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Cardinal Health Settles, Novartis Settles

And the march of settlements continues.... As reported <a href="http://www.tulsaworld.com/news/article.aspx?subjectid=11&articleid=20100220_11_A8_Acompa624488">by the Tulsa (Oklahoma) World</a>, <blockquote>A company that provides hospital pharmacy management services in Tulsa has agreed to pay $1 million in civil penalties for failing to account for large amounts of missing prescription drugs, the U.S. Attorney's Office in Tulsa announced Friday. Cardinal Health Pharmacy Services agreed to settle allegations with the federal prosecutors' office, which alleged that the company's two Tulsa pharmacies were negligent and violated several provisions of the Controlled Substances Act. An audit showed that nearly 400,000 dosage units of hydrocodone, a painkiller, and 234,000 units of alprazolam, an anti-anxiety drug, were unaccounted for at the Hillcrest Medical Center pharmacy from October 2005 through June 2007, according to a news release. The investigation also revealed that more than 30,000 doses of drugs at the Oklahoma State University Medical Center pharmacy were unaccounted for between April 2007 and July 2008. </blockquote> Meanwhile, as reported by Associated Press (<a href="http://www.nj.com/business/index.ssf/2010/02/novartis_subsidiary_to_pay_35.html">via Nj.com</a>), <blockquote>Federal prosecutors say a Princeton-based pharmaceutical company has agreed to pay $3.5 million to settle allegations that it claimed its heart drug was eligible for Medicaid reimbursement. The U.S. attorney's office in Boston said Monday that Eon Labs Inc., a subsidiary of Swiss company Novartis AG, submitted false reports to the government between April 1999 and September 2008 that misrepresented Nitroglycerin SR's regulatory status and failed to advise that the drug did not qualify for Medicaid coverage. Prosecutors say Eon Labs did so even after the Food and Drug Administration determined that there was a lack of evidence that Nitroglycerin SR was effective.</blockquote> Note that we most recently <a href="http://hcrenewal.blogspot.com/2010/01/drowning-our-sorrows-in-ketchup.html">discussed</a> a settlement by Novartis last month (January, 2010).  The march of settlements continues. To repeat, seemingly ad infinitum, these are just the latest in a now long <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of settlements</a> that serve as reminders of poor behavior by myriad health care organizations. As we have previously noted, these settlements seem to have little deterrent effect on future bad behavior. (Note that many large health care organizations have settled or plead guilty in several major cases since we started commenting on such settlements.)  Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health.

Cardinal Health Settles, Novartis Settles

And the march of settlements continues.... As reported by the Tulsa (Oklahoma) World , A company that provides hospital pharmacy management ...

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Deja Vu All Over Again - Sheffield Researcher Under Threat for Trying to Present Data that Offends Research Sponsor

