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...

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Question for the New Year: Why is There Next to No Reaction to the Gilded Age of Health Care?

For the New Year, it is time to ponder- why is there still no organized outrage over the ongoing <a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management">incompetent</a>, <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">uncaring</a>, <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">self-interested</a>, <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicted</a>, and often outright <a href="http://hcrenewal.blogspot.com/search/label/crime">corrupt</a> leadership of health care organizations we have documented incessantly on Health Care Renewal?<br /><br />For example, just a few days ago, we <a href="http://hcrenewal.blogspot.com/2012/12/tis-season-for-legal-settlements.html">documented</a> a series of cases in which large US and multinational health care organizations settled cases alleging they deceptively marketed drugs so as to exaggerate their benefits and conceal their harms, bribed doctors and officials  outside of the US, gave kickbacks to US doctors, defrauded the US government, and monopolized markets for drugs, yet few leaders, and no top leaders of the companies involved suffered any negative consequences for authorizing, directing, or implementing these activities.  We have discussed many previous <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> involving similar bad behavior and similar impunity by the leaders of the organizations involved.   Again and again we have discussed how large organizations, often but not always drug, biotechnology and device companies, have manipulated the scientific literature (e.g., see examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a>, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of clinical research,</a> and specific practices such as <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writing</a> of apparently scholarly articles to benefit vested interests.)   We have discussed <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">overblown compensation</a> that made top managers and other organizational insiders rich without any rationale other than their ability to take such money off the top.  Yet in the US, despite ever rising costs presumably provoked by such leadership, without corresponding improvements in quality or access, there is still no organized movement for change.<br /><br />The problems in US health care, however, seem to parallel problems in the larger society, and the world at large.  We have discussed parallels with bad leadership of <a href="http://hcrenewal.blogspot.com/search/label/finance">financial firms</a>, including the firms that drove us into the global financial collapse/ great recession, and to continuing income stagnation, recession, austerity, and decreasing opportunity for the poor and middle class around the world.<br /><br />Yet parallel questions are just beginning to be asked about larger related political economic problems.  Recently, historian Brad DeLong attempted to address the question, "why next to no reaction to the second gilded age?"  (See <a href="http://delong.typepad.com/sdj/2012/12/brad-delong-why-next-to-no-political-reaction-to-the-second-gilded-age.html">this</a>.).  Unfortunately, while he could demonstrate two powerful political movements that opposed the first Gilded Age, he was completely at a loss to explain why there has been no similar organized outrage about the second Gilded Age in which we exist today.  Despite incompetent, uncaring, self-interested, conflicted, and often outright corrupt leadership of many large corporations, non-profit organizations, and government agencies only a few voices, often bloggers like us, have objected.<br /><br />Economist Mark Thoma then took up the question, but the best he could do was suggest that outrage has been moderated because of the existing, if frayed, social safety net, and because many people nonetheless saw the last two decades as a time of increasing economic opportunity. (See <a href="http://economistsview.typepad.com/economistsview/2012/12/why-next-to-no-political-reaction-to-the-second-gilded-age.html">this</a>. )   He did not address how this view may have been wrong, since the last two decades were a time of obviously worsening income inequality.<br /><br />Yves Smith of Naked Capitalism finally offered some insight (see <a href="http://www.nakedcapitalism.com/2012/12/links-123012.html">this</a>) by noting the importance of "propaganda," corresponding, I think, to the widespread deceptive <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a> and <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a>, and the use of covertly paid <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders </a>to further both that we frequently discuss.  Finally she suggested that people feel powerless because they see themselves as "atomized individuals," even though they many are currently being treated as interchangeable parts by the leaders of large organizations who can control the actions of large number of employees to further their self-interest.<br /><br />There must be more reasons.  There ought to at least be some organized discussion of these reasons.  After that there needs to be some organized action to promote real reform.  I conclude the often miserable 2012 with a plea for those who are interested and concerned to come together to create real solutions. <br /><br />ADDENDUM (1 January, 2013) - see <a href="http://theeconomismscam.blogspot.com/2012/12/why-no-outrage-more-on-how-economism.html">comments</a> by Dr Howard Brody on the Economism Scam blog.

Question for the New Year: Why is There Next to No Reaction to the Gilded Age of Health Care?

For the New Year, it is time to ponder- why is there still no organized outrage over the ongoing incompetent , uncaring , self-interested ,...

