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Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> turns out to be more interesting than it first appeared. The Basic Story: Off-Label Marketing  The story was initially briefly reported in the media.  A <a href="http://blog.seattlepi.com/boomerconsumer/2014/01/09/company-to-pay-40-1-million-to-settle-medicaid-fraud-kickback-charges/">report</a> in the Seattle Post-Intelligencer on 9 January, 2014, was perhaps the most complete, <blockquote class="tr_bq">CareFusion, a manufacturer of medical and surgical supplies and medical devices, has agreed to settle charges of illegal marketing practices and kickback payments for promoting sales of the company’s surgical preparation solution, Chloraprep. Under the terms of the settlement with Washington, other states, and the federal government, CareFusion will pay a total of $40.1 million.</blockquote> In particular,   <blockquote class="tr_bq">When the FDA approves a surgical solution such as Chloraprep as safe and effective, its manufacturer can’t market or promote it for an 'off-label' use – any use not approved by the FDA. Chloraprep was approved for specific inpatient hospital procedures, including the preparation of a patient’s skin prior to surgery or an injection. The FDA rejected its use for prepping the skin prior to inserting catheters into veins for administering medications, or cleaning the skin as part of closing wounds. The lawsuit alleges that from Sept. 1, 2009 to Aug. 31, 2011, CareFusion promoted Chloraprep for improper uses. CareFusion also allegedly publicized unverified information about Chloraprep during the same time period, Ferguson said.</blockquote> So this follows a template we have seen before, most recently <a href="http://hcrenewal.blogspot.com/2014/01/more-pharmaceutical-misadventures.html">here</a>.  A company promotes a drug or device for "off-label" uses.  While physicians are legally allowed to prescribe a drug or use a device for reasons other than its official indications, companies are not legally allowed to promote such uses.  Sometimes it turns out that the drug has benefits that outweigh its harms when used off-label, in which case the violation could be considered technical.  In other cases, the drug might turn out to be useless or even net harmful when used off-label, so the violation indicates putting revenue ahead of patients' welfare.   The reporting on the CareFusion Chloraprep settlement did not clearly suggest that the off-label use was harmful to patients. Allegations of Kickbacks to Promote Off-Label Use, but How? It gets more interesting.  The Post-Intelligencer also noted, <blockquote class="tr_bq">The states also contend that in 2008 CareFusion’s predecessor corporation entered into agreements that CareFusion assumed legal and financial responsibility for. This included payments to Health Care Concepts Inc., payments that were allegedly made to hide kickbacks to the physician-owner of HCC for promoting and influencing providers to use Chloraprep, he said. This violates federal and state anti-kickback laws.</blockquote> Now the allegations also include kickbacks to the "physician-owner" of a company to facilitate off-label promotion.  So the issue goes beyond a technical violation of the law.  The Post-Intelligence report, however, did not make clear what Health Care Concepts Inc actually did to contribute to off-label promotion. A quick attempt to find out more about this company via the web was not fruitful.  There are lots of companies/ organizations called Health Care Concepts or some variant.  The most relevant may be<a href="http://www.hcc1.com/"> this one</a>, which lists CareFusion as a "partner" on its main web-page.  What this company actually does is a bit unclear.  Its business model is <a href="http://www.hcc1.com/node/3">described</a> as "a private incubator of early products, services, and technologies, as well as an accelerator of mature solutions that will be taken to scale." What that has to do with off-label promotion of a product of a big established company like CareFusion is not clear.  How this company could have influenced providers is not clear, given that it is not an advertising firm, public relations firm, or medical education and communication company (MECC). So what is going on here?   Allegations of a $11.6 Million Payment to Manipulate the National Quality Forum Standards Yesterday, 21 January, 2014, Modern Healthcare began to <a href="http://www.modernhealthcare.com/article/20140120/NEWS/301209952/nqf-committee-member-paid-11-6m-by-carefusion-to-influence-panels">explain</a> the mystery.    <blockquote class="tr_bq">Many healthcare companies have been accused of paying kickbacks to influence physicians' medical decisions, but one major supplier allegedly tried to steer an entire industry by influencing the recommendations of the National Quality Forum The NQF, which reviews medical evidence and makes recommendations for improving healthcare, acknowledges that a well-known patient safety advocate is alleged to have received millions of dollars to promote a surgical sterilization product while co-chairing an NQF committee that suggested hospitals use that product.  Federal officials say Dr. Charles Denham, co-chair of NQF's Safe Practices Committee in 2010, received $11.6 million from San Diego-based CareFusion to promote the company's ChloraPrep line of skin-preparation products. Denham's committee at the NQF also recommended surgeons use ChloraPrep products to prevent surgical infections, the NQF said. </blockquote> The allegations about the role of Dr Denham in the NQF also did appear in the the official US Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">press release</a>. Allegations of Bogus Contracts, and Non-Denial Denials The allegations produced some <a href="http://en.wikipedia.org/wiki/Non-denial_denial">non-denial denials</a> (in the phrase found in All the President's Men). Dr Denham responded, but through a lawyer: <blockquote class="tr_bq">A statement from Denham's attorney, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, said reports that the underlying lawsuit involved Dr. Denham were 'blatantly false.' Denham was not accused of wrong-doing in the whistleblower lawsuit, and Gondelman said Denham has and continues to cooperate with investigators in the case.</blockquote> Note that while the attorney denied that Dr Denham was named in the underlying lawsuit, he did not apparently specifically deny the allegations. The NQF also reponded, <blockquote class="tr_bq"> An NQF review committee removed the reference to the specific product before final publication of '<a href="http://www.qualityforum.org/Publications/2010/04/Safe_Practices_for_Better_Healthcare_%E2%80%93_2010_Update.aspx">Safe Practices for Better Healthcare</a>' in 2010. 'An NQF ad hoc review did not find sufficient evidence to support one skin preparation over another,' <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">a statement from the organization said</a>. 'The ad hoc review effectively served its role of rapidly responding when a potential issue is identified.'</blockquote> Note that the <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">NQF press release</a> did not deny that the CareFusion money was given to Dr Denham's organization, nor that the NQF report might have promoted the use of a class of products in which CareFusion's Chloraprep resides. A <a href="http://www.modernhealthcare.com/article/20140121/NEWS/301219952/nqf-panel-member-admits-he-got-11m-from-carefusion-but-calls">follow-up story</a> in Modern Healthcare noted that Dr Denham confirmed the payment of the money to his company, but not its purpose, <blockquote class="tr_bq"> Renowned quality expert Dr. Charles Denham confirms that CareFusion paid his company more than $11 million, but Denham says he was surprised to see the U.S. Justice Department describe the money as kickbacks intended to influence national quality-of-care guidelines published by the National Quality Forum.