High Heels, Short Skirts, and Recruiting Bone Marrow Donors

Once again, you just can't make this stuff up.  Here is the New York Times description of new state of the art in recruiting donors for bone marrow transplant.

On its face, it seemed reasonable enough: a bone marrow registry sending recruiters to malls, ballparks and other busy sites to enlist potential donors.

But the recruiters were actually flirtatious models in heels, short skirts and lab coats, law enforcement officials say, asking passers-by for DNA swabs without mentioning the price of the seemingly simple procedure. And the registry, Caitlin Raymond International, was paying up to $60,000 a week for the models while billing insurance companies up to $4,300 per test.

In New Hampshire, where prosecutors say thousands of people appeared to have provided swabs, the attorney general is investigating the registry’s marketing and billing practices. The registry is a nonprofit subsidiary of UMass Memorial Medical Center in Worcester, which said Thursday that it had stopped seeking donors in New Hampshire and using models altogether.

James T. Boffetti, the state’s senior assistant attorney general, said the registry had hired models based on their photographs and had given them 'explicit instructions' to wear heels and short skirts.

The recruitment seemed to be based more on in-your-face sex appeal than an appeal to altruism:

'The models worked the crowds, if you will,' he said. 'We were told basically they would engage a lot of younger men with some sort of flirtatious thing: ‘Hey, don’t you want to be a hero? Come on, do this!’ '

What the models did not tell their, um, prospects was that apparent acts of charity would result in a hefty bill to the volunteers' health insurance:

They got people to do this without telling them it could be a charge of $4,300 against their insurance

To put that charge in perspective, as reported by Liz Kowalczyk in the Boston Globe:

In the last decade, Massachusetts, New Hampshire, and Rhode Island became the only states where legislators mandated insurers pay for bone marrow testing.

Nationally, most hospitals and other donor-recruitment organizations do not charge for the testing, said Michael Boo, chief strategy officer for the National Marrow Donor Program. The test typically involves a DNA analysis to determine whether the donor is a match for anyone on the bone marrow transplant waiting list.

Boo estimates it costs the organization about $100 to test and recruit each potential donor, although he said that, as the largest bone marrow donor registry in the United States, the program gets a volume discount from labs for the DNA analysis. The organization has about 8 million registered donors. (The Caitlin Raymond registry has 185,000 potential donors.)

But in New Hampshire, UMass Memorial charges self-insured employers, like the city of Manchester, that do not have a negotiated rate upwards of $4,000 per person for testing. It generally has charged insurers like Blue Cross and Harvard Pilgrim $700 to $1,500 person for testing, said James Boffetti, senior assistant attorney general in New Hampshire and chief of the consumer protection bureau.

'We haven’t been able to get a clear explanation from UMass about the reasons for the costs,' he said. As for the unusual recruiting, he said, 'they’re doing it because they are making money on this test.'

Finally, although the medical center sent initial bills for the tests to volunteers' insurers, sometimes the volunteers got stuck with part of the bill. As reported by National Public Radio:

Marc Ferland, a 45-year-old father of two in Bow, N.H., stopped at a registry booth after giving blood at a Red Cross drive. A month later, he received a bill that said he owed more than $2,000 to cover the costs of the test. When he complained, the amount was cut to $760, which he paid out of a health care account offered by his employer.

'When you take money out of my spending account, that's a cost to me,' Ferland said.

So here is an almost unbelievable example of how the a culture of marketing gone amok has taken over an academic health care institution. It seems darkly humorous now that the UMass Memorial Medical Center includes in its stated values:

Staff members of UMass Memorial Medical Center are committed to:

* Excelling at patient-centered care
Achieving patient-focused excellence through the highest standards of quality care, patient safety and patient satisfaction
* Acting with integrity
Dealing honestly, fairly and responsibly with each other
* Respecting one another
Valuing the contributions, ideas and opinions of our coworkers, colleagues, patients and partners
* Contributing to the community
Partnering with the community at large and with other health care and social agencies in meeting the health needs of the community
* Improving through teamwork and systems thinking
Working to continuously improve ourselves, our processes and our patient services through cooperation and thinking as an integrated health care system
* Embracing accountability
Holding ourselves, our coworkers and our leaders to the highest standards of performance

Integrity? Partnering with the community? - maybe that is what some of the recruits were hoping for, in a sense.   Embracing accountability?  Maybe the new vision statement should be "a sucker is born every minute."

Again, it would be funny if it were not so tragic.  Here we see a major academic medical institution debased into something that a Las Vegas casino might frown upon.

As we have noted ad infinitum, however, previous attempts at health care reform have not dealt with how the "greed is good" culture of Wall Street, run by amoral financiers and fueled by cynical marketers, has taken over health care.  Until we get health care leaders who really do care about patients, and about the integrity of teaching and research, the show will go on.  Meanwhile, the suckers better watch out.

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. 

Another Wheel Already Invented (in 1988) - the WHO Ethical Criteria for Medicinal Drug Promotion

At the 2010 Gezonde Scepsis (Healthy Skepticism) "Selling Sickness" conference, I was made aware of another wheel invented a long time ago, the 1988 WHO Ethical Criteria for Medicinal Drug Promotion, a document about which few now seem to be aware.  Were this code to have been widely followed, it might have prevented some of the problems afflicting the pharmaceutical industry today.

Some relevant quotes follow:

Drug Promotion

6. In this context, 'promotion' refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.

7. Active promotion within a country should take place only with respect to drugs legally available in the country. Promotion should be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word 'safe' should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Promotional material should not be designed so as to disguise its real nature.

8. Scientific data in the public domain should be made available to prescribers and any other person entitled to receive it, on request, as appropriate to their requirements. Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs.

9. Scientific and educational activities should not be deliberately used for promotional purposes.

Note that these provisions would seem to prohibit promotional efforts begun before a drug is legally approved (e.g., ghost-writing as in this case), the use of "key opinion leaders" without full disclosure of their role as marketers of drugs, suppression of clinical research sponsored by pharmaceutical companies whose results did not support these companies' marketing interests, e.g. studies which failed to show efficacy of their products, nearly all kinds of payments to physicians, and nearly all pharmaceutical sponsored continuing medical education.

