Atricure Settles

The march of legal settlements continues.  This time, the US Department of Justice announced,

Atricure Inc., a medical device manufacturer, has agreed to pay the United States $3.76 million to resolve civil claims in connection with the alleged promotion of its surgical ablation devices, the Justice Department announced today. Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.

The settlement resolves allegations that the West Chester, Ohio-based company marketed its medical devices to treat atrial fibrillation (the most common cardiac arrhythmia or abnormal heart rhythm), a use that is not approved by the U.S. Food and Drug Administration (FDA). Atricure also allegedly promoted expensive heart surgery using the company’s devices when less invasive alternatives were appropriate, advised hospitals to up-code surgical procedures using the company’s devices to inflate Medicare reimbursement, and paid kickbacks to health care providers to use its devices. The United States asserted that by engaging in this conduct, Atricure knowingly violated the Food, Drug, and Cosmetic Act and caused the submission of false and fraudulent claims in violation of the False Claims Act.

This settlement relates to topics we discussed back in the early days of Health Care Renewal, the convoluted financial ties beween the renowned Cleveland Clinic, its current CEO, and Atricure. In 2005,  investigative reporting published in the Wall Street Journal revealed the complicated relationships among the Clinic, its current CEO Dr Toby Cosgrove, the Clinic's venture capital fund, Foundation Medical Partners, and a small medical device company called Atricure. This coincided with the Clinic's firing of Dr Eric Topol from his leadership positions there. (See posts here and here.) The Cleveland Plain Dealer uncovered more conflicts, involving Dr Cosgrove, the Clinic's board of trustees, Dr Bernadine Healy, and Invacare (see post here.)  In response, in 2006, the Clinic promised to revise its conflicts of interest policy, and held a big conference on the topic of conflicts of interest, although some were skeptical of these efforts (see post here.)

As the Cleveland Plain Dealer just noted,

Cleveland Clinic Chief Executive Dr. Toby Cosgrove helped create the 'AtriClip Gillinov- Cosgrove LAA Exclusion System,' which is being sold by the company and won approval in October for use in the European market. While Cosgrove is eligible to receive royalties from the company, he has not recieved any, Clinic spokeswoman Eileen Sheil said.

This settlement is just the latest in a now long parade of settlements that serve as reminders of poor behavior by myriad health care organizations.  As we have repeatedly noted, these settlements seem to have little deterrent effect on future bad behavior.  Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior.  Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue. 

The wrinkle in this case comes from the numerous past ties between the company involved and a prestigious US health care system and its top leadership.  But I doubt that Cleveland Clinic CEO Dr Toby Cosgrove will have any public comment about it.  But why should I expect that a former company director will admit any accountability for that company's poor behaivor? 

Hat tip to the White Collar Crime Prof Blog.

Post Title → Atricure Settles

Diversity Nightmare And Federal Antidiscrimination Laws: Cleveland Clinic CEO Delos M. Cosgrove Would Proudly Discriminate Against Fat People

The following stunning quote appeared in the Nov. 27, 2009 Newsweek article "The Hospital That Could Cure Health Care" about the Cleveland Clinic:

[Cleveland Clinic president and CEO Dr. Delos M. Cosgrove, a former cardiac surgeon] has even taken on the most intractable driver of American health-care costs: Americans. Having already banned the hiring of smokers (a dictate enforced by urine tests for nicotine), Cosgrove declared this year that if it weren't illegal under federal law, he would refuse to hire fat people as well. The resulting outcry led him to apologize for "hurtful" comments. But he has not backed down from his belief that obesity is a failure of willpower, which can be attacked by the same weapons used to combat smoking: public education, economic incentives, and sheer exhortation.

My thoughts come from the perspective of a former fitness-for-duty evaluator and drug testing officer (Medical Review Officer) for the regional transit authority in a very large city, and a hiring manager in the hospital and pharmaceutical sectors. I find a profoundly discriminatory statement that a hospital CEO would "refuse to hire fat people" if he could get away with it, and that he refuses to hire smokers and forces people (presumably candidates) to take a urine nicotine test, totalitarian and highly abhorrent.

Nothing about smoking or obesity [except in very specialized job situations for the latter] makes a person unfit to work in a hospital.

This attitude is exactly why we have federal anti-discrimination laws, to protect people from biased autocrats like this.

I should add that talent apparently is irrelevant to this autocrat; if a person is overweight, this self-righteous SOB would send an applicant out the door. So much for talent management if he could get his way.

One wonders if he would also send current employees who are overweight out the door - if he could get away with it.

A May 2008 USA Today article entitled "Weight discrimination could be as common as racial bias" here made the point that:

Weight discrimination, especially against women, is increasing in U.S. society and is almost as common as racial discrimination, two studies suggest.