</blockquote> Dr Denham's lawyer confirmed the payment, but did not further explain it: <blockquote class="tr_bq">Denham's lawyer, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, acknowledged that CareFusion did pay Denham's company under two contracts. </blockquote> And, <blockquote class="tr_bq">Gondelman said the $11.6 million paid to Denham's company covered 'an array of services' and that he could not elaborate.</blockquote> Again, note that Mr Gondelman did not specifically deny that the money served as a kickback. Meanwhile, the Department of Justice alleged something more elaborate, and nefarious,  <blockquote class="tr_bq">The Justice Department, though, says the contracts were written to look as though CareFusion was buying consulting, software development and strategic marketing services, as well as the completion of three unnamed projects. The value of the deals, the government alleges, far exceeded the fair-market costs of those services, and that one of the actual purposes of the deals was to conceal kickbacks to Denham while he served on the National Quality Forum.</blockquote> Interval Summary So what is clear so far is that: -  CareFusion agreed to a $40.1 million settlement of allegations that it provided kickbacks to promote off-label use of its product. -  CareFusion paid $11.6 million to Health Care Concepts -  Health Care Concepts is run (and possibly owned) by Dr Charles Denham, who chaired a National Quality Forum committee that recommended use of CareFusion's product ChloraPrep in a performance standard and the final version of the NQF standard recommended use of a group of products including ChloraPrep We have frequently discussed how health care corporations may promote goods, particularly drugs and devices and services through <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> and unethical practices, including inducements ranging form creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> to outright <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribes </a>and <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>.   We have also discussed the influence of individual and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a> on <a href="http://hcrenewal.blogspot.com/search/label/guidelines">clinical practice guidelines</a>.  This has become an important enough problem for the US Institute of Medicine to weigh in with <a href="http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">standards for trustworthy guidelines</a> that markedly limit such conflicts of interest.  This case seems notable because it may link the problems of <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> and unethical promotion with the influencing of clinical practice guidelines.  It is particularly notable because the organization generating the guidelines in question, the National Quality Forum, has become large, influential, and authoritative.  Re the latter point, the latest Modern Healthcare article affirmed, <blockquote class="tr_bq">The NQF is a standards-setting organization for the healthcare provider industry. It holds the exclusive contract to provide Medicare and Medicaid with recommendations on a national quality-of-care strategy and the measures used to gauge improvements.</blockquote> In fact, while the NQF performance standards can function as guidelines, they also may be bases for <a href="http://hcrenewal.blogspot.com/search/label/pay%20for%20performance">pay for performance</a> schemes that attach real incentives to guidelines, which could become <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse</a> if the guidelines have been manipulated. Can the NQF Defend Against Conflicts, and If Not, Should it Remain So Authoritative? So the big question is whether the NQF, given its unique influence, has any meaningful approach to prevent its standards from being influenced by conflicts of interest? The NQF does have a <a href="http://www.qualityforum.org/docs/CDP_Conflict_of_Interest_Policy.aspx">recent conflicts of interest policy</a>. However, according to my reading, it neither bans committee members with conflicts of interest, nor even requires public disclosure of conflicts of interest.  All it seems to require is that committee members disclose conflicts internally and <strike>voluntarily</strike> recuse themselves from deliberations which may be affected by them.  Although the policy states that conflicts of interest may be made public, I could find nothing in the <a href="http://www.qualityforum.org/Publications/2010/04/Safe_Practices_for_Better_Healthcare_%E2%80%93_2010_Update.aspx">report</a> which Dr Denham co-authored about conflicts of interest or competing interests affecting any of the authors, including Dr Denham Furthermore, a very quick look at information publicly available on the NQF web-site suggests the organization itself may have major institutional conflicts of interest.  The NQF is one of those "public-private partnerships" that have become all the rage.  Several members of its <a href="http://www.qualityforum.org/About_NQF/Board/Board_of_Directors_Roster.aspx">board of directors</a> have leadership positions in large health corporations, financial firms with large health care interests, or trade associations for large health care corporations:  <a href="http://www.qualityforum.org/About_NQF/Board/Elizabeth_Fowler.aspx">- Elizabeth J. Fowler</a>, PhD, JD, is Vice President, Global Health Policy, in the Government Affairs & Policy group at Johnson & Johnson. - <a href="http://www.qualityforum.org/About_NQF/Board/Robert_Galvin.aspx">Robert Galvin</a>, MD, is Chief Executive Officer, Equity Healthcare, at The Blackstone Group.  - <a href="http://www.qualityforum.org/About_NQF/Board/Karen_Ignagni.aspx">Karen Ignagni</a>, President and Chief Executive Officer of America’s Health Insurance Plans (AHIP), is the voice of health insurance plans.... - <a href="http://usa.healthcare.siemens.com/infrastructure-it/healthcare-it/about-health-services/leadership-profile-healthcare-it">J Mark Overhage</a> MD, PhD,  Chief Medical Informatics Officer, Health Services, Siemens Healthcare Thus it is conceivable that they could personally profit, and that their organizations could institutionally profit from standards that favor their organizations' interests.   Furthermore, NQF receives <a href="http://www.qualityforum.org/About_NQF/Funding.aspx">funding</a> from the US government and private foundations, but also from pharmaceutical companies and their in-house foundations: <blockquote class="tr_bq">the Bristol-Myers Squibb Foundation, the Cardinal Health Foundation, Pfizer Inc., Sanofi-aventis,...</blockquote> Unless the current case leads to big changes in the prevalence of conflicts of interest among the NQF board, the continuation of its institutional conflicts of interest generated by its sources of funding, and its weak policy on conflicts affecting committee members, the question becomes whether it should continue to have such an authoritative role? As we have said over and over, pervasive conflicts of interest affect health care decision-makers and policy makers and the organizations within which they function.  Such conflicts threaten to put various private interests way ahead of patients' and the public's health.  If we really want health care that will put patients' and the public's health first, we need to end such arrangements that favor private gain.    Roy M. Poses MD on Health Care Renewal ADDENDUM (23 January, 2014) - A closer re-reading of the NQF conflict of interest policy made it clear that recusal is not voluntary, and that conflicts of interest may be revealed publicly, but that such disclosure is not mandatory.  The paragraph above dealing with these issues was revised accordingly.

