No Needle, but the Damage was Done - A New Example of Suppression of Research about Adverse Effects of Prescription Narcotic Analgesics

This story feels personal, since as a physician who trained starting in the 1970s, figuring out how to manage patients who desperately wanted narcotics, whether to relieve pain, relieve addiction, or relieve financial distress has been a constant challenge.<br /><br /><b>Background  - Treating Pain while Avoiding "the Needle and the Damage Done"</b><br /><br />Almost as soon as I started clinical training in medical school I came up against the problem of narcotics.  In the 1970s, narcotic addiction was a pressing problem that threw a dismal shadow over society..  In the hospital and emergency room we daily saw overdoses and the complications of narcotics addiction, including some particularly nasty infections like bacterial endocarditis,  While dealing with these, we tried to do our best to manage the severe pain of cancer and other relentless diseases with limited tools, narcotics being the most potent.<br /><br />We knew that we should not let our bleak experiences with addiction to illicit narcotics prevent us from giving adequate pain medication to those with metastatic cancer.  However, it was never clear how to best to help people with chronic pain from diseases that were not so immediately deadly.  And whatever it took we wanted not to promote "the needle and the damage done."<br /><br /><iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/k0t0EW6z8a0" width="420"></iframe> <br />Things did not become easier in the 1990s when we  incessantly heard about under-diagnosis and under-treatment of  pain, and how we should not be so afraid of addiction and other adverse effects when prescribing legal narcotics.  As we heard this, however, it seemed that more people with less well-defined chronic pain were coming to us seeking relief, sometimes while preoccupied with narcotics as the solution to their problems.  Yet many of these patients seemed at risk of addiction, appeared already addicted, or even appeared to be seeking drugs so they could sell them to others.<br /><br />In my most recent clinical position, it seemed I was always dealing with new patients with years of obscure musculoskeletal pain who felt I was the miracle physician they were seeking, often specifically to prescribe something like Vicodin, Percodan, or Oxycontin.  When on weekend call I inevitably hear from some poor patient who had somehow run out of or lost an important medication, which turned out to be Vicodin, Percodan, or Oxycontin, and just needed a simple refill without the bother of actually seeing a doctor.  Etc, etc, etc.<br /><br />How could I relieve real suffering without becoming the pusher man?  <br /><br /><b>The Over Promotion of Narcotic Pain Treatment</b>   <br /><br />Then the realization began to dawn that patients, doctors and society were being victimized by a new type of pusher man, this time dressed in a suit and working for an "ethical" drug company.  In the earlier days of Health Care Renewal, we first <a href="http://hcrenewal.blogspot.com/2006/11/cephalons-promotion-of-actiq.html">posted</a> (in 2006) about allegations of deceptive and unethical promotion of fentanyl by Cephalon that lead to its overuse by patients beyond those with cancer who were its ostensible target population.  Then in 2007 came the <a href="http://hcrenewal.blogspot.com/2007/05/guilty-pleas-for-purdue-pharmas.html">spectacular case</a> of guilty pleas by a subsidiary of Purdue Pharma and several of its executives for "misbranding" Oxycontin,  that is, promoting it far beyond any medically legitimate use in severe chronic pain.  Following that various investigations, <a href="http://www.jsonline.com/news/health/99478824.html">well chronicled in the Milwaukee Journal Sentinel</a>, showed how pharmaceutical companies employed deceptive marketing techniques, subverting medical education and research, and creating conflicted key opinion leaders and institutionally conflicted disease advocacy groups, to push more "legal" narcotics  For example, see the Journal Sentinel reports the subversion of :  <a href="http://www.jsonline.com/watchdog/watchdogreports/119130114.html">medical schools and their faculty</a>; .<a href="http://www.jsonline.com/watchdog/watchdogreports/painkiller-boom-fueled-by-networking-dp3p2rn-139609053.html">medical societies, disease advocacy groups, and foundations</a>; and <a href="http://www.jsonline.com/news/health/doctors-with-links-to-drug-companies-influence-treatment-guidelines-ki7pjr6-184041791.html">guideline writing panels</a>.  