healthy4u: suppression of medical research

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

<b>Introduction - New Leadership for the US Department of Veterans Affairs </b><br /><br />After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US Department of Veterans Affairs, the country's large government run health system, has had a massive leadership overhaul.  President Obama's nominee to head the agency is now Robert A McDonald, former CEO of Procter and Gamble.<br /><br />The choice of a former CEO or a large corporation was called "unorthodox" <a href="http://www.bostonglobe.com/news/nation/2014/06/29/bob-mcdonald-former-chief-obama-nominee-lead-veterans-affairs/zVA9EH7PlMNWaTU7Yyp8NP/story.html">by the Boston Globe</a>, but many saw merit in a business leader running the VA.  As reported by the Globe, House Speaker John Boehner said that as a "private sector" leader,  Mr McDonald is the "kind of person who is capable of implementing the kind of dramatic  systemic change that is badly needed and long overdue at the VA."  The Chairman of Boeing, also a member of the P&G board, hailed Mr McDonald as the person who "navigated Procter & Gamble through the difficult  post-financial-crisis years, where he expanded business in developing  markets and made substantial progress improving the efficiency of the  company’s internal operations...."<br /><br />On the other hand, a <a href="http://www.washingtonpost.com/politics/federal_government/obamas-choice-for-va-will-find-fixing-it-is-harder-than-selling-soap/2014/07/01/84cf28d6-0139-11e4-b8ff-89afd3fad6bd_story.html">column in the Washington Post</a> suggested that expertise in "selling Tide and Pantene" might not be relevant to fixing the VA. Yet aside from a <a href="http://ringoffireradio.com/2014/07/obama-nominates-former-corporate-exec-as-veteran-affairs-secretary-2/">single article</a> on the Ring of Fire web site, all news coverage and discussion so far has ignored Mr McDonald previous experience in health care leadership, but also that his relevant track record ought to raise questions about his fitness for the VA position.<br /><br /><b>Procter and Gamble and Health Care</b><br /><br />According to Mr McDonald's <a href="http://www.pg.com/en_US/downloads/company/executive_team/bios/pg_executive_bio_bob_mcdonald.pdf">official P&G biograpy</a>, after various roles in various countries, before becoming CEO,  <br /><br /><blockquote class="tr_bq">Bob returned to the U.S. as the <i>Vice Chairman of Global Operations</i> (2004 to 2007) and later P&G’s <i>Chief Operating Officer</i> (2007 to 2009).</blockquote><br /><br />Although not widely known as a pharmaceutical company, P&G actually had a subsidiary that made prescription drugs, which Mr McDonald sold off in 2009 (see this <a href="http://online.wsj.com/news/articles/SB125111032092353427">Wall Street Journal report</a>.)  As we noted <a href="http://hcrenewal.blogspot.com/2014/05/abort-retry-fail-lancet-avoided-much.html">here</a>, its products still include over the counter pharmaceuticals (e.g., Pepto-Bismal,  Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not  make it very obvious, it has owned MDVIP, a company that employs  physicians to provide concierge medical services, since 2010, although  as Cincinnati.com just <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, it will soon sell this unit to private equity.  So during Mr McDonald's tenure, his company was to some extent a pharmaceutical company, and a health care provider.<br /><br /><b>The Blumsohn - Procter and Gamble - Sheffield University Case</b><br /><br />Furthermore, on Mr McDonald's watch as Vice Chairman of Global operations and Chief Operating Officer, there was a case involving Procter and Gamble that raised multiple concerns about the ethics of its pharmaceuticals operations.  We first posted about the case in 2005 (<a href="http://hcrenewal.blogspot.com/2005/12/another-challenge-to-integrity-of.html">here</a>).  For all relevant posts, look <a href="http://hcrenewal.blogspot.com/search/label/Actonel">here</a>. In 2009 we <a href="http://hcrenewal.blogspot.com/2009/12/british-medical-journal-interviews-dr.html">described the case</a> thus,<br /><br /><blockquote class="tr_bq">The case involved <i>suppression and manipulation of research</i>,  <i>ghost-writing</i>, <i>institutional conflicts of interest, and attempts to  silence a whistle blower. </i>It provides lessons about the downsides of  letting commercial firms sponsor and hence control human research  designed to evaluate the products or services they sell; and of academic  medicine becoming dependent on research money from such firms for such  research.</blockquote><br />We previously <a href="http://hcrenewal.blogspot.com/2009/09/reappearance-of-ghost-of-seasons-past.html">summarized</a> the case's events<br /><br /><blockquote><ul><li>Dr Aubrey Blumsohn, a senior lecturer at Sheffield  University, and Professor Richard Eastell performed a research project  on the effects of the drug risedronate (<a href="http://www.actonel.com/index.jsp">Actonel</a>, made by Procter & Gamble Pharmaceuticals [P&G]) under a <a href="http://www.fraudinscience.org/PG/contract.pdf">contract</a> between P&G and the University.</li><li>Although  the research contract designated Blumsohn and Eastell as  "Investigators" under whose direction the project would be carried out,  Blumsohn was not given access to the original data collected by the  project.</li><li>Despite numerous requests, (like <a href="http://www.fraudinscience.org/PG/20050525mckay.pdf">this one</a>), P&G <a href="http://www.fraudinscience.org/PG/20030619email.htm">refused access </a>to this data <a href="http://www.fraudinscience.org/PG/attorneyreq.pdf">repeatedly</a>.<br />Blumsohn  was concerned that he and Eastell could be accused of scientific fraud  if they continued to make presentations and write articles and abstracts  without access to the data which they were supposedly writing about.</li><li>Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially <a href="http://www.fraudinscience.org/PG/20030909audio.htm">related to a graph shown to him that omitted 40% of patient data</a>.</li><li>Blumsohn objected to <a href="http://www.fraudinscience.org/PG/20030424email.htm">P&G arranging for papers and abstracts to be written by a professional writer</a>,  but with Blumsohn listed as first author. Blumsohn was concerned that  such ghost-written documents were mainly meant to convey "key messages"  in support of P&G's commercial interests.</li><li><a href="http://www.fraudinscience.org/PG/20030910audio.htm">Eastell warned Blumsohn </a>not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."</li><li>After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including <a href="http://www.fraudinscience.org/PG/20040526eastell.pdf">Eastell</a>, medical school Dean <a href="http://www.fraudinscience.org/PG/20050708weetman.pdf">Tony Weetman</a>, University Vice-Chancellor <a href="http://www.fraudinscience.org/PG/20050814bouche.pdf">Robert Boucher</a>, and the Head of the University's Department of Human Resources, <a href="http://www.fraudinscience.org/PG/20050627boucha.pdf">Ms R Valerio</a>.</li><li>Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then <a href="http://www.fraudinscience.org/PG/gag.doc">offered him a severance agreement </a>if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.</li></ul></blockquote><blockquote>So  the case involved suppression and manipulation of research,  ghost-writing, institutional conflicts of interest, and attempts to  silence a whistle blower. It provides lessons about the downsides of  letting commercial firms sponsor and hence control human research  designed to evaluate the products or services they sell; and of academic  medicine becoming dependent on research money from such firms for such  research.</blockquote><br />Although this case occurred in the UK, it involved actions by the US based Procter and Gamble.  While many of the events in the case occurred before 2004, from 2004 to 2009 it became clear that Procter and Gamble was not going to go easy on Dr Blumsohn.  For example, <a href="http://scientific-misconduct.blogspot.com/2007/03/advice-to-p-pharmaceuticals-how-not-to.html">according to Dr Blumsohn</a>, in 2006, P&G released some scientific data relevant to the case, but not complete enough data to be meaningful.  In 2007, there was still shady business going on involving scientific abstract submissions apparently made in Dr Blumsohn's name by P&G operatives.<br /><br />Since Procter and Gamble never made any known attempt to apologize, explain its conduct, or ameliorate Dr Blumsohn's plight during 2004 - 2009, as one of the most senior leaders of Procter and Gamble, seemingly with direct authority over its pharmaceutical operations in the UK during that time period, Mr McDonald ought to be held accountable for the company's misbehavior described above.  To my knowledge, though, no one at P&G, including Mr McDonald, has ever admitted responsibility or been made accountable in any way.   <br /><br /><b>Summary</b><br /><br />Since Mr McDonald recently was an executive of a company that sold prescription and non-prescription pharmaceuticals, and provided direct health care, confirmation as Veterans Affairs secretary could be regarded as a transit through the revolving door, and hence open to question.  Since Mr McDonald got <b><i>$15,928,015</i></b> in total compensation during his last year as CEO (2012-13) (see the company's 2013 proxy statement), and had accumulated 2,247,593 shares of stock or equivalent by 2013, worth approximately <b><i>$179 million</i></b> at today's price of $79.67, his ability to understand the needs of the often poor veterans whom the VA serves is also open to question.  <br /><br />More importantly, while Mr McDonald held high executive positions at Procter and Gamble, the company was involved in a dodgy affair involving conflicts of interest, manipulation of research, and attempted silencing of whistle blowers.  In my humble opinion, given that these events occurred directly on his watch, his fitness to run a huge health care system ought to be in question unless his responsibility for these events is disproved.<br /><br />The widespread huzzahs for Mr McDonald as potential VA leader based mainly on his exalted status as CEO of a big corporation show that many in the US still see corporate CEOs as aristocracy.  True health care reform would hold health care leaders accountable, particularly for upholding the health care mission and putting patients' and the public's health ahead of revenue generation and especially personal profit.<br /><br />ADDENDUM (7 July, 2014) - Link to McDonald's official P&G biography fixed. <br /><br />ADDENDUM (8 July, 2014) - This post has been re-posted <a href="http://www.nakedcapitalism.com/2014/07/obama-va-robert-macdonald-procter-gamble-scandal.html">on Naked Capitalism</a>, and <a href="http://www.openhealthnews.com/story/2014-07-07/robert-mcdonald-fit-be-va-secretary">on Open Health News</a>.

