, the Synthes board chairman, who also was chief executive officer when the illegal bone-cement trial occurred, was not in the courtroom but still was part of Monday's events. Gurney, Bohner's attorney, said Wyss was the undisputed leader of the company. 'He made some of the very critical decisions that put the trials on the ultimate pathway,' Gurney said. 'The culture of an organization is set at the top.' Wyss could not be reached for comment.</blockquote> Meanwhile, Mr Wyss continues to grow richer. <a href="http://www.forbes.com/profile/hansjorg-wyss/">Forbes</a> currently lists him as number 164 on its list of the world's wealthiest people, estimating his assets at $6.4 billion. A Golden Parachute for the Current CEO Mr Wyss may be made even more wealthy because US health care corporate giant Johnson and Johnson has agreed to buy Synthes. Furthermore, as also <a href="http://articles.philly.com/2011-12-02/business/30467555_1_depuy-sec-filing-j-j-spokesman">reported</a> by the Philadelphia Inquirer, the current Synthes CEO is in line to also greatly benefit from that deal: <blockquote>Orsinger is getting $51.9 million for leaving the old company and a multimillion-dollar pay package from the new company. His new base salary of $700,000 will be a cut in pay from his old firm, but he will have some lucrative bonus opportunities. If he can make do clipping coupons for three years, he will get a stock package worth $17.2 million. Orsinger is the chief executive officer of Synthes Inc., the medical-device manufacturer based in Switzerland but with U.S. headquarters and facilities in West Chester.</blockquote> Implications On one hand, up to now, it has been very rare for any top executives of health care corporations to suffer any negative consequences due to ethical missteps by their companies, much less to go to jail. The current case may be the first real example of government prosecutors using the responsible corporate officer doctrine in such a setting. We first discussed this concept <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">here</a> in 2010. As <a href="http://www.reuters.com/article/2011/12/06/us-legal-idUSTRE7B50Q420111206">noted</a> in Reuters about the Synthes case, <blockquote>After decades in relative obscurity, a U.S. legal doctrine that holds corporate officers liable for company wrongdoing is finding its way back into some high-profile healthcare prosecutions. The 'responsible corporate officer' doctrine allows for prison terms of up to one year for misdemeanor violations of the Federal Food, Drug and Cosmetic Act, but typically defendants have received only probation. Recently, however, the government has sought to reinvigorate the doctrine, and some executives are facing stiffer penalties than they had ever imagined.</blockquote>Why only now has this doctrine been dusted off, when it has been around for over 70 years, and validated by the Supreme Court over 35 years ago, remains unclear. Does its use now signal the end of health care leaders' impunity? We have noted that despite all sorts of misbehavior leading to a <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a>, almost no one who authorized, directed or implemented the bad behavior within a large health care corporation has ever paid any penalty for it. The penalties for the four Synthes executives are certainly a break in the pattern. Moreover, while in the Synthes case the executives who pleaded guilty were aware of what was going on, the doctrine allows prosecution of responsible corporate officers who were not so aware. As in the Reuters article, <blockquote>The principle behind the doctrine was validated by the Supreme Court in 1975, when it affirmed the conviction of John Park, the chief executive of a national food chain who had been charged with allowing warehoused food to be exposed to rodent contamination. The court held that, to convict Park, the jury did not have to find that he was aware of the unsanitary conditions, only that he was in a position of authority to prevent them.</blockquote> However, in the Synthes case, there was no attempt made to prosecute even more highly placed "responsible corporate officers." As noted above, the past and current CEO were not charged, and meanwhile have engineered a merger that may make them even more wealthy (ironically, with a company, Johnson and Johnson, that has also had a <a href="http://hcrenewal.blogspot.com/search/label/Johnson%20and%20Johnson">troubled recent record</a>). Furthermore, as per Reuters, prosecutors are not exactly gung ho about using the responsible corporate doctrine: <blockquote>Over the next few decades, prosecutors used the doctrine sparingly, concerned that overuse would bring unwanted judicial scrutiny, said Paul Hyman, formerly of the U.S. Food and Drug Administration's Chief Counsel's Office and now a director at the law firm of Hyman, Phelps & McNamara.</blockquote> Also, <blockquote>The future of the responsible corporate officer doctrine could depend on whether executives who plead guilty under the doctrine are able to find other employment. Cory Andrews, a lawyer with the Washington Legal Foundation, which filed a friend-of-the-court brief on behalf of the Purdue defendants, said that as the severity of penalties increase for misdemeanors, so do the odds of a constitutional challenge. 'Arguably, where the deprivation is very small, the due process violations are not as significant,' Andrews said. 'But where the deprivation goes to someone's ability to earn a living -- I think that raises the constitutional temperature.'</blockquote> Many of the legal settlements we have discussed involved activities that threatened the safety, health or even lives of patients. But if a corporate executive might not be able to get further lucrative employment as such after participating in such misbehavior, quelle horreur! Let us hope that government officials, who have been so solicitous in the past about the financial well-being of the health care corporations they are supposed to oversee, will start thinking about the consequences of these corporations' misbehavior for the public to whom those officials are supposed to answer. I conclude, de rigueur, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

It Was the Best of Times, It Was the Worst of Times ... for Synthes Executives

The latest news about the Synthes Norian XL bone cement case shows just how bizarre incentives for health care leaders can be. The Synthes ...

