healthy4u: confidentiality clause

At Merck's Urging, a Federal Judge Threatens to Sanction a Lone Professor for Trying to Reveal Evidence about Vioxx

We have written often, and most recently<a href="http://hcrenewal.blogspot.com/2014/06/justice-delayed-is-justice-denied.html"> this week,</a> about the limp posture taken by US law enforcement and regulatory agencies in the face of misbehavior by large health care organizations.  At best, official action often results in<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> legal settlements</a> which let companies pay fines, sometimes large, while the individuals who profited most from the alleged wrongdoing do not suffer any negative consequences.  Worse, the legal settlements often allow the companies to continue to deny any culpability, and the legal evidence underlying the settlement, which might let the public at least estimate culpability, is often kept sealed, or confidential.  As Judge Rakoff wrote in turning down such a settlement involving a financial, not health care company, sealing evidence hides "any proven or admitted facts upon which to exercise even a modest degree of independent judgment,"  and prevents courts and presumably anyone else from trying to determine whether the government endorsement of such a settlement serves any public purpose (look <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">here</a>). Keeping Evidence from the Latest Vioxx Case Secret But Ed Silverman, <a href="http://blogs.wsj.com/pharmalot/2014/06/16/merck-seeks-sanctions-against-expert-witness-for-talking-to-a-journalist/">posting</a> to the revived PharmaLot blog, found an example of how far big health care organizations will go to try to keep secret evidence uncovered during litigation that lead to legal settlements, and how judges other than Judge Rakoff may let them do so. <blockquote class="tr_bq">A federal judge may sanction a physician who served as an expert witness in the ongoing litigation over the Vioxx painkiller for describing confidential documents to The Wall Street Journal. Earlier this month, U.S. District Court Judge Eldon Fallon issued a <a data-ls-seen="1" href="http://freepdfhosting.com/56538c8069.pdf">restraining order</a> saying David Egilman, who is a Brown University clinical professor of family medicine, 'may have acted in derogation of his responsibilities.'  Egilman was an expert witness with access to documents in litigation over the Merck pill that took place in various courts around the country. Vioxx was withdrawn a decade ago over links to heart attacks and strokes. Fallon, who presides over Vioxx litigation that was consolidated in federal court in New Orleans, had issued an order in 2005 that marked swaths of documents as confidential. Much of the documentation was filed as evidence in litigation in both state and federal courts.</blockquote> The Nature of the Information to be Kept Secret The post is vague about what secret information Dr Egilman was accused of making public.  Apparently, it had to do with his work as <blockquote class="tr_bq">a paid expert witness for plaintiffs in a lawsuit that had been filed by the Kentucky Attorney General, who alleged Merck violated consumer protection laws by failing to disclose to doctors and patients that taking Vioxx significantly raised the risk of a heart attack. The lawsuit was settled last November for $23 million, although the drug maker did not admit to any wrongdoing. Egilman maintains that some documents demonstrated a failure to properly inform research subjects of side effects and risks, and thus he believes the information should be publicly available. 'In general, there’s information on the toxicity of the drug that’s not been previously published by Merck and there is information that Merck published that misrepresents the health effects of the drug,' he told us three months ago, which prompted the drug maker to complain to the federal judge.</blockquote> So apparently the information had to do with the possibility that Merck withheld or misrepresented information about the toxicity and health effects of Vioxx.  Also, apparently another judge thought that there was at least an argument that this evidence should be public. What About the Public's Interest? <blockquote class="tr_bq">Three months ago, though, a Kentucky state judge permitted Egilman to challenge the confidentiality of the documents, since he had standing as an expert witness which gave him previous access to the materials. <a data-ls-seen="1" href="http://blogs.wsj.com/corporate-intelligence/2014/03/26/more-disclosure-coming-in-mercks-decade-long-vioxx-nightmare/?KEYWORDS=silverman+egilman">As we noted at the time</a>, the judge wrote that 'important public policy questions regarding consumer protection and public health have been raised. The public has an interest in evaluating Dr. Egilman’s opinions and the documents on which they were based.'</blockquote> Merck appears to be squirming in response to the prospect that this information could become public, and that the public might have an interest, in any sense, in it. <blockquote class="tr_bq"> Merck continues to decline comment about the content of the documents and the legal fight with Egilman. But the drug maker argued at a recent hearing that, by virtue of describing the documents to The Wall Street Journal, Egilman violated the 2005 protective order. Moreover, <a data-ls-seen="1" href="http://freepdfhosting.com/359c9a7427.pdf">the drug maker maintained</a> that it would be harmed if the documents were disclosed, and Fallon agreed.</blockquote> While the judge seemed very concerned that Merck somehow might be harmed were to truth to be revealed, it is not obvious either the judge or Merck were at all concerned about the public interest in this truth, if for no other reason than it would say something about what appointed and elected government law enforcement officials are willing to keep secret.  Nor did the judge seem concerned about the imbalance for forces obvious when a huge drug company and US law enforcement are on one side, and a single physician is on the other. Merck's Track Record Vis a Vis Vioxx By the way, while past results do not guarantee future performance, as financial reports are wont to say, past results suggest that Merck was up to no good on a grand scale in its promotion of Vioxx. As we noted <a href="http://hcrenewal.blogspot.com/2011/12/merck-admits-little-while-settling.html">here</a>, all these settlements  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 after all that, Merck is still trying to hide evidence from Vioxx litigation, and a federal judge and apparently federal prosecutors are willing to go along, opposed only by Dr David Egilman  Summary We have long talked about what we have called the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how inconvenient truths that might reflect badly on the current health care status quo and especially those insiders who are making so much money from it are treated as recent unpleasantness that one just should not talk about.  The anechoic effect does not arise merely from politeness, or desire not to discomfit the powerful, but from active measures the powerful take to keep dissent down.  Here we have an example of a huge drug company, apparently helped by US law enforcement and US courts trying to keep truths about how it marketed a drug out of the public eye, even after so much information suggesting that its marketing was deceptive and unethical, and lead to patients dying has come out. As we have said endlessly, until health care professionals, policy makers, and the public can obtain and openly discuss information about health care dysfunction, even if that information and its discussion may threaten those who lead health care and make so much money doing so, health care dysfunction will continue.  True health care reform would improve transparency and put an end to the anechoic effect. Disclosure Note that both Dr Egilman and I are voluntary faculty at Brown, although we do not directly work together.  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>. ADDENDUM (19 June, 2014) - See also <a href="http://1boringoldman.com/index.php/2014/06/19/first-order-solution/">comments</a> on the 1BoringOldMan blog.