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the march of legal settlements turns out to be more interesting than it first appeared. The Basic ...

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Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"

Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial penalties soon start to accrue for non-users or non-adopters of "certified" systems and in at least one state, denial of medical licensure), the HHS's Office of the National Coordinator for health IT released the cutely-named "SAFER" guides ("Safety Assurance Factors for EHR Resilience"). That's progress.  (A previous ONC leader, for instance, had opined that the FDA’s injury findings related to health IT that appeared in the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA memorandum on HIT risks</a> were merely “anecdotal and fragmentary”;  see my April 2, 2011 post "Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector" at <a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html</a>.) While these Guides are a welcome first step, I observe: These Guides are really an admission HHS and the pundits have been pushing a technology, at best, of an unknown safety profile onto medicine and onto the public.  (The harm profile is becoming better understood, e.g., see the ECRI Institute Deep Dive Study on health IT risk at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>, a study not just remarkable for its results but also for its strange regulator and press invisibility).  I guess that's par for the course in today's world. I also opine these guides would not have appeared at all, if not for grass-roots efforts in exposing health IT dangers over the years. That said, more on the guides, and a link to them: <blockquote class="tr_bq"><a href="http://www.healthit.gov/policy-researchers-implementers/safer">http://www.healthit.gov/policy-researchers-implementers/safer</a> SAFER Guides The SAFER guides consist of nine guides organized into three broad groups. These guides enable healthcare organizations to address EHR safety in a variety of areas. Most organizations will want to start with the Foundational Guides, and proceed from there to address their areas of greatest interest or concern. The guides identify recommended practices to optimize the safety and safe use of EHRs. The content of the guides can be explored here, at the links below, or interactive PDF versions of the guides can be downloaded and completed locally for self-assessment of an organization’s degree of conformance to the Recommended Practices. The downloaded guides can be filled out, saved, and transmitted between team members.</blockquote> The overall purpose: <blockquote class="tr_bq">This guide is designed to help safely manage the individual and organizational responsibilities in a complex "sociotechnical" healthcare organization. </blockquote> (I note that "sociotechnical" is not really a decriptor of an organization; rather, it is a descriptor of inter-related issues in a healthcare organization.  More properly, a healthcare organization is an entity where implementation of health IT requires "consideration of many sociotechnical issues", or, "is an organization that is sociotechnically complex".  I also note a somewhat loose use of the scientific term "Informatics" in the guides, e.g., "Informatics-type department."  But, whatever.  When a word is used in healthcare today, it means, paraphrasing what a character in a Lewis Carroll book said to a woman named Alice, just what the healthcare leadership chooses it to mean - neither more nor less. (The irony is that Medical Informatics is a field that has as one of its major core competencies the defining of precise language and definitions.) Read the Guides at the above link, but these "guides" are really a set of "Health IT 101", Masters-of-the-Obvious rules of thumb, presented in a "sparse display" format. For instance: <ul><li>The highest-level decision makers (e.g., boards of directors or owners of physician practices) are committed to promoting a culture of safety that incorporates the safety and safe use of EHRs.</li></ul><ul><li>An effective decision-making structure exists for managing and optimizing the safety and safe use of the EHR.</li></ul><ul><li>Staff members are assigned responsibility for the management of clinical decision support (CDS) content.</li></ul><ul><li>Practicing clinicians are involved in all levels of EHR safety-related decision making that impact clinical use.</li></ul> I won't display them further. While this is not an unwelcome development, here are the caveats: 1.  Disclaimer on page 1 of "Organizational Responsibilities" document: <blockquote class="tr_bq">In some instances, Meaningful Use and/or HIPAA Security Rule requirements are identified in connection with recommended practices. The SAFER Guides are not intended to be used for legal compliance purposes, and implementation of a recommended practice does not guarantee compliance with Meaningful Use, HIPAA, or other laws. The SAFER Guides are for informational purposes only and are not intended to be an exhaustive or definitive source. They do not constitute legal advice or offer recommendations based on a healthcare provider’s specific circumstances. Users of the SAFER Guides are encouraged to consult with their own legal counsel with regard to compliance with Meaningful Use, HIPAA, and other laws.</blockquote> "For informational purposes only?" Wow.  I feel SAFER already ... (too late for my mother, though). <table cellpadding="0" class="Bs nH iY" role="presentation"><tbody><tr><td class="Bu">Who is going to evaluate whether hospitals are carrying out these recommendations properly?    Joint Commission?  FDA?  As it appears now, the answer is ... nobody.  </td></tr></tbody></table> In effect, these "guidelines" are issued for "self-assessment" in a regulatory vacuum, with no validation of compliance, no reporting requirements, no formal surveillance, etc.  Hiring the right people, doing all these things, and doing them effectively, is not cheap. Translation: these guidelines are safely ignored, to be put on a shelf somewhere. 2.  The focus of these documents seems to put the responsibility for health IT safety on the customer/user.  Problem is, the ability to compensate for the deficits of fundamentally poorly designed and bad health IT is limited, just as a "safe flying practices" manuals for pilots cannot compensate completely for faulty aircraft design.  Especially if the manuals are for "self assessment" and there is no FAA-mandated oversight, testing and operational surveillance ... 3.  Thus, these guides appear to be a "baby step" in the true sense of the word, and "tension management" in the political sense, a term used by my claimed-Communist sociology professor several decades ago to refer to government actions that made it appear, falsely, that the government was truly "doing something" for the people.  While I am certainly not a Communist, he had a point... <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWSGFFdv9UG9AMt1HpcQpSULolTX-pATxEc9hW4tQJiNySMgmh3P8MjLvCnvrqc2bXIClwbKrJs4_UHUN_mFdTJps6bwhtffM3I2Ftgl4xzfTyfFlIUNWR5o3uwlnTApItIDurTvsb3mJT/s1600/caspar.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWSGFFdv9UG9AMt1HpcQpSULolTX-pATxEc9hW4tQJiNySMgmh3P8MjLvCnvrqc2bXIClwbKrJs4_UHUN_mFdTJps6bwhtffM3I2Ftgl4xzfTyfFlIUNWR5o3uwlnTApItIDurTvsb3mJT/s1600/caspar.jpg" width="145" /></a></div> In summary, while welcome, at best a "milk and toast" award needs to be given to HHS and its health IT arm, ONC for these guidelines. -- SS

Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"

Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial pena...

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Computers + a few docs can manage "an entire city", and other cybernetic miracles

