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King Pharmaceuticals Settles and One Columnist Writes that Such Settlements are Not the Answer

Here we go again.  The latest settlement in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade</a> was made by the Alpharma subsidiary of King Pharmaceuticals, as <a href="http://www.reuters.com/article/idUSN1611445520100316">reported by Reuters</a>: <blockquote>Alpharma Inc, a unit of King Pharmaceuticals (KG.N), has agreed to pay $42.5 million to resolve allegations that it gave kickbacks to doctors to prescribe the pain drug Kadian and misrepresented its safety and effectiveness, the Justice Department said on Tuesday. Kadian, which is based on morphine [that is, a long-acting preparation of morphine], is used to treat chronic moderate to severe pain.</blockquote> We have ranted frequently about how settlements like this, which simply impose costs on large organizations that can easily be regarded as costs of doing business, but impose no penalties on the people who authorized, directed, or implemented bad behavior, do nothing to deter future bad behavior. Now at least we have company (see recent example of rant <a href="http://hcrenewal.blogspot.com/2010/03/sacks-medical-kv-pharmaceutical-plead.html">here</a>). Last week, a commentary by An Woolner <a href="http://www.businessweek.com/news/2010-03-16/jail-time-for-executives-might-stop-drug-crimes-ann-woolner.html">on Bloomberg</a>, included: <blockquote>Examples abound that these companies keep breaking rules and violating laws to make and market their products, no matter how many times they are caught, fined and forced to promise to go straight.</blockquote>Yet, <blockquote>The biggest fine ever imposed in U.S. history, $2.3 billion against recidivist Pfizer, represented a mere 14 percent of the revenue stream from selling the drugs at issue over seven years. [see our post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here.]</a> So immune to criminal sanctions was the New York-based company that it launched its off-label Bextra campaign at the same time the company was pleading guilty to doing precisely the same thing with other drugs. The anti-inflammatory medication was later yanked from the market because of increased risk of heart attacks and stroke.</blockquote> So, <blockquote>What’s to be done? The government can essentially kill a company by pushing for the parent firm to be barred from government work, which would include Medicaid and Medicare. Teaching a Lesson That would teach the company a lesson. But it would also hurt the millions of people who depend, in Pfizer’s case, on products from Accupril to treat congestive heart failure to Zyvox when you have certain pneumonias or infections. And then there are those thousands of company employees who do good, honest work and who would suddenly find themselves in already massive unemployment lines.</blockquote> Instead, <blockquote>The challenge is to find a way to make it not worthwhile to break the rules. Executives Behind Bars Throwing a few company executives in jail might do the trick. On occasion, sales managers and physicians have been prosecuted. As for top managers at pharmaceuticals, six have been convicted or pleaded guilty, mostly for misbranding or promoting off-label uses, according to the Justice Department. Winning felony convictions is tough to pull off because you have to prove they had specific intent to commit fraud. As with any white-collar crime, that is tricky. But there is a way around that obstacle, and the FDA announced this month that it would go that route to focus on pharmaceutical executives, the Wall Street Journal reported. The Food and Drug Act allows misdemeanor convictions without proof of intent to do wrong. That is an awesome power and it can be easily abused. The timing of the FDA announcement suggests that it’s a response to critics in Congress and a brutal Government Accountability Office report that the division operates without scrutiny or, well, accountability. And yet, used for the right cases, the misdemeanor prosecution of an executive or two who set up incentives for the sales force to push drugs illegally and withhold information about devices from regulators just might do the trick. Nothing else has yet.</blockquote> To which I say, amen.

King Pharmaceuticals Settles and One Columnist Writes that Such Settlements are Not the Answer

Here we go again. The latest settlement in the parade was made by the Alpharma subsidiary of King Pharmaceuticals, as reported by Reuters ...

