healthy4u: Risperdal

How Many Legal Settlements Does it Take... to Lead to Real Change in Johnson and Johnson Leadership?

And the latest Johnson & Johnson settlement is (as <a href="http://www.businessweek.com/news/2012-08-30/j-and-j-will-pay-181-million-to-settle-risperdal-ad-claims">described </a>in Bloomberg/ BusinessWeek): <blockquote>Johnson & Johnson (JNJ) will pay $181 million to resolve claims by 36 states that it improperly marketed and advertised the antipsychotic drugs Risperdal and Invega. J&J and its Janssen unit settled claims that it promoted the drugs from 1998 through 2004 for uses not approved by the U.S. Food and Drug Administration. New York Attorney General Eric Schneiderman said today the accord is the largest multistate consumer protection-based pharmaceutical settlement. 'This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules,' Schneiderman said in a statement. J&J agreed it won’t promote the drugs for off-label uses or tout them falsely.</blockquote> Specific Bad Behaviors The allegations were of the sorts of behavior that should make health professionals cringe, <blockquote>Using speaker programs on unapproved uses, sham consulting programs for physicians, and lucrative agreements with doctors who prescribed off-label, J&J 'sought to enhance Risperdal’s off-label market penetration across a wide range of diagnoses and patient populations, according to Florida’s complaint. </blockquote> So reading slightly between the lines, the behaviors included various ways to pay physicians ("sham consulting," "lucrative agreements") for prescribing drugs, providing physicians monetary incentives to violate the most core of their core values, putting the individual patient's welfare and needs ahead of personal enrichment. Why these were not labeled kickbacks or bribes is not obvious. No Individuals Pay any Penalty Nonetheless, as in nearly every other legal action by state or federal law enforcement against a big pharmaceutical company or other big health care company, the entire settlement involved no penalties to any individuals who may have authorized, directed or participated directly in the misbehavior. In fact, <blockquote>The company, based in New Brunswick, New Jersey, settled 'to resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process,' it said in a statement. J&J didn’t admit wrongdoing or pay a fine or penalty. </blockquote> The tough law enforcers claimed <blockquote>The agreement 'sends a message to all pharmaceutical companies that these practices will not be tolerated,' Florida Attorney General Pam Bondi said in a statement. </blockquote> Of course, there was another part to the settlement. The company promised not to do these sort of bad things again, <blockquote>Bondi said Janssen agreed to several steps over five years. They include having policies to ensure that financial incentives aren’t given to encourage off-label marketing; sales and marketing employees can’t develop the medical contents of responses to health-care providers; and it must describe the effectiveness and risks of drugs in a balanced manner. </blockquote> Should we believe them? Their record is not promising. Earlier this year Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians about the very same drug at issue in this suit, Risperdal (look <a href="http://hcrenewal.blogspot.com/2012/04/once-more-with-feeling-johnson-and.html">here</a>). That was just the latest in a remarkable string of legal cases suggesting an ongoing pattern of unethical and illegal behavior by this very large health care corporation. As we <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">wrote </a>recently, this included - Convictions in two different states in 2010 for misleading marketing of Risperdal, as noted above - A guilty plea for misbranding Topamax in 2010 - Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary - A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above) - Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post <a href="http://hcrenewal.blogspot.com/2011/09/smart-alecs-strange-bedfellows.html">here</a>) - A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>) - More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>). - Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see this <a href="http://www.businessweek.com/news/2012-03-12/j-and-j-said-to-face-u-dot-s-dot-demand-to-raise-risperdal-settlement-offer">BusinessWeek story</a>.) One might think that the leadership on whose watch this all occurred would be in disgrace. There has been, however, no major changes in leadership of the company. The CEO who was in power during the time when these settlements, and much of the behavior leading to them, will be retiring, after earning huge compensation, and with a retirement package valued somewhere between $143 and $197 million (see this <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">post</a>). Rather than disgrace, he recently was put on the committee responsible for investigating JP Morgan Chase's $5.8 billion dollar trading loss (as reported by Bloomberg, <a href="http://www.nj.com/business/index.ssf/2012/08/jjs_weldon_to_help_review_jpmo.html">via NJ.com</a>). Summary As we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">noted again and again and again</a>, many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care. As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.