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

Introduction - New Leadership for the US Department of Veterans Affairs After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US…

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02 Jul 2014

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

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26 Dec 2013

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

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29 Nov 2013

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">righteously angry post</a> in support of transparent clinical research.  As we have noted frequently, clinical trials done on human subjects are often <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> to increase the likelihood of results favorable to commercial sponsors, or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a> when even such manipulation does not produce the desired results.<br /><br />Note that such suppression and manipulation degrade the scientific value of the studies, impede the <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> process to rationally apply clinical research evidence to improve the health of patients and the public, and violate the trust of research subjects who volunteer to participate based on the assumption that clinical research is meant to improve patient care and public health, and contribute to science, not just secure commercial advantage.   <br /><br />A European initiative to combat suppression of clinical research has been opposed by a lawsuit from US pharmaceutical manufacturers AbbeVie, spun off from Abbott Laboratories, and Intermune.  The European Medicines Agency had been willing to to make public unpublished patient level data from commercially sponsored clinical trials.  The lawsuit has shut down the process, and is meant to shut it down permanently, claiming that the clinical data, obtained from volunteer research subjects, includes "trade secrets."<br /><br />As <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">summarized </a>by Mickey, their motivation seems to be to conceal how pharmaceutical manufacturers and other commercial sponsors of human research use this research for promotional, rather than scientific purposes.<br /><br />An AbbeVie lawyer asserted that some adverse effects data should be kept confidential, and that "<span style="color: #200020;">internal tactical decisions on how we are  going to run a study, engage with regulators, and confront and solve  problems and challenges we have uncovered during clinical trials</span><b><span style="color: #200020;">" </span></b>should also be kept secret because revealing them could "give other companies a tremendous competitive advantage," <i>never mind whether keeping secrets could undermine science, decrease the study's usefulness to aid clinical and policy decision making, and break the implicit contract between researchers and study subjects.</i><br /><br />It is becoming more obvious that many drug company executives, and other leaders of large health organizations, may care more about "competitive advantage" than patients, science or the public good, as Mickey points out.  So much for that advertising puffery  about drug development to improve patient health.  Thus it may be ridiculous to think that these executives they will negotiate to improve transparency of clinical research in good faith when doing so could decrease such advantage, again no matter what the effect on patients, public health, or science.<br /><br />On this case there is an opportunity to speak out, Dr David Healy has a <a href="http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data?utm_source=guides&utm_medium=email&utm_campaign=petition_lonely">petition up on Change.org</a> to oppose the AbbeVie and Intermune lawsuit which might get some notice if there are enough signatures.

