Former NIH Director Spins Through Revolving Door, Ends Up at Sanofi-Aventis

A bit of news that got little attention this month was a new job for the former head of the US National Institutes of Health (NIH).  Dr Elias Zerhouni had left the NIH in October, 2008.  Here is the Reuters version of the story of his hew career:

French drugmaker Sanofi-Aventis (SASY.PA) replaced its head of research and development with a leading academic and former top U.S. health official on Tuesday to raise its game in medical innovations.

The company said Elias Zerhouni would lead R&D of drugs and bring R&D for vaccines under his control too as Sanofi reshapes its portfolio and looks to vaccines as one area for growth to offset sales losses from mounting generic competition.

The appointment of Zerhouni, a professor of radiology and biomedical engineering, comes as Sanofi battles to buy U.S. rare disease specialist Genzyme.

Chief executive Chris Viehbacher brought in Zerhouni in February 2009 as his scientific adviser, shortly after taking charge of the group which he has been transforming to include the development of drugs based on biotechnology.

Zerhouni's Embrace of Corporate Health Care

Although Zerhouni ostensibly left the NIH to return to academia at Johns Hopkins University, note that by February, 2009, four months after his resignation was announced, Zerhouni was already advising the Sanofi CEO. 

Soon after he joined the corporate health care world in earnest.  In April, 2009, he was proposed for membership on the board of directors of Actelion Ltd, a Swiss biotechnology company.  On December 8, 2009, he was elected to the board of Danaher Corp, a diversified technology corporation which makes medical devices.  At some time he had become President of the Zerhouni Group, which advertised itself as a resource to "pharmaceutical and biotechnology companies, trade organizations, sovereign wealth funds, government agencies, and research entities around the globe."

Zerhouni at the NIH: His Response to the Conflict of Interest Scandal

There is more than a little irony inspired by Zerhouni's quick circuit through the revolving door.

Zerhouni became director of the NIH in 2002, and announced his departure in October, 2008. In December, 2003, David Willman published his landmark article in the Los Angeles Times on severe conflicts of interest affecting NIH scientists and leaders.  It revealed that formerly stringent conflict of interest policies at the Institutes were rescinded by then director Dr Harold Varmus in 1995, during the Clinton administration, and increasingly since 1998, disclosure of NIH personnel's conflicts of interest had been reduced.  Thus, in 2002, Zerhouni had taken charge of an agency already deeply affected by conflicts of interest affecting many of its leaders, even though that was not yet public.  He initially did nothing about the situation. 

Willman published another series of articles revealing even more breathtaking conflicts of interest in December, 2004.  (See our post here.)   By then, a Los Angeles Times editorial said there was the "appearance of corruption" at the NIH, and called for Dr Zerhouni's resignation. 

Only after the second series of articles did Dr Zerhouni swing into action (see post here).  In February, 2005, he announced that he would now hold the NIH to a "higher standard."  Yet new conflict of interest stories kept surfacing and their handling kept provoking concern (e.g., see this post from 2007, and this post from 2008), and concerns about how NIH deals with conflicts of interest affecting the extramural researchers it funds persist to this day (e.g., see this post). 

By the late 1990s, the NIH, like many other government agencies, seemed to have become extremely cozy with the world of big corporations.  Dr Zerhouni did nothing to obvious to reduce the local version of this coziness until it had become a public scandal.  His actions let questions about the relationships of the NIH, once a pristine example of a government run biomedical research agency, with big health care business persist to this day. 

So it should perhaps be no surprise that he so quickly transitioned from the government that is supposed to be"of the people, by the people, for the people" to top leadership positions in corporate health care.

Other US Government Health Care Agency Leaders Transit the Revolving Door

Meanwhile, the previous commissioner of the US Food and Drug Administration, Dr Andrew von Eschenbach, is Senior Director for Strategic Initiatives at the Center for Health Transformation, a group whose membership includes some of the biggest health care organizations, many of which have had their own moments in the sun on Health Care Renewal.  For example, see Charter Members, AstraZeneca, Sutter Health, and Wellpoint; and Platinum Members, GlaxoSmithKline and Merck.  Dr Eschenbach is also on the board of directors of Histosonics Inc. 

Also, the previous director of the Centers for Disease Control, Dr Julie Geberding, became President of Merck Vaccines in late 2009. 

Conclusions

So the revolving door just keeps spinning, its revolutions suggesting how closely tied together big government and big corporations have become in what is now the health care business.  Whatever the motivations of Doctors Zerhouni, von Eschenbach, and Geberding were, the message to every person in a leadership position in health care in the US government has to still be: you too can earn big corporate compensation soon after you leave here.  Who knows how much that siren song will lead current government leaders to avoid antagonizing the leaders of big health care corporations during their government "service."  That is, of course, not what we want them to be thinking about if government agencies ae to serve the people, not the CEOs of big corporations. 

I am sure that the career transitions of Doctors Zerhouni, von Eschenbach, and Geberding were perfectly legal.  If we want government health care agencies to put the peoples' interests ahead of those of the CEOs of big health care corporations, should not, however, the law be changed to at least slow down the revolving door?

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Spine Surgeons Reticent About Disclosing Huge Medtronic Payments

Starting in 2007, we posted (here, here, here, here and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

In 2008, our post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.  In 2009, an article in the New England Journal of Medicine showed that almost 30% of surgeons who got such payments in 2007 failed to disclose them when they presented at the 2008 American Academy of Orthopedic Surgeons meeting.(1)

Medtronic's Payments to Spine Surgeons

This month, the media reported that Medtronic also made payments, sometimes huge, to orthopedic and spine surgeons (see this post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and our summary post here.) 

