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

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.

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.

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. 

THAT'S EDUCATION!

THAT’S EDUCATION!

You can’t make this stuff up.

This week I received a cheerful E-mail from a well known academic key opinion leader or KOL. Only the E-mail didn’t really come from Dr. Ian Cook at UCLA. It really came from a company called PeerView Institute for Medical Education. The E-mail offered on-line CME content with the topic Essential Aspects to Building a Therapeutic Alliance Between Patients and Practitioners for the Treatment of Mood Disorders. Whenever I see an anodyne title like that I know there’s trouble ahead.

The content came in the form of a dialogue between Dr. Cook and another well known academic KOL, Dr. Michael Thase from Penn. Beneath two prominent corporate logos, a disclosure stated This activity is supported by educational grants from AstraZeneca LP and Lilly USA, LLC. Another disclosure stated This CME/CNE/CPE activity is jointly sponsored by Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. The program also states This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. Purdue University College of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians.

I happen to know Dr. Cook and Dr. Thase, so already I am thinking why are these productive academic researchers from first tier universities doing a yawner CME gig like this? Then I get it. Most academic physicians have been told by now that they may no longer speak for hire at dinners and events sponsored by Pharma. You know, the sort of thing that Charles Nemeroff tried to pass off as CME-like, only Senator Grassley wasn’t buying it. So now the action has moved to commercial CME activities that carry the imprimatur of ACCME, thus confirming the principle that the flow of marketing money must find an outlet.

My jaundiced view of ACCME’s performance and credibility is a matter of record. For that matter, I am on record with a jaundiced view of the entire CME business. Here is what I said back in 2008.

…Continuing Medical Education (CME) is a second front in the campaign to expand (drug markets). The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content. The KOLs are chosen for their willingness to be “on message” for the corporate sponsor. If they go “off message” they know they will not be invited back. The talk of “unrestricted grants” is window dressing. The MECC also secures the imprimatur of a nationally accredited CME sponsor, typically an academic institution. The sponsor is paid to certify that the CME program meets the standards of the Accreditation Council on Continuing Medical Education (ACCME). Everybody turns a buck: the MECC and its staff are handsomely paid (CME is now a multi-billion dollar business); the KOLs are generously rewarded with honoraria and perquisites; the academic sponsor is well paid by the MECC; the ACCME receives dues from the academic sponsor; the audience obtains free CME credits rather than having to pay for these required educational experiences; and the corporate sponsor gets what it considers value for its marketing dollar.

So, I approached this free on-line CME offering with a good deal of skepticism. Most of the content was pedestrian and scripted – not because these KOLs couldn’t have done better but because someone at the MECC scripted it for them. Someone at the MECC also put the slides together, about which more in a moment. The material was formulaic, a succession of clinical banalities accompanied by Power Point slides that said everything and nothing. I cannot imagine that a physician would learn anything substantive from these educational tropes.

The impresarios at PeerView Institute for Medical Education, funded by Lilly and AstraZeneca, came through with the desired spin. The corporate sponsors obtained the soft messaging they wanted. Their products olanzapine and quetiapine were not promoted overtly, but it was surely gratifying that the content emphasized the accepted place of such second generation antipsychotic drugs as a class in mood stabilization for bipolar disorder and in augmentation for nonresponsive major depression. This soft messaging was delivered with the appearance of authority, within a package of algorithms, strategies, Venn diagrams, and measurement tools that featured potential upsides but gave hardly a nod to the worrisome side effects of such drugs, especially in depressed patients . And it surely was no accident that the sponsors’ drugs appeared as exemplars in slides and in the follow-up questions – another form of soft messaging.


Finally, I came upon incontrovertible evidence that these KOLs did not prepare the educational content of the program. A slide that discussed antidepressant drug options contained a panel dealing with the MAO Inhibitors (MAOIs). This class of antidepressant drug appeared in the 1950s, and MAOIs still have a limited place in clinical practice. The information given about the MAOI drugs in the enduring material (slide) of this program, however, is dated, inaccurate, and dangerous. Here is the relevant section of the slide.