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Merck Admits Little While Settling the Vioxx Case

A week ago, another legal settlement with some noteworthy aspects came marching along.  As <a href="http://online.wsj.com/article/SB10001424052970204531404577054472253737682.html">reported</a> by the Wall Street Journal, here are the details. A Guilty Plea to "Misbranding" First, there was a guilty plea (to a misdemeanor): <blockquote>Merck & Co. agreed to pay $950 million and plead guilty to a criminal misdemeanor charge to resolve government allegations that the company illegally promoted its former painkiller Vioxx and deceived the government about the drug's safety.</blockquote> In particular, <blockquote>The Justice Department said Merck illegally promoted Vioxx for rheumatoid arthritis before that use was approved by the Food and Drug Administration in 2002. The drug was initially approved in 1999 to treat certain types of pain. Drug companies are barred from promoting drugs for unauthorized, or 'off label,' uses, though doctors may prescribe off-label uses. Merck agreed to plead guilty to introducing a 'misbranded' Vioxx into interstate commerce, which is a misdemeanor violation of the Food, Drug and Cosmetic Act, and to pay a $321.6 million criminal fine.</blockquote> So the company actually admitted to violating the law in the form of a misdemeanor, selling a drug for unapproved uses. The importance of this sort of activity has been frequently challenged, especially by those who claim that corporations have free speech rights that allow them to promote practically anything they want. However, this was not the only issue apparently resolved. A Civil Settlement <blockquote>The company agreed to pay $628.4 million to settle civil allegations.</blockquote> What were these allegations? <blockquote>The government also made allegations against Merck in parallel civil litigation related to Vioxx in addition to the criminal charges. According to the government, Merck representatives made inaccurate, unsupported or misleading statements about Vioxx's cardiovascular safety, in order to increase sales of the drug. The government also said Merck made false statements to state Medicaid agencies about the drug's safety. </blockquote> However, <blockquote>Merck isn't admitting liability or wrongdoing in the civil aspect of the settlement. Mr. Rogers said Merck expressly denies the civil allegations. 'We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx,' said Merck General Counsel Bruce Kuhlik in a statement.</blockquote> So this is yet another example of a legal settlement made by a health care organization involving that organization paying a fine, but not admitting it did anything wrong. The Parallel with the Citigroup Settlement Last week, we <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">wrote</a> about how one US federal judge refused to accept a settlement (in a case of alleged financial misbehavior involving Citigroup) which did not require the company to admit wrongdoing. The judge noted that this presented the logically incomprehensible situation of a company apparently being punished for a reason that is unknown. At that point, one (admittedly outspoken) critic wrote, "This has essentially created a parallel or secret criminal justice system, in which both crime and punishment are adjudicated behind closed doors." Furthermore, these <blockquote>settlements have evolved into a kind of cheap payoff system, in which crimes may be committed over and over again, and the ... [government's] only role is to take a bribe each time the offenders slip up and get caught. If you never have to worry about serious punishments, or court findings of criminal guilt (which would leave you exposed to crippling lawsuits), then there’s simply no incentive to stop committing fraud. These SEC settlements simply become part of the cost of doing business....</blockquote> What No One Had to Admit In the case of the current Merck settlement, we do know something about the activities that lead to the settlement.  The settlement arose out of what was called the "Vioxx scandal." In summary, Vioxx (rofecoxib, Merck) a Cox-2 inhibitor non-steroidal anti-inflammatory drug used for pain, and touted for its ostensibly low risk of gastrointestinal side-effects, was withdrawn from the market in 2004 because of its cardiac risks.  The Vioxx case is flush with examples of how the company used deception to market a very profitable drug without regard to its risks to patients.  There is evidence is that the company knew about these effects since 2000, but suppressed the clinical research evidence until 2003.(1)  In particular, in 2005, the editors of the New England Journal of Medicine raised concerns that an article published in that journal in 2000 about the results of the VIGOR study of rofecoxib sponsored by Merck failed to report data that would have suggested that the drug caused excess cardiovascular risks.(2) In 2007, the company paid more than $4.9 billion to settle patient lawsuits alleging harm due to Vioxx.(3)  Also in 2008, the company made a $58 million settlement of claims its advertising of Vioxx deceptively minimized its risks.(4) In 2008, it became clear that at least one apparently clinical trial of Vioxx, the ADVANTAGE trial, was merely a "seeding trial,' that is, a marketing exercise.