Now further investigation by John Fauber of the Milwaukee Journal-Sentinel suggests that surgeons receiving often huge payments from Medtronic may not have been good at disclosing them either.

The article examined payments made to surgeons who authored two major studies about bone morphogenetic protein-2, a biologic drug manufactured by Medtronic used to promote bone growth at surgical sites:

Over the last decade, a small group of prominent surgeons from around the country has been enlisted by medical device-maker Medtronic to do clinical research or write articles about the company's new spine surgery product.

This year alone, many of those doctors received payments of hundreds of thousands to millions of dollars each in royalties for a variety of other Medtronic spinal devices, according to a Journal Sentinel analysis of newly released company payments. Medtronic began disclosing the payments this year, in advance of a federal requirement set to take effect in 2013.

Since it won approval for narrow uses in 2002, the product - bone morphogenetic protein-2, known as BMP-2 - has been an increasingly dominant force in spinal fusion surgery, with sales of about $800 million a year, often for use in other procedures.

Independent doctors say the product's success is due largely to positive findings made by the surgeons affiliated with the company.

Doctors involved with two of the many research articles on BMP-2 published since it was approved - one in 2002, the other in 2004 - received a combined $6 million in royalties this year for other Medtronic spinal products, the newspaper found. The payments went directly to the doctors or business entities they are associated with.

No Disclosure in a 2002 Article

The Journal-Sentinel article referred to two scholarly articles written about BMP-2. Regarding the first,

At the time BMP-2 was approved in 2002, little was known about the financial connections between Medtronic and doctors associated with the clinical trial. Likewise, little was known that year when the Journal of Spinal Disorders & Techniques published the article on the trial.

The paper made no mention of doctors getting royalties or having any financial connection to the company.

[Note: I am unable to find this article using standard search techniques, so I cannot give a citation for it.]
Regarding the lack of disclosures made in the first article,

The four co-authors of a 2002 paper about that trial received a total of $2.8 million this year from Medtronic in royalties for products not including BMP-2.

The paper made no mention of any financial relationship between the authors and Medtronic.

Burkus, who also was involved in the 2004 study, again declined to say if he was receiving royalties from Medtronic or if had some other financial connection with the company at the time the 2002 paper was published. He got $573,000 through September.

Curtis Dickman, a Phoenix surgeon, did not respond to phone calls and e-mails. He and Vantage Investments LLC received $306,000 in royalties.

Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $591,000 in royalty payments.

Gornet said he did not have a financial connection with the company at the time of the study, though he developed a relationship as a consultant right after the trial, an arrangement that ended after about a year.

He said his patent rights with Medtronic did not begin until 2003 and none of his royalties involves BMP-2.

The last author listed was Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health. Through September, he and Taz Consulting received $1.4 million in royalties for a variety of products.

Other records show Zdeblick has received more than $23 million in royalties from Medtronic since 2002.

In an e-mail, Zdeblick said he had no financial interest in BMP-2. He does receive royalties for the invention of the LT-Cage, which was used in the BMP-2 clinical trial, but the two products are sold separately.

Little Disclosure in the 2004 Article

Regarding the second article,(2)

Three of the four authors of a 2004 article on the study of the productare listed as receiving nearly $4 million this year in royalties from Medtronic for a variety of spinal products, not BMP-2.

That paper was important because it involved a clinical trial that had to be stopped because the product was causing troubling bone formation in the spinal canal of patients. In the paper, that finding was downplayed, with the authors describing the results as 'encouraging.'

[Professor Dan] Spengler, the Vanderbilt orthopedic surgeon and former medical journal editor, said he doubted the paper would have been written in such positive terms by authors without financial ties to Medtronic.

He described the article as egregious, saying it 'just blew off the complications. It's a horrible article.'

Orthopedic surgeon [University of California - Irvine Clinical Professor Charles] Rosen said the paper was biased, calling it 'more of a marketing paper than an objective scientific study.'

Regarding the disclosures made in the second article,

The article described three of the authors as consultants to Medtronic, though it did not disclose that any of them were receiving royalties at the time.

Regis Haid, lead author of the article and an Atlanta neurosurgeon, told the Journal Sentinel he was getting royalties for other Medtronic products. Haid noted disclosure rules for medical journals have become more stringent in recent years.

He said BMP-2 provides excellent benefit to patients, adding he had it implanted in his own neck in an off-label procedure. ;I have BMP in me, and I would put it in you . . . ,' he told a reporter.

Through September, Haid and Spinal Engineering LLC received about $2 million in royalties this year from Medtronic.

Meanwhile, co-author Ken Burkus, a Columbus, Ga., surgeon, and RBCK Research & Consulting, received $573,000.

'Very importantly, you cannot assume that such royalty payments were made prior to 2010,' he said in an e-mail, declining to say whether he got royalties at the time the paper was written. 'I follow the rules to my fullest ability as put forward by the specific journal.'

He took issue with criticism that the paper put a positive spin on a troubling clinical trial.

'I believe the words used were appropriate . . . ,' he said. 'I believe the words used were neither 'positive nor negative' but rather were representative of the data presented.'

He said if other doctors have problems with the paper, they should take it up with the editor of the journal: 'They can write a letter to the editor.'

Co-author Charles Branch Jr., chairman of neurosurgery at Wake Forest University, and the university itself have received $1.2 million in royalties this year