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'Tis the Season for Legal Settlements: GlaxoSmithKline, Eli Lilly, Orthofix, Sanofi all Settle

Reports of legal settlements by big health care organizations tend to dribble out towards the end of the year, maybe in a rush to finalize the year's accounting, maybe because the news will not register as well at times when people are distracted by holidays.  Here is a round-up in alphabetical order of some recent settlements of interest made by drug and device companies.<br /><br /><b>GlaxoSmithKline</b><br /><br />Earlier this year GSK made the largest settlement, in monetary terms, ever by a pharmaceutical company (see <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">this post</a>).  At the end of the year it made two more.  Neither got much media attention.  The first was related to the earlier $3 billion settlement.  As <a href="http://lebanon-express.com/news/glaxosmithkline-pays-to-settle-avandia-lawsuit/article_59b5a4fe-3426-11e2-ae3b-001a4bcf887a.html">reported</a> by the [Great] Lebanon [Oregon] Express:<br /><br /><br /><blockquote class="tr_bq">Oregon Attorney General Ellen Rosenblum announced in a press release that pharmaceutical giant GlaxoSmithKline has agreed to pay $90 million to Oregon and 37 other states to settle claims that it unlawfully promoted its diabetes drug, Avandia.<br /><br />As the co-leader of the lawsuit, Oregon will receive $3.9 million of the settlement, according to the release.<br /><br />The 38 attorneys general claimed in lawsuits filed Nov. 15 that GlaxoSmithKline <i>misrepresented the cardiovascular risks posed by Avandia</i>. A negotiated consent judgment was filed shortly thereafter.<br /><br /> Avandia was a blockbuster drug for GlaxoSmithKline. First approved by the Food and Drug Administration in 1999, annual sales peaked at more than $2.5 billion in 2006.</blockquote><br />Furthermore,<br /><br /><blockquote class="tr_bq"> Oregon and the 37 other states claim GlaxoSmithKline made<i> safety claims about Avandia not supported by the scientific evidence.</i><br /><br />The states allege the company <i>failed to disclose negative information about Avendia’s cardiovascular health effects.</i></blockquote><br />In addition to the monetary settlement, the agreement included all sorts of pledges by GSK:<br /><br /><blockquote class="tr_bq">As part of the consent judgment between the parties, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. It agreed to several conditions:<br /> • To refrain from making false, misleading, or deceptive claims about any diabetes drug;<br />• To refrain from making comparative safety claims not supported by substantial evidence or substantial clinical experience;<br />• To refrain from presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;<br />•   To refrain from misusing statistics or otherwise misrepresenting the nature, applicability, or significance of clinical trials.<br /><br />The Consent Judgment also has the following terms that are effective for at least eight years:<br />• GlaxoSmithKline must post summaries of all company sponsored observational studies or meta-analyses conducted by the company that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;<br />• The company post summaries of company-sponsored clinical trials of diabetes products within eight months of the primary completion date;<br />• GlaxoSmithKline must register and post all company-sponsored clinical trials as required by federal law.</blockquote><br />Even more under the radar was a second, unrelated settlement, only briefly chronicled by Reuters (here <a href="http://www.chicagotribune.com/business/sns-rt-us-glaxosmithkline-settlementbre8bi14f-20121219,0,2970904.story">via</a> the Chicago Tribune):<br /><br /><blockquote class="tr_bq"> British drugmaker GlaxoSmithKline Plc has reached a $150 million preliminary settlement with U.S. drug wholesalers who claimed the company<i> improperly delayed entry to the market of generic alternatives to its nasal spray Flonase, </i>according to court documents.<br /><br />The settlement was reached with, among others, AmerisourceBergen Corp, Cardinal Health Inc, and McKesson Corp, who maintained that Glaxo had abused the citizen's petition process to maintain a market monopoly and overcharge for the spray by restricting access to less expensive generic versions.</blockquote><br />Note that while the first settlement was clearly about misleading, deceptive marketing of a relatively dangerous drug as safe, a practice that likely lead to suffering and death of some patients, the second settlement which involved an unfair business practice that likely increased the cost of care to some patients, and decreased the profits of some competitors, lead to a monetarily larger settlement.