How Many Legal Settlements Does it Take... to Lead to Real Change in Johnson and Johnson Leadership?

And the latest Johnson & Johnson settlement is (as described in Bloomberg/ BusinessWeek): Johnson & Johnson (JNJ) will pay $181 mill...

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Once More with Feeling - Johnson and Johnson Found Guilty, Fined $1.1 Billion

The latest legal black eye for giant pharmaceutical and device company Johnson and Johnson appeared in an Arkansas court room.  As documented by Bloomberg, <a href="http://www.nj.com/business/index.ssf/2012/04/johnson_johnson_ordered_to_pay.html">via NJ.com</a>, <blockquote>Johnson & Johnson was ordered to pay $1.1 billion by a state judge after an Arkansas jury found the company’s officials misled doctors and patients about the risks of the antipsychotic drug Risperdal. Jurors in Little Rock yesterday said the company’s marketing campaign also violated consumer-protection laws. The panel deliberated about three hours before finding J&J and its Janssen unit engaged in 'false or deceptive acts' by sending a 2003 letter touting Risperdal as safer than competing drugs to more than 6,000 doctors across the state. </blockquote> The prosecutors had alleged a variety of kinds of deceptions about Risperdal, <blockquote>Along with contending that J&J and Janssen defrauded the Medicaid program by failing to properly outline the antipsychotic medicine’s risks, Arkansas officials alleged J&J officials deceptively marketed the drug as safer and better than competing medicines. The state also argued the companies marketed the drug for 'unapproved uses, including various symptoms in children and the elderly' after being warned by federal authorities to halt such sales. </blockquote> In summary, <blockquote>Arkansas Attorney General Dustin McDaniel said in an e- mailed statement that he sued because residents in the state deserved to be protected from 'fraud and deceptive practices.' He said that jurors found 'Johnson & Johnson and Janssen Pharmaceuticals lied to patients and doctors because they cared more about profits than people.' </blockquote> Bloomberg noted that <blockquote>It’s the third jury verdict against J&J, the second-biggest maker of health products, in cases where states alleged it hid Risperdal’s risks and tricked Medicaid regulators into paying more than they should have for the medicine. Louisiana and South Carolina juries also found the company’s Risperdal marketing violated consumer-protection laws. </blockquote> In fact, this is just the latest in a remarkable string of legal cases suggesting an ongoing pattern of unethical and illegal behavior by this very large health care corporation. As we <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">wrote </a>recently, this included - Convictions in two different states in 2010 for misleading marketing of Risperdal, as noted above - A guilty plea for misbranding Topamax in 2010 - Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary - A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above) - Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post <a href="http://hcrenewal.blogspot.com/2011/09/smart-alecs-strange-bedfellows.html">here</a>) - A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>) - More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>). - Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see this <a href="http://www.businessweek.com/news/2012-03-12/j-and-j-said-to-face-u-dot-s-dot-demand-to-raise-risperdal-settlement-offer">BusinessWeek story</a>.) Meanwhile, as we also <a href="http://www.blogger.com/profile/00497209843184497847">discussed </a>recently, Johnson and Johnson seems to have lost the ability to manufacture high quality products. It has had to make 30 separate product recalls since 2009. The latest was Liquid Infant Tylenol. (The current WSJ Health Blog list of recalls can be found <a href="http://blogs.wsj.com/health/2012/02/17/jj-recall-watch-mcneil-pulls-liquid-infant-tylenol-on-dosing-system-concerns">here</a>.) So the real question here is how many instances of manufacturing of defective, mislabeled, contaminated, or harmful products, and how many court cases showing unethical or illegal behavior will it take until the leadership and governance of this company improves (and by extension, the leadership and governance of other large health care corporations with similar bad records improves). As we <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">posted </a>not long ago, the CEO who presided over most of these messes will be allowed to retire with a huge golden parachute.  His devotion to "making the numbers," that is, hitting short-term revenue targets ahead of all other goals, probably had something to do with a company once thought of as a paragon of corporate behavior turning so bad.  Yet he became extremely rich doing this, and neither his riches nor his legal status have ever been challenged.  His successor apparently will be another former sales representative who may be just as devoted to "making the numbers,."  Thus has the business school dogma that short-term financial results, prettied up as "shareholder value," is the only thing that should matter to corporate leadership (look <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here</a>) poisoned health care. How many more doctors and patients have to be deceived, how many products have to be contaminated or defectively made before we demand better leadership of health care organizations?