At Merck's Urging, a Federal Judge Threatens to Sanction a Lone Professor for Trying to Reveal Evidence about Vioxx

We have written often, and most recently this week, about the limp posture taken by US law enforcement and regulatory agencies in the face of misbehavior by large health care organizations. At best, …

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17 Jun 2014

Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">take care of patients as corporate employees</a> give up their professionalism. Shut Up... In April, 2013, Medscape published an <a href="http://www.medscape.com/viewarticle/781964">article</a> whose striking title was "Can You Speak Out Without Getting Fired or Being Labeled a Troublemaker?"  The answer was basically "no." <blockquote class="tr_bq">Physicians often see problems at their workplaces relating to patient quality of care, financial practices, mistreatment of staff, and other issues. But as more doctors take jobs as employees of hospitals, medical groups, and other large organizations, they increasingly face the same dilemmas as millions of other working stiffs. When they come across actions or policies that they don't think are right, they have to decide whether it's worth it to speak out and get labeled as a troublemaker -- or perhaps even get fired.  Across the country, a growing number of physicians are indeed losing their jobs -- and often their hospital staff privileges -- after protesting employment conditions. Such complaints may involve patient quality-of-care problems, short staffing, misallocation of funds, improper financial incentives, fraud and abuse, discrimination, overuse or withholding of medical services, or other misconduct, say organized medical groups, employment attorneys, and physician recruiters.</blockquote> Of course, physicians swear oaths to put the needs of their individual patients first, and doing so within a large organization might well involve protesting conditions and practices that may affect the quality of care or even endanger patients.  But woe unto physicians who try to fulfill their professional responsibility when doing so goes up against the top executives to whom the physicians must now report. <blockquote class="tr_bq">'We were naive when we went into this,' says Maria Rivero, MD, who with her professional colleague and significant other Derek Kerr, MD, filed administrative complaints against their long-time hospital employer in 2010. 'We thought if we just brought it to people's attention, they would fix the problem and leave us alone. But if you blow the whistle on high-level executives, you need to prepare to be harassed and lose your job.'</blockquote> Even working within the system to fix problems can lead to big trouble, <blockquote class="tr_bq">Still, the formal professional approach doesn't always work either. Cloyd Gatrell, MD, an emergency physician who was employed by EmCare, says that he and his wife Kathryn, a nurse, voiced concerns and presented data to executives at Carlisle Regional Medical Center in Pennsylvania in 2008 and 2009 on what they saw as inadequate nurse staffing levels that endangered patients. After getting no results, Dr. Gatrell contacted the state health department, prompting a state inspection that found insufficient staffing. In 2010, he was fired by EmCare at the request of the hospital, according to his 2011 lawsuit against the hospital and EmCare claiming violation of whistleblower protection laws. His wife was fired earlier, and she sued separately. The hospital issued a statement declining comment on the litigation. 'We're supposed to be advocates for patients, but being employed puts us in a precarious position in taking a position on patient interests that's against what the hospital administration favors,' says Dr. Gatrell, whose suit is in the discovery stage. 'I think a physician still has that responsibility.'</blockquote> Physicians who sign contracts with corporate employers, perhaps thinking that they will have less bureaucracy with which to contend and a more certain salary than they did in private practice, seem blissfully, or willfully unaware that those contracts may take away their ability to control their practices and stand up for their patients. <blockquote class="tr_bq">Still, federal and state whistleblower laws only provide protection from retaliation for physicians in certain situations, such as those employed by public entities or those who complain about civil rights violations or Medicare and Medicaid fraud and abuse. Otherwise doctors may have to rely on contract provisions or on state employment law, which may not offer much protection. [An anesthesiologist on the AMA Board of Trustees and his hospital system's board,] Dr. Annis says that the AMA's new statement of principles for physician employment -- which asserts that physicians should not be retaliated against by their employers for speaking out on patient care issues -- provides support for doctors when they raise legitimate professional concerns with their employers. He says it's best for physicians to work through their medical staff organization. But Dr. Gatrell points out that the AMA statement explicitly accepts that physician employment contracts may allow hospitals to strip doctors of their medical staff membership and clinical privileges at the same time they are terminated, known as a 'clean sweep' clause. 'If that's accepted by the AMA, the rest of the principles protecting physicians are meaningless," he argues. "If physicians can be fired without cause and then automatically lose their medical staff membership and its due process protection, how many will dare be a patient advocate?' Some experts advise physicians not to sign employment agreements with such onerous provisions. But others say that physicians often have little leverage to remove them. 'It's not an equal negotiating table,' says Dr. Gatrell, who's now working for a small urgent care practice.</blockquote> A May, 2013 <a href="http://www.medscape.com/viewarticle/782136">article</a> again in Medscape about the "4 Top Complaints of Employed Doctors," explained why physicians often see a lot they could or should protest to assure the quality of their patients' care, <blockquote class="tr_bq"> Some doctors report that hospital administrators treat them with a lack of respect. One female doctor said, also on condition of anonymity, that her biggest challenge on her job was 'how to handle nonphysician high school grads bossing you around when they function as your 'superiors' in your employer's organization. They manage their insecurities by bullying physicians and through passive aggressiveness, but always seem to gain the upper hand with those at the top.'</blockquote> These are the sorts of brilliant administrators often hired by brilliant top executives, maybe at a cheap price to keep the bottom line and <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> healthy..  