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More On Healthcare Management By Domain Neutral Generalists: CIO's Running Hospital Pharmacies and Home Healthcare Divisions?

Both Roy Poses and I have written on a plague of healthcare mismanagement and perhaps malfeasance in part due to leadership by domain amateurs, i.e., healthcare leadership profoundly lacking in biomedical education and experience. Examples of recent posts about the risks posed by domain neutral biomedical leadership are: <blockquote> "<a href="http://hcrenewal.blogspot.com/2009/08/ny-times-proclaims-anyone-can-run.html">NY Times Proclaims Anyone Can Run a Health Care Organization with a Little Studying Up</a>" (Poses) "<a href="http://hcrenewal.blogspot.com/2009/08/health-care-leaders-dont-know-much.html">Health Care Leaders: Don't Know Much About Health Care</a>" (Poses) "<a href="http://hcrenewal.blogspot.com/2009/08/on-optimal-expertise-for-leadership-in.html">On Optimal Expertise for Leadership in Biomedicine</a>" (me) "<a href="http://hcrenewal.blogspot.com/2009/02/informatics-or-infomagic-health-it.html">Informatics, or Infomagic? Health IT Cannot Flourish When Everybody is an Expert</a>" (me) and "<a href="http://hcrenewal.blogspot.com/2009/01/pfizerwyeth-merger-and-sacrificing.html">Pfizer/Wyeth Merger And Sacrificing The Future: Laying Off Scientific Staff All Over The Place</a>" (me).</blockquote> I have also written of a <a href="http://hcrenewal.blogspot.com/2009/04/business-week-on-health-it-dubious.html">cross-occupational invasion</a> of healthcare by the IT profession, in the form of power and territorial grabs over clinicians with regard to the tools clinicians increasingly need in order to provide patient care. These leadership inversions, where domain neutral personnel are viewed as best able to lead any endeavor as if the world consists of interchangeable, faceless resources following equally interchangeable processes, are due to attitudinal laxity and permissiveness on the part of medical leadership, a takeover of healthcare by those with primary pecuniary interests, and perhaps a lack of appreciation for the value of domain expertise as sign of a waning western culture. In a <a href="http://histalk2.com/2009/09/10/histalk-interviews-avery-cloud/">recent hospital CIO interview</a>, in this case of CIO Avery Cloud at New Hanover Regional Medical Center in Wilmington, NC, we see both of these elements - supportive views towards healthcare leadership by domain amateurs, and towards a cross-occupational invasion of healthcare by IT personnel - combined: <blockquote> Q: Is that inherent in their background, though, when you’ve got a lot of folks who worked to move their way up through IT, which is the argument of “are you better off with someone who’s risen through the IT ranks”, or better off to get a visionary who just lets other people worry about the nuts and the bolts? A: That’s an interesting debate. I’ll just tell you about me: I came up through the technical ranks. I hold an MBA, but more importantly, I have an affinity to business. When people ask me about me and my job, I tell them I’m a business person who just happens to know IT. I’d like to think that I could run any of the departments in this hospital [wow - ed.] A good example is that nobody is surprised when the CFO runs the pharmacy department [i.e., nobody in this CIO's limited circles - ed.], or the CFO runs materials management. It should be no big surprise either that the CIO can do the same, or does the same [In fact, it likely would be a big surprise to many -ed.] A very good friend of mine in another hospital — he’s the CIO there — runs the pharmacy down there. Another friend of mine who’s a CIO runs the home care division [this is, in fact, stunning and should be a cause of great concern to healthcare regulators if true - ed.] </blockquote>I'm sure CIO's would like to think that they could "run any of the departments in a hospital." (How about: Legal? Risk management? Health Information Management a.k.a. Medical Records? Biomedical engineering? Nursing? Trauma? Diagnostic Imaging? Neurosurgery?) The question is this: is this a realistic view? Or, is it an extreme form of hubris and the <a href="http://gagne.homedns.org/%7Etgagne/contrib/unskilled.html">Dunning Kruger effect</a>? Can they run complex departments far outside their core competencies optimally? Or will they more likely be running an area they know little about by the seat of their pants? Further, do leadership roles in organizations such as NIH or the Centers for Disease Control call merely for an MBA and domain neutral backgrounds? If not, why not? Why are hospitals exempt from a requirement for domain specific expertise in their leadership? As to CIO's (and, for that matter, CFO's) running hospital pharmacies, let's show the knowledge gaps graphically by first exploring the prerequisite <a href="http://www.hsc.wvu.edu/sop/students/Curriculum/Curriculum2011_2012_2013_fall2009.htm">training of a typical Pharm.D. pharmacist:</a> <blockquote> Professional Degree (Pharm.D. Degree) Curriculum Class of 2011, 2012, & 2013 (Admitted Fall 2007, 2008 & 2009) First Year, Fall Semester <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">NBAN 301</td> <td width="400">Principles of Human Anatomy</td> <td width="135">3 credit hours</td> </tr> <tr> <td>PSIO 743</td> <td>Fundamentals of Physiology</td> <td>5 credit hours</td> </tr> <tr> <td>PHAR 700</td> <td>Pharmacy as a Profession</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 701</td> <td>Pharmaceutical Care Lab 1</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 702</td> <td>Physical Pharmacy</td> <td>3 credit hours</td> </tr> <tr> <td>PHAR 703</td> <td>Intro Pharmacy Practice Experiences 1</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 720</td> <td>Patient Health Education</td> <td>2 credit hours</td> </tr> <tr> <td> </td> <td class="bld">Total hours</td> <td class="bld">17 hours</td> </tr> </tbody></table> First Year, Spring Semester <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">BIOC 531</td> <td width="400">General Biochemistry</td> <td width="135">4 credit hours</td> </tr> <tr> <td>PHAR 708</td> <td>Pharmaceutics</td> <td>3 credit hours </td> </tr> <tr> <td>PHAR 709</td> <td>Immunology and Biotechnology</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 