"I'm Not Here to Sell Drugs" - Then Why Use Company Provided "Correct" Slides?

In October, 2010, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records. 

Since then, news media around the US have looked into interactions among local physicians and academic medical institutions and the seven pharmaceutical companies.  In November, 2010, here we discussed cases that suggested that pharmaceutical companies like physician speakers because they are more "believable" than pharmaceutical representatives, and choose physicians who already are prolific prescribers of the drug to be promoted, and that suggested that some physicians realized that speaking for pharmaceutical companies influenced their own prescribing.

Since then, more investigations of local physicians' interactions with pharmaceutical companies have appeared that reinforced contrasts between rationalizations that physicians and drug companies use to support continued payments for "drug talks," and what these talks are really about.

"Leaders in Their Field" vs Sanctions and Crimes

 Many pharmaceutical (and other health care corporations) have repeated the mantra that the physicians they hire to give talks are the best and the brightest.  The physicians who give the talks sometimes get to believe this.  For example, a ProPublica follow-up report[1] on discrepancies between data the pharmaceutical companies put on the web and gave to state regulators noted:

Pfizer, for example, told the state it paid Dr. Randy Schapiro $1,770 last year. But on the firm�s website, it reported spending $43,827 on him in the second half of 2009 alone.

It then quoted Dr Schapiro:

Schapiro said the doctors paid by pharmaceutical companies are 'leaders in their fields,' and patients should want to see their physician among them. 'If their doctor is not on the list,' he said, 'maybe they should look for a different doctor.'

On the other hand, several of the local news articles focused on physicians who were paid drug company speakers despite having chequered backgrounds, shall we say. In the Elmira Star Gazette[2]:

Tulio Ortega, a Rochester psychiatrist who made $144,548 from Eli Lilly and AstraZeneca for speaking to groups of peers during the last two years - was put of [sic] probation for two years in 2008 and ordered to pay a $7,500 fine after being sanctioned for negligence and incompetence.

Also,

Lilly also paid Yonkers physician Ali Sherzoy $4,334 in the first two quarter of this year, even though he had his license suspended in New York and New Jersey earlier this year after pleading guilty to a count of criminal sexual contact in 2008.

Sherzoy told ProPublica the incident involted his family's nanny and had nothing to do with his ability to practice medicine.

Other New York doctors were sanctioned for incidents ranging from deficiencies in handling controlled substances to being convicted of tax evasion.

Another article by the same author[3] noted two more cases:

In 1991, Johnson City doctor Louis Mateya was charged with professional misconduct after a 22-year-old woman accused him of unzipping his pants and fondling himself during an examination.

Mateya admitted guilt to the charge. The State Board for Professional Medical Conduct suspended his license for two months, followed by a 58-month probationary period, during which he was monitored by a psychiatrist and a health professional selected by the board.

During the last nine months of 2009, GlaxoSmithKline paid Mateya, an internist at United Health Services, $1,750 to speak on behalf of Lovaza, Glaxo's prescription omega 3 fish oil, according to an e-mail from a United Health Services spokeswoman.

Also,

A second Southern Tier physician, Robert Douenias, of Corning, was also paid by Glaxo: $20,000 during the same time frame to deliver speeches, even though he received sanctions in 1992.

According to the Office for Professional Medical Conduct (OPMC) records, Douenias lied about a previous criminal conviction on his application for a New York medical license. He received a censure and reprimand from the OPMC, was ordered to perform 200 hours of public service and was placed on probation for two years. Douenias said on his application he had never been convicted of a crime in any state or country, even though he had a previous conviction, according to OPMC records.

Note that the original ProPublica reporting from their database emphasized cases of physicians paid to speak by pharmaceutical companies who also had been sanctioned by medical boards or the criminal justice system (see post here).

Although drug marketers like to tell physicians they are selected as "thought leaders" because of their brilliance, it appears that the selection of such "key opinion leaders" is not necessarily based on sterling character.

"I'm Not There to Sell a Drug," But Then Why Use the Company's Slides?

A number of the reports featured physicians who asserted their independence, at least from marketing goals. 

For example, as reported by the Duluth (MN) News Tribune[4],

A Duluth psychiatrist has received more than $525,000 since 2002 in payments from pharmaceutical companies, far more than any other Northland doctor, an analysis by the News Tribune shows.

Dr. Tracy Tomac of St. Luke�s hospital was paid by the companies to give presentations on health and drug issues.

Furthermore,

'I�m there as an educator and resource,' she said. 'I�m not in business to do a sales pitch. I�m not a salesperson.'

Also,

In 2007, [Dr] Tomac said her presentations included content that was screened and approved by the FDA,....

However, other reporting suggested that content "screened and approved by the FDA" was content provided by the pharmaceutical companies.

For example, The Tennessean noted[5]:

Dr. Jan Brandes heads the Nashville Neuroscience Group, a clinic that's now part of Nashville-based Saint Thomas Health Services. She made $111,150 in outside income over the past two years, largely in speaker fees paid by drug company GlaxoSmithKline, which markets a wide array of brand-name drugs, literally from A to Z.

Dr Brandes also asserted,

'The real point is I'm not there to sell a drug,' Brandes said. 'I'm there to interpret trial results, talk about disease states and help physicians understand where this research might fit in the context of their practice.'

However,

Most drug companies now require physicians to use the company's slides and presentations if they pay them to speak at an event. The industry says that is to ensure that all U.S. Food and Drug Administration rules are met and that physicians don't wander off into discussing uses for a particular product that haven't been approved by regulators.

Also, an article in the Alexandria (VA) Gazette Packet[6] noted:

Whistleblower lawsuits filed in recent years have accused firms of using doctors to push pills for unapproved uses during dinnertime talks, prompting at least 10 firms to settle cases for nearly $7 billion in the last three years. Since that time, pharmaceutical companies have tightened control over what happens during presentations given on their dime. Last year, for example, GlaxoSmithKline instituted a new policy prohibiting doctors from using their own slides during presentations. Starting in 2010, all doctors giving speeches sponsored by GlaxoSmithKline must use slides presented by the pharmaceutical company in the order specified.

'We want to make sure that everything is correct,' said Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline. 'The best way to do that is to have our team prepare the slide.'

Note that Dr Brandes above was paid mainly by GlaxoSmithKline, who presumably also provided all her slides and made sure that everything she said was "correct," at least in terms of what GlaxoSmithKline thought was correct.

And one more example per MyFoxAtlanta[7]:

Some of Georgia's highest paid physicians? .... and Roswell psychiatrist Dr. Michael Banov: over $68,000, also from Lilly.

Dr Banov asserted:

We don't sell medications. We simply educate physicians about data, and they make their own mind up.

However,

Banov says, the drug company - not him - creates the materials used in his speeches, and he says there's a reason for that.

'We are only able to present the data. We're not able to present our personal opinions. Our personal preferences, how we use the medication off label. any of that. So we're held to a very tight standard by the FDA,' said Banov.

Drug companies may say they make their paid physician speakers use slides provided by the company to prevent them from talking about "off-label" uses.  However, there is no reason for a physician-educator not to talk about "off-label" uses, and physicians can prescribe any legal drug for whatever purpose they see fit, whether or not the drug is on or "off label." 

But drug companies are prohibited by law from promoting off-label uses.  Requiring physicians to use drug companies' slides and preventing them from talking about "off-label" uses demonstrates that the physicians are functioning as marketers, not educators. 

Summary

As local reporters look into more cases, it becomes increasingly clear that up to now, pharmaceutical companies have been none too fussy about which physicians they pay to speak about their products. It is self-serving, but inaccurate for both sets of parties to assert that the companies choose only the "best and the brightest." 

Furthermore, it has now become glaringly obvious that the purpose of "drug talks" is, well, to sell drugs.  Some physicians paid by drug companies to speak may bluster about their independence, but if they are using company provided slides, who can deny they are influenced  by the company.  Furthermore, when companies insist not merely on providing slides, but on ensuring that "everything is correct," then it is clear that it is the companies' talks that the physicians are giving.  Physicians giving company talks cannot be speaking independently, and hence must be regarded as company sales personnel, whose disguises as independent doctors or medical academics are now in tatters.

Doctors who still choose to go to "drug talks" should have no illusions that they are being exposed to anything other than marketing.  Thus, I urge my colleagues to forgo the nice meals and the company prepared "correct" slides, and spend the time trying to more critically assess the clinical evidence. 