It's deja vu all over again.  A case <a href="http://www.timeshighereducation.co.uk/story.asp?sectioncode=26&storycode=410419&c=2">reported</a> (so far only) in the UK Times Higher Education Supplement of a biomedical researcher apparently threatened because she tried to present data that did favor a particular commercial health care product. Here is the summary: <blockquote>An academic has risked the wrath of her university by submitting results to a forthcoming conference without permission. The University of Sheffield has claimed that the submission has been made in breach of a contract it has with a pharmaceutical company, which funds work in the scholar's field. Guirong Jiang, a research radiologist who has worked at Sheffield for 13 years, is due to face a disciplinary hearing over her actions this week. Her findings - submitted to a symposium of the European Calcified Tissue Society (ECTS), to be held in Glasgow in June - add to the debate over what some have claimed is a distortion in the field of osteoporosis caused by the over-diagnosis of vertebral fractures.</blockquote> Here are more particulars: <blockquote>Sheffield has censured her for making the submission without the consent of her supervisor, Richard Eastell, head of Sheffield's Academic Unit of Bone Metabolism. It said her actions breached the terms of a 2007 contract the unit has with pharmaceutical manufacturer Sanofi-Aventis to conduct studies relating to the osteoporosis treatment risedronate, which is sold as the drug Actonel. It also said Dr Jiang failed to follow 'reasonable requests' to withdraw the submission. Dr Jiang said she believed her results should be published as they had not been reflected in the unit's previous output. She added that last December she was informed that her contract would not be renewed when it came to an end this March, which she said had prompted her to throw caution to the wind and publish without permission. She has queried whether her work is bound by Sheffield's Sanofi-Aventis contract, which stipulates that the company must be allowed to review manuscripts and abstracts prior to publication. She pointed out that the work was carried out in 2002 when the unit's risedronate work was funded by Procter & Gamble in partnership with Aventis. Dr Jiang added that she had not seen or signed the full Sanofi-Aventis contract.</blockquote> Dr Jiang is still under threat: <blockquote>The disciplinary hearing, scheduled to take place on 18 February, will consider the allegation that Dr Jiang 'acted inappropriately in making a direct submission of an abstract to a journal outside unit protocol and in contravention of the terms of the research contract'. It will also consider the charge that she 'failed to follow a request by her head of unit and head of department to rectify her actions', which 'aggravated a situation which otherwise could have been quickly resolved'.</blockquote> A long time ago, in a galaxy far, far away, academics had the expectation that they could publish or present their research without first acquiring the express approval of their academic superiors (at least as long as their work was original, the research project was under their control, and that they had properly protected the rights of any human subjects). Furthermore, in at least the US, academics are citizens who expect to have free speech. But as academic institutions became more enamored of and dependent on "external funding," faculty were increasingly pressured to do only sponsored research. The growing dependence on sponsored research allowed the sponsors to try to get more control over how research was done. In the 1990s, there were several important cases in North America in which academic researchers tried to present or publish results that clashed with their research sponsors' vested interests. Doing so resulted in lesser or greater threats to the faculty. Two of the classic cases of research suppression in the 1990's demonstrated this issue. * In the "David Kern case," a textile manufacturer, Microfibres Inc., tried to prevent Dr. David Kern, a general internist and occupational medicine physicians at Memorial Hospital of Rhode Island and faculty member at Brown University, from presenting an abstract that described a case-series of a new pulmonary disease, flock-workers lung, that affected workers at Microfibres Inc. factories. Kern did present the abstract, but under a threat, never carried out, of law-suit, Memorial Hospital of Rhode Island removed Kern as head of the Occupational Medicine program, and refused to renew his contract, even though he was an Associate Professor. Brown University was unable to reverse these moves by the hospital, and Brown officials blamed Kern for signing an agreement to protect trade secrets, even though the agreement was unrelated to the research Kern did on the disease, and his research did not obviously reveal any trade secrets. [1-4] * In the "Nancy Olivieri case," Apotex, a pharmaceutical company, acted against Dr. Nancy Olivieri for revealing preliminary data from a trial of deferiprone, a chelating agent for the treatment of iron overload in thalassemia, suggesting that the drug was often ineffective in treating iron overload, and appeared to be associated with hepatic fibrosis. Ultimately, a report by the Canadian Association of University Teachers also held that her academic freedom was abridged, in the context of a negotiation between the University of Toronto and Apotex over a large donation, and that the hospital harassed Dr. Olivieri during her dispute with Apotex (link <a href="http://www.caut.ca/uploads/OlivieriInquiryReport.pdf">here</a> for report)   In the early 21st century, there was a case in the UK with spooky similarites to the present case: at the same university involved in the present case, and with at least one participant in common with that case.  About a year after we started <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. Our most recent summary of the case was <a href="http://hcrenewal.blogspot.com/2009/09/reappearance-of-ghost-of-seasons-past.html">here</a>. Dr Blumsohn was also doing clinical research on the drug Actonel, again at the University of Sheffield.  He was denied access to the very data he had collected, and to analyses of the data by Procter and Gamble, the then manufacturer of the drug and sponsor of the research.  Dr Blumsohn found that Procter and Gamble seemed to be arranging for ghost-writers to author abstracts about the research based on these hidden analyses.  After he complained to numerous officials at Sheffield, including Dr Richard Eastell, to no avail, he spoke to the press, and thereafter lost his academic position.  The case was just recapped in an interview of Dr Blumsohn published in the British Medical Journal(5).   So we seem to have made little progress.  Most clinical research at academic medical institutions is sponsored by firms that make drugs and devices.  The firms try to secure contracts that give them control over most aspects of the research.  Thus, they can determine how the research is designed, implemented, ana analyzed.  If the resulting <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> still does not yield results that make the firms' products look good, the sponsors can then just <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppress</a> them.  Academics who naively think it is their duty to find and disseminate the truth are in jeopardy when they attempt to present or publish results that challenge their research sponsors' vested interests.   Suppression of clinical research, however, is bad for patients and honest health care professionals, since it misleads about the benefits and harms of tests and treatments.  Suppression of clinical research dishonors research subjects who volunteer for studies, often at risk to themselves, thinking they may help to advance science and clinical care.  Suppression of clinical research undermines the fundamental mission of academia: to seek out and disseminate the truth.   Those who truly want better health care, here in the US and globally, should advocate for clinical research done without the influence of those with vested interests in how the research comes out.    Thanks to an anonymous Health Care Renewal scout who located the Times article.    References 1. DG Kern, RS Crausman, TH Durand et al. Flock worker's lung: chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med 1998; 129: 261-272. (link <a href="http://www.annals.org/cgi/content/full/129/4/261">here</a>) 2. Shuchman M. Secrecy in science: the flock worker's lung investigation. Ann Intern Med 1998; 129: 341-344. (link <a href="http://www.annals.org/cgi/content/full/129/4/341">here</a>) 3. Marsh DJ. Intimidation of researchers by special interest groups. N Engl J Med 1997; 337: 1317-1318. (link here) 4. Shuchman M. Consequences of blowing the whistle in medical research. Ann Intern Med 2000; 132: 1013-1015. (link <a href="http://www.annals.org/cgi/content/full/132/12/1013">here</a>) 5.  Cyer C. Aubrey Blumsohn: academic who took on industry. Brit Med J 2009; 339:b5293. (link<a href="http://www.bmj.com/cgi/content/full/339/dec15_1/b5293"> here</a>)

Deja Vu All Over Again - Sheffield Researcher Under Threat for Trying to Present Data that Offends Research Sponsor

It's deja vu all over again. A case reported (so far only) in the UK Times Higher Education Supplement of a biomedical researcher appa...

