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Kamis, 15 Maret 2012

Despite Recalls, Legal Settlements and Guilty Pleas - A $143.5 Million (or Perhaps $197 Million) Golden Parachute for the Former Drug Representative Who Is Now CEO of Johnson and Johnson

After 30 separate product recalls since 2009, and multiple legal settlements and guilty pleas, we noted that the former pharmaceutical representative who is now the CEO of Johnson and Johnson will be retiring. 

The $143.5 Million (or Perhaps $197 Million) Golden Parachute

The Wall Street Journal just reported his retirement will come with an immense golden parachute:
Johnson & Johnson Chairman and Chief Executive William Weldon stands to collect pension benefits and deferred compensation currently valued at $143.5 million after his retirement, according to new details released by the health-care conglomerate.

The details were:
Mr. Weldon, who will be succeeded as CEO by Vice Chairman Alex Gorsky, stands to collect benefits from two main sources. The present value of his accumulated pension benefits is $48.4 million, portions of which are paid out as a monthly annuity for life, according to Wednesday's filing with the Securities and Exchange Commission.

His pension's value places Mr. Weldon well into the top 10% of CEOs of Standard & Poor's 500 companies, said Paul Hodgson, chief communications officer and senior research associate at GMI Ratings, which tracks corporate-governance information.

Mr. Weldon also has amassed $95.1 million in nonqualified deferred-compensation plans. This represents parts of his salary and bonus that had been deferred in prior years, as well as company contributions to savings plans. Portions of Mr. Weldon's deferred compensation have been recorded each year as part of his total annual pay.

Of the $95.1 million, more than $70 million represents Mr. Weldon's accumulated balance from a legacy cash-incentive plan that J&J has discontinued and replaced with a new executive-compensation plan. This sum would be paid to Mr. Weldon at retirement, J&J said. All deferred compensation is subject to taxes.

Actually, an argument that the $143.5 million figure is an major under-estimate appeared in the Shearlings Got Plowed blog:
The MSM reports calculate only the cash values for soon to be Ex-CEO Weldon, not the present value of his stock options, at today's NYSE closing price for J&J of $65.08. So, that -- plus the vesting of his February 2012 JNJ RSUs and Stock Option awards [see page 45 of the link (but such amounts are ommitted from the year end 2011 proxy, on which the WSJ relied)] -- add about $53.47 million to the Weldon walkaway haul.

Thus, Mr Weldon's golden parachute may be as big as $197 million.

The Board's Justification for the Riches

Of course, the Johnson and Johnson board justified the latest additions to Mr Weldon's wealth, as reported by the WSJ:
In a regulatory filing Wednesday, the board said Mr. Weldon 'successfully managed our company through a challenging economic environment in 2011,' with solid financial results and advances in J&J's pharmaceutical pipeline.

The board added that while J&J made progress in addressing manufacturing-quality issues in 2011, 'continued focus is needed to address critical product supply and quality issues that impact our responsibility of being able to deliver products to patients and customers who need them.'

Johnson and Johnson's Recent Record

The board's upbeat assessment sharply contrasts with Johnson and Johnson's actual recent record.

As we discussed recently, Johnson and Johnson seems to have lost the ability to manufacture high quality products. It has had to make 30 separate product recalls since 2009. The latest was Liquid Infant Tylenol. (The current WSJ Health Blog list of recalls can be found here.)  This seems to be more than a "rough patch," which is how the WSJ article described the manufacturing problems.

In addition, the WSJ article failed to mention that Johnson and Johnson also has an amazing recent record of ethical lapses and guilty pleas, including:
- Convictions in two different states in 2010 for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax in 2010
- Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see this link for all of the above)
- Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post here)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
- More recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Most recently, there are reports that the company is in negotiation with the US Department of Justice to settle other lawsuits about the marketing of Risperdal, perhaps for as much as $1.8 billion (see this BusinessWeek story.)