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a righteously angry post in support of transparent clinical research. As we have noted frequently, clinical trials done on human subjects ar…

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12 Sep 2013

Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity

I had guessed that this sort of thing was going on all the time, but being kept very well hidden.  Now we have some more evidence.<br /><br />An<a href="http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trials"> article</a> in yesterdays Guardian showed how the pharmaceutical industry is using pet patient advocacy groups in a public relations campaign to defeat calls for for measures against <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of clinical research. In summary,<br /><br /><blockquote class="tr_bq"><i>The pharmaceutical industry has 'mobilised' an army of patient groups to  lobby against plans to force companies to publish secret documents on drugs<a href="http://www.guardian.co.uk/science/drugs" title="More from guardian.co.uk on Drugs"></a> trials.</i></blockquote><br />More specifically,<br /><br /><br /><blockquote class="tr_bq"><i>The strategy was drawn up by two large trade groups, the  <a href="http://hcrenewal.blogspot.com/search/label/PhRMA">Pharmaceutical Research and Manufacturers of America (PhRMA)</a> and the  European Federation of Pharmaceutical Industries and Associations  (EFPIA)</i>, and outlined in a memo to senior industry figures this month,  according to an email seen by the Guardian.  The memo, from Richard  Bergström, director general of EFPIA, went to directors and legal  counsel at <a href="http://hcrenewal.blogspot.com/search/label/Roche">Roche</a>, <a href="http://hcrenewal.blogspot.com/search/label/Merck">Merck</a>, <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">Pfizer</a>, <a href="http://hcrenewal.blogspot.com/search/label/GlaxoSmithKline">GSK</a>, <a href="http://hcrenewal.blogspot.com/search/label/AstraZeneca">AstraZeneca</a>, <a href="http://hcrenewal.blogspot.com/search/label/Eli%20Lilly">Eli Lilly</a>, <a href="http://hcrenewal.blogspot.com/search/label/Novartis">Novartis</a>  and many smaller companies. It was leaked by a drugs company employee.<br /><br />The  email describes a four-pronged campaign that starts with<i> 'mobilising  patient groups to express concern about the risk to public health by  non-scientific re-use of data'.</i> Translated, that means<i> patient groups go  into bat for the industry by raising fears that if full results from  drug trials are published, the information might be misinterpreted and  cause a health scare.</i><br /><br />The lobbying is targeted at Europe where the  European Medicines Agency (EMA) wants to publish all of the clinical  study reports that companies have filed, and where negotiations around  the clinical trials directive could force drug companies to publish all  clinical trial results in a public database.</blockquote><br />The argument for continuing to allow clinical trials to be suppressed was to be,<br /><br /><blockquote class="tr_bq">The patient groups focus on the concern that if companies release all of  their clinical trials data, the information might be misconstrued, or  intentionally cherry-picked, and spark damaging health scares around  certain drugs or vaccines.</blockquote><br />The Guardian story did not disclose which patient groups were cooperating with this effort. <br /><br />By the way, the other parts of this strategy involved using scientific associations and academics to push the pharmaceutical companies' agenda,<br /><br /><blockquote class="tr_bq"> Two other strands of the campaign include discussions with scientific  associations about the risks of data sharing, and work with other  businesses that are concerned about the release of trade secrets and  confidential data. The final strand calls, in the long term, for a  network of academics across Europe that can be called on to correct  false interpretations of the data. </blockquote>Several of the large multinational drug companies contacted by the Guardian issued the usual non-denial denials<br /><br /><blockquote class="tr_bq">In response to  queries from the Guardian, GSK said: 'This is not something we are  doing. One of the reasons we're involved in this is we want more  companies to move towards greater transparency. I don't think it's for  us to be mobilising patient groups to campaign on a negative level.'<br /><br />A  Roche spokesperson said the company consulted patient groups to  understand their concerns about clinical trials, but 'to our knowledge  Roche has not been involved in any EFPIA's potential activity in  mobilising patient groups to express concern about the risk to public  health by non-scientific re-use of data'.<br /><br />A Lilly spokesman said: 'Lilly is committed to working with Europe-based patient advocacy  organisations for the benefit of patients in a way that is true to the  EFPIA code of practice and Lilly's integrity in business policy.'</blockquote><br /><br /><b>Summary</b><br /><br />We have long discussed and decried how vested interests, chiefly health care corporations with services and products to sell, have<a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research"> manipulated clinical research</a> to make their wares look better, and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed research </a>whose results, even if manipulated, could not be made sufficiently favorable. This has resulted in making drugs and devices look more efficacious and/or less hazardous than they really are.  See <a href="http://hcrenewal.blogspot.com/2013/06/a-call-to-restore-integrity-of-clinical.html">this post</a> for our latest discussion, and information on the latest effort to counter suppression and manipulation of clinical research.<br /><br />It is not surprising that pharmaceutical companies do not want to have to publish every clinical trial they sponsor, or expose their manipulations of these trials.  Instead, the Guardian article suggests that companies and their trade associations, including the US based pharmaceutical trade association, and several large US companies, and well as large companies based elsewhere, are using a third-party public relations strategy.  Wendell Potter's muckraking book on the US commercial health care insurance industry, <i>Deadly Spin</i>, revealed how similar strategies were used by US based health insurance companies to defeat the Clinton administration's attempt at health care reform, and other measures targeted to make the US commercial health care insurance system more equitable and ethical  (see post <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">here</a>).  Third party strategies are fundamentally deceptive.    <br /><br />The current alleged use of the third party strategies by pharmaceutical companies to support ongoing suppression and manipulation of clinical research is more than just deceptive.  It is corrupt.<br /><br />Patient advocacy groups are usually believed to represent patients' interests.  For such groups to support a public relations campaign that could allow ongoing harm of patients (by suppressing and manipulating evidence to prevent it from being used to forestall excess use of ineffective, dangerous drugs) is abuse of their entrusted power.  To do it for money, money used to support these groups, or help underwrite generous compensation for their executives, fits the definition of corruption used by Transparency International - abuse of entrusted power for private gain.<br /><br />Note that the Guardian provided this viewpoint,<br /><br /><blockquote class="tr_bq">Tim Reed, of Health Action International, a group that has previously  exposed the pharmaceutical industry's financial links with patient  groups, said: 'It's incredibly ironic that this is a transparency  initiative and we've now got clear indications that the pharmaceutical  industry is ready to use patient organisations to fight their corner.<br /><br />'It  underlines the fact that<i> patient groups who are in the pay of the  pharmaceutical industry will go into battle for them.</i> There's a hidden  agenda here. The patient groups will say they think it's a great idea to  keep clinical trials data secret. Why would they do that? They would do  that because<i> they are fronts for the pharmaceutical industry.</i><br /><br />'Patient  groups get traction because they are assumed to represent the voice of  the suffering. But industry uses them to say we're not going to get  innovative medicines if the industry is deterred from investing by  having to be transparent about their clinical trials,' he added.</blockquote><br />We have previously noted isolated examples of evidence that particular US based <a href="http://hcrenewal.blogspot.com/search/label/patient%20advocacy%20groups">patient advocacy groups</a> were being supported by commercial firms presumably to aid their marketing.  We have also found examples of conflicts of interest affecting<a href="http://hcrenewal.blogspot.com/search/label/medical%20societies"> medical societies</a>, and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">many affecting</a> non-profit hospitals and academic medical institutions, and<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest"> their staff and faculty</a>.  I begin to wonder if most health care non-profit organizations in the US, and now it appears maybe in UK and in Europe, have been paid off to support marketing and/or public relations interests of health care corporations.<br /><br />This latest example suggests that health care worldwide has become deeply corrupt, even more corrupt than <a href="http://hcrenewal.blogspot.com/search/label/Transparency%20International">Transparency International</a>'s <a href="http://www.transparency.org/whatwedo/pub/global_corruption_report_2006_corruption_and_health">Global Report on health care corruption in 2006</a>, or the those responding to Transparency International's <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">global corruption survey in 2013</a>, could envision.<br /><br />I only hope that the pile up of new examples - each seemingly worse than the one before - of health care corruption, will be sufficient to overcome the anechoic effect, and create enough global outrage to give us a chance to clean up our corrupt health care before it destroys our health.<br /><br />ADDENDUM (25 July, 2013) - See also <a href="http://brodyhooked.blogspot.com/2013/07/the-astroturf-speaks-out-more-industry.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. <br /><br />ADDENDUM (29 July, 2013 - See the <a href="http://1boringoldman.com/index.php/2013/07/28/a-closing-argument/">comment</a> on the 1BoringOldMan blog.

Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity

I had guessed that this sort of thing was going on all the time, but being kept very well hidden. Now we have some more evidence.An article in yesterdays Guardian showed how the pharmaceutical indust…

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22 Jul 2013

A Call to Restore the Integrity of Clinical Research - but Will Anyone Heed it?

Concerns about <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of clinical research to serve vested interests have finally gotten a little more mainstream.<br /><br /><b>Background: Suppression and Manipulation of Clinical Research </b><br /><br />For a long time, we have decried and discussed examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a> done to increase the likelihood that its results would please vested interests, often drug, device or other corporations that sponsored the research and often exerted considerable control over its design, implementation, analysis, and dissemination.  We have also decried and discussed examples of <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of research</a> whose results offended such vested interest, sometimes done when manipulation did not succeed in producing such pleasing results. <br /><br /><br />I wrote about suppression of research in my 2003 paper on health care dysfunction,(1) <br /><br /><blockquote class="tr_bq">The integrity of medical research has been violated by the deliberate suppression of its results.</blockquote><br />That assertion was based on several important, although understandably largely anechoic cases. <br /><br />I first wrote about systematic attempts to manipulate clinical research <a href="http://hcrenewal.blogspot.com/2005/05/medical-journal-are-extension-of.html">in 2005</a>, based on Richard Smith's PLoS Medicine commentary which listed specific tactics that vested interests could use to make it more likely that research studies would provide them with favorable results.<br /><br />Although striking cases of manipulation and suppression appeared more frequently starting in the 1990s, in the last few years it has become more apparent that these are widespread problems. <br /><br /><b>A Call to Restore Integrity </b><br /><br />This week, the British Medical Journal published a special article  calling for restoration of suppressed or manipulated clinical trials(2),  accompanied by an editorial entitled, "restoring the integrity of the  clinical trial evidence base."(3)<br /><br />The article used slightly different terminology than we do, replacing suppression with invisibility, and manipulation with distortion, thus,<br /><br /><blockquote class="tr_bq">Two basic problems of representation are driving growing concerns about relying on published research to reflect the truth. <a class="xref-bibr" href="http://www.bmj.com/content/346/bmj.f2865#ref-15" id="xref-ref-15-1"></a> The first is<i> no representation (invisibility), which occurs when a  trial remains unpublished years after completion</i>. The second is  <i>distorted representation (distortion), which occurs when publications in  medical journals present a biased or misleading description of the  design, conduct, or results of a trial.</i></blockquote><br />The article boldly asserted<br /><br /><blockquote class="tr_bq"><i>Both go against the fundamental scientific and ethical responsibility  that all research on humans be used to advance knowledge</i> and are  symptomatic of a general culture of data secrecy. The end result is that  the <i>healthcare, biomedical research, and policy communities may,  despite best intentions and best practices, end up drawing  scientifically invalid conclusions</i> based on only those parts of the  evidence base they can see.</blockquote><br />The editorial went further, asserting that<br /><br /><blockquote class="tr_bq">This crisis of hidden or misreported information from clinical  trials—and the resulting distortion of the clinical evidence base—is  widely recognized and commonly decried.<a class="xref-bibr" href="http://www.bmj.com/content/346/bmj.f3601#ref-8" id="xref-ref-8-1"></a> It is <b><i>one of the leading scientific problems of our time,</i></b> but few solutions have been put forward.</blockquote><br />Furthermore, it concluded with a warning about the immorality of continuing on the current course,<br /><br /><blockquote class="tr_bq">T<i>he results of clinical trials are a public, not a private, good.</i> The  public interest requires that we have a complete view of previously  conducted trials and a mechanism to correct the record for inaccurately  or unreported trials.<i> If we do not act on this opportunity to refurbish  and restore abandoned trials, the medical research community will be <b>failing its moral pact </b>with research participants, patients, and the  public. </i>It is time to move from whether to how, and from words to  action.</blockquote><br />Thus the notion that suppression and manipulation of clinical research is a systemic, severe problem that confounds health professionals and hurts patients is no longer a concern of only a few fringe dissidents, but a matter for discussion in the foremost mainstream medical journals.<br /><br /><b>Will Anyone Heed the Call?</b><br /><br />Furthermore, this dire problem formulation suggests the need for a  strong solution, as proposed by the article, and seconded by the  editorial.  Using the term "abandoned trials" for "  unpublished trials  for which sponsors are no longer actively working to  publish or published trials that are documented as misreported but for  which authors do not correct the record using established means such as a  correction or retraction (which is an abandonment of responsibility),"  Doshi and colleagues wrote,<br /><br /><blockquote class="tr_bq">We call on institutions that funded and investigators who conducted  abandoned trials to publish (in the case of unpublished trials) or  formally correct or republish (in the case of misreported trials) their  studies within the next year.</blockquote><br /><a href="http://hcrenewal.blogspot.com/2005/12/power-speaking-to-truth.html">Starting in 2005</a>, we have repeatedly called for protection of " researchers' rights to speak truth to power," but then noted that "right now, it is more often power that speaks to truth."  The question is whether without some bigger allies, individual clinical researchers will stand up on their own to restore the integrity of clinical research.<br /><br />The big reason to worry is that most of these researchers work within a context which strongly favors vested interests, rather than scientific truth, or the rights of research subjects.  