CLASS
MAOIs (eg, benmoxin, hydralazine phenelzine, pheniprazine)

EFFICACY
↓ efficacy compared to TCAs 4

COMMON SIDE EFFECTS
• Drowsiness, dizziness, loss of visual acuity, GI side effects, insomnia, irritability 4

What’s wrong with this? Plenty. Benmoxin has never been marketed in the US and was discontinued in Europe many years ago. Hydralazine is not an MAOI but an antihypertensive agent. Pheniprazine was discontinued many years ago due to marked toxicity. Meanwhile there is no mention of tranylcypromine or selegiline or moclobemide, which are in current use. The listing of hydralazine, which has no antidepressant activity, is especially dangerous. Likewise, the laundry list of side effects manages to omit the single most important problem with the MAOI class – potentially lethal dietary and drug interactions.

There is only one way to say it – this educational content is incompetent, reckless, and dangerous. I know both the KOLs well enough to be certain they would never develop such educational content themselves. So, who did develop it? Some functionary at PeerView Institute for Medical Education, who had no clue what s/he was doing. Compounding the problem, the Purdue University College of Pharmacy waved through this incompetent material for CME credit. If the Purdue University College of Pharmacy wants to provide continuing education for pharmacists, fine. But I draw the line at allowing an institution that does not train physicians to provide continuing education for physicians. I do not understand why this is permitted by ACCME. On the evidence of this program, the Purdue University College of Pharmacy lacks the expertise to provide continuing education for physicians.

The standard is simple. The standard is not ‘we try to ensure accuracy’… the standard is we get it right – that’s what our role models teach us in medical school and residency training. These KOLs are accountable for the reckless errors in this content because they allowed their names to be featured as the authorities. Plainly, they did not develop the educational content and they did not take the time to review the enduring materials as their accountability required.

Why have the deans of US medical schools not banned academic physicians from participating in such commercial CME gigs? It is no secret how phony these events are. Why not help these busy academic clinical scientists to maintain their focus by limiting them to educational programs at academic medical centers and at meetings and functions genuinely sponsored by professional medical societies? As the present example shows, anything else is business as usual under cover of a fig leaf.

I want to be clear that I have enjoyed friendly relationships with Ian Cook and Michael Thase for a long time. It’s not personal, it’s about standards and it’s about tradecraft. If academic KOLs are too busy to maintain standards and tradecraft then they should pass up these educational charades. For shame, guys.

Bernard Carroll

Not "the Best and the Brightest" - Drug Marketers and the Creation of "Thought Leaders"

A combined investigative reporting effort by Pro Publica, partnering with the Boston Globe, Consumers Reports, the Chicago Tribune, National Public Radio, the Public Broadcasting System on seven major pharmaceutical companies' payments to doctors who make speeches on the companies' behalf has gotten a lot of press.  It inspired several separate reviews by news organizations in Colorado, Illinois, Minnesota, Ohio,Washington, etc on local doctors who were paid to talk.  Many of my fellow health care skeptic bloggers, including the Carlat Psychiatry Blog, Hooked: Ethics,Medicine and Pharma blog, the Health Beat blog, have been all over this story.

Yet I think it is reasonable to underline three important points.

Not the Brightest

Pharmaceutical and other health care corporations are fond of saying that the doctors they hire to give talks are the "best and the brightest," thought leaders respected by other physicians.  In fact, the lead article by Pro Publica suggested that some of these supposed "best and the brightest" have dubious credentials, indeed.

Some were not board-certified, and lacked credentials suggesting great expertise:

Among the top-paid speakers, some had impressive resumes, clearly demonstrating their expertise as researchers or specialists. But others did not –contrary to the standards the companies say they follow.

Forty five who earned in excess of $100,000 did not have board certification in any specialty, suggesting they had not completed advanced training and passed a comprehensive exam. Some of those doctors and others also lacked published research, academic appointments or leadership roles in professional societies.

In summary,

Pharma companies often say their physician salesmen are chosen for their expertise. Glaxo, for example, said it selects 'highly qualified experts in their field, well-respected by their peers and, in the case of speakers, good presenters.'

ProPublica found that some top speakers are experts mainly because the companies have deemed them such. Several acknowledge that they are regularly called upon because they are willing to speak when, where and how the companies need them to.

Not the Best

Worse, some of the pharmaceutical paid speakers had records of ethical problems.

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.


More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

The Pro Publica story lead with three disturbing anecdotes:

The Ohio medical board concluded [1] that pain physician William D. Leak had performed 'unnecessary' nerve tests on 20 patients and subjected some to 'an excessive number of invasive procedures,' including injections of agents that destroy nerve tissue.