In 2012, we <a href="http://hcrenewal.blogspot.com/2012/12/the-king-of-pain-recants-pharmaceutical.html">posted</a> about how a drug company paid key opinion leader admitted to second thoughts about his role promoting narcotics.<br /><br />The realization that that overtreatment of chronic pain, no<strike>w</strike> matter how sketchy, never mind the adverse effects of narcotics, was driven by greed and marketing did not make managing chronic pain and patients who wanted narcotics easier.<br /><br />One strategy we used was to try to find drugs nearly as effective as narcotics (although we began to realize that narcotics are also no<strike>tw</strike> as effective as we thought) but less addictive.  The <a href="http://www.jsonline.com/watchdog/watchdogreports/drug-tramadol-escapes-stricter-regulation-b99158486z1-236900801.html">latest story</a> by the indefatigable John Fauber of the Milwaukee Journal-Sentinel suggests that strategy too was subverted.<br /><br /> <b>Suppression of Research about Addiction to Tramadol</b><br /><br />One workaround I sometimes attempted was to prescribe tramadol (e.g., Ultram, Janssen), an opioid which was promoted as non-narcotic and non-addicting.  However, like many quick pharmaceutical solutions to difficult problems promoted in the last few years, that did not often seem to work as well as expected.  Now, per Mr Fauber, it appears that<br /><br /><blockquote class="tr_bq">the <i>FDA failed to heed a key piece of research indicating tramadol had the potential to be abused</i> when it first appeared on the U.S. market in 1995. The drug was not placed under the Controlled Substance Act.<br /><br />Despite recent research affirming its abuse potential, restrictions on prescribing it are no more stringent than for Lipitor or Viagra.<br /><br />The Controlled Substance Act places drugs into five progressively restrictive categories based on their abuse potential. At the top of the list are drugs such as heroin. At the other end are cough medicines with limited amounts of codeine.<br />In deciding tramadol need not be on the list, the FDA based its decision largely on research in which the drug was injected as well as reports from Europe, where it had been on the market for years, that showed very little abuse.<br /><br />However, the agency also had <i>unpublished research showing that when given to opioid abusers orally in high doses, rather than being injected, it produced opiate-like effects that were similar to those from oxycodone</i>, the narcotic in OxyContin, one of the most abused drugs in America. </blockquote><br />Oops.  Here is more detail about the suppressed research, <br /><br /><blockquote class="tr_bq">Tramadol was first introduced in Germany in 1977.<br /><br />Data from Germany had suggested it was only about one-tenth as potent as morphine when injected. Other data showed that after years of use in Germany and other countries there was very little abuse of the drug.<br /><br />However, <i>in the early 1990s, researchers at Johns Hopkins University did a study in which high doses of the drug were given orally to opioid abusers.</i> Taken that way, tramadol acted much differently than when injected.<br /><br /><i>At very high doses it produced opiate-like effects that were similar to high-dose oxycodone.</i><br /><br />Taken by mouth, <i>the drug is transformed in the liver to a metabolite known as M1, which is able to attach to and activate opioid receptors in the brain. It is M1 that is believed to produce the desirable, opiate-like effect.</i><br /><br />In 1994, Ortho-McNeil, part of the R.W. Johnson Pharmaceutical Research Institute of Johnson & Johnson, sought approval from the FDA to sell its brand-name version of the drug, Ultram, in the United States.<br /><br />The Johns Hopkins study never was published, but the company said it was provided to the FDA.</blockquote><br /><br />Also, oops.  The FDA decided not to list the drug as a controlled substance, realized more thought might be needed in the future, but did not appear too worried about who would be doing the thinking.   <br /><br /><blockquote class="tr_bq">That was when <i>the FDA allowed Ortho-McNeil to fund its own committee, separate from the FDA, that would monitor the country for problems with the drug.</i><br /><br /><i>While it was called an 'independent steering committee,' Ortho-McNeil paid for the group's work and also paid consulting fees to its members.