The researchers who would be most likely to be able to heed the call by Doshi et al are those within academic medicine. Yet clinical research in the academic medical world now functions within a strong and deep web of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual</a> and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional </a>conflicts of interests, subjects that we also have written about incessantly.<br /><br />There is evidence suggesting that the majority of medical faculty,(4) and the majority of their academic departmental leaders(5) have important financial ties to the health care corporations most likely to have reason to want to suppress or manipulate research.  Furthermore, most academic medical institutions have stated their interest in increasing "collaboration" with industry, usually giving the rationale that this will lead to "innovations" that will bring better tests or treatment to patients. (See posts <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a>,  <a href="http://hcrenewal.blogspot.com/2012/03/logical-fallacies-in-defense-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/11/if-medical-school-is-just-part-of.html">here</a> for some examples.)  Such collaboration also tends to bring a lot of money to institutional budgets.  Further collaboration with industry is likely favored by academic leaders' own financial ties to the same sorts of corporations discussed above.  Thus it should be no surprise that a study by Mello et al in 2005 suggested that most of the managers of academic medical institutions who control research contracts are willing to give significant control of of research design, implementation, analysis, and dissemination to the sponsors, not the researchers.  (See <a href="http://hcrenewal.blogspot.com/2005/05/troubling-study-of-contracts-between.html">this post.</a>) (6)<br /><br /><br />Thus, a researcher who volunteers to restore suppressed or manipulated  clinical studies might become suddenly very unpopular with his or her colleagues or  supervisors, and perhaps with people who are already paying him or  her.<br /><br />So as long as health care professionals, policy makers, and the public at large are willing to go along with the notion that academic medical institutions' "collaboration" with "industry" is absolutely necessary to foster "innovation" and hence medical progress, it is very unlikely that academic medical researchers will be willing to help restore the integrity of clinical research.  In fact, while we continue on our present course, the integrity of clinical research will probably get even worse.<br />  <br />Since questioning the integrity of contemporary clinical research  might make those with vested interests who have been willing to suppress  or manipulate research very uncomfortable, perhaps it should be no  surprise that the paired articles  in the British Medical Journal have been relatively <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  For example, while one might think the publication of these simultaneous articles might get at least a little coverage in the "main-stream media," I can find not a single mention of them there.  (So far, only the <a href="http://chronicle.com/article/Journals-Agree-to-Publish/139821/">Chronicle of Higher Education</a>, <a href="http://www.medscape.com/viewarticle/806280">MedScape</a> the <a href="http://news.sciencemag.org/scienceinsider/2013/06/unmasking-invisible-drug-trials.html">Science Insider blog</a> and <a href="http://www.the-scientist.com/?articles.view/articleNo/36059/title/Restoring-Hidden-Clinical-Data/">The Scientist blog </a>have provided news coverage.) <br /><br /><br />So I hope the brave people who wrote the article and editorial are also willing to join us in decrying the web of individual and institutional conflicts of interest that have entangled health care professionals and academic medicine.  Individuals and institutions who make medical or health care decisions, or who are involved in medical and health care education and research should reveal all their conflicts of interest, at least in the interests of honesty.  Furthermore, in the interest of patients' and the public's health, clinical research meant to assess medical tests, treatments, and programs should be done completely independently from the corporations that sell them.   <br /><br /><br /><span style="font-size: x-small;"><b>References</b></span><br /><br /><span style="font-size: x-small;">1.  Poses RM.  A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/12719032">here</a>..</span><br /><span style="font-size: x-small;">2.  Doshi P, Dickersin K, Healy D et al.  Restoring invisible and abandoned trials: a call for people to publish the findings.  Br Med J 2003;  <cite><span id="article-slug-jnl-abbr">      <abbr class="slug-jnl-abbrev" title="BMJ">      BMJ       </abbr>    </span>    <span class="slug-pub-date-pop">2013;</span>    <span class="pop-slug-vol">346</span>    <span class="slug-doi" title="10.1136/bmj.f2865">doi: http://dx.doi.org/10.1136/bmj.f2865  Link <a href="http://www.bmj.com/content/346/bmj.f2865">here</a>.</span></cite></span><br /><span style="font-size: x-small;">3.  Loder E, Godlee F, Barbour V et al.  Restoring the integrity of the clinical trial evidence base.  Br Med J 2003;  <cite><span id="article-slug-jnl-abbr">      <abbr class="slug-jnl-abbrev" title="BMJ">      BMJ       </abbr>    </span>    <span class="slug-pub-date-pop">2013;</span>    <span class="pop-slug-vol">346</span>    <span class="slug-doi" title="10.1136/bmj.f3601">doi: http://dx.doi.org/10.1136/bmj.f3601  Link <a href="http://www.bmj.com/content/346/bmj.f3601">here</a>.</span></cite></span><br /><span style="font-size: x-small;">4. Campbell EG, Gruen RL, Mountford J et al.  A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa064508">here</a>.</span><br /><span style="font-size: x-small;">5. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=209192">here</a>.</span><br /><span style="font-size: x-small;">6.  Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards  for clinical-trial agreements with industry. N Engl J Med 2005; <span class="citation"> 352:2202-2210</span>. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa044115">here</a>.</span>

A Call to Restore the Integrity of Clinical Research - but Will Anyone Heed it?

Concerns about suppression and manipulation of clinical research to serve vested interests have finally gotten a little more mainstream.Background: Suppression and Manipulation of Clinical Research Fo…