Yet the finding, posted on the board’s public website, didn’t prevent Eli Lilly and Co. from using him as a promotional speaker and adviser. The company has paid him $85,450 since 2009.

In 2001, the U.S. Food and Drug Administration ordered [2] Pennsylvania doctor James I. McMillen to stop 'false or misleading' promotions of the painkiller Celebrex, saying he minimized risks and touted it for unapproved uses.

Still, three other leading drug makers paid the rheumatologist $224,163 over 18 months to deliver talks to other physicians about their drugs.

And in Georgia, a state appeals court in 2004 upheld [3] a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. The anesthesiologist had admitted giving young female patients rectal and vaginal exams without documenting why. He’d also been accused of exposing women’s breasts during medical procedures. When confronted by a hospital official, Taylor said, 'Maybe I am a pervert, I honestly don’t know,' according to the appellate court ruling.

Last year, Taylor was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June.

It also included:

The Medical Board of California filed a public accusation against psychiatrist Karin Hastik in 2008 and placed her [8] on five years’ probation in May for gross negligence in her care of a patient. A monitor must observe her practice.

Kentucky’s medical board placed Dr. Van Breeding on probation [9] from 2005 to 2008. In a stipulation filed with the board, Breeding admits unethical and unprofessional conduct. Reviewing 23 patient records, a consultant found Breeding often that gave addictive pain killers without clear justification. He also voluntarily relinquished his Florida license.

New York’s medical board put Dr. Tulio Ortega on two years’ probation [10] in 2008 after he pleaded no contest to falsifying records to show he had treated four patients when he had not. Louisiana’s medical board, acting on the New York discipline, also put him on probation [11] this year.

Yet during 2009 and 2010, Hastik made $168,658 from Lilly, Glaxo and AstraZeneca. Ortega was paid $110,928 from Lilly and AstraZeneca. Breeding took in $37,497 from four of the firms.

The Biggest Prescribers = "Thought Leaders"

An accompanying NPR story suggested that most physicians are recruited as speakers because they are big prescribers of the drugs the companies want to market, with the expectation that they will be even bigger prescribers once they start giving paid talks. Furthermore, the companies' representatives use a carefully programmed psychological strategy to allow the physicians they recruit to think they are being paid as "thought leaders" to give educational talks.

Drug companies train representatives to approach a narrow set of doctors in a very specific way, using language that deliberately fosters this idea that the doctors who speak are educators, and not just educators, but the smartest of the smart.

For example, every drug representative interviewed for this story used the exact same phrase when approaching a doctor with a pitch to become a speaker: Each doctor approached to speak was told that he was being recruited to serve as a "thought leader."

This phrase, Webb says, seems to have incredible psychological power.

'When you do say 'thought leader' I think it's a huge ego boost for the physicians,' Webb says. 'It's like a feather in their cap. They get a lot from it.'

This is because most doctors have a very specific idea in mind when you ask them what constitutes a thought leader. Most doctors, including Clawson, cite two important qualifications. 'First, the other doctors in the community respect that person's opinion,' Clawson says. 'And the other way to become a 'thought leader' is to become an academic researcher and try to push the bounds of science further, and then by definition you're a thought leader.'

But some drug representatives, like Maher, have a more cynical view of why drug companies choose the doctors they choose. It's not about how well respected the doctor is, according to Maher; it's about how many prescriptions he writes.

'I think nowadays a thought leader is defined as a physician with a large patient population who can write a lot of pharmaceutical drugs. Period,' she says.

These "thought leaders" may find it comfortable to think that they are paid as experts to give educational talks, but really, they are paid to persuade themselves to prescribe more. If audiences prescribe more, it's just a bonus.

This doesn't mean that every doctor recruited is not a high-quality doctor. Many are. But every representative NPR spoke to had a stable of stories about profoundly unimpressive doctors that they'd recruited as thought leaders essentially for the same reason that a robber robs a bank: because that's where the money is.

The fact is that the top 20 doctors in a representative's territory prescribe the vast majority of the medication. According to Webb, the top 20 percent prescribe as much as the lower 80.

So if you want to sell more of your product, and every representative is required to sell more, those are the physicians to target.