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Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">query link</a>). One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry. One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "<a style="font-weight: bold;" href="http://www.bmj.com/cgi/content/full/340/mar18_1/c1344">Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review</a>" (BMJ 2010;340:c1344). Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the <a href="http://www.philly.com/inquirer/business/homepage/20100320_Study__Researchers_with_Glaxo_ties_favored_Avandia.html">Philadelphia Inquirer</a>:<blockquote> "We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.</blockquote> From the BMJ article itself, free full text available as of this writing at link above: <blockquote>For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.</blockquote> The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing. Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's. As to results (see the full article for statistical details I am omitting here): <blockquote> Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.</blockquote> While causality is not proven, these results are still stunning. Per the Inquirer's summary: <blockquote>... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found. Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.</blockquote> The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy). The authors observe that: <blockquote>In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest. </blockquote> Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements: <blockquote> Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.] </blockquote>One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist. <blockquote>... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]</blockquote> So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue. Finally, the pharmaceutical company's view, also published in the Inquirer article cited above: <blockquote>A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site. "It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure." </blockquote> "Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view. The Mayo researchers wisely conclude: <blockquote> Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.</blockquote> Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers. We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues. These practices also simply need to be abolished, for as I have written before on these pages ("<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?</a>"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already. -- SS

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without r...

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Gruber at MIT to Senators: "I Promise To Be Good ... Next Time"

Frequently expressed on this blog are concerns about conflicts of interest and their corrosive effects upon healthcare (<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">query link</a>). We also have expressed concern about the mental gymnastics used by the privileged or those in positions of power to rationalize these COI's and/or justify keeping these COI's from the public's eye. In a stunning display of academic arrogance, MIT economics professor <a href="http://econ-www.mit.edu/faculty/gruberj/shortbio">Jonathan Gruber</a>, who promoted and defended the administration's health care policies before the U.S. Senate Committee on Finance as well as the Health, Education, Labor & Pensions Committee, while collecting $400,000 from HHS for his services, literally blew off a letter of inquiry from Senators Grassley and Enzi regarding possible conflicts of interest. (See <a href="http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&source=hp&q=jonathan+gruber+conflict+of+interest+HHS&btnG=Google+Search">this Google search</a> on the terms "jonathan gruber conflict of interest HHS".) The professor has been a source of support for what many consider improbable arguments of the impact of current health care reform efforts, while being on the HHS dole. Sen. Grassley and Sen. Enzi have thus written Dr. Susan Hockfield, President of MIT, to "encourage" the professor to be a little more forthcoming in his replies. The letter to Hockfield and a copy of the original letter to Prof. Gruber can be <a href="http://finance.senate.gov/press/Gpress/2010/prg031710a.pdf">downloaded </a><a href="http://finance.senate.gov/press/Gpress/2010/prg031710a.pdf">here</a> (PDF). On Jan. 26, 2010 Gruber was asked some very specific questions by letter (summary below, see full letter at link above for details). He was asked by the Senators: <ul><li>To identify each contract, grant or cooperative agreement he has executed with the federal government, including the White House and HHS and its operating divisions, during the past five years. For each contract, he was asked to respond to a series of detailed questions on: specifics of work performed, federal official serving as contact, start/end dates, amount of compensation, plus a request for copies of the contracts, grants, cooperative agreements, and a copy of the deliverables;</li><li>To identify which of the contracts are "sole source", and provide the reasons the contracts were sole source, what official made that determination, and who is