710</td> <td>Intro Pharmacy Practice Experiences 2</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 711</td> <td>Chemical Properties of Drugs</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 712</td> <td>Pharmaceutical Care Lab 2</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 737</td> <td>Disease Prevention and Health Promotion</td> <td>2 credit hours</td> </tr> <tr> <td> </td> <td>Elective</td> <td>2-3 credit hours</td> </tr> <tr class="bld"> <td> </td> <td>Total hours</td> <td>18-19 hours</td> </tr> </tbody></table> First Year, Late Spring – after spring term concludes <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">PHAR 714</td> <td width="400">Introductory Community Rotation (2 weeks)</td> <td class="bld" width="135">2 credit hours</td> </tr> </tbody></table> Second Year, Fall Semester <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">PCOL 743</td> <td width="400">Pharmacology 1</td> <td width="135">3 credit hours</td> </tr> <tr> <td>PHAR 715</td> <td>Pathophysiology & Therapeutics 1</td> <td>4 credit hours</td> </tr> <tr> <td>PHAR 716</td> <td>Chemistry of Drug Action 1</td> <td>3 credit hours</td> </tr> <tr> <td>PHAR 717</td> <td>Intro Pharmacy Practice Experiences 3</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 723</td> <td>Pharmaceutical Care Lab 3</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 727</td> <td>Medical Literature Evaluation</td> <td>2 credit hours</td> </tr> <tr> <td> </td> <td>Elective</td> <td>2-3 credit hours</td> </tr> <tr class="bld"> <td> </td> <td>Total hours</td> <td>16-17 hours</td> </tr> </tbody></table> Second Year, Spring Semester <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">PCOL 744</td> <td width="400">Pharmacology 2</td> <td width="135">3 credit hours</td> </tr> <tr> <td>PHAR 719</td> <td>Intro Pharmacy Practice Experience 4</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 724</td> <td>Pharmaceutical Care Lab 4</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 725</td> <td>Pathophysiology & Therapeutics</td> <td>4 credit hours</td> </tr> <tr> <td>PHAR 726</td> <td>Chemistry of Drug Action 2</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 728</td> <td>Pharmacy Management</td> <td>2 credit hours</td> </tr> <tr> <td> </td> <td>Elective</td> <td>2-3 credit hours</td> </tr> <tr class="bld"> <td> </td> <td>Total hours</td> <td>16-17 hours</td> </tr> </tbody></table> Second Year, Late Spring – after spring term concludes <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">PHAR 729</td> <td width="400">Introductory Institutional Rotation (2 weeks)</td> <td class="bld" width="135">2 credit hours</td> </tr> </tbody></table> Third Year, Fall Semester <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">PHAR 730</td> <td width="400">Pathophysiology & Therapeutics 3</td> <td width="135">4 credit hours</td> </tr> <tr> <td>PHAR 731</td> <td>Biopharmaceutics & Pharmacokinetics</td> <td>3 credit hours</td> </tr> <tr> <td>PHAR 732</td> <td>Non-Prescription Drugs</td> <td>3 credit hours</td> </tr> <tr> <td>PHAR 733</td> <td>Pharmacy Systems</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 735</td> <td>Pharmaceutical Care Lab 5</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 742</td> <td>Intro Pharmacy Practice Experiences 5</td> <td>1 credit hour</td> </tr> <tr> <td> </td> <td>Elective</td> <td>2-3 hours</td> </tr> <tr class="bld"> <td> </td> <td>Total hours</td> <td>16-17 hours</td> </tr> </tbody></table> Third Year, Spring Semester <table class="alltrBodytext" cellpadding="0" cellspacing="0"> <tbody><tr> <td width="103">PHAR 734</td> <td width="400">Pharmacy Law and Ethics</td> <td width="135">3 credit hours</td> </tr> <tr> <td>PHAR 736</td> <td>Pharmaceutical Care Lab 6</td> <td>1 credit hour</td> </tr> <tr> <td>PHAR 738</td> <td>Outcomes Assessment/Quality Improvement</td> <td>2 credit hours</td> </tr> <tr> <td>PHAR 739</td> <td>Therapeutic Patient Monitoring</td> <td>3 credit hours</td> </tr> <tr> <td>PHAR 740</td> <td>Pathophysiology & Therapeutics 4</td> <td>4 credit hours</td> </tr> <tr> <td>PHAR 741</td> <td>Clinical Pharmacokinetics</td> <td>3 credit hours</td> </tr> <tr> <td>PHAR 746</td> <td>Intro Pharmacy Practice Experiences 6</td> <td>1 credit hour</td> </tr> <tr> <td> </td> <td>Elective</td> <td>0-2 credit hours</td> </tr> <tr class="bld"> <td> </td> <td>Total hours</td> <td>17-19 hours</td> </tr> </tbody></table> Fourth Year Students complete eight five-week experiences beginning in the summer preceding their fourth year. Students will have required experiences, such as ambulatory care and acute care, and elective experiences. Students are required to complete at least 10 professional elective hours selected from an approved course list during their first, second, or third professional year and prior to fourth year experiential rotations. With the exception of Fall semester in the first professional year, one elective can be taken each semester of the didactic program. Electives are intended to complement the required curriculum and allow students to select courses based on professional interests. Students wishing to take electives during summer terms may do so after their first professional year on any of the campuses in the WVU system (Morgantown, Parkersburg, Potomac State, West Virginia Tech) provided the courses are selected from the list of professional electives or are deemed equivalent by the University. Students wishing to receive course credit for courses taken outside of the WVU system must have pre-approval by the Curriculum Committee.</blockquote> Of course, even assuming no requirement for a Dissertation defense (which is a typical Ph.D. requirement), the candidate needs to take state and/or federal exams for <a href="http://www.bls.gov/oco/ocos079.htm">licensure</a>: <blockquote>Licensure. A license to practice pharmacy is required in all States, the District of Columbia, and all U.S. territories. To obtain a license, a prospective pharmacist must graduate from a college of pharmacy that is accredited by the ACPE and pass a series of examinations. All States, U.S. territories, and the District of Columbia require the North American Pharmacist Licensure Exam (NAPLEX), which tests pharmacy skills and knowledge. Forty-four States and the District of Columbia also require the Multistate Pharmacy Jurisprudence Exam (MPJE), which tests pharmacy law. Both exams are administered by the National Association of Boards of Pharmacy (NABP). Each of the eight States and territories that do not require the MJPE has its own pharmacy law exam. In addition to the NAPLEX and MPJE, some States and territories require additional exams that are unique to their jurisdiction.