Furthermore, given that as we have discussed, "<a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>" of hospital management often puts a bigger priority on short-term revenue than on quality care, as per one senior physician, <blockquote class="tr_bq"> 'physicians are being increasingly targeted when they get in the way' of hospitals' agendas</blockquote> To make more money faster, many hospital systems now seem to want physicians to only make referrals for lucrative tests and treatments within the system, even if some patients might be better served elsewhere, <blockquote class="tr_bq">The AMA recently issued guidelines for physician employment stating that 'a physician's paramount responsibility is to his or her patients.' Employers should not retaliate against physicians for asserting their patients' interests, according to these guidelines. 'In any situation where the economic or other interests of the employer are in conflict with patient welfare, patient welfare must take priority,' the AMA says. The guidelines also call for employers and employed physicians to disclose to patients any agreements or understandings they have that restrict, discourage, or encourage particular treatment or referral options. Nevertheless, employed physicians are often expected to refer patients within their own groups and send tests to a hospital laboratory or imaging center. Hospitals may tell employed surgeons which kinds of joint implants to use, and according to a New York Times article even whether to implant defibrillators in Medicaid patients. It's unclear how often any of this is disclosed to patients. 'What we doctors say is that we're ethically bound to our patients because we took an oath, and that's what our license is based on,' says Linda Brodsky. 'But many hospitals say, 'No, you're employed here, and what we say goes.'</blockquote> Note that so far there seems to be little evidence that the AMA guidelines about physician employment are being honored other than in the breach.  It is also disappointing that the leadership of the medical society that represents internists seems so unworried, <blockquote class="tr_bq"> David L. Bronson, MD, President of the American College of Physicians, disputes Brodsky's assertion that hospitals tend to squelch doctors who criticize leadership for policies that they believe harm patient care. In fact, he says, healthcare organizations may identify outspoken physicians as potential leaders, 'as long as they're collaborative and trying to solve problems, and not just be a thorn in the side of everyone they know. Organizations are looking for physician leaders, and physicians who can collaborate and not just be adversarial can go far inside organizations.'</blockquote> I would guess, having seen so many examples of <a href="http://hcrenewal.blogspot.com/search/label/generic%20management">generic management</a>, <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">mission-hostile management</a>, management that seems more <a href="http://hcrenewal.blogspot.com/search/label/financialization">focused on the money than patient care,</a> and management that seems to be able to <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">make itself rich</a> without evidence that it has done anything noteworthy to uphold hospitals' clinical missions, that hospital systems that promote physicians who are willing to speak out against hired executives are vanishingly rare. And Sell In June, 2013, Beckers Hospital Review published an <a href="http://beckershospitalreview.com/hospital-physician-relationships/teaching-doctors-how-to-sell.html">article</a> suggesting that now hospitals are going beyond just pressuring employed physicians to refer potentially profitable patients within the system, and now are pressuring physicians to act as salespeople to their colleagues, <blockquote class="tr_bq"> A few hospitals are beginning to train their employed physicians to "sell" the hospital, which involves asking referring doctors in the community to send patients their way....  the pressure to bring doctors into sales is mounting.</blockquote> The author, the former publisher of Modern Healthcare, made a remarkable argument based on a definition that seems wildly optimistic, <blockquote class="tr_bq"> Customer service lies at the core of salesmanship. The Business Dictionary defines salesmanship as satisfying customer needs through a sincere and mutually beneficial process aimed at a long-term relationship.</blockquote> Of course, skeptical physicians used to exposure to the sales tactics pharmaceutical and device companies use (look <a href="http://hcrenewal.blogspot.com/2007/05/fool-me-once-shame-on-you-fool-me-twice.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/what-drug-reps-really-care-about.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2008/04/more-about-cynical-world-of-drug-reps.html">here</a>,  for example) might wonder why the author did not discuss such marketing tactics as the employment of half-truths and biased information, and the use of emotional appeals to trump reason and logic. That the author was serious was shown by his list of seven pointers for hospitals seeking to transform its employed physicians into marketers. Of course, physicians who are already "key opinion leaders" employed by drug and device companies, whose marketing executives may think. that "key opinion leaders were sales people for us," (see <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">this post</a>), might not be fazed by now being asked to market their own hospital.  Never mind about Principle II of the <a href="http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/principles-medical-ethics.page?">AMA Code of Ethics</a> <blockquote class="tr_bq">II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.</blockquote> The Moral of the Story We have previously discussed various aspects of the travails of the brave new world of the <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate physician</a>.  Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to their professional values</a>, and who are subject to <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> that support such hostility, including the potential for huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a>.  Physicians seem to be willing to sign <a href="http://hcrenewal.blogspot.com/search/label/contracts">contracts </a>that underline their new subservience to their corporate overlords, and likely trap them within <a href="http://hcrenewal.blogspot.com/search/label/confidentiality%20clause">confidentiality clauses</a> that make blowing the whistle likely to lead to extreme unpleasantness. It is disappointing that even medical societies that ostensibly support physicians' professional values have been afraid to warn against such employment, or do much to help physicians trapped within it. Physicians who go to work for big corporations have to realize that they may be forced to put corporate executives' vested interests ahead of their patients.  Patients whose physicians work for big corporations must realize that their health care will now be corporate, with all that entails.   As I have said before, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.

Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to take care of patients as corporate employees give up their professionalism.Shut Up...In April, 2013, Medscape publ…

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26 Jun 2013

How the Anechoic Effect Is Institutionalized - A Hospital Policy Against Unsupervised Discussion with the Media

In a single sentence, a short, obscure <a href="http://www.wbjournal.com/news50656.html">article </a>in the Worcester (MA) Business Journal on life at a community hospital after a for-profit corporate take-over: <blockquote>Several Nashoba employees, who didn't want their names used because it's against hospital policy to talk to the media without authorization, said they're happy with the new insurance plan.</blockquote> We have often discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how cases involving or discussions of the topics we address on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, the concentration and abuse of power in health care, fail to produce any responses, or echoes.  It was almost an aside, but the sentence above provides evidence of the existence of apparently blanket hospital policies against unsupervised discussion with the media. Here is an example of the institutionalization of the anechoic effect. This example raises three immediate questions. How prevalent is this? How long has it been going on? What is it meant to hide? Prevalence This article is only about a single hospital. However, the context of the article is the take-over of Nashoba Hospital by Steward Health Care. <a href="http://hcrenewal.blogspot.com/search/label/Steward%20Health%20Care">Steward Health Care</a> is a for-profit health care corporation that grew out of the take-over of the formerly not-for-profit <a href="http://hcrenewal.blogspot.com/search/label/Caritas%20Christi">Caritas Christi</a> health system by the private equity firm <a href="http://hcrenewal.blogspot.com/search/label/Cerberus">Cerberus Capital Management</a>. Steward Health Care now comprises <a href="http://www.steward.org/our-hospitals.html"> eight hospitals</a>, and also owns physician practices (apparently including over 2000 doctors based on a quick search using its <a href="http://www.stewardhealth.org/doctorfinder/search_form">"doctor finder" function</a>.) Thus it is likely that the policy at Nashoba Hospital that prevents unsupervised discussion with the media also applies at seven other hospitals, and perhaps to the practices of over 2000 doctors. Thus it is very likely that this hospital gag policy is not unique, and may be widespread. However, recursively, the existence of such gag policies will make it hard to determine their own prevalence. Note that we have posted a few times about confidentiality clauses mainly within physicians' contracts <a href="http://hcrenewal.blogspot.com/search/label/confidentiality%20clause">here</a>. Duration This policy is likely relatively new, since the take-over of Caritas Christi by Cerberus occurred in 2010. My guess is that the rise of such policies may parallel the resurgence of for-profit hospitals and hospital systems, and perhaps the new involvement of <a href="http://hcrenewal.blogspot.com/search/label/private%20equity">private equity firms</a> in such organizations. In my humble experience, gag policies and confidentiality clauses at least within non-profit teaching hospitals were virtually unheard of from the time I began medical school (1974) to when I left my last full-time academic medical position (2005). Note that we<a href="http://hcrenewal.blogspot.com/2012/01/barbarians-at-gate-making-private.html"> recently found out</a> (because of investigative journalism about presidential candidate Mitt Romney's previous involvement with private equity firm Bain Capital) that such firms are generally rebranded leveraged buy-out firms. They have become known for their secretiveness. Therefore, maybe it should not be surprising that they have imposed such secretiveness on hospitals and health care professionals. Rationale  The big question is why should hospital employees not be allowed to talk to the media without management supervision? I can only speculate. In this case, perhaps such secretiveness is just the habit of the private equity executives who now run the hospital system. Even if this is the reason, they ought to reconsider. Hospitals and health care professionals due have a solemn obligation to keep confidential their patients' medical information. However, otherwise health care organizations and health care professionals ought to be as transparent as possible. Maintaining such a level of secrecy could lead to some suspicions, for example, that the generic managers of the organization distrust the professionals they hire who actually provide patient care; worse, that the managers fear discussion that might question their actions or abilities; worse, that the managers want to silence whistle-blowers; or even worse, that the managers have something unethical or illegal to hide. That is all speculation, of course. On the other hand, we have discussed again and again how the anechoic effect has stifled discussion of what is wrong with health care, and hence prevented meaningful health care reform. Gagging hospital employees is an obvious extension and institutionalization of the anechoic effect. It should not be done, because we need honest discussion of what is really wrong with health care so we can come up with some real solutions.

How the Anechoic Effect Is Institutionalized - A Hospital Policy Against Unsupervised Discussion with the Media

In a single sentence, a short, obscure article in the Worcester (MA) Business Journal on life at a community hospital after a for-profit corporate take-over:Several Nashoba employees, who didn't want …

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31 Jan 2012

The Perils of Physicians Practicing as Corporate Employees: the Contract Trap

A seriously chilling cautionary tale corroborated some of my <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">previously expressed fears</a> about the perils of physicians practicing as corporate employees.  It unlikely venue was the April 25, 2011 issue of Medical Economics.  The article, not yet on the web, was "Selling to a Corporation Poses Challenges," by Todd R C Neely. Here is how the case started: <blockquote>A start-up company with a new medical treatment became a publicly traded corporation. The company's top managers were not physicians; they were finance and business experts familiar with the ways of Wall Street. To meet the corporation's goals and Wall Street expectations, the company used stock sale proceeds to aggressively market itself to doctors and buy established physician practices around the country. It quickly captured market share, exponentially raised the number of patients by the practices it owned, and developed substantial revenue streams. The physicians who sold their practices thought that selling would be a win-win situation for them and for the corporation. As marketed to them, the company would handle the business aspects of owning a medical practice - the ubiquitous paperwork, employee issues, and all the rest of the nonclinical task so distasteful to doctors. The physicians would spend all their work time practicing medicine using the latest technology. Benefiting from the company's promotion to the public, they would see an increase in their patient base. They would receive a base salary and, most significantly, a percentage of the profits of their practice.</blockquote> But here is how things turned out: <blockquote>Everything was great until the end of the first year. The physicians expected large payments from their practices' increased profits, but the large bonuses never came. </blockquote> What went wrong? The physicians were so blinded by the marketing pitch that they apparently never read the fine print: <blockquote>In negotiating the sale of the practices and the employee contracts, the doctors had not required the company to specify in writing what expenses the corporation would charge an individual practice and what accounting rules would be followed. So the corporation charged the practices for marketing, accounting, human resources, financing, and other services, wiping out the profits of each practice.</blockquote> The contracts were apparently designed by the corporation to favor all its interests (which should not have been surprising), but was accepted as is by the physicians: <blockquote>The contracts specified in precise terms the physicians' responsibilities, noncompete provisions, confidentiality, dispute resolution and the like. But although the contracts stated the corporation's initial responsibilities - mainly making payment on the negotiated purchase price - it phrased the company's other obligations in remarkably vague terms, or, astonishingly, did not specify them at all. The company was to make its 'best efforts' to accomplish certain goals, but the contract left the phrase 'best efforts' undefined. The phrase turned out to be quite malleable. The company's other responsibilities were to be determined at a later, unspecified time. The company's best efforts always turned out to be whatever efforts it chose to make.</blockquote> It was a trap,baited by marketing, into which the physicians neatly fell: <blockquote>Many sought legal advice and were told they had no legal resource. The noncompete clauses - fair provisions under the contract terms to which the physicians thought they were agreeing but that were disastrous under the terms (or lack thereof) of the actual contract - were broad, tight, specific, and ironclad. Many of the physicians even were barred from practicing medicine within the geographic area in which they lived. And under the equally ironclad confidentiality clause, the doctors could not publicly discuss their situations or, for that matter, anything else of significance about the corporation; if they did, they would be subject to high fines and penalties. What had appeared to the doctors as a mutually beneficial situation turned into a nightmare for them. They lost their practices and money and took years to recover. They had no legal recourse. They could not even warn others. The corporation could, and did, continue with impunity.</blockquote> Note that it is now obvious why the article was so vague about the identity of the corporation and the physicians it ensnared, and why it took so long for even such a vague version of this story to surface. The confidentiality (and probably anti-disparagement) clauses made it hazardous for anyone who signed these contracts to be forthright witnesses.  Obviously, the willingness of corporations to employ such clauses means that there may be many more cases like this out there, hidden behind the veil of contractual restrictions on free speech. We previously discussed how physicians often seem willing to blithely sign contracts without fully understanding them, thereby sacrificing their economic well-being and core values.  Here is another striking case of this phenomenon.  We previously attributed this tendency to <a href="http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html">learned helplessness</a>.  The author of this article, however, suggested  that physicians were victims of carefully targeted marketing based on psychological manipulation.  It was meant to capitalize on three major factors: physicians' naive belief that everyone involved with medicine is interested in helping people by behaving rationally and logically; physicians' over-confidence in their ability to avoid failure (presumably including failure due to ignorance or misinterpretation of legal contracts); and physicians' feelings of entitlement.  In addition, the physicians seemed (probably foolishly) unaware that corporate executives are not interested in physicians' core values: <blockquote>Unlike physicians, the corporation and its top executives, non-doctors all, were involved in the practice of medicine solely to make money; the medical practices, and the very practice of medicine, were just commodities [to them].</blockquote> This observation corresponds with numerous observations about how leaders of health care organizations may ignore, or be expressly<a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management"> hostile</a> towards physicians' core values. Thus, while the article went on to give some straight-forward advice about negotiating combined practice buy-out and corporate employment agreements, it becomes obvious that the main lesson is: physicians should not practice medicine as corporate employees. They should not sell their practices to and become employees of for-profit corporations as a way to practice medicine.  Otherwise, rather than being practitioners, they will end up as medical assembly line workers for bosses who only care about the revenue they generate. Physicians who have already inadvertently, foolishly, or under duress signed contracts that could threaten their professionalism and their patients' welfare need to do the right thing and challenge these contracts.  , or else there will soon be nothing left of the medical profession, and no one left to ethically care for patients.  With each new anecdote, it becomes clearer that the corporate practice of medicine will end up exploiting physicians and patients alike. So there is also a main lesson for patients: you should not go to doctors who are corporate employees, or practices or clinics that are run by corporations. If you do, you will end up being used only as a means for the bosses to make money. At a policy level, if we do not stop the corporate practice of medicine, we will all end up as increasingly unhealthy cogs in the corporate health care machine.