The computing aboard the Apollo spacecraft, that provided computation and electronic interfaces for guidance, navigation, and control of the spacecraft that went to the moon, was primitive by today's standards.   From Wikipedia (<a href="http://en.wikipedia.org/wiki/Apollo_Guidance_Computer">http://en.wikipedia.org/wiki/Apollo_Guidance_Computer</a>): <blockquote class="tr_bq">The Apollo flight computer was the first to use integrated circuits (ICs). While the Block I version used 4,100 ICs, each containing a single 3-input NOR gate, the later Block II version (used in the crewed flights) used 2,800 ICs, each with dual 3-input NOR gates.  [Today's CPUs alone have millions of logic gates and can have billions of transistors, <a href="http://en.wikipedia.org/wiki/Transistor_count">http://en.wikipedia.org/wiki/Transistor_count</a> - ed.]  The ICs, from Fairchild Semiconductor, were implemented using resistor-transistor logic (RTL) in a flat-pack. They were connected via wire wrap, and the wiring was then embedded in cast epoxy plastic. ... The computer had 2048 words [2K - ed.] of erasable magnetic core memory and 36 kilowords of read-only core rope memory. Both had cycle times of 11.72 micro-seconds. The memory word length was 16 bits: 15 bits of data and 1 odd-parity bit. The CPU-internal 16-bit word format was 14 bits of data, 1 overflow bit, and 1 sign bit (ones' complement representation).</blockquote> Today's computers that you buy in WalMart have several million times more memory and long term storage, and are thousands or millions of times faster.  Very roughly, a cycle time of 11.72 microseconds or 0.00001172 seconds/cycle translates out to about 85,324 cycles/second = 85 KHz = 0.085 MHz.  Today's computers have clock speeds in the GHz (1 GHz = 1,000 MHz = 1,000,000 KHz) and do far more per clock cycle than the Apollo guidance and navigation computers. Therefore, we should be going to the moon millions of times faster, and millions of times cheaper, requiring millions of less man-hours of work, now than in 1969, no? This, of course, is bizarre and absurd, but it is the type of wild (il)logic received by Presidents and Congress and other national leaders regarding healthcare computing: <blockquote class="tr_bq"><a href="http://www.healthcareitnews.com/news/mu-creates-medical-bridges-nowhere">http://www.healthcareitnews.com/news/mu-creates-medical-bridges-nowhere</a> MU creates 'medical bridges to nowhere' Clinton Foundation event draws industry heavyweight who would change meaningful use if he could January 15, 2014 As far as Patrick Soon-Shiong is concerned, the $34 billion health IT and electronic medical record incentive program was a grave misstep for the healthcare industry -- but not necessarily for the reasons one might think. Soon-Shiong, MD, who serves as chairman and chief executive officer of healthcare IT company NantHealth and heads the Chan Soon-Shiong Family Foundation, said one of the biggest failures that led to the creation of the Meaningful Use EHR Incentive Program was an inherently flawed mindset of how we view the healthcare industry. "Nobody has looked at healthcare as a systems approach," he said, speaking at the Clinton Foundation's 2014 Health Matters Conference Tuesday.</blockquote> I don't think that "nobody" has looked at healthcare via a systems approach, but the point is well-taken. <blockquote class="tr_bq">... The meaningful use program, Soon-Shiong opined, incentivized providers with a process issue, not an outcomes issue -- so what big effect does that have on patient care? The effect, he said, could be much bigger.  </blockquote> All we need is to do a few things with computers and interopearability, and... <blockquote class="tr_bq">... Soon-Shiong then opted to act on his own, privately. He sold two of his companies, Abraxis BioScience and American Pharma Partners, took $1 billion from the sales and starting building an integrated, interoperable clinical operating system. This system, he says, talks to any software.   </blockquote><blockquote>The operating system has been up and running for three million people with cancer and used by some 8,000 oncologists for the past three years, said Soon-Shiong. "We've built in a software system that actually takes 10,000 cancer protocols and provides for the doctor in real time the knowledge of which cancer protocol to give to the patient."   He then went further, inking deals with Verizon and AT&T to build an electronics company that created boxes that could talk to each other -- blood pressure machines, pulse oximeters, you name it. Soon-Shiong and his team wrote to the APIs of 6,000 medical devices made from every different vendor, and went into hospitals with a real-time wireless, biometric connect box. "We are now capturing 3 billion vital signs, real-time, self-populating in the electronic medical record," he explained. Device connectivity is now operational at more than 250 hospitals, according to NantHealth officials, 120 of those being Epic sites. </blockquote> And now ... Presto! <blockquote class="tr_bq">... Soon-Shiong and his team also have an Internet-based telemedicine device with a four-to-five way video conferencing ability. "If you look at this from a systems perspective, if you can now manage a patient from a home, a clinic, hospital and through a supercomputer do the genomic analysis in 47 seconds, which we've now accomplished," said Soon-Shiong, "you then have an engineered system for the nation." </blockquote> Here's where we go off the cliff of Cybernetic Miracles: <blockquote>... He continued, "You have the ability to create what I call, 'NORADs' of healthcare. You then have the ability to create a building with three cardiologists, 10 oncologists, two pathologists, one pediatrician that can manage an entire city."  </blockquote> 3 cardiologists, 10 oncologists, 2 pathologists, 1 pediatrician + computers can manage an entire city. Remotely. Strap yourself in for the next departure from your local spaceport to the moon.  We have the high-speed computing and the Internet, after all ... For related health IT and moon illogic, see my 2007 presentation to the IEEE Medical Technology Policy Committee "To The Moon In A Hot Air Balloon:  Why Is Clinical IT Difficult?" at <a href="http://www.cci.drexel.edu/faculty/ssilverstein/IEEE_12102007.zip">http://www.cci.drexel.edu/faculty/ssilverstein/IEEE_12102007.zip</a>. -- SS

Computers + a few docs can manage "an entire city", and other cybernetic miracles

The computing aboard the Apollo spacecraft, that provided computation and electronic interfaces for guidance, navigation, and control of the...

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More Pharmaceutical Misadventures - Actelion Damages Upheld, Genzyme (Sanofi Subsidiary) Settled, Merck Fined