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19 Jun 2013

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream.<br /><br /><b>The Goldacre Version in the New York Times in 2013 </b><br /><br />In his <a href="http://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html">op-ed</a>, Ben Goldacre introduced it thus:<br /><br /><blockquote class="tr_bq">the entire evidence base for medicine has been undermined by a <i>casual  lack of transparency</i>. Sometimes this is through a failure to report  concerns raised by doctors and internal analyses, as was the case with  Johnson & Johnson. More commonly, it involves the <i>suppression of  clinical trial results, especially when they show a drug is no good.</i></blockquote><br />He noted that this problems was supposed to be fixed by the registration of clinical trials, and by changes in editorial policies at medical journals:<br /><br /><blockquote class="tr_bq">many in the industry now claim it has been  fixed. But every intervention has been full of loopholes, none has been  competently implemented and, lastly, with no routine public audit, flaws  have taken years to emerge.        <br /><div itemprop="articleBody"><br /></div><div itemprop="articleBody"> The Food and Drug Administration Amendments Act of 2007 is the most widely cited fix. It required that new clinical trials  conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.  But in 2012, the <a href="http://www.bmj.com/content/344/bmj.d7373">British Medical Journal</a> published the <a href="http://www.bmj.com/content/344/bmj.d7373">first open audit of the process</a>,  which found that <i>four out of five trials covered by the legislation had  ignored the reporting requirements. Amazingly, no fine has yet been  levied. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">An earlier fake fix dates from 2005, when the International Committee of Medical Journal Editors <a href="http://www.icmje.org/clin_trial.pdf">made an announcement</a>:  their members would never again publish any clinical trial unless its  existence had been declared on a publicly accessible registry before the  trial began. The reasoning was simple: if everyone registered their  trials at the beginning, we could easily spot which results were  withheld; and since everyone wants to publish in prominent academic  journals, these editors had the perfect carrot. Once again, everyone  assumed the problem had been fixed. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">But four years later we discovered, in <a href="http://jama.jamanetwork.com/article.aspx?articleid=184503">a paper from The Journal of the American Medical Association</a>,  that the <i>editors had broken their promise: more than half of all trials  published in leading journals still weren’t properly registered, and a  quarter weren’t registered at all. </i></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Goldacre's conclusions were:</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">Withholding data not only <i>misleads doctors and  patients; it’s an insult to the patients who have participated in  clinical trials, believing that they were helping to improve medical  knowledge.</i> </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Medicine routinely overcomes enormous technical challenges, and there is  nothing complicated about the changes needed to prevent Johnson &  Johnson, or Roche — or anybody — from withholding information.</div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Hear, hear! </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>Our Version, Starting in 2003 </b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Note that 10 years ago, in 2003, in my article on American health care dysfunction that could have been only published in Europe, (Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Intern Med 2003 Mar;14(2):123-130.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/12719032">here</a>)  I noted that an important cause of this dysfunction is that:</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">the scientific basis of medicine is increasingly under attack.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>The integrity of medical research has been violated by the deliberate suppression of its results.</i></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">At that time, I suggested one solution would be:</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">Medical schools and universities must re-affirm their support of scholarly work in the spirit of free enquiry,...</div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Furthermore, in <a href="http://hcrenewal.blogspot.com/2004/12/another-facet-of-ssri-suppression-of.html">one of our first posts</a> on Health Care Renewal in December, 2004, in the context of the discovery of internal company documents (in this case, from Eli Lilly) that showed that information about the adverse effects of a drug (in this case, increased aggression associated with fluoxetine, that is, Prozac), we wrote,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq">The increasingly complex story of suppression of SSRI research seems to  be part of <i>a growing epidemic of suppression of medical research. </i></blockquote><blockquote class="tr_bq">Let's say it again. Withholding data from clinical research is unethical because:<br />1. <i> it breaks the promise to research subjects that their voluntary  participation has scientific or social value, but undisseminated  research has no value;</i> (See <a href="http://jama.ama-assn.org/cgi/reprint/283/20/2701.pdf">Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.</a>)<br />2. it <i>impedes scientific progress;</i><br />3. it <i>prevents patients from receiving the best possible medical care.</i> </blockquote><blockquote class="tr_bq"><div itemprop="articleBody">But  <b><i>until this unethical behavior starts having negative consequences for  its perpetrators, the epidemic of research suppression is likely to  continue. </i></b></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Note the similarity to what Goldacre published in the Times yesterday.  <a href="http://hcrenewal.blogspot.com/search/label/You%20heard%20it%20here%20first">You heard it here first</a>. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>Summary </b></div><div itemprop="articleBody"></div><div itemprop="articleBody">To date we have published 102 posts with the label "<a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of medical research</a>."  Obviously, Ben Goldacre's NY Times op-ed shows that suppression of research still rarely leads to negative consequences for its perpetrators.  Obviously, by making drugs, devices, and other health care interventions appear safer and more effective than they really are, suppression of medical research has lead to huge revenues for health care corporations, and has made many health care executives exceedingly rich, and many of the health care professionals and academic leaders who have enabled or implemented research suppression somewhat rich.  In the face of such <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a>, until we end the <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> of those who suppress medical research (and by the way, those who authorize, direct, or implement all sorts of other unethical, criminal and corrupt behavior we discuss on Health Care Renewal) things will not get better.  I can only hope that having this subject appear in a New York Times op-ed may lead to some real progress.<br /><br />ADDENDUM (2 February, 2013) - see also <a href="http://1boringoldman.com/index.php/2013/02/02/watchful-waiting-no-more/">comments</a> on 1BoringOldMan blog.  </div><div itemprop="articleBody"><br /></div>

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream.The Goldacre Version in the New York Times in 2013 In his op-ed, Ben Goldacre introduced it thus:the entire evidence base for medicine has been …

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02 Feb 2013

Oh, the Prices we Pay ... for Questionable Drug Marketing to Enrich Corporate Insiders - the Case of Questcor's H P Acthar Revisited