</i><br /><br />Sidney Schnoll, a former member of the committee, said <i>he could not remember how much the committee members were paid. In total, the program cost Ortho-McNeil about $15 million a year, said Schnoll, now an executive with Pinney Associates, a Bethesda, Md., company that works with drug and opioid companies.</i><br /><br /><i>'There was absolutely nothing independent about this group,'</i> said Andrew Kolodny, a New York addiction specialist and advocate of tighter controls on opioids.<br /><br />From early on, Ortho-McNeil's marketing plan for tramadol meant keeping it off the list of controlled substances where it would have difficulty competing against other narcotic painkillers such as Tylenol 3 and Tylenol 4, Schnoll said in a 2009 interview. Both Tylenol products contain codeine and are schedule 3 drugs.<br /><br />The Schnoll interview was done by two professors, one from the University of Florida and one from Rensselaer Polytechnic Institute in New York, as part of a project at University of Michigan Substance Abuse Center.<br /><br /><i>'There were equally good products that were cheaper on the market,' Schnoll said</i>, according to a transcript of the interview. 'So they really wouldn't have much of the market. <i>They wanted to see if it would be possible to get the drug onto the market as a non-controlled substance.'</i><br /><br />After a decade, the eight-member Ortho-McNeil committee dissolved itself in December 2005, <i>without ever having recommended that tramadol be put under the Controlled Substances Act.</i></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Oops, again.  Meanwhile, the adverse effects of tramadol were becoming more apparent.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">An analysis by the Journal Sentinel and MedPage Today found that <i>tramadol use is up dramatically since 2008,</i> the earliest year for which data is available. It rose from 25 million prescriptions that year to nearly 40 million in 2012, according to data from IMS Health, a market research firm.<br /><br /><i>In 2011, the drug was linked to 20,000 emergency department visits around the country. In Florida alone, there were 379 overdose deaths involving tramadol that year, up from 106 in 2003, </i>according to the DEA.<br /><br /><i>In Milwaukee County, 20 people died of a drug overdose involving tramadol from 2010 through October 2013,</i> according records from the Medical Examiner's Office. In most of those cases, tramadol was one of several opioids that had been taken.</blockquote><br />Final oops.  Perhaps no needles were involved, but the damage was being done.   <br /><br /><b>Summary - Goddam the Pusher Man </b><br /><br />The over-promotion of addictive narcotics for pain relief has become an instructive example of <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> and unethical practices used by commercial health care firms seeking revenue no matter what it takes to get it.  Just the latest article on tramadol illustrated the use of paid <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a> and more broadly, the creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicted</a> medical academics for marketing objectives (here, apparently, obfuscating the dangers of the product); the <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of clinical research</a> (for the same reason); and at least raised the possibility of <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a>.  It seems unlikely that whoever made the decisions to use the tactics worried about adverse effects including loss of the integrity of research, subversion of academic medicine, ;undermining medical decision making, and obviously most importantly direct harm to patients.  (I would note that the decision makers appeared to be working for <a href="http://hcrenewal.blogspot.com/search/label/Johnson%20and%20Johnson">Johnson and Johnson</a>, a company which seems to have a growing history of questionable behavior.)   <br /><br />Health care professionals should at least learn that the pusher man does not always look like a character out of Easy Rider.<br /><br /></div><iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/Z-9iNVoeghI" width="420"></iframe>

No Needle, but the Damage was Done - A New Example of Suppression of Research about Adverse Effects of Prescription Narcotic Analgesics

This story feels personal, since as a physician who trained starting in the 1970s, figuring out how to manage patients who desperately wante...

