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.

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

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.