References


1.  Ornstein C, Weber T. In Minnesota, drug company reports of payments to doctors arrive riddled with mistakes.  ProPublica, Dec 10, 2010.  Link here.
2. Hunter J. Rochester psychiatrist, sanctioned for incompetence, made $144K from drug companies. Elmira Star-Gazette, Dec 4, 2010.
3. Hunter J. Despite sanctions, physicians hired as drug company pitchmen. PressConnects.com, Dec 4, 2010. Link here.
4. Stahl B. Duluth doctor denies payments from drug companies sway decisions.  Duluth News Tribune, Dec 20, 2010.  Link here.
5. Ward G. They say they prescribe based on patients, not Big Pharma. Tennessean, Dec 19, 2010. Link here.
6. Pope ML. Conflict of interest? - Alexandria doctors receive thousands of dollars from Big Pharma.  Alexandia Gazette Packet, Jan 13, 2010.  Link here.
7. Galvin B. Health watch: doctors and drug companies. MyFoxAtlanta, Dec 29, 2010. Link here.

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KOL Phollywood

I have wondered many times about the proliferating offers I've received in increasing numbers in recent years for medical symposia, talks, conferences, etc. that appear either subtly or overtly geared to promote some treatment or product for a disease area.

Roy Poses' post "Key Opinion Leader Services Companies: the Creation of Useful Idiots and Usefully Idiotic Organization" would appear to help explain this phenomenon.

Worse:

At my Aug. 2009 post "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" here I wrote:

... Will we ever be able to peel back all the layers of the ghostwriting onion to get to the core of impartial and objective scientific articles related to drugs and medical devices? Perhaps not, but the practice must stop going forward.

Tainted literature creates tainted scientific knowledge, the carriers of which may then further taint the knowledge base (with the best of intentions and with firm belief in the fairness and accuracy of their activities, of course).

Practitioners of evidence-based medicine may be unwittingly practicing "evidence-tainted medicine", or "pseudo-evidence based medicine" as described by others on this blog.

We now learn that an entire industry exists to identify, catalog, index social networks, and do other data mining to quantify "KOL suitability factors", and then interact with pharma and surely other healthcare sectors to launch and "nurture" people so identified, as Hollywood might do to identify actors for a movie. It thus seems the situation with regard to medical science might be even worse than I thought.

I ask:

• Can we ever fully trust information given at medical presentations, especially by "popular", even well-published physicians any more?

• Can we truly trust any medical literature, period?

Even worse - do pharmas and other healthcare sectors use these services not just to identify what might be called "positive" KOLS to be seduced and romanced and deployed to spread the company's charms, but also to identify "negative" KOLs (with messages not to the liking of the industry) to be marginalized?

Finally, I coin a new term for this circle jerk of pharma KOL 'services companies' (a.k.a. KOL peddlers), KOL handlers and KOL promoters:

"Phollywood."

-- SS

Jan 12, 2011 addendum:

See the post "A Massive Cynical Effort" at the blog of 1BoringOldMan for interesting observations about these issues.

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Key Opinion Leader Services Companies: the Creation of Useful Idiots and Usefully Idiotic Organizations

In researching the conflicts of interest of the University of California "36," I stumbled upon a fascinating corner of the pharmaceutical/ biotechnology/ medical device marketing universe, the companies that find and manage key opinion leaders (KOLs), also known as "thought leaders."  Reviewing their own marketing materials reveals how KOLs truly are health care corporate marketing's useful idiots.

I found three companies which seem entirely devoted to the adoption, care and feeding of KOLs, plus numerous companies, including some medical education and communication companies (MECCs) that provide KOL-related products and services.  I will first describe the companies briefly, then draw upon their marketing materials to underline what KOLs are really about.

Leadership in Medicine Inc

This is the company I found first, because one of its directors is a member of the UC 36, the group of top university leaders who threatened to sue the university to increase their already generous pensions.

Leadership in Medicine Inc's web-site describes its reason for being thus:

IF YOU NEED TO KNOW who are the most prominent, admired, and influential actors in healthcare, how they are interconnected, and why, you need our expertise.

Given how vastly complex are the relationships among providers, researchers, and other significant actors in healthcare, it is vital to focus on key opinion leaders (KOLs) at local, regional, and global levels, and to understand the ties among them.

Its clients are:

Over 80 client companies
* All of the top 15 largest pharmaceuticals
* 8 of the 10 largest biotechs
* 5 of the 10 largest medical device companies

A graphic on its "experience" page listed the following companies: Baxter, Wyeth, Lilly, Roche, Gilead, GlaxoSmithKline, Pfizer, Abbott Laboratories, Genzyme, Bristol-Myers-Squibb, Medtronic, Johnson and Johnson, Genentech, and Covidien.

KOL LLC

Company description:

As our name implies, we are a company devoted to providing Key Opinion Leader software and Key Opinion Leader Management services for pharmaceutical, biotechnology and device companies.

The company's graphic client list included: Cephalon, Scios, Novartis, Schering-Plough King Pharmaceuticals, Pfizer, Genentech, Reliant Pharmaceuticals, McNeil (division of Johnson and Johnson, Jazz Pharmaceuticals, Endo Pharmaceuticals, Cytogen, Health Products Research, Shire, Reckitt Benckiser, Protein Design Labs, and Odyssey Pharmaceuticals.

Thought Leader Select

The relevant parts of the company description:

Thought Leader Select is a Chapel Hill, NC-based private research and consulting firm serving the biopharmaceutical and healthcare industries.

and

We serve these industries and the medical community at large by assessing medical experts (known as 'thought leaders' and 'key opinion leaders')....

Perusal of the materials used by these companies, and other companies which market KOL or thought leader related services makes the nature of the relationship between KOLs and commercial health care firms, and the purpose of employing KOLs clear.

KOLs are Employed by Marketing Departments to do Marketing

The best example comes from a description of a KOL information technology application sold by Nagarro:

A web-based application was developed by Nagarro to help the marketing department of a global pharmaceutical company exploit Key Opinion Leader (KOL) information in order to promote products and remain ahead of its competition.

Problem Description

In today s fast-paced competitive environment, pharmaceutical companies cannot solely rely on superior products to succeed. Well organized marketing departments help sales departments reach goals and give companies an edge over competition, but without access to valuable resources, like KOLs, they are ineffective. KOLs influence the medical community and ultimately the end users of pharmaceutical products.

Pharmaceutical companies that are able to identify and work with KOLs will be better positioned to compete....

Benefits

[include]
Creation of market intelligence from highly specialized and customizable reports containing previously unavailable aggregate data....

Ability to group KOLs by product knowledge and associations in order to better promote products

Ability to maximize ROI from KOL related events

Enhanced sales and marketing productivity through streamlining of complex multi-source information

That makes it crystal clear that marketers use KOLs to market, to sell products. While at times KOLs might actually be used to advise health care corporations about clinical or scientific issues, that is hardly their major point. KOLs are almost always hired to market by marketing departments.

In case someone might argue that this is only one example, let us look at materials from the other companies.

KOL LLC described the usefulness of KOLs thus:

Everyone recognizes the value of opinion leaders (OL), or thought leaders. While national level OLs may not write many prescriptions they influence thousands of prescribers and hence prescriptions through their research, lectures, publications and their participation on advisory boards, committees, editorial boards, professional societies and guidelines/consensus document development. Regional level OLs are often involved in state societies or legislative initiatives in addition to their speaking and publications. While local level OLs may not publish, they provide advice to local colleagues and may speak at grand rounds. And who are the �rising stars� in your therapeutic area?

It is imperative that you know the OLs in your market at a national, regional and local influence level as well as those �rising stars�.

This is a bit more indirect, but it is clear that the goal is to "influence prescribers" to prescribe, not provide scientific or clinical advice to the company.

Leadership in Medicine Inc's materials also continually emphasized the point of KOLs is to influence, for example, they boasted of pioneering analyses "to assess paths of influence in healthcare," developed a particular tool called "Centrality Ranking" to "provide fine-grained ratings of KOLs' influence," and claimed to "have identified, profiled, and mapped the influence of tens of thousands of individual KOLs...." The clear implication is that KOLs' influence is the central consideration, and what else is this influence good for other than to sell products, and perhaps advocate for corporations in general?