</blockquote> (I can add that the typical M.D. curriculum, such as at the medical school I attended, is even <a href="http://www.bumc.bu.edu/admissions/curriculum/">more rigorous</a>. That is prior to the medical internship, residency, and postdoctoral fellowship(s) most physicians also must perform, where they become intimately familiar with the services of many hospital departments). Now, let's explore the comparable pharmacy science/biomedical training of the typical hospital CIO or CFO (or CEO for that matter): <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgBqfEJsMhbThujn4qjQ-ZGDRwKAIs5mBKCFMQEyuL6A1O00AQGi4ASPA6hYitEmS9RhxTgGvWR3kc7hAhaKVUZLKepJ9HMSizizlkkfN_pD3RniLanguQEBx5h6kWaRv-oZSeStyz-egao/s1600-h/FC_NullSet_41726_lg.gif" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5380374871468209650" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgBqfEJsMhbThujn4qjQ-ZGDRwKAIs5mBKCFMQEyuL6A1O00AQGi4ASPA6hYitEmS9RhxTgGvWR3kc7hAhaKVUZLKepJ9HMSizizlkkfN_pD3RniLanguQEBx5h6kWaRv-oZSeStyz-egao/s320/FC_NullSet_41726_lg.gif" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 85px; height: 112px;" /></a> (This, of course, is the mathematical symbol for the <a href="http://en.wikipedia.org/wiki/Null_set">null set</a>.)<div> </div><div>For comparison and contrast, see Roy Poses' post "<a href="http://hcrenewal.blogspot.com/2008/11/what-is-not-taught-about-leadership-in.html">What is Not Taught About Leadership in Healthcare</a>" for the healthcare MBA curriculum at a prominent School of Management, namely Yale's. Dr. Poses observed:</div><div> </div><div></div><blockquote><div>... So what is missing? There seem to be two obvious areas that are not taught. </div><div> </div><div>The first is health care. There are only two courses in this curriculum on "healthcare policy" and "healthcare management." ... The second area missing is ethics, particularly the business ethics of health care. There are simply no courses even remotely related.</div></blockquote><div></div><div> In the first of my posts linked above I wrote: <blockquote>... Those in charge [and who lack domain credentials -ed.] cannot see that which the domain specialist sees. They cannot see because they lack the training, experience, and what is described as 'meta-competence' (in <a href="http://gagne.homedns.org/%7Etgagne/contrib/unskilled.html">this brilliant article</a> on competence [the Dunning-Kruger effect - ed.]) essential to seeing that which is obvious. Obvious, that is, to those who do not lack these characteristics. In addition, I've also observed that some lack the fundamental analytical abilities essential to understanding and managing the complexities of biomedical R&D. Why those without domain expertise are in charge of organizations whose long term viability depends entirely on the most advanced and creative pursuit of biomedical 'miracles' [i.e., pharma - ed.] is another matter. I won't address this here, other than saying it reflects the adverse consequences of a bias that has evolved in management "science." That bias is the belief that all the world consists of faceless labor resources performing easily definable processes upon interchangeable widgets, and that management can therefore be done by generic managers, exclusively. Some of the world is like that [i.e., fast food chains - ed.], but some isn't, such as biomedical R&D. [And clinical medicine as well - ed.] <div style="text-align: left;">Management in the absence of domain expertise in this industry is, in fact, mismanagement. </div> There is nothing here to spin, there is nothing to debate. There is nothing to discuss. This is a first principle. Failure to accept this reality results in corporate failure.</blockquote> These views apply to hospitals perhaps even more critically than to biomedical R&D. In hospitals, mistakes in judgment can result in great patient harm, and far more rapidly than in an R&D organization. Finally, in the same CIO interview there's this: <blockquote> Q: If you’re talking to your CIO peers, what would you tell them is the key to know that you need to have this done and the thoughts to entertain before they start? A: I think, you know, customer’s king. The key is to evaluate the customer’s level of satisfaction with services being provided. You can’t do that without getting very involved and face to face with the customers. So that’s number one ... So I think that is really what IT leaders have got to strive for, the user viewpoint, the user view of the services that IT provides. </blockquote> The fact that this "customer is king" advice seems to merit constant repetition among healthcare IT leadership circles, especially when the “customers” are clinicians with patient care obligations and responsibilities, should be a cause of deep reflection and introspection among those in HIT. At the very least, they need to ask themselves - and healthcare professionals need to ask them - "who are you, and what are your motives for stepping foot in our hospital?" It is also such a fundamental first principal that its frequent repetition suggests typical hospital CIO's are not truly fit in 2009 to lead anything in healthcare where domain expertise and viewpoints are essential, healthcare IT included. Its need for frequent repitition - dating to many HIT publication I've seen since I entered the Medical Informatics field professionally in the early 1990's - suggests they don't truly recognize that the business of hospitals is taking care of patients, the clinicians being the enablers of that business, everyone else being facilitators. The <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">known problems and failure rates of heath IT in hospitals</a> is corroborative of that view. Healthcare reform will certainly require healthcare leadership reform, and the first task of that reform should be a re-evaluation of expertise required to tamper with people's lives and well being in a hospital setting. -- SS</div>