The march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations goes on, albeit with ever more quiet footsteps as the number of journalists available to amplify their sounds declines.  Last week we <a href="http://hcrenewal.blogspot.com/2014/01/pharmalot-sent-down-memory-hole.html">noted</a> the shutdown of PharmaLot, a journalistic blog edited by Ed Silverman that was one of the few that reported fearlessly on the pharmaceutical industry, warts and all. So we dedicate this round up of legal settlements by pharmaceutical companies announced last month, December, 2013, to Ed Silverman, who reported on two of the cases below, and whose reports have been silenced by the shutdown of the PharmaLot web-site by its corporate owner. In alphabetical order by name of the pharmaceutical company, Actelion $40.7 Million Damages for Keeping Possibly Competitive Drug Off the Market Upheld This story was reported by Ed Silverman on Pharmalot, and <a href="http://www.sfgate.com/business/article/Actelion-loses-appeal-in-lung-drug-case-5079481.php">by the San Francisco Chronicle</a>.  The basics, according to the latter article, were: <blockquote class="tr_bq">A state appeals court has upheld $407 million in damages against the Swiss biotechnology giant Actelion and its executives for buying a Bay Area company and using it to thwart another firm's plans to market a competing hypertension drug in the United States. The drug, Fasudil, is manufactured by Ashai Kasei Pharma Corp of  Japan<a href="http://www.sfgate.com/?controllerName=search&action=search&channel=business&search=1&inlineLink=1&query=%22Asahi+Kasei+Pharma+Corp.+of+Japan%22"></a> for treatment of pulmonary arterial hypertension, an often fatal disease of the lung arteries. In June 2006, Asahi signed a licensing agreement with the South San Francisco biotech firm CoTherix, which agreed to develop oral and inhaled versions of Fasudil and seek regulatory approval in the U.S. and Europe. Less than five months later, Actelion bought CoTherix, paying a premium price of more than $400 million, and announced soon afterward that it was dropping plans to develop Fasudil. Actelion's own drug, Tracleer, dominates the U.S. market for treatment of the same disease and generates more than $1 billion in revenue a year.</blockquote> Note that the federal appeals court judge, Terence Bruiniers, found that the actions by Actelion were not only anti-competitive, but may have harmed patients, <blockquote class="tr_bq">'By impeding the development of Fasudil, Actelion not only sabotaged a competitive and foreseeably profitable commercial venture, but prevented a drug with the potential for alleviating the suffering of patients with life-threatening and debilitating diseases from reaching the market,' Bruiniers wrote.</blockquote> Further note that in this civil lawsuit, it appears that the top executives who engineered the anti-competitive actions that may have harmed patients will actually face negative consequences.  The judge also said, <blockquote class="tr_bq">the jury was entitled to conclude that three Actelion executives - CEO Jean Paul Clozel, chief scientific officer Martine Clozel, and Simon Buckingham, director of corporate and business development - had shown a disregard for the rights of Asahi and its customers and were liable for $30 million in punitive damages, about 10 percent of the executives' net worth.</blockquote> Sanofi Subsidiary Genzyme Settled Charges of Encouraging Unapproved Internal Use of SepraFilm for $22 Million The longest version of this story appeared <a href="http://www.tampabay.com/news/courts/civil/boston-biotech-firm-genzyme-agrees-to-pay-22-million-in-tampa/2158332">in the Tampa Bay Times</a>.  The basics were:  <blockquote class="tr_bq"> A Massachusetts-based biotechnology company has agreed to pay $22.28 million to resolve allegations brought by whistle-blowers in Tampa and Miami that it marketed an inappropriate use for a surgery medication, U.S. government attorneys said. Genzyme, a corporation known for its research into drugs for rare genetic diseases, is paying the settlement in a lawsuit over Seprafilm, a material it manufactures for use in the operating room. According to court documents, Genzyme sales representatives encouraged doctors to use the product in a manner not approved by the U.S. Food and Drug Administration, leading to improper claims for reimbursement from hospitals.</blockquote> The details were: <blockquote class="tr_bq"> According to court documents, Seprafilm is intended to be applied during open surgery to prevent organs and muscle tissue from sticking together. However, the whistle-blowers and lawyers for the federal government alleged that Genzyme sales representatives taught doctors to use it in less invasive procedures — such as laparoscopic or 'keyhole' surgeries — by mixing it into a liquidlike 'slurry' that could be injected into the body.</blockquote> Apparently the sales representative who blew the whistle in this case "recognized that this was a potential danger."  It certainly seems possible that the unapproved use of this material modified to be injected within the body might have resulted in harm to patients, and that at least its harmfulness when used in this manner had had never been tested.  However, in this litigation as supported by the US Department of Justice the plaintiffs were "not required to prove ... that patients had been harmed." Note that unlike the civil case above, and as is typical of federal lawsuits against big health care organizations, those company employees who authorized or directed the questionable actions did not suffer any negative consequences. (Added on 19 January, 2013) - Further note that as the article implied, but did not emphasize, since 2011, Genzyme has been owned by Sanofi.  Sanofi's last three major settlements since 2007 were summarized <a href="http://hcrenewal.blogspot.com/2012/12/tis-season-for-legal-settlements.html">here</a>.  Merck Fined 15.3 Million Euros for Smear Campaign Against Generic Competition This case was reported by Ed Silverman on PharmaLot, and briefly <a href="http://www.reuters.com/article/2013/12/19/france-fine-idUSL6N0JY2DE20131219">by Reuters</a>, <blockquote class="tr_bq">The French competition authority said on Thursday it had fined Schering-Plough, now owned by Merck, 15.3 million euros ($21 million) over what it called a smear campaign against generic competition to Subutex, its drug for opioid addiction. It also handed out a fine of 414,000 euros to parent Merck and another of 318,000 euros to British supplier Reckitt Benckiser for anti-competitive behaviour in staging the campaign in late 2005.</blockquote> Note that while this case did not involve any implications of physical harm to patients, it seemed to involve active deception. Summary First, as we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">said for years</a>, legal actions like those listed above may or may not result in huge financial penalties, and rarely result in penalties for individuals who authorized, directed or implemented the actions in question, but do serve as markers of the extent of misbehavior by large health care organizations.  Such misbehavior may have adverse consequences for patients and for public health and the health care system. Second, also as we have said for years, such actions mark the problem, but are unlikely to deter future problems.  In fact, many large health care organizations have settled strings of cases since we started trying to keep track of them (and may not have done so completely).  For example, the Genzyme, hence Sanofi settlement this year is at least the fourth major settlement by this company since 2007.  Settlements resulting in fines imposed on a company as a whole are diffused, paid by stockholders, employees, and patients, and hence are likely to be regarded as a cost of doing business by top  management.  Managers, however, often are given huge financial incentives for all actions that increase short term revenue.  So managers are likely to continue to enable or direct bad behavior as long as it can bring in lots of revenue at no personal risk. Third, while there has been a modest increase in discussion of ill-informed, mission-hostile, self-interested, conflicted, or even criminal or corrupt management since we started Health Care Renewal, the increasing plight of journalism seems to be making these issues more <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  The shutdown of PharmaLot and the silencing of its archives is another reminder of how public relations and marketing are now overwhelming disinterested reporting (see <a href="http://www.propublica.org/article/pr-industry-fills-vacuum-left-by-shrinking-newsrooms">this report</a> by Pro Publica). If we really want to reverse the downward spiral of our ever more expensive, less accessible, and lower quality health care system, we first have to preserve our ability to identify and loudly discuss its problems. Roy M. Poses MD for Health Care Renewal

More Pharmaceutical Misadventures - Actelion Damages Upheld, Genzyme (Sanofi Subsidiary) Settled, Merck Fined

The march of legal settlements by large health care organizations goes on, albeit with ever more quiet footsteps as the number of journalis...

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WaPo: "When treating a patient with dementia, electronic health records fall short"