Once More with Feeling - Johnson and Johnson Found Guilty, Fined $1.1 Billion

The latest legal black eye for giant pharmaceutical and device company Johnson and Johnson appeared in an Arkansas court room. As documente...

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The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug Respirdal (risperidone) by the Janssen subsidiary of Johnson and Johnson opened yet another window on organized stealth marketing campaigns in health care. (Note that we first discussed this case <a href="http://hcrenewal.blogspot.com/2006/12/guidelines-in-whose-interest.html">here </a>in 2006, and that this trial and the case was ably covered in detail on the <a href="http://1boringoldman.com/">1BoringOldMan blog</a>.)  Even so, given all the recent attempts to dismiss critics of the pharmaceutical industry as "pharmascolds," (e.g., <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>), and to otherwise uphold the current status quo in our dysfunctional health care system, I thought it would be useful to rediscuss this case to show how systematic stealth marketing threatens the ideals of rational, evidence-based health care. <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">Evidence-based medicine</a> may simply be viewed as medicine based on evidence and logic tempered with humanity. A slightly longer definition is practice based on the best evidence from clinical research derived from systematic searches, critically reviewed, used to maximize individual patients' benefits and minimize their harms according to their values. In contrast, brief summaries of sworn testimony during the trial, and of a key report by an expert witness suggested how a commercial health care organization, in this case, the Jennssen subsidiary of Johnson and Johnson, could organize a stealth marketing campaign to promote practice based on deception and falsehoods, entangled in illogic and emotional and psychological manipulation. This was all done to market a product which could not so easily be supported by evidence and logic. Deception and Falsehoods: Suppression of Medical Research A Bloomberg <a href="http://www.businessweek.com/news/2012-02-01/j-j-hid-3-risperdal-diabetes-studies-from-fda-texas-jury-told.html">report</a> of the last day of the trial showed how the Respirdal stealth marketing campaign used the now classic mechanism of suppression of medical research: <blockquote>Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified. As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday. That study concluded Risperdal caused 'medically serious weight gain' that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added.</blockquote> In particular, <blockquote>Glenmullen, testifying as an expert for the state, told jurors Janssen officials didn’t turn over Study 113, which found Risperdal posed a higher diabetes risk than Zyprexa, to the U.S. Food and Drug Administration when regulators began probing links between anti-psychotic medications and the disease in 2000. The drugmaker also didn’t turn over the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks to the FDA.</blockquote>Suppression of research is a severe threat to evidence-based medicine because it can severely bias the clinical evidence base on which it depends. Deception and Falsehood: Ghostwriting A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided this example of ghostwriting: <blockquote>A member of J&J's Speakers Bureau, [University of Texas Professor of Psychiatry Dr Alexander] Miller collected at least $82,000 from Janssen and its contractors. He declined to comment for this story, saying he may be called as a witness in the lawsuit. Miller was a 'guest author' for one of Janssen's ghostwritten articles. Upon receiving the manuscript, Miller wrote, 'Yes, I am happy to be included as a co-author. I made a few minor edits and comments in the manuscript.'</blockquote>In addition, another <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch/">article</a> in the Houston Press summarizing the issues before the trial provided this overview of the ghostwriting process: <blockquote>As described in the AG's expert witness report, a company called Excerpta Medica was hired to draft some of Janssen's Risperdal articles. In 2003, according to Rothman, Excerpta Medica issued 'Risperidone Publication Program Status Reports,' indicating that 30 of the 145 articles to be published had authors listed as 'to be determined.' Rothman also examined what he considered a signature ghostwritten piece meant to boost Risperdal's pediatric profile; the study is included in the 2010 parameters. Rothman cited a barrage of e-mails between Excerpta Medica and J&J in crafting the article. At one point, an Excerpta Medica employee wrote, 'It would be very helpful to receive some guidance in relation to the flow, format and subject in this paper and whether you think this is too marketing oriented or not, in order to prepare a next draft. Besides that we would like [to] have some suggestions for external authors on this paper. Maybe [a] U.S. and a European KOL? Your input will be much appreciated.'' The article eventually appeared in a 2007 volume of the European Journal of Child and Adolescent Psychiatry. For a lead author, J&J scored a heavy hitter: Dr. Peter Jensen, former associate director of child and adolescent research at the National Institute of Mental Health, and the founding director of the Center for the Advancement of Children's Mental Health at Columbia University. Now with the Mayo Clinic, Jensen declined to comment for this story.