When KOLs are Involved, Many Activities that Appear to be Educational or Scientific Really Are For Marketing

Strikingly, KOL LLC claimed its role in guideline development:

Guidelines produced by national societies are optimal, but often can be a slow, painful and expensive process to develop. KOL, L.L.C. can provide a faster alternative. We have experience convening a panel of experts in a therapeutic area. We serve a project management role to ensure the timelines and deliverables are met. We have access to a medical writing team of 25 healthcare professionals who can write the initial drafts, as our experience tells us it is easier for experts to edit, than to write from scratch.

There has been growing realization that guidelines may be biased by commercial sponsorship and by the participation by individuals with conflicts of interest. The KOL LLC marketing materials suggest, however, that guidelines have become purpose-built marketing vehicles through the participation of selected KOLs with allegiances to drug, device and biotechnology companies. As an aside, note that guideline-development services includes the participation of a team of ghost-writers who will write the first drafts, a function that naive academics might have thought should be that of clinical and scientific experts.

For another example, KOL LLC asserted it could manage "investigator meetings," :

We�ll help you better plan to maximize the communication of the trial results through targeted abstracts, posters, publications and lectures.

so

Due to the time constraints placed on Clinical Research Departments, many times �research mills� are selected as the trial sites. This is fine, but who is going to publish the results and stand up and present the results at national, regional and local meetings. We can provide you advice and counsel about how to involve your KOLs effectively, while maintaining your aggressive timelines.

The goal of KOL management here is for the company to control how the research is disseminated. Note also the cynical view of "research mills," which likely refers to contract research organizations. Do we really think that CROs are used by commercial firms because they do better research?

Key Leading Organizations

A bonus from reading through the offerings on KOL management was to discover another related business that has not been subject of polite conversation before. Leadership in Medicine Inc put it this way:

Equally essential is recognizing the roles played by key leading organizations (KLOs) such as medical institutions, payers, professional organizations, patient groups, government entities, and journals in structuring KOL activities and relationships, since those are the stages on which KOLs perform.

Key Leading Organizations (KLOs) apparently include influential organizations, e.g., academic medical institutions, medical societies, and patient advocacy groups that can be deliberately turned into organizations of useful idiots for marketing purposes. Note that we and others have discussed how institutional conflicts of interest and conflicts of interest affecting leaders of of such organizations can lead to bias in favor of commercial interests. But what Leadership in Medicine Inc has written suggests that such organizations can be deliberately taken over to function as industry's fellow travelers.

Similarly, Thought Leader Select advertised services to manage organizations to support "thought leadership":

Through Centers, all of our research and assessment skills culminate in our evaluation of universities, influential clinics, and research foundations for a holistic approach to thought leadership in the medical community. With centers of excellence assessments we take a drill-down approach, starting at the academic medical centers, then moving into affiliated hospitals and clinics....

Summary

Industry spokespeople and key opinion leaders tout themselves as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There are documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

However, the marketing materials used by KOL service companies (for lack of a better name) show that KOLs are largely meant to be stealth marketers, and hired for that purpose, that KOLs participate as marketers in the sorts of activities that to the naive appear to be educational or scientific, and that marketers try to recruit whole organizations, such as medical schools, research organizations, medical societies, and patient advocacy groups as disguised sales organizations.

This goes beyond the problem of bias of physicians, or individual health professionals due to their financial relationships.  It goes beyond the problem of bias of organizations due to their sources of financial support or the financial relationships of their leaders.  It looks like there has been a massive campaign by health care corporate marketers to make useful idiots out of possibly a majority of medical academics and academic, professional, and supposedly patient-centered organizations.  This appears to be a massive, cynical effort to hollow out our once respected health care institutions and professionals in the service of marketing.

A final word to any individuals reading this who are paid by corporate marketers to be KOLs.  If you think that you are paid for educational or scientific purposes, you likely have been made into a chump.  The people who did this to you were likely not acting in your best interests, or those of society, but to cynically market their product and increase their own earnings.  If you doubt this, look at the materials cited above.  You really don't want to continue being chumps, do you?

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Why Would Directors of Health Care Corporations Push for Bigger Pensions for Academic Administrators?

We recently posted about 36 well-paid top executives in the University of California system, including leaders of medical schools, academic medical centers, and public health, who threatened a lawsuit if their pensions were not increased according to what they claim was a promise made to them in 1999.

Riddle me this: why would a group of directors of for-profit corporations that provide health care goods and services. plus a director of a leading biotechnology trade group, and the director of a leading mutual fund family band together to support this demand, thus to push for bigger pensions for these top managers of the University of California system?

Here is a list of the directors, and their corporations:

-  Mark R Laret, director of Varian Medical Systems and Nuance Communications Inc, which provides numerous health care products 
- Dr David Feinberg, director of OSI Systems, whose Spacelabs Healthcare subsidiary manufactures medical devices
- Steven C Currall, director of Leadership in Medicine Inc, which claims to be a leading provider of intelligence about key opinion leaders (KOLs) in medicine and health care.  Its web-site asserts, "IF YOU NEED TO KNOW who are the most prominent, admired, and influential actors in healthcare, how they are interconnected, and why, you need our expertise.  Given how vastly complex are the relationships among providers, researchers, and other significant actors in healthcare, it is vital to focus on key opinion leaders (KOLs) at local, regional, and global levels, and to understand the ties among them."  (Note that we have often discussed how KOLs function as stealth marketers for pharmaceuticals and devices.)

They joined:
-  Robert S Sullivan, PhD - director of BIOCOM, whose web-site asserts it is the" largest regional life science association in the world, representing more than 550 member companies in Southern California."
-  Richard K Lyons, director of iShares, a leading provider of mutual funds.

The answer is simple.  All the corporate directors listed above are also members of the group of 36 litigious executives.  See their name on the list of 36 here in the San Francisco Chronicle.

- Mark R Laret, director of Varian Medical Systems and Nuance Communications Inc, which provides numerous health care products, is also CEO of UCSF Medical Center.
- Dr David Feinberg, director of OSI Systems, whose Spacelabs Healthcare subsidiary manufactures medical devices, is also CEO of the UCLA Hospital System
- Steven C Currall, director of Leadership in Medicine Inc, which claims to be a leading provider of intelligence about key opinion leaders (KOLs) in medicine and health care, is also Dean, and Professor of Management of the University of California - Davis Graduate School of Management.
Robert S Sullivan, PhD - director of BIOCOM, whose web-site asserts it is the" largest regional life science association in the world, representing more than 550 member companies in Southern California, is also Dean of the University of California - San Diego Rady School of Management.

- Richard K Lyons, director of iShares, a leading provider of mutual funds, is also Bank of America Dean and Professor of Business, University of California - Berkeley Haas School of Business.

Their inclusion within the larger group seems ironic, at best.  As corporate directors, they have outside income and have accumulated assets that will likely keep them out of poverty in their old age.  For example, Mr Laret had accumulated the equivalent of 37,168 shares of Varian, and was paid $267,300 a year for his services according to the company's 2010 proxy statement.

Furthermore, for those who directly lead health care institutions, Mr Laret and Dr Feinberg, their memberships on the boards of health care corporations, which imply fiduciary responsibilities to the companies and their stock-holders, conflict with their duties as leaders of academic health care to uphold teaching, research and patient care.  Dean Currall's responsibilities to an organization which seems entirely dedicated to helping drug, device, and biotechnology companies turn health care professionals and academics into stealth marketers at least seems unseemly given that his school is part of a university which also includes a medical school and academic medical center. 

Since our earlier post, it appears that the University of California president will not accede to the demands of the 36, as noted in the San Francisco Chronicle.  Their demands have continued to provoke outrage.  A recent discussion in Inside Higher Ed interviewed Emeritus Professor Helen Henry, a member of the University's Academic Senate, who posited:

the debate as part of a fundamental philosophical disagreement within the university. The signatories to the letter, many of whom are based in medicine or management, have a different view of the university than faculty from other disciplines, she said.

'I don�t think there�s any question but that there are these two different mindsets that are fighting for what the university should be. It�s transparent in this letter,' said Henry, a professor emeritus of biochemistry at the Riverside campus. 'They are running businesses. But there are those of us that don�t feel this is what the university should be.'