the federal official with whom he negotiated the sole sourcing;</li><li>To answer similar questions about contracts with state and local governments and private entities and individuals he had executed in the past five years;</li><li>To identify all interviews or statements made to the media on healthcare reform since the federally funded work began, and if asked during the interview or if he did so voluntarily, to state if he revealed the HHS relationship; and </li><li>To answer similar questions on all speaking engagements. </li></ul> To these detailed inquiries, the response was this (emphases mine): <blockquote>February 23, 2010 Dear Senators Grassley and Enzi: This letter responds to your letter to me dated January 26, 2010. I appreciate your commitment to the principle of transparency in government and can assure you that I never intentionally withheld my two HHS contracts from Congress. Indeed, my contracts were publicly disclosed on the federal government website, <a href="http://www.usaspending.gov/">www.usaspending.gov</a>. [Prof. Gruber seems to confuse the passive "publicly disclosed" with active "public disclosure," and apparently misses the point that a possible conflict of interest is an obligation of the principal(s) to disclose when they publish or speak, not an obligation of the audience to discover ex post facto via governmental or other websites - ed.] As you know, my professional research focuses on public finance and health economics and throughout my career I have worked with Democrats and Republicans alike on the critical issue of health care reform. I served as a consultant to then-Governor Mitt Romney in connection with health care reform efforts in Massachusetts and have also testified before the Congress on these issues. [That worked out <a style="font-weight: bold; font-style: italic;" href="http://www.washingtonexaminer.com/opinion/columns/What-Obamacare-has-already-done-for-Massachusetts-88191372.html">rather poorly</a>, according to Massachusetts Treasurer Tim Cahill - ed.] I was invited to testify jointly by the Majority and Minority Members of the Senate Finance Committee in the Summer of 2008 on the interaction of health insurance and the tax code and have testified more recently as well. In addition, over the past year in connection with my economic analysis work for HHS, I have worked closely with the staffs of both the Senate Finance and the Senate HELP Committees in evaluating various health care reform proposals and assessing how such proposals might be scored by the Congressional Budget Office. To the best of my recollection, during the course of my health care reform work with Congress, no Member or staffer ever asked me whether I held any government contracts. Given that the staff saw the time that I was devoting to this effort, in retrospect, I suppose I assumed they understood I was being paid for that work. [Assumed you were being paid ... to the tune of nearly half a million dollars? - ed.] Both my congressional testimony and the health care opinion pieces that I have authored reflect my longstanding policy views -- and were in no way influenced by my contracts with HHS, which related to technical economic modeling designed to determine the costs of various health care reform policy options. [Which raises another question: was that 'modeling' influenced by the HHS money? - ed.] It certainly did not occur to me that anyone would view my HHS contracts as relevant to my independent, long-held opinions regarding the economics of health care reform. [Really? - ed.] I regard the contract work I performed for HHS and my public speaking and writing as being independent and unrelated. But I do recognize the public interest in these disclosure issues and will certainly consider them in the context of future appearances on the Hill or in the media. [I note that "I will consider them" (i.e., disclosure 'issues') is an ambiguous statement, as opposed to "I will disclose my possible conflicts" - ed.] Thank you for your work on these issues. Sincerely, Jonathan Gruber </blockquote> In other words, I guess the public does have a right to know about my possible conflicts of interest when a major portion of the US economy's about to be up-ended, and I'll be a good boy and team player - next time. By the way, regarding your detailed questions, you do good work, but get lost. Academic contempt for disclosure of conflicts of interest seems to know few bounds. I doubt the letter to the MIT President will accomplish very much. Let's hope the responses from the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/grassley_erecords102409.pdf">healthcare IT vendors</a> to Sen. Grassley's inquiries are more forthcoming than this academic one. Finally, it occurs to me that profligate spending of almost a half million dollars for the sole-source consultation of a single (already salaried) professor raises a concern about cherry-picking for theories supporting a certain point of view, and shows questionable governmental fiscal responsibility. That is the size of a research grant that could support, say, a significant fraction of the time of a half dozen academic collaborators with a diverse set of theories and views. -- SS Disclosure: I have not received a penny from HHS, government, academia, industry, or even Tinkerbell or the Tooth Fairy for these views.