</blockquote> This indicates the scope of this particular ghostwriting initiative: 145 articles were planned.  Thus, ghostwritten articles could comprise a major proportion of the apparently scholarly literature relevant to Risperdal.  Ghostwriting is fundamentally deceptive because it allows marketing to appear in the guise of scholarly work.  Ghostwritten reviews can deceptively shift the focus from the questions that need to be addressed by the evidence-based process to benefit patients to those whose answers would benefit marketers. Deception and Falsehoods: Key Opinion Leaders Emotional and Psychological Manipulation: Creation of Conflicts of Interest An important element of most stealth marketing campaigns is the creation of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>.  These are academics or professionals who can promote products in the guise of unbiased expertise.  A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided the example of Dr Steven Shon: <blockquote>As the head of the state's mental health agency, Shon was perhaps Janssen's most crucial key opinion leader; his influence in pushing Risperdal was invaluable. He accepted at least $47,000 from Janssen and its medical ghostwriter, Excerpta Medica, and signed an agreement to be a member of Johnson & Johnson's Speakers Bureau. Rothman writes, 'The medical director of the state's mental health agency should not be serving as an official spokesperson for a pharmaceutical company whose product state agencies are purchasing.' The company paid for his trips across the country, and even overseas, to promote Risperdal as a safe and effective medication. (But the romance between Janssen and Shon was not without its bumps; Shon would get 'upset' if the checks he accepted from Janssen were made out to the MHMRA instead of directly to him. Apparently, those were more difficult to funnel into his personal account.) Shon retired in 2005, allowing him to collect his taxpayer-funded pension. He moved to Las Vegas, where he's the director of psychiatry for a mental health and substance abuse clinic called Harmony Healthcare. Shon was so influential that Janssen grew paranoid and possessive when it learned that other companies sought his partnership as well. When J&J employee Yolanda Roman heard that Eli Lilly had flown him to their headquarters on a private jet, she wrote, "Steve I suppose is enjoying the vast attention and response he can command from Industry...Obviously, Steve has the right to be served by all Industry, let's hope he remains fair [and] balanced and remembers who PLACED HIM ON THE 'TMAP' MAP." Meanwhile, another employee busted out the caps-lock to warn that "WE WILL NOT LET LILLY OR PFIZER PREVAIL WITH OUR MOST IMPORTANT PUBLIC SECTOR THOUGHT LEADER."</blockquote> Similarly, a Bloomberg <a href="http://www.bloomberg.com/news/2012-01-11/johnson-johnson-paid-texas-official-to-speak-around-the-u-s-jury-told.html">report</a> of Dr Shon's trial testimony included: <blockquote>Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said. Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin.</blockquote> Also, <blockquote>Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006. Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called 'Mental Health Issues Today' and was a continuing medical education speaker in programs sponsored by the company. Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said. In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years. </blockquote> Dr Shon's value to Janssen derived from his position as the respected leader of the state's mental health agency. While he was apparently paid by Janssen marketers who saw him as an ally, his marketing was all the more effective because it seemed to come from an unbiased expert. As such it was deceptive. The <a href="http://iom.edu/Activities/Workforce/ConflictOfInterest.aspx">Institute of Medicine report on conflicts of interest</a> defined them as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." The report, and indeed much of the discussion of conflicts of interest in health care assumes that most secondary interests are "-within limits - legitimate and even desirable goals." For example, an academic physician who also was a basic scientist could be paid by a pharmaceutical company to do a specific assay on samples used in research. In that case, the payments could conceivably create a risk that the academic's professional judgment in a clinical setting would be unduly favorable to the products of the company. However, the relationship hardly seems intended to cause such a bias. Notions that conflicts of interest are "inevitable" but "manageable" may stem from consideration of conflicts of interest like this. However, conflicts of interest deliberately created as perverse incentives may be much more consequential, and as this example shows, perhaps not rare. It appears that Janssen paid Dr Shon not to do some task that was unrelated to how he fulfilled his primary entrusted responsibilities as director of mental health, but in order to influence how he fulfilled them. We have noted previous examples in which corporate marketers consider paid key opinion leaders as sales people (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>). Such conflicts are deliberately created so that the recipient of payments uses his or her entrusted responsibilities to serve the vested interests of the payer may be deceptive, as noted above.  