<br /><br />Again, these latter two settlements seem to just ice the cake of the $3 billion settlement earlier this year.<br /><br /> <b>Eli Lilly</b><br /><br />Eli Lilly pleaded guilty to a misdemeanor charges and settled allegations about questionable marketing practices for its anti-psychotic drug Zyprexa for over $1 billion in 2009 (see post <a href="http://hcrenewal.blogspot.com/2009/01/what-me-worry-lilly-fined-over-zyprexa.html">here</a>).  The settlement provided some instructive information about how big pharmaceutical companies employ ghost writing to sell product (see <a href="http://hcrenewal.blogspot.com/2009/06/handbook-for-ghost-writing.html">this post</a>).  Now at the end of 2012, Eli Lilly has settled charges that it bribed government officials in countries outside of the US.  The most colorful version of this story <a href="http://online.wsj.com/article/SB10001424127887324461604578191550218188808.html">appeared</a> in the Wall Street Journal.  In summary,<br /><br /><br /><blockquote class="tr_bq"> Eli Lilly & Co. agreed to pay $29.4 million in a settlement of U.S. government <i>allegations that the drug maker's units made improper payments to foreign government officials to win business</i>.<br /><br />Indianapolis-based Lilly didn't admit or deny the allegations, but agreed to have an outside consultant review the company's internal controls and its measures to comply with the U.S. Foreign Corrupt Practices Act, or FCPA. </blockquote><br />The colorful details were:<br /><br /><br /><blockquote class="tr_bq">The SEC said in a civil complaint filed in U.S. District Court for the District of Columbia that employees of Lilly's China unit <i>falsified expense reports to provide spa treatments, jewelry and other gifts and cash payments to government-employed doctors</i> between 2006 and 2009.<br /><br />The SEC also alleged: Lilly hired a drug distributor in 2007 that <i>paid bribes to health officials in a Brazilian state</i> to facilitate about $1.2 million in sales of a Lilly drug to the state; Lilly's Polish unit<i> paid $39,000 between 2000 and 2003 to a charitable foundation run by the head of a regional government health authority </i>and dedicated to restoring a castle in Chudow, Poland; and that its Russian unit <i>paid millions of dollars between 1994 and 2005 to offshore entities that the SEC said 'appear to have been used to funnel money to government officials' </i>to obtain business for the Lilly unit. <br /><br />The SEC said Lilly didn't curtail the activities of its Russian unit for several years, even after an internal Lilly review raised questions about its use of these offshore arrangements. </blockquote><br />As in the previous set of settlements, no individual was charged or had to pay any penalty for authorizing, directing, or implementing any unethical actions.  Note that the alleged bribery went on in multiple different countries, suggesting a systemic problem with the operations of the company.  Note also that the allegations involved bribing doctors as well as bureaucrats.<br /><br /><b>Orthofix</b><br /><br />We <a href="http://hcrenewal.blogspot.com/2012/11/phony-consulting-and-royalty-agreements.html">discussed</a> three settlements made by medical device company Orthofix only a month ago.  These involved various vivid details including bribes to physicians disguised as consulting and royalty agreements, bribes of foreign government officials disguised as chocolate, and a device sales representative turned stripper.  As best as I can tell, Orthofix just made yet another settlement, maybe not quite so picaresque.  As<a href="http://www.bloomberg.com/news/2012-12-15/orthofix-medicare-probe-settlement-accepted-by-u-s-judge-1-.html"> per Bloomberg</a>, <br /><br /><br /><blockquote class="tr_bq">Orthofix International NV won court approval of a settlement of federal regulators’ claims that <i>the maker of bone-repair products defrauded Medicare through a kickback scheme involving doctors,</i> prosecutors said.<br /><br />U.S. District Judge William G. Young in Boston<a href="http://topics.bloomberg.com/boston/"></a> yesterday accepted an Orthofix unit’s offer to <i>plead guilty to a felony count of obstructing an audit and pay a $7.6 million criminal fine</i>....</blockquote><br />This settlement like some of the previous ones involved allegations of payments to doctors to induce them to use Orthofix devices.