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Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?

At "<a href="http://hcrenewal.blogspot.com/2010/02/networked-interoperable-secure-national.html">Networked, Interoperable, Secure National Medical Records a Castle in the Sky?</a>" I wrote that the holy grail of electronic medical record efforts - the creation of a networked, interoperable, secure national medical records system - may be far more difficult than anyone expected due to vulnerabilities in current, widespread IT networking and OS platforms. Now we hear the situation is even worse than in the articles I cited at that post: <blockquote> Wall Street Journal Feb. 18, 2010 <a href="http://online.wsj.com/article/SB10001424052748704398804575071103834150536.html">Broad New Hacking Attack Detected</a> Global Offensive Snagged Corporate, Personal Data at nearly 2,500 Companies; Operation Is Still Running Hackers in Europe and China successfully broke into computers at nearly 2,500 companies and government agencies over the last 18 months in a coordinated global attack that exposed vast amounts of personal and corporate secrets to theft, according to a computer-security company that discovered the breach. The damage from the latest cyberattack is still being assessed, and affected companies are still being notified. But data compiled by NetWitness, the closely held firm that discovered the breaches, showed that hackers gained access to a wide array of data at 2,411 companies, from credit-card transactions to intellectual property. </blockquote> One can only imagine how internet-connected hospitals, generally an IT backwater, might fare under such an onslaught. <blockquote>... In more than 100 cases, the hackers gained access to corporate servers that store large quantities of business data, such as company files, databases and email. They also broke into computers at 10 U.S. government agencies. In one case, they obtained the user name and password of a soldier's military email account, NetWitness found. A Pentagon spokesman said the military didn't comment on specific threats or intrusions. At one company, the hackers gained access to a corporate server used for processing online credit-card payments. At others, stolen passwords provided access to computers used to store and swap proprietary corporate documents, presentations, contracts and even upcoming versions of software products, NetWitness said. Data stolen from another U.S. company pointed to an employee's apparent involvement in criminal activities; authorities have been called in to investigate, NetWitness said. Criminal groups have used such information to extort sensitive information from employees in the past.</blockquote> Read the while article. These breaches are an unpleasant reality in 2010, but what's worse is there really are no solid metrics for the true extent of this 'disease.' Perhaps future Internet technologies will reduce or eliminate the problem, as one reader suggested in a comment to my aforementioned post. I do not believe, however, that patients and their medical records should be used as guinea pigs until those new networking and security technologies are widely deployed and well-proven. In effect, this is probably not a good time for actual records-level interoperability to be deployed in any manner other than in consideration of a future strategy. Operationalizing that strategy should probably await a time when the "digital ether" in which the data resides and moves is more mature, unless proprietary networks and technology are to be used and without connection to the Internet. Planning data-level compatibility between systems, on the other hand, is work that should continue. Finally, the layoffs and staffing levels in today's IT departments (at both vendor and user shops), plus the outsourcing of critical IT functions to overseas contractors where workers' loyalty to the primary firm is questionable at best, may be a contributing factor to the nakedness of corporate America's information systems. -- SS

Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?

At " Networked, Interoperable, Secure National Medical Records a Castle in the Sky? " I wrote that the holy grail of electronic m...

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University of California CEO - You Can Reduce My Pay if "You Throw In Air Force One"