In 2007, we first <a href="http://hcrenewal.blogspot.com/2007/10/once-again-oh-prices-we-pay-acthar-for.html">discussed</a> the case of the amazing pricing of H P Acthar, a very old drug of questionable usefulness, as an example of the irrationality of health care prices in the US, and of the failure of the organizations that ought to resist outrageous pricing in our mixed, pseudo-market based health care system to do so.  A recent New York Times <a href="http://www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html">article</a> has updated this case.<br /><br /><b>Background</b><br /><br />As we wrote in 2007, ACTH (adrenocorticotrophic hormone) is a naturally occurring hormone that stimulates the activity of the adrenal gland, which produces cortisol and other glucocorticoid and mineralocorticoid hormones.   ACTH produced from pigs' adrenals was first marketed as a biologic agent in the 1940s.  It was used for some conditions that appear to benefit from the effects of increasing cortisol production induced by ACTH.<br /><br />It has been traditionally used to treat infantile spasms, a rare but distressing condition, and exacerbations of multiple sclerosis (MS).  However, since the drug was introduced so long ago, it was never subject to rigorous controlled trials to assess its efficacy and adverse effects for these indications.  Furthermore, since the 1940s, synthetic glucocorticoid hormones have become widely available as generic drugs.  Yet these slightly newer drugs have never been rigorously compared to ACTH for infantile spasms or MS.  The most recent review (edited in 2009) by the Cochrane Collaboration found that steroids and ACTH have some evidence in their favor for the treatment of acute MS, but found no evidence showing that ACTH was superior.  [Filippini G, Brusaferri F, Sibley WA, Citterio A, Ciucci G, Midgard R, Candelise L. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database of Systematic Reviews 2000, Issue 4. Art. No.: CD001331. DOI: 10.1002/14651858.CD001331].  Also, the most recent review (edited in 2009) of treatment of infantile spasms concluded, "it is not clear which treatment [including ACTH] is optimal." [Hancock ED, Osborne JP, Edwards SW. Treatment of infantile spasms.  Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No. : CD001770. DOI: 10.1002/14541858.CD001700.pub2.]<br /><br /><b>The Pricing of H P Acthar</b><br /><br />Possibly because some physicians thought ACTH might be useful for some patients with two conditions, infantile spasms and acute exacerbations of MS, ACTH has remained on the market.  It was manufactured by a single company, Aventis, (now part of Sanofi-Aventis), the successor to Rhone-Poulenc-Rorer.  In 2001, Aventis sold the rights to manufacture ACTH, with the trade name H P Acthar, to a new, small biotechnology company, Questcor.  In 2007, Questcor raised the price of ACTH from $1650 per vial to more $23,000 per vial.  That got <a href="http://www.philly.com/philly/business/20071002_Drugs_price_up_more_than__21_000.html">the attention</a> of the Philadelphia Inquirer, on whose article we based <a href="http://hcrenewal.blogspot.com/2007/10/once-again-oh-prices-we-pay-acthar-for.html">our commentary.</a> We used the price increase as an example of how pricing in health care has become untethered from any sort of clinical reality, and wondered why insurance companies and the US government seemed willing to pay this outrageous price for an old drug with little evidence from clinical research to support its use.  But the issue then seemed, like many others we have discussed , to become anechoic, until the very end of 2012.<br /><br /><br />Now the  <a href="http://www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html">New York Times story</a> has provided an example of how health care corporations can do very well without doing anyone, except corporate insiders, much good.  It included instances of many of the kinds of ethically questionable practices we have discussed over the years on<a href="http://hcrenewal.blogspot.com/"> Health Care Renewal</a>.<br /><br /><b>Deceptive Marketing</b><br /><br />Per the NY Times,<br /><blockquote class="tr_bq">Questcor <i>did almost no research or development  to bring Acthar to market, merely buying the rights to the drug</i> from  its previous owner for $100,000 in 2001. And while the manufacturing of  Acthar is complex, it accounts for only about 1 cent of every dollar  that Questcor charges for the drug.<br /><br /><div itemprop="articleBody">Moreover, the tiny 'orphan' market soon became much bigger. Before long, <i>Questcor began marketing the drug fo multiple sclerosis, nephrotic syndrome and rheumatologic conditions, even though there is little evidence that  Acthar is more effective for those other conditions than alternatives  that are far cheaper.</i> And the company did so without being required to  prove that the drug actually works. That is because Acthar was approved  for use in 1952, before the Food and Drug Administration required  clinical trials to show a drug is effective for a particular disease.  Acthar is essentially grandfathered in. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Today, only about 10 percent of the drug’s sales are for infantile  spasms. The new uses, Mr. Bailey has told analysts, represent  multibillion-dollar opportunities for Acthar and Questcor, its sole  maker. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>The results have been beyond even the company’s wildest dreams</i>. Sales of  Acthar, which accounts for essentially all of Questcor’s sales, totaled  nearly $350 million in the first nine months this year, up 145 percent  from the period a year earlier. In the same period, Questcor’s earnings  per share nearly tripled, to $2.12. In the five years after the big  Acthar price increase in August 2007, Questcor shares rose from around  60 cents to about $50, in one of the best performances of any stock in  any industry. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So Questcor leadership was clever enough to use loopholes in the law to promote ACTH for particular kinds of patients without any good evidence that it did those patients any good.  Furthermore, Questcor used several questionable tactics  </div>in this promotion.<br /><br /><a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research"><b>Manipulated Research</b></a><br /><br />Apparently Questcor leaders decided they needed some sort of minimal research results to promote their products, so as the Times reported,<br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">Because Acthar was approved for these conditions decades ago, Questcor  has not had to do large clinical trials to show that the drug works. It  has paid for <i>some small studies, mainly by individual doctors</i>, who then  publish a paper that the sales force can present to doctors. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The study that justified calling on rheumatologists involved<i> five  patients</i> with rare conditions, all of them treated by a single doctor.  All the patients had much improvement on Acthar after failing to benefit  from more standard therapies, the doctor, Todd Levine, said in a  Questcor conference call.        </div></blockquote><br />Too call the research Questcor sponsored minimalist would be too polite.  A case series of five patients, lacking any control group proves almost nothing.  It proves less when the research is done in an unblinded  fashion by a single doctor who presumably was invested in the outcome being favorable for his sponsor's product.  (I suppose some might quibble with calling this research manipulated, but I contend but doing such crude research when it would be possible to do something much more credible amounts to manipulation.) <br /><br /><a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research"><b>Suppression of Research</b></a><br /><br />Moreover, it seems that even such rudimentary studies sometimes failed to produce the wanted results.  In these cases, the Times reported that Questcor simply suppressed them.<br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">Still, it appears that at least a couple of <i>small studies that may have  raised questions about the drug have been suspended. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">'From my standpoint it just didn’t work,' said Dr. Sungchun Lee, a  Phoenix nephrologist who stopped a small study testing Acthar as a  treatment for nephrotic syndrome. <i>'I think they were O.K. with me  stopping because we weren’t getting the results</i>,' he said. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Another study that was terminated sought to determine whether multiple  sclerosis patients who did not have a good response to steroids should  be treated with either another round of steroids or with Acthar. The  study was halted midway through 'to analyze data,' according to the summary of the trial on the federal clinical trial database. </div></blockquote><div itemprop="articleBody"></div><div itemprop="articleBody"><br /><a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders"><b>Use of Paid Key Opinion Leaders</b></a><br /><br />Despite the lack of good clinical evidence in support ACTH, there are some physicians who defend its use.  