<br /><br /><blockquote class="tr_bq">As part of the agreement, Orthofix also will pay $32.3 million plus interest to resolve civil claims first raised in a whistle-blower’s lawsuit that the company defrauded the federal Medicare program through payments to doctors who used its bone-growth stimulators....</blockquote><br />This series of cases is unusual because they resulted in a guilty plea to a felony (but by a subsidiary of the company, not the company itself), and in guilty pleas by some company employees (but not apparently any penalties to top management).<br /><br /><blockquote class="tr_bq"><i>Five Orthofix employees have pleaded guilty</i> in connection with the probe, the U.S. Justice Department<a href="http://topics.bloomberg.com/justice-department/"></a> said. Thomas Guerrieri<a href="http://www.justice.gov/usao/ma/news/2012/April/GuerrieriThomasPleaPR.html" rel="external" title="Open Web Site"></a>, a company vice president, pleaded guilty to<i> violating the federal anti-kickback statute by setting up fake consulting agreements for doctors who used the company’s products. </i></blockquote><br /><b>Sanofi</b><br /><br />French multinational pharmaceutical corporation Sanofi-Aventis settled charges of overcharging the US Medicaid system in 2009 for over $90 million  (see post<a href="http://hcrenewal.blogspot.com/2009/05/sanofi-aventis-settles.html"> here</a>),  and of overcharging the US Medicare system in 2007 for over $190 million (see post <a href="http://hcrenewal.blogspot.com/2007/09/190-million-settlement-for-sanofi.html">here</a>).  Now it just settled charges that it gave kickbacks to doctors to induce them to prescribe its product.  <a href="http://www.bloomberg.com/news/2012-12-19/sanofi-to-pay-109-million-to-settle-false-claims-case.html">Per Bloomberg</a>,<br /><br /><blockquote class="tr_bq"> Sanofi,  France’s biggest drugmaker, reached a settlement to pay $109 million over <i>allegations that its U.S. units gave doctors free doses of a medicine to win their business</i> and subvert Medicare’s drug reimbursement system. </blockquote><blockquote class="tr_bq">Sanofi sales representatives entered into 'illegal sampling arrangements' with physicians,<i> giving them the arthritis drug Hyalgan as kickbacks</i> and 'promising to provide negotiated' amounts of the medication to lower its effective price in violation of the False Claims Act, the U.S. Justice Department said yesterday in a statement.<br /><br /><i>'Kickback schemes</i> subvert the health-care marketplace and undermine the integrity of public health-care programs,” Stuart Delery,  who heads the department’s civil division, said in the statement. 'We will continue to hold accountable those who we allege are <i>providing illegal incentives to influence the decision-making of health-care providers </i>in federal health-care programs.'</blockquote><br />Again, no individual suffered any negative consequences for authorizing, directing or implementing the bad behavior in this case.<br /><br /><b>Summary</b><br /><br />So here we go again, four more settlements by large, rich, well known pharmaceutical and device companies.  Most of the companies involved now have a history of recent settlements for a variety of ethical misadventures.  Most of the new settlements involved allegations of deceiving and bribing physicians. <br /><br />As we have noted endlessly before, <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> like this are useful to provide documentation of how unethical the practices, particularly marketing practices of large health care organizations have become.  However, the increasing number of repeat settlers suggest that the settlements are not deterring bad behavior.  Since the fines involved are usually small compared to the revenues that can be generated by deceptive and unethical marketing of expensive drugs, and the fines are paid out of company coffers, and are thus spread out in their impact over employees and stockholders alike, they usually have no more impact than a lash with a wet noodle, maybe at best a slap on the wrist.  Since the people involved in authorizing, directing and implementing the bad behavior can likely greatly improve their "numbers" and hence generate big salaries and bonuses, but face a minimal risk of any individual negative consequences, they are likely to continue unethical practices.<br /><br />Given that so many of these cases involve deception and/or bribery of health care professionals, I still hope that some will get upset at the effect on their professional values to take action.<br /><br />Meanwhile, I repeat until blue in the face....   we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