Which raises the question:  for what patient types do EHRs in 2014 not "fall short" in many of the ways cited by this author? <blockquote class="tr_bq">When treating a patient with dementia, electronic health records fall short By Regina Harrell and Pulse December 23, 2013 <a href="http://www.washingtonpost.com/national/health-science/when-treating-a-patient-with-dementia-electronic-health-records-fall-short/2013/12/20/7bb51b34-416d-11e3-a751-f032898f2dbc_story.html">http://www.washingtonpost.com/national/health-science/when-treating-a-patient-with-dementia-electronic-health-records-fall-short/2013/12/20/7bb51b34-416d-11e3-a751-f032898f2dbc_story.html</a></blockquote><div class="article_body entry-content classic"><blockquote></blockquote> <article><blockquote>I am a primary-care doctor who makes house calls in and around Tuscaloosa, Ala. Today my rounds start at a house located down a dirt road a few miles outside town. ... We chat about the spring garden and the rain, then we move on to Mr. Edgars’s arthritis. Earlier on in his dementia, he wandered the woods, and his wife was afraid he would get lost and die, although the entire family agreed that this was how he would want it. ... We talk about how anxious he grows whenever she’s out of his sight and how one of his children comes to sit with him so that she can run errands. </blockquote> The omitted lines of this physician's encounter are poignant.  Read them at the Wash. Post link above. <blockquote class="tr_bq">... When I get back to the office, I turn on the computer to write a progress note in Mr. Edgars’s electronic health record, or EHR. In addition to recording the details of our visit, I must try to meet the <a data-xslt="_http" href="http://www.healthit.gov/providers-professionals/meaningful-use-definition-objectives">new federal criteria for “meaningful use</a>,” criteria that have been adopted by my office with threats that I won’t get paid for my work if I don’t.</blockquote> The "meaningful use" criteria, I point out, are an unproven experiment, decided upon by committee.   They are not evidence-based.  Physicians are, in effect, being threatened with nonpayment as part of the experiment.  They have become experimental subjects themselves, for free, and without true informed consent. <blockquote class="tr_bq">Under “History of Present Illness” (HPI), I enter “knee pain.” Up pops a check-box menu: injury-related (surely the chronic wear on Mr. Edgars’s knees from his work as a farmer is some sort of injury, but I don’t think that’s what the computer programmer had in mind), worsening factors (I know of none that apply, since he couldn’t give his own history), relieving factors (there’s no check box for a tired, sleep-deprived wife who’s purposely keeping the dose of acetaminophen low) and so on. Nothing fits, so I exit the HPI and type in “follow-up” (f/u), for which my EHR doesn’t have a pop-up menu. It yields only a blank screen.</blockquote> As a medical student, I was forbidden to use paper templates to "remind me" of what I needed to record in an H&P or progress note.  The "table of contents" had to be learned and applied from memory.  The continued patronization of physicians, nurses and other clinicians via templates like this, and the resultant de-skilling, time-wasting and other deleterious effects, is harmful to quality care.  This physician comments later that without EHRs and "meaningful use," she could see twice as many patients. <blockquote class="tr_bq">I type the Edgars’s story in my own words, so different from the computer-speak generated by the check boxes. I move on to the Review of Systems — another pop-up menu.</blockquote> Translation:  handwritten or typed narrative is meaningful; computer-generated prose is largely "legible gibberish", i.e., garbage.  I note that the EHR output in a recent ED visit of my own would have received a failing grade for documentation quality when I was in medical school - and I would have had serious words with a trainee who'd written such sloppy prose when I was a senior resident and attending. <blockquote class="tr_bq">I used to simply write “patient is an unreliable historian” at the beginning of this section, but the computer doesn’t understand that this statement could apply to the entire review.  [Actually, the designers and programmers who believe they are "revolutionizing" the field didn't understand the real world of clinical medicine - ed.] Using a template, it generates a page of 13 sentences, one for each body system, and, under each sentence, the option “Positive: Other: unreliable historian.”  [Which much then be clicked 13 times - ed.] Sometimes I wonder if it is disrespectful to a patient to say 13 times in one progress note how unreliable a historian he or she is, but I remember that this is great data to mine for research, so I plug on.</blockquote> This is not just "disrespectful", but a waste of clinician time. <blockquote class="tr_bq">Under “Physical Exam,” there is a template for geriatric patients. I pretend that the computer-speak it generates creates logical sentences, although I know better. In the check boxes, a person can be oriented to person, place and time, or not. Mr. Edgars is oriented to person and place; he knows that he is with his wife and at home, and is happy nowhere else. He no longer cares what year it is. There isn’t a check box for that.</blockquote> Obviously this "feature" was not even run by medical students, who know that orientation is not "x3" or "none" as the only pertinent options. Technically speaking, this represents inadequate and insufficiently granular data modeling ... a task I wrote years ago that requires the highest levels of clinical and biomedical informatics expertise, not computer or programming expertise.  There are likely many other examples of poor data modeling in this EHR. <blockquote class="tr_bq">I remember that I must go back to “Social History” and document tobacco use. It occurs to me that if you have not tried tobacco products by your 80th birthday, you are unlikely to suddenly change your mind. Especially when you can’t remember where the store is to buy them. So I slog through the series of check boxes for “never smoker,” an extra six mouse clicks.</blockquote> More wasted time. <blockquote class="tr_bq">After 15 minutes, the note is finished. And on goes my day of house calls, five in all.  There aren’t enough physicians to see all the homebound patients in my area, so I try to visit as many as I can safely care for. At day’s end, I review my meaningful use.  I spent more time checking boxes than talking to patients and their families. I could see twice as many patients if I could write their notes at the bedside while visiting with them.</blockquote> In other words, in this underserved area in and around Tuscaloosa, Ala., the "meaningul use" of EHRs deprives homebound patients of care. <blockquote class="tr_bq">I would happily do this on paper or using an EHR that created a logical note within the same amount of time. But that is not an option.</blockquote> Such EHRs are rare, if they exist at all.  Besides, this physician is likely contractually bound to use some larger organization's choice. <blockquote class="tr_bq">The reality is that I spend more time talking to the Information Technology people about Internet connections, firewalls and box-checking than I do answering messages from concerned family members.</blockquote> In other words, computerization is in the way of the best practice of medicine. <blockquote class="tr_bq">As a teaching doctor, my feedback to the residents now consists mainly of explaining how to document their visits so that we will all get paid, instead of teaching them how to take care of frail elders in their homes.</blockquote> I remember my community medicine clerkship in the early 1980s in a relatively underserved region in Maine.   Other classmates at Boston University School of Medicine did similar clerkships in Roxbury, an exceptionally poor and harsh section of Boston near Boston City Hospital.  We were taught patient care...with nothing less than the patient's best interests at heart.  Medicine today is now being financially and cybernetically deprived of its heart and soul. </article><article> </article><article>I believe I can honestly say the EHR here contributed nothing to the care of this patient, and was deleterious to the overall clinical mission for this patient, and for others. <blockquote class="tr_bq">Harrell is a geriatrician and assistant professor of family medicine at the College of Community Health Sciences, University of Alabama. This is an edited version of a story that originally appeared in <a data-xslt="_http" href="http://pulsemagazine.org/archive/stories/310-checking-boxes">Pulse — Voices From the Heart of Medicine</a>, an online magazine of stories and poems from patients and health-care professionals.</blockquote> I hope that patients who are not suffering dementia will increasingly take notice that these systems are depriving them of their clinicians' attention and of providing good documentation for their future care.  </article><article> </article><article>Clinicians themselves, with the exception of some unionized nurses, have grown largely complacent about bad health IT, the "meaningul use" experiment and IT's getting in the way of medical care to feed the bureaucracy. -- SS</article><article> </article><article>Jan. 15, 2014 Addendum: </article><article> </article><article>The reader comments at the original story in "Pulse" magazine are worth reading, and are at the bottom of this page:  <a href="http://pulsemagazine.org/archive/stories/310-checking-boxes">http://pulsemagazine.org/archive/stories/310-checking-boxes</a></article><article> </article><article>-- SS</article></div><div class="article_body entry-content classic"></div>

WaPo: "When treating a patient with dementia, electronic health records fall short"

Which raises the question: for what patient types do EHRs in 2014 not "fall short" in many of the ways cited by this author? When...

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PharmaLot Sent Down the Memory Hole