Which brings us to the hard reality about doctor speaking: Although doctors believe that they are recruited to speak in order to persuade a room of their peers to consider a drug, one of the primary targets of speaking, if not the primary target, is the speaker himself.

That's where reps look for a real increase in prescriptions — after a speech.

Here's how the money works out, at least for Webb. It's hard to know whether he's typical because there haven't been any published studies of this subject. But according to Webb, he would give a high-prescribing doctor about $1,500 to speak. And following that speech, Webb would see the speaking doctor write an additional $100,000 to $200,000 in prescriptions of his company's drug.

Webb points out that the people recruited to speak are almost always high prescribers with incredibly high patient populations. 'That much money, easily,' he says. 'So yeah, it was a good return on investment.'

The article also suggested that most of the paid "thought leaders" do not realize on a conscious level how they have been bought.

Dr. James Dickie, an endocrinologist in Westminster, Md., was very clear that his prescription-writing was unaffected by speaking. 'Absolutely not. The physicians who are in the audience may notice it if they have been educated to that drug and the benefits of that drug — they may see an increase in writing. But specifically in my own? I don't believe so.'

When NPR told Dickie about the findings learned from drug reps like Maher and Webb, he seemed genuinely surprised and disturbed and began to wonder out loud if he was, in fact, affected.

'It would really bother me,' Dickie says. 'Because I perceive myself as always prescribing in the best interest of my patient, and even unconsciously if I was unduly influenced, that would really bother me. I usually pride myself on keeping up my guard to prevent undue influence.'

But Maher says it's almost impossible for a doctor to keep up his guard. She points out that before doctors speak to their peers about a drug, they review slides provided by the company and talk to the company medical officers. And this process, she says, focuses the doctor on the most positive aspects of a drug.

'What is happening is that you are being manipulated to talk about the drug out loud,' Maher says. 'Kind of like talking themselves into knowing that what they were saying, were actually believing. And if they believed what they were saying, then they would write more drug.'

Summary

Marketers, especially but not only pharmaceutical marketers, have become very adept at using psychology to manipulate their targets, so that marketing campaigns have begun to resemble disinformation campaigns.  Pharmaceutical marketers in particular have used their ability to convince physicians that they are "thought leaders," (or "key opinion leaders") to get physicians who are already favorably inclined toward their products to prescribe even more.  It is a bonus for the companies if these physicians can also persuade other physicians to prescribe more.  The fact that these supposed "thought leaders" have become real leaders of medicine, to a great extent on the basis of marketers' decisions (also abetted in the academic setting by medical schools' and academic medical centers' love of "external funding," including the sort supplied by marketers to "thought leaders", see this post) is the perhaps unintended but unhappy consequence.  Thus the leaders of medicine and health care are more and more those doctors who are most compliant with and least questioning of pharmaceutical (and other health care) companies' marketing. 

No wonder the leadership of medicine has been so passive as health care has become more dysfunctional.

What is to be done?

-  Physicians and others who are paid to give talks by commercial firms must read the series of articles noted above. 
-  We need to be very skeptical of all "thought leaders" and "key opinion leaders," especially if it is not clear whether they were first dubbed as such by marketers rather than by their own achievements.
-  We need as rapidly as possible to mandate full disclosure of all payments by health care corporations others with vested interests in promoting products or services to physicians, academics, and others with decision making ability or influence in medicine and health care.
-  Hopefully full disclosure of the scope of the thus revealed conflicts of interest will persuade health care professionals and society that we need to eliminate such conflicts, allowing professionals to eventually return to their once respected status as those pledged to put their patients' (rather than their financial backers') interests first. 

Insel Admits His Statements "May be Viewed as Misleading"

Dr Bernard Carroll has posted several times, most recently here, about shenanigans by "key opinion leaders" in psychiatry whose apparently academic writing and speeches have conveyed messages in line with the marketing agendas of drug and device companies, while they downplayed or concealed their financial ties to these companies.  Lately, Dr Carroll noted how the current director of the US National Institute for Mental Health (NIMH), Dr Thomas Insel, has defended Dr Charles Nemeroff, whose recent move to the University of Miami let him shed sanctions imposed by Emory University for his failure to disclose conflicts of interest while he was there. Dr Carroll wrote, "For the past three months, Insel has been trying to put some distance between himself and Nemeroff, but the public isn’t buying it. I have called his statements disingenuous...."