Gruber at MIT to Senators: "I Promise To Be Good ... Next Time"

Frequently expressed on this blog are concerns about conflicts of interest and their corrosive effects upon healthcare ( query link ). We a...

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AMA And Almost 100 Physician Societies Sound Off To CMS On Health IT, Use "F" Word

In a remarkable development, the American Medical Association and nearly one hundred other physician specialty societies submitted a letter to CMS on Mar. 15 (in PDF at <a href="http://www.ama-assn.org/ama1/pub/upload/mm/399/meaningful-use-comments-15mar2010.pdf" target="_blank">http://www.ama-assn.org/ama1/pub/upload/mm/399/meaningful-use-comments-15mar2010.pdf</a>). These organizations wish to prevent physicians from purchasing ill conceived and poorly designed HIT that does not support better practice. The organizations also express deep concern about ominous reporting requirements and overly aggressive timelines, the latter an issue I've written about repeatedly such as in my formal reply to ONC's "Proposed Establishment of Certification Programs for Health Information Technology" <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html">at this link</a>. The entire letter is available at the PDF link above and is quite lengthy, but the section of the letter that immediately caught my eye is this: <blockquote>... Aggressive timelines and criteria during the initial stage of the incentive program will only serve to undermine this effort. Some government officials have relayed that complex measures and high reporting thresholds are needed to discourage EPs ["eligible professionals" eligible for ARRA money -ed.] from switching back to the use of paper during this transition to EHRs. We are very troubled by this assertion. Physicians are deeply supportive of and committed to incorporating well-developed EHRs into their practices to improve quality of care delivery, enhance patient safety, as well as support practice efficiencies. [Some are - many are not - perhaps the medical specialty societies need to stop acting as if they speak for all physicians - ed.] It is also very unlikely that after physicians make a significant up front investment in health IT and changes to their workflow that they will revert back to manual processes. </blockquote> That assertion, in fact, is not quite true, as in "Failure, De-installation Of EHRs Abound" <a href="http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20071030/FREE/310300002/0/FRONTPAGE#">here</a>. However, coercion through ominous reporting requirements is not going to improve adoption rates and will undermine HIT efforts as well, for example via physician fear of the uses to which the data will be put by a coercive, authoritarian-leaning government. Now comes what I believe is the most critical passage where the "F" word ("failure") is used: <blockquote> We believe that the larger concern should be deterring the purchasing of costly EHR products that fail to improve physician workflow, patient care, and practice needs. Industry experts have cited that such failures have adversely affected EHR adoption rates ranging from 50 to 80 percent. [<a style="font-weight: bold; font-style: italic;" href="http://www.tinyurl.com/hostileuserexper">Mission hostile health IT</a> falls into that category - ed.] </blockquote> Note the acknowledgment of healthcare IT failure. The letter was a bit weak in the area of <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">patient safety related to HIT</a>. Further, it presented physicians as monolithic eager adopters of HIT (a characterization that is most assuredly false), and minimized the issue of the messiness and Murphy's Law nature of IT installation and maintenance that often make IT a nightmare. The fact, however, that a letter from the major medical societies challenged the irrational exuberance and beliefs in technological determinism that surround health IT (i.e., that computerization 'automagically' fosters improvement), and used the "failure" word is itself somewhat astonishing. I was not inventing anything when I began <a href="http://www.tinyurl.com/healthITfailure">writing about HIT difficulties over ten years ago</a> using the "failure" word, merely reporting the obvious (to those sober about IT) from observation and reports of many colleagues. It's good to see the rest of the medical world start to catch up with common sense. -- SS Addendum: the letter was also signed by the following groups: American Academy of Dermatology Association American Academy of Family Physicians American Academy of Home Care Physicians American Academy of Neurology Professional Association American Academy of Ophthalmology American Academy of Otolaryngology – Head and Neck Surgery American Academy of Pain Medicine American Academy of Physical Medicine and Rehabilitation American Academy of Sleep Medicine American Association of Clinical Endocrinologists American College of Cardiology American College of Chest Physicians American College of Gastroenterology American College of Obstetricians and Gynecologists American College of Osteopathic Family Physicians American College of Osteopathic Internists American College of Osteopathic Surgeons American Academy of Pediatrics American College of Physicians American College of Radiation Oncology American College of Rheumatology American College of Surgeons American Gastroenterological Association American Geriatrics Society American Medical Association American Osteopathic Academy of Orthopedics American Osteopathic Association American Psychiatric Association American Society for Clinical Pathology American Society for Gastrointestinal Endoscopy American Society for Radiation Oncology American Society of Anesthesiologists American Society of Clinical Oncology American Society of Hematology American Society of Nephrology American Society of Plastic Surgeons American Thoracic Society American Urological Association Heart Rhythm Society Infectious Diseases Society of America Joint Council of Allergy, Asthma and Immunology Medical Group Management Association North American Spine Society Renal Physicians Association Society for Cardiovascular Angiography and Interventions Society for Vascular Surgery Society of Hospital Medicine The Endocrine Society Medical Association of the State of Alabama Alaska State Medical Association Arizona Medical Association Arkansas Medical Society California Medical Association Colorado Medical Society Connecticut State Medical Society Medical Society of Delaware Medical Society of the District of Columbia Florida Medical Association, Inc. Medical Association of Georgia Hawaii Medical Association Idaho Medical Association Illinois State Medical Society Indiana State Medical Association Iowa Medical Society Kansas Medical Society Kentucky Medical Association Louisiana State Medical Society Maine Medical Association MedChi, The Maryland State Medical Society Massachusetts Medical Society Michigan State Medical Society Minnesota Medical Association Mississippi State Medical Association Missouri State Medical Association Montana Medical Association Nevada State Medical Association New Hampshire Medical Society Medical Society of New Jersey New Mexico Medical Society Medical Society of the State of New York North Carolina Medical Society North Dakota Medical Association Ohio State Medical Association Oklahoma State Medical Association Oregon Medical Association Pennsylvania Medical Society Rhode Island Medical Society South Carolina Medical Association South Dakota State Medical Association Utah Medical Association Wisconsin Medical Society Vermont Medical Society Medical Society of Virginia Washington State Medical Association West Virginia State Medical Association Wyoming Medical Society

AMA And Almost 100 Physician Societies Sound Off To CMS On Health IT, Use "F" Word

In a remarkable development, the American Medical Association and nearly one hundred other physician specialty societies submitted a letter ...