Furthermore, by being intended to induce changes in how the payee performs his or her primary responsibilities, these conflicts are particularly likely to lead to abuse of these entrusted responsibilities. Given that the <a href="http://www.transparency.org/news_room/faq/corruption_faq">Transparency International definition of corruption</a> is abuse of entrusted power for private gain, we need a new and more incisive term to described this variety of conflicts of interest. The motivation of key opinion leaders by created conflicts of interest can result in powerful manipulation of the key opinion leaders, but more importantly of their audience.  Emotional and Psychological Manipulation: Intimidation Another Bloomberg <a href="http://www.bloomberg.com/news/2012-01-12/j-j-whistle-blower-recounts-firing-after-finding-payments.html">report</a> included testimony about how someone who attempted to blow the whistle about the Respirdal stealth marketing campaign was intimidated: <blockquote>Allen Jones testified yesterday in state court in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients, Jones said. Jones, 57, said he found a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “\'to the attention of' Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent 'in care of' of Fiorello, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said. 'The account was used to deposit money from drug companies,' Jones said yesterday in the trial’s third day of testimony. 'There were real problems here. On many levels, the account was improper.' Janssen also paid $2,000 directly to Fiorello as an honorarium for his speaking at a company-sponsored event in 2002, Jones said. Jones said he followed the money trail and explored efforts by Janssen to promote, on a state-by-state basis, Texas guidelines favoring drugs like Risperdal. The funds sent to the hospital account helped pay travel expenses for programs related to setting up the Texas guidelines in Pennsylvania, he said. The state adopted the guidelines that favored Risperdal in 2003, Jones said. </blockquote> Note that this testimony appears to be about yet another KOL paid to promote guidelines that would in turn promote the marketing of Respirdal. So this is yet another case of a conflict of interest apparently deliberately created to influence the individual's primary responsibility. However, then <blockquote>Jones said his boss told him to ease off his probe. He said he was told, 'Stay away from the drug companies. This is a personnel issue. Stay away from the drug companies, stay away from TMAP. Jones said his boss said, 'Drug companies write checks to both sides of the aisle. Stay away from it.' His boss told him that 'morally and ethically I was correct, but politically, this was dead.' Jones said that later he was removed as the lead investigator from the case, and he was 'marginalized completely.' He continued to pursue the case on his own time, and spoke to the New York Times for a story that ran Feb. 1, 2004. He said he was fired for talking to the newspaper. </blockquote> So Jones was intimidated to the extent that he lost his job. Note further that the implication is that this intimidation stemmed from yet more conflicts of interest created by Janssen, payments to politicians. This underlines how stealth marketing campaigns become complex systems. Note further that in retrospect, Jones' complaints were deemed true by a court of law and a state commission: <blockquote>Fiorello, once the chief pharmacist for Pennsylvania’s public welfare department, was convicted in December 2008 of felony conflict-of-interest charges for taking payments from drug companies, including Janssen and Pfizer Inc. He was sentenced to 18 months of probation and fined $3,000. He also paid more than $27,000 in civil fines after the Pennsylvania Ethics Commission cited him. </blockquote>In a sense, intimidation and created conflicts of interest are two sides of the same coin.  Both involve the deliberate imposition of incentives, either positive or negative.  These incentives are designed to further marketing aims and organizational interests, not to improve patient care or public health, or advance science.  Thus they are powerful tools of emotional and psychological manipulation. Summary Note that even the brief summaries of trial evidence suggested how systematic the campaign was, and how within it, the elements of deception and falsehoods (instead of evidence), and emotional and psychological manipulation (instead of logic and humanity) were predominant. This should be added to previous discussion of <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing campaigns</a>, including such examples as that of Neurontin <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>). Stealth marketing campaigns are complex examples of how behavior meant to further vested interests may directly threaten evidence-based practice, physicians' professionalism, and ultimately patients' and the public's health. There have been many calls (e.g., see recent posts <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/11/if-medical-school-is-just-part-of.html">here</a>) for increased "collaboration" among health professionals and academics and industry.  Often they are justified by the need for "innovation," while resulting conflicts of interest are deemed "manageable."  The current examples show how the vested interests of health care organizations operating within a laissez faire, anything goes environment may make such collaboration poisonous.