Medical Representatives

17. Medical representatives should have an appropriate educational background. They should be adequately trained. They should possess sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers are responsible for the basic and continuing training of their representatives. Such training should include instruction regarding appropriate ethical conduct taking into consideration the WHO criteria. In this context, exposure of medical representatives and trainees to feed-back from the medical and allied professions and from independent members of the public, particularly regarding risks, can be salutary.

18. Medical representatives should make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data sheet or other source of information with similar content.

19. Employers should be responsible for the statements and activities of their medical representatives. Medical representatives should not offer inducements to prescribers and dispensers. Prescribers and dispensers should not solicit such inducements. In order to avoid over-promotion, the main part of the remuneration of medical representatives should not be directly related to the volume of sales they generate.

Note that these provisions appear to prohibit the current cheer leader/ ex-athlete model of the drug representative, and to prohibit many of the current activities of such representative, including providing gifts, meals, travel to meetings, honoraria, etc  (e.g., see posts here and here).

If only these standards had gotten some traction, think of the trouble that could have been averted.  On the other hand, it is obvious that such traction would have threatened some peoples' lucrative incomes and power, who may have worked hard to make sure it did not happen.

Deceptive Marketing, For-Profit Universities, and Health Care Education

Last week, reports about deceptive marketing and other questionable practices used by the growing for-profit higher education industry in the US appeared in the news.  For example, per Bloomberg:

Recruiters at U.S. for-profit colleges lied to entice students and encouraged them to commit fraud to qualify for aid, a report by the Government Accountability Office found.

Recruiters at all 15 colleges studied by the GAO, Congress’s investigational arm, misled potential students about the costs, duration and quality of their programs, according to a report obtained by Bloomberg News....

Other deceptions include:

“'college representatives exaggerated undercover applicants’ potential salary after graduation and failed to provide clear information about the college’s program duration, costs, or graduation rate,' the report said. 'Admissions staff used other deceptive practices, such as pressuring applicants to sign a contract for enrollment before allowing them to speak to a financial advisor about program cost and financing options.'

Also,

In one case cited by the report, a GAO investigator posing as an applicant was told to lie on an aid application about the number of household members to qualify for grants. When the investigators told college employees that they had $250,000 in savings, officials at three colleges told them to hide their savings in order to qualify for financial aid.

In addition,

For-profit colleges overstated the quality of their programs and the organizations overseeing their accreditation, the report said. One recruiter told an investigator posing as an applicant that his school was accredited by the same one that accredits Harvard University.

'It’s the top accrediting agency,' the recruiter said, according to the report. 'Harvard, University of Florida --they all use that accrediting agency.'

Recruiters exaggerated their colleges’ benefits and graduation rates, the report said. A beauty college recruiter said barbers earn as much as $250,000 a year, while the Bureau of Labor Statistics said 90 percent of barbers make less than $43,000 annually, according to the report.

A later report by the Dow Jones news service named some of the corporate players whose educational "institutions" were involved in dubious schemes.

Colleges operated by Apollo Group Inc. (APOL), Corinthian Colleges Inc. (COCO) and Washington Post Co.'s (WPO) Kaplan Higher Education unit were among the schools the U.S. Government Accountability Office found provided 'deceptive and otherwise questionable information' to agents who posed as prospective students in an undercover investigation of for-profit student recruitment tactics.

It is tempting to look for parallels with health care, once a calling like higher education, but now increasingly an "industry," often run, as we have documented endlessly, by people with little experience or knowledge about how health care is actually done on the ground, with little sympathy for the values of health care professionals, and given strong incentives to maximize the money coming in, whatever it takes.

However, the issue goes beyond these parallels. In fact, many of the bigger for-profit education corporations provide considerable health care education, including the three named above. The University of Phoenix, a subsidiary of the Apollo Group Inc, offers a Masters of Science in Nursing degree. Several of the "brands" of Corinthian Colleges Inc offer offer "diploma and/or degree programs in health care." Kaplan University, a subsidiary of Kaplan Higher Education Corporation, has a School of Health Sciences.  So it seems likely that many health care professionals, or would-be health care professionals, have been enticed by the sorts of sales practices documented in the report. 

There are no known for-profit US medical schools.  However, as we have discussed, many US students go to for-profit "off-shore" medical schools, often in the Caribbean, who mainly "educate" US citizens who want to practice here (as opposed to all the schools in countries other than the US whose main goal is to educate doctors for their own countries.)  Some of these off-shore schools are owned by big US corporations.  One can only wonder whether their recruitment tactics are similar to those of the for-profit "universities" located in the US. 

We have discussed deceptive marketing of hospitals, drugs and devices, but now it seems that deceptive marketing is even more widespread in health care than we originally thought, along with the take the money and run ethos that has infected so much of the business world.

If we truly want to reform health care to improve quality and access, and control costs, we need to restore the focus to care, the care of the patient, and away of the false pursuit of economic efficiency that only seems to benefit the quick buck artists. 

BLOGSCAN - Deceptive Pharmaceutical Marketing

Perhaps in honor of the recently concluded meeting organized by Dr Adriene Fugh-Berman and her colleagues at PharmedOut.org on the pharmaceutical industry and its influence on continuing medical education, three significant posts appeared this week about deceptive pharmaceutical marketing practices. 
On the Health Business Blog, David Williams analyzed how a former pharmaceutical and biotechnology executive spun the Vioxx case, blaming it all on the public's risk aversion. 
On the Hooked: Ethics, Medicine and Pharma Blog, Dr Howard Brody summarized two significant articles by Kalman Applbaum on complex psychological campaigns, really versions of disinformation campaigns, used to to market pharmaceuticals. 
On the Carlat Psychiatry Blog, Dr Daniel Carlat published a letter about life at a medical school department lead by Dr Charles Nemeroff, one of the "key opinion leaders" most lavishly paid by pharmaceutical companies to help them market questionable drugs for questionable reasons, and giving observations on Dr Nemeroff's new career.

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.  

Reading Between the Lines: "Scrappy" WellPoint as an Illustration of Contemporary Health Care's Flaws

Giant US for-profit insurance company/ managed care organization WellPoint has provided numerous examples of problems with the current way health care organizations are lead.  Here we discussed charges that recent rate increases by its Anthem subsidiary may have violated previous agreements not to directly fund from premiums the golden parachutes of executives who left after the merger of Anthem and WellPoint; that WellPoint used magical accounting to make administrative costs appear to be from patient care; and that WellPoint investigated patients who developed cancer to find minor errors in their policy applications, and  used these as excuses for post-hoc cancellations (rescissions) of their policies.  And here we discussed a long list of WellPoint's previous ethical issues.