More On Healthcare Management By Domain Neutral Generalists: CIO's Running Hospital Pharmacies and Home Healthcare Divisions?

Both Roy Poses and I have written on a plague of healthcare mismanagement and perhaps malfeasance in part due to leadership by domain amateu...

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Make History with the National September 11th Memorial & Museum

The anniversary of September 11th evokes difficult memories here in New York and all over the world. The events of the day left an indelible mark on many New Yorkers, including me. The offices of my startup were at <a href="http://maps.google.com/maps?f=q&source=s_q&hl=en&geocode=&q=30+west+broadway+nyc&sll=40.713753,-74.011135&sspn=0.135841,0.350189&ie=UTF8&z=16">30 West Broadway</a>, right next door to 7 World Trade Center, so I was downtown that morning. I saw the planes hit and then watched, shocked, from the West Side Highway as the towers fell. It was a terrible day for all who were there, an impossible day for those who lost friends and loved ones and a shared experience of loss and grief for New York and the world. Today I'm proud that Google is part of the launch of <a href="http://www.911history.org/">Make History</a>, a website created by the <a href="http://www.national911memorial.org/">National September 11th Memorial & Museum</a> in partnership with design firm <a href="http://www.localprojects.net/">Local Projects</a>. Make History is a participatory archive that invites people to share their experiences of 9/11 and its aftermath in an effort to preserve the memories of that time. The Museum has created a collaborative storytelling tool that makes innovative use of Street View through the <a href="http://code.google.com/apis/maps/">Google Maps API</a>. The Make History site allows people to place and then share their photos and videos in geographical context, collectively piecing together the history that was witnessed, one photo and video at a time. To participate, simply go to the <a href="http://www.911history.org/">site</a> and click "Add Your Story." You'll be asked to write about your experience of 9/11 and share your photos and videos, and then to place them at the spot where they were captured. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi1OrEbIiKWwim1Lad5dOluoscbp7S3I0prcSEOWqazQB2jJ_MF7OhJGvO4jHsTj72TdKKrJ_pfrXAf-9pllM1tnNvJHL154YNLvIfaJoOAeji7KDZe5wm7llKjPZ7Dv2Y0AqOAhAWUsGtM/s1600-h/NS11_MH_Press_11_WBroadway_Ron_Agam.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5379620598838655250" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi1OrEbIiKWwim1Lad5dOluoscbp7S3I0prcSEOWqazQB2jJ_MF7OhJGvO4jHsTj72TdKKrJ_pfrXAf-9pllM1tnNvJHL154YNLvIfaJoOAeji7KDZe5wm7llKjPZ7Dv2Y0AqOAhAWUsGtM/s400/NS11_MH_Press_11_WBroadway_Ron_Agam.png" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 400px; height: 304px;" /></a> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhirQ65py2O1bWEkbcDVxdbNY6b00W2HjVbD6iYJlFtZDPNLndaRc5QQXIC84Z5VFcR25yj-uXKDKr_RibhyphenhyphenqaSPFe23lhK0vPXvf6jENjuFt2W0EDpcsE8MYET3l60xL2ASBAK_zBhg4i6/s1600-h/NS11_MH_Press_03_homepage.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5379620585023930594" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhirQ65py2O1bWEkbcDVxdbNY6b00W2HjVbD6iYJlFtZDPNLndaRc5QQXIC84Z5VFcR25yj-uXKDKr_RibhyphenhyphenqaSPFe23lhK0vPXvf6jENjuFt2W0EDpcsE8MYET3l60xL2ASBAK_zBhg4i6/s400/NS11_MH_Press_03_homepage.png" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 400px; height: 304px;" /></a> To power the Make History website, the Museum is using <a href="http://code.google.com/appengine/">App Engine</a> and leveraging the power of cloud computing. By taking advantage of the scalability of Google's infrastructure, the Museum can focus on building great applications and telling important stories — not on how many servers they will need. The developer community that uses our tools and APIs is a source of inspiration for all of us at Google who work on platforms, partnerships and developer outreach — and <a href="http://www.911history.org/">Make History</a> is a powerful example of why we all do what we do. This September 11th, as we sit with our memories of the day, we're honored to have been able to help enable the creation of such a significant and deeply moving archive. Posted by Jill Szuchmacher, New Business Development

Make History with the National September 11th Memorial & Museum

The anniversary of September 11th evokes difficult memories here in New York and all over the world. The events of the day left an indelible...

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Now S-U-P-E-R-sized!

<a href="http://www.google.com/">Search</a>, that is. For us, search has always been our focus. And, starting today, you'll notice on our homepage and on our search results pages, our search box is growing in size. Although this is a very simple idea and an even simpler change, we're excited about it — because it symbolizes our focus on search and because it makes our clean, minimalist homepage even easier and more fun to use. The new, larger Google search box features larger text when you type so you can see your query more clearly. It also uses a larger text size for the suggestions below the search box, making it easier to select one of the possible refinements. Over the past 11 years, we've made a number of <a href="http://www.google.com/corporate/timeline/#homepage-original-prototype">changes to our homepage</a>. Some are small and some are large. In this case, it's a small change that makes search more prominent. Google has always been first and foremost about search, and we're committed to building and powering the best search on the web — now available through a supersized search box. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlaOghn_RZAuYlgs3jwy9j740_UYNCEDAZ1hT5vw7VAljQsJsSinm1SthGwF4SXznKUgaRvI8To3jWcvTJ7vu7dGIf5aoeafEL6mFblD8eVjmKYpVH9wigDSrcuSn88YUn_Am4OhDU63vJ/s1600-h/new-old-search-next.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5379583174096973298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlaOghn_RZAuYlgs3jwy9j740_UYNCEDAZ1hT5vw7VAljQsJsSinm1SthGwF4SXznKUgaRvI8To3jWcvTJ7vu7dGIf5aoeafEL6mFblD8eVjmKYpVH9wigDSrcuSn88YUn_Am4OhDU63vJ/s400/new-old-search-next.png" style="margin: 0px auto 10px; display: block; text-align: center; width: 500px;" /></a> <div style="text-align: center;">Before and after on Windows XP, running Google Chrome. Click on the image for a larger view. </div> Posted by Marissa Mayer, Vice President, Search Products & User Experience

Now S-U-P-E-R-sized!

Search , that is. For us, search has always been our focus. And, starting today, you'll notice on our homepage and on our search results...