The Perils of Physicians Practicing as Corporate Employees: the Contract Trap

A seriously chilling cautionary tale corroborated some of my previously expressed fears about the perils of physicians practicing as corporate employees. It unlikely venue was the April 25, 2011 issu…

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02 May 2011

"You Can't Say That" - Non-Disparagement Clauses and the Anechoic Effect

Here is another example of why health care organizations' leaders are different from you and me, and why that may not be a good thing for health care.  A few days ago, the San Jose (California) Mercury News <a href="http://www.mercurynews.com/peninsula/ci_17356043">reported</a> on the upcoming departure of a local hospital CEO: <blockquote>El Camino Hospital's handsomely-paid president and CEO Kenneth Graham is out of a job, the hospital announced Thursday afternoon. Graham's contract will end June 30 'without cause, at the request of the hospital's Board of Directors,' according to a statement released to the media. Until then, Graham will continue to fulfill his duties as the hospital's top administrator, according to the statement. Graham has been president and CEO of the hospital for 4½ years. The brief statement did not explain why Graham has been ousted, focusing instead on his accomplishments. Graham earns an annual base salary of $632,640.</blockquote> Not only was the CEO "handsomely paid," he will be handsomely paid to depart, as <a href="http://www.mercurynews.com/peninsula/ci_17367849">reported</a> two days later by the same newspaper: <blockquote>Former El Camino Hospital president and CEO Ken Graham may be out of a job, but he won't be hurting for a paycheck anytime soon. Fired 'without cause' by the hospital's board of directors on Wednesday, Graham is now entitled to nearly $1 million in severance pay, according to his contract, which the hospital provided to The Daily News on Friday. Specifically, the hospital will pay Graham a lump sum of 18 months' salary when he officially steps down June 30. Based on his annual salary of $632,640, he would receive $948,960.</blockquote> The reporter could not get any clearer fix on the reason for his departure: <blockquote>Hospital officials Friday were tight-lipped about their decision to drop Graham. Reached by phone, board Chairman Wesley Alles would only say it was 'without cause.' 'I guess as a generic (explanation) the only thing I can say is it's without cause, that (the board wants to take) some different directions, perhaps, as a generic (explanation),' Alles said. El Camino Hospital spokeswoman Chris Ernst said she couldn't say more than what was written in a statement released to the media Thursday, which simply stated Graham's contract was ended 'without cause, at the request of the hospital's Board of Directors.' 'I know everyone wants to know if there's something really there, but it was clearly without cause,' Ernst said. 'It's not like you can point to one particular thing and say this is why this action was taken.'</blockquote> Now wasn't that informative? It appears the CEO was let go "without cause." But reporter Diana Samuels did uncover why nobody was saying anything meaningful about this lucrative departure: <blockquote>The contract also includes a 'non-disparagement' clause, which says the hospital and Graham cannot make any statements about each other that could cause 'any embarrassment or humiliation or otherwise reflect negatively on the other party(ies).'</blockquote> I discussed the subject of executive contracts with one of our Health Care Renewal scouts who knows about such things. For high level executives in business, seemingly tidy severance packages are the rule.  We have discussed the problem with excess executive compensation in health care <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a>. Furthermore, various <a href="http://hcrenewal.blogspot.com/search/label/confidentiality%20clause">confidentiality</a>, non-compete, and non-disparagement clauses are often common. However, whether or not these are common practices in the larger business world, these contract provisions, especially non-disparagement clauses, pose problems in health care.  As we have discussed, there are lots of good reasons that the governance and leadership of health care ought to be maximally <a href="http://hcrenewal.blogspot.com/search/label/transparency">transparent</a>. Just to provide one example, consider the problem of medical errors, a subject which has received unending discussion since the report by Institute of Medicine entitled "<a href="http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf">To Err is Human</a>."  One widely espoused doctrine about medical error prevention is that such errors ought to be disclosed and discussed openly so that their root causes can be found, and methods to prevent them developed.  Now suppose, for example, that the CEO of a hospital had discovered some medical errors, but made himself unpopular by pursuing them.  Were he to have a bilateral non-disparagement clause in his contract, and were this unpopularity to cause him to lose his job, he could say nothing about these errors, possibly allowing them to recur, but more seriously.  Of course, the example could be turned on its head.  Suppose the CEO had introduced a new process that was thought to be the cause of such errors.  Were he to lose his job because of this, hospital officials could say nothing about the problem, etc, etc.  Similarly, other problems at the hospital either discovered by the CEO or possibly caused by the CEO could remain anechoic due to non-disparagement clauses in hospital executives' contracts. Of course, in the current case, the CEO might have left due to simple personality differences, and his departure might have nothing to do with medical errors, etc, etc. However, this case suggests that the sort of non-disparagement clauses that may appear in contracts for executives in various type of businesses have metastasized to contracts for hospital executives.  These clauses, and their cousins, confidentiality clauses and non-compete clauses, may be major reasons for the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, and the general lack of transparency of hospital leadership and governance.  However, up to now, such clauses seem to be, you guessed it, <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> in discussions of health care policy and health care reform.  Thus, one step to true health care reform would be for there to be some open discussion of the reasons we cannot openly discuss many important issues in health care, particularly the likely increasing use of contractual clauses such as non-disparagement clauses.  Likely an even more important step would be discrediting such contractual provisions that reduce <a href="http://hcrenewal.blogspot.com/search/label/transparency">transparency</a>.