Meanwhile, an article from the Wharton Business School suggested that the problems at Johnson and Johnson stemmed directly from former drug representative Weldon's management approach, which put short term revenues, "making the numbers," ahead of everything else, apparently including good manufacturing practices, or ethical business practices:
[University of Michigan Ross School of Business Professor Erik] Gordon argues that CEO Weldon's relentless focus on the bottom line -- the company's website touts its record of 27 consecutive years of adjusted earnings increases and 49 consecutive years of dividend increases -- is the reason for the current woes. 'Bill Weldon sets the priorities and the culture for the company,' says Gordon. And the problems, from overly aggressive marketing to underinvestment in safety and quality systems, reflect 'people trying to get their bonuses, hit their numbers and keep their job.'

No doubt the global economic collapse in 2008 put renewed pressure on managers at multinationals like Johnson & Johnson. John Kimberly -- a Wharton management professor and executive director of the Wharton/INSEAD Alliance who has worked with J&J executives in Europe since the late 1990s -- says he detected a shift among those managers starting in 2008. 'I got the sense that there were some things happening at corporate, and that messages were being sent about the need to deliver profitability,' Kimberly notes. 'It seemed as though the people I was working with were feeling pressure from above to pay closer attention to the bottom line. It was a palpable, tangible change.'

Wharton's Donaldson gives J&J management credit for the aggressive steps the company is now taking to overhaul its manufacturing processes and plants. But he also notes that the balance between profits and patients is a tricky one. Managers at J&J, he says, 'are juggling a lot of balls. In the credo, they say they put patients first and stockholders further down the line. But there is a red ball that every manager knows about, [which is] profit -- and they don't let that red ball drop.' Figuring out how to serve patients well and still deliver for Wall Street is not easy. 'J&J believes they can do both those things,' Donaldson says. 'But if the weight of one side of that formula gets too heavy, the entire structure collapses.'

Summary

The ongoing news from the once proud Johnson and Johnson, whose credo famously states:
We believe our first responsibility is to doctors, nurses and patients, to mothers and fathers, and all others who use our products and services. In meeting their needs, everything we do must be of high quality.
suggests that instead, the company's first responsibility is now to the hired managers, to obey their dictates no matter how they undermine the credo, and most importantly, to pay them so much as to make them some of the most wealthy people in the world. Johnson and Johnson has become exemplary, not of putting patients or health care professionals first, but of how hired managers took over health care, and turned it to their own advantage.

So should we trust Johnson and Johnson to do better, now that another former pharmaceutical representative will be its new CEO?

The case of Johnson and Johnson indicates why we need a huge change in how health care organizations are lead.

Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

EHRs and test ordering: Health Affairs authors reply to ONC

At my March 9, 2012 post "Increased Lab Ordering with EHR's?" I refuted ONC's response to a Harvard-based research study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that may contradict the notion that HIT reduces medical costs.

Now the authors themselves have responded to ONC. There are many similar themes in their response. I've bolded them below:

The Effect Of Physicians’ Electronic Access To Tests: A Response To Farzad Mostashari