Recently, Reed Abelson penned a discussion of WellPoint's leadership in the New York Times, entitled "A Scrappy Insurer Wrestles With Reform."  Reading between the lines suggests some fundamental flaws in our current model of leadership for health care organizations.

The Halo Effect

Over long years of service in the last century, many health care organizations built up sterling reputations. Blue Cross and Blue Shield health insurance plans, which were all originally not-for-profit, regionally (state-wide) based organizations, became known for paying for care rather generously and with little fuss. (However, in retrospect, this may have certainly contributed to rising health care costs.)  However, their reputation was clearly for good service leading to generous care.

However, in the last 20 years, many of these plans converted to for-profit corporations, and/or were bought out by for-profit corporations. WellPoint is now a for-profit corporation that operates many subsidiaries that still do business as "Blue Cross" and "Blue Shield."

Over the last decade, WellPoint has become one of the nation’s largest insurers by buying up the Blue Cross plans that dominate the individual and small group markets in their states.

So,

[WellPoint CEO] Ms. [Angela] Braly argues that WellPoint is well positioned because of its size and the strong appeal of the Blue Cross name. 'We have a lot of historical strengths,' she said in an interview

However, it is likely that the "strong appeal" of many of these Blue Cross plans is based on a halo effect. Many individuals and small businesses may still think that the plans are relatively local, not-for-profit organizations. If not, they may still believe the plans are run as mission-driven organizations, not subsidiaries of a massive for-profit corporation.

Thus many health care organizations may so profit by an outdated "halo effect." People may not realize that leadership of these organizations is no longer a calling, but a way to become very rich.  The strong appeal of the Blue Cross name may, in fact, be misleading.  Such confusing, if not deceptive marketing has become a hallmark of our era of commercialized health care.

Market Domination and Health Care Costs

Prior to almost every merger, one hears an argument that larger organizations and corporations are more efficient, and hence will charge lower prices and lead to lower costs. Mr Abelson wrote,

WellPoint now has about 34 million customers, putting it ahead of the UnitedHealth Group in membership, and $60 billion in revenue, second behind UnitedHealth. While UnitedHealth and the other national companies tend to focus on providing services to large employers with workers in multiple locations, WellPoint’s focus has been on the local markets. Its strong presence allows it to demand the lowest prices from doctors and hospitals, while still offering customers a broad network of providers from which to choose.

I doubt there is any good data to show that such market power has resulted in lower premiums or lower health care costs.

In fact, Mr Abelson also wrote,

Because of its dependence on the higher profit margins of its traditional business, WellPoint has also not been as adventurous in trying new approaches,....

If WellPoint really meant to use its market dominance to force down its costs, it appears that the main beneficiary of this has been the company's profit margin, not its policy-holders.

Furthermore,

Starting in 2014, WellPoint and its competitors will have to offer coverage to anyone who wants it, including people with potentially expensive pre-existing conditions, rather than carefully selecting the people they are willing to cover. As soon as next year, insurers will also have to spend at least 80 cents of every dollar they collect in premiums on providing health care to individual customers.

So WellPoint used its market power to "carefully select" the people it insured so as to avoid anyone who might get sick, thus making a mockery of the concept of health insurance. Furthermore, the implication is that WellPoint spent more than 20% of premiums on management and administration (including the breathtaking compensation of its top leaders), and less than 80% on actually paying for health care.

As Mr Abelson noted, (as we did here), just how personally remunerative WellPoint's market power has been for its top leader:

Ms. Braly, ... received $13.1 million last year in compensation....

In fact, as we should have learned in this country more than 100 years ago, market domination leads to higher profits for the dominant company, higher compensation for its employees, and higher prices. However, in health care, for some reason people still believe that concentration of power leads to efficiency.

Health Care Leaders Who Know Little About Health Care

Ms Braly appears to have no direct experience, training, or expertise in health care, medicine, public health, or biologic science.

Ms. Braly, 48, a native of the Dallas area who received a law degree from Southern Methodist University, worked as a lawyer before she became general counsel to a small Blue Cross insurer in Missouri. She eventually ran that company, which is now part of WellPoint. Before being picked for WellPoint’s top job in June 2007, Ms. Braly worked as both a corporate executive and the company’s general counsel.

Her selection as C.E.O. surprised many analysts and investors. While some believed that she would bring a warmer touch to the company, others worried that she did not have enough years as a manager to navigate a highly regulated and often highly political environment.

In the last year, WellPoint became a favorite example of Congress and the administration for why health care overhaul was needed. Even people inside the industry say the company has been painfully slow to recognize consequences of some of its controversial actions, whether canceling a sick patient’s coverage or raising premiums on policies that lawmakers already call too expensive. And some say that Ms. Braly’s quickness to argue with WellPoint’s critics, revealing her training as a lawyer, is not always productive.

'WellPoint is the most incredibly tone-deaf insurance company in an industry full of deaf executives,' says Mr. Laszewski, the Virginia consultant. He criticizes Ms. Braly, who received $13.1 million last year in compensation, as being insensitive to the politics involved in running a health insurer, at both the state and federal levels. 'I don’t think she has the scar tissue and experience,' he says. 'I don’t think she has the marketplace instincts.'

Ms. Braly says her experience in government affairs makes her well suited for handling a complex regulatory environment.

Ms. Braly's background was cited as unusual for a health care CEO not because she has no obvious experience in direct health care, or its scientific or social scientific bases, but because she is a lawyer, not an MBA. It is interesting that we as a society have become so used to health care run by businesspeople that nothing in the article even obliquely suggested that Ms. Braly could benefit from some direct knowledge of or experience in caring for patients (or in biology, epidemiology, public health, etc), much less some sympathy for the values of health care professionals.

So I submit that this profile of the leadership of WellPoint provides another reason to reconsider why we have journeyed so far from an era when the AMA asserted, "the practice of medicine should not be commercialized, nor treated as a commodity in trade."  Current commercial health insurance (and the power that generally has been concentrated in large health care organizations) has certainly turned medicine into a commercialized venture, and treated the work of the individual health care professional as a commodity in trade.  Yet so far, what we have called health care reform in the US has just reinforced the power of large health care organizations. 