(5) On Health Care Renewal, we starting <a href="http://hcrenewal.blogspot.com/search/label/Vioxx">writing about Vioxx</a> in 2005, including, - <a href="http://hcrenewal.blogspot.com/2005/04/more-evidence-of-ghostwriting.html">here</a> about ghost-writing of a Vioxx research publication; - <a href="http://hcrenewal.blogspot.com/2005/06/allegations-that-merck-threatened.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/12/more-allegations-that-merck-executives.html">here</a> about allegations that Merck executives tried to intimidate Vioxx critics; - <a href="http://hcrenewal.blogspot.com/2007/03/drug-crazy.html">here</a> about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case; - <a href="http://hcrenewal.blogspot.com/2008/08/article-in-annals-of-internal-medicine.html">here</a> about the ADVANTAGE "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and - <a href="http://hcrenewal.blogspot.com/2010/01/physician-pleads-guilty-to-fraud-for.html">here</a> about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs. -  <a href="http://hcrenewal.blogspot.com/2010/02/merck-settles-another-vioxx-case.html">here</a> about how in settling a shareholder lawsuit Merck vowed to improve its scientific and academic integrity, and refrain from manipulating and suppressing clinical research. In 2010, we <a href="http://hcrenewal.blogspot.com/2010/02/merck-settles-another-vioxx-case.html">summarized </a>the Vioxx case thus, " the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case)."  In case there are any doubts about the harms patients suffered as a result of using Vioxx as a pain reliever, in 2004, a cumulative meta-analysis of published trials of Vioxx known by then estimated the risk of myocardial infarction (heart attack) due to Vioxx compared with placebo or other non-steroidal anti-inflammatory drugs was 2.3 times the baseline rate.(6)  That analysis suggested that there was data by 2000 that Vioxx increased the risk of bad cardiovascular events.  A cumulative meta-analysis from 2009 suggested that the risk of death due to Vioxx was 1.7 times the baseline rate.(7)   That analysis suggested there was data by 2001 that Vioxx increased the risk of bad cardiovascular events.  Graham and colleagues' nested case-control study of Vioxx use in a large managed care organization lead them to estimate that "88 000 - 140 000 excess cases of serious coronary heart disease probably occurred in the USA over the market-life of rofecoxib."(8) Yet despite all the evidence of deceptive practices used to market Vioxx as a first-line pain reliever, and all the evidence that Vioxx may have lead to a large number of myocardial infarctions and premature deaths, the US government's settlement with the maker of Vioxx allowed it to deny that its marketers concealed the dangers of the drug.  This shows that the US regulation of health care organizations has been reduced to Kabuki theatre, detached from reality, and in this case, from what appears to be very clear clinical epidemiological evidence.  As noted above, and by us frequently in the past, as long as the only punishments for bad behavior are fines (paid by the entire organization, not those who authorized, directed or implemented the bad behavior), such "punishments" only modestly add to the cost of doing business, and do not deter future bad behavior.  The continuing bad behavior, indicated in part in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of legal settlements</a> we have documented, doubtless leads to much of our health care problems, particularly high costs, poor access, poor quality, and demoralized health care professionals. Like a broken record (for anyone who remembers what that means), I repeat...   to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. References 1. Topol EJ. Failing the public health - rofecoxib, Merck and the FDA. N Engl J Med 2004; 351: 1707-1709.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMp048286">here</a>. 2. Curfman GD, Morrisey S, Drazen JM et al.  Expression of concern reaffirmed. N Engl J Med 2006; 354:1193. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe068054">here</a>. 3. Charatan F. Merck to pay $5bn in rofecoxib claims. Brit Med J 2007; 335: 1011. Link <a href="http://www.bmj.com/content/335/7628/1011.1.full">here</a>. 4. Charatan F. Merck to pay $58m in settlements over rofecoxib advertising. Brit Med J 2008; 336: 1208-1209. Link <a href="http://www.bmj.com/content/336/7655/1208.2.full">here</a>. 5. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Int Med 2008; 149: 251-258. Link<a href="http://www.annals.org/content/149/4/251.full"> here</a>. 6.  Juni P, Nartey L, Reichenbach S et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis.  Lancet 2004; 364: 2021-2029.  Link <a href="http://www.sciencedirect.com/science/article/pii/S0140673604175144">here</a>. 7.  Ross JS, Madigan D, Hill KP et al.  Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.  Arch Intern Med 2009; 169: 1976-1984.  Link <a href="http://archinte.ama-assn.org/cgi/content/full/169/21/1976">here</a>. 8.  Graham DM, Campen D, Hui R et al.  Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study.  Lancet 2005; 365: 475-481.  Link <a href="http://www.sciencedirect.com/science/article/pii/S0140673605178647">here</a>.