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A Simple Lesson for the Health IT Industry

From an Op Ed "<a href="http://online.wsj.com/article/SB10001424052748703734504575125533112150508.html">Living with the Electronic Car</a>" in today's Wall Street Journal: <blockquote>"A Toyota executive recently explained to a Congressional committee investigating claims of uncontrolled acceleration: "We need to reduce the number of things we ask our customers to do correctly." In fact, the exec was describing the essence of responsible engineering - though perhaps the balance in auto design has gotten out of whack."</blockquote> Considering the feedback from physicians on the needless complexity of electronic medical records and other computerized medical devices for example at "<a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">An Honest Physician Survey on EHR's</a>", it seems the healthcare IT industry has yet to learn this simple lesson. I'm frankly not convinced there's "anyone home" in this complexity-loving industry who could fathom such advice as a good business practice. It also seems that industry may not give a damn about such lessons, even in the most safety critical of environments, the intensive care unit, as long as profits are maintained. See for example "<a href="http://hcrenewal.blogspot.com/2010/02/lawsuit-over-health-it-whistleblowing.html">A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare</a>." Also see "<a href="http://hcrenewal.blogspot.com/2010/03/third-party-reviews-of-devices-come.html">Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation</a>" on political maneuvering by this industry to avoid the federal regulation other healthcare drug and device sectors have been subject to for decades (largely as a result of public health disasters such as <a href="http://en.wikipedia.org/wiki/Harrison_Narcotics_Tax_Act">this</a> and <a href="http://en.wikipedia.org/wiki/Thalidomide">this</a>, I might add). The interesting aspect of these issues is that the executives and officials behind these decisions and machinations are setting themselves up as near-indefensible defendants in future litigation by patients (and their estates) harmed or killed by healthcare IT-related problems. For instance, I had communications with the Joint Commission leadership over issues I raised in my July 22, 2009 JAMA letter to the editor "<a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>." Namely, on how hospital executives were violating their fiduciary and Joint Commission safety standards obligations, and jeapardizing patient safety, in signing the traditional health IT contract calling for confidentiality about health IT malfunctions and defects. The JC Leadership is quite well aware of this letter and my more thorough essay <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=koppel_kreda">here</a>. Nothing has been heard from the Joint Commission on these issues since. Perhaps never before have the malpractice lawyers been provided a better scenario for taking the houses and personal property from irresponsible and/or conflicted healthcare and health IT regulators and other officials via lawsuits as health IT diffusion increases, with its "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">tip of the iceberg</a>" injury and death occurrences now firmly established. -- SS

A Simple Lesson for the Health IT Industry

From an Op Ed " Living with the Electronic Car " in today's Wall Street Journal: "A Toyota executive recently explained t...

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Abbott's TriCor Fails To Beat A Sugar Pill in Diabetics - And In Pharma's Current Death Spiral, Forget About a Drug That Will