"You Can't Say That" - Non-Disparagement Clauses and the Anechoic Effect

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14 Feb 2011

VCU President Rao's Previous Code of Silence

We recently <a href="http://hcrenewal.blogspot.com/2010/11/confidentiality-clause-or-oath-of.html">posted</a> about the code of silence imposed by Virginia Commonwealth University President Stephen Rao on his staff.  It turns out now that this was not his first exercise in imposing a code of silence. Before he was at Virginia Commonwealth University, Rao was President of Central Michigan University.  Central Michigan Life just <a href="http://www.cm-life.com/2010/12/03/rao-retracts-confidentiality-agreements-at-vcu-cmu-employees-not-in-same-circumstance-under-ross">reported</a>: <blockquote>While serving as CMU president, Rao required all office employees to sign a similar confidentiality agreement stating all names, places, dates or incidents that happened in his office were not to be shared with anyone or discussed outside the office. 'I understand that the information and all files, letters, projects, telephone calls and anything relating to the work performed in the President’s Office and in my capacity as an employee is highly confidential,' stated the agreement, which was obtained through a Freedom of Information Act request. 'I understand that it may not be discussed with anyone outside this office who does not have a need to know, which includes any other CMU employee, as well as my family members, friends, etc.' The CMU confidentiality agreement extended past any employee’s tenure at CMU, stating that the contract must not be broken past the term of employment. If an employee were to break the confidentiality agreement past employment, possible consequences included personal liability and potential lawsuits.</blockquote> Note that just as was the case in Virginia, this agreement placed employees at risk not only of losing their jobs, but of being sued were they to violate the agreement. By the way, while Central Michigan University does not include a medical school and academic medical center, as does VCU, it does have, and therefore the previous agreement affected the operations of multiple health related programs (see <a href="http://www.cmich.edu/Admissions/Academic_Programs/Health-related.htm">here</a>) including allied health, health administration, physical therapy, and psychology. As we wrote previously, such a code of silence subverts the university's central mission, and directly opposes the transparency I believe is necessary for good governance in health care.  The discovery of this previous confidentiality agreement at CMU suggests that such agreements may not be rare in health care.  We have long <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">discussed</a> the anechoic effect in health care, how certain topics and issues are just not to be discussed, especially those that might embarrass or oppose the personal interests of health care leaders.  We have postulated that the effect operates through fear of offending supervisors, colleagues, or those who provide one's pay.  It may be, however, that the anechoic effect has been codified through confidentiality clauses.  As noted above, such codification can mean whistle-blowers may risk lawsuits as well as job loss and ostracism. If there are other codes of silence operative in health care, I hope that sunlight soon shines upon them.  That sunlight may cause such codes to shrivel is suggested by President Rao's rescinding of the code at VCU soon after it was made public, as reported by the Richmond Times-Dispatch: <blockquote>With the board of visitors meeting yesterday to evaluate his performance, Virginia Commonwealth University President Michael Rao rescinded the confidentiality agreements he required employees working in his office to sign. Rao sent employees a letter Wednesday that said the confidentiality agreements were intended "to protect the privacy of my family, particularly my children, in my home." 'The confidentiality agreements have been the subject of recent scrutiny and criticism and, unfortunately, have been misinterpreted in terms of what I sought to be accomplished by these agreements,' he wrote. 'I sincerely regret any undue burden or ill will that these agreements may have caused. Therefore, I have decided to withdraw all such confidentiality agreements.'</blockquote>Such codes ought to be perceived as unethical, and perhaps should be made illegal.  Meanwhile, though, the anechoic effect continues.

VCU President Rao's Previous Code of Silence

We recently posted about the code of silence imposed by Virginia Commonwealth University President Stephen Rao on his staff. It turns out now that this was not his first exercise in imposing a code o…

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06 Dec 2010

A Confidentiality Clause or an Oath of Fealty?