Reported discrimination based on weight has increased 66% in the past decade, up from about 7% to 12% of U.S. adults, says one study, in the journal Obesity. The other study, in the International Journal of Obesity, says such discrimination is common in both institutional and interpersonal situations — and in some cases is even more prevalent than rates of discrimination based on gender and race. (About 17% of men and 9% of women reported race discrimination.)

Among severely obese people, about 28% of men and 45% of women said they have experienced discrimination because of their weight.

"Weight discrimination is a very serious social problem that we need to pay attention to," says Rebecca Puhl of the Rudd Center for Food Policy and Obesity at Yale University, a co-author of both studies.

... Institutional discrimination involved health care, education or workplace situations, such as cases in which people said they were fired, denied a job or a promotion because of their weight. Interpersonal discrimination focused on insults, abuse and harassment from others.

This raises several questions:

• The CEO of an organization sets the tone. What does such a statement about "fat people" do to staff morale?

• As a result of this CEO's stated preferences, is there subtle or covert discrimination against overweight employees at the Cleveland Clinic, preventing promotions and/or causing or contributing to situations of constructive discharge?

• Is there subtle or covert hiring discrimination against overweight candidates, with the hiring managers knowing the CEO's expressed views?
  

• One also wonders if this CEO has similar attitudes towards gays, minorities, and people with physical and emotional disorders that also would not affect their ability to perform their jobs.

• How well does the Cleveland Clinic respect other aspects of diversity considerations in its hiring, firing, and job promotion practices?

• What kind of care and quality of staff interactions do overweight people receive/experience at the Cleveland Clinic?

This CEO will not be "curing healthcare" any time soon IMO, since a primary consideration is compassion. He seems somewhat deficient in that attribute.

He also seems deficient in the characteristic known as business wisdom, especially in an era of competition and trigger-finger litigation.

His statement could be used by competitors to steer people away from the Cleveland Clinic and its affiliates. It could very likely also be used in support of discrimination lawsuits against the Cleveland Clinic and its affiliates by current, former, and potential employees (as well as by overweight patients, conceivably) which can be very expensive and damaging to an organization's reputation.

In addition to all of the problems exhibited by healthcare leaders as covered on this blog, I add a new one apropos to this CEO's cerebral anatomy: fathead.

-- SS

Post Title → Diversity Nightmare And Federal Antidiscrimination Laws: Cleveland Clinic CEO Delos M. Cosgrove Would Proudly Discriminate Against Fat People

A Few Small Steps Towards Better Disclosure of Conflicts of Interest

Various kinds of conflicts of interest affecting medical academics, practicing physicians, and diverse health care decision makers have frequently been topics of discussion on Health Care Renewal.

Recently, on several fronts there have been moves to increase disclosure of financial relationships among health care decision makers and various health care organizations. For example, two weeks ago, the Cleveland Clinic announced it would post some information about the financial relationships of its physicians on its web-site. According to Reed Abelson reporting for the New York Times,

The Cleveland Clinic plans to announce this week it has begun publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers.

In particular,

Under the effort led by Dr. [Guy M] Chisolm, [Chair of the Cleveland Clinic Innovation Management and Conflict of Interest Committee,] every scientist and doctor employed by the clinic must report any industry relationship to the clinic at least once a year. Members of the committee, which meets monthly, typically interview the doctors involved, often requiring documentation like letters to academic journals alerting editors to the industry relationships.

The clinic has been working for more than a year to set up the public listing on its Web site, where consulting payments of more than $5,000 a year, and all royalty and equity interests, will be disclosed.

'Disclosure is a minimum,' said Dr. Chisolm, who hopes to begin listing the actual dollar amounts involved in a doctor’s consulting arrangements next year. The current disclosure simply lists the companies for whom the consulting takes place. He said the group was planning to improve the clinic’s ability to audit the information it received from doctors, because the clinic must now rely on doctors’ self-reporting to find potential conflicts.

My first comment is that in general, more transparency is better than less. For an elite institution like the Cleveland Clinic to start some sort of systematic reporting of such financial relationships is a step in the right direction.

However, it is, at the moment, a very small step. The sort of disclosures now appearing are extremely telegraphic. For example, here is what is appears about Dr Delos Cosgrove, the CEO of the Clinic, and the Chair of its Board of Governors,

Royalty Payments. Dr. Cosgrove has the right to receive royalty payments for inventions or discoveries related to the companies shown below:

* Allegiance (Cardinal Health)
* AtriCure
* Edwards Lifesciences
* Kapp Surgical
* Terumo

It is interesting to contrast the terseness of this text with the amount of detail about Dr Cosgrove's financial relationships that previously caused controversy (for example, see our posts here and here.)