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The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Last week, Gardiner Harris <a href="http://www.nytimes.com/2009/09/02/business/02drug.html">writing</a> for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Laboratories' Fiscal Year 2004 Marketing Plan for the drug Lexapro (escitalopram oxalate), an anti-depressant. The document is available <a href="http://www.nytimes.com/packages/pdf/politics/20090831MEDICARE/20090831_MEDICARE.pdf">here</a>. Review of this plan revealed the marketing department's various activities, including activities that others might have believed were educational, scientific, or had some other high minded purpose. Continuing Medical Education Overall, one "promotional objective" was to "Maintain SRI category leadership in total number of medical education events (including CME symposia, speaker promotion, teleconferences, and peer selling programs)" One "critical issue" was to "increase Med Ed efforts: more sponsorships of CME, increased level of speaker programs, maintain level of teleconferences and peer selling." Under "Marketing Tactics" was a long section on "Continuing Medical Education." It covered various venues for CME such as internet/electronic CME, "sponsoring symposia at major meetings," "regional CME symposia" which would "serve a number of medical specialties," "sponsorhips of scientific sessions," etc Production of Scholarly Articles The "Publications" section of "Marketing Tactics" noted "publications will be geared toward psychiatrists, PCPs, .... Articles will appear in several formats, including original reports, review articles, and journal supplements." Thought Leaders and Consultants Under the "Continuing Medical Education" section of "Marketing Tactics," and then in the "Advisor Relations" section, there were numerous references to what "thought leaders" would do, including - "present new data" at "symposia at major meetings" - act "as advisors to Lexapro in order to obtain critical feedback and recommendations on educational and promotional strategies and tactics." - sit on the "Lexapro Exectuive Advisory Board" to "keep our advisors apprised of the commercial development ... of escitalpram." - sit on the "Primary Care Advisory Board" to "obtain critical feedback and recommendations on educational and promotional strategies and tactics...." Role of Medical Centers Under the CME section of "Marketing Tactics," we see that "academic health centers" would help develop "regional CME symposia." Under the "Sponsorship" section are plans to fund the "Professional Relations Group in their mission of establishing mutually beneficial long-term relationships with appropriate professionals and associations." Specific plans included funding the Department of Psychiatry and Behavioral Sciences at Emory Medical Societies The "Sponsorship section" also noted that these relationships "will also provide the basis for advocacy development and issues management, and will establish an appropriate environment for commercial and policy activities." Under the CME section of "Marketing Tactics, we see that "medical associations and professional societies" would help develop "regional CME symposia" Also in this section is the note that "smaller, more prestigious societis do not accept industry-sponsored symposia." So instead, "sponsorship of a study groups or plenary sessions is recommended. Marketing will work with the professional relations group regarding potential opportunities." Appendix VII, "Professional Associations of Priority" noted funding provided for guideline development by a "collaboration between APA, AAFP and ACP" for "chronic depression in primary care practice;" by AAGP for guidelines for late-life depression; multiple guidelines developed by AMDA; The appendix also noted that Forest supports ACNP "annual programming, and is a founding sponsor of it's newly created International College of Geriatric Pscyhopharmacology (ICGP)," is a "Corporate President's Circle Sponsor of AAFP," became a "corporate sponsor of ACP in FY03," became "a Corporate Sponsor of AMDA for the last few years," Also, it noted that Forest has "expanded its involvement" with APA for "lobbying of State Health Departments...." Disease Advocacy Organizations Also in Appendix VII, Forest was identified as a "Corporate Sponsor of NAMI," a "major Corporate Sponsor of NMHA," and a "major Corporate Sponsor of DBSA." Summary We have often heard from pharmaceutical, biotechnology, device and other health care corporations that they are only involved in education to disseminate accurate information for the good of society. We have often heard from physicians and academics who consult for such corporations that their advice is sought about clinical, scientific, and technical issues. We often hear from academic medical institutions, medical associations and disease advocacy groups that the money they get from such corporations does not influence the content of their educational and scientific work. Yet here we see, in considerable detail, that in the case of one drug company's promotional efforts for one drug, - The marketing plan from the marketing department paid for medical education as a "promotional objective," that is, to market, not to educate. - Thought leaders and consultants were again paid by marketing to market, and sometimes to provide opinions about "promotional strategies" and "commercial development." - Medical associations are funded by marketing "for commercial and policy activities." This suggests that health care corporations develop financial relationships with physicians, academics, academic institutions, medical and professional associations, and disease advocacy groups to support marketing first. This allows the corporations to advance marketing disguised as education, research, and other high-minded and apparently selfless activities by professionals, not-for-profit organizations, and dedicated inviduals. Such marketing, of course, is DECEPTIVE and DISHONEST. It also is in conflict with the professionals' ideals, and the missions of the medical and professional assocations and disease advocacy groups. The physicians, other health care professionals, and not-for-profit organizational leaders involved may rationalize these activities as consistent with their mission and professionalism, but such rationalizations are at best self-delusion. No one knows how representative the Lexapro marketing plans are of the marketing of other drugs, devices and health care services. The only way to find out would be to force many other corporations' marketing plans into public view. The Lexapro documents suggest that society would benefit if many more marketing plans were made public, but that such publication might generate a wave of revulsion about how deceptive marketing of health care goods and services has become, and the extent that health care professionals have betrayed their professional ideals, and academic medical institutions, professional and medical societies, and patient advocacy groups have betrayed their missions. I submit that we will not truly reform health care without making the marketing of health care goods and services honest, getting health care professionals to give up their financial relationships with health care corporations to reclaim their professionalism, and getting academic medical institutions, professional and medical societies, and patient advocacy groups to give up their financial relationships with health care corporations to reclaim their missions. See additional comments on how the marketing plan was meant to promote CME <a href="http://carlatpsychiatry.blogspot.com/2009/09/forests-promotional-objective-use-cme.html">by Dr Daniel Carlat</a> on the Carlat Psychiatry Blog.

The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Last week, Gardiner Harris writing for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Labo...