March 12th, 2012

by Danny McCormick, David Bor, Stephanie Woolhandler, and David Himmelstein

Our recent Health Affairs article linking increased test ordering to electronic access to results has elicited heated responses, including a blog post by Farzad Mostashari, National Coordinator for Health IT. Some of the assertions in his blog post are mistaken. Some take us to task for claims we never made, or for studying only some of the myriad issues relevant to medical computing. And many reflect wishful thinking regarding health IT; an acceptance of deeply flawed evidence of its benefit, and skepticism about solid data that leads to unwelcome conclusions.
Dr. Mostashari’s critique of our paper, will, we hope, open a fruitful dialogue. We trust that in the interest of fairness he will direct readers to our response on his agency’s site. [If not, HC Renewal posts get highly ranked by Google - ed.]
Our study analyzed government survey data on a nationally representative sample of 28,741 patient visits to 1187 office-based physicians. We found that electronic access to computerized imaging results (either the report or the actual image) was associated with a 40% -70% increase in imaging tests, including sharp increases in expensive tests like MRIs and CT scans; the findings for blood tests were similar. Although the survey did not collect data on payments for the tests, it’s hard to imagine how a 40% to 70% increase in testing could fail to increase imaging costs.
Dr. Mostashari’s statement that “reducing test orders is not the way that health IT is meant to reduce costs” is surprising, and contradicts statements by his predecessor as National Coordinator that electronic access to a previous CT scan helped him to avoid ordering a duplicate and “saved a whole bunch of money.” A Rand study, widely cited by health IT advocates including President Obama, estimated that health IT would save $6.6 billion annually on outpatient imaging and lab testing. Another frequently quoted estimate of HIT-based savings projected annual cost reductions of $8.3 billion on imaging and $8.1 billion on lab testing.
We focused on electronic access to results because the common understanding of how health IT might decrease test ordering is that it would facilitate retrieval of previous results, avoiding duplicate tests. Indeed, it’s clear from the extensive press coverage that our study was seen as contravening this “conventional wisdom”.
Nonetheless, Dr. Mostashari criticizes us for analyzing the impact of physicians’ electronic access to imaging and test results, but not other aspects of electronic health record (EHR) use. We did, however, analyze the relationship of EHRs to test ordering in a subsidiary analysis. While physicians use of a full EHR was associated with a 19% increase in image ordering, as we noted in the paper this finding was not statistically significant. While we cautiously (and properly) interpreted this as a “null” finding, these data are inconsistent with Mostashari’s optimistic view that use of a full EHR reduces costs.
He asserts that our 2008 data are passe, and that health IT meeting today’s “meaningful use” criteria definitely saves money. The data we analyzed were the latest available data when we initiated the study. While the proportion of outpatient physicians utilizing health IT has grown since 2008, we are unaware of any “game changing” health IT developments in the past four years that are would produce substantially different results if the study were repeated today. The EHR vendors that dominated the market in 2008 remain, by and large, today’s market leaders, and their products have undergone mostly modest tweaks. Mostashari’s contention that 2012 EHRs – incorporating decision support and electronic information exchange – save money in ways not possible in 2008 should be tested through additional research but remains merely a hypothesis. We hope that some day his predicted savings can be achieved.
Dr. Mostashari offers his own explanation for our findings, suggesting that doctors who are inclined to order more tests are also inclined to purchase health IT for viewing test results electronically rather than on paper. He offers no evidence for this assertion and ignores the fact that we explored (and rejected) this explanation by analyzing subgroups of doctors who are unlikely to be the decision maker for IT purchases – e.g. employed physicians, those working in an HMO setting etc. In other words, electronic access to results predicted more test ordering whether or not the ordering physician was responsible for health IT purchases.
He incorrectly states that our analysis did not take into account patients’ severity of illness, physicians’ level of training, and the nature of physicians’ financial arrangements. In fact, we reported subsidiary multivariate analyses that included several serious diagnoses; all of our models included physician specialty (which we specified in several different ways); and all models included adjustment for an extensive list of indicators of financial arrangements (e.g. whether the physician owned the practice or was an employee; the type of office; whether the practice was owned by a hospital; whether the physician was a solo practitioner; whether the physician’s compensation was based, in part or whole on “profiling”; and whether the practice was predominantly prepaid). We also performed a series of subsidiary analyses that explored whether physicians with a proclivity to “self refer” patients for imaging tests accounted for our finding; they didn’t.
Dr. Mostashari criticizes us for failing to assess whether health IT improved the quality or appropriateness of care. Of course, these were not the topic of our research. Those are different studies for a different time. However, we would note that other large-scale studies have found no, or trivial quality improvements associated with HIT outside of a few flagship institutions4-6.
Dr. Mostashari’s strongest claim is that observational studies like ours (and most other health policy studies, including some by Dr. Mostashari himself) cannot prove causation. This is surely true. As long time teachers of evidence based medicine we took care to couch our conclusions in cautious terms, stating only that “Computerization, whatever its other benefits, remains unproven as a cost control strategy.”
But Dr. Motashari is less cautious, asserting that the case for HIT is closed. The paper he cites to buttress this claim (authored by members of his own agency) culled studies reporting any impact of HIT on virtually any aspect of care, and accepted authors’ claims of benefit without regard to study quality or statistical niceties. Thus, a focus group’s impressions of benefit are accorded the same weight as nationwide studies of Medicare data showing virtually no impact of computerization on quality measures. Reports of a reduction from 70% to 38 % in “missed billing opportunities” or a $7,000 reduction in office supply costs are among the 92% of studies judged “positive”. While the literature review he cites is interesting, nothing in it contradicts our findings.
Dr. Mostashari is also correct in reiterating that randomized trials are the best way to assess health IT. In fact, no randomized trial has ever been published that examines patients’ outcomes or costs associated with off-the-shelf health IT systems that dominate the U.S. market. No drug or new medical device could pass FDA review based on such thin evidence as we have on health IT. Yet his agency is disbursing $19 billion in federal funds to stimulate the adoption of this inadequately evaluated technology. Dr. Mostashari is perhaps the only person in our nation who commands the resources needed to mount a well done randomized controlled trial to fairly assess the impact of health IT, and the comparative efficacy of the various EHR options.
Finally, Dr. Mostashari’s unbridled faith in technology is mirrored by his belief that ACOs are the next panacea for health costs and quality. That health policy flavor-of-the-month also remains wholly unproven.