Review of this and other listings suggest that for the moment, the only information that will be provided will be the broad nature of the relationships (royalty payments, consulting, etc) and the names of the companies or organizations involved. Perhaps in the future, the financial scope of these relationships will be revealed.

But the ostensible goal of this effort, according to Dr Chisolm, is to aid patients' decision making:

Guy M. Chisolm III, the cell biologist who is chairman of the conflict-of-interest committee, says patients should know about such links so they can talk to their doctors or others at the clinic about any financial tie that raises questions.

'Patients are vulnerable,' Dr. Chisolm said.

But how could a patient evaluate the sorts of disclosures that the Clinic is now making? How, for example, would a patient of Dr Cosgrove determine whether a royalty paid to him by one of the listed companies could have any influence on the care that patient would receive? Such a judgment might require some knowledge about whether the company makes any product that could be relevant to the patient's care, and whether the royalty was paid to the doctor for any reason relevant to the patient's care. It might be hard to even begin to make such judgments without some very detailed information along these lines. (Even with that information, it might be hard to judge the importance and influence of the relationship. We have noted findings from cognitive psychology that suggest people have great trouble judging the importance of disclosures about conflicts of interest, and determining the influence of such conflicts on the judgements and behaviors of the people who have the conflicts.)

So although the disclosure to be provided by the Cleveland Clinic is an improvement over what was done before, and an improvement over what most academic medical centers and medical schools currently do, it is only a small improvement.

The Times also reported that

As Dr. Cosgrove sees it, potential conflicts of interest need to be managed, not automatically eliminated, because working with industry encourages innovation by the clinic and its doctors. He has even made 'innovation management' part of the committee’s official title: the Cleveland Clinic Innovation Management and Conflict of Interest Committee.

As I have said before, it is not unreasonable to assert that collaboration between academic medicine and industry could lead to innovation. However, it is not clear to me why such collaboration must always entail payments, often large, by industry directly to individual academics. If such payments occur, it is also not clear to me that tersely disclosing their occurrence will "manage" them sufficiently.

By the way, while this was going on, further details came out about the state of Massachusetts new regulations mandating disclosure of financial relationships among physicians and health care corporations in that state. As discussed by Dr Daniel Carlat on the Carlat Psychiatry Blog, and by Alison Bass on the Alison Bass Blog, it appears that the disclosure initially required by the regulations would also be incomplete. In Massachusetts, no disclosure of any payments related to research would be required. So, once again, a baby step towards full transparency is better than no step at all, but not very much better. Given the pervasive nature of conflicts of interest affecting physicians, medical academics, and health care decision makers, and the questions these raise about in whose interest health care decisions are made, there is a very long journey ahead.

Post Title → A Few Small Steps Towards Better Disclosure of Conflicts of Interest

The Pots and Kettles Argue About Conflicts of Interest at the Cleveland Clinic

There is yet another twist to the tangled story of conflicts of interest at the renowned Cleveland Clinic.

Two years ago investigative reporting published in the New York Times revealed the complicated relationships among the Clinic, its current CEO Dr Toby Cosgrove, the Clinic's venture capital fund, Foundation Medical Partners, and a small medical device company called Atricure. This coincided with the Clinic's firing of Dr Eric Topol from his leadership positions there. (See posts here and here.) The Cleveland Plain Dealer uncovered more conflicts, involving Dr Cosgrove, the Clinic's board of trustees, Dr Bernadine Healy, and Invacare (see post here.)

In response, last year the Clinic promised to revise its conflicts of interest policy, and held a big conference on the topic of conflicts of interest, although some were skeptical of these efforts (see post here.)

Now for the latest twist. David Armstrong writing in the Wall Street Journal revealed that last year, the clinic fired Dr Jay Yadav allegedly for violating its conflict of interest disclosure rules. But Yadav sued the Clinic in return, claiming he was a scapegoat whose firing distracted attention from even more conflicts at the clinic:

A former department head at the Cleveland Clinic sued the hospital over alleged defamation and discrimination, saying that the institution is plagued by financial conflicts of interest similar to the kind that were cited as grounds for his dismissal.

Jay Yadav, who headed the clinic's vascular intervention unit until he was fired last year, said a number of the hospital's top doctors promote devices and treatments that they have a financial interest in, sometimes without informing patients.

The clinic, in a statement, denied the allegations in the lawsuit and said it planned to file a response as well as a 'counter claim for substantial expenses incurred to review his research.'

Getting rid of doctors over issues related to conflicts of interest is rare. Dr. Yadav says others at the clinic weren't sanctioned -- and his legal action could become an embarrassing public battle for the clinic.