'Tis the Season for Legal Settlements: GlaxoSmithKline, Eli Lilly, Orthofix, Sanofi all Settle

Reports of legal settlements by big health care organizations tend to dribble out towards the end of the year, maybe in a rush to finalize t...

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Denying the Inconvenient Truth About Study 329

On 1BoringOldMan, Mickey, the semi-anonymous retired psychiatrist blogger, has updated the saga of <a href="http://hcrenewal.blogspot.com/search/label/Study%20329">Study 329</a>.  The manipulation of Study 329 was a central part of the US government's case against GlaxoSmithKline that was recently settled for $3 billion and resulted in three guilty pleas by the company (look <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/09/twilight-of-anechoic-effect-new-england.html">here</a>.) <br /><br />Mickey's previous voluminous series of posts on this subject are listed <a href="http://hcrenewal.blogspot.com/2012/08/continuing-dissection-of-infamous-study.html">here</a>.  He and others, most notably Dr Jon Jureidini, have attempted to get the journal that published the now widely ridiculed Study 329 retracted.  His three recent posts on the subject are:<br /><a href="http://1boringoldman.com/index.php/2012/12/23/the-lesson-of-study-329-an-unfinished-symphony/" rel="bookmark">the lesson of Study 329: an unfinished symphony…</a><br /> <a href="http://1boringoldman.com/index.php/2012/12/21/hide-and-go-seek/" rel="bookmark">hide-and-go-seek… </a><br /> <a href="http://1boringoldman.com/index.php/2012/12/21/a-response-2/" rel="bookmark">a response… </a><br /><br /> In the most recent of these, he argued,<br /><br /><blockquote class="tr_bq">In this particular case, there are no facts in question. It was a negative trial, declared negative by the people who did it. The paper was <i>ghost-written</i> and reviewed by the sponsor before any of the twenty two authors ever saw a manuscript. The science was <i>jury-rigged to imply a positive outcome where none was supported</i> using well-documented sleight of hand. None of that is speculative. And the article has been a centerpiece for court settlements worth billions of dollars.</blockquote><br /><br />Yet, the  Journal of the American Academy of Child and Adolescent Psychiatry refused to retract the article. Mickey's opinion in the second of the posts listed above,<br /><br /><blockquote class="tr_bq">One can only conclude that they found this article to be <i>an inconvenient truth</i>, and that Dr. Andres Martin and his colleagues in the American Academy of Child and Adolescent Psychiatry believe that acknowledging that truth would do more harm than good [or maybe even found a way not to see the truth at all, though it's hard to imagine how]. Sooner or later, this whole tawdry saga is going to find its way out of the blogs and courtrooms and into the full light of day. And the question that’s going to be asked is why didn’t Medicine itself deal with the problem? Why didn’t the Journal itself retract the misinformation once they knew about it? Why didn’t the industry sponsor itself call for the retraction as part of their settlement with the DOJ? What possible reasonable reason could there be for leaving a paper that is a lie in their journal without even an expression of concern, much less a retraction? And there aren’t going to be any believable answers.</blockquote><br />Mickey concluded the most recent post,<br /><br /><blockquote class="tr_bq">The loser in this story is the American Academy of Child and Adolescent Psychiatry, and ultimately psychiatry itself…</blockquote><br />The longer inconvenient truths are ignored or suppressed, the more inconvenient, and hazardous they will ultimately become.  <br /><br />ADDENDUM (26 December, 2012) - One more post on 1BoringOldMan: <a href="http://1boringoldman.com/index.php/2012/12/26/telling-the-truth-as-a-liability/" rel="bookmark">telling the truth as a liability… </a><br /><br />Its conclusion<br /><br /><blockquote class="tr_bq">By any criteria, the conclusion to the 2001 Keller et al article is wrong ["<em>Paroxetine is generally well tolerated and effective for major depression in adolescents</em>"]. That’s not the reason that some of us have been so persistent in pushing for retraction. The reason is that it was wrong at the time the article was published, and <em><strong><span style="color: #200020;">they knew it was wrong</span></strong></em>, but published it anyway. We want to make a statement about the integrity of the scientific literature. </blockquote>