Merck Admits Little While Settling the Vioxx Case

A week ago, another legal settlement with some noteworthy aspects came marching along. As reported by the Wall Street Journal, here are th...

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In Michigan, Intentional Alteration of Medical Records is a Felony

I addressed the issue of alteration of electronic medical records and the dearth of truly meaningful penalties at posts such as: <blockquote>"<a href="http://hcrenewal.blogspot.com/2011/09/stroud-v-abington-memorial-hospital-is.html">Stroud v. Abington Memorial Hospital: Is This Why Chart Alteration Might Be Appealing?</a>", "<a href="http://hcrenewal.blogspot.com/2011/07/on-penalities-for-alteration-of.html">On Penalties for Alteration of Electronic Health Records</a>"</blockquote>and <blockquote>"<a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence</a>."</blockquote> A commenter to the latter post led me to another blog where it was pointed out that in Michigan, intentional chart alteration by a healthcare provider <a style="font-weight: bold;" href="http://legislature.mi.gov/doc.aspx?mcl-750-492a">is a</a><a href="http://legislature.mi.gov/doc.aspx?mcl-750-492a"> felony</a> (a criminal act, not just a civil matter), and looks like it has been since the early 1930's. This would apply not just to paper records, but electronic as well, since the advent of HIT did not alter the essentials of medical record keeping: <table border="0" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0in;"> </td></tr></tbody></table><blockquote><table border="0" cellpadding="0" cellspacing="0"><tbody><tr><td style="padding: 0in;">Section 750.492a </td></tr><tr style="min-height: 22.5pt;"><td style="padding: 0in; min-height: 22.5pt;" valign="top"> </td></tr></tbody></table>THE MICHIGAN PENAL CODE (EXCERPT)<div style="text-align: center;">Act 328 of 1931 </div> 750.492a Placing misleading or inaccurate information in medical records or charts; alteration or destruction of medical records or charts; penalties; applicability of subsections (1) and (2); basis for civil action for damages not created.Sec. 492a.(1) Except as otherwise provided in subsection (3), a health care provider or other person, knowing that the information is misleading or inaccurate, shall not intentionally, willfully, or recklessly place or direct another to place in a patient's medical record or chart misleading or inaccurate information regarding the diagnosis, treatment, or cause of a patient's condition. A violation of this subsection is punishable as follows:(a) A health care provider who intentionally or willfully violates this subsection is guilty of a felony.(b) A health care provider who recklessly violates this subsection is guilty of a misdemeanor, punishable by imprisonment for not more than 1 year, or a fine of not more than $1,000.00, or both.(c) A person other than a health care provider who intentionally or willfully violates this subsection is guilty of a misdemeanor, punishable by imprisonment for not more than 1 year, or a fine of not more than $1,000.00, or both.(d) A person other than a health care provider who recklessly violates this subsection is guilty of a misdemeanor.(2) Except as otherwise provided in subsection (3), a health care provider or other person shall not intentionally or willfully alter or destroy or direct another to alter or destroy a patient's medical records or charts for the purpose of concealing his or her responsibility for the patient's injury, sickness, or death. A health care provider who violates this subsection is guilty of a felony. A person other than a health care provider who violates this subsection is guilty of a misdemeanor punishable by imprisonment for not more than 1 year, or a fine of not more than $1,000.00, or both.(3) Subsections (1) and (2) do not apply to either of the following:(a) Destruction of a patient's original medical record or chart if all of the information contained in or on the medical record or chart is otherwise retained by means of mechanical or electronic recording, chemical reproduction, or other equivalent techniques that accurately reproduce all of the information contained in or on the original or by reproduction pursuant to the records media act that accurately reproduces all of the information contained in or on the original.(b) Supplementation of information or correction of an error in a patient's medical record or chart in a manner that reasonably discloses that the supplementation or correction was performed and that does not conceal or alter prior entries.(4) This section does not create or provide a basis for a civil cause of action for damages.History: Add. 1986, Act 184, Eff. Mar. 31, 1987 ;-- Am. 1992, Act 210, Imd. Eff. Oct. 5, 1992 © 2009 Legislative Council, State of Michigan</blockquote> I will be giving some attention to try to make this well-deserved penalty the Law of the Land for electronic medical records. -- SS

In Michigan, Intentional Alteration of Medical Records is a Felony

I addressed the issue of alteration of electronic medical records and the dearth of truly meaningful penalties at posts such as: " Stro...

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"Corruption Kills," So Why Is Health Care Corruption Ignored?