The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug ...

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Why Cultivate Weldon's Confidence? - CEO Goes to White House Days After His Company's Latest Guilty Plea Announced

Earlier this month, US President Barack Obama met "with eight business leaders to hunt for ideas to revive the economy," <a href="http://online.wsj.com/article/SB10001424053111904006104576504261025589134.html">according to</a> the Wall Street Journal.  At the session, the President asked "what he and his administration could do to improve their confidence...."  The reporters' White House informants emphasized that the point was "listening to the CEOs and not telling them what to do." Included amongst the eight CEOs was "Bill [William] Weldon of Johnson & Johnson."  Why would the US President want to improve Mr Weldon's confidence? Johnson and Johnson's Latest Guilty Plea After all, two days earlier, Bloomberg <a href="http://www.bloomberg.com/news/print/2011-08-09/j-j-reaches-tentative-agreement-with-u-s-on-risperdal-criminal-charge.html">noted</a> how Mr Weldon's company was ready to plead guilty, yet again. <blockquote>Johnson & Johnson (JNJ) said it reached an agreement to settle a misdemeanor criminal charge related to marketing of its antipsychotic drug Risperdal. The U.S. has been investigating its Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses, J&J said in its quarterly filing yesterday. The Justice Department and the U.S. attorney in Philadelphia 'are continuing to pursue both criminal and civil actions,' the company said. </blockquote> In particular, <blockquote>The agreement in principle on the criminal charge is 'pursuant to a single misdemeanor violation of the Food, Drug and Cosmetic Act,' the company said. </blockquote> Other Recent Johnson and Johnson Legal Misadventures This would be just the latest in a string of adverse legal results for Johnson and Johnson. As Bloomberg noted regarding Risperdal: <blockquote>Last year, jurors in Louisiana ordered the drugmaker to pay almost $258 million to state officials for making misleading claims about the antipsychotic’s safety. J&J has appealed. [see our post <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>] In June, a South Carolina judge ordered J&J officials to pay $327 million in penalties for deceptively marketing the medicine. J&J has asked the judge to throw that verdict out. [see our post <a href="http://hcrenewal.blogspot.com/2011/03/jury-finds-johnson-and-johnsons.html">here</a>] 'The attorneys general of approximately 40 other states have indicated a potential interest in pursuing similar litigation against' the Janssen unit, J&J said.</blockquote> Furthermore, the company has been in legal hot water regarding how it sold other products: <blockquote>In April, in a separate case, J&J agreed to pay $70 million to resolve criminal and civil charges after admitting it bribed doctors in Europe and paid kickbacks in Iraq to win contracts and sell drugs and artificial joints. As part of a deferred prosecution agreement, J&J subsidiary DePuy was charged with conspiracy and violations of the Foreign Corrupt Practices Act. [see our post <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here</a>] In May 2010, J&J’s Ortho-McNeil Pharmaceutical LLC pleaded guilty to a misdemeanor charge of selling a misbranded drug, admitting it illegally marketed its Topamax epilepsy drug. J&J paid $81 million to resolve criminal and civil cases. [see our post <a href="http://hcrenewal.blogspot.com/2010/05/sunday-settlement-and-guilty-plea.html">here</a>]</blockquote> Johnson and Johnson's 25 Recalls And just a few days after President Obama's meeting with Mr Weldon and his fellow CEOs, just the latest in the string of recalls of apparently defective products was announced by Johnson and Johnson. Tylenol, made by the McNeil Consumer Healthcare division of Johnson and Johnson, was the recalled product this time, <a href="http://blogs.wsj.com/health/2011/08/15/jj-recall-watch-tylenol-cold-gelcaps-pulled/">per</a> the Wall Street Journal Health Blog. Note that this post was part of the blog's now long-running J+J Recall Watch feature, and the post cataloged 25 separate recalls of Johnson and Johnson products since 2009, including previous recalls of various versions of Tylenol, and a June, 2011, recall of Risperdal. We have written several times about the inability of Johnson and Johnson management to fulfill a core component of any drug company's mission, to produce pure, unadulterated products (look <a href="http://hcrenewal.blogspot.com/2011/01/why-is-johnson-and-johnson-spinning-out.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/09/should-president-of-university-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/07/are-ill-informed-leaders-cause-of-drug.html">here</a>). We have also noted several times (e.g., <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here,</a> <a href="http://hcrenewal.blogspot.com/2011/03/jury-finds-johnson-and-johnsons.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">here</a>) how CEO William Weldon continues to get richer and richer despite his company's guilty pleas, product recalls, and other questionable behavior (for more details about the latter, look <a href="http://hcrenewal.blogspot.com/search/label/Johnson%20and%20Johnson">here</a>). Whose Confidence to Cultivate? So again I ask, why would the US President want to cultivate William Weldon's confidence?  At best, I can only hope that Mr Weldon was invited to the White House because its staff did not do their homework, and only noted the size of the company he leads, rather than the rate of its blunders and misdeeds.  There is already too much evidence that government is excessively cozy with the leaders of big health care (and other) corporations, and gets too much of advice from them rather than from less well-heeled citizens.  At least, if the President is going to get advice from corporate CEOs, he should try to find some whose companies appear to be better lead.     Maybe the difficulty he would have finding such CEOs in the health care field would provide a clue that true health care reform requires better leadership and governance of health care organizations.