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A Solution To Pharma's Repeated Drug Offenses: Incarceration

Some straightforward common sense follows. No spin, no indirection, no excuses: Pfizer has recently paid a $2.3 billion dollar settlement on civil and criminal charges that potent drugs were being improperly promoted (i.e., pushed onto unsuspecting physicians and patients) for uses not approved by the regulatory agencies responsible for such matters. What is the real world meaning of these charges? The meaning is that patients - the final consumers - were ingesting drugs that were not only not indicated, but held possibilities of harming the drug taker. We have seen negative outcomes from these practices before in the form of, for example, children in whom improperly pushed antidepressants caused suicidal thoughts and actual suicide (the teenage daughter of a friend of my mother hanged herself after starting such drugs, resulting in a lawsuit that the parents ultimately won). It demonstrates reckless and malicious disregard for others to tamper with people's lives in this fashion. Perhaps sociopathy is an apt description of such behavior. One wonders about the adverse consequences to patients of this latest round of pharma fraud. Ultimately, those engaging in these practices (usually at the group director or VP level) are doing the following: They are gambling with the lives and well-being of countless patients. In some of these cases, patients will have been harmed; in others, patients will have died. In the former case, the perpetrators of the fraud are facilitators of the injury. In the latter case, the perpetrators are accessories to murder. Fining a corporation is a nearly useless exercise, as ultimately the conversation in the executive offices and Wall Street will be about the <a href="http://www.investors.com/NewsAndAnalysis/Article.aspx?id=505405">cost of doing business</a>, not about crimes or morals. Terminating perpetrating individuals is also not extremely effective in motivating reform, even if terminated with prejudice, if those terminated have already made their fortune. <div>(The $2.3 billion could have been used, in fact, as a war chest to reduce the need for layoffs during economic downturns, like our current one, were it not wasted in paying fines due to the behaviors of unscrupulous executives.)</div><div> The solution to this problem is straightforward. Deal with the individuals involved in the following manner: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMJeiV3peuzXP_OVWQdui0uhnqmvF77W2w9YkrOlwTAFpOgZ9L16lt8mnOwhfGPydqmuM4YnvnbxQu5Yr5KMQng-WL4EobGpr1BDf2w693deGnPiADvBmVLukn2dkZ2F6BM6pF2G1vqnhL/s1600-h/Jail_doors.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5379191722950654450" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMJeiV3peuzXP_OVWQdui0uhnqmvF77W2w9YkrOlwTAFpOgZ9L16lt8mnOwhfGPydqmuM4YnvnbxQu5Yr5KMQng-WL4EobGpr1BDf2w693deGnPiADvBmVLukn2dkZ2F6BM6pF2G1vqnhL/s320/Jail_doors.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 320px; height: 214px;" /></a>Where the executives behind these abuses belong: jail </div> Time in jail for these executives is a needed remedy. The following, however, is the situation we have: <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlM3HQADphppCKx0jG-iHRaW9hyphenhyphenga4rcXPGJOIBqUhJdISSbTmVZX_L6SYtMVzzzS2tMoVwQcy-TlEt1YXNlQSfsEhoXOkVvhs399U-u3LghBgleIELg-MTreXqqLXLhIkQrYYKovW7TGM/s1600-h/get_out_of_jail_free.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5379192350058766658" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlM3HQADphppCKx0jG-iHRaW9hyphenhyphenga4rcXPGJOIBqUhJdISSbTmVZX_L6SYtMVzzzS2tMoVwQcy-TlEt1YXNlQSfsEhoXOkVvhs399U-u3LghBgleIELg-MTreXqqLXLhIkQrYYKovW7TGM/s320/get_out_of_jail_free.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 246px; height: 144px;" /></a> This is inexcusable. Healthcare advocacy groups and relatives of those injured need to lobby for the solution proposed in the first picture: long, stiff sentences for those committing medical fraud and quackery by proxy in the form of these industry abuses. Finally, the Pfizer scenario causes me to ask: Is the leadership of this company competent to manage its operations? Or, is that leadership - for instance a CEO lacking science and biomedical education and experience - an "enabler" of the creative marketing for drugs -- creative advertising campaigns being seen as a virtue in his <a href="http://hcrenewal.blogspot.com/2006/07/pfizer-brings-life-to-my-if-youve-run.html">prior industry</a>? -- SS</div>

A Solution To Pharma's Repeated Drug Offenses: Incarceration

Some straightforward common sense follows. No spin, no indirection, no excuses: Pfizer has recently paid a $2.3 billion dollar settlement o...

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Five million students going back to school are "going Google"

(Cross-posted on the <a href="http://googleforstudents.blogspot.com/2009/09/five-million-students-going-back-to_08.html">Google Students Blog</a>) It's always tough to bid farewell to summer and hit the books again, but for a few million students this back-to-school season, things are looking up. As of this fall, over five million students at thousands of schools in more than 145 countries have "<a href="http://googleblog.blogspot.com/2009/08/going-google-with-google-apps.html#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908">gone Google</a>" and are actively using <a href="http://www.google.com/a/help/intl/en/edu/index.html#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908">Google Apps Education Edition</a> on campus. Since this time last year the number of students using Google Apps on campus has increased by 400%. Because more schools sign up for Apps everyday, we wanted to celebrate the start of the 2009 school year by launching a<a href="http://www.google.com/a/help/intl/en/edu/appsatschool.html#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908"> </a><a href="http://www.google.com/a/help/intl/en/edu/appsatschool.html#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908">new site</a> that shows off some of these schools, provides product tips and tricks, introduces a community discussion forum and more. <a href="http://www.google.com/appsatschool#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5379161785424650018" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgYwTy48MYcc1IUzcdpoPJ_OjT2stbUI8QzmjjszckLeyZssxcKokoEmpQgyHvpwoVm9mLDyEr1Gs2dpS2vm-8g9Ob4YTPG-cVrCElsdAMpTTKBWyh20U_aig4OOn1GA1CEDKH9URdY84Vs/s400/cf25nc3h_48ccrqm6fk_b.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 174px;" /></a><div style="text-align: center;">A snapshot of some of the thousands of schools "going Google" this fall. Every location in green indicates Apps users. </div> When you visit the site, you'll also find an interactive map packed with interesting trivia. For example, in addition to the 70,000 students using Apps at Temple University, their 5,000 staff and faculty were given a choice between Gmail and alternative vendor, and over 90% chose to go Google. Or when Kent State first deployed, they saw more than 700 students migrating each hour. And a single admin at Montana State successfully deployed over 30,000 accounts in less than 90 days. Or as we learned in the <a href="http://www.youtube.com/watch?v=PuteocMftek#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908">recent webinar</a> from another school on the map — Notre Dame — they saved $1.5 million by switching to Apps. You can hear their full story in this video: <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/PuteocMftek&hl=en&fs=1&"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/PuteocMftek&hl=en&fs=1&" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="344" width="425"></embed></object> We hope more schools will continue to go Google and bring Apps to their campuses in an effort to improve communication and collaboration while cutting costs and resources. In the meantime, check out <a href="http://www.google.com/a/help/intl/en/edu/appsatschool.html#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908">our site</a> and find out what Apps has done for other schools and what Apps can do for your school — and if you're already a part of the movement, <a href="https://spreadsheets.google.com/a/google.com/viewform?hl=en&formkey=dElDTTBzTjJBejgzUXZFcVJGbHZLT1E6MA#utm_campaign=gonegoogleuni&utm_medium=blog&utm_source=en-ogblog-na-us-edugogoogle_0908">add yourself to the map</a>!<div> Posted by Miriam Schneider and Jason Cook, Google Apps Education Edition team</div>

