healthy4u: Roche

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">argued</a> that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared <a href="http://online.wsj.com/article/SB10001424052970203686204577116374283814362.html">in yesterday's Wall Street Journal</a>.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.) The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began, <blockquote>Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.</blockquote> Then it stated that the interviewee: <blockquote>has no such qualms.</blockquote> The defense of this lack of qualms was heavily based on logical fallacies. Biased Sample or Hasty Generalization The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked: <blockquote>What are the trickiest conflicts of interest to navigate?</blockquote> The answer was: <blockquote>Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?</blockquote>This may be tricky, but is arguably not the most tricky kind of conflict of interest. The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote Risperdal as a safe and effective medication." (See <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">this post</a>.) Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a>).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) <a href="http://www.nizkor.org/features/fallacies/biased-sample.html">biased sample</a>, if not, it appears to be a <a href="http://www.nizkor.org/features/fallacies/hasty-generalization.html">hasty generalization</a>. The interview also included a few other choice logical fallacies that went unchallenged by the interviewer. False Dilemma The interviewer asked: <blockquote>What do you tell professors who won't work with drug or biotech companies?</blockquote> The response was: <blockquote>I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.</blockquote> Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative. The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a <a href="http://www.nizkor.org/features/fallacies/false-dilemma.html">false dilemma</a>. Straw Man The interviewee worked another argument into the same paragraph: <blockquote>When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'</blockquote> I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man fallacy</a>. Summary So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies.  We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples <a href="http://hcrenewal.blogspot.com/2011/03/once-more-with-feeling-another-defense.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html">here</a>,  <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests. In 2011, I <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">noted</a>, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power. The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just <a href="http://www.fiercebiotech.com/special-reports/25-most-influential-people-biopharma-today/susan-desmond-hellmann-25-most-influentia">named</a> one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a>).  She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">here</a>, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche.  As we <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">noted previously</a>, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world. - A <a href="http://www.athletepromotions.com/celebrity/Susan-Desmond-Hellmann-appearance-booking-agent.php">web-site</a> for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009." - In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see<a href="http://www.reuters.com/article/2011/11/03/teva-pg-idUSN1E7A20BZ20111103"> this Reuters article</a>). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's <a href="http://www.pg.com/en_US/downloads/investors/annual_reports/2011/PG_2011_Proxy.pdf">2011 proxy statement</a>, she appears to be in line to collect over $250,000 a year in compensation for this position. It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care. The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link <a href="http://jama.ama-assn.org/cgi/content/extract/307/7/669?etoc">here</a>.] <blockquote>Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.</blockquote> True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care. Recently, I argued that the most pernicious are ...

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Legal Settlements Have Become So Common that They are Barely News