'This is absolutely a manifestation of that clash between the people who see UC as their business � and the people who see UC�s mission as teaching, and research and service to the state. That�s a dual personality that the university always has to live with.'

Five of the university leaders demanding higher pensions for themselves have responsibilities as directors of corporations that may conflict with their academic institutions' missions, while these corporate positions ought to insulate them from financial concerns about their retirement. This corroborates Prof Henry's notion that they see themselves as businesspeople whose role is separate from, and not necessarily supportive of the university mission.

I disagree, however, with Prof Henry's implication that the University has to live with such a split among its leadership. People who lead academic institutions have a primary responsibility to support the academic mission. Their goals should not be to maximize profits, much less to enrich themselves. Letting academia, and academic medicine be lead by leaders out to make money and line their own pockets will lead to just that, but hardly better teaching, research, and patient care.

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How Marketing Mixes Into Medical School Curricula - an Example from Canada

Misery loves company, so here is an interesting case reported by the Canadian Press, via CTV News, about how students in a pain management course at the University of Toronto complained that marketing seemed to have been mixed into their curriculum:

The complaint centered around students being provided a book on managing chronic pain that was funded and copyrighted by the maker of the prescription pain killer OxyContin. The book had been brought in by a non-faculty lecturer with financial ties to the drug company.

It turned out that:

From 2002 to 2006, the pain course was funded by donations, included $117,000 in unrestricted educational grants from four drug companies -- Merck-Frosst, Purdue Pharma, Pharmacia Canada and Pfizer -- although they had no input into course content. Since 2007, the program has been funded solely from faculty budgets.

[Dean of Dentistry Dr David] Mock said Purdue's copyrighted book on pain management had been brought in by Dr. Roman Jovey, an unpaid guest lecturer and co-author of the book who left copies 'for anyone to take.' Jovey, medical director for a chain of clinics called the Centres for Pain Management, is a member of Purdue's speakers' bureau, paid by the company to conduct workshops and lectures.

Dr Jovey defended handing out the free book produced by his part-time employer:

Jovey confirmed he had left copies of the 371-page book, entitled 'Managing Pain: The Canadian Health Care Professionals Reference,' for students.

'It was a gift from Purdue. I'm not at all embarrassed or ashamed. I think it's a darn good book.

"If we all want to be politically correct and have the appearance of being politically correct, then I guess I get it, that nothing that has any kind of pharma logo or name or ownership should be given out to medical students,' he said Wednesday.

'But the losers are the medical students because I think it's a high-quality book, it's very readable and they're deprived of it this year because of this controversy. And I guess they will be in the future.'

However, it appeared that the "darn good" book's content was biased in favor of Purdue's product, Oxycontin:

Dr. Irfan Dhalla said he has concerns about the content of the book, which a medical student taking the course brought to his attention.

'There are definitely things that are not consistent with the evidence,' said Dhalla, a staff physician at St. Michael's Hospital and a lecturer at the university. 'For example, oxycodone ... is listed as a moderate-potency opioid, when I think everybody agrees it's a very strong opioid, up to twice as strong as morphine.'

While it's appropriate to prescribe oxycodone for severe acute pain or cancer pain, Dhalla said the book suggests that physicians can prescribe the drug for chronic non-cancer pain with relative safety for the patient.

'And I think people with experience know that that is just not the case. When you prescribe to people with chronic non-cancer pain, it's very difficult to do that safely,' he said, noting that the book pays little attention to issues of addiction and deaths from overdose.

'The book in several places makes reference to a claim that the rates of addiction if opioids are used for chronic non-cancer pain are very low. And they're not nearly as low as is claimed in the book.'

In fact, a study by Dhalla and colleagues published last year showed prescription rates for opioids -- including OxyContin, a long-acting form of oxycodone -- soared in Ontario over the last two decades, as did the number of deaths linked to the narcotic.

A subsequent inquiry has recommended revising the curriculum and dispensing with the drug company funded book.

This is another example of how marketing has infiltrated medical education. It suggests that market influenced education likely includes not only opinions in favor of the specific product being marketed, but distortions of fact to support the product that are hardly evidence-based.

Furthermore, it shows how conflicts of interest facilitate marketing influenced medical education. Note that the bringer of the biased textbooks in this case was being paid honoraria to speak on behalf of the pharmaceutical company, but presumably not to teach the particular course in question. However, his enthusiasm readily carried over to his work in that course.

We have discussed how pharmaceutical marketers regard the "key opinion leaders" whom they pay to speak as salespeople. One would expect salespeople to be enthusiastic for their product even outside of their normal working hours. In my humble opinion, this is why no medical academic should be allowed to simultaneously be a commercially paid "key opinion leader."

By the way, note that this case also suggests how the issues we discuss on Health Care Renewal are relevant globally, not just to the US. I tend to be wary of blogging about cases in other countries, since there may be subtle difference in context across countries that might make interpretation of cases more difficult when viewing them from abroad. However, I think that the facts and language here are straightforward enough for me to be fairly confident about what was going on. Nonetheless, if any Canadian think I have got this wrong, please let me know.

Meanwhile, if anyone is blogging about similar issues from beyond the US shores, please let me know so I can add their work to our blog roll.

Hat tip to Prof Margaret Soltan on the University Diaries blog.

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These Pharma-Paid "Key Opinion Leaders" Know Better

At "The Lancet Emphasizes the Threats to the Academic Medical Mission" Roy Poses summarized the major categories of ills affecting healthcare today.

The list reads like a list of the Ten Plagues of Egypt visited upon the Pharaohs (actually thirteen categories are listed, but plagues they are indeed to patients and conscientious medical practitioners).

This list, with keyword-hyperlinked examples, can serve as an index to the threats to healthcare's core values covered at the Healthcare Renewal blog:

• 1. Abandonment of traditional prohibitions of the commercial practice of medicine
• 2. Making money takes precedence over education
• 3. The medical school re-imagined as a biotechnology company
• 4. Faculty become employees of industry
• 5. Academics become "key opinion leaders" paid to market drugs and devices
• 6. Control of clinical research given to commercial sponsors
• 7. Conflicts of interest allow manipulation and suppression of clinical research
• 8. Academics take credit for articles written by commercially paid ghost-writers
• 9. Whistle blowers are discouraged, or worse, and academic freedom is damaged
• 10. Leadership of academic medical centers by businesspeople
• 11. Leaders of teaching hospitals and universities become millionaires
• 12. Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations
• 13. Leaders of failed finance firms become stewards of academic medicine

Today in my local newspaper, the Philadelphia Inquirer, an article that focused on plagues #4 and #5 was published entitled "Faculty still paid by drug firms." The article contains a personal reminder to me that the "faculty" know of the dubiousness of their deeds from long ago. More on that momentarily.

Posted on Fri, Dec. 24, 2010

Faculty still paid by drug firms

Medical-school policies often fail to keep doctors from lecturing on Big Pharma's dime.
By Tracy Weber and Charles Ornstein
PROPUBLICA

Officials at the University of Pennsylvania believed they had a strong tool to prevent pharmaceutical-company money from corrupting the medical faculty.

In 2006, they acted to keep drug marketers out of their hospital and clinics, to ensure that treatment decisions were made for the right reasons. In one of the country's first policies of its kind, Penn also told its physicians that they "should not participate in industry marketing activities."

Penn's chief medical officer, P.J. Brennan, said he thought the policy was clear: Company-paid lectures are forbidden. "It flies in the face of what a professional ought to be," he said.

[Perhaps the policy would have been clearer to the esteemed academic faculty if written in Latin, as in "Vexillum pensus lectures es inconcessus", or perhaps Greek "eta??e?a p????�???? d???e?? e??a? apa???e?�????"? - ed.]

But an investigation by ProPublica found that 20 of Penn's doctors have delivered such lectures since 2009. Five, including one who left Penn last month, were paid more than $40,000.

$40,000 can buy a lot of opinions, or skew the opinions of otherwise scientific personnel. Those who deny this are either deluded or overly enamored by the hot sports car they plan to have in their garage...

What's the big deal with giving pharma-sponsored and paid "educational talks", anyway, when you can then more easily afford one of these?

The article continues:

[Penn] was not the only [school] caught off-guard. ProPublica checked on 12 medical schools and teaching hospitals and found that faculty at half also lectured for drug firms in the last two years, despite restrictions on such speeches. Among them, Stanford University, the University of Pittsburgh, and the University of Colorado Denver have initiated reviews.