It also suggests that true health care reform ought to address the power now concentrated in large health care organizations, and ought to foster more honest and less profuse marketing by companies lead by people who have some knowledge of health care, and sympathy for its values.  We need to reinforce the neglected idea that health care ought to be a calling, not simply a way for some to become rich.

Spun Silly: Academic Medical Center Cancer Treatment Advertising in the Era of Hype and Flim-Flam

Over the weekend, the New York Times reported on how prestigious academic medical centers advertise cancer care.  Here are some examples,

Prostate Cancer Surgery at Mount Sinai

A print advertisement for prostate cancer surgery at Mount Sinai Medical Center in Manhattan is typical of the way many elite research and teaching hospitals sell hope to the public.

'Our newest prostate specialist, Dr. David Samadi, has pioneered a minimally invasive approach that allows him to retain the highest cancer cure rates with the lowest risk of side effects,' says the ad.

Highest cure rates. Lowest risk. What evidence does the medical center have to back up such superlatives?

The ad’s claims are based on the successful results of Dr. Samadi’s operations and testimonials from his patients, said Jane Zimmerman, Mount Sinai’s chief marketing officer.

However, the article noted that the hospital could provide no studies that showed that its or Dr Samadi's results were superior to those of other hospitals or other surgeons.

... the ad with the superlative prostate cancer claims ... was later revised to say that Dr. Samadi’s approach gives 'high rates of success coupled with lowered risks of side effects.' Ms. Zimmerman said Dr. Samadi was not available to be interviewed.

Also,the people who concocted the advertisement said it was not really meant to tell prospective patients that the surgeon had better results than all others:

But marketing executives defend their approach, saying cancer treatment ads tend to play more heavily on emotion than on medical statistics because the ads are not intended to inform people who already have the disease. They are meant to make an impression on future patients, who may decide on treatments years after they have seen an ad, or to sway influential people who might advise a future patient.

'This isn’t retail advertising,' said Ellis Verdi, president of the DeVito/Verdi Agency in Manhattan.

The agency produced the Mount Sinai ad, which ran in The New York Times, and has created cancer ads for other hospital clients. 'This is reputation advertising,' Mr. Verdi said. 'There is a very big difference.'

But the advertisement said that the hospital's prostate cancer specialist had the highest survival and lowest adverse event rates.  How would a patient with prostate cancer realize that the advertisement was only meant to enhance the hospital's reputation, but not meant to speak to him?  

Radiation for Brain Tumors at Massachusetts General Hospital

'We gave Nick something he couldn’t find anywhere else in the Northeast. Life without cancer.'

That was the text of a print ad last year by the Massachusetts General Hospital Cancer Center in Boston, promoting its $50 million center for proton beam therapy, a kind of high-energy radiation to treat brain tumors and other cancers.

The hospital was the only medical center in the region with a proton therapy center, the ad said, enabling doctors there to successfully treat the brain tumor of a young man named Nick.

The ad’s concept was that Nick had a greater chance of survival because the precise proton beam could destroy malignant brain tissue while leaving surrounding healthy brain tissue intact, said Jodie Justofin, the marketing director at Mass General’s cancer center.

Dr. Thomas F. DeLaney, the medical director of the Francis H. Burr Proton Therapy Center at Mass General, said he had no involvement in the ad and did not have any information about Nick.

However, the article also noted that "no rigorous studies have shown that proton beam therapy has higher brain-cancer cure rates than other treatment methods, said Dr. [John D] Birkmeyer of Michigan [a professor at the University of Michigan and cancer outcomes researcher]. 'The ad might be accurate that they are the only hospital in the Northeast with this particular widget,' he said. 'But it could be misleading that the availability of this particular widget gave this patient better odds of survival.'"

Again, the advertisement said that the patient got "life without cancer," something he could not get anywhere else in the Northeast.  How would a patient with a brain tumor realize that the advertisement was merely based on a "concept," rather than scientific evidence that his  or her only hope for "life without cancer" could come from proton beam therapy at the Massachusetts General Hospital?

Surgery for Cervical Cancer at Memorial Sloan-Kettering Cancer Center

'Cancer, You said I’d never bear children,' reads the handwritten letter, held out by a pretty, healthy-looking woman, as a toddler peeks from behind the paper. 'My daughter says you’re wrong.'

That recent print ad from Memorial Sloan-Kettering Cancer Center in Manhattan tells the story of Michelle Rogala, a patient with cervical cancer.

Ms. Rogala’s hospital in New Jersey could offer her only a hysterectomy, an operation that would have left her unable to have children. Instead, she went to Memorial Sloan-Kettering, where she entered a clinical trial that was studying less invasive surgery. Ms. Rogala now has a little girl named Maddie.

Ellen Miller-Sonet, vice president for marketing at Memorial Sloan-Kettering, said consumers seeing the ads realizes that these were individual stories. 'They know that no two people are the same,' she said.

However, Ms Rogala told the NY Times, "hers had indeed been a special case. She had early-stage cervical cancer, she said, making her eligible for a novel operation that has now become a standard treatment at the center. After her operation, doctors told her she would need fertility treatments to conceive. But she said she turned out to be one of the few patients in the study who did not need radiation — which can cause fertility problems. She later became pregnant without medical intervention."

Again, why "consumers," much less patients with cervical cancer, would realize that the advertisement was just an "individual story," not a promise that the hospital's treatment of cervical cancer would not prevent future pregnancies, was entirely obscure.

Summary

The three advertisements described in the NY Times article had some features in common. All seemed to promise exceptional results. None were based on clear scientific evidence. All seemed to have been products of marketers and advertising agencies working without input from the physicians who actually provide the treatments they were advertising. All the marketers defended their work by saying that the advertisements did not actually mean what they appeared to mean.

My most obvious comment is that hospitals, even the most prestigious teaching hospitals, now seem to be willing to market their services like the used car salespeople seen on late night television.  Such advertisements, of course, are unseemly and undignified coming from such august institutions.  Worse, they seem to promise more than what these or any hospitals can be proved to deliver, and the only defense of the marketers who produced the advertisements were that they did not mean what they seemed to mean.

This shows the sad, and ultimately deceptive and unethical effects of turning the leadership of our best medical institutions over to businesspeople with little knowledge or understanding of the values of  health care.