An article published last month by PLoS One(1) emphasizes the stark contrast between the likely impact on health of corruption, including health care corruption, and the attention paid to it.  The Methodologic Details The authors performed an ecological, country-level analysis to assess the association of perceived national corruption level (measured by <a href="http://www.transparency.org/policy_research/surveys_indices/cpi">Transparency International's Corruption Perceptions Index [CPI]</a> using 2008 data) and national mortality rates for children under five years old, controlling for the best known measurable predictors of such mortality.   Their final model included the following other predictors: GDP per capita, people with access to improved water source, people with access to improved sanitation, percentage of rural population, literacy rate, dependency ratio, population density, total health expenditure per capita, health expenditure as percentage of GDP, DTP vaccine coverage, measles vaccine coverage, food supply, presence of equatorial, arid, warm temperate and snow climate on national territory, civil liberties, political rights, national battle-related deaths.  The final model had a pseudo R squared = 0.89, and the addition of CPI to the model increased it by 1.61%. The Results and Implications The results were that corruption explained approximately 1.61% of the variance of country-level child mortality.  This suggested the hypothesis that: <blockquote>roughly 1.6% of world deaths in children could be explained by corruption meaning that, of the annual 8.795 million children deaths, more than 140000 annual children deaths could be indirectly attributed to corruption.</blockquote> The authors emphasized that this was only a hypothesis, and that ecological models are prone to bias. In particular, I would point out that such models can omit variables that are associated with the included variables, but are better predictors, or even true causes of the outcome. Nonetheless, as the authors pointed out, "all the data used in this analysis is the only available to study the problem at this scale." Another problem is that the analysis could not distinguish the effects of health care corruption from those of other kinds of corruption. In the introduction, the authors emphasized what has been written about the importance of health care corruption as having "pejorative health consequences." However, general corruption could also affect health. The authors gave the example of how corruption could affect access to uncontaminated water. Nonetheless, the analysis appears highly plausible, and may be the best possible given the available data. It suggests, as the authors noted, that corruption could causes deaths "that largely exceeds the conspicuous pooled total of cholera, rabies, Ebola, and combat-related deaths." This suggests the big paradox. As the authors put it, <blockquote>because the equation corruption = deaths is seldom explicit, corruption only seems like a nuisance.</blockquote> As we have said, most recently <a href="http://hcrenewal.blogspot.com/2011/11/will-freeze-of-global-fund-finally-put.html">here</a>, most of the organizations one might have expected would have provided some response to health care corruption instead have largely treated it as at best a nuisance. Specifically, there is almost no teaching or research on corruption in health care academics (including medical and public health schools, and programs in health care research and policy.)  There is almost no mention of corruption by health care professional associations.  There are almost no initiatives to fight corruption on the part of health care charities and donors.  There is almost no interest in corruption among patient advocacy organizations.  (See previous discussion <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a>.) Because there is so little interest in and attention to corruption, and particularly health care corruption, there has been little research on it, and therefore the best available estimate of the effect of corruption on health may now be the study by Hanf et al.  I also <a href="http://hcrenewal.blogspot.com/2011/11/will-freeze-of-global-fund-finally-put.html">postulated</a> that at least in the US context, this lack of interest in corruption may partially be explained by these organizations' institutional conflicts of interest and the individual conflicts of interest affecting their leaders.  It may be further explained by the exposure of some leaders to the irresponsible, if not amoral culture that now currently pervades finance, which may have in turn been one cause of the great recession, or global financial collapse.  Hanf and collaborators concluded, <blockquote>The global response to child deaths must involve a necessary increase in funds available to 1) develop water and sanitation access and 2) purchase new methods for prevention, management, and treatment of major diseases killing children around the globe (principally pneumonia, diarrhoea and malaria). However, without paying attention to the anti-corruption mechanisms needed to ensure their proper use, it will also provide further opportunity for corruption. In practice, donors and governments still treat health, water/sanitation access and corruption as separate rather than integral components of the same strategy. To address these obstacles, designing dedicated indicators at micro and macro levels which monitor efficiently corruption impacts on health and heath related services, is urgently needed. Policies and interventions supported by governments and donors must integrate initiatives that recognise how health and corruption are inter-related.</blockquote> I wonder if the realization that corruption, including health care corruption may be leading to the deaths of children will be enough for academic health care institutions, professional societies, health care charities and donors, and patient advocacy groups to develop "initiatives that recognise how health and corruption are inter-related"? Reference 1.  Hanf M, Van-Melle A, Fraisse F et al. Corruption kills: estimating the global impact of corruption on children deaths.  PLos ONE 2011; 6: e26990. doi:10.1371/journal.pone.0026990.  Link <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0026990">here</a>.