Conflict-of-interest policies have become more important as academic medical centers worry that promotional talks undermine the credibility not only of the physicians giving them, but also of the institutions they represent.

[Asking a physician about conflicts of interest who is recommending some relatively new therapy or device, or novel use of an existing treatment, should now be considered standard patient operating procedure - ed.]

Yet when it comes to enforcing the policies, schools have allowed permissive interpretations and relied on the honor system. [In other words, the academic old boy's club turns a blind eye to abuses - ed.] ProPublica's review shows that approach isn't working: Many doctors are in apparent violation, and ignorance or confusion about the rules is widespread.

As a result, some faculty stay on the pharmaceutical lecture circuit, where they can net tens of thousands of dollars in extra income.

I find this doubly troubling. When I was a pharma research lab middle manager, a careful analysis I'd conducted over several months with the key scientific stakeholders demonstrated a $4 million+ annual gap in funding for provision of drug scientists with the information assets and informatics tools they needed to optimally perform their work.

Yet, I was only able to secure about a third of that (much of which was later rescinded after several late-state drugs in develpoment were withdrawn) while massive amounts of money was spent on marketing activities. (Even worse, the decisions were made by non-science-grounded computer personnel, further insulting my intelligence...and insulting the pocketbooks of investors and stockholders.)

The article then notes something we've noted frequently at this blog:

Critics of the practice say delivering talks for drug companies is incompatible with the job of teaching future generations of physicians. That's because drug firms typically pick the topic of the lecture, train the speakers, and require them to use company-provided presentation slides.

"You're giving someone else's messages, someone else's talk, someone else's judgments," said Bernard Lo, a medical professor at the University of California, San Francisco, who chaired a national panel examining conflicts of interest in medicine.

Lo then delivers the coup de gr�ce in a single sentence:

"We don't allow our students to use someone else's work."

Indeed, my students are now required by our university to attest to the originality of every assignment of submission, with penalties up to and including failure of a course and/or expulsion. In the face of the plagiarism made possible by new information and communications technologies (e.g., the Web), this policy will become more common.

Yet, it seems that some esteemed academic faculty, due to desire for money, cannot "keep it in their pants" and practice the morals their organizations preach. (The oldest profession suffers a similar vice.)

Then there's this startling finding:

Reporters compared the names of faculty members at a dozen medical schools and teaching hospitals with ProPublica's Dollars for Docs database of payments to doctors publicly reported by seven drug companies. Lists of the physicians whose names matched were provided to the universities and hospitals for verification and comment.

... "For God's sake, if the media can look at these websites, why can't we?" said David Rothman, president of the Institute on Medicine as a Profession at Columbia University. "Why trust if you can verify?"

I would suggest the answer to that question has to do with will, as opposed to lacking a way.

Now the personal angle:

At Penn, the top paid speaker, according to Dollars for Docs, was Corey Langer, director of thoracic oncology at Penn's Abramson Cancer Center. He made nearly $70,000 speaking for Eli Lilly & Co. in 2009 and the first half of 2010.

Langer also received unknown amounts from other firms, such as Genentech Inc., OSI Pharmaceuticals Inc., and Bristol-Myers Squibb Co., according to his disclosure for a medical education program this month.

By e-mail, Langer said he was "now fully aware" of Penn's policy and was "taking measures to curtail speaking for pharmaceutical companies.

I find this very sad.

This is a former medical school classmate at Boston University School of Medicine, Class of '81; in fact for a year we stood at adjacent tables in Gross Anatomy dating back to 1977. I knew him to be a brilliant student, and in several interactions with him in the early 1990's when I worked at an adjacent hospital to his, felt he had become an excellent clinician.

Interestingly, there was, in fact, a significant brouhaha in the class over gifting by pharmaceutical companies offering stethoscopes, black bags, and other accouterments of practice ca. 1978 or 9 as clinical rotations began. Several in the class were actually militant about the class setting a "no gifts from pharma" policy due to its potential effects on medical judgment and practice, and I recall the vigorous debates in the BU lecture halls vividly. This was in the late 1970's, I note, not 2010.

That one of my former classmates claims to only now be "fully aware" of pharma-related anti-conflict of interest issues in 2010 (like many others as in the article appear to become - after they are caught red handed) is a sad reminder to me of the state of healthcare and the corrosive influence of money.

The phenomenon is not just at a few organizations. The article continues:

UC Denver's experience was mirrored at other schools where officials discovered their policies were not working as expected.

The University of Pittsburgh's 2008 policy bans paid speaking in many cases, said Barbara Barnes, an associate vice chancellor in charge of industry relationships. Yet ProPublica found 22 Pitt doctors in its database.

At Stanford University, ProPublica found that more than 12 of the school's doctors were paid speakers, in apparent violation of its 2009 policy. Two had earned six figures since last year.

Philip Pizzo, the dean of Stanford's medical school, sent an e-mail to all medical school staff last week calling the conduct "unacceptable." Some doctors' excuses, he wrote, were "difficult if not impossible to reconcile with our policy."

[I'll bet those "excuses" would have made superb case studies in logical fallacy as well - ed.]

At least some are willing to own up to their behavior, although probably under duress:

Some Stanford doctors said they were in the wrong.

Among them was Alan Yeung, vice chairman of Stanford's department of medicine and chief of cardiovascular medicine, who has been paid $53,000 by Lilly since 2009. In an e-mail, Yeung said he quit speaking for the company this fall.

"I take full responsibility for this error," he said. "Even though I felt that these activities are worthwhile educational endeavors, the perceived monetary conflict may be too great."

While this is stated with typical academic fabric softeners and odor removers ("perceived", "may be", etc.), it's a start.

Finally, ethical simplicity itself:

[Stanford Medical School dean] Pizzo compared some doctors' explanations to what a police officer might hear after catching a motorist running a late-night stop sign.

"You can give 1,000 reasons: 'There was nobody around. It's safe,' " he said. "The reality is, it's still a stop sign."

Perhaps universities need to develop a suitable "stop sign" for posting outside their faculty offices.

May I suggest the following version:

(click to enlarge)

-- SS

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Abbott Laboratories and Pig Roasts, the "Philly Mob," and Legal Settlements

Help.... The health care muck is now being raked so fast I can't keep up.

Abbott Laboratories, Prolific Stenters, Pig Barbecues, Etc

In the last week, multiple media outlets picked up the story of the cozy relationship between Abbott Laboratories and a doctor now accused of implanting too many cardiac stents for too much money.  The essentials were, as summarized from New York Times, Wall Street Journal, and Baltimore Sun articles -

Dr Mark Midei was a prolific user of cardiac stents for patient with coronary artery disease (blocked cardiac arteries)

In the June deposition, Dr. Midei estimated that in 2005 � before research revealed that many stents were unnecessary � he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei�s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph�s size. [NYT]

Therefore, hospitals sought him out

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore�s private hospitals. Dr. Midei was one of the practice�s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei�s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital�s staff. [NYT]

However, it appeared he performed the procedures on patients who would not benefit from them.

The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007. [NYT]

Nonetheless, Abbott Laboratories had been rewarding him for frequent use of their products

Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company�s cardiac stents in a single day in August 2008, 'which is the biggest day I remember hearing about,' an executive wrote in a celebratory e-mail.

Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei�s home, according to a report being released Monday by the Senate. The dinner was just a small part of the millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore. [NYT]

When his over-use was alleged, Abbott continued to use him as a key opinion leader.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. 'It�s the right thing to do because he helped us so many times over the years,' an Abbott executive wrote in a January e-mail cited in the Senate report. [NYT]

Also,

After St. Joseph barred Dr. Midei from practicing there in May 2009, Abbott arranged consultant work for him, according to emails released by the Senate committee.

In December 2009, an Abbott senior vice president wrote in an email that he was 'very open' to having Dr. Midei do consulting 'to see how it might go�either getting the word out in China/Japan, medical or safety work.'

The following month, the Sun reported on the allegations against Dr. Midei and St. Joseph. According to the Senate report, an Abbott executive subsequently said in an internal company email, 'We recommend that we not use Dr. Midei in the U.S. at this time (the press is just too hot).'

Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the report that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,' yet another Abbott executive said in an email.

Dr. Simonton didn't return phone calls seeking comment.