In numerous national publications today, we are once again reminded that lowering the risk of diabetics for vascular events (MI/heart attack, CVA/stroke etc.) and death is far more complex than lowering measures such as cholesterol and blood pressure. Note these articles: <a href="http://blogs.forbes.com/sciencebiz/2010/03/abbotts-tricor-fails-to-beat-a-sugar-pill/"></a><blockquote><a href="http://blogs.forbes.com/sciencebiz/2010/03/abbotts-tricor-fails-to-beat-a-sugar-pill/">Abbott's TriCor Fails To Beat A Sugar Pill</a> March 14, 2010 - 9:58 am Matthew Herper Forbes.com ATLANTA -- A popular triglyceride-lowering drug that has been taken by millions of Americans failed to prevent heart disease in a big federal study being presented today. The drug, TriCor from Abbott Laboratories, has been used for over a quarter of a century to lower levels of fatty particles in the blood called triglycerides. The presumption has been that doing so would prevent heart attacks or heart-related deaths. TriCor has annual sales of more than $1 billion. But the new study being presented at the American College of Cardiology meeting casts doubt on this. In the study, funded by the National Heart, Lung and Blood Institute, 5,500 patients with diabetes got either TriCor or a placebo. After five years, there was no difference in the rate of heart attacks, strokes and deaths in the patients who got Tricor versus those who took a sugar pill. </blockquote>and <a href="http://online.wsj.com/article/SB10001424052748703457104575121951874047506.html"></a><blockquote><a href="http://online.wsj.com/article/SB10001424052748703457104575121951874047506.html">Search for Better Diabetes Therapy Falls Short</a> Mar. 14, 2010, 9:39 P.M. ET Ron Winslow Wall Street Journal Current Treatments, While Effective, Failed to Also Help Prevent Heart Attacks and Stroke ATLANTA—New strategies to prevent and treat diabetes and heart disease failed to improve care in two major studies, frustrating researchers' efforts to find more-effective approaches to the world's burgeoning diabetes epidemic. The studies are among the first large trials to test whether treatments recommended for diabetes patients also reduce the risk of heart attacks and strokes. Diabetics are between two and four times as likely to die of cardiovascular causes as nondiabetics. The lack of data on whether strategies to treat diabetes actually lower heart risk is of growing concern to physicians, researchers and regulators. One new study, called Accord, found that treating blood pressure to lower levels than recommended in current practice doesn't further reduce risk of death, heart attack and stroke among people with diabetes. The same study also found that the drug Tricor, marketed by <a href="http://online.wsj.com/public/quotes/main.html?type=djn&symbol=ABT" class="companyRollover link11unvisited">Abbott Laboratories</a>, failed to prevent such events even though it lowered levels of blood fats called triglycerides that are associated with high diabetes risk. In the other report, dubbed Navigator, a diabetes drug called Starlix failed to prevent people at high risk of diabetes from progressing to the disease. The blood-pressure medicine Diovan did modestly reduce risk of developing diabetes in the same study, but neither drug significantly cut the risk of heart-related deaths, heart attacks and strokes. Both pills in this study are sold by <a href="http://online.wsj.com/public/quotes/main.html?type=djn&symbol=NVS" class="companyRollover link11unvisited">Novartis</a> SA of Switzerland.</blockquote> There is a meta-issue I wish to bring up: It's clear there are many phenomena going on in diabetes and other metabolic disorders that we simply do not understand. It's also very likely that there are new drugs, yet undiscovered, that could be developed and that would improve mortality and morbidity. It's too bad the pharmaceutical industry is now largely run by <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=pharma">dyscompetents, incompetents</a>, and other <a href="http://hcrenewal.blogspot.com/2009/01/pfizerwyeth-merger-and-sacrificing.html">management charlatans</a>, not to mention those responsible for questionable or outright criminal behaviors (such as <a href="http://hcrenewal.blogspot.com/search/label/fraud">here</a>, <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>). This privileged class has apparently so demoralized pharma rank and file including the very soul of drug discovery (chemists) - based for example on "layoff thread" comments on a very popular blog for medicinal, synthetic and other chemists such as <a href="http://pipeline.corante.com/archives/2010/02/17/merck_announces_cuts.php">here</a> - that these new drugs are increasingly unlikely to be developed at all. The industry in its current anti-intellectual, "lay them off and watch the stock price rise", short-term narrow-minded idiocy-driven death spiral is basically good for nothing except money games. Pity. -- SS

Abbott's TriCor Fails To Beat A Sugar Pill in Diabetics - And In Pharma's Current Death Spiral, Forget About a Drug That Will

In numerous national publications today, we are once again reminded that lowering the risk of diabetics for vascular events (MI/heart attack...