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There They Go Again, Again... - Johnson and Johnson Loses Two Civil Cases, Makes $2.5 Billion Settlement Based on Claims it Withheld Safety Data on its Products

There has been some talk by US government officials that any day now they will actually get tough on corporate executives whose organizations are involved in multiply unethical actions (perhaps using the legally valid, but massively neglected responsible corporate officer doctrine, look <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">here</a>).  However, the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> by such corporations continue without any hints of negative consequences for the people who might have actually been involved in unethical activity.  <br /><br />So, we note another week, another multi-billion dollar settlement and another loss of a civil lawsuit by huge drug, device and biotechnology company <a href="http://hcrenewal.blogspot.com/search/label/Johnson%20and%20Johnson">Johnson and Johnson</a><br /><br /><b>The Articular Surface Replacement Metal-on-Metal Hip Prosthesis Settlement</b><br /><br />After various rumors, the report of the settlement appeared in a New York Times <a href="http://www.nytimes.com/2013/11/20/business/johnson-johnson-to-offer-2-5-billion-hip-device-settlement.html">article</a> on November 19, 2013.  The basics were,<br /><br /><blockquote class="tr_bq">Johnson & Johnson and lawyers for patients injured by a flawed hip implant announced a multibillion-dollar deal on Tuesday to settle thousands of lawsuits, but it was not clear whether the deal would satisfy enough claimants.<br /><br /><div itemprop="articleBody">Under the agreement, <i>the medical products giant would pay nearly $2.5 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Separately, the company has agreed to pay all medical costs related to such procedures, expenses that could raise the deal’s cost to Johnson & Johnson to $3 billion, people familiar with the proposal said. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Under the plan, the typical patient payment for pain and suffering caused by the device would be about $250,000 before legal fees. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, with those who negotiated the plan emerging as big winners. </div><br />The proposed settlement, which was submitted on Tuesday to a federal judge in Toledo, Ohio, must receive the support of 94 percent of eligible claimants to go forward.</blockquote><br />An <a href="http://www.nytimes.com/2013/11/13/business/johnson-and-johnson-said-to-agree-to-4-billion-settlement-over-hip-implants.html">earlier NY Times article </a>on a rumored version of the settlement emphasized that relevant litigation had featured strong allegations that Johnson  and Johnson's DePuy subsidiary hid what it knew about the faults of the device,<br /><br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">The A.S.R. hip was sold by DePuy until mid-2010, when the company recalled it amid sharply rising early failure rates. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However,<i> internal company documents disclosed during the trial of a patient lawsuit this year showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases outside the United States also showed that the A.S.R. was failing at high rates in patients after just a few years. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Internal DePuy projections estimate that it will fail in 40 percent of those patients in five years, a rate eight times higher than for many other hip devices. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">A <a href="http://www.nytimes.com/2013/11/26/business/frustration-from-a-deal-on-flawed-hip-implants.html">later NY Times article</a> about plaintiffs' sometimes negative reactions to the settlement added,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> The DePuy Orthopaedics division of Johnson & Johnson estimated in an internal document in 2011 that the device would fail within five years in 40 percent of patients. Traditional artificial hips, which are made of metal and plastic, typically last 15 years or more before replacement. </div><div itemprop="articleBody"><br /></div></blockquote><div itemprop="articleBody"><blockquote> <i>DePuy officials have insisted that they acted properly in handling the device, including waiting until 2010 to recall it. However, internal company documents show that company officials were warned years before by their own consultants that the device was so problematic they would not use it in their patients. </i></blockquote><br />In January, 2013, the NY Times had <a href="http://www.nytimes.com/2013/01/26/business/johnson-johnson-hid-flaw-in-artificial-hip-documents-show.html">reported</a> in more detail about how DePuy executives concealed evidence about safety issues with the hips,<br /><br /><blockquote class="tr_bq">. <i>Johnson and Johnson executives knew years before they recalled a troubled artificial hip in 2010 that it had a critical design flaw, but the company concealed that information from physicians and patients</i>, according to internal documents disclosed on Friday during a trial related to the device’s failure.<br /><br /><div itemprop="articleBody"><i>The company had received complaints from doctors about the device, the Articular Surface Replacement, or A.S.R., even as it started marketing a version of it in the United States in 2005. </i>The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implantation, and <i>the model failed an internal test in 2007</i> in which engineers compared its performance to that of another of the company’s hip implants, the documents show. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>Still, executives in Johnson & Johnson’s DePuy Orthopaedics unit kept selling the A.S.R. even as it was being abandoned by surgeons who worked as consultants to the company. DePuy executives discussed ways of fixing the defect, the records suggest, but they apparently never did so. </i></div></blockquote></div><blockquote><div itemprop="articleBody">Plaintiffs’ lawyers introduced the documents on Friday in Los Angeles Superior Court during opening arguments in the first A.S.R.