<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">Legal settlements</a> by big health care organizations have become so common that those of less than blockbuster size barely seem to qualify as news.  They have become "dog bites man" stories.  For example, the following stories barely got noticed in the media (presented chronologically). Novartis Settles Price Misrepresentation Suit for $150 Million This story was mentioned as an aside in a a <a href="http://www.businessweek.com/news/2011-09-15/watson-sandoz-pay-145-million-to-settle-drug-price-case.html">news story</a> covering a settlement by Watson Pharmaceuticals in September.  In slightly more detail, it has only appeared <a href="http://www.pharmalot.com/2011/11/novartis-pays-150m-to-settle-pricing-fraud">in PharmaLot</a> in November.  In a very small nutshell, <blockquote>the Sandoz unit of Novartis earlier this week agreed to pay $150 million to settle lawsuits filed by the states of Florida and California, as well as a whistleblower, to settle charges that it deliberately misreported pricing information in order to hike reimbursements from Medicaid.</blockquote> By the way, per <a href="http://freepdfhosting.com/0885cf397f.pdf">the settlement document</a>, the allegations were that Novartis' subsidiary knowingly maintained, set or reported "false, fraudulent, and/or inflated Reported Prices," yet, as is typical of nearly all settlements, the settlement "shall not constitute or be construed as an admission of fault, liability, or unlawful conduct." Roche Settles Off-Label Promotion, Physician Kickback Suit for $20 Million This story was reported briefly in some blogs, including again PharmaLot, and in the most detail <a href="http://www.bizjournals.com/sanfrancisco/blog/biotech/2011/12/genentech-roche-rituxan-whistleblower.html">in the San Francisco Business Times</a>. The basics of it were: <blockquote>Genentech Inc. will pay $20 million to settle a whistleblower lawsuit around off-label marketing of the cancer-fighting drug Rituxan.</blockquote> It only took eight years since a whistle-blower raised the issue: <blockquote>John Underwood, ... was a senior manager of sales development from the start of Genentech’s oncology franchise in 1997. When Underwood filed the suit in July 2003 in U.S. District Court for the Eastern District of Pennsylvania, he was a senior hospital systems specialist for Genentech.</blockquote> This suit is actually of particular interest because it was not just about off-label promotion, <blockquote>Genentech, the suit claimed, retained doctors to act as independent speakers on behalf of Rituxan and its off-label uses, paid kickbacks to doctors that were disguised as consulting payments, 'exerted significant pressure' on sales reps to increase off-label uses of Rituxan, and devised and conducted 'selling skills workshops' for sales reps devoted to non-label uses, What’s more, the suit claimed, Genentech invited doctors to attend “medical education seminars” at 'luxurious locations' and gave financial incentives to sales reps to get doctors who sold the most Rituxan to attend the events.</blockquote> These were serious allegations, involving allegedly direct efforts by the company to subvert physicians' ethics by tying their decisions for individual patients to payments for prescribing specific products whatever the benefits and risks of those products for those patients.  The allegations suggested that "consulting payments" to physicians may be nothing more than disguised bribes, and that the companies making these payments may be quite conscious of this.  Nonetheless, as usual, <blockquote>Genentech, the South San Francisco-based U.S. subsidiary of Swiss drug giant Roche, did not admit wrongdoing....</blockquote> So, as in the famous recent Citigroup case (see <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">this post</a>), the settlement obfuscates the crucial question, did the corporation involved commit illegal acts? It seems likely that what they did was in some sense unethical, since they were willing to pay millions not make the matter go away. By the way, one member of the Executive Committee of Genentech at the time these events were allegedly occurring is now the <a href="http://ucsfchancellor.ucsf.edu/leadership/susan-desmond-hellmann-md-mph">Chancellor of the University of California - San Francisco</a> (See our post <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">here</a>). Maybe concerned students or faculty might ask her what really went on. CVS Caremark Settles Fraud Suit for about $20 Million As <a href="http://latimesblogs.latimes.com/money_co/2011/12/cvs-caremark-to-pay-20m-to-three-states-over-fraud-allegations.html">reported</a> briefly in the Los Angeles Times, <blockquote>Pharmacy and prescription drug management company CVS Caremark Corp. has agreed to pay nearly $20 million to settle three lawsuits involving allegations that the company defrauded pension systems in three states, including California’s giant pension fund, attorneys said. The whistleblower lawsuits, filed by two former CVS Caremark pharmacists, accused the company of reselling returned drugs, changing prescription orders to make them more expensive and submitting false reports about how long it took to fill prescriptions.</blockquote> Not the least bit surprisingly, the company did not admit liability in the settlement, and had no comment for the Times. Ho, hum, another big company paying millions to make allegations of fraud go away... nothing to see here, so we will just move on. Merck Settles Fraud Suit for $24 Million This story was picked up by AP, so a very brief version of it did appear in a variety of locations. A longer version was <a href="http://bostonglobe.com/business/2011/12/21/merck-pay-overcharging-case/05zJqmztpJGuD3elBs0HkM/story.html">published</a> by the Boston Globe, At this point, it should be no surprise that it took a long time to get to this settlement, eight years in fact, just as in the case above, <blockquote>Merck & Co. has agreed to pay $24 million to the state Medicaid program to settle long-running civil charges that it charged too much for some drugs, in the largest single-case Medicaid fraud settlement in Massachusetts history. The agreement, unveiled yesterday by Attorney General Martha Coakley’s office, closes out a 2003 lawsuit....</blockquote> Again, the allegations were of fraud, <blockquote>Coakley said her office’s Medicaid fraud division wanted to hold accountable drug companies that defraud taxpayers. </blockquote> Again, "hold accountable" did not translate into establish the allegations as true, <blockquote>Ron Rogers, a spokesman at Merck corporate headquarters, said the drug company did not admit liability or wrongdoing in the settlement. He said Merck agreed to resolve the claims to put the matter behind it.</blockquote>Nothing more to see here, so we will move on again. Summary Every month, it seems that<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> more settlements</a> are announced of cases alleging all sorts of wrongdoing by major health care organizations. Very often, the allegations are of wrongdoing that appears serious to the uninitiated. For example, most of the above cases involved allegations of fraud, and one involved allegations of kickbacks, that is, bribes to doctors. Yet, in every one of these cases - - The monetary penalties were barely more than pocket change for the corporations involved. - The payments were made by the organization as a whole, and hence would disadvantage many people who were not involved in and did not benefit from the specific actions alleged. Such de facto victims of the settlement included company shareholders, employees, and probably patients (who may have paid prices raised to pay for settlements), and the public (who may have indirectly paid these higher prices through insurance premiums or taxes.) - The organization did not have to admit any facts, leaving the record foggy, and clouding the chances for any people who might have been hurt by the actions to take legal action. - No people who actually authorized, directed, or implemented the apparent bad behavior suffered any negative consequences. Thus, these settlements, like many others we have discussed, did not appear to be any major deterrent of future bad behavior. These settlements do provide a public, if largely ignored, record that suggests how a miasma of sleazy behavior, if not outright corruption has settled over health care. These settlements do provide the context for many pithy questions that could be asked of health care organizational leaders, if anyone dared to do so. The settlements do suggest a need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, particularly when these organizations misbehave.

Legal Settlements Have Become So Common that They are Barely News

Legal settlements by big health care organizations have become so common that those of less than blockbuster size barely seem to qualify as...

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