The San Francisco Chronicle recently <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/02/15/BA6A1BUGLU.DTL">reported</a> how students at the University of California have been providing a satirical approach to the problems of the university's leadership: <blockquote>It's been a seriously dramatic year at the University of California, where hundreds of students seized buildings, demonstrated and shut down regents meetings last fall to protest rising tuition and the perceived privatization of the public school. It's also been a satirically dramatic year, thanks to the UC Movement for Efficient Privatization, a fledgling group of mostly grad students in business attire that uses humor tinged with sarcasm to lampoon UC officials. Their own name is an example. Many UC students believe leaps in tuition and reduced state funding are turning the public university into a private institution.</blockquote> In particular, they drew attention to the university president's sense of entitlement: <blockquote>UCMeP has made itself known on the Berkeley campus since September. That's when UC President Mark Yudof, who earns about $600,000, drew students' ire for telling the New York Times he'd take a $200,000 pay cut for salary parity with President Obama - if Air Force One were part of the package. Seeing this as a philanthropic opportunity, UCMeP issued fundraising flyers: 'Help Buy Mark Yudof a Plane!'</blockquote>The relevant parts of the <a href="http://www.nytimes.com/2009/09/27/magazine/27fob-q4-t.html">New York Times interview</a>, which I regret to say I missed at the time it was published, are: <blockquote>Some people feel you could close the U.C. budget gap by cutting administrative salaries, including your own. The stories of my compensation are greatly exaggerated. When you began your job last year, your annual compensation was reportedly $828,000. It actually was $600,000 until I cut my pay by $60,000. So my salary is $540,000, but it gets amplified because people say, 'You have a pension plan.' What about your housing allowance? How much is the rent on your home in Oakland? It’s about $10,000 a month. Does U.C. pay for that on top of your salary? Yes, and the reason they do that is because they have a president’s house, it needed $8 million of repairs and I decided that was not the way to go. Why the heck would I ever authorize $8 million for a house I didn’t want to live in anyhow? Why can’t you have architecture students repair the house for course credit? Let me ponder that. What do you think of the idea that no administrator at a state university needs to earn more than the president of the United States, $400,000? <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT2dQCrvLxxi5nojjEMyPLIkI317MeI3P-ns4ZiESpXjSefmnUowhjM3i4TtGWzxx7rTAwKf6BdcTJAXSUi4E77ZRVZhdp9LDnmqS8GGqYo_VBwBB6-aoPtYT0bo0xDc7lqyjlTnKX4Euq/s1600-h/Air_Force_One_over_Mt__Rushmore.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" ct="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT2dQCrvLxxi5nojjEMyPLIkI317MeI3P-ns4ZiESpXjSefmnUowhjM3i4TtGWzxx7rTAwKf6BdcTJAXSUi4E77ZRVZhdp9LDnmqS8GGqYo_VBwBB6-aoPtYT0bo0xDc7lqyjlTnKX4Euq/s320/Air_Force_One_over_Mt__Rushmore.jpg" /></a></div>Will you throw in Air Force One and the White House?</blockquote> While Yudof's response is clearly sarcastic, he obviously never substantively addressed why he is entitled to be paid comparably to the President of the richest country in the world. We have written a few times about the travails of the <a href="http://hcrenewal.blogspot.com/search/label/University%20of%20California">University of California</a>, some of its multiple campuses, and in particular its medical schools and teaching hospitals.  Most recently we have written about how leaders of its teaching hospitals also seemed to feel entitled to substantial compensation, including bonuses for "performance" even when their institutions were receiving bad publicity for quality problems (posts <a href="http://hcrenewal.blogspot.com/2010/01/more-california-medical-centers-plagued.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/uci-medical-center-fails-inspection-uci.html">here</a>). Again and again we see examples of leaders of academic medical institutions, and health care organizations in general who seem to feel entitled to be judged differently, and rewarded differently than the common folk.  These entitlements exist even when the economy, or the financial performance of the specific organization prevents other people from making any economic progress. This entitlement exists even if those other poeple actually do the work, and ultimately provide the money that sustains the organization. Although the executives of not-for-profit health care organizations generally make far less than executives of for-profit health care corporations, collectively, hired managers of even not-for-profit health care organizations have become richer and richer at a time when most Americans, including many health professionals, and most primary care physicians, have seen their incomes stagnate or fall. They are less and less restrainted by passive, if not crony boards, and more and more unaccountable. In a kind of multi-centric coup d'etat of the hired managers, they have become our new de facto aristocracy. Or as we wrote in our previous post, executive compensation in health care seems best <a href="http://hcrenewal.blogspot.com/2009/12/compensation-madness-insiders-hijacking.html">described as Prof Mintzberg</a> described compensation for finance CEOs, "All this compensation madness is not about markets or talents or incentives, but rather about insiders hijacking established institutions for their personal benefit." As it did in finance, compensation madness is likely to keep the health care bubble inflating until it bursts, with the expected adverse consequences. Meanwhile, I say again, if health care reformers really care about improving access and controlling costs, they will have to have the courage to confront the powerful and self-interested leaders who benefit so well from their previously mission-driven organizations. It is time to reverse the coup d'etat of the hired managers.

University of California CEO - You Can Reduce My Pay if "You Throw In Air Force One"

The San Francisco Chronicle recently reported how students at the University of California have been providing a satirical approach to the ...

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Quintiles to More Heavily Directly Invest in the Drugs Which it Evaluates - But Not to Worry, Says an Expert?