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Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation

This WSJ article caught my eye: <a href="http://online.wsj.com/article/SB10001424052748703447104575117892340074732.html"></a><blockquote><a href="http://online.wsj.com/article/SB10001424052748703447104575117892340074732.html">Third-Party Reviews of Devices Come Under Scrutiny at the FDA </a> March 15, 2010 By ALICIA MUNDY and JARED A. FAVOLE WASHINGTON—When medical-equipment makers like Philips Electronics NV, Siemens AG and General Electric Co. need approval for some new devices, they don't always have to start at the Food and Drug Administration. They can pay companies to do the reviews, which are then routinely approved by FDA officials most of the time. Now this third-party outsourcing program has come under fire at the FDA, and the agency is weighing whether to end it. Agency officials question the quality of the reviews and whether they have served the program's original purpose: saving U.S. taxpayers money. The "real value to industry may be that this is perceived as a way to 'sneak things,'" said an FDA official at a December meeting on device approvals, according to minutes reviewed by The Wall Street Journal. Some third-party reviewers advertise speed and a friendlier process. </blockquote> At a time when the FDA is moving against third party device reviews, HHS and its Office of the National Coordinator for health IT (ONC) are soliciting to create third party EHR "certification" bodies for <a href="http://hcrenewal.blogspot.com/2009/11/2009-pivotal-year-in-healthcare-it.html">healthcare information technology (HIT) medical devices</a> such as electronic medical records systems, decision support tools, clinician order entry and alerting, etc. (see RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology", PDF available <a href="http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf">at this link</a>.) This comes at the same time as FDA admitting this technology harms and kills patients, but the extent is unknown (existing FDA data is likely the "tip of the iceberg" reports Jeffrey Shuren MD JD at the HIT Policy Committee, Adoption/Certification Workgroup, special meeting on health IT safety on February 25, 2010). See: "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" rel="nofollow" target="_blank">http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html</a> and "On ONC's "Proposed Establishment of Certification Programs for Health Information Technology" at <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" rel="nofollow" target="_blank">http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html</a> More from the WSJ article: <blockquote>... The agency's concerns about the third-party reviews come as the FDA is re-evaluating its entire device-approval process. In addition, the agency has recently announced tighter regulation of some machines that deliver radiation in the wake of reports of more than 300 cases of overdoses from CT scanners at four hospitals. Changes under consideration at the FDA include terminating the third-party program, limiting the kinds of devices that it covers, or giving the outside reviewers more data on devices to improve the quality of their work, according to the minutes and interviews with agency officials. Jeffrey Shuren, the device division director, said the FDA will release proposed changes later this year and cautioned that no decisions have been made. To qualify for an outsourced review, a new device must be similar to a device already on the market, and it must carry low or moderate risk to the patient. The December 2009 minutes say "third parties often don't have appropriate expertise." The minutes cite "poor quality of review documents— they often just repeat what is in the submission, and don't provide any analysis of the data."</blockquote> (The point on lack of expertise is a point I raise in my aforementioned commentary on ONC's "Proposed Establishment of Certification Programs for HIT." I wrote: HHS should not be creating new, potentially (likely?) amateur organizations and bureaucracies overseeing these new virtual medical devices that will have variable (or no) experience in software validation, certification, regulation, postmarketing safety surveillance, etc. Rather, HHS should be leveraging existing governmental expertise in certifying, validating and regulating mission critical IT.) The industry as always is looking out for - itself, patients coming in second: <blockquote>Terry Sweeney, vice president of clinical affairs at Philips Healthcare, said the third-partyprogram benefits industry and helps relieve the FDA of a burden. "Every week's delay [i.e., in rigorously assuring medical device safety - ed.] can cost the company a large sum of money," he said.</blockquote> It's not like the time differential is enormous: <blockquote> It takes an average of about 72 days for a company to get final clearance for a device when it goes the third-party route, according to the FDA. That includes the time for the agency to sign off on the outside reviewer's conclusion and compares with an average 109 days for similar applications that go directly to the FDA.</blockquote> So, the vendors seem to be saying, let's compromise the device safety evaluation process via third party reviewers so we can get to market a month sooner. The FDA is having serious second thoughts about this state of affairs. Worse, on health IT devices, the HHS itself via ONC is soliciting for the creation of third party reviewers for HIT, while the FDA itself seems marginalized or even unwilling to shoulder the burden of patient protection from faulty HIT. Odd. Why do computerized HIT medical devices such as EMR's get special government accommodation? -- SS <div style="text-align: justify;">For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - <a style="font-style: italic;" href="http://tinyurl.com/healthITfailure">http://www.tinyurl.com/healthITfailure</a></div>

Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation

This WSJ article caught my eye: Third-Party Reviews of Devices Come Under Scrutiny at the FDA March 15, 2010 By ALICIA MUNDY and JARED A. FA...

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