Dr. Yadav had financial stakes in two companies whose experimental products were tested on clinic patients. He says the clinic was well aware of his conflicts and that he properly reported them -- but that he was fired so that the clinic could look tough ahead of a Cleveland Plain Dealer article about his outside activities.

His suit alleges the clinic has been 'indifferent' to financial conflicts of interest and that such situations are "widespread and pervasive." Those conflicts start at the top with clinic chief executive Delos 'Toby' Cosgrove, according to the complaint.

The lawsuit says the clinic heavily promotes and uses an invention of Dr. Cosgrove's in patients undergoing heart-valve surgery. Dr. Cosgrove and the clinic both receive royalties from sales of the product, known as the Cosgrove-Edwards ring and marketed by Edwards Lifesciences Corp. The lawsuit says patients aren't given the choice of using competing rings or told that the hospital and its chief executive profit from sales of the Cosgrove-Edwards ring.

The clinic confirmed Dr. Cosgrove and the hospital share royalties, but declined to answer questions about what patients are told and how much the institution and Dr. Cosgrove earn from sales of the ring. The clinic said the royalty payments were proper.

In another case, the lawsuit says orthopedic surgeon Isador Lieberman, a member of the hospital's conflict-of-interest committee, failed to disclose his significant financial interests in Kyphon Inc. That company manufactures equipment for an orthopedic procedure that Dr. Lieberman advocated and tested at the clinic. The clinic said Dr. Lieberman fully cooperated with a review of his conflict disclosures and that 'all appropriate actions were taken.'

In all of the cases cited in the lawsuit, Dr. Yadav alleges there was no disciplinary action taken against those doctors. The lawsuit alleges that Dr. Yadav, who was born in India, was a victim of discrimination. The clinic, however, said it 'consistently and fairly applied its policies to all of its physicians.'

Dr. Yadav says the clinic accused him of not properly disclosing royalty payments for a device he invented to prevent blockages in patients who receive a neck stent. While he doesn't receive royalty payments, Dr. Yadav says he was compensated with shares by the company that acquired his technology. That company, called Angioguard Inc., was bought by a unit of Johnson & Johnson in 1999 [apparently Cordis].

A copy of that purchase agreement indicates that all shareholders of Angioguard were entitled to deferred payments if certain milestones were met, such as sales targets. Among the other shareholders entitled to the same deferred payments were top officials at the clinic, such as surgeon Kenneth Ouriel, according to the lawsuit.

Dr. Ouriel didn't disclose these payments, according to the lawsuit. The clinic yesterday said: 'Dr. Ouriel received a few hundreds of dollars versus tens of thousands of dollars that Dr. Yadav received. Dr. Ouriel's situation was thoroughly reviewed and he fully cooperated by taking appropriate actions to rectify the situation immediately. After the review, the Clinic officials determined that Dr. Ouriel had not knowingly violated Cleveland Clinic policies.'

A conflict here, and conflict there, soon it starts adding up.

What can one conclude from all this? First, it seems that there are lots of conflicts of interest at the Cleveland Clinic. Of course, perusal of Health Care Renewal suggests that the Clinic is therefore like many other generally revered US medical centers.

Second, it reminds us how confusing and, well conflicted conflicts of interest can become. I will not offer an opinion about the merits of Dr Yadav's lawsuit.

It does suggest that when highly conflicted high powered academics get in disputes over their respective conflicts, the result is lots of smoke and not much light. Will Angioguard, now Cordis guy win, or will the Atricure, Edwards Lifescience, and Kyphon guys win? Will the results benefit anyone other than the parties involved and the companies they represent? But core values like putting individual patients first, teaching the next generation of physicians, and practicing medicine informed by science are likely to be lost in smoke from the battle among vested economic interests.

Post Title → The Pots and Kettles Argue About Conflicts of Interest at the Cleveland Clinic

Newspaper Publisher Joins Board of Medical Center - Just a Potential Conflict of Interest?

The Cleveland Plain Dealer just reported (although right now the web-link is not working correctly) a story that may help explain why stories about questionable management of health care organizations often are anechoic,

Plain Dealer President and Publisher Terrence C. Z. Egger was named Monday a Cleveland Clinic board trustee, an appointment he said will not compromise the newspaper's duty to cover the Clinic impartially.

Egger said in an interview that trustee Chairman Mal Mixon asked him to serve on the 60-member board. He accepted to be involved with the growth engine of the area economy, he said.

The Plain Dealer did at least allow that this new appointment might be controversial.

The newspaper should take steps to assure the public that Egger's role as trustee has no influence on news coverage or editorials related to the hospital, said Bob Steele, a journalism values scholar at the Poynter Institute, a newspaper think tank in St. Petersburg, Fla.