It also shows what has happened to health care in an age of hype, scam, sham, spin and flim-flam.  It all seems part of what Frank Rich just wrote about in the NY Times:

If there’s been a consistent narrative to this year and every other in this decade, it’s that most of us, Bernanke included, have been so easily bamboozled. The men who played us for suckers, whether at Citigroup or Fannie Mae, at the White House or Ted Haggard’s megachurch, are the real movers and shakers of this century’s history so far. That’s why the obvious person of the year is Tiger Woods. His sham beatific image, questioned by almost no one until it collapsed, is nothing if not the farcical reductio ad absurdum of the decade’s flimflams, from the cancerous (the subprime mortgage) to the inane (balloon boy).

What makes the golfing superstar’s tale compelling, after all, is not that he’s another celebrity in trouble or another fallen athletic 'role model' in a decade lousy with them. His scandal has nothing to tell us about race, and nothing new to say about hypocrisy. The conflict between Tiger’s picture-perfect family life and his marathon womanizing is the oldest of morality tales.

What’s striking instead is the exceptional, Enron-sized gap between this golfer’s public image as a paragon of businesslike discipline and focus and the maniacally reckless life we now know he led. What’s equally striking, if not shocking, is that the American establishment and news media — all of it, not just golf writers or celebrity tabloids — fell for the Woods myth as hard as any fan and actively helped sustain and enhance it.

People wanted to believe what they wanted to believe. Tiger’s off-the-links elusiveness was no more questioned than Enron’s impenetrable balance sheets, with their 'special-purpose entities' named after 'Star Wars' characters. Fortune magazine named Enron as America’s 'most innovative company' six years in a row. In the January issue of Golf Digest, still on the stands, some of the best and most hardheaded writers in America offer 'tips Obama can take from Tiger,' who is typically characterized as so without human frailties that he 'never does anything that would make him look ridiculous.'

I would note that the health care precursor to all this was how the former CEO of the Allegheny Health Education and Research Foundation (AHERF), the biggest health care system in Pennsylvania in the 1990s, was hailed as a visionary in the medical press and scholarly literature, which later ignored AHERF's bankruptcy and its former CEOs criminal conviction (see post here.)  So my one disagreement with Mr Rich is that the problems are much older than the 21st century.
Rich concluded,

after a decade of being spun silly, Americans can’t be blamed for being cynical about any leader trying to sell anything. As we say goodbye to the year of Tiger Woods, it is the country, sad to say, that is left mired in a sand trap with no obvious way out.

The way out of our sand trap in health care, of course, is to refuse to be spun any more. We need to stop believing the hype propogated by all the clever marketers, and all the self-interested CEOs who hire them.

Meanwhile, I would suggest to any cancer patient who failed to get the wonderful results promised by some slick hospital advertisement, there may be some lawyers who with whom you ought to speak.

UPMC Fouls Another One Off

It's almost World Series time in the US, so here's a baseball story, courtesy the Pittsburgh Business Times,

University of Pittsburgh Medical Center lobbyist Leslie McCombs used Pittsburgh Pirates baseball tickets purchased by UPMC’s insurance arm to entertain film executives and others to promote the creation of a state film tax credit, according to the State Ethics Commission.

The commission fined McCombs $5,025 for failing to promptly register as a lobbyist for Lions Gate Entertainment Corp. and omitting a daytime phone number in registering as a lobbyist for UPMC, according to a commission ruling reached on July 22. The confidential decision was disclosed Sept. 9 by The Associated Press.

McCombs, who works for UPMC as a consultant, received permission from UPMC President and CEO Jeffrey Romoff to lobby on behalf of Lions Gate, which she described in a February 2007 e-mail to him as the, 'largest independent producer and distributor of motion pictures and television in the country.'

Romoff cleared her work with Lions Gate after consulting with UPMC legal counsel and assured by McCombs in the e-mail that, 'UPMC signs will be prominently featured throughout the (‘Kill Pit’ television) series.'

Filming for the eight-part miniseries, which was renamed 'The Kill Point,' began in March 2007 in Pittsburgh. Gov. Ed Rendell signed the Film Production Tax Credit bill into law in July 2007, which provided for a 25 percent film tax credit to offset production expenses.

Also,

From 2005 to 2006, McCombs was director of public relations for UPMC Health Plan, a for-profit subsidiary of the nonprofit hospital network. She was then named senior consultant with UPMC’s government relations department.

The State Ethics Commission lists 18 baseball games where McCombs treated Lions Gate and government officials using UPMC tickets.

In addition, she attended a June 15, 2007, matchup against the Chicago White Sox with Rendell and his wife, Marjorie, and Romoff and his wife, Stefania, according to the commission.

It’s not clear from the commission report whose interests McCombs was representing at that game, but Rendell later reimbursed $960 for the tickets to the five games that he attended, which was returned to the health plan.

In 2007, UPMC Health Plan bought $61,440 worth of Pittsburgh Pirates tickets, which were available to employees of the insurer 'in the performance of their duties,' the report states. The sum included a $20,000 seat license.

So did you get all that? The director of public relations for the UPMC Health Plan, the managed care subsidiary of UPMC, a large academic medical center, lobbied the state governor for the enactment of a tax credit for television and movie production, partially so that the UPMC logo would appear in a television series, and entertained the governor using a few of the more than $60,000 worth of baseball tickets the medical center purchased for employee use. Amidst the complication, the public relations director violated state lobbying rules. None of these shenanigans had anything directly to do with health care, or medical education and research. The only conceivable advantage accruing to the institution would be the appearance of the UPMC logo in a television series. But most likely everyone had good times at the ball game.

This story again suggests that managers of health care organization are more focused on playing marketing and political games than on health care, and generally are more focused on benefiting themselves than upholding their organizations' mission. The amounts of money involved in this case may be small, but do not underestimate the collective effects on health care access, cost and quality of managers who have their eyes on the wrong balls.

UPMC has provided grist for the Health Care Renewal mill before, see earlier posts here, here, here and here.

The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Last week, Gardiner Harris writing for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Laboratories' Fiscal Year 2004 Marketing Plan for the drug Lexapro (escitalopram oxalate), an anti-depressant. The document is available here.

Review of this plan revealed the marketing department's various activities, including activities that others might have believed were educational, scientific, or had some other high minded purpose.

Continuing Medical Education

Overall, one "promotional objective" was to "Maintain SRI category leadership in total number of medical education events (including CME symposia, speaker promotion, teleconferences, and peer selling programs)"

One "critical issue" was to "increase Med Ed efforts: more sponsorships of CME, increased level of speaker programs, maintain level of teleconferences and peer selling."