-related lawsuit to go to trial.</div></blockquote><div itemprop="articleBody"></div><div itemprop="articleBody">In particular, </div><div itemprop="articleBody"></div><div itemprop="articleBody"><blockquote class="tr_bq"><div itemprop="articleBody">In 2007, DePuy engineers tested the A.S.R.’s rate of wear to see if it matched the wear rate of another all-metal hip implant made by the company. It did not. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>'The current results for A.S.R. do not meet the set acceptance criteria for this test,' that report stated.</i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>The same year, company officials began discussing ways to fix the problem, like redesigning the cup</i> to eliminate the groove. But <i>at the same time, it was actively marketing the A.S.R. to surgeons in the United States</i>, who were implanting it into tens of thousands of patients. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">'<i>We will ultimately need a cup redesign, but the short-term action is <b>manage perceptions</b>,'</i> one top DePuy sales official told a colleague in a 2008 e-mail. <i>A DePuy executive, <b>Andrew Ekdahl, who is now the unit’s president</b>, was also told by a company consultant that the A.S.R. was flawed,</i> according to another document. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">In mid-2008, DePuy apparently abandoned the redesign project, an internal document indicates. A company spokeswoman, Mindy Tinsley, declined to comment on the document. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">In the fall of 2009, the Food and Drug Administration rejected DePuy’s application to sell the resurfacing version of the A.S.R. in the United States, saying it was concerned about, among other things, “high concentration of metal ions” in the blood of patients who received it. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">DePuy executives soon started making financial estimates of when the company should stop selling the A.S.R., based on the time it would take to convert surgeons to another company implant, a document shows.</div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the evidence introduced in litigation suggested that top DePuy executives knew the design was faulty, but chose to not disclose the evidence of this, and not to withdraw the product, but rather to "manage perceptions."  </div></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">As is typical of most settlements made by big health care corporations in the last 10 years, no one at DePuy or its Johnson and Johnson parent who might have authorized, directed, or implemented the continued sales of the device despite warnings that it might be unsafe would have to suffer any negative consequences.  In particular, apparently Mr Ekdahl will not suffer any such consequences (and was not obviously named in the few news reports of the settlement.)   Mr Ekdahl, now Worldwide President, DePuy Synthes Joint Reconstruction, was quoted in the official Johnson and Johnson <a href="http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=808497">news release</a> about the settlement.<br /><b><br /></b></div><div itemprop="articleBody"></div><div itemprop="articleBody"><b>The Topamax Verdicts</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">This case, which was much smaller in terms of the monetary amounts involved, got much less coverage, but Bloomberg did <a href="http://www.bloomberg.com/news/2013-11-18/j-j-s-janssen-loses-11-million-jury-verdict-over-topamax.html">report</a> on November 18, 2013,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">Johnson & Johnson's  Janssen Pharmeceuticals unit was <i>ordered by a Philadelphia jury to pay $11 million</i> in a case claiming its anti-seizure drug Topamax caused birth defects,<i> the second such loss in less than a month.</i></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Again, the case involved claims that the company withheld information about the safety of its product,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><i>Janssen failed to adequately warn doctors </i>for Haley Powell, a stay-at-home mother, of the risks of Topamax before she gave birth to a son with a cleft lip,<i> jurors in state court in Philadelphia found today.</i><br /><br />'Janssen has long known that this drug causes debilitating birth defects and yet <i>intentionally kept this information from physicians and patients,</i>' Shelley Hutson, an attorney for Powell, said after the verdict was read.</blockquote><br />Furthermore,<br /><br /><blockquote class="tr_bq"><i> Janssen knew as early as 1997 that animal studies showed an increased risk for birth defects</i>, especially oral clefts, Hutson said during closing arguments on Nov. 15.<br /><br /><br />Hutson accused Janssen of <i>operating in a culture of secrecy and of intentionally concealing safety reports in 2003 and 2005.</i>She rejected arguments by the company that it presented the information on poster boards, in abstracts and at medical conferences. Those actions “do not keep patients safe,” Hutson said.<br /><br />'As early as 1997 in admission after admission, this company knew and they didn’t tell the doctors,' Hutson said.</blockquote><br />A <a href="http://www.law360.com/articles/489739">report</a> in Law360 emphasized,<br /><br /><blockquote class="tr_bq"> Plaintiffs in the Pennsylvania suits <i>alleged the company didn't fully, truthfully or accurately disclose Topamax data to the FDA, to them and to their doctors. As a result, Janssen intentionally and fraudulently misled the medical community, the public and herself </i>about the risks to a fetus associated with the use of Topamax during pregnancy, plaintiffs claimed.</blockquote><br /><b> Summary</b><br /><br />There they go again....  So Johnson and Johnson has announced two multi-billion dollar settlements in one month (November, 2013, look <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">here</a> for the first).  