'It's dicey territory,' said Steele. 'You have competing loyalties. And competing loyalties, if not properly recognized and professionally and ethically addressed, can create conflicts of interest [that] can corrode the credibility of either organization.'

It's interesting how the paper chose to quote someone who could not bring himself to say that the newspaper publisher's new position created a conflict of interest, only the potential for one.

News reporters are usually very careful about not having any financial relationships with people or organizations about which they may report (to the point of refusing a cup of coffee from someone who someday might be in a story they would report). Yet when the boss of the newspaper, to whom ultimately all those reporters report, is now also the boss of a major hospital system, that's only a potential conflict of interest.

In fact, the wishy-washy way in which this story was reported suggests just why this sort of conflict is important and troubling. It would take a courageous reporter to write a story critical of the Cleveland Clinic, when he or she knows the newspaper's boss is a leader of the Clinic.

This story does illustrate another mechanism for the propagation of the anechoic effect.

Post Title → Newspaper Publisher Joins Board of Medical Center - Just a Potential Conflict of Interest?

Cleveland Clinic to Host Symposium, Modify Policy on Conflicts of Interest

The Cleveland Clinic has announced major changes in how it handles conflicts of interest. Last year, there was considerable media coverage of alleged conflicts affecting a variety of Clinic leaders (see most recent post here.)

Previously, the Clinic had announced that it will host a symposium on conflict of interest, which "hopes to attract more than 500 leaders in research, medicine, industry, government and bioethics." (See the Cleveland Plain Dealer.)

The Associated Press reported (via the Washington Post) that the Clinic's board of trustees will create a standing committee on conflicts of interest, which will meet regularly with staff. They will also create a data-base covering all people who work for the clinic. They will "require disclosure and competitive bidding if the business of an outside trustee is trying to sell to the clinic." The New York Times added that the "clinic will prevent doctors who have relationships to particular drug or device companies from involvement in the clinic's purchasing decisions about these companies' products."

However, the Times also noted that "the clinic has stopped short of making information about the outside relationships of its doctors and trustees available to patients and others outside of the clinic itself."

An article in the Cleveland Plain Dealer added some further skepticism, noting that the board was "short on specifics," and noting that David Rothman of the Institute of Medicine as a Profession "wondered how the board's commitment would translate into practice and whether the hospital would, for example, make its database available to patients who want to know if their physicians have stock in certain companies."

I guess these are some signs of progress, although it is disconcerting that the Clinic will not make their conflict of interst database public, nor ban dealing with organizations in which members of the board of directors have a direct financial interest.

Post Title → Cleveland Clinic to Host Symposium, Modify Policy on Conflicts of Interest

The Topol - Merck - Cleveland Clinic Case Gets More Complex, and Gets More Attention

The Cleveland Plain Dealer and the New York Times are continuing to uncover new complications in the story of how Dr Eric Topol lost his academic leadership position at the Cleveland Clinic. We most recently discussed the story here.

The Times suggested that what is going on at the Clinic "goes far beyond a simple power struggle between strong-willed men," but has "focused attention on the many longstanding corporate ties at the clinic." It suggested that Topol first made himself unpopular with the rest of the Clinic leadership when be publicly criticized Merck and its handling of Vioxx in 2004. Soon, "Dr Topol soon found himself under attack. He was the subject of the Fortune magazine article, which contended he had a conflict of interest." Furthermore, "Dr Topol soon found himself under fire at the clinic.... The Clinic investigated Dr Topol's business dealings, according to people briefed on the inquiry." Dr Topol's response was to "cut all ties to industry." That made him even less popular. "When his contract came up for renewal at the clinic at the end of last year, the clinic put Dr Topol on a form of probation, giving him a six-month contract rather than the usual yearlong agreement...." Thus, the Times implies that Dr Topol lost his academic leadership positions because he renounced the sort of industry ties that other Clinic leaders cultivated.

These ties were even more complex than previously reported. The Times reported these new examples:

• Malachi Mixon, the Chairman of the Clinic's Board of Trustees, is the CEO of Invacare, a major home health care supply company. Invacare does about $200,000 worth of business with the Clinic yearly, although Mixon dismissed this as "peanuts."
• Dr Bernadine Healy, the first women to head the US National Institutes of Health (NIH), the former President of the American Heart Association, the former head of the Red Cross and wife of the former CEO of the Clinic, Dr Floyd Loop, is a Trustee of Invacare, and owns 41,570 of its stock options.