"Corruption Kills," So Why Is Health Care Corruption Ignored?

An article published last month by PLoS One(1) emphasizes the stark contrast between the likely impact on health of corruption, including he...

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Health IT Pundits and Perhaps the Most Logically Fallacious (And Even Cold-Hearted) Statement I've Seen About Health IT to Date

The KevinMD blog has <a href="http://www.kevinmd.com/blog/2011/11/health-problems-worth-price.html">reposted</a> George Lundberg's MedPage Today post "Health IT: Garbage In, Garbage Out", retitled as "Health IT has problems, but is worth the price." I covered Dr. Lundberg's original post at my Nov. 16, 2011 essay "<a href="http://hcrenewal.blogspot.com/2011/11/george-lundberg-promise-of-health-it.html">George Lundberg, MD: The Promise of Health IT, and a Caveat</a>." As the <a href="http://www.kevinmd.com/blog/">KevinMD blog</a> is exceptionally well-read, I expected the HIT pundits to come in with "see no evil, hear no evil, speak no evil" accolades for the technology. I was right, even early on. Keep in mind that Dr. Lundberg specifically quotes me in his article: <blockquote>... However, there is another harsh critic worth listening to. His name is Dr. Scot Silverstein, and he seems to have made it his life's work to call attention to really <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">bad problems</a> that he discovers in this mass move to automation. Heed his cautions. They are real.</blockquote> My writings and opinions are known of by the following pundit, including the fact that my relative was injured as a result of the technology, who commented on KevinMD's reposting of the Lundberg essay. The comment is <a href="http://www.kevinmd.com/blog/2011/11/health-problems-worth-price.html#comment-375415956">here</a> (I do not personally know the commenter, only having exchanged numerous back-and-forth comments on a few health IT blogs in the past): <blockquote><a href="http://onhealthtech.blogspot.com/" target="_blank" class="dsq-commenter-name" rel="nofollow">Margalit Gur-Arie</a> [a partner at <a style="font-weight: bold;" href="http://www.ehrpathway.com/">EHR pathway, LLC</a> and <a style="font-weight: bold;" href="http://www.grosstechnologies.com/">Gross Technologies, Inc.</a> - ed.] Wow! There's something to be said for extreme statements, whether right or wrong. ... do EHRs kill people? Probably, but every single item used in medicine can be shown to have killed people at one time or another, depending on how you define "killed" [1]. Do more people get harmed where EHRs are present, compared to where they are not? There are no conclusive studies to that effect and there are no conclusive studies showing the opposite either. There are not very good studies at all, but if mass murder was occurring, we would have probably known by now. </blockquote> The <a style="font-style: italic;" href="http://www.nizkor.org/features/fallacies/appeal-to-ridicule.html">appeal to ridicule</a> and/or <a href="http://en.wikipedia.org/wiki/Argument_from_ignorance">argumentum ad ignorantiam</a>-like statement "if mass murder was occurring, we would have probably known by now" is both fallacious and egregious. Is that a criteria medicine uses, in the explicitly admitted situation where conclusive studies are lacking, to promote diffusion of some new treatment or tool? That is, since we don't note catastrophic levels of toxicity, the toxicity is of minor import? On other logical fallacies, the statement that "every medical intervention can kill", implying that any morbidity and mortality due to EHRs is just a foregone conclusion, is doubly fallacious. One fallacy is the absolute nature of the statement itself. It isn't true that 'all medical interventions can kill.' Another fallacy is the cavalier lack of distinction between a small vs. large risk of injury or death. That said, even without considering 1) the literature aggregated <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">here</a>, 2) the context of the IOM Committee on Patient Safety and Health Information Technology's report that states the technology has risks, and worse, that impediments to information diffusion prevent the magnitude of the risks from being known (PDF available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">here</a>), and 3) the context of my<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary"></a> relative's travails, this is perhaps the most wishy-washy, ethically unsatisfying, cold-hearted excuse for health IT's problems -- and for reneging on fixing those problems before national rollouts -- that I have ever seen. The argument is so bad, it's difficult to parse out the precise nature of all the <a href="http://www.fallacyfiles.org/taxonomy.html">logical fallacies</a> contained within. COI disclosure: I note that I have no associations with, receive no payments or royalties from, or have any other relationships with healthcare IT vendors, consultants or customers. I decided to offer my services as an expert witness for attorneys on health IT-related injuries and records tampering as a result of my relative's travails, however. Note: [1] "Depending on how you define "killed"? Let me take a stab at that (it should be easier than defining what the meaning of the word 'is' is). How about "resulted directly or indirectly in the termination of all biological functions, as in, the patient's dead?" -- SS