Denying the Inconvenient Truth About Study 329

On 1BoringOldMan, Mickey, the semi-anonymous retired psychiatrist blogger, has updated the saga of Study 329 .  The manipulation of Study 32...

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ONC's Christmas Confessional on Health IT Safety: "HIT Patient Safety Action & Surveillance Plan for Public Comment"

This time of year is certainly appropriate for a confessional on the health IT industry and <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyperenthusiasts</a>' sins.<br /><br />In the first report I've seen that seems genuinely imbued <b>with a  basic level of recognition of social responsibility incurred</b> by conducting the grand human subjects experiment known as national health IT, ONC has issued a Dec. 21, 2012 report "<b>Health Information Technology Patient Safety Action & Surveillance Plan for Public Comment</b>." It is available <a href="http://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf" target="_blank">at this link</a> in PDF.<br /><br />Statements are made that have appeared repeatedly since 2004 at this blog, and my health IT difficulties site that went online years before this blog (1998 to be exact); it is possible through my early writing and that of like-minded colleagues that we were the origin of most of these memes.  We wrote them with the result of bringing much scorn upon ourselves. After all, "how could health IT possibly not be a panacea?" was the "you are an apostate" attitude I certainly experienced (e.g., as in my Sept. 2012 post "<a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html" target="_blank">The Dangers of Critical Thinking in A Politicized, Irrational Culture</a>").<br /><br />Observations echoed in the new ONC report:<br /><br /><ul><li>"Just as health IT can create new opportunities to improve patient care and safety, it can also create new potentials for harm."</li><li>Health IT will only fulfill its enormous potential to improve patient safety if the risks associated with its use are identified, if there is a coordinated effort to mitigate those risks, and if it is used to make care safer.</li><li>Because health IT is so tightly integrated into care delivery today, it is difficult to interpret this initial research <i>[such as the PA Patient Safety Authority study  - ed.]</i>, which would seem to suggest that health IT is a modest cause of medical errors. However, it is difficult to say whether a medical error is health IT-related. <span style="color: red;"><i><b>[Not emphasized, as I wrote</b></i></span> <i><a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank"><b>here</b></a><b>, <span style="color: red;">is the issue of risk when, say, </span></b></i><a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank"><b><i>tens of </i></b></a><i><a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank"><b>thousands of prescriptions are erroneous</b></a><b><span style="color: red;"> due to one software bug, a feat impossible with paper - ed.]</span></b></i></li><li>The proper steps to improve the safety of health IT can only be taken if there is better information regarding health IT’s risks, harms, and impact on patient safety.</li></ul><br />Suggested steps to be taken include:<br /><br /><ul><li>Make it easier for clinicians to report patient safety events and risks using EHR technology.</li><li>Engage <b>health IT developers to embrace their shared responsibility</b> for patient safety and promote reporting of patient safety events and risks. <span style="color: red;"><i><b>[I am frankly amazed to see this admission.  In the past, that sector excused itself entirely on the basis of the "learned intermediary" doctrine and "hold harmless" clauses; where the clinician is an all-knowing Deity between computer and patient.  I've been writing for years, however, that the computer is now the intermediary between clinician and patient since all care 'transactions' have to traverse what is now an enterprise clinical resource and clinician control system - ed.]</b></i></span></li><li>Provide support to Patient Safety Organizations (PSOs) to identify, aggregate, and analyze health IT safety event and hazard reports.</li><li>Incorporate health IT safety in post-market surveillance of certified EHR technology</li><li>Align CMS health and safety standards with the safety of health IT, and train surveyors.</li><li>Collect data on health IT safety events through the Quality & Safety Review System (QSRS).</li><li>Monitor health IT adverse event reports to the Manufacturer and User Facility Device Experience (MAUDE) database. <i><b><span style="color: red;">[I've been promoting the use of MAUDE for just that purpose, and much more regarding documenting and reporting on mission-hostile health IT; see</span> <a href="http://hcrenewal.blogspot.com/2012/08/clinicians-how-to-document-ehr-screens.html" target="_blank">this </a><span style="color: red;"><a href="http://hcrenewal.blogspot.com/2012/08/clinicians-how-to-document-ehr-screens.html" target="_blank">post </a>- ed.]</span></b></i></li></ul><br />These steps are to be taken in order to "<i>Inspire Confidence and Trust in Health IT and Health Information Exchange."</i><br /><br />The title of my keynote address to the Health Informatics Society of Australia this summer was, in fact, "<a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step</a>". <br /><br />My thoughts on this report:<br /><br /><ul><li>It is at least two decades overdue.</li><li>It was produced largely if not solely due to the pressure of the "HIT apostates", finally overcoming industry memes and control of information flows through great perseverance.</li><li>It is indeed a confessional of the sins committed by the health IT industry over those decades.  Creating, implementing and maintaining mission critical software in a safety-cognizant way is not, and was not, a mystery.  It's been done in numerous industries for decades.</li><li>It is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of <b>risk</b> <b>vs. 'confirmed body counts' </b>as I wrote at my recent post "<a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank">A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk</a>". </li><li>It is unfortunate that this report did not come from the informatics academic community in the United States, i.e., the <a href="http://www.amia.org/" target="_blank">American Medical Informatics Association (AMIA)</a>.  AMIA's academics have done well in advancing the theoretical aspects of the technologies, and how to create "good health IT" and not "bad health IT."  However, they have largely abrogated their social responsibilities and obligations, including but not limited to those of physicians, in ensuring the theories were followed in practice by an industry all too eager to ignore academic research (which, in order to follow, utilizes money and resources and reduces margins).</li></ul>(On the latter point, just last week did the American College of Medical Informatics [ACMI] refuse to permit me to be a speaker at their early 2013 annual retreat despite support from some of its members.)<br /><br />And this:<br /><br /><ul><li>If the industry and the academics had been doing their job responsibly, I might be spending this Christmas and New Years's holiday with my mother, rather than visiting her in the cemetery. </li></ul><br />All that said, the report is welcome.<br /><br />Finally, it is hoped - and expected - that public comments <b>will indeed be "public"</b>, and that <b>any irregularities in such comments</b> (such as appeared in the public comments period for MU2 due to industry ghostwriting as in my Aug. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html" target="_blank">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?</a>" and Sept. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html" target="_blank">Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?</a>") will be reported and acted upon in an aggressive manner.<br /><br />And finally, from the Healthcare Renewal blog, Merry Christmas.<br /><br />-- SS

ONC's Christmas Confessional on Health IT Safety: "HIT Patient Safety Action & Surveillance Plan for Public Comment"

This time of year is certainly appropriate for a confessional on the health IT industry and hyperenthusiasts ' sins. In the first report...

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Amgen Settles, Pleads Guilty to Misbranding Aranesp