One example in the Times article was a physician who is paid by Questcor<br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">But some doctors say Acthar can be effective in cases that are not well  treated by steroids. They say that there is emerging evidence that  Acthar does more than just stimulate the body to produce its own  steroids. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>'It really looks like the ACTH does bring something different</i> to the table that standard steroids don’t,' said Dr Ben W Thrower, director of the multiple sclerosis institute at the Shepherd Center, a hospital in Atlanta. Dr. Thrower, who is <i>a paid speaker for Questcor</i>,  said his institute had tried Acthar for about 60 of its 3,000 patients,  ones who did not respond to steroid treatment. Acthar made the symptoms  subside in about half of them.        </div></blockquote></div><div itemprop="articleBody">Where to begin?  Just because ACTH is different does not mean it is better.  Since MS is a disease whose symptoms wax and wane, patients who fail standard treatment may get better on their own, and without a control group, it is impossible to say whether the ACTH given to such patients was the reason they got better.  <br /><br /></div><div itemprop="articleBody"><b>Creation of <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">Institutional Conflicts of Interest</a> for Disease Specific Foundations</b><br /><br />Questcor's ACTH also has support from a disease specific foundation, but one that Questcor has also supported financially.<br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">Dr Lawrence Brown, a neurologist at the Children's Hospital of Philadelphia, and the president of the Child Neurology Foundation<a href="http://www.childneurologyfoundation.org/" title="The foundation’s Web site.">,</a> says of Questcor: '<i>They have gone out of their way to help every kid</i>  who needs the medicine to get it quickly and efficiently.'</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">This year, the <i>foundation awarded its first corporate citizenship award  to Questcor</i>. Dr. Brown says <i>Questcor’s donations — the amount has not  been disclosed </i>— <i>to the foundation</i> didn’t influence the award.        </div></blockquote></div><div itemprop="articleBody"></div><div itemprop="articleBody"><br />Who could be so naive to think that giving an organization funding might influence its actions?  After all, human response to financial incentives is the basis for most current economic thinking.<br /><br /><b>Insiders Get Rich</b><br /><br />Admittedly, these questionable tactics did lead to an increase in "shareholder value,"  As the <a href="http://files.shareholder.com/downloads/ABEA-2S424C/2250593841x0xS1193125-12-143634/891288/filing.pdf">company's proxy statement </a>boasted in 2011,<br /><br /><blockquote class="tr_bq">While we generated strong financial returns in 2011, we are most proud of our patient focus and investments in Questcor which we believe will generate sustainable value to our shareholders, employees, patients and all of the communities that we serve. We believe that our patient focus and commitment to generating sustainable value to all of our constituencies results in strong value creation for our shareholders.</blockquote><br />However, as of today, Qustcor's share price has dropped to $26.74 from a peak of 53.42 in June, 2012, with most of the drop in December, 2012, around the time the Times article came out, <a href="https://www.google.com/finance?hl=en&gl=us&q=questcor&um=1&ie=UTF-8&sa=N&tab=ne">according to Google Finance</a>.  So whether share holder value will turn out to have increased in the long run is not clear.  <br /><br />Meanwhile, some Questcor employees did very well.  The largess started with some drug representatives, <br /><br /><blockquote class="tr_bq">Questcor sales representatives who are lucky enough or skillful enough  to have a big prescriber in their territory can <i>reap bonuses of <b>$50,000</b> a  quarter</i>, according to former employees of the company.        </blockquote></div><div itemprop="articleBody"><br />More highly placed corporate insiders did even better.<br /><br /><blockquote class="tr_bq">Executives are paid well, too. In 2009, Mr. Bailey, [the CEO]  <i>hired his daughter</i>  Kirsten Fereday as director of business analytics and evaluation, a job  that paid<b><i> $275,000 </i></b>in cash and stock last year. </blockquote><br /> Left out of the Times article, somewhat surprisingly, was what the top executives make.  Information from up to 2011 is publicly available, however, in proxy fillings.<br /><br />In the company's <a href="http://files.shareholder.com/downloads/ABEA-2S424C/2250593841x0xS1193125-12-143634/891288/filing.pdf">2012 proxy statement</a>, we find the following figures for total compensation:<br />Don M Bailey, President and CEO - <b><i>$4,546,230</i></b>, up <i><b>192%</b></i> of his compensation in $1,554,503 in 2009<br />Michael H Mulroy, Senior Vice President, Chief Financial Officer and General Counsel -  <b><i>$1,749,891</i></b> (his first year)<br />Stephen L Cartt, Chief Operating Officer -  <b><i>$2,298,308</i></b>, up <b><i>168%</i></b> from $855,460 in 2009<br />David J Medeiros, Executive Vice President and Chief Technical Officer - <b><i>$1,232,556</i></b>, up <b><i>78%</i></b> from $692,188 in 2009<br />David Young Pharm D, Chief Scientific Officer - <b><i>$1,948,804</i></b> up <b><i>182%</i></b> from $1,066,159 in 2009<br /><br />In addition, by 2011, Mr Bailey, the CEO, had acquired 1.92% of the company's total stock, 3,834,910 shares, today worth <b><i>$102,545,490.</i></b><br /></div><div itemprop="articleBody"><br />Finally, per the Times,<br /><br /><blockquote class="tr_bq">one group of shareholders has done pretty well for itself. Over the last  two years, as the company’s share price mainly soared, <i>Questcor  insiders have sold more than <b>$100 million</b> of stock. </i></blockquote><br /><b>Summary</b><br /><br /> So, in summary, a small biotechnology company drastically increased the price of its only product, a drug which has never been subject to modern clinical  trials, and whose efficacy has never been proven.  Its marketing tactics  have included manipulation and suppression of research, and payments to  physicians and non-profit organizations.  Although its most  breathtaking price increases were made in 2007, they attracted little  public attention until five years later.   Meanwhile, corporate insiders, from drug representatives to top executives and their relatives, have done very well for themselves.<br /><br />In the US, there a lot of people who advocate free market based health care for its efficiency and innovation.  For example, see "<a href="http://www.cato.org/sites/cato.org/files/pubs/pdf/pa650.pdf">Yes, Mr President, a Free Market Can Fix Health Care,</a>" published by the Cato Institute, in which its Director of Health Policy Studies proclaimed, "The great advantage of a free market is that <i>innovation</i> and <i>more prudent decisionmaking</i> means that fewer patients will fall through the cracks," and then "a free market can <i>and would</i> control costs, expand choice, improve health care quality, and make health coverage more secure." [italics added for emphasis]<br /><br />Unfortunately, the case of Questcor's ACTH makes it seem that in the current US system, which is supposedly more market based than systems in many other countries, the efficiency and innovation is characteristic of the marketing of corporate health care, not of the health care itself.  Here is a stellar example of how clever, and not always very scrupulous marketing can be used to sell a very old drug with little demonstrated clinical value for a stratospheric price, enriching corporate insiders, perhaps enriching stockholders (although, not so much lately, and we will see how they do in 2013), at the expense of the public who pays taxes and insurance premium.  This case suggests a need for more attention to market failures and less insistence on market fundamentalism.  Of course, it also suggests the continuing need for health care professionals, policy makers, patients and the public to be extremely skeptical about heavily promoted commercial health products.</div><div itemprop="articleBody"><br /></div>

Oh, the Prices we Pay ... for Questionable Drug Marketing to Enrich Corporate Insiders - the Case of Questcor's H P Acthar Revisited

In 2007, we first discussed the case of the amazing pricing of H P Acthar, a very old drug of questionable usefulness, as an example of the irrationality of health care prices in the US, and of the fa…

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03 Jan 2013

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