The Associated Press just <a href="http://www.google.com/hostednews/ap/article/ALeqM5jbIAnadjVl8lbQLqzQgrd0T3mPzwD9DSRKEO0">reported </a>on the latest trend in commercially sponsored clinical research, direct investment by contract research organizations (CROs) in the development of specific drugs by particular pharmaceutical or biotechnology companies. Here is the background in the article: <blockquote>Pharmaceutical companies previously did all their own research and testing and submitted the results to the Food and Drug Administration for approval to put a medication on the market. Since the 1990s or so, Big Pharma has farmed out more and more of that testing to companies like Quintiles Transnational Corp., which grew quickly to meet the demand.</blockquote>Now Quintiles is branching out... <blockquote>Now Durham, N.C.-based Quintiles is the world's biggest contract research organization, and more than ever, it's using its deep pockets to entwine itself with the pharmaceutical companies, fronting them cash and services for a piece of the profits once a drug is approved. Quintiles, which was created in 1982, upped the ante last month, saying it wants to invest even more in potential drugs as pharmaceutical companies grapple with the down economy. Quintiles is hoping its new investments will produce enormous payoffs in the future,.... Quintiles' decision to become more aggressive in taking investment risks comes at a time it's betting drug makers can use the resources it can offer, both cash and services. 'They're both currency for managing risk and having skin in the game,' said Ron Wooten, a Quintiles executive vice president who heads the company's capital investment group. Controversy over creating the drug investment unit in 2000 was key in pushing Quintiles founder Dennis Gilling and several private-equity firms to buy out shareholders for $1.75 billion and take the company private again in 2003. Wall Street analysts complained they couldn't estimate what the drug investments were worth, prompting Gilling and others to decide the company's stock was undervalued. The private company no longer publishes its profits. It claims revenues of about $3 billion a year. That's also about what Quintiles has invested in other drug companies.</blockquote>Furthermore, <blockquote>Quintiles appears to be uniquely positioned to both invest in and test potential medications. None of the half-dozen major shareholder-owned contract research organizations will have a drug-investment division after Wilmington, N.C.-based Pharmaceutical Product Development Inc. spins off its unit in a few months, Coldwell said. The payoffs for the risk of developing a drug can be huge. In 2002, Quintiles took a chance on Eli Lilly and Co.'s antidepressant Cymbalta. Quintiles said it invested $125 million in cash, then spent another $400 million on a sales force of more than 550 after the product launch. Cymbalta is now Lilly's second-biggest drug. Quintiles said it's brought in more than $700 million so far for a stream of royalties lasting to 2012. Japan's Eisai Co. is hoping Quintiles' money and experience helps it double the number of potential treatments it can put through testing simultaneously</blockquote> The article raised a concern that "the buffer between drug makers and testers are again blurred." But not to worry.... Here is the response from Quintiles, <blockquote>Wooten, the Quintiles executive, doesn't see his company's increased interest in bringing drugs to the market affecting its testing objectivity. Instead Quintiles is the outsider turning a hard eye on which pharmaceuticals will become profitable. 'It allows you to really get to the essence of the data that you're looking at instead of what you hope it says,' he said. There isn't 'the natural bias that you would have with your own babies.'</blockquote> Furthermore, the AP reporter got reassurances from a noted academic expert in the area, <blockquote>The FDA preserves the integrity of testing in a landscape already pockmarked with potential conflicts of interest that include company-sponsored academic research and investigators testing drugs while owning shares in companies that own the drug, said Kenneth Getz, a senior fellow at Tufts University's Center for the Study of Drug Development. The FDA's view is that any company with a financial stake in a potential drug will face similar scrutiny from the agency. 'It's assumed,' FDA spokeswoman Karen Riley wrote in an e-mail, 'that drug/device/biologic companies who sponsor trials of pending products have a conflict because they will gain if the product is approved.' Besides, pharmaceutical companies have navigated the tricky territory that comes with testing, Getz said. So have the companies like Quintiles that have taken on the outsourced work, he said. 'These potential conflicts of interest are ever-present, and the real question is how do companies manage these potential conflicts effectively,' he said. 'These are massive, massive companies that have thousands of staff that are not generally aware of a conflict of interest at a corporate level. They are paid to do a quality job that meets internal and regulatory guidelines or they are not going to keep their jobs.'</blockquote> Here on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, we have discussed how the <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> that are now pervasive in health care can adversely affect clinical care, teaching, and research.  We have looked at how clinical research sponsors, who have a vested interest in having the results favor the products and services they sell, may <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate</a> the design, implementation, analysis, and dissemination of research, and when all else fails, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppress</a> unfavorable results.  We have also looked at problems with the ethics and quality of research done by <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>, who are, after all, paid by companies again with vested interests in selling particular products or services. Given all that, one may argue that having contract research organizations invest in particular drugs or devices which they are also evaluating through clinical research may not make things much worse.  However, at the least, it seems to me that it further obfuscates conflicts of interest that may lead to biased research results, dishonoring the patients who volunteered for the trials, and biasing the information on which patients and physicians make decisions. Finally, I should note how Quintiles new investments in specific drugs was defended in the article.  The article quoted Quintiles executive vice president Ron Wooten suggesting that Quintiles might be able to be objective in making the original decision to invest in a drug. He conveniently did not address what might happen after the investment was made, when Quintiles was performing, analyzing, and reporting clinical research on a drug or device in which it had invested. The article also quoted Kenneth Getz, the Senior Fellow at Tufts, who seemed unconcerned about the issue.  What the article did not mention is that the Tufts Center for the Study of Drug Development, at which Mr Getz is based, <blockquote>receives unrestricted grants from pharmaceutical and biotechnology firms, as well as companies that provide related services to the research-based industry (e.g., contract research, consulting, and technology firms). These grants represent approximately 40% of Tufts CSDD’s operating expenses. </blockquote>per the Center's <a href="http://csdd.tufts.edu/about/financial_disclosure">web-site</a>. Another <a href="http://70.42.48.93/printpage.asp?ref=http://70.42.48.93%2FAbout%2FResearchStaff.asp">page on the web-site</a> lists Mr Getz's qualifications, <blockquote>Kenneth A. Getz is a senior research fellow at the Tufts CSDD. Considered an expert on the investigative site and CRO markets, R& D management, ECT solutions adoption and clinical research volunteerism,.... Mr. Getz is the founder and chairman of CISCRP .... He holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor's degree, Phi Beta Kappa, from Brandeis University. Mr. Getz worked for over seven years in management consulting, where he assisted biopharmaceutical companies in planning and implementing drug development strategies. He is also the founder and former CEO of CenterWatch.</blockquote> Note that Mr Getz seems to have no training in biomedical science, medicine, or health care.  Furthermore, CISCRP (the Center for Information and Study on Clinical Research Participation), has an advisory board (see their web-site <a href="http://www.ciscrp.org/patient/who.html">here</a>) that includes representatives of pharmaceutical companies (Vertex Pharmaceuticals, Biogen Idec, and Roche), and contract research organizations, (PPD Inc, and particularly, in this case, Quintiles). The vast <a href="http://www.ciscrp.org/patient/supporters.html">list</a> of the Center's "supporters" include a catalog of drug and biotechnology companies (including Abbott Vascular, Amgen, AstraZeneca, Biogen Idec, Daiichi Sankyo Pharmaceutical Development, Eli Lilly, Forest Laboratories, Genentech, Genzyme, GlaxoSmithKline, Janssen, Johnson and Johnson, Merck, Novo Nordisk, Novartis, Ortho-McNeil, Pfizer, Roche, Sankyo, Sanofi-Aventis, Serono, Shire, Takeda, and Wyeth), and contract research organizations, (including Covance, Parexel, PPDI, and notably again, Quintiles.) So the other lesson from this bit of news is how the information the public, health care professionals, and policy makers  receive about health care policy is frequently shaped by people with horses in the race, but that such influences are rarely disclosed.  This article included an interview with a single apparently academic expert who provided reassurance that the conflicts of interest discussed in the article were not really so worrisome.  This expert, however, failed to disclose his own extensive, albeit somewhat indirect ties to a variety of corporations that might benefit from the conflicts discussed as the main topic of the article, including corporations that were directly involved in them (Quintiles and Eli Lilly).  Maybe because the reporter thought that the expert was unbiased, there was no attempt to find a contrasting opinion. So I say again, again, again, health care professionals, policy  makers, and people in general need to be extremely skeptical of most of the apparently unbiased pronouncements made about medical and health care policy issues in the media.  It would be a small step toward a more transparent discussion if those who expressed opinions would also fully disclose in detail their relevant conflicts of interest.