The Cleveland Plain Dealer also disclosed more possible conflicts of interest affecting the leadership of the Clinic:

• Via a report in the Wall Street Journal, Clinic CEO Dr Toby Cosgrove publicly praised a heart lung machine made by a company called CardioVention without revealing his or the Clinic's financial interests in it. CardioVention was sued in 2002 after a patient on whom its machine was used at the Clinic died, and the company ceased operations in 2003.
• Harry Rein, founder of Canaan Partners, who helped the Clinic set up and run its own venture capital fund, Foundation Medical Partners, was revealed to be a member of the Clinic's Board of Trustees.

The Times quoted Dr Jerrome Kassirer, former Editor of the New England Journal of Medicine, saying that the potential conflicts of interest at the Cleveland Clinic are "extremely serious," but that in having such conflicts, the Clinic "is not unique at all." Thus, the case of Dr Topol's dispute with the Cleveland Clinic is becoming emblematic of how leaders of large health care organizations are increasingly affected by more and more severe conflicts of interests. Such conflicts may undermine their organizations' missions and the core values of their physicians and other health professionals.
There is one bit of good news here. The national attention this case has received is a sign that the anechoic effect is ending.
The anechoic effect is our term for how cases of ill-informed, incompetent, conflicted, or even corrupt management of health care organizations, and how they threaten health care's core values seem to vanish without any wider echoes. For example, some of the biggest whistle-blower cases of the 1990s, those of Dr David Kern and Dr Nancy Olivieri, were hardly noticed in the national media (US and Canadian, respectively) despite aggressive reporting in regional news outlets.
But, now the New York Times and the Wall Street Journal seem to be sticking with the case of Dr Eric Topol, not just leaving it to the Cleveland Plain Dealer. And it has attracted the attention of Paul Krugman, one of the Times' national columnists, who is now warning of a "medical-industrial complex," and corruption as a systemic problem in health care.
Maybe this will make physicians, policy makers, and the public at large recognize conflicted health care leadership, and the larger issues of concentration and abuse of power in health care as fundamental threats.

Post Title → The Topol - Merck - Cleveland Clinic Case Gets More Complex, and Gets More Attention

The "Whiff of Corruption": Update on the Topol - Merck - Cleveland Clinic Case

There are a number of developments in the Topol - Merck - Clevleand Clinic case.

We have previously discussed, most recently here and here, the complex story of how Dr Eric Topol abruptly lost his academic leadership positions at the prestigious Cleveland Clinic shortly after he testified about Merck, its handling of research about and marketing of Vioxx, and its attempts to intimidate him; and just before a report came out alleging serious conflicts of interests affecting the Clinic's leadership, conflicts which Topol had been investigating.

First, excerpts of an interview with Topol appeared in an article in theheart.org, (here, subscription required), a web-site edited by Topol, and were picked up in an article in the Cleveland Plain Dealer. On the timing of his dismissal, Topol said:

It's a little hard to believe it was a coincidence. I'm not trying to say that the Vioxx/Merck thing was the only reason this occurred; I'm just saying it contributed and certainly the timing of it had to play a role, unquestionably.

Furthermore,

All I can say is, if you have a table of organization changed, it doesn't need to be done on an immediate basis like this. My appointment naturally would have run out at the end of the calendar year, so ti could have been set up that, in January, we'd start off with this different configuration .... The emergency action is very peculiar, and the fact that it was not even approved first by the board of trustees - you'd have thought that this would have been approved before they told me. So this is what's troubling about this whole thing: why did this have to be such a rush?"

Meanwhile, the Plain Dealer also reported that the Cleveland Clinic was going to do an "independent review" of the conflicts of interest issue. The newspaper quoted James Unland, who consults for hospitals about compliance, "This is a house that needs to be cleaned." Furthermore, he stated that the review should be conducted by "someone with no hidden agenda or prejudice one way or another." We'll see how it actually is done.

Finally, New York Times columnist Paul Krugman took note of this case. He wrote,

The real story is bigger than either the company or the the clinic. It's the story of how growing conflicts of interest may be distorting both medical research and health care in general.
The essence is simple: crucial scientific research and crucial medical decisions have to be considered suspect because of the financial ties among medical companies, medical researchers, and health care providers.
The past quarter-century has seen the emergence of a vast medical-industrial complex, in which doctors, hospitals and research institutions have deep financial links with drug companies and equipment makers. Conflicts of interest aren't the exception -they're the norm.
The whiff of corruption in our medical system isn't emanating from a few bad apples. The whole system of incentives encourages doctors and researchers to serve the interests of the medical industry.

Krugman will be suggesting how to change the bad policies that lead to all this. I'm not sure I'll end up agreeing with all his suggestions. And readers of Health Care Renewal will note that the problems goes beyond research, and beyond the organizations he mentioned. But I do believe that in general, he gets it.