I think readers comparing my response to the authors', and who are familiar with the many posts at HC Renewal going back to 2004, will recognize the themes I have bolded in the author's response to HHS.

-- SS

Nancy Finn, author of "e-Patients Live Longer", openly calls for unethical medical experimentation without consent

My construct of the "Ddulite" orientation largely driving health IT is not merely a theoretical construct. Ddulites (derived from the term "Luddite" with first four characters reversed) are:

Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

Here is an example of this disposition on display:

In a March 14, 2012 Pittsburgh Post Gazette article "Digital ease may complicate health care" by Bill Toland about the recent controversy caused by a Harvard study showing EHR's may actually increase test ordering thus raising, not lowering, medical costs, Nancy Finn, a medical consultant and author of "e-Patients Live Longer" is quoted as saying:

... In an ideal world, management would know if a software suite is going to improve health outcomes before it's rolled out, said Nancy Finn, a medical consultant and author of "e-Patients Live Longer." Unfortunately, though, uncertainty is built into the process.

"The only way to know [the systems] are inefficient and flawed is to deploy them, then correct them as we go," she said. [That is, they are experimental - ed.]

"That is the way that all of the new innovative technologies have worked over the years. We have to take the risk, and then improvements get made."


This statement in highly alien to medical ethics.

She is explicitly stating that this technology is experimental - "The only way to know [the systems] are inefficient and flawed is to deploy them" - and then states "We have to take the risk" where the "we" are unconsenting patients, i.e., not afforded the opportunity for true informed consent, and 'investigators' also often coerced to use these systems, i.e., clinicians themselves.

Never mentioned are the downsides of experimental technology such as health IT: patient injury, death, litigation against physicians and other clinicians entrapped into "use error" (errors promoted by the common mission hostility of today's health IT), or led into errors by poor software quality causing data corruption, misidentification or outright loss, and additional issues described by FDA (link) and others. Nor are ethical issues considered.

NO, Ms. Finn: "We" do NOT have to "take the risk."

There are scientific methods for improving experimental technologies such as "controlled clinical trials" with informed consent, opt-out provisions and built-in protections for patients and investigators.

The "trial and error", "learn-as-we-go", "computers' rights supercede patients' rights" approach you suggest, while perhaps appropriate for mercantile computing, is highly inappropriate for healthcare.

Such issues, I had believed, had been settled after WW2.

There is nothing to argue, and nothing to discuss.