Abbott sent Dr. Midei to Japan to promote the Xience stent, but bad publicity caused that trip to be cut short in late January, the report says. In total, Abbott paid the doctor $30,623 to help market the Xience, the Senate investigators found. [WSJ]

When the relationship was criticized, Abbott executives responded with threats, or were they jokes?

I called David Pacitti, vice president of global marketing for Abbott Laboratories' cardiac-plumbing division, to ask why he seems to want goons to beat me up in the newspaper parking lot.

'Don't you have connections in Baltimore?????' Pacitti e-mailed a subordinate regarding a January column I wrote on heart-artery stents. 'Someone needs to take this writer outside and kick his ass! Do I need to send in the Philly mob?'

Pacitti and other Abbott execs apparently don't care for suggestions that their expensive vascular devices often do patients little good and that a star Baltimore doctor took their encouragement to be 'truly outstanding' a bit too much to heart. [Sun]

Furthermore,

Pacitti didn't return my phone calls, but an Abbott flack got in touch on Monday.

'We sincerely apologize if this caused you any concern or distress,' the company spokesman said. Pacitti's comment, he said, 'wasn't meant to be taken seriously.'

Yeah, that's what King Henry II said after they whacked Thomas Becket. [Sun]

So here is a particularly vivid case showing how big health care corporations make "key opinion leaders" out of doctors apparently just because they use or prescribe a lot of the company's products, regardless of the doctors' expertise, or ethics.  As we noted before, "key opinion leaders" are seen by corporate marketing executives as fellow travelers or useful idiots (see posts here, and here). It again appears is that all that health care corporate marketers care about is selling product. Whether their pitches are honest or ethical is besides the point. Those who get in their way are treated with contempt, and maybe, just maybe are threatened with violence

The physicians who are flattered at being called "key opinion leaders," or "thought leaders" have got to realize that the marketers think they are chumps. If they think they are providing honest information, or education, they are deluded.

This case has already been widely discussed in the blogsphere.  See, in particular, posts by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and Larry Husten on the CardioBrief blog.

But if that were not enough, on the heels of this story came several more about Abbott Laboratories

Abbott Laboratories Settles, Twice

As reported by the Los Angeles Times, while Abbott was trying to hide Dr Midei overseas, it was also busily negotiating settlements of completely separate charges:

Abbott Laboratories and two other pharmaceutical firms agreed to pay more than $421 million to settle claims of defrauding Medicare and Medicaid in the latest in a string of nine- and ten-figure health care fraud settlements announced by the Justice Department.

The drug companies charged one set of prices to doctors and pharmacies but reported another set of inflated figures that were used as benchmarks by government insurers reimbursing health care providers. The spread, or difference, amounted to kickbacks to the companies' customers, according to Tony West, assistant attorney general for the Justice Department's civil division, who announced the settlements on Tuesday.

In particular,

Abbott, of North Chicago, Ill, agreed to pay $126.5 million to settle accusations that it charged the government inflated prices for products ranging from sterile water and saline solution to vancomycin, an antibiotic.

An Abbott spokesman said the company believes 'that we have complied with all laws and regulations' and settled the case to avoid 'the uncertainty associated with continued litigation.'

At least he did not threaten the Department of Justice officials with an attack by the "Philly mob."

But that is not all. The Wall Street Journal reported that Abbott had to make a second, unrelated settlement:

Separately on Tuesday, the Justice Department announced an unrelated $41 million settlement with Abbott subsidiary Kos Pharmaceuticals Inc. on charges that it paid kickbacks to doctors and other health professionals to encourage them to prescribe or recommend the cholesterol drugs Advicor and Niaspan.

As part of that settlement, Kos entered into an agreement that will allow it to avoid prosecution on criminal charges. 'These actions occurred prior to Abbott's acquisition of Kos in 2006 and Abbott has not been accused of any wrongdoing,' an Abbott spokesman said.

However, Abbott chose to acquire a company that allegedly chose to pay kickbacks of this sort. The apparent resemblance to Abbott's payments to Dr Midei in the case above are striking.

By the way, the Los Angeles Times article also noted previous black marks on Abbott's record:

Abbott also paid $614 million in civil and criminal penalties in 2003 to end a federal investigation of the company's marketing practices and Medicaid and Medicare reimbursements.

In 2001, TAP Pharmaceutical Products Inc., of Lake Forest, Ill., an Abbott joint venture, agreed to pay $875 million and plead guilty to a criminal charge of conspiring with doctors to overbill Medicare.

At the time, the TAP penalty was the largest health care fraud settlement in U.S. history, but it has since been eclipsed by at least two others.

So we once again illustrate how punishing wrong doing by fining large corporations, when the fines are just seen as a cost of doing business, in the absence ofany negative consequences on the real people who authorized, directed, or implemented the bad behavior fails to deter future bad behavior.

This remarkable confluence of cases suggest how rotten are the ethical foundations of even large and previously respected health care organizations. I imagine, though, that as long as these corporations richly reward their executives regardless of the ethics of their actions, and regardless of the long term effects on the organizations' reputations, and as long as their are no externally imposed negative consequences on these leaders, the practices will continue, and will get worse.

Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.)

If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.

ADDENDUM (8 December, 2010) - See also comments by Maggie Mahar on the HealthBeat blog, David Williams on the Health Business Blog, and Paul Thacker on the Project on Government Oversight blog.

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Of Drug Talks, Deception, and Denial

A month ago, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records. 

Since then, a series of local or regional news organizations have reported on physicians in their areas.  These reports (all listed below as "references" in somewhat chronological order ) further explained how these "drug talks" are just marketing exercises, and how some of the physicians involved rationalized making money hawking drugs.

Physicians as Marketers

Considered together, the articles documented how the drug talks served marketing rather than educational needs.

Doctors are the Most Influential Speakers

As noted previously, corporations and the doctors they hire chronically characterize the doctors' talks as educational. However, from New York City,(9)

[Dr Stephen] Friedes said drug companies can�t use sales reps to give the same speeches. Instead, they need doctors to serve as speakers because the presentations are more believable when they come from an expert�s mouth. And that�s why companies will pay the biggest bucks to get the biggest experts to read their slides.

Paying Doctors Who Already are Prolific Prescribers

From Chattanooga, Tennessee(7), came pulmonologist Daniel Smith's acknowledgment that the corporations choose speakers who they already know favor their products:

He emphasized that his use of GlaxoSmithKline's Advair inhaler began long before he started speaking for the company.

'The assumption is if the doctor didn't have the relationship, he wouldn't prescribe the medication,' he said.

Also, as reported from Des Moines, Iowa(8):

Several doctors said drug company representatives asked them to become paid speakers because sales records showed the physicians often prescribed the companies' products.

'They're like, 'We noticed you're using a lot of our drugs, would you mind telling other doctors why?' ' said [Sioux City internist Dr Mark] Carlson, who emphasized that he prescribes the medications he believes work best.

Furthermore, from New York City(9) :

First, the industry says it picks the doctors who are the most knowledgeable about the drugs. But [Dr Richard] Schloss said Pfizer first picked him because he was a high prescriber of Geodon.

'What they do is they get the pharmacy records, and they know who�s prescribing what,' said Schloss, 'and they can come in and say, �I see you�re prescribing, you know, a lot of, in this case, Geodon. What do you like about it?� And you if say nice things, they say, �Will you be interested in speaking for us?�'

Payments Influence Behavior

Even though health care corporations may select speakers who already favor their products, probably to reinforce this pattern, that does not mean that such payments do not induce even more enthusiasm. From Chattanooga, Tennessee(7), obstetrician-gynecologist Kirk Brody

said he hasn't actually spoken on behalf of a drug company for eight years or so. He quit after one year when he realized the drugs he lectured about ended up popping into his head when it came time to prescribe, he said.

'I felt like it was probably influencing my prescription habits,' he said. 'If you're out there singing the praises of something, you tend to believe it. It was just an ethical problem.'

Also, from New York City(9):

[Dr Richard] Schloss said he agreed to be a speaker because he genuinely believes in Geodon, and he enjoys teaching. But even he admitted the speaking has actually changed the way he prescribes.

'You know, I may use Geodon maybe 10 percent more than I did before I was a speaker,' said Schloss. 'I use it 10 percent more because I�ve spoken about it so many times....'