Dr Carroll is on vacation, so in his absence, I note the following from a brief article in the Chronicle of Higher Education:

The director of the National Institute of Mental Health, Thomas R. Insel, has softened his denial of a mutually helpful relationship with Charles B. Nemeroff, a university researcher found to have repeatedly collected undisclosed corporate payments. In an update to his official blog posting, Dr. Insel said his initial denial of job assistance from Dr. Nemeroff 'may be viewed as misleading,' and acknowledged that Dr. Nemeroff served in key positions related to Dr. Insel's hiring by Emory University.

This seems to corroborate Dr Carroll's skepticism. I wonder what other statements by Dr Insel, or Dr Nemeroff for that matter, ought to be "viewed as misleading?"

We have said repeatedly that commercially sponsored "key opinion leaders" are really part-time drug marketers disguising themselves as academics or distinguished practitioners. The deceptions inherent in these roles seem to lead to a certain habitually elastic approach to the truth.

Medical academics and practitioners will need a renewed commitment to honesty and transparency if they want to regain the respect of an increasingly skeptical, if not cynical public.

When a Key Opinion Leader Questions the Hand That Fed Him: from "Master Teacher to Someone Who Didn't Know What He Was Doing"

We just posted an update on the ongoing cozy relationship with medical device companies, in particular, those that make prosthetic hip and knee joints, and some orthopedic surgeons.  Some surgeons, including many prominent academic leaders and practitioners, have been paid huge amounts, and have often failed to make more than the most minimal disclosure to their patients, or to the audiences of their talks or the readers of their ostensibly scholarly articles.  Deferred prosecution agreements with device companies shed light on these payments, but did not curtail them.  Yet the surgeons and the companies who paid them defended the payments as legitimate consulting agreements, and royalties for worthy innovations. 

Now the New York Times has reported on a dispute between a well-paid consultant and an artificial joint manufacturer that provides new insights into these financial relationships. To summarize,

IT was a long, fruitful medical marriage that is fast becoming an angry public divorce, one that offers a rare look at a clash between a top-shelf consultant and his corporate patron over patient safety.

For years, Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings, trained hundreds of doctors to use its products and talked it up wherever he went. In return, Zimmer, an orthopedic implant maker, helped enrich Dr. Berger, portraying him as a master surgeon and paying him more than $8 million over a decade.

Those days are gone. Dr. Berger started complaining to Zimmer a while back that one of its artificial-knee models was failing prematurely, and he went public recently with a study that he says proves it. Zimmer told him that the problem was not the artificial knee, but his technique, and pointed to data overseas indicating that the knee was safe.

Last year, Zimmer did not give Dr. Berger a new contract. The company says it routinely rotates consultants.

'I trained hundreds of doctors for them and made them tens of millions,' Dr. Berger said in interview here, in which he also lambasted Zimmer executives as dissembling, out-of-touch bureaucrats. 'So was this just a coincidence? Maybe it was. Maybe it wasn’t.'

In more detail, here is how Dr Berger's relationship with Zimmer began:

The surgeon, a tall, balding man with a boyish manner, was finishing his fellowship at the Rush University Medical Center in Chicago at the time, one of the country’s top centers for joint replacement. The center has had long ties to Zimmer, whose headquarters is about two hours away, in Warsaw, Ind., and the young surgeon quickly came to the company’s attention.

'Rich has a very clever set of hands, and because of that he is enabled with the ability to innovate surgical techniques,' said Roy Crowninshield, who was Zimmer’s chief scientific officer.

Dr. Berger’s skills matched Zimmer’s marketing strategy. To distinguish itself from competitors, the device maker had started promoting minimally invasive surgery, a technique that uses smaller incisions than traditional surgery. Zimmer trained doctors in the procedure, using its device.

Soon, Dr. Berger, who was then pioneering a type of small-incision surgery that allowed patients to leave the hospital on the day of surgery, became a linchpin of Zimmer’s efforts. In 2002, he was prominently featured in a press release about Zimmer’s plans to build a training facility for minimally invasive surgery.

'We are clearly excited about Dr. Berger’s data,' J. Raymond Elliott, the company’s chairman and chief executive at the time, stated in the release.

Over the next few years, the physician estimates, he helped train hundreds of surgeons on Zimmer’s behalf.