Why Cultivate Weldon's Confidence? - CEO Goes to White House Days After His Company's Latest Guilty Plea Announced

Earlier this month, US President Barack Obama met "with eight business leaders to hunt for ideas to revive the economy," according...

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A Jury Finds Johnson and Johnson's Risperdal Marketing "Willfully Deceptive," but What Will It Take to Change Company Leadership?

For Johnson and Johnson, it's deja vu all over again, as <a href="http://www.goupstate.com/article/20110324/ARTICLES/103241022/1083/ARTICLES?Title=Spartanburg-jury-says-maker-of-drug-Risperdal-deceptive">reported </a>by the Spartansburg (SC) Herald Journal: <blockquote>A Spartanburg jury decided that Johnson & Johnson and a subsidiary violated South Carolina's Unfair Trade Practices Act, but the company will wait until damages are determined next month before it decides whether to appeal the jury's decision.</blockquote> Also, <blockquote>The jury decided Tuesday the company willfully violated the act by sending a 2003 letter to doctors that attorneys for the state said sought to minimize the risk of hyperglycemia — or high blood sugar — and diabetes reported by patients using Risperdal. The letter was sent to about 700,000 doctors nationwide — 7,200 of those in South Carolina. The jury decided that warning labeling included with the drug was also willfully deceptive.</blockquote> This is not the first such lawsuit involving Risperdal, <blockquote>South Carolina's lawsuit was the fourth state lawsuit to go to trial. In West Virginia, claims involving Risperdal were dismissed with prejudice last December following the company's appeal. In October, a jury in Louisiana awarded almost $258 million in civil penalties to the state. Janssen will appeal that decision. In a jury trial in Pennsylvania in June, a judge dismissed the state's case against Janssen.</blockquote> Note that we posted about the Louisiana verdict <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>. The hits, they just keep on coming for Johnson and Johnson, which has been recalling a dizzying array of products due to manufacturing problems.  A new recall was just <a href="http://blogs.wsj.com/health/2011/03/24/jj-recall-watch-360000-surgical-wound-drainers/">announced today</a>, and there have been 20 separate recalls since mid-2009. Just eight days ago we <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">contrasted</a> the opulent compensation given the Johnson and Johnson CEO in 2010 (about $29 million) with the company's poor financial performance, seeming inability to make pure, unadulterated, safe products as manifested by multiple recalls, and ethical problems as indicated by legal settlements and guilty pleas. Today we have added another recall, and a jury verdict against the company finding its marketing was deceptive.  So the cognitive dissonance evoked by comparison of executive pay and corporate dysfunction continues.  Is there any degree of organizational dysfunction that could possibly induce a health care corporate CEO to feel shame for continuing to extract millions from the flailing beast?  Is there any degree of disconnection between executive compensation and corporate performance that could possibly induce complacent corporate boards to feel shame for enriching the hired executives who presided over the mess? Probably not.  The events surrounding the global financial collapse suggested that somehow expecting corporations to regulate themselves was at best foolishly naive (e.g., see <a href="http://economistsview.typepad.com/economistsview/2011/03/wall-streets-performance-enhancement-scandals.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+EconomistsView+%28Economist%27s+View+%28EconomistsView%29%29">here</a>).  