Under "Marketing Tactics" was a long section on "Continuing Medical Education." It covered various venues for CME such as internet/electronic CME, "sponsoring symposia at major meetings," "regional CME symposia" which would "serve a number of medical specialties," "sponsorhips of scientific sessions," etc

Production of Scholarly Articles

The "Publications" section of "Marketing Tactics" noted "publications will be geared toward psychiatrists, PCPs, .... Articles will appear in several formats, including original reports, review articles, and journal supplements."

Thought Leaders and Consultants

Under the "Continuing Medical Education" section of "Marketing Tactics," and then in the "Advisor Relations" section, there were numerous references to what "thought leaders" would do, including
- "present new data" at "symposia at major meetings"
- act "as advisors to Lexapro in order to obtain critical feedback and recommendations on educational and promotional strategies and tactics."
- sit on the "Lexapro Exectuive Advisory Board" to "keep our advisors apprised of the commercial development ... of escitalpram."
- sit on the "Primary Care Advisory Board" to "obtain critical feedback and recommendations on educational and promotional strategies and tactics...."

Role of Medical Centers

Under the CME section of "Marketing Tactics," we see that "academic health centers" would help develop "regional CME symposia."

Under the "Sponsorship" section are plans to fund the "Professional Relations Group in their mission of establishing mutually beneficial long-term relationships with appropriate professionals and associations." Specific plans included funding the Department of Psychiatry and Behavioral Sciences at Emory

Medical Societies

The "Sponsorship section" also noted that these relationships "will also provide the basis for advocacy development and issues management, and will establish an appropriate environment for commercial and policy activities."

Under the CME section of "Marketing Tactics, we see that "medical associations and professional societies" would help develop "regional CME symposia" Also in this section is the note that "smaller, more prestigious societis do not accept industry-sponsored symposia." So instead, "sponsorship of a study groups or plenary sessions is recommended. Marketing will work with the professional relations group regarding potential opportunities."

Appendix VII, "Professional Associations of Priority" noted funding provided for guideline development by a "collaboration between APA, AAFP and ACP" for "chronic depression in primary care practice;" by AAGP for guidelines for late-life depression; multiple guidelines developed by AMDA;

The appendix also noted that Forest supports ACNP "annual programming, and is a founding sponsor of it's newly created International College of Geriatric Pscyhopharmacology (ICGP)," is a "Corporate President's Circle Sponsor of AAFP," became a "corporate sponsor of ACP in FY03," became "a Corporate Sponsor of AMDA for the last few years,"

Also, it noted that Forest has "expanded its involvement" with APA for "lobbying of State Health Departments...."

Disease Advocacy Organizations

Also in Appendix VII, Forest was identified as a "Corporate Sponsor of NAMI," a "major Corporate Sponsor of NMHA," and a "major Corporate Sponsor of DBSA."

Summary

We have often heard from pharmaceutical, biotechnology, device and other health care corporations that they are only involved in education to disseminate accurate information for the good of society. We have often heard from physicians and academics who consult for such corporations that their advice is sought about clinical, scientific, and technical issues. We often hear from academic medical institutions, medical associations and disease advocacy groups that the money they get from such corporations does not influence the content of their educational and scientific work.

Yet here we see, in considerable detail, that in the case of one drug company's promotional efforts for one drug,
- The marketing plan from the marketing department paid for medical education as a "promotional objective," that is, to market, not to educate.
- Thought leaders and consultants were again paid by marketing to market, and sometimes to provide opinions about "promotional strategies" and "commercial development."
- Medical associations are funded by marketing "for commercial and policy activities."

This suggests that health care corporations develop financial relationships with physicians, academics, academic institutions, medical and professional associations, and disease advocacy groups to support marketing first.

This allows the corporations to advance marketing disguised as education, research, and other high-minded and apparently selfless activities by professionals, not-for-profit organizations, and dedicated inviduals. Such marketing, of course, is DECEPTIVE and DISHONEST. It also is in conflict with the professionals' ideals, and the missions of the medical and professional assocations and disease advocacy groups.

The physicians, other health care professionals, and not-for-profit organizational leaders involved may rationalize these activities as consistent with their mission and professionalism, but such rationalizations are at best self-delusion.

No one knows how representative the Lexapro marketing plans are of the marketing of other drugs, devices and health care services. The only way to find out would be to force many other corporations' marketing plans into public view. The Lexapro documents suggest that society would benefit if many more marketing plans were made public, but that such publication might generate a wave of revulsion about how deceptive marketing of health care goods and services has become, and the extent that health care professionals have betrayed their professional ideals, and academic medical institutions, professional and medical societies, and patient advocacy groups have betrayed their missions.

I submit that we will not truly reform health care without making the marketing of health care goods and services honest, getting health care professionals to give up their financial relationships with health care corporations to reclaim their professionalism, and getting academic medical institutions, professional and medical societies, and patient advocacy groups to give up their financial relationships with health care corporations to reclaim their missions.

See additional comments on how the marketing plan was meant to promote CME by Dr Daniel Carlat on the Carlat Psychiatry Blog.

Another Key Opinion Leader Confesses

The Milwaukee Journal-Sentinel published another story in their series on physicians' entanglements with health care corporations. This one tells the story of a single university faculty member who was seduced by pharmaceutical companies, then eventually became disillusioned.

[Dr James] Stein, now a professor at the University of Wisconsin School of Medicine and Public Health, was a 29-year-old cardiology fellow in Chicago in 1994 when his faculty mentor asked him to fill in for him at a drug company-funded lecture to a large group of doctors.

It would be his first taste of life as a drug company speaker and consultant.

Stein got first-class airfare to Dallas. A limousine took him to a luxury hotel for the talk.

He walked off the stage, and a doctor from the conference handed him an envelope containing a $500 check.

'I got a pat on the back and he said, 'There's more where that came from, son.' I had no idea what that meant, but I went home and paid off part of my student loans,' Stein said in a presentation at UW this month.

Stein's first drug company talk led to more than a decade of work for drug companies before he gave it up for ethical reasons. Now he is speaking out.

Over the years, many of the big names in the drug industry would hire Stein to give speeches or serve as a consultant, eventually leading to fees of $2,000 to $3,000 per talk.

About a month after his first talk in 1994, Stein was asked by another drug company to give a lecture on cholesterol at a small hospital in Chicago, just as blockbuster statin drugs were coming on the market.