Five million students going back to school are "going Google"

(Cross-posted on the Google Students Blog ) It's always tough to bid farewell to summer and hit the books again, but for a few million s...

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Pfour Legal Settlements for Pfizer - Why is the Company "Recidivist?"

We recently posted about Pfizer's $2.3 billion dollar settlement with the US government (<a href="http://hcrenewal.blogspot.com/2009/09/pfizers-2300000000-settlement-no-longer.html">here</a>), which we first mentioned six months ago (<a href="http://hcrenewal.blogspot.com/2009/02/pfizer-settles-for-mere-2300000000.html">here</a>). It is worth reviewing what we know about this settlement. We will start with quoted from the article by Gardiner Harris writing <a href="http://www.nytimes.com/2009/09/03/business/03health.html">in the New York Times</a>. We will also use quotes from other articles listed below: A Big Settlement (from the NYT) <blockquote>The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn. It was the largest health care fraud settlement and the largest criminal fine of any kind ever. </blockquote>The penalties include a very large criminal fine, an even larger civil fine, and a corporate integrity agreement (from the NYT). <blockquote>Under the agreement with the Justice Department, Pfizer will pay a $1.3 billion criminal penalty related to Bextra and $1 billion in civil fines related to other medicines. In addition, a Pfizer subsidiary, Pharmacia and Upjohn, will plead guilty to violating the Food, Drug and Cosmetic Act for its promotion of Bextra. The company has agreed to sign another corporate integrity agreement that requires senior company executives to annually certify legal compliance and mandates that Pfizer post on its Web site many of its payments to doctors. </blockquote>For Specific Unethical and Illegal Activities The activities for which Pfizer incurred the penalties included marketing drugs for "off-label" indications for which the company did not have US Food and Drug Administration (FDA) approval, and other deceptive marketing practices (from the NYT). <blockquote>The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. [Acting US Attorney for Massachusetts] Mr. Loucks, the prosecutor, accused Pfizer of aggressive marketing tactics. 'Among other things, Pfizer did the following: Pfizer invited doctors to consultant meetings, many in resort locations. Attendees expenses were paid; they received a fee just for being there,' he said. Such weekend getaways for doctors are still common throughout the drug and medical device industries. </blockquote>Also, <a href="http://www.nj.com/news/ledger/jersey/index.ssf?/base/news-14/1251938706305590.xml&coll=1">per the Newark Star-Ledger</a>, <blockquote> The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer's sales representatives often created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages. The civil settlement covered Pfizer's promotions of Bextra, blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. The agreement with the Justice Department resolves the investigation into promotion of all those drugs, Pfizer said. The government said Pfizer also paid kickbacks to market a host of big-name drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec. </blockquote> Pfizer's Previous Unethical Behavior Pfizer has previously been charged with unethical conduct, and the penalties it paid for this conduct did not seem to deter it (from the NYT). <blockquote>It was Pfizer’s fourth settlement over illegal marketing activities since 2002. 'Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism,' said Michael K. Loucks, acting United States attorney for the Massachusetts district. Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave. </blockquote> Some more details of these settlements, <a href="http://www.philly.com/philly/business/homepage/20090903_FDA__Pfizer_ignored_warnings__gets_record_fine.html">from the Philadelphia Inquirer</a>, <blockquote>Repeat Offender: Previous Pfizer Settlements April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug. May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000. October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor. </blockquote> On Health Care Renewal, we have posted about other instances of unethical behavior by Pfizer. Most recently, these included producing allegedly misleading direct to consumer (DTC) advertising about Lipitor (see post <a href="http://hcrenewal.blogspot.com/2008/02/rower-mis-impresses-pfizer-ends-its.html">here</a>), and conducting unethical research in Africa (see post <a href="http://hcrenewal.blogspot.com/2009/08/pfizer-settles-trovan-case-with-kano.html">here</a>). So it appears that Pfizer is, as the prosecutor put it above, recidivist. Why has the company repeatedly behaved unethically? One argument is that company executives have learned that the rewards of unethical behavior exceed its costs (thus, are responding to a form of perverse incentives.) Perverse Incentives Favoring Unethical Behavior The fines paid by Pfizer were not that large for a company of Pfizer's size (from the NYT). <blockquote> While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales. </blockquote> In lieu of other punishments, the company's managers may just look upon paying fines as the cost of doing business. <a href="http://abcnews.go.com/Health/PainManagement/story?id=8476391">Per ABC News</a>, <blockquote> Industry insiders say drug companies often forgo legal considerations in favor of profit. If companies, people or entities 'are able to make that decision and determine that there's an economic incentive to break the law, they'll break the law,' said Reuben Guttman, attorney for Glen Demott, a former Pfizer drug representative. Change in a financially driven industry depends on whether a few billion dollars of penalty will affect the company's net profits or share costs. In 2008, Pfizer earned $48.3 billion in revenue. </blockquote> Bloomberg commentator Ann Woolner <a href="http://www.bloomberg.com/apps/news?pid=20601039&sid=ahodmf54hyPA">said</a> one reason the penalties have not been stiffer is that somehow the government views the company as too big to fail. <blockquote> So how does Pfizer get away with civil settlements given its history? The penalties have ranged from hand slaps to a light punch in the gut, none of which have hurt the company enough for things to change. Last year Pfizer earned $8.1 billion on sales of $48.3 billion. The New York-based company repeatedly winds up as the target of government accusations. Its misdeeds cost federal and state programs hundreds of millions of dollars, says the Justice Department, not to mention the human suffering that comes with taking the wrong drug in the wrong dosage. But Pfizer is the pharmaceutical equivalent of insurance giant American International Group Inc., which was too interwoven into the global economy to be allowed to fail. Likewise, if Pfizer were convicted of a crime, it would face debarment from federal programs. And that would mean that Medicaid and Medicare patients would have to either somehow pay pocket for vital medicines the company produces or go without. 