Now it's Amgen's turn to settle and plead.  <a href="http://www.nytimes.com/2012/12/19/business/amgen-agrees-to-pay-762-million-in-drug-case.html">Per the New York Times,</a><br /><br /><blockquote class="tr_bq"><i>The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out</i>, federal prosecutors said on Tuesday.<br /><br /><div itemprop="articleBody"> The federal charges were made public as <i>Amgen pleaded guilty to illegally marketing the drug and agreed to pay <b>$762 million</b> in criminal penalties and settlements of whistle-blower lawsuits.</i> </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Amgen was '<i>pursuing profits at the risk of patient safety</i>' Marshall L. Miller, acting United States attorney in Brooklyn, said in a telephone news briefing on Tuesday. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to <i>a single misdemeanor count of misbranding the drug, Aranesp</i>, meaning selling it for uses not approved by the F.D.A. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The article noted the key charge against Amgen,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> In court on Tuesday, prosecutors charged that <i>Amgen had promoted the use of Aranesp to treat anemia in cancer patients who were not undergoing chemotherapy, even though the drug’s approval was only for patients receiving chemotherapy. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>A subsequent study sponsored by Amgen showed that use of Aranesp by those nonchemotherapy cancer patients had actually increased the risk of death</i>, and the off-label use diminished. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Also,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> The federal charges also say Amgen promoted using larger but less frequent injection of Aranesp than stated in the label as a way of making the drug more attractive to doctors and patients than Procrit, a rival anemia drug from Johnson & Johnson. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">As is typical of such cases, the prosecutors could not figure out how to charge any individuals who might have authorized, directed, or implemented the bad behavior,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> Mr. Miller said that the<i> evidence in the Amgen case was not sufficient to charge individuals</i>. However, he said, Amgen agreed to sign a corporate integrity agreement that requires executives and board members to personally certify compliance with regulations. That would make it easier to prosecute individuals should violations occur again, he said. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>The Charges in Context</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">In some reports of the settlement, the issue appeared to be money.  For example, Pharmalot <a href="http://www.pharmalot.com/2012/12/amgen-to-plead-guilty-in-marketing-probe/">reported</a> that after a whistle-blower filed suit against Amgen, "a subsequent investigation by the Justice Department found that these practices induced physicians to use Amgen medications unnecessarily when lower cost alternatives were available." </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">However, Amgen's practices could have had much worse effects than just removing money from the US Treasury.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Consider the context.  Only a few of the not very numerous articles in the media on this case noted that the key complaint was that Amgen was pushing use of Aranesp for patients with cancer, specifically those not receiving chemotherapy.   (<a href="http://news.yahoo.com/amgen-pleads-guilty-misbranding-charges-pay-762-million-161356503--finance.html">Reuters</a> made this explicit, for example, but not so the <a href="http://www.latimes.com/business/la-fi-amgen-plea-20121219,0,7120268.story">Los Angeles Times,</a> or <a href="http://www.bloomberg.com/news/2012-12-18/amgen-expected-to-plead-guilty-to-charges-u-s-says.html">Bloomberg's initial coverage</a>.)</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"> In fact, there has been concern about the adverse effects of Aranesp for patients with cancer for a while.  In 2007, Khuri noted in a commentary in the New England Journal of Medicine(1) that "concern about a detrimental effect of ESAs [erythropoiesis stimulating agents, a class of drugs of which Aranesp is a prominent member] in patients with cancer arose" after results of a small clinical trial of epoetin beta in patients with oral, pharyngeal or laryngeal cancer receiving radiation therapy showed worse survival in patients receiving that drug.  Subsequently, in 2008, a meta-analysis of multiple randomized clinical trials showed that patients with cancer receiving ESAs, including Aranesp, had an increased risk of venous thromboembolism (drug clots) and death.(2)  In 2009,  another meta-analysis showed that ESAs lead to decreased survival in patients with cancer.(3)</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Recall, though, that Aranesp is meant to improve anemia.  It was not meant to cure cancer, or even put the disease into remission.  Its use therefore was mainly adjunctive.  Thus, it appears its benefits for cancer patients (improved anemia, and possibly decrease in such symptoms as fatigue) could not outweigh its harms (including hastening death).</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the issue was not merely that Amgen was promoting a drug in an instance in which its use had not been improved by the US Food and Drug Administration (FDA), or that such use of the drug was unnecessarily costly.  The issue was that Amgen was promoting a drug that had no proven benefits for the patients, but could hasten their death.  It appears that Amgen was pursuing profits at the expense of lives.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>Summary</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So it is particularly disturbing that no individual apparently will be held responsible for the promotion of Aranesp for patients for whom its use might prove fatal.  The assurance that the proposed corporate integrity agreement will prevent further abuse is notably hollow.  I can recall no recent case in which the government authorities have used such an agreement to pursue charges against individuals.  The likely deterrent effect of the monetary settlement will likely be minimal.  $762 million may look just like a cost of doing business when the drug in question was bringing in over $2 billion a year (<a href="http://www.latimes.com/business/la-fi-amgen-plea-20121219,0,7120268.story">per the Los Angeles Times</a>).  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> march on and on.  The government continues to extract fines from health care organizations whose actions endanger not only the federal budget, but patients' well being and lives, without even trying to hold individuals responsible.  The impunity of health care corporate executives thus also continues.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">As we have said far too many times, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.</div><div itemprop="articleBody"></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>References</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">1.  Khuri FR. Weighing the hazards of erythropoiesis stimulation in patients with cancer.  N Engl J Med 2007; 356: 2445-2447.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMp078101">here</a>.</div><div itemprop="articleBody">2.  Bennett CI, Silver SM, Djulbegovic B et al.  Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia.  JAMA 2008; 299: 914-924.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=181533">here</a>.</div><div itemprop="articleBody">3.  Bohlius J, Schmidlin K, Brillant C et al.  Recombinant human eryhtropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials.  Lancet 2009; 373: 1532-1542.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2960502-X/abstract">here</a>.</div>