'I was really flattered because over and over again I was told that I was a future thought leader,' he said. 'I did my talk. I got a $750 honorarium and I was hooked.'

Stein said he now realizes that the speech at the hospital was just an audition.

'They wanted to know what I would say and how I would deliver,' he said. 'And I think they also wanted to know what I would say about their product.'

He joined speakers bureaus for several drug companies. It was a kind of badge of honor, he said. The more companies a doctor spoke for, the more highly he or she was regarded.

Stein, now 44, came to UW in 1996. Over the years, he would give talks and do other work for many of the top names in the pharmaceutical industry.

For instance, in 2005 Stein did work for six drug makers, according to a disclosure form filed with UW. That year, Pfizer paid him between $10,000 and $20,000 for four days of work as a speaker and advisory board member.

LipoScience, a firm that markets a cholesterol test, paid him $10,000 to $20,000 for four days of similar work.

Another firm, Schering-Plough, paid him about $12,000 for two days as a lecturer.

Although he said he had concerns about the propriety of his work, Stein said he was assured by his superiors there was nothing wrong with it as long as he did it on his own time. Indeed, they said it enhanced the reputation of the university.

And, he said, he considered himself an educator, not a salesman.

He said he tried to manage any conflicts of interest by disclosing who paid him, controlling the content of what he said and doing the work on personal time.

Things started to change rapidly beginning several years ago.

Drug companies began referring to the talks as promotional. They wanted him to use their slides; he refused. Then, medical journals and the lay press began printing articles questioning the ethics of the relationships.

A 2006 article in a Madison newspaper listed Stein as being among the UW doctors who reported the most money from the drug industry. Stein said he was embarrassed.

But, he said, he continued to try to manage his relationships with drug companies. He sent letters to patients disclosing his ties to industry. As of December 2006, he donated all the money from his talks to charity.

Why didn't he just stop doing the work?

He said he believed he could save more lives lecturing than by working in the emergency room. Stein said he saw no harm in being paid. But he admitted that giving the talks also made him feel important.

At the same time, new scientific articles suggested that it is impossible for doctors to be unbiased when they receive gifts or payments from drug companies.

'I have learned that human beings, physicians included, are incapable of recognizing bias in themselves, and even when you try not to be biased it is impossible to avoid it, especially when money is involved,' he said.

He said he came to realize that drug and medical device firms were no longer trustworthy partners in medical education.

He also said it has become obvious that patients have the least power and drug companies have the most power.

'I was wrong,' he said.

Stein said he stands by what he taught.

But, he added, 'I was naïve to think I was not influenced by the money and power of the drug and device companies.'

As of last December, he said, he stopped all drug company speaking and consulting other than bona fide research.

It is nice that a few commercially paid "key opinion leaders" have realized what they were really doing. Maybe, Dr Stein will follow in the footsteps of Dr Daniel Carlat, and try to atone for his previous role in drug marketing disguised as education. (See Dr Carlat's excellent blog here, and his now classic article, "Dr Drug Rep.")

This compelling narrative reinforces some points about relationships among physicians and health care corporations.

Health care corporations do not pay for nothing, and are not charitable organizations. If a company pays a physician to give talks, it is almost certainly because those talks will help market company products or services.

Pharmaceutical and device companies have argued that they only pay the best and the brightest physicians as speakers and consultants. But this story (and others, e.g. here) suggest that they recruit young physicians who seem to be malleable and likely to go along with the company line, and groom them to do marketing in the guise of education.

The company's money thus helps mold "key opinion leaders." Worse, at many medical schools, being a commercially supported speaker or consult was a badge of honor. Thus, faculty chosen by commercial firms as most tractable and sympathetic to the companies' viewpoints, came to be regarded as the best and the brightest.

Why getting money from commercial firms was regarded as indicative of honor and intelligence, rather than gullibility, naivete, or worse, is not clear. I wonder whether it correlated with increasing alignment of the leadership of medical schools with commercial interests, and domination of the very top leadership, that is, the universities' board of directors, by those formerly regarded as Masters of the Universe (but now often seen as stupid, arrogant, greedy, or even corrupt. See posts about how the boards of Dartmouth, Harvard, and Yeshiva were disproportionately populated by leaders of [faux] finance).

At any rate, this is truly a cautionary tale of seduction of academia into hucksterism.

Hat tip to Margaret Soltan at University Diaries.

ADDENDUM (30 April, 2009) - See also the comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

Three Troubled Device Companies: ArthroCare, Stryker, AM2PAT

It was quite a week in the medical device business.

Arthrocare

Last week we discussed the shenanigans at ArthroCare Corporation here. Since then, more information has come out about in the Austin Business Journal provided more information about these improper practices:

While the internal review, being conducted with the assistance of outside counsel Latham & Watkins LLP, is not yet complete, the ArthroCare’s audit committee has reviewed evidence that indicates that the company’s spine unit engaged in and may have caused others to engage in improper practices in certain instances by:

* seeking separate reimbursement from insurers for company products in connection with procedures which were contractually reimbursed on a global basis;
* making inaccurate statements in claims submitted to insurers regarding the place where particular procedures were performed;
* providing physicians and insurers with descriptions of company technologies which had the effect of circumventing payor policies that did not cover such technologies;
* recommending and advocating to physicians the use of a Current Procedural Terminology code to identify its coblation nucleoplasty technology that was not approved by the American Medical Association and may have not properly described the procedure that was performed.

These improper practices identified so far may have occurred since at least 2006.

Investigators were informed that certain sales and marketing personnel within the spine unit provided physicians and their billing staff with merchandise and administrative services at no charge potentially in exchange for their utilization of the company’s products. The audit committee has determined that company personnel at all levels lacked adequate health care compliance training and that company billing personnel lacked adequate training and supervision in insurance reimbursement requirements. In addition to considering and implementing remediation efforts, the committee is undertaking a review of such practices in other business units.

Stryker

Meanwhile, the New York Times reported about Stryker:

A Justice Department inquiry into Stryker’s marketing of human bone growth products has resulted in guilty pleas by former company sales representatives.

One former sales official pleaded guilty two weeks ago, and another one did in November, court documents show.

Stryker, a leading maker of medical devices, and the United States attorney’s office in Boston, which is conducting the inquiry, declined to comment. A spokeswoman for the attorney’s office said the investigation was continuing.