Post Title → The "Whiff of Corruption": Update on the Topol - Merck - Cleveland Clinic Case

Was Topol Fired for Investigating Conflicts of Interest at the Cleveland Clinic?

The story of the firing of Dr Eric Topol from his leadership positions at the Cleveland Clinic Lerner College of Medicine has just gotten murkier.

The Wall Street Journal published an investigative report on the Cleveland Clinic's complex financial dealings, involving the Clinic's own venture capital fund, and a company called AtriCure. It suggests the possibility of multiple conflicts of interest affecting the top leadership of the Clinic, which were under internal investigation by a conflict of interest committee which included Dr Topol, that is, until he was fired.

In summary,

• Searching for "new ways to make money," the Cleveland Clinic sent up its own venture capital fund, Foundation Medical Partners (FMP).
• The Clinic became the biggest single investor, or limited partner, in FMP, putting in $25 million, which entitles the clinic to 38% of FMP's profits.
• Dr Delos (Toby) Cosgrove was one of the original general partners who managed the fund, and he invested in it personally. At the time, Dr Cosgrove was Chairman of the Department of Thoracic and Cardiovascular Surgery at the Clinic. "The fund's general partners were entitled to share an annual management fee of 2.75% of the money raised from investors that totals about $1.7 million a year. There were three general partners." Furthermore, "the fund's profits are known as 'the carry.'" "Dr Cosgrove was 'compensated with carry,' but didn't receive any of the management fees.."
• "Dr Cosgrove said he was required to invest in the fund by virtue of his role as general partner." Dr Cosgrove invested about $200,000 in the fund. "The fund lent ... the money to invest."
• In 2002, FMP invested $3 million in AtriCure, a private start-up company making medical devices. AtriCure makes a device that it advertises as allowing "you to make linear, transmural lesions that you can trust every time in a matter of seconds." Furthermore, "Using discreet field bi-polar radiofrequency, the AtriCure ASU delivers targeted ablative energy while simultaneously measuring the change in conductive properties of the lesion as it is created." The AtriCure web-site is very vague about what one might use such a device to do.
• Dr Cosgrove became a member of AtriCure's board of directors.
• "Dr Cosgrove also has developed a device for AtriCure ... which the company says it plans to begin marketing in the second half of next year. Dr Cosgrove would receive royalties for the device, known as the Cosgrove Clip."
• "Dr Cosgrove confirmed he also has a financial interest in companies doing research at the Clinic through his personal investment in Canaan partners," another venture fund run by Harry Rein, a friend of Cosgrove's who helped set up FMP.
• Physicians at the Cleveland Clinic have actually used to AtriCure device to treat atrial fibrillation (an irregular heart rhythm that predisposes patients to strokes) by ablating (destroying) electrically conductive heart fibers. For example, a group of Clinic physicians, including Dr. Cosgrove, published an article describing the results of this procedure on 513 patients. (Gillinov AM, McCarthy PM, Blackstone EH et al. Surgical ablation of atrial fibrillation with bipolar radiofrequency as the primary modality. J Thorac Cardiovasc Surg 2005; 129: 1321-8.) Cleveland Clinic physicians, specifically including Dr. Cosgrove, have promoted this procedure, using the AtriCure device, at national meetings.
• These physicians, again specifically including Dr Cosgrove, have not revealed their direct or indirect financial ties to AtriCure to the patients on whom they use this device, in their talks, and in their publications. For example, the article above lists Dr Gillinov and Dr McCarthy as consultants to AtriCure, but did not mention any ties that Dr Cosgrove had to the company. The article also did not mention that at the time it was written, Dr Gillinov and McCarthy had both been offered options to buy 25,000 shares of AtriCure stock.
• The US Food and Drug Administration (FDA) "has three times rejected AtriCure's application to have the system approved for cardiac use...." "Four patients are know to have died shortly after having the AtriCure procedure, at hospitals other than the Cleveland Clinic. AtriCure didn't notify the FDA...."
• "FMP has also invested in two other companies conducting trials at the Clinic: Immunicon Corp. and CardioMems Inc." The amounts it invested were $5 million and $3 million respectively. The Clinic also directly invested $2.75 million in Immunicon.
• "Last winter the Cleveland Clinic's conflict-of-interest committe learned that the FMP venture fund was an investor in companies doing research at the Clinic...." One of the members of the committee was Dr Eric Topol. "Some committee members worried that the Clinic's ties to AtriCure could color what patients were told when weighing treatment options. They also worried that their CEO's roles at AtriCure and the venture fund that invested in the company created a conflict...." "The Institutional Review Board in February directed Clinic researchers conducting clinical trials of the three companies' products to put a 'voluntary' hold on their work...." "The hold was lifted in May after the Clinic reworded consent forms."
• "The conflicts committee began to look into the role of Dr Cosgrove at FMP and AtriCure.... Not long afterward, Dr Cosgrove stepped down from AtriCure's board and said he would give up his position as a general partner at FMP."
• "Dr Cosgrove last week told Dr Topol he was losing his top post at the Clinic's medical school, a change that will take Dr Topol off the conflict-of-interests committee and the Clinic's board of governors."