The advancement of modern scientific medicine depends on the search for and dissemination of truth. Academic medicine, like the rest of academia, ought to be based on openness, transparency, and academic freedom. The 1940 American Association of University Professors (AAUP)<a href="http://www.aaup.org/AAUP/pubsres/policydocs/contents/1940statement.htm"> Statement of Principles on Academic Freedom and Tenure</a> opened with: <blockquote>The common good depends upon the free search for truth and its free exposition. </blockquote>Yet we have written about dark clouds of secrecy spreading over medicine and health care. The increasingly powerful leaders of health care increasingly use opacity and secrecy to keep what they are doing out of the public eye. We have frequently discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations.  People may feel it is unseemly to speak badly of renowned institutions such as hospitals and universities.  People with conflicts of interest may not be inclined to criticize those who pay them.  Now people employed by contemporary health care organizations may have to pledge theri silence to keep their jobs. The latest story in this regard comes from Virginia Commonwealth University (VCU), which includes VCU Health Systems, and MCV Hospital and Physicians.  (Full disclosure: I was a VCU full-time faculty member from 1987-1994, and still am on the adjunct faculty.)  In 2008, the VCU President resigned after the university's secret research contract with a tobacco company, and the President's own position on the board of directors of another tobacco company were revealed (see blog post <a href="http://hcrenewal.blogspot.com/2008/08/after-controversy-over-tobacco-money.html">here</a> and others <a href="http://hcrenewal.blogspot.com/search/label/Virginia%20Commonwealth%20University">here</a>). Michael Rao, the President since 2008, is now under outside review after it was revealed that he required his staff to sign a secrecy pledge.  The <a href="http://www2.timesdispatch.com/news/local-news/2010/nov/17/vcuu17-ar-658103/">story</a> appeared in the Richmond Times-Dispatch: <blockquote>Virginia Commonwealth University President Michael Rao asks employees who work in his office to sign an unusual <a href="http://static.mgnetwork.com/rtd/pdfs/vcuu17.pdf">confidentiality agreement</a> that bars them from talking about what they observe about him or his family. The prohibition goes beyond the standard agreement that university employees sign acknowledging that they can't disclose personal or proprietary information. The agreement, a copy of which was obtained by the Richmond Times-Dispatch, covers interactions at Rao's office and at his residence. It bars disclosure not just to the news media, family or friends, but also to colleagues, 'clergy and attorneys, or to any other person not otherwise identified.' 'I agree that any such disclosure in violation of this nondisclosure agreement could result in irreparable damage and harm to VCU, President Rao, and/or his family'" the agreement states. 'Any such violation or anticipated violation' would entitle Rao to seek 'injunctive relief' in Richmond or Henrico County circuit courts. VCU spokeswoman Pam Lepley said she could not comment immediately yesterday. Several current or former employees of the president's office confirmed that they had been asked to sign the agreement, including Kimberley Busch, Rao's former scheduler. She described it as a 'what happens in the president's office stays in the president's office' agreement.</blockquote> The newly uncovered confidentiality clause provoked strong criticism: <blockquote>Raymond D. Cotton, a Washington attorney who specializes in higher-education governance, said such a confidentiality agreement is highly unusual and goes against the culture of openness and transparency in higher education. 'There is this concept of academic freedom that is broader than the First Amendment,' he said.</blockquote> In fact, since Virginia Commonwealth University is a state-supported institution, the confidentiality clause may be unconstitutional, as <a href="http://www.wtvr.com/news/wtvr-mark-on-vcu-president-111810,0,1379760.story">reported</a> by WTVR: <blockquote>Kent Willis with the Virginia American Civil Liberties Union said the agreement doesn't pass constitutional muster. 'A public employee, no matter where they are in the government, has a right to speak out on matters of public concern,' Willis said. 'That's a U.S. Supreme Court case, it's guaranteed to every public employee by the First Amendment to the Constitution.' Willis said there are numerous legal issues raised by the contract. But, he said, the bottom line problem with the contract 'is the attitude. This is a contract that says 'I'm not transparent. I don't want you to know what is going on. I'm running a closed shop.''</blockquote> Times-Dispatch columnist Michael Paul Williams <a href="http://www2.timesdispatch.com/news/2010/nov/19/mike19-ar-663326/">wrote</a>: <blockquote>VCU, we have a problem. This confidentiality agreement does not inspire confidence. The lack of transparency only gives the appearance that someone's hiding something.</blockquote> He also further quoted Kent Willis: <blockquote>Rao's contract 'fails to address this whistle-blower right and could create conflicts for employees, who are silenced by the employment contract,' yet have a constitutional right to speak out on some matters, Willis said. And as Willis points out, even if a person's constitutional right trumps the contract, how many employees are willing to take that risk? 'Particularly disturbing is the prohibition against talking to an attorney,' he said. 'If an employee believes something illegal is going on at work, an attorney is precisely the person he or she should be talking with.'</blockquote> We just <a href="http://hcrenewal.blogspot.com/2010/07/stifling-whistle-blowers-old-and-new.html">posted</a> about how a pharmaceutical company included a confidentiality clause in a consulting contract, suggesting the deliberate creation of a conflict of interest in order to prevent criticism of the company's products or practices.  However, in several ways, the present example is more insidious.  First, it involves a university, whose mission is to discover and disseminate the truth.  Thus, as noted above, the confidentiality agreement subverts the university's core mission.  Second, it was required of full-time employees who wanted to keep  their jobs, making choose between secrecy and unemployment.  Third, it was particularly harsh, addressing incipient as well as actual disclosure, and including injunctive relief as well as the threat of  termination.  Fourth, it protected not just the organization and its products, but personally protected the organization's leader and his family.  It was not just a contract, but an oath of fealty, as if the CEO were nobility, or even royalty. The good news is that this confidentiality agreement now sits in the glare of sunlight.  One does wonder, however, how many other such agreements are already in force so that the would be nobility who now run too much of health care to avoid any embarassing revelations about what their leadership really is about. We are a long way from the transparency that true health care reform requires.

A Confidentiality Clause or an Oath of Fealty?