-- SS

Ciri-Ciri Cowok Matre


Unik Informatika - Wanita mana yang tidak kebat-kebit hatinya ketikabertemu pria tampan dan simpatik? Tentunya, perhatian si dia bisa bikin hati berbunga-bunga. 
Namun, bagaimana jika di balik sikapnya yang memesona, dia malah sedang ‘menguras’ kantong Anda alias dia ini adalah Cowok Matre. 
Menurut Cherie Carter-Scott dalam bukunya 'If Love is a Game, These are the Rules', ada beberapa tanda yang bisa Anda kenali untuk mendeteksi pria materialistis alias matre. 

Ini Dia Ciri-ciri Cowok Matre:

1.  Awalnya tidak pelit Tipe pria matre ini awalnya memang tergolong royal. 
Pada awalnya dia menghujani Anda kiriman bunga, cokelat, dan benda-benda unik. Tentunya, Anda bisa luluh pada godaan pria romantis itu. Pria jenis ini pintar melakukan berbagai cara untuk menaklukkan wanita. Sifat matre-nya baru akan kelihatan kalau wanita yang diincar sudah berhasil didapat. 

2. Penampilan gaya. 
Sebagai wanita, sebaiknya mengenal baik pria seperti apa yang sedang mendekati Anda. Jangan mudah tertarik pada penampilan saja, sebab biasanya pria matre itu penampilannya bergaya. Untuk mengenalinya juga bisa dilihat dari cara dia memilih teman dan pasangan. 
Coba perhatikan, siapa-siapa saja temannya atau mantan-mantannya. Apakah selama ini ia hanya bergaul dengan kalangan jetset saja atau tidak. 

3. Banyak alasan. 
Pada saat mau membayar sesuatu Pria matre biasanya enggan mengeluarkan uang dari kocek sendiri untuk keperluan pasangannya. Dan, kondisi semacam ini berlangsung terus-menerus. 

 Ciri lainnya, mereka terlalu berhitung alias pelit, tapi bisa royal untuk kesenangannya sendiri. Mereka juga tidak punya rasa sungkan untuk meminta sesuatu dari sang kekasih. Tapi, benarkah seorang pria matre adalah seratus persen sosok ‘tanpa hati’ yang cuma melirik isi dompet wanita? Ada kemungkinan si pria matre sungguh-sungguh jatuh hati pada kekasihnya, tapi juga sekaligus mengambil keuntungan materi darinya. 
 Lantas, bagaimana bila Anda sudah kepincut dengan pria tipe ini? Saran Cherie, cobalah ungkapkan masalah keuangan ini padanya. Tahapan selanjutnya adalah melakukan negosiasi. Ada pun negosiasi bisa dilakukan melalui tindakan. Misalnya, Anda yang biasanya murah hati, tiba-tiba menolak jika dia meminta sesuatu. Atau, biasanya ringan mentraktir, jadi mulai hitung-hitungan.
 Yang biasanya mudah memberi hadiah, dihentikan dulu untuk sementara. Lakukan berulang kali agar ia menangkap isyarat pelan-pelan, tapi 'menusuk' dari Anda. Cara semacam itu lumayan jitu untuk mengukur kesungguhan cintanya.
 Jika si dia belum tobat juga dari matre-nya? Apa boleh buat, Anda harus berani mengambil keputusan untuk hidup Anda. Sebelum telanjur terlibat jauh, lebih baik segera tinggalkan saja. Karena, banyak kasus konflik suami-istri yang berakhir pada perceraian, bersumber dari masalah keuangan.

source : Facebook Page

Logical Fallacies in Defense of the European Society of Cardiology's Lenient Approach to Conflicts of Interest

The European Society of Cardiology just published its recommendations for interactions between medical societies and industry.(1)   The report emphasized the supposed benefits of industry relationships and funding, and suggested few restrictions on current practices.  Like other defenses of leniency towards conflicts of interest, its arguments seemed to rest on a series of logical fallacies.  