'You have to balance the desire, an appropriate desire, to punish the company against the harm to patients,' says attorney Kelton. </blockquote> This begs the question about why no people, save for two relatively low level managers, no individuals paid any penalties. The unethical behaviors listed above must have been implemented by scores of line personnel, lead by mid-level managers. They, in turn, were acting at the behest of a hierarchy of managers and executives, culminating in "C-level" officers, lead by the CEO. Finally, these executives all reported, in theory at least, to the board of directors. So almost none of the people responsible for the unethical activities paid any penalty. No individuals had to pay fines, or even lose their jobs, much less face criminal proceedings. Maybe the apparent ability of company personnel, starting with those in the trenches, all the way up through levels of management to the CEO, and thence to the board of directors to act with impunity has lead to a culture of amorality. A Culture of Amorality Some evidence that the culture of the company is pathologic comes from former Pfizer insiders charged that the comany's culture promotes unethical behavior (from the NYT). <blockquote> John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government’s Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra. 'The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,' said Mr. Kopchinski </blockquote> Also, per ABC News, <blockquote>'At Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives,' Kopchinski said, in a statement. 'I couldn't do that.' </blockquote> In light of the list of unethical behaviors documented above, that company leaders deny any big problems itself becomes a problem (from the NYT). <blockquote>Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again. 'The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner,' she said. </blockquote>Note that the majority of Pfizer employees may be ethical, but all it takes to accomplish unethical behavior is a few people in key leadership positions willingo to direct unethical activities to increase sales and profits, and for their subordinates to be willing to just follow orders. Also, per a <a href="http://www.bloomberg.com/apps/news?pid=20601087&sid=aFFALMOwjfrg">report in Bloomberg News</a>, Ms Schulman added, <blockquote> This gives us a very important opportunity to put final closure on the universe of material open items involving our U.S.-based operations. This is a significant opportunity because it allows Pfizer to return its attention to the things that really should matter most to a biopharmaceutical company, which is the practice of developing innovative medications and bringing them to market in an appropriate fashion. </blockquote> Summary: What is to be Done? So will even a $2,300,000,000 settlement and yet another corporate integrity agreement make Pfizer or any other health care corporation act more ethically? I doubt it. Remember, Pfizer may be a corporation, and thus be before the law a sort of pseudo-person. However, it is not really a person. In this settlement, like others before it, it was people who implemented the behavior, made the decisions which lead to the behavior, and condoned the behavior. The people involved ranged from those in the trenches, through layers of management, to C-level executives, to the board of directors. In my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. Finally, I say again that we cannot improve health care until we address this sort of unethical behavior. As reported by ABC News, <blockquote> 'It won't make a dent if the conduct that led to the settlement is not addressed as part of health care reform,' said [Harvard Medical School faculty member Dr Jon]Abramson, who was the expert consultant for the plaintiff attorneys in the Bextra case in 2007. 'The real problem is this behavior is not isolated to Bextra nor Pfizer but in essence is the way the pharmaceutical industry expands the sales of its drugs,' Abramson said. 'Unless health care reform can address misrepresentations, withholding science and control claims made to consumers, Americans will continue to pay too much for health care that is not as effective and is expensive.' </blockquote> PS - According to Bloomberg commentator Ann Woolner, one of the whistle-blowers in this case was a physician who noticed that a Pfizer drug representative was pushing him to use drugs off-label, <blockquote>Pfizer Inc. sales folks had one tough customer in psychiatrist Stefan Kruszewski. He didn’t buy their pitch to prescribe the anti-psychotic drug Geodon to children, a use that hadn’t been approved by federal regulators. Nor did he go for the so-called off-label uses they suggested, such as treating dementia in the elderly. Kruszewski didn’t just say no. He went and checked the research and saw Geodon could have serious cardiac side effects not mentioned by the salesmen, who boasted of its relative safety, according to his lawyer, Brian Kenney. And he noticed that Pfizer was paying his peers to promote the drug to other psychiatrists. But the worst for Pfizer was that Kruszewski didn’t keep it to himself. He found a lawyer, Kenney, who specializes in whistleblower cases, and they took what they had to the government. </blockquote> So to all you physicians out there, this shows that you can succesfully blow the whistle on unethical practices by health care organizations. And you may even make some money doing so. Apparently several of the whistle-blowers in this case will get sizable payments under the US False Claims Act. ADDENDUM (8 September, 2009) - See also comments <a href="http://alison-bass.blogspot.com/2009/09/pfizers-23-billion-fine-is-only-tip-of.html">by Alison Bass </a>on the Alison Bass Blog, and <a href="http://brodyhooked.blogspot.com/2009/09/pfizer-assessed-record-fine-why-we-need.html">by Dr Howard Brody </a>on the Hooked: Medicine, Ethics and Pharma blog.

Pfour Legal Settlements for Pfizer - Why is the Company "Recidivist?"

We recently posted about Pfizer's $2.3 billion dollar settlement with the US government ( here ), which we first mentioned six months ag...

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