"Push Poll"

From New Hampshire(1), Dr. Leonard Korn, president of the New Hampshire Psychiatric Society, described how the drug talks resembled a "push poll" (biased poll meant to sell a viewpoint)

'We sat there being educated by their people and they sent us a check,' he said, recalling the usual fee was about $500.

The doctors would then give feedback about the positive and negative aspects of a particular medication and of drugs made by competitors.

'It was a bit like a focus group ... except a focus group is not really promoting its product,' he said. 'This is much more like a push poll.'

His concern is that such events can influence doctors, even subconsciously, to choose that company's drug.

Why Hide the "Education?"

If the physicians' talks are educational, as some of the speakers and their corporate pay-masters assert, why should they be hidden from the media. However, as reported from Des Moines (Iowa)(8):

The companies say they favor openness. 'We believe transparency is critical to rebuilding trust in our industry, and Lilly seeks to continue to be a leading voice and example in transparency efforts in the biopharmaceutical industry,' said J. Scott MacGregor, a spokesman for Eli Lilly.

In that spirit, The Des Moines Register asked MacGregor and his counterparts at the other two leading companies to let a reporter observe one of their doctor-education sessions. All three declined.

'It would be inappropriate for you to attend an event,' AstraZeneca spokeswoman Katie Lubenow said. She said the sessions are open only to medical professionals.

Also, from New York City(9):

But for talks that are supposed to be purely educational, there seems to be a lot of secrecy. WNYC called the seven companies in the ProPublica database, and asked if it could observe a presentation. Each company declined. And none would send copies of their slides. [Columbia Unviersity urologist Franklin] Lowe wouldn�t provide a copy either. He said the slides were company property and he could get into trouble if he passed them out.

Physicians' Rationalizations for Getting Paid to Give Pharmaceutical Talks 

Denial: Industry Sponsored Talks are Educational

Despite the evidence above and elsewhere that pharmaceutical companies pay physicians to give talks to market their products, not to altruistically provide unbiased education, many physicians asserted what they were doing is educational. Those providing the rationalizations included high ranking academics. For example, from New Hampshire(1):

Dr. Craig L. Donnelly, chief of the child psychiatry section at Dartmouth-Hitchcock Medical Center, said he views such appearances as part of his mission to educate the next generation of physicians.

Donnelly is the second-highest earner on Pro Publica's list for New Hampshire, earning $136,578 from Eli Lilly in 2009 and the first quarter of 2010.

When he gives talks, Donnelly said in an e-mail, he advocates not for one particular drug but for a "full range of treatment options," including non-pharmacological ones.

'When I speak to colleagues, I am putting my reputation on the line,' he said. 'I genuinely believe that these talks provide educational value to my colleagues in primary care, above and beyond the informational component on the particular drug topic.'

Denial:  Physicians are Not Chosen to Speak Because they Favor the Product

Despite the evidence above and elsewhere that corporations pick physician speakers who already favor their products, from San Francisco, California(10), former Stanford faculty member psychiatrist Manoj Waikar said:

he does not disclose what drugs he prescribes to pharmaceutical companies so they hire him for his expertise, not because of his prescribing patterns.

He seemed unaware that the companies already have easy access to data about his prescribing habits.

Rationalization: The Need for "Collaboration" Implies the Need to Get Paid for Marketing

Furthermore, even academics who were uncomfortable with industry supported talks recited the mantra that academic-industrial "collaboration" is needed to provide "innovation." This begs the question of why such "collaboration" needs to include payments by industry to academia for marketing, or in fact any activities other than pure research. For example, from an article specifically about the Dartmouth-Hitchcock Medical Center in New Hampshire(2), Dr James L. Bernat, a DHMC neurologist and chairman of the bioethics committee,

said the relationship between medicine and industry can be 'synergistic and useful' for both groups. But he said, 'There are potential conflicts of interest that can occur ... that need to be identified, mitigated and prevented.'

Also, co-chair of the hospital's integrity and ethics task force Dr. Carl DeMatteo, an infectious-disease physician and chief quality and compliance officer,

said academic physicians who share their research with pharmaceutical or medical-device companies 'can bring forward treatments and cures to the public that can make a real difference in people's lives.'

The latter, of course, is mainly an argument for publication and dissemination of basic science research, not for academic physicians working with drug, device or other companies on evaluating the products those companies have a vested interest in, much less involving academics in marketing.

Universities are always promoting academic-industrial collaboration, but never seem to explain why such collaboration requires academics to be paid to give talks, or for that matter, for ill-defined consulting work.  They talk about the benefits of research as a monolithic whole, rarely explaining why it is good for industry to sponsor and control human research meant to evaluate the products in which companies have vested interests.

Reasoning from a Biased Sample: Multiple Conflicts as De-Biasing

Physicians asserted that being paid by multiple corporations is reduces bias in favor of a particular drug, ignoring the possibilities that multiple conflicts of interest might bias in favor of expensive drugs vs generics, in favor of drug therapy vs other approaches, or even in favor of aggressive vs conservative therapy. For example, from Erie, Pennsylvania(3), a report quoted Dr Gurjaipal Kang,

'I don't feel there is a conflict of interest,' Kang said. 'I speak for competing drug companies. I speak about some drugs that I don't often prescribe.'

Also, from Vancouver, Washington(4), a quote from Dr Jeffrey L Hansen, psychiatrist:

'I don�t believe it influences my prescribing practices because I work with a number of companies,' Hansen said. 'I want to make sure that no matter who�s sponsoring my speaking the message is the same.'

Denial: Conflicts of Interest Do Not Influence Behavior

Many doctors simply asserted that being paid to give a talk does not influence their prescribing. This begs the question of whether they were hired to speak to reinforce their pre-existing preference for the products of their employers. It also seems to simply deny that financial incentives matter, a position supported by common sense, and underlying essentially all of economics. For example, from Syracuse, New York(5), the chief of urology at Crouse Hospital, said

'Morally my goal is to treat the patient with the best medications I know of,' Albala said. 'I find it hard to believe some people would write a (prescription for) a medication just because they are a speaker.'

'I would be happy to do these gratis,'....

Note, of course, that despite the last assertion, he was apparently even happier to get paid. Dr Albala was the top recipient of drug company honoraria in the Syracuse region, getting $180,200 from GlaxoSmithKline.

False Dilemma: If It is Not Illegal, It Must be Good

An old argument in politics and business is the assertion that one's behavior is good as long as one has not been convicted of a crime.  An analogous argument made by physicians is to claim that compliance with local administrative processes certifies one's actions as ethical. For example, from Durham, North Carolina)(6), Duke Medicine oncologist David Rizzieri,

asked whether the substantial sums he has received from drug companies could lead to ethical issues, Rizzieri replied, 'I respect this concern and feel the multiple layers of oversight and conflict of interest management planning ... help assure appropriate application and presentation of the data.

Rationalization: Entitlement

Physicians may feel that because of the hardships they have endured, especially during training, they are entitled to be rewarded, apparently no matter what the circumstance. So, from Durham, North Carolina,(6) a medical student noted:

There is certainly a sense that once you go through medical school and you go through residency, you're kind of entitled to these gifts from industry, or to be paid well enough for speaking

Also, from Chattanooga, Tennesse(7), local pulmonologist Daniel Smith sarcastically asserted:

We're considered experts in our field. I guess we're supposed to spend hours and hours of time educating other doctors for free

This, of course, begs the question of who should be paying.

Appeal to Common Practice: Pharmaceutical Paid Talks are Part of the Culture

Some in the academic world seemed to assert that since the talks are common practice, they must continue.  From Durham, North Carolina(6), Ross McKinney, director of Duke's Trent Center for Bioethics, Humanities and History of Medicine, said

the new policies will also have to consider the existing culture among doctors.

'It is hard to set restrictions when that is the existing culture. This isn't the Mayo Clinic where everybody is just a salaried employee,'....

Summary

There is a growing body of evidence that pharmaceutical companies, and presumably other for-profit health care corporations, may pay physicians to give talks to help market their products, not to altruistically support unbiased education.  Physicians may command more respect than sales people.  The companies may choose those who are already known to favor their products.  While the speakers may influence other physicians, payments to them may reinforce, if not enhance their favorable stance towards the companies' products.  The setting of the talks may be designed to favor their marketing purpose.  Pharmaceutical companies and the physicians they pay may be wary of letting skeptics witness these talks because they have the above considerations to hide.