Wonderful "Innovations ... Through Productive Collaboration" - Appeal to Belief and the Fallacy of Division

The report made several arguments about the benefits of professional - industrial interaction.  These included:
In recent decades, cardiology has been a fast-moving medical speciality. Many advances have come from basic and clinical research conducted by universities and by pharmaceutical and medical device companies. Innovations have been realized in part through productive collaborations between clinicians, academia, and industry. Such links are essential and need to be encouraged and supported by appropriate investment if medical progress is to be sustained.

The notion that interactions between physicians and industry is a source, perhaps the most important source of wonderful "innovations" is often used to justify the sorts of interactions, involving payments by industry to academia and physicians, that are now prevalent. In this report, this first appears as an assertion without any evidence to justify it.

Later, the report noted:
The Association of American Medical Colleges has stated that there are benefits from effective partnerships between industry and academic medical centres.

This statement came with a citation, to a 2008 report entitled "Industry Funding of Medical Education."(2) This AAMC report, in turn, contained many similar assertions, e.g.,
An effective and principled partnership between academic medical centers and various health industries is critical in order to realize fully the benefits of biomedical research and ensure continued advances in the prevention, diagnosis, and treatment of disease.
However, the AAMC report also failed to cite any evidence in support of these assertions.

There are two major problems with these assertions, which form the foundations of both reports. The first is they do not seem to have a clear evidence base.

While the notion that current research efforts marked by substantial interaction between physicians, academia and industry are producing wonderful innovations is appealing, what evidence there is suggests that clinically important innovation is rare. For example, I quote a 2009 review of global drug discovery by Light(3) on whether new drugs represent advances over older treatments:
the best evidence of clinical quality comes from systematic efforts to assess therapeutic advantage and adverse effects compared with existing drugs. A detailed analysis of therapeutic quality in new drugs over the past twenty years found that 14 percent of all new chemical entities are either therapeutic breakthroughs or substantially superior to existing medications. Likewise, a comprehensive review of all new drugs approved between 1989 and 2000 in the United States concluded that 14.8 percent were new chemical entities that provided significant clinical improvement, and a Canadian review board concluded that 10.7 percent of new chemical entities in 2000–2004 did so.
Thus while many new drugs are introduced, only a few introduced recently were chemically unique or had effects different than older treatments.  I would argue that most of these will prove not to be truly clinically innovative, in that good clinical research will not show that they produce substantial improvements in clinical outcomes without major adverse effects for a good number of patients with not uncommon problems.  (It is not hard to think of really important innovations developed before the era of major industry-academic-physician interactions: antisepsis for surgery, anesthesia for surgery, antibiotics, hormone replacement therapy with insulin, thyroid hormone, etc, smallpox vaccination, polio vaccination, etc, etc)  However, it is actually very hard to think of more than a handful of new drugs or devices discovered in the last 20 years which were that hugely innovative.  (The closest might be multi anti-viral drugs used to treat HIV, and Gleevec for chronic myelogenous leukemia.)  If there has been very little really important innovation in the last 20 plus year era of enhanced industry-academic-physician interactions, these collaborations could not have produced tremendous innovation. 

So the report's arguments rests on an assertion that is not clearly justified, and which appears to be at best a huge exaggeration. Resting an argument on a belief that is not further supported by evidence amounts to a obvious logical fallacy.  It is an appeal to belief.

Furthermore, while both reports emphasize physician-industry collaboration or interaction, there are many ways interaction or collaboration can occur without involving substantial payments by the latter to the former. It is possible for two people or organizations to work together without one paying the other.  Yet both reports use the broad assertions about interaction and collaboration to justify interactions and collaborations in which industry makes substantial payments to physicians or academic institutions. This appears to be an example of the fallacy of division, that is, an unjustified assertion that "what is true of a whole must also be true of its constituents."

CME Would Wither if Financing Were Reduced, and Industry is the Only Possible Source of Such Money - A Slippery Slope and a False Dilemma

The ESC report made the argument that without industry funding, CME would wither. For example,
Should Europe choose to follow the strategy proposed in the USA, severing links between industry and medical societies, CME could be severely compromised. Relying completely on public funding is not a viable option for Europe at the moment. The removal of industry support for medical associations would be followed by increased fees and reduced attendance at congresses especially by clinical trainees and young fellows. It is the view of the ESC that in the absence of alternative funding, or until alternative funding is identified, maintaining links with industry is appropriate....

