"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.

"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.

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.

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.

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?

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?

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.

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.

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.

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.

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 "εταιρεία πληρωμένος διάλεξη είναι απαγορευμένος"? - 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 grâce 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