Quintiles to More Heavily Directly Invest in the Drugs Which it Evaluates - But Not to Worry, Says an Expert?

The Associated Press just reported on the latest trend in commercially sponsored clinical research, direct investment by contract research o...

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A University President, But No Longer a Goldman Sachs Director

A frequent topic on Health Care Renewal is how leaders of not-for-profit health care organizations now frequently value their "margin," that is, revenue generation more than mission.  (One good example <a href="http://hcrenewal.blogspot.com/2007/04/medical-schools-to-faculty-show-me.html">here</a> shows how medical school leaders value faculty most for how much money they bring in, rather than the quality of their teaching, research, or patient care.)  "Masters of the Universe" as Leaders of Academic Medicine As we have cast about for reasons behind this important and unfortunate transformation, we noticed that many of the members of the boards of trustees of some of the most prestigious universities that house medical schools, medical schools, and teaching hospitals seemed to be leaders in the finance industry. The importance of that finding became more relevant after the global financial collapse, aka "great recession," became evident.  Since then, we noted the influence of finance leaders on the leadership of <a href="http://hcrenewal.blogspot.com/2009/04/investment-bankers-strike-back.html">Dartmouth College</a>, <a href="http://hcrenewal.blogspot.com/2008/12/what-linked-parallel-declines-of.html">Harvard University</a>, <a href="http://hcrenewal.blogspot.com/2009/04/hedge-fund-u.html">Yeshiva University</a>, and the <a href="http://hcrenewal.blogspot.com/2009/10/board-of-trustees-or-social-club-for.html">Hospital for Special Surgery</a>. Although it seems that the complex relationships between various "masters of the universe" and academia, particularly academic medicine ought to have generated considerable discussion, they remained almost as <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> as many of the other issues discussed on Health Care Renewal. Therefore, with some regret, I will take up the latest example of such relationships from my own alma mater, Brown University.  ((Full disclosure: I am an alumnus of the College at Brown, and of the Medical School. I am a former full-time Brown faculty member, and currently a voluntary Clinical Associate Professor in the  Alpert Medical School.)  (Also note that <a href="http://hcrenewal.blogspot.com/2009/04/pension-fund-scandals-payment-agents.html">here </a>we discussed some of the questions about the financial dealings of a prominent member of Brown's Board of Fellows, the inner circle of the Brown Corporation, the equivalent of its board of trustees, who was also the very wealthy leader of a prominent hedge fund.  We noted then that his connection to Brown was not noted in current media stories about the controversy.) A Goldman Sachs Director as University President Last week (9 February, 2010), the Brown Daily Herald published <a href="http://www.browndailyherald.com/simmons-won-t-be-buffeted-about-on-boards-1.2144610">an interview</a> with the President of Brown, Ruth Simmons, about her service on the board of directors of Goldman Sachs, one of the most prominent, profitable and controversial investment banks.  Some of the main points were: - President Simmons seemingly denied responsibility for any of the company's past actions that have inspired criticism: "There are lots of things in a complex institution that go on." So, "you're not in charge of everything that your friends do and every policy that organizations that you're affiliated with issue." - She also implied that she joined the board expressly and only to advocate for women and minorities in finance: "We had a big push to think about how we could improve the knowledge and ability of women to manage their financial affairs." Also, "at the same time, there was a good deal of interest in the fact that women have not done so well in the financial sector and on Wall Street." The goal was "to make certain fields more accessible to women and minorities through her service on the boards of Goldman, Texas Instruments and Pfizer." "She called her work with women and minorities on boards meaningful to her in 'a way that a lot of people won't understand.'" She stated "the seniority she now enjoys on Goldman's board allows her to advocate for programs to help women and minorities." - She implied that she served on the board to learn something about economics, "her service on Goldman's board gave her the economic savvy to take certain risks...." So in summary, in her role as a member of the board of Goldman Sachs, one of the most important financial companies in the world, which had major involvement in the events that lead to the global economic collapse, or "great recession," President Simmons claimed that her major role was to advocate particular political positions on the board, implied that she did not know much about the company's core business when she joined the board, and took no responsibilities for any actions of the company which might have inspired criticism. Presdient Simmons' responses might have made sense were she just a member of an advisory board on diversity.   