The argument is that CME would fail if financial support for it would be reduced, and that industry is the only possible source of financial support at the current level. The notion that CME must inevitably fail if financing of it were reduced is a slippery slope fallacy, that is, a statement that a inevitably causes b when such inevitability is not proven. Why could not adequate CME be done at a lower cost, even if the result were less luxurious? Furthermore, the notion that industry is the only source of funding is a false dilemma fallacy. In fact, there are other possibly sources of funding. Given that physicians are among the world's best paid professionals, why could they not pay for their own CME?

"Conflicts of Interest are Unavoidable and ... They Cannot Be Abolished" - False Dilemma

The third major argument on which the report bases its recommendations is encapsulated above, and was buttressed by:
The risk of bias in medical education is not restricted to activities that are supported by industry. It can affect any type of scientific communication, even an educational meeting organized independently by a university or medical association.

Underlying these assertions seem to be extremely broad definitions of bias and conflicts of interest, coupled with unwillingness to see a distinction between trivial and serious varieties of each. This again appears to be a false dilemma. The distinctions should be between no conflicts, trivial conflicts, and serious conflicts, not between no conflicts and any conflicts, even if trivial.  This also could be called an example of how "the perfect is the enemy of the good."  Even if perfectly preventing all conflicts of interest is impossible, does this imply that preventing serious conflicts of interest is not worthwhile.   

Summary

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, herehere, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.

So we add to our ongoing series how, based on a series of logical fallacies, the European Society of Cardiology provided a series of recommendations that allowed nearly any kind of relationship among CME speakers and selection committees and industry, as long as the relationships were disclosed.  The only relationships banned were those "which would represent a significant conflict of interest" for the Chairperson of a Congress Programme Committee.  Similarly, the only stipulations for the society's cardiology journals were that interests affecting editors and editorial board members must be declared, and board members and reviewers should decline reviews of manuscripts "relating to topics, drugs, or devices, in which they have significant commercial of academic interests."  The rules for guideline committees were somewhat more rigorous, but "receipt of consultancy fees or fees for lecturing would not debar an individual from being a member of a committee but must be fully disclosed."

It is discouraging that the web of conflicts of interest that currently enmeshes much of academic medicine and many medical professionals is so heavily defended.  It is more discouraging that its defenders include so many prominent academics and practicing physicians.  It is more discouraging that so many well trained people resort to logical fallacies to make their arguments, and do so in prestigious scholarly journals.

Our continuing series about how logical fallacies are used to support the status quo and the powers that be in health care suggests, if nothing else, that health care professional education ought to include courses in logic.

Finally,  in 2011, I noted, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  Last month, however, I discussed how the leader of one of the most acclaimed US medical schools made an argument in support of conflicts of interest based on logical fallacies,  Now we have just seen such arguments made by the leaders of European cardiology.  The new paper suggested that disclosure is the best way to manage conflicts of interest.  True to this belief, the paper included a disclosure section that took up an entire journal page.

It seems likely that number and magnitude of ongoing commercial interests so disclosed may have influenced the content of the position paper.  Yet while it may be unsurprising, it is most disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care.

The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA(4):
Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.
True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals, others who make decisions about patients' or the public's health, and academic health care institutions. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

References
1. ESC Board. Relations between professional medical associations and the health-care industry, concerning scientific communication and continuing medical education. Eur Heart J 2012; 33: 666-674. Link here.
2. Association of Americian Medical Colleges. Industry Funding of Medical Education. Washington, DC: AAMC, 2008. Link here.
3. Light DW. Global drug discovery: Europe is ahead. Health Aff 2009; 28: w969-w977. Link here.
4. Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link here.