As noted in blog posts (<a href="http://www.the-scientist.com/?articles.view/articleNo/38780/title/Goodbye--Pharmalot/">The Scientist</a>, the <a href="http://pharmamkting.blogspot.com/2013/12/where-have-all-critical-pharma-bloggers.html">Pharma Marketing Blog</a>, <a href="http://shearlingsplowed.blogspot.com/2014/01/if-you-know-ed-and-like-his-work-please.html">Shearlings got Plowed</a>), and one solitary newspaper article (<a href="http://www.utsandiego.com/news/2014/Jan/02/pharmalot-ubm-canon-silverman/">San Diego Union-Tribune</a>), Ed Silverman's PharmaLot blog is no more. The main page of the blog has been replaced with a simple announcement. <blockquote class="tr_bq">UBM Canon has ceased the production of the following brands: Med Ad News, PharmaLive.com, Pharmalot, eKnowledgeBase and R&D Directions. Thank you for your loyalty and support that has played such an important part over the last thirty years. </blockquote> As others have noted, the shutdown of PharmaLot will remove an important source of news and opinion about the pharmaceutical and biotechnology industry.  Ed Silverman provided unbiased, insightful reporting.  Notably for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> audience, he was not afraid to report on the good, the bad, and the ugly. He was no friend of marketing and public relations smarm.  Often he was first to break stories involving legal settlements, guilty pleas, and miscellaneous misconduct, and in some cases was one of the few to document such stories. For example, in my current file, I note that PharmaLot provided one of the few accounts of a $21 million fine imposed on Merck by French antitrust regulators (here is the brief <a href="http://www.reuters.com/article/2013/12/19/us-france-fine-idUSBRE9BI0Q420131219">Reuters version</a>.)  PharmaLot reported on a judgement against Actelion for anti-competitive practices in support of its drug for pulmonary artery hypertension.  The only other media report on this was <a href="http://www.sfgate.com/business/article/Actelion-loses-appeal-in-lung-drug-case-5079481.php">in the San Francisco Chronicle</a>, and it was less detailed.  As we have noted endlessly, bad behavior by large health care organizations, including pharmaceutical and biotechnology companies and the various organizations with which they interact, like <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communication companies (MECCs)</a>, etc has often been <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  If one likes to get along by going along, it is not a good idea to make too much of a fuss about such issues and <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 of clinical research</a>, <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a> in  <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a>, and <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> including the creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interests</a>, much less outright <a href="http://hcrenewal.blogspot.com/search/label/crime">crime </a>and <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corruption</a>.  Ed Silverman was known to fuss about such issues. So the loss of his ongoing reporting, and willingness to post controversial interviews and editorials, will be sorely missed. Even more concerning, however, is the loss of his previous work. As noted in <a href="http://www.the-scientist.com/?articles.view/articleNo/38780/title/Goodbye--Pharmalot/">The Scientist's blog</a>, the PharmaLot archives are now inaccessible.  Although there are workarounds for the web-savvy that may allow retrieval of some of his previous work, especially if one knows what one is looking for, straightforward access is now difficult, and may become more difficult as it ages. Since PharmaLot provides an important archive of important problems with ethics, management and governance in the pharmaceutical and biotechnology industry, and since such issues as noted above often go minimally or not reported, permanent loss of previous PharmaLot content would be a big blow to transparency in health care, and a big boost for the anechoic effect. The current owner of PharmaLot is UBM Canon.  This company, as noted by a comment on The Scientist's blog post, easily verified <a href="http://ubmcanon.com/medical/">here</a>, is heavily involved with marketing and promotion for the pharmaceutical industry.  I can only hope that they will not succumb to any temptation to suppress the important documentation of the industry that PharmaLot provided, even if that documentation might have not always made industry honchos happy.  ADDENDUM (17 January, 2014) - the <a href="http://www.outcomes-marketing.com/pharmalot">PharmaLot site </a>is now entirely unavailable, that is, going to it yields a 404 not found error.

PharmaLot Sent Down the Memory Hole

As noted in blog posts ( The Scientist , the Pharma Marketing Blog , Shearlings got Plowed ), and one solitary newspaper article ( San Diego...

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The Smarming of Health Care - How to Spin a Minimally Efficacious Variant on an Old Drug as New and Wonderful