And in more detail, here is how things went wrong: 

As he tells it, his relationship with Zimmer frayed over a version of a widely used Zimmer knee, known as the NexGen. The model at issue, called the NexGen CR-Flex, is designed to provide a greater range of motion than the standard NexGen.

Most surgeons implant an artificial knee using a cement-like adhesive to bond the thigh bone to the portion of the device that bends. But some specialists, like Dr. Berger, try to avoid adhesives because the cement can break down and cause device failure. So Zimmer also sells an uncemented version of the CR-Flex that relies instead on the bone naturally fusing with the implant.

Dr. Berger says that he gave the device, which is supposed to last about 15 years, to about 125 patients in 2005, the first full year he used it. But by early 2006, some X-rays showed lines where the implant met the thigh bone, an indication that the device was loose and had not fused completely. Patients could walk, but they were reporting pain, apparently a result of the loose joint.

He says he soon brought the problem to the attention of Zimmer officials, including the company’s new top scientist, Cheryl R. Blanchard. Zimmer executives pointed to the success of the NexGen, but the company did not have separate test data on the uncemented flexible model because the F.D.A. had not required the company to study it in patients before selling it.

Later, as more patients complained about the device and Dr. Berger had to replace some of them, he spoke to Ms. Blanchard again, he said. This time, he said, she and other Zimmer officials suggested that his technique was the problem because no other surgeon had complained.

'Suddenly, I went from someone who was their master teacher to someone who didn’t know what he was doing,' he said.

BY 2007, Dr. Berger, although still a Zimmer consultant, had stopped using the device and had learned, he said, that several other surgeons had also experienced problems with it. But unlike Dr. Dorr, the physician who sent out the alert about Zimmer, Dr. Berger said he initially had hoped to avoid a public showdown with the company. So he followed a more traditional route by performing a study with another Rush surgeon, Dr. Craig J. Della Valle, who was also having to replace the Zimmer knee.

Dr. Berger and Dr. Della Valle first presented their study at a medical meeting last fall and again this year at a national meeting of the American Association of Orthopedic Surgeons. They found that the uncemented Zimmer knee failed early in about 9 percent of some 100 patients studied. Also, the knee exhibited signs of looseness in about half of all patients and has since been replaced in some of them, Dr. Berger said.

But Zimmer was unswayed. In a filing with the Securities and Exchange Commission, Zimmer made note of the study but also pointed to the knee’s very positive results in a large database of orthopedic patients in Australia. Officials there confirmed the low failure rate. The company also said that the cement-free CR Flex accounted for only a small fraction — about 2 percent — of its overall knee sales.

The most striking lesson of this case is that Dr Berger was only valued as a consultant as long as his work completely followed the marketing party line.  As soon as he questioned the company's product, or the executives who were promoting it, he became "someone who didn't know what he was doing."  Of course, a truly valued consultant should be respected, if not sought for honest advice, whether or not it fit  preconceived notions or marketing strategies.  Thus, how Dr Berger was finally treated suggested he really was hired to market product.  "Consultant" was just a pretty title.. 

We  (and many others) have discussed (e.g., here) how pharmaceutical, biotechnology, and device companies cultivate "key opinion leaders" who really are nothing more than salespeople with fancy academic titles or well-known practices.  The case of Dr Berger suggests that apparently distinguished academics and practitioners hired as "consultants" by such companies ought to be regarded as salespeople until proven otherwise.  Physicians who are wooed by company marketers to take on such consulting roles, often with praise for their ability to "innovate," "excite," or become a "master teacher," may want to consider whether those flattering them merely want to hire another high-profile part-time salesperson.  They may further may want to think about how they would look should this relationship be revealed for what it really is.  If something goes wrong, they should think about what it would be like to deal with "dissembling, out-of-touch bureaucrats."  Sometimes there is a price to pay for taking all that money.

I hope that Dr Berger will consider donating the $8 million he made to the cause of more honest teaching and research about orthopedic devices. 

Meanwhile, patients and physicians should be extremely skeptical about the pronouncements of paid consultants and key opinion leaders who work for corporations marketing health care goods and services.  We all should demand at least that those paid by such vested interests reveal such financial arrangements in detail if they expect us to listen to their spiels, take their advice, and particularly be subject to their decisions.