However, she <strike>is</strike> was a member of the board of directors. In this interview, she seemed to ignore her fiduciary duties as a board member to show "unyielding loyalty"  to the stockholders of the company and their interests  [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]. She in particular seemed to disavow any responsibility for overseeing the actions of hired Goldman Sachs management.  It is a testament to the power of the anechoic effect that an interview showing a member of the board of directors of one of the most important and controversial finance firms involved in the global financial collapse seemed to dodge responsibility for the firm's overall direction and financial practices seemed to inspire only one piece of commentary beyond Brown.  Felix Salmon <a href="http://blogs.reuters.com/felix-salmon/2010/02/10/revamping-goldmans-board/">opined</a> <blockquote>In all the bellyaching about the governance of the biggest banks, and the fact that their boards were spectacularly unqualified to provide any kind of oversight of what they were doing, Goldman Sachs has gone largely unmentioned. But what’s true of Merrill Lynch and Bank of America is true of Goldman too: its executives need some kind of adult supervision, seeing as how they work for their shareholders, rather than just for themselves.</blockquote> He then noted, <blockquote>this interview with one Goldman board member, Ruth Simmons, hardly instills in me the confidence that she can or will understand what Goldman is doing, stop them from acting in a reckless manner, or keep a close eye on compensation as she wears her hat as a member of the compensation committee....</blockquote>A Rapid Resignation However, what happened next does suggest maybe the times they are "a-changing." On 13 February, 2010, <a href="http://www.bloomberg.com/apps/news?pid=20601087&sid=aNg3joWQ08zs&pos=5">per Business Week</a> <blockquote>Goldman Sachs Group Inc., the most profitable securities firm in Wall Street history, said Ruth Simmons will leave its board after 10 years because of 'increasing time requirements' in her role as Brown University president. </blockquote>This despite the small fortune that President Simmons had made learning to develop "economic savvy," <blockquote>According to a Feb. 5 filing with the U.S. Securities and Exchange Commission, Simmons owned 27,386 restricted stock units in Goldman Sachs, worth $4.2 million at yesterday’s closing share price of $153.93. According to the filing, the units convert to shares on the first trading day in the third quarter of the year following her retirement from the board. Simmons also has 10,000 options that she can exercise on the date she ceases to be a director, according to the filing. </blockquote> Felix Salmon then <a href="http://blogs.reuters.com/felix-salmon/2010/02/13/simmons-leaves-goldmans-board/">commented</a>, <blockquote>I said after Tuesday’s interview with Simmons was published that she seemed to think about her membership on Goldman’s board much more in terms of what it could do for her and her pet causes than in terms of being a shareholder representative tasked with overseeing senior management, and I called for a revamp of the board. Friday’s news is exactly the step in that direction that I was looking for: maybe Simmons took my comments to heart!</blockquote>Summary So in the end, the complex relationships among academic, and academic medical leaders and the finance industry are at least less anechoic. The issue is likely not over at Brown. While the initial Brown Daily Herald interview focused on whether President Simmons' position on the Goldman Sachs board might have lead to a direct conflict of interest, he did not ask whether her position in the leadership of Goldman Sachs had any relevance to the prominence of financial leaders on the Brown Corporation.  In fact, the same day that the Brown Daily Herald published the interview, it published <a href="http://www.browndailyherald.com/trustee-may-face-lawsuit-from-ex-wife-1.2144625">an article</a> on the legal travails of a Brown Corporation who has become one of the richest hedge fund leaders in the world.  The 2008-09 Brown Corporation (webpage no longer works <a href="http://brown.edu/Administration/News_Bureau/Info/Corporation.html">here</a>, but cached <a href="http://74.125.47.132/custom?q=cache:ZAu0jiCokecJ:brown.edu/Administration/News_Bureau/Info/Corporation.html+Brown+Corporation&cd=5&hl=en&ct=clnk&gl=us&client=google-coop-np">here</a>) included three other current or retired Goldman Sachs leaders, a <a href="http://www.brown.edu/Administration/News_Bureau/2004-05/04-022.html">former partner</a>, <a href="http://www.brown.edu/Administration/News_Bureau/2004-05/04-146.html">head of merchant banking</a>, and former leader <a href="http://www.brown.edu/Administration/News_Bureau/2006-07/06-166.html">with less specified responsibilties</a>.  It also included numerous other leaders of various other finance companies.  In the aftermath of the global economic collapse, and in an ongoing health care crisis, it seems reasonable to hypothesize that some of the problems of academia, and particularly the problems of medical academia, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission.  I hope that Brown's latest travails will inspire more interest in who now leads academia, especially medical academia, how they got there, and what they have wrought.  Academic medical institutions and other not-for-profit health care organizations need leaders who value their missions more than the money they may bring in.