However, it seems that many physicians who give the talks, and sometimes the academic institutions with which they are affiliated, are in denial about the nature of these talks.  They are quick to rationalize what they do, sometimes with the help of logical fallacies.

I submit that physicians and health professionals should shun commercially sponsored talks as deceptive marketing.  Physicians who give such talks are at best naive, and at worst complicit in the deception.  Deceptive marketing is never good, but is particularly upsetting and dangerous when it is used to sell products that have serious health consequences. 

ADDENDUM (24 November, 2010) - See this related post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

References


1.  Wickham SE. Three Doctors paid $100,000-plus by drug companies. New Hampshire Union-Leader, Nov 8, 2010.  Link here.
2. Wickham SE. Dartmouth-Hitchcock takes fresh look at such payments. New Hampshire Union Leader, Nov 8, 2010. Link here.
3. Bruce D. Drug companies pay Erie doctors to speak about their drugs, devices. Erie (Pennsylvania) Times-News, Nov 8, 2010. Link here
4. Lasher B. Pharmaceutical industry spends millions on doctors: Clark County doctors got $190,000 over 18 months. Vancouver (Washington) Columbian, Nov 7, 2010. Link here.
5. Mulder JT. Drug makers pay 51 central New York doctors nearly $1 million to talk about their products. Syracuse (New York) Post-Standard, Nov 7, 2010. Link here.
6. Chen M. 'Dollars for Docs' hits home. Durham (North Carolina) Herald-Sun, Nov 13, 2010. Link here.
7. Bregel E. Prescription for concern: pharmaceutical companies' payments to doctors raise questions amid soaring U. S. drug costs. Chattanooga (Tennessee) Times- Free Press. Nov 14, 2010. Link here.
8. Leys T. 121 Iowa physicians collect from drug firms. Des Moines (Iowa) Register, November 14, 2010. Link here.
9. Chang A. Physicians on pharma's payroll: educators or marketers? WNYC, November 18, 2010. Link here.
10. Colliver V. Disciplined doctors receiving pharmaceutical funds. San Francisco (California) Chronicle. Nov 18, 2010. Link here.

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There You Go Again: Richard Epstein Says "Conflict-of-Interest Rules Thwart Medical Progress"

Richard Epstein, a professor at the New York University and University of Chicago law schools, just authored a report on the perils of conflict of interest rules.  In his blog, "The Libertarian," he summarized his beliefs that strict conflict of interest (COI) rules and restrictions on pharmaceutical marketing "spell lower rates of innovation and slower dissemination of new products." 

Prof Epstein is extremely prominent.  The Manhattan Institute, of which he is a fellow, claimed, "Professor Epstein's influence is profound: he is one of the three most cited law professors in the United States and the most cited professor writing largely in private law." Thus, it is disturbing that it appears that his objections are based on a series of logical fallacies.  (Note that we critiqued a defense of certain conflicts of interest he made in 2007 here on similar grounds.)

Ad Hominem: Enemies of Capitalism

Prof Epstein implied that the people who advocate strong conflict of interest rules are enemies of capitalism and free markets.  For example, he wrote, "most of the modern critics of the drug and medical device industries start with the assumption that the profit-motive alone is sufficient to distort the behavior of all scientists and researchers."  Later, "the people who line up most strongly against drug and device companies often treat the phrase 'market forces' as though it embodies the worst things in life."  How he was able to read the minds of those who disagree with him is unclear.  Attacking proponents of strict COI regulation as anti-capitalists (and by implication, socialists or communists) appears to be an ad hominem fallacy.

Burden of Proof: Ignoring Evidence of Harms of COI, Asserting Evidence of Benefits

Prof Epstein argued that COIs rarely if ever leads to bad effects: "the number of instances of serious abuses of power in the drug and device industry, like in medical research itself, is small, relative to the huge number of interactions that have taken place." Thus, he ignored evidence that commercially funded research may be biased in favor of the sponsors' products.(1-4) On the other hand, he implied that financial relationships  among physicians and researchers and commercial firms that sell health care products and services are necessary for "rapid development and deployment of new pharmaceuticals and medical devices," and for "innovation" in the field, but provided no evidence for these points.  Thus, while ignoring evidence of the possible harms of COIs, he failed to provide evidence for their benefits.  By placing the burden of proof on those who disagree with him, while avoiding it himself, he invoked the burden of proof (or appeal to ignorance) fallacy.

Appeal to Common Practice: Scientists Wearing Multiple Hats

Prof Epstein asserted that strict COI rules would disturb what is now common practice.  They would threaten how "the best research scientists in universities ... wear multiple hats.  In addition to researching within the academy, they also offer consulting services to drug companies, or start businesses of  their own."  Academics may currently behave in this way, but that does not mean this behavior is optimal in any sense.  Thus, Epstein employed the fallacy of the appeal to common practice. 

Slippery Slope: Silencing Communication and Collaboration

Prof Epstein asserted that strict rules on COI would "prohibit the collaborative efforts that have long characterized standard practices [in research]."  Specifically, he asserted the rules could stipulate that "no scientist who sits on any Food and Drug Administration (�FDA�) review committee, or any hospital conflict of interest committee, should be allowed to have connections with the pharmaceutical industry."  Also, "collaborations between government and industry scientists on research projects of common interests should either be totally eliminated or heavily regulated."  Finally, he asserted, "free interchange of information within and across firm boundaries is best calculated to allow the sharing and coordination of vital information," but "strong conflict of interest regulation poses real threats to these dynamic interactions."

Yet rules about conflicts of interest generally refer to those generated by financial relationships, most often payments by commercial firms to academics, researchers or physicians.  Payments are not necessary for collaboration.  Researchers can communicate, share information, even work together without one party paying the other.  Warning of such dire consequences of regulations that have nothing directly to do with communication or collaboration amount to the slippery slope fallacy.

Appeal to Authority: the "Most Gifted Members of the Academy"


Prof Epstein noted above that it was the best researchers who consult for commercial firms or start their own firms.  Later, he stated, "the ablest scientists often have the most extensive outside practices."  In complaining about rules that limit the pay of faculty members for services on boards of directors of for-profit health care companies, he asked, "why crimp the behavior of the most gifted members of the academy who can also make major contributions to industry?"  Thus he seemed to agree with the arguments made by representatives of pharmaceutical and device companies that the doctors who they pay to speak, consult, or do research are the best and the brightest.  However, there is considerable evidence (e.g., see posts here and here), that such "key opinion leaders" or "thought leaders" are chosen because of their sympathy to the companies and their products, and their malleability.  In addition, there is evidence that medical schools now put more emphasis on ability to attract external funding than any other faculty characteristic in decisions about payment, promotion, and retention (see post here).  Prof Epstein's invocation of the need to honor the best and the brightest appears to be a variant on the appeal to authority fallacy. 

Summary

So here we have another example, by " one of the nation's most prolific legal thinkers, (according to the Manhattan Institute) of a defense of the prevalent conflicts of interest that affect academic physicians and clinical researchers.  Like many previous such defenses, it seemed to be mainly based on logical fallacies. 

Also, like many previous such defenses, it was made by someone with a history of his own financial relationships with health care corporations.  To his credit, Prof Epstein did disclose, "over the years, I have worked extensively with various groups in the pharmaceutical industry, but have done no such work in the past few years."  On the other hand, he did not disclose his previous relationships with eSapience, a company which once claimed it "shapes the debate on issues that intersect law, economics, and policy."  (See post here.)

The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them.  I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone who does not have such relationships.

By the way, Prof Epstein also complained about overly rigorous regulation of pharmaceutical marketing in the same blog post, but since this really seems to be a distinct topic, I will not discuss his arguments here. 

References

1.  Bekelman JE et al. Scope and impact of financial conflicts of interest in biomedical research: a systematic review.  JAMA 2003; 289: 454-465.  Link here.
2.  Lexchin J et al.  Pharmaceutical industry sponsorship and research outcome and quality: systematic review.  Brit Med J 2003; 326:  1167.  Link here.
3.  Jorgenson AW et al. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. Brit Med J 2006; 333: 782.  Link here.
4.  McGauran N et al. Reporting bias in medical research - a narrative review.  Trials 2010; 11: 37.  Link here. 

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