Presumably former US Federal Reserve Chair Allan Greenspan <a href="http://www.huffingtonpost.com/2010/04/09/financial-crisis-panel-gr_n_531647.html">really thought</a> that markets could regulate themselves, and that fraud could not exist because markets in his idealized view would punish it themselves, <blockquote>he didn't believe that fraud was something that needed to be enforced or was something that regulators should worry about....</blockquote> But then he later admitted:  <blockquote>Those of us who have looked to the self-interest of lending institutions to protect shareholder's equity – myself especially – are in a state of shocked disbelief</blockquote>We do not yet seem to be at the point that will we generate enough "shocked disbelief" about the misbehavior of current health care organizations to realize that they will not police themselves, and a true health care reform movement will have to figure out how to reasonably regulate them.  (I submit that perusing the archives of Health Care Renewal will suggest that we should have been at that point years ago.) If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

A Jury Finds Johnson and Johnson's Risperdal Marketing "Willfully Deceptive," but What Will It Take to Change Company Leadership?

For Johnson and Johnson, it's deja vu all over again, as reported by the Spartansburg (SC) Herald Journal: A Spartanburg jury decided th...

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Does Pharma Want its Researchers to Believe They Are Next to God?

In "<a href="http://www.nytimes.com/2009/03/20/us/20psych.html?_r=1">Drug Maker Told Studies Would Aid It, Papers Say</a>" (New York Times, Mar. 19, 2009), the Times discusses the case of psychiatrist Dr. Joseph Biederman. Dr. Biederman outlined plans to test Johnson & Johnson’s drugs including risperidone/Risperidal in presentations to company executives and seemed to guarantee positive outcomes for his studies of the drug, raising questions about his research. Biederman has become a key witness in a series of lawsuits filed by state attorneys general claiming that makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines. His work helped fuel a rapid rise in the use of these medicines in children. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but about $200,000 of this income to university officials. However, if a passage about Dr. Biederman's testimony in court is correct, I believe pharma should consider whether it wants to use someone who believes they are next to God in any capacity whatsoever. There are certain damning statements that, once made by a person, cast a deep shadow over a person's character. I believe this one, if true, may rise to that level: <blockquote>In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered. “What’s after that?” asked a lawyer, Fletch Trammell. “God,” Dr. Biederman responded.“Did you say God?” Mr. Trammell asked.“Yeah,” Dr. Biederman said.</blockquote> One does not usually joke in deposition. I've been Yale faculty, and would never, ever have made anything even approaching such a comment, least of all in a deposition about drug issues affecting kids. Let alone the the palm-greasing he was afforded, could Dr. Biederman's apparently hyperinflated ego have clouded his judgment and scientific objectivity? In drug R&D, that is inherently an extremely dangerous proposition. Where children are concerned, catastrophic might be a more apt term. -- SS

Does Pharma Want its Researchers to Believe They Are Next to God?

In " Drug Maker Told Studies Would Aid It, Papers Say " (New York Times, Mar. 19, 2009), the Times discusses the case of psychiatr...

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