A recent announcement of the approval of a new drug showed the latest ways pharmaceutical companies can spin products as new and effective when in reality they are barely either.  Announcing a Drug Approval with a Twist United Therapeutics just got US Food and Drug Administration (FDA) approval for their new oral prostacyclin agent for the treatment of pulmonary arterial hypertension. The basics, <a href="http://www.bloomberg.com/news/2013-12-21/united-therapeutics-wins-u-s-approval-for-lung-therapy.html">per Bloomberg</a>, were: <blockquote class="tr_bq">United Therapeutics Corp. (UTHR)’s gained U.S. marketing approval for the oral version of its treatment for high blood pressure in the arteries that supply the lungs. The Food and Drug Administration cleared orenitram, an extended-release tablet, for the treatment of pulmonary arterial hypertension to improve exercise capacity in some types of patients, the Silver Spring, Maryland-based company said today in a statement. The pill’s active ingredient, treprostinil, is the same as in the company’s approved injection and inhalation solution for PAH, a life-threatening disorder, United Therapeutics said. The FDA had rejected the oral version of the therapy in March and in October> 'This approval marks the first time that the FDA has approved an orally administered prostacyclin analogue for any disease -– and our fifth approval from the FDA for treatment of PAH -- supporting our mission of providing a wider choice of PAH therapies for physicians and patients,' Roger Jeffs, the company’s president and chief operating officer, said in the statement. 'We are grateful for the FDA’s thorough review and will continue to build clinical support for the use of Orenitram.' </blockquote> But the triumphant announcement by the company CEO had some unusual twists.  As<a href="http://www.npr.org/blogs/health/2013/12/24/256839330/orenitram-united-therapeutics-names-pill-after-ceo-who-sought-daughters-cure"> reported</a> on National Public Radio's (NPRs) Shots blog, <blockquote class="tr_bq">'When I started the company 17 years ago, the only option for treating pulmonary hypertension was intravenous ,' Martine Rothblatt, CEO of United Therapeutics told investors in a celebratory conference call Monday. 'My young daughter looked at me and said, 'Can't there be a pill?'' Now there is </blockquote> So,  <blockquote class="tr_bq">'What it has resulted in is something that as the parent of a lovely young lady with pulmonary hypertension, I cannot even put into words, the emotional meaning that it has to have a pill form of prostacyclin,' Rothblatt said.</blockquote> It appears to be such a warm and happy story.  A mother is so concerned about her daughter's serious illness that she founds a company to develop treatments for it.  Now many years later they have come up with something groundbreaking. How could anyone not shed a tear?  How could anyone not be happy about this triumph of commercial drug development. However, while it may seem snarky to point this out, drug development is usually about issues other than "emotional meaning," and this discussion of emotional meaning took place during the public relations/ marketing blitz put on after the approval of the marketing of a new drug, so maybe closer examination, and some skepticism are warranted. How Well Does Orenitram Work? The quote above from the CEO was about "emotional meaning," not efficacy or effectiveness.  In fact, the blog post by Mr Hensley hinted at and a review of the one relevant published article strongly suggested that the drug really had minimal efficacy, and possibly benefits that failed to outweigh its harms. Mr Hensley wrote, <blockquote class="tr_bq"> The FDA approved Orenitram on the basis of a study that gauged its safety and effectiveness as a standalone treatment. The drug helped people walk a little farther in a timed walking test. The most common side effects seen in the study were headache, nausea and diarrhea.</blockquote> On my review of the evidence.... A single randomized controlled trial(1) showed that patients given treprostinil could walk on average 26 meters (less than 100 feet) more in 6 minutes after 12 weeks of treatment than they could at the beginning of the treatment, while those given placebo were only able to walk about as far as they did before.  The treated patients also had some improvement in their shortness of breath.  On the other hand, they were substantially more likely to experience adverse effects, particularly nausea, vomiting, diarrhea, flushing, jaw pain, or pain in the extremities.  Furthermore, the study lasted only 12 weeks, and provided no information about outcomes after that.  Treated patients were not spared overall worsening of their clinical situation compared to untreated patients.  Treated patients were no less likely to be hospitalized or to die. Various aspects of its design may increase doubts about its validity, including emphasis on a "modified intention-to-treat population" which was not clearly defined, a relatively high rate of premature study drug discontinuation, and a complex statistical analysis scheme which seemed unnecessary to assess the main results of a randomized controlled trial. Finally, the generalizability of the study was limited to patients already optimally treated with conventional therapy, and perhaps by ist predominantly Asian female population. So the only apparently positive trial of trepronsinil did not provide good evidence that its benefits outweighed its harms.  At best, some patients might find that the modest increases in exercise capacity and decreases in dyspnea it may produce may be worth nausea, vomiting, diarrhea, flushing, or jaw or extremity pain.   Note that treprostinil is an oral version of a type of compound called a prostacyclin.  As noted above, United Therapeutics markets other forms of prostacyclin.  However, the latest (2005) Cochrane Collaboration systematic review of this class of drugs for pulmonary arterial hypertension only found evidence that the drugs helped when added to first-line drugs to improve symptoms for the short-term, no more than 12 weeks.  It found no evidence that prostacyclin prolongs survival, or lessens complications of the illness(2)  So having an oral prostacyclin treatment for PAH may have emotional meaning, but the pill, while likely more convenient than an injectable prostacyclin, does not seem to have sufficient efficacy to outweigh its harms for many patients.  What Does Orenitram Cost, and Why? But United Therapeutics may have been able to make one aspect of this drug superlative, - its price.  Per Scott Hensley in the Shots blog, <blockquote class="tr_bq">Orenitram won't be available for sale for about six months, the company said, and its exact price hasn't been determined either. But it will be very expensive, about $150,000 a year, according to an estimate by Dr. Mark Schoenebaum, an industry analyst with ISI.</blockquote> That would be about three times the median US family income.  But the CEO shrugged concerns about the price off, <blockquote class="tr_bq">Rothblatt acknowledged that the cost of the drugs is high but manageable, because pulmonary hypertension remains pretty rare, though the exact prevalence is hard to pin down.</blockquote> One explanation for that amazingly high price comes from a <a href="http://www.forbes.com/sites/matthewherper/2013/12/23/this-drug-company-ceo-just-named-her-new-drug-after-herself/">post</a> on Forbes by Matthew Herper, <blockquote class="tr_bq">She commercialized [prostacyclin] ..., and was able to get investors interested because she realized there was no maximum price insurers would pay for an effective drug. United Therapeutics became one of biotech’s great success stories.</blockquote> A lack of an upper limit on pricing has other effects of course.  <a href="http://financials.morningstar.com/ratios/r.html?t=UTHR&region=usa&culture=en-US&ownerCountry=USA">According to Morningstar</a>, the company's sky high pricing enabled a net profit margin over 33% in 2012-13.   According to the <a href="http://ir.unither.com/common/download/download.cfm?companyid=UTHR&fileid=660323&filekey=f90b5dc7-52ac-4a2a-9350-8446eaeee34d&filename=UTHR_2013_Proxy_Statement_v2.pdf">United Therapeutics 2013 proxy statement</a>, CEO Martine Rothblatt's total compensation is $7,958,328.  Three other executives got more than $4.5 million. So I imagine that marketing a drug that may produce so much revenue may have emotional meaning for company executives.  On the other hand, in this era of high insurance deductibles and co-payments it may have considerable negative emotional meaning for patients. Some Off-Key Notes The recent publicity about the new oral prostacyclin did not dwell on an issue that appeared earlier in a December, 2013, <a href="http://ir.unither.com/releasedetail.cfm?ReleaseID=812424">press release</a> from United Therapeutics about its other prostacyclin products, <blockquote class="tr_bq"> United Therapeutics Corporation (NASDAQ: UTHR) announced today that it has received a subpoena from the Office of the Inspector General of the Department of Health and Human Services reflecting an investigation by the United States Department of Justice, principally represented by the United States Attorney's Office in Baltimore. The subpoena requests documents regarding Remodulin® (treprostinil) Injection, Tyvaso® (treprostinil) Inhalation Solution and Adcirca® (tadalafil) Tablets, including the company's marketing practices relating to these products.</blockquote>Instead, as we discussed above, the CEO of the company that will market this very expensive but not very efficacious drug went out of her way to bring up emotional issues about her own daughter's illness.  Certainly, anyone can believe the CEO was motivated to develop prostacyclins for PAH by concerns about her daughter's own illness.  However, focusing on such emotional issues may also distract from concerns about other aspects of the company's marketing. So maybe it is not a surprise that she decided to name the new drug in a personal way,...  But she did not name it for her daughter.  Again per Scott Hensley, <blockquote class="tr_bq"> Now there is: Orenitram. The name comes from 'Martine Ro,' as in Martine Rothblatt, backward.</blockquote> Instead, Martine Rothblatt names her company's new drug for.... herself.  So what is this very emotional and personal drug marketing/ public relations campaign really about? On Smarm in Health Care So it appears that United Therapeutics and its CEO used what may now be called smarm to promote their vested interests and divert attention from uncomfortable facts.  In a now widely read and commented upon article in Gawker, Tom Scocca asserted that smarm has become "an omnipresent, unnamed cultural force."  Some aspects of smarm, as discussed in the article, <blockquote class="tr_bq">Smarm is a kind of performance—an assumption of the forms of seriousness, of virtue, of constructiveness, without the substance.</blockquote> <blockquote class="tr_bq"> it expresses one agenda, while actually pursuing a different one. It is a kind of moral and ethical misdirection. Its genuine purposes lie beneath the greased-over surface.</blockquote> <blockquote class="tr_bq"> Smarm, whether political or literary, insists that the audience accept the priors it has been given. Debate begins where the important parts of the debate have ended.</blockquote> So the smarmy element in the public relations about Orenitram was the misdirection created by invoking the CEO's daughter's illness and its emotional ramifications.  By focusing on an emotional issue which apparently only the callous could dismiss, the issues of the drug's minimal efficacy, frequent side effects and very high price were eclipsed.   Yet they, not the emotional connection between a particular parent and chile should be salient to patients, doctors, regulators, and the general public.  (The issues of the investigation of the company's marketing of other prostacyclin products, and the egotism implied by the drug's name were certainly eclipsed as well.) Presumably by raising these truths which might be unpleasant to United Therapeutics executives, I am now guilty of "snark."  As Scocca pointed out, one aspect of smarm is to exile reasonable criticism and skepticism as "snark," <blockquote class="tr_bq">What is snark reacting to? <div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa"> </div><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa">It is reacting to smarm. </div></blockquote><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa"> </div><div data-textannotation-id="723f1b5670939f8ac0e1ede8374c51aa">So snarky as it may be, I believe that the major considerations for patients and physicians when considering a therapy - like Orenitram - should be the benefits versus harms of the the therapy for the individual patient, and the strength of the evidence supporting both.  The more marketers, public relations functionaries, and executive try to distract from that, and the more smarm they employ to do so, the more skepticism is required.  </div> References 1.  Jing ZC, Parikh K, Pulido T et al.Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial.  Circulation 2013; 127: 624-633. Link <a href="http://circ.ahajournals.org/content/127/5/624.full">here</a>. 2. Paramothayan NS, Lasserson TJ, Wells A et al.   Prostacyclin for pulmonary hypertension in adults. Cochrane Review 2005; Link <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002994.pub2/abstract;jsessionid=631C530B905482CD4A1108101CF1D775.f04t04">here</a>.

The Smarming of Health Care - How to Spin a Minimally Efficacious Variant on an Old Drug as New and Wonderful

A recent announcement of the approval of a new drug showed the latest ways pharmaceutical companies can spin products as new and effective w...

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