10 TIPS TO STAGE YOUR GAMES

Lloyds TSB National School Sport Week 2012
Top 10 Ideas  to Stage YOUR Games

The Lloyds TSB National School Sport Week is taking place between Monday June 25th to Friday June 29th 2012 and schools across Wales are being encouraged to register at www.schoolsportweek.org

In 2011, 560 primary and secondary schools across Wales registered for NSSW which equated to approximately 170,000 pupils who were exposed to sport during the week.  This goes a long way to helping the sports sector achieve the vision of getting every child hooked on sport for life so Sport Wales and partners are hopeful more schools will sign up in 2012, especially as it is Olympic and Paralympic year!

Once schools have registered they will receive resources and case studies to help them plan their NSSW event under the theme ‘Stage Your Games’.  To get schools started here are our top 10 tips to Stage Your Games.....

1.       London 2012 World Sport Day – kickstart your Lloyds TSB National School Sport Week with London 2012 World Sport Day, on Monday 25 June. It is a great way to celebrate the sport and culture of the competing Olympic and Paralympic teams, and to welcome the world to the UK. This could involve other subject departments such as music, dance and art to you help create an inspirational opening ceremony – registered schools will receive London 2012 World Sport Day resources to support them.

2.       Become a Flame Follower – the Olympic Flame spreads a message of peace, unity and friendship. Lloyds TSB has created eight fantastic lessons to get your pupils excited about the Olympic Torch Relay. Each lesson plan is linked to a range of subjects to help pupils explore and learn about the Olympic Torch Relay. Registered schools can visit www.schoolsportweek.org to access these resources.

3.       Make a pledge – encourage pupils to make a pledge. This could be to try something new, do more sport, volunteer, officiate or could have a behavioural focus. Many schools which have done this in the past have seen improvements in pupil behaviour. You could create a school pledge, perhaps incorporating the Olympic and Paralympic Values, giving the pupils ownership and responsibility to promote and commit to them.

4.       Link with local sports clubs – invite clubs into the school to showcase their sport, take coaching sessions and discuss opportunities in the local area. Try to feature sports that are inclusive, new to young people, aligned to the different cultures in your school and fun!

5.       Incorporate the whole school – 95% of teachers that used Lloyds TSB National School Sport Week themes in English, ICT and Maths said they had successfully enhanced student learning. Other subjects can also be used to enrich the learning for pupils; such as Geography, Business Studies, History and Languages.

6.       Hold a Paralympic day – The International Paralympic Committee (IPC) and Get Set, the official education programme for London 2012, offers a number of resources, ideas and opportunities to help you plan a successful and inspirational Paralympic Day.

a.       Visit the IPC website - www.paralympic.org/Science_Education/Education/
b.      Visit the Get Set website - https://getset.london2012.com

7.       Transition day – schools have used Lloyds TSB National School Sport Week as a transition week, inviting local primary schools into the secondary school for a day of sport. These events offer invaluable opportunities for young people to familiarise themselves with their new school surroundings and meet new friends before the start of the school year. Schools can offer pupils the chance to try Olympic and Paralympic sports and to meet young leaders within the school.

8.       Volunteers – Volunteering is an integral part of the London 2012 Olympic and Paralympic Games. Many schools already have a huge number of young volunteers who are often at the heart of the most successful Lloyds TSB National School Sport Week events. Volunteers could help shape the week by planning the activity, supporting on the day, officiating, reporting, photography, co-ordinate opening and closing ceremonies and so on.

9.       Celebrate – hold a closing ceremony at the end of Lloyds TSB National School Sport Week to celebrate the success and achievements of your pupils throughout the week. You could use certificates to congratulate pupils on exceptional behaviour linked to the Olympic and Paralympic Values or for their participation.

Olympic and Paralympic Values – registered schools can visit www.schoolsportweek.org to access videos of athletes discussing the Values. You can use these as part of an assembly or discussion groups within lesions.

We hope this helps you get involved! Remember to let us know how you get on and tweet us any updates and pictures to @sport_wales. Pob Lwc!
 

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