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30 Nov 2010

Stifling Whistle-Blowers: Old and New Approaches

We have frequently discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations.  We have discussed many possible causes of the anechoic effect, but one particularly obvious cause is the silencing of dissenters and <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">whistle-blowers</a>. Three recent stories illustrate old and new tactics to reinforce the anechoic effect. A Classic Case - ValleyCare Medical System Nurse Fired <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/07/23/BA6H1EJ0NA.DTL">From the San Francisco Chronicle</a>, <blockquote>An Alameda County jury awarded more than $344,000 in damages this week against ValleyCare Medical System for refusing to rehire a Castro Valley operating nurse who claimed the hospital was retaliating against her for complaints she made about patient safety issues, including concerns about surgical equipment left inside patients. Kristeen Klaas, a 15-year veteran at ValleyCare and a registered nurse for more than 30 years, sued the hospital system, which has services in Pleasanton and Livermore, after she quit in distress in May 2008 and hospital managers failed to respond to her request to be rehired days later. The 54-year-old Klaas, who now works at Alta Bates Summit Medical Center in Oakland and San Leandro Hospital, had brought numerous safety complaints about the Pleasanton hospital to the attention of ValleyCare's management over the two years prior to her resignation. Klaas complained about a fellow nurse who brought a dog into the operating team's break room and jumped rope with an electrical cord in the operating room, as well as a surgical technician who brought a rifle into the operating room office to sell. She also complained that a tip of a surgical instrument went missing during a surgery and was never found, and that an instrument was left in a patient because the hospital did not have a formal policy of counting instruments after surgery. She also accused a supervisor of forging her signature on a performance evaluation after she refused to sign an evaluation that was backdated to comply with state regulations.</blockquote> Here is the tactic allegedly used to silence the whistle-blowing nurse: <blockquote>On her last day on the job, Klaas got permission from her supervising nurse to leave work because she was in distress after a colleague, the subject of three of her complaints, screamed at her. 'She realized, for the patient's safety, she couldn't continue to go forward that day in the operating room because she was so upset,' he said. But then a supervisor called her at home and accused her of leaving without permission, prompting Klaas to resign, he said.</blockquote> This is the classic, rather blunt way to do it: just make the would-be truth-teller's job experience so miserable that she quits. Now we will present two examples of a more subtle approach, one directly from health care, one at least from a sphere with major health care implications. A New Approach: A Contract Preventing Communication "Inimical" to a Pharmaceutical Company's Business This case was documented by a personal narrative by Marc Lipsitch, a Professor of Epidemiology and the Harvard School of Public Health, <a href="http://chronicle.com/article/The-Hidden-Risk-to-Academic/66050/">published in the Chronicle of Higher Education</a>, <blockquote>I received a request from a large pharmaceutical company to assist in the design of a clinical trial, and the proposed terms seemed to require that I sign away my right to criticize the product. One provision would prohibit me from entering into 'any agreement or relationship to render services as ... adviser or consultant to, any other individual, firm, or corporation that would be inimical to or in conflict with' the aspects of the company's business covered by the agreement. Another would forbid me to engage, in any capacity, directly or indirectly, in "any business," with or without compensation, relating to the class of products under discussion—not just for the term of the contract, but for the year after as well. Those provisions could restrain me from providing candid advice to a regulator, a government official, or the editor of a peer-reviewed journal about the class of products on which I was consulting, even if the advice were based on publicly available information. I objected to those terms, as did a colleague who was offered the same arrangement.</blockquote> Prof Lipsitch also noted that government research funding agencies and universities may not provide any protections to their faculty against such agreements. He also noted that the contract he was asked to sign was not one of a kind: <blockquote>Discussions with my colleagues suggest that the problem is not limited to one pharmaceutical company ....</blockquote> We and many others have frequently discussed the conflicts of interest that may be generated by physicians or health care academics having financial relationships with industry. The Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">Conflict of Interest in Medical Research, Education, and Practice</a>, is: <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....</blockquote> Thus the concern is that a faculty member,for example, who is paid to consult for a drug company might tend to favor the company, its products, or policies to its advantage in his or her clinical teaching, scholarly talks and writing, or public policy opinions. That might happen even if the consulting work is technical or scientific and not directly related to the particular topic about which communication might be influenced. However, the situation described by Prof Lipsitch is much worse. Were he to have signed the contract, he would have been constrained by this legal agreement from writing or saying anything "inimical to or in conflict with" the company's business. Last week, a similar, but more wide-spread example surfaced (pardon the pun) in a domain that is at least related to health care. Another Version of the New Approach: the BP Consulting Contracts Making Any Communication Between the Company and the Consultant Confidential Originally <a href="http://www.bbc.co.uk/news/world-us-canada-10731408">reported by the BBC</a>, <blockquote>The head of the American Association of Professors has accused BP of trying to 'buy' the best scientists and academics to help its defence against litigation after the Gulf of Mexico oil spill. 'This is really one huge corporation trying to buy faculty silence in a comprehensive way,' said Cary Nelson. The BBC has obtained a <a href="http://news.bbc.co.uk/2/shared/bsp/hi/pdfs/22_07_bp_contract.pdf">copy of a contract</a> offered to scientists by BP. It says that scientists cannot publish the research they do for BP or speak about the data for at least three years, or until the government gives the final approval to the company's restoration plan for the whole of the Gulf. It also states scientists may perform research for other agencies as long as it does not conflict with the work they are doing for BP. And it adds that scientists must take instructions from lawyers offering the contracts and other in-house counsel at BP.</blockquote> Here are some examples of the wording of<a href="http://news.bbc.co.uk/2/shared/bsp/hi/pdfs/22_07_bp_contract.pdf"> the contract</a> as obtained by the BBC about confidentiality. <blockquote>Confidentiality. All communications (including non-public information disclosed in such communications) between you (and your agents), BP Attorneys and/or other BP representatives in the course of your performance of the BP NRDA Services are deemed to be incidental to the rendering of legal services and are to be privileged and confidential. You shall maintain a strict confidentiality of such non-public communications and information unless or until a person from whom you are authorized to take instructions informs you in writing that this restriction is no longer applicable to any particular non-public communications and information. In the event you are required to disclose such privileged and confidential non-public communication and information by an order entered by a court or by similar judicial process, or by a judicial or administrative subpoena, you shall notify a person from whom you are authorized to take instructions as soon as practicable, and you are required to cooperate with BP if BP decides to seek relief from such required disclosure, including commencement of a legal or administrative proceeding to prevent or limit disclosure of such privileged or confidential information.</blockquote>Here is the description of those from whom the signer of the contract must take orders. <blockquote>Instructions. You agree to take your instructions only from me, from other lawyers in my firm, from Brian Israel or other lawyers in the Arnold & Porter law firm, and from Donna Ward or other in-house counsel at BP (collectively 'BP Attorneys').</blockquote> Note that the contract defines privileged, confidential information as any communication between BP and its representatives and the contract signer. Thus, to make something confidential, all BP would have to do is mention it in a communication. It appears that this would allow BP to render off-limits any topic it chose. Also, since by the same mechanism, it appears that the contract itself, once signed, would also become privileged and confidential. Summary I submit that ideally medicine and health care ought to be a very transparent calling.  Physicians are obliged to keep confidential the information disclosed to them by patients, enabling the patients to trust physicians sufficiently to provide them the accurate information needed for optimal care.  However, it is hard to think of much other information or communication in health care that ought to be kept secret, (other than the processes used by commercial firms to manufacture drugs or devices.)  Yet as health care becomes more of a business and less of a calling, businesspeople's proclivity to keep as much as possible secret to avoid giving any advantage to a competitor has become more influential.  Furthermore, those leading big organizations have realized that it is easier to maintain their power if they can keep their mistakes, if not misconduct secret.  So businesspeople's proclivity to mount overwhelming legal defenses of their interests may lead to persuading or fooling people who might be inclined to delve into such mistakes and misconduct to sign contracts to keep them silent through confidentiality clauses, requirements to protect privileged or proprietary information, non-disparagement clauses and the like.  The result will be better coddled self-interests, but more opacity that is inimical to good patient care, teaching, research, and public policy discussion. To truly reform health care, we need more transparency.  To produce more transparency, we need constraints on contracts that inhibit needed clinical, teaching, research and public policy communication. Meanwhile, as my father, who was an attorney, done told me: "don't sign a contract you don't understand, and don't sign a contract giving away any right you need to keep."

Stifling Whistle-Blowers: Old and New Approaches

We have frequently discussed the anechoic effect, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-intereste…

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26 Jul 2010

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