The Cleveland Plain Dealer reported today that the Cleveland Clinic's board of directors has confirmed the removal of Dr Eric Topol as chief academic officer and provost of the Lerner Medical School. This action also definitively removed Dr Topol from the conflict of interest committee that had been investigating the ties among Dr Delos Cosgrove, Cleveland Clinic CEO, other Clinic physicians, FMP, AtriCure, and other companies doing research at the Clinic. Dr Cosgrove reiterated that this was part of a "streamlining move, nothing more." He said, "there are a lot of people trying to put a lot of spin on what the facts are." However, "students at the medical college sent a letter to the Clinic's board of trustees in support of Topol...." The Plain Dealer article suggested "the exposure also opens the door to questions from the Senate Finance Committee Chairman Charles Grassley, who has launched an investigation into the practices of nonprofit hospitals.
So was Dr Topol fired from his academic leadership positions to streamline the administration? This explanation seems unlikely, given Topol's prominence, and his role in creating the very medical school from whose leadership he was fired.
Was Dr Topol fired because he criticized Merck's Vioxx drug and its marketing, and revealed how Merck executives tried to intimidate him? Or was it because he helped investigate some conflicts of interest and other strange financial goings on involving top Clinic physicians and leaders, including its current CEO?
It seems more credible to suggest that Topol was punished by his own institution for blowing a whistle, regardless of which whistle proved most offensive.
Again, if such a prominent physician and academic leader can be published for whistle blowing, who in health care is safe? And if no physician or medical academic can feel safe speaking truths that offend the powerful, should any patient or student feel safe?
[Update: the MedPundit take on this story is here, the Schwitzer Health Care News take is here. Retired Doc is a bit ambivalent. Medical Rants doesn't agree, though.]

Post Title → Was Topol Fired for Investigating Conflicts of Interest at the Cleveland Clinic?

"One Horrible Debacle," Indeed: Topol Fired

Dr Eric Topol, an internationally known cardiologist at the Cleveland Clinic, a member of the Institute of Medicine, has been an important skeptic about Vioxx (rofecoxib), a drug recently withdrawn from the market by Merck amidst questions about its cardiac adverse effects. We recently posted about how Merck executives tried to discredit Topol, as revealed by Topol's trial testimony last week (see our posts here, here and here.)

After the New England Journal of Medicine published an editorial suggesting that Merck had suppressed data about the adverse effects of Vioxx in a landmark 2000 article, Topol said, "This is one horrible debacle in American medical history. I've never seen the likes of this."

Only a few days later, Topol was fired from the positions of Chief Academic Officer of the Cleveland Clinic and Provost of the Cleveland Clinic Lerner College of Medicine, of Case Western Reserve University, according to the Cleveland Plain Dealer. Although Topol "deserves a lot of credit" for the founding of the medical school, the newspaper reported that there had been recent "tension" between Topol and Cleveland Clinic CEO Dr. Delos "Toby" Cosgrove.

The New York Times talked to Topol, however, who suggested that the real reason he was fired was his testimony against Merck. Topol said,

The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified. No wonder nobody stands up to the industry.

A Clinic spokesperson countered that Topol's firing was just part of an administrative reorganization, "the organization made the decision that position was no longer needed." There was no word of who, if anyone, would now be in charge of the medical school.

(Note: Via the blog GoozNews, the Wall Street Journal just reported serious allegations about Dr. Cosgrove's conflicts of interest related to a company named AtriCure, in which the Cleveland Clinic has a minority interest.)

Thus in the last week we have heard about two major cases involving retaliation against health care whistle blowers. We just posted about the plight of Dr. Aubrey Blumsohn, who was suspended from Sheffield University for telling the press how he had to fight a pharmaceutical company for the integrity of his clinical research (most recently here.)

The plight of whistle blowers is becoming increasingly dire. If Eric Topol can be fired for critical comments about a drug, who will be able to say anything that displeases the powers that be in health care?

Medicine cannot function if physicians cannot speak their minds. Medical research cannot function if scientists cannot freely express their opinions.

The process is even closer to "collapsing into rubble" than Dr. Curfman thought last week.

If we do not speak out for Blumsohn and Topol now, will anyone speak out later when they come for us?

[Update: MedRants doesn't agree.]

Post Title → "One Horrible Debacle," Indeed: Topol Fired