A University President, But No Longer a Goldman Sachs Director

A frequent topic on Health Care Renewal is how leaders of not-for-profit health care organizations now frequently value their "margin,...

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The Yin and Yang of Electronic Health Records

Lest we be led into believing that healthcare IT is a tried and true, safe, proven technology:<a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=b748bf66abed4f66accf9bada595b371&URL=http%3a%2f%2fwww.ihealthbeat.org%2fdata-points%2f2010%2fhas-your-organization-had-a-patient-safety-issue-directly-resulting-from-an-electronic-system.aspx" target="_blank"> </a> <blockquote><p style="margin: 1.45em 0.833em 0.7em; padding: 0px; border-width: 0px; outline-width: 0px; font-weight: bold; font-style: inherit; vertical-align: baseline; color: rgb(0, 0, 0); line-height: 1.235em;font-size:1em;">Friday, February 05, 2010 <p style="margin: 1.45em 0.833em 0.7em; padding: 0px; border-width: 0px; outline-width: 0px; font-weight: bold; font-style: inherit; vertical-align: baseline; color: rgb(0, 0, 0); line-height: 1.235em;font-size:1em;">iHealthBeat.org <p style="margin: 1.45em 0.833em 0.7em; padding: 0px; border-width: 0px; outline-width: 0px; font-weight: bold; font-style: inherit; font-size: 1em; vertical-align: baseline; color: rgb(0, 0, 0); line-height: 1.235em;"><a href="http://www.ihealthbeat.org/data-points/2010/has-your-organization-had-a-patient-safety-issue-directly-resulting-from-an-electronic-system.aspx">Has Your Organization Had a Patient Safety Issue Directly Resulting From an Electronic System?</a> <div style="margin: 0.5em 1em; padding: 0px 0px 2em; border-width: 0px; outline-width: 0px; font-weight: inherit; font-style: inherit; vertical-align: baseline; line-height: 1.235em;font-size:1.084em;"> Thirty-two percent of health IT professionals surveyed said their health care organization has had a patient safety or health care quality issue that could be classified as being a direct result of having an electronic system, according to a recent <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=b748bf66abed4f66accf9bada595b371&URL=http%3a%2f%2fwww.himss.org%2fcontent%2ffiles%2fvantagepoint%2fvantagepoint_201002.asp" style="margin: 0px; padding: 0px; border-width: 0px; outline-width: 0px; font-weight: inherit; font-style: inherit; font-size: 13px; vertical-align: baseline; color: rgb(62, 82, 146); text-decoration: none;" target="_blank">Healthcare Information and Management Systems Society survey</a>. Meanwhile, 10% of respondents said they have had clients report patient safety or health care quality issues that were a direct result of having an electronic system, according to the survey. The survey also found that 29% of respondents said their electronic health record implementation has exceeded or vastly exceeded their expectations, while 22% of respondents said their EHR implementation has not met expectations. Results are based on an online survey conducted in January of 217 health IT professionals. Source: HIMSS, "Value of Electronic Health Records."</div></blockquote>It might perhaps be prudent to heed this three-decade-old Texan wisdom on the true nature of computers (<a href="http://www.radioshackcatalogs.com/catalogs_extra/1981_rsc-05/">link</a>, see page 2): What is a Computer?" <blockquote>... A computer is an extension of the human brain. It is to the mind what the lever is to the arm - a machine capable of multiplying effectiveness. It can free you from tedious, repetitive work which does not require judgment. IT can provide facts and figures with lightning speed, giving you more time to exercise your judgment thoughtfully. </blockquote> The key words are that IT can free a person from tedium which "does not require judgment." That has not changed, and in medicine it is likely to not change before we retire. There is an existential problem related to what IT can do, and what it cannot do in a cognitive, judgment-based field such as medicine, as opposed to straight information retrieval or other "tabulating machine"-based uses of IT. (As I wrote previously, medicine's problems are not due to a reductionist "<a href="http://hcrenewal.blogspot.com/2010/01/does-ceo-of-google-use-google.html">platform database</a><a href="http://hcrenewal.blogspot.com/2010/01/does-ceo-of-google-use-google.html"> deficiency</a>.") Health IT designed and oversold as if it can do more than freeing clinicians from tedium so they may exercise better clinical judgment (based on hard-earned experience), and that in fact often makes their work <a href="http://www.tinyurl.com/hostileuserexper">more tedious than it already is</a>, will always be a double edged sword. -- SS

The Yin and Yang of Electronic Health Records

Lest we be led into believing that healthcare IT is a tried and true, safe, proven technology: Friday, February 05, 2010 iHealthBeat.org H...

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