Health IT Pundits and Perhaps the Most Logically Fallacious (And Even Cold-Hearted) Statement I've Seen About Health IT to Date

The KevinMD blog has reposted George Lundberg's MedPage Today post " Health IT: Garbage In, Garbage Out ", retitled as "...

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Will the Citigroup Ruling Challenge Health Care Leaders' Impunity?

A federal judge's refusal to approve yet another cozy settlement that was supposed to resolve allegations of wrong-doing by a giant corporation has left the financial world atwitter.  It may be that this ruling will also affect the coziness between giant health care corporations and government regulators.  Summary of the Citigroup Case We first discussed this case twp weeks ago <a href="http://hcrenewal.blogspot.com/2011/11/parallels-between-health-care-and.html">here</a>.  Here is a summary of the government's (in this case, the Securities and Exchange Commision's) original allegations <a href="http://www.nytimes.com/2011/11/29/business/judge-rejects-sec-accord-with-citi.html">from the New York Times</a>. <blockquote>According to the Securities and Exchange Commission, Citigroup stuffed a $1 billion mortgage fund that it sold to investors in 2007 with securities that it believed would fail so that it could bet against its customers and profit when values declined. The fraud, the agency said, was in Citigroup’s falsely telling investors that an independent party was choosing the portfolio’s investments. Citigroup made $160 million from the deal and investors lost $700 million.</blockquote>The Problems with the Proposed Settlement Judge Jed Rakoff refused to approve the settlement because of a series of problems, listed below as summarized by <a href="http://www.economist.com/node/21540667">the Schumpeter columnist in the Economist</a>. <blockquote>Mr Rakoff faulted the SEC for prosecuting Citigroup for negligence when a fraud prosecution was warranted; for failing to provide the court with 'any proven or admitted facts upon which to exercise even a modest degree of independent judgment'; for erroneously contending that 'public interest…is not part of [the] applicable standard of judicial review'; and for wrongly arguing that 'if the public interest must be taken into account, the SEC is the sole determiner'.</blockquote>Furthermore, <blockquote>Mr Rakoff also attacked a second condition of the settlement. Citigroup had agreed to operate under a court injunction if it ever violated the deal, which could lead to contempt charges. Whatever threat this carried, Mr Rackoff wrote, it was mitigated because Citigroup, as other financial firms, had been cited similarly over the past decade—and never faced any consequences. </blockquote>The Parallels with Legal Settlements Made by Health Care Organizations Several of the features of the settlement that the Judge found so objectionable are commonly also features of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlements</a> we have seen involving health care organizations. Government regulators often seem to make much milder charges that were warranted by the apparent facts. They make the organizations party to <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreement">corporate integrity</a> or <a href="http://hcrenewal.blogspot.com/search/label/deferred%20prosecution%20agreement">deferred prosecution</a> agreements, even though sometimes the same corporations were already subject to such agreements when they appeared to misbehave again. The agreements often allow the organizations to neither admit to or deny any charges, leaving the facts of the case forever in doubt. <a href="http://www.rollingstone.com/politics/blogs/taibblog/federal-judge-pimp-slaps-the-sec-over-citigroup-settlement-20111129">Matt Taibi in the Rolling Stone</a> provided some pithy comments on these commonly seen features of legal settlements. <blockquote>By accepting hundred-million-dollar fines without a full public venting of the facts, the SEC is leveling seemingly significant punishments without telling the public what the defendant is being punished for. This has essentially created a parallel or secret criminal justice system, in which both crime and punishment are adjudicated behind closed doors. This system allows for ugly consequences in both directions. Imagine if normal criminal defendants were treated this way. Say a prosecutor and street criminal come into a judge’s chamber and explain they’ve cooked up a deal, that the criminal doesn’t have to admit to anything or plead to any crime, but has to spend 18 months in house arrest nonetheless. What sane judge would sign off on a deal like that without knowing exactly what the facts are? Did the criminal shoot up a nightclub and paralyze someone, or did he just sell a dimebag on the street? Is 18 months a tough sentence or a slap on the wrist? And how is it legally possible for someone to deserve an 18-month sentence without being guilty of anything? Such deals are logical and legal absurdities, but judges have been signing off on settlements like this with Wall Street defendants for years.</blockquote>As we have said numerous times before, (starting <a href="http://hcrenewal.blogspot.com/2008/07/amerigroup-settles.html">here</a> in 2008) the current manner of regulation, in which organizations pay fines (and sometimes submit to corporate integrity or deferred prosecution agreements), rarely admit any guilt, but in which individuals who directed, authorized or implemented the alleged misbehavior almost never suffer any negative consequences, fails to deter future bad behavior. We have noted that the costs of the settlements are paid by the organization as a whole, and thus simply regarded as costs of doing business by executives. The leaders' impunity will allow the bad behavior to be repeated again and again. Here is how Taibbi and Rakoff put it: <blockquote>these crappy settlements have evolved into a kind of cheap payoff system, in which crimes may be committed over and over again, and the SEC’s only role is to take a bribe each time the offenders slip up and get caught. If you never have to worry about serious punishments, or court findings of criminal guilt (which would leave you exposed to crippling lawsuits), then there’s simply no incentive to stop committing fraud. These SEC settlements simply become part of the cost of doing business, as Rakoff notes: <blockquote>As for common experience, a consent judgment that does not involve any admissions and that results in only very modest penalties is just as frequently viewed, particularly in the business community, as a cost of doing business imposed by having to maintain a working relationship with a regulatory agency, rather than as any indication of where the real truth lies. This, indeed, is Citigroup's position in this very case.</blockquote> That line, 'a cost of doing business imposed by having to maintain a working relationship with a regulatory agency,' is one of the more brutally damning things you’ll ever see a judge write. Rakoff is essentially saying that these fines are payoffs to keep the SEC off the banks’ backs. They’re like the pad that numbers-runners or drug dealers pay to urban precinct-houses every month to keep cops from making real arrests. That's what he means when he refers to 'maintaning a working relationship.' It's heavy stuff.</blockquote> What the Judge appears to be saying is that the whole system stinks of <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a>, and that the settlements paid by the organizations are the moral equivalent of bribes paid to government officials. That is indeed "heavy stuff." Now that Occupy Wall Street has made it socially acceptable to discuss the economic dysfunction that lead to the great recession or global financial collapse, I can only hope that this discussion will lead to a parallel discussion about health care dysfunction. It certainly seems that the regulatory capture that seems to be part of the dismantling of regulation of finance is similar to regulatory capture affecting health care. But I await someone beyond us few lonely bloggers to take up this topic. I might as well end with this sentiment<a href="http://hcrenewal.blogspot.com/2009/09/biovail-settles-and-judge-explains-why.html"> from 2009</a> regarding another case over which Judge Rakoff presided: Again, in my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations.