It also announced a smaller settlement involving the marketing of Topamax, which is now in addition to a 2010 guilty plea for misbranding Topamax in 2010 (look <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">here)</a>.  Note that all the November, 2013 legal actions involved allegations, often backed by seemingly convincing evidence produced in litigation (as noted above), of deceptive, unethical practices.  Both cases above included allegations that the company sold products without fully disclosing those products' harms to patients.  Furthermore, all the month's legal actions are now added to a long list of Johnson and Johnson's legal woes, often involving allegations and evidence of other unethical actions, sometimes involving guilty pleas to charges of such actions (see compilation of the record through July, 2013 <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">here</a>.)  (By the way, Synthes, which is now another Johnson and Johnson subsidiary, and is not run by the same individual on whose watch the ASR case occurred, has had its own legal and ethical woes, look <a href="http://hcrenewal.blogspot.com/search/label/Synthes">here</a>.)  <br /><br />Yet despite this lengthy and sorry record, no individual manager or executive at Johnson and Johnson, including its many and confusing subsidiaries, seems to have suffered any negative consequences for authorizing, directing, or implementing any unethical activities, whether they risked harming patients, or whether they resulted in a guilty plea by a corporate entity.  Instead, as we have discussed most recently <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">here</a>, the top executives of the company have grown very rich.  <br /><br />So since the US government seems to continue to recycle its policy of allowing corporate managers and executives impunity regardless of how repetitively harmful their actions might be to patients' and the public's health, I will recycle my comments from earlier in November, 2013,....<br /><br />The latest settlement in the parade is another marker of the sort of conduct that big health care organizations have exhibited to increase revenue, and to use that revenue as a rationale for making their top insiders very rich.  The particular conduct alleged here could have put patients at risk, partly by deceiving health care professionals.  Yet in their wisdom, top US law enforcement saw fit not to try to hold any individuals accountable for this conduct, and allowed the company to deny any misconduct other than a single misdemeanor by a subsidiary.  This occurred despite the company's history of multiple legal settlements and findings of guilt in various courtrooms.<br /><br />Yet none of these actions has resulted in any negative consequences for any individual within the company.  No one who authorized, directed, or implemented bad behavior will pay any penalty, even were the bad behavior to have lead to significant personal enrichment.<br /><br />As we have said ad infinitum, and <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">on the occasion of a previous Johnson and Johnson settlement</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. <br /><br />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.<br /><br />As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.<br /><br />Roy M. Poses MD on Health Care Renewal  <br /><br />

There They Go Again, Again... - Johnson and Johnson Loses Two Civil Cases, Makes $2.5 Billion Settlement Based on Claims it Withheld Safety Data on its Products

There has been some talk by US government officials that any day now they will actually get tough on corporate executives whose organization...

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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>,<br /><blockquote>Johnson & Johnson was ordered to <em>pay <strong>$1.1 billion</strong></em> by a state judge after <em>an Arkansas jury found the company’s officials misled doctors and patients about the risks of the antipsychotic drug Risperdal.</em><br /><br />Jurors in Little Rock yesterday said <em>the company’s marketing campaign also violated consumer-protection laws.</em> The panel deliberated about three hours before finding J&J and its Janssen unit <em>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</em>. </blockquote><br />The prosecutors had alleged a variety of kinds of deceptions about Risperdal, <br /><blockquote>Along with contending that J&J and Janssen <em>defrauded the Medicaid program by failing to properly outline the antipsychotic medicine’s risks</em>, Arkansas officials alleged J&J officials <em>deceptively marketed the drug as safer and better than competing medicines</em>.<br /><br />The state also argued the <em>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. </em></blockquote><br />In summary,<br /><blockquote>Arkansas Attorney General Dustin McDaniel said in an e- mailed statement that he sued because residents in the state deserved to be <em>protected from 'fraud and deceptive practices.'</em><br /><br />He said that jurors found <em><strong>'Johnson &</strong></em> <em><strong>Johnson and Janssen Pharmaceuticals lied to patients and doctors because they cared more about profits than people.' </strong></em></blockquote><br />Bloomberg noted that<br /><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><br />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<br />- Convictions in two different states in 2010 for misleading marketing of Risperdal, as noted above<br />- A guilty plea for misbranding Topamax in 2010<br />- Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary<br />- 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)<br />- 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>)<br />- 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>)<br />- 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>).<br />- 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>.)<br /><br />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>.)<br /><br />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).<br /><br />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.<br /><br />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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