Amgen Settles, Pleads Guilty to Misbranding Aranesp

Now it's Amgen's turn to settle and plead.  Per the New York Times, The biotechnology giant Amgen marketed its anemia drug Aranesp ...

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A Significant Additional Observation on the PA Patient Safety Authority Report "The Role of the Electronic Health Record in Patient Safety Events" -- Risk

At a Dec. 13, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/12/pennsylvania-patient-safety-authority.html" target="_blank">Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events</a>" I alluded to <i>risk</i> in a comment in red italics: <br /><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;"><span class="ms-rteCustom-text-PSASubhead1-H"><span class="ms-rteCustom-text-PSABody-P">... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) <span style="color: red;"><i><b>[a risk best avoided to start with, because luck runs out eventually - ed.]</b></i></span>, and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event.  </span></span></span></blockquote><br />The focus of the report is on how the "events" <i>did not </i>cause harm.  Thus the relatively mild caveat:<br /><blockquote class="tr_bq"><br /><span style="font-family: Arial,Helvetica,sans-serif;">"<span class="ms-rteCustom-text-PSASubhead1-H"><span class="ms-rteCustom-text-PSABody-P">Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure."</span></span></span> </blockquote><br />It occurs that if the title of the paper had been "<b><i>The Role of the Electronic Health Record in</i> <i>Patient Safety <span style="color: red;"><u>Risk</u></span></i></b>", the results might have been interpreted far differently:<br /><br />In essence, from from June 2, 2004, through May 18, 2012 (the timeframe of the Pennsylvania Patient Safety Reporting System or PA-PSRS database), from a dataset <b>highly limited in its comprehensiveness</b> as written in the earlier post, <u>there were approximately 3,000 "events" where an error did occur that potentially put patients at risk</u>.<br /><br />That view - risk - was not the focus of the study.  Should it have been?<br /><br />These "events" really should be called "risk events." <br /><br />It is likely the tally of <b>risk events</b>, if the database were more comprehensive (due to better recognition of HIT-related problems, better reporting, etc.) would be much higher.  So would the reports of "harm and death" events as well.<br /><br />That patient harm did not occur from the majority of "<b>risk events</b>" was through human intervention, which is to say,<i> luck</i>, in large part<br /><br />Luck runs out, eventually.<br /><br />I have personally saved a relative several times from computer-related "risk events" that could have caused harm if I were not there personally, and with my own medical knowledge, to have intervened.  My presence was happenstance in several instances; in fact a traffic jam or phone call could have caused me to have <b>not </b>been present.<br /><br />What's worse, the report notes:<br /><br /><blockquote class="tr_bq">Analysts noted that EHR-related reports are increasing over time, which was to be expected as adoption of EHRs is growing in the United States overall.</blockquote><br />In other words, with the current national frenzy to implement healthcare information technology, these "risk events" - and "harm and death events" - counts will increase.  My concern is that they will increase significantly.<br /><br />I note that health IT is likely the only mission-critical technology<b> that receives special accommodation regarding risk events</b>.  "If the events didn't cause harm, then they're not that important an issue" seems to be the national attitude overall.<br /><br />Imagine aircraft whose avionics and controls periodically malfunction, freeze, provide wrong results, etc., but most are caught by hyper-vigilant pilots so planes don't go careening out of control and crash.  Imagine nuclear plants where the same occurs, but due to hypervigilance the operators prevent a nuclear meltdown.<br /><br />Then, imagine reports of these "risk events" - based on fragmentary reporting of pilots and nuclear plant operators reluctant to do so for fear of job retaliation - where the fact of their occurrence takes a back seat to the issue that the planes did not crash, or Three Mile Island or Chernobyl did not reoccur.<br /><br />That, in fact, seems to be the culture of health IT.<br /><br />I submit that<i> the major focus that needs addressing in health IT is <b>risk</b> </i>- not just confirmed body counts. <br /><br />-- SS<br /><br />

A Significant Additional Observation on the PA Patient Safety Authority Report "The Role of the Electronic Health Record in Patient Safety Events" -- Risk

At a Dec. 13, 2012 post " Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events ...

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