Will the Citigroup Ruling Challenge Health Care Leaders' Impunity?

A federal judge's refusal to approve yet another cozy settlement that was supposed to resolve allegations of wrong-doing by a giant corp...

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Will the Freeze of the Global Fund Finally Put Health Care Corruption on the Agenda?

In February, 2011, we <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">posted</a> about problems with corruption affecting the Global Fund to Fight AIDS, Tuberculosis and Malaria. At the time, the Fund promised to better detect fraud and corruption affecting its grants programs. We later <a href="http://hcrenewal.blogspot.com/2011/05/global-fund-will-not-suppress.html">posted</a> about how after an internal debate, the Fund promised to make more information public about any losses to fraud and corruption. Now it has made more such information public, but it also appears that further problems with corruption have lead to the freezing of the Fund. The New Findings of Corruption First, as <a href="http://www.bloomberg.com/news/2011-11-01/disease-funds-may-have-gone-to-home-renovations-blood-diamonds.html">reported</a> by Bloomberg on 1 November, <blockquote>A $22 billion disease-fighting fund backed by Microsoft Corp. (MSFT) founder Bill Gates found that money intended for people with life-threatening illnesses was used for home renovations in India and diverted to a person linked with money laundering and so-called blood diamonds in Nigeria. The Global Fund to Fight AIDS, Tuberculosis and Malaria is seeking to recover as much as $19.2 million from grants in eight countries, the Geneva-based organization said in a set of reports today. As much as $1.3 million was misused by the head of a non-governmental AIDS organization in India to buy a car and renovate his apartment, one report said. In Nigeria, money was siphoned to a person arrested in 2003 for money-laundering and smuggling diamonds that are mined and sold to support war. </blockquote> This amount was in addition to previous amounts disclosed before: <blockquote>The organization said last year it was seeking the recovery of $44.2 million in four nations for 'grave misuse of funds.'</blockquote> It is not clear how much money the Fund has lost to corruption in total. According to an AP report, <a href="http://www.cbsnews.com/8301-501714_162-20128601/global-health-fund-probe-uncovers-$20m-in-losses">via CBS News</a>, <blockquote>Earlier probes by the fund's internal watchdog, the inspector general's office, had detected about $53 million in losses, according to fund documents, some unpublished, provided by senior officials. The fund's board chairman Simon Bland told The Associated Press it has now reviewed about one-seventh of $14 billion in grants disbursed.</blockquote>Whether similar amounts of corruption affected the other six sevenths of grants is unclear. The Freeze on Grants This week, several reports that the Fund would stop funding new grants appeared in the media. As <a href="http://www.businessweek.com/news/2011-11-25/gates-backed-fund-halts-new-grants-as-crisis-hurts-giving.html">reported</a> by BusinessWeek, <blockquote>The world’s biggest disease-fighting fund canceled its next round of grants as the global financial crisis crimps donations and threatens its ability to curb the spread of the world’s deadliest infections. The Global Fund to Fight AIDS, Tuberculosis and Malaria, which has spent or committed to spending $22 billion since 2002 on preventing and treating disease, will only have enough money to pay for essential services for existing programs through the end of 2013, the Geneva-based fund said in a statement today. It will not make new grants until 2014,...</blockquote> The reason for this freeze on grant making was, <blockquote>The fund faces 'accelerating deterioration' in its finances for the next three years because of economic distress in donor nations, combined with corruption in some of the poor countries it helps,...</blockquote> A NY Times <a href="http://www.nytimes.com/2011/11/24/health/global-aids-fund-cancels-fund-raising-and-seeks-new-manager.html">article</a> implied that one reason for the financial shortfall was that some donor nations withheld money due to their concerns about corruption: <blockquote>Several countries, including Djibouti, Mali, Mauritania and Zambia, lost their grants or had new safeguards put in place after officials were accused of stealing. The Global Fund’s own inspector general exposed the fraud and earlier this month was trying to recover about $20 million that had been stolen; that amount is less than 1 percent of the $13 billion that has been disbursed. There have been reports of friction between Dr. Kazatchkine and the inspector general, John Parsons. They each report separately to the board. Some major donors, including Germany and Sweden, expressed their dismay by freezing their donations.</blockquote> Also, CBS News <a href="http://www.cbsnews.com/8301-202_162-57331033/global-health-fund-halts-new-programs">reported</a>, <blockquote>Germany, the European Commission and Denmark withheld hundreds of millions of euros in funding pending reviews of the fund's internal controls. Germany — the fund's fourth-largest donor- has since restored its funding.</blockquote> Summary and Comment In summary, the uncovering of specific instances of corruption that wasted the assets of the Global Fund, and the concerns of international donors about the effects of corruption on the Fund have been some of the causes of a freeze in funding that will preclude new initiatives at least until 2014. This is a dramatic illustration of how corruption can undermine health care. We <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">wondered</a> previously whether the realization that corruption was subverting the Fund's activities would lead the Fund to actively address corruption.  In fact, the Fund seems to have investigated previous corruption affecting its work more aggressively than have many other health care organizations.  However, the Fund did not appear to have instituted any initiatives to prevent, forestall, or challenge corruption.  In that, it is typical of nearly every health care organization in the world. Transparency International defines corruption as "abuse of entrusted power for private gain."  By that definition, many of the cases discussed on Health Care Renewal are about corruption.  For example, if a pharmaceutical company pays physicians as part of a deceptive marketing campaign that exaggerates the benefits or minimizes the harms of a drug, and that campaign increases sales and hence executive compensation, one could argue that the case involves corruption of both of physicians and of company management.  We have discussed many such cases on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  One striking example was the stealth marketing campaign for Neurontin as described in posts <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/10/did-pfizer-marketers-suppress-and.html">here</a>, <a href="http://hcrenewal.blogspot.com/2009/11/editorial-that-wasnt-evidence-for.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/04/pfizer-settles-one-lawsuit-loses.html">here</a>. Thus, there are many examples of corruption affecting health care professionals and academics, and all sorts of health care organizations, hospitals, health care insurers, pharmaceutical and device companies, health care information technology companies, medical education and communication companies, contract research organizations, etc, etc, etc  In 2006, <a href="http://www.transparency.org/publications/gcr/gcr_2006">Transparency International's Global Corruption Report</a> asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  As we summarized <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a>, the report discussed the scale and diversity of health care corruption, and the severity of its adverse effects. However, at least for a generation, there has been almost no opposition to such corruption.  In fact, as we have noted, health care corruption, and the problems and leadership and governance that lead to it, have been nearly <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  Specifically, there is almost no teaching or research on corruption in health care academics (including medical and public health schools, and programs in health care research and policy.)  There is almost no mention of corruption by health care professional associations.  There are almost no initiatives to fight corruption on the part of health care charities and donors.  There is almost no interest in corruption among patient advocacy organizations.  (See previous discussion <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a>.) Why do they all ignore such a huge problem?  Most likely it is because of <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional</a> and <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual conflicts of interests</a>.  Most of the these organizations are substantially funded by health care corporations, including corporations most involved in corruption, (and parenthetically, by financial firms whose corruption was likely a major cause of the global financial collapse / great recession, the other ostensible cause of the freeze of Global Fund grants.)  Many prominent health professionals and academics, and health care organizational leaders themselves have individual financial relationships with such companies.  For example, a majority of US medical school department chairs have significant financial relationships with health care corporations (see post <a href="http://hcrenewal.blogspot.com/2007/10/medical-school-leaders-conflicts-of.html">here</a>).  We have shown how top medical school leaders may simultaneously serve on the boards of directors of health care corporations (see post <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">here</a>).  People who are personally profiting from relationships with health care corporations are unlikely to question such relationships.  The leaders of organizations which depend on funding from such corporations are unlikely to question whether conflicts of interest might lead to corruption.  People whose colleagues, friends, family members, or supervisors are personally benefiting from conflicts of interest may hesitate to challenge such relationships. So will the freeze of new grants at the Global Fund at least get health care corruption on the agenda?  One can only hope.  I personally hope that there are enough honest and unconflicted people remaining who will raise their voices above a murmur, even if that might discomfit those around them. Of course, one reason we started <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> was to make these issues less anechoic. So hear we go again. PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information.

Will the Freeze of the Global Fund Finally Put Health Care Corruption on the Agenda?

In February, 2011, we posted about problems with corruption affecting the Global Fund to Fight AIDS, Tuberculosis and Malaria. At the time,...

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