The inquiry, which began last year, involves several issues, according to court papers and Stryker filings with the Securities and Exchange Commission. The questions include whether Stryker abused a federal exemption that authorized it to sell only limited quantities of its bone growth products for 'humanitarian' reasons, according to the documents.

The two former sales officials pleaded guilty to charges that they had promoted off-label use of the products even though they knew that such use had earlier caused problems in some patients.

The products in question are used by surgeons to aid the growth of bones that fail to heal properly.

This case is not the only one raising ethical questions about Stryker's management.

The inquiry poses new complications for Stryker, which is already operating under federal oversight as a result of an earlier Justice Department investigation of kickbacks paid by makers of artificial hips and knees to doctors.

We posted about this previous issue, first here, most recently here.

AM2PAT

Last, but most assuredly not least, was a story, (here reported by Newsday) about AM2PAT:

Federal authorities are hunting the mastermind behind a 'horrific case' in which bacteria-laden syringes shipped from an Angier, N.C., plant sickened hundreds of people and killed five.

Two men pleaded guilty Monday in U.S. District Court in Raleigh for their roles in ignoring sterility standards at the former AM2PAT Inc. plant. The court heard of conditions at the plant more consistent with a Third World textile factory than a pharmaceutical facility.

The men - plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma - were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace. They were rewarded with a relatively light sentence in exchange for information about chief executive Dushyant Patel, whose company sold $6.9 million worth of heparin and saline syringes in 2006-07 that did not undergo proper sterility testing.

Dushyant Patel, indicted late last week on 10 charges that include fraud and selling adulterated medical devices, has not been arrested. Authorities think he may have fled to his homeland in India and are seeking help from Interpol.

Syringes from AM2PAT were pulled from the market early last year, and the Angier plant shuttered after an outbreak of Serratia, a bacterial infection, hit patients in Colorado, Texas, Illinois, Florida and other states.

On Monday, prosecutors laid out a scheme before Judge Terrence Boyle in which the plant's operators routinely failed to follow sterility rules to keep production running faster. The drugs were not produced at the plant, but were loaded into syringes there, then shipped.

The plant was subject to U.S. Food and Drug Administration requirements for its production. The syringes were supposed to be loaded in a 'clean room,' with employees in caps and gowns and air carefully ventilated to keep germs from spreading.

A photograph entered into evidence Monday shows a 'clean room' refreshed with a common window fan held together with duct tape. In another photo, women work on an assembly line under lamps, surrounded by what look like green plastic recycling bins.

Once the syringes were loaded with drugs, each batch was required to be held for two weeks, while employees tested for bacteria and other contaminants. If bacteria were cultured from the medicines, the whole batch should have been held back. That wasn't happening, court documents show.

Batches of syringes went straight from the production line into the marketplace, with Sharma falsifying manufacturing dates to make it appear to regulators that requisite quality tests had been done. And when tests were done, results were ignored.

Note first that none of these cases was isolated, in that each of these companies had questions raised about management behavior before (at Arthrocare, about accounting; at Stryker, about marketing and payments to doctors; at AM2PAT, raised by health care professionals about quality of its products.)

In the US, we are undergoing yet another great debate about health care reform. Two big issues are the high cost and questionable quality of our health care. All three of these cases involved behavior that could have raised costs. Two may have had indirect effects on quality. One may have directly caused patient death and disease.

Yet, even after executive arrogance, misbehavior, self-interest, and corruption have lead to the global financial meltdown, we are still not really addressing such behavior as a cause of our global health care crisis.

Pfizer Settles (For a Mere $2,300,000,000)

Last week, in thee Wall Street Journal, Ron Winslow reported on this little item that slipped out at the time the giant Pfizer/ Wyeth merger was announced (see our previous post here):

In a disclosure nearly drowned out by news of its $68 billion acquisition of Wyeth, Pfizer Inc. said it agreed to pay $2.3 billion to settle a federal investigation into its alleged off-label marketing of the now-withdrawn painkiller Bextra.

The settlement, which requires the approval of a federal judge, would be the largest ever paid by a drug company to resolve alleged marketing missteps. It easily eclipses the $1.4 billion Eli Lilly & Co. agreed to pay earlier this month to settle similar charges related to its antipsychotic medicine Zyprexa.

Pfizer mentioned the settlement in two sentences in a news release about its earnings. The $2.3 billion charge it took for the deal -- the New York company described the figure as 'pretax and after tax' -- is the main reason its fourth-quarter net income fell 90% to $266 million from $2.72 billion a year earlier.

Pfizer released its earnings at the same time it announced an agreement to acquire Wyeth to form a pharmaceutical behemoth that would have annual revenues of more than $70 billion.

On Monday, Pfizer declined to elaborate on the settlement. A spokeswoman for Michael Sullivan, the U.S. attorney in Massachusetts who led the probe, declined to comment.

The FDA approved Bextra to treat arthritis, rheumatoid arthritis and menstrual pain. It isn't clear what off-label uses Pfizer's marketing of Bextra allegedly involved.

So far, I have found no other details about this in the media. Of course, it's merely a $2.3 billion settlement. It is just amazing that something this big can produce so few echoes. Ah, but that is the anechoic effect, again (see this post).

We have posted about numerous settlements of charges of misbehavior by drug, device, insurance and other health care organizations. Stacking them all up suggests the magnitude of bad behavior by the leaders of health care organizations. Yet it's not clear that all these monetary penalties are discouraging bad behavior.

In some cases, like this one, it is not immediately clear what bad behavior the settlement addressed. Without knowing what actions might cause monetary loss, it is hard to avoid such actions in the future.

In almost all cases, the monetary penalties accrue to the organization as a whole, not to the individuals whose behavior incited the settlement. And I have not so far ever heard of a case in which the organization which has to pay a settlement turns around and enforces a penalty upon the responsible leaders. Thus, the deterrent effect, even of large penalties, is thus diffuse. An executive, knowing that bad behavior may increase short term profits, and hence may markedly increase his or her compensation in the short run, may be undeterred by the threat of a future settlement that he or she does not have to pay. Instead, the settlement may come out of the pockets of stock-holders, employees as a whole, customers, clients, or patients, or the public.

If we want to prevent health care leaders from continuing "childish" behaviors, allowing health care to "spin out of control," (as per President Obama' inaugural address, see post here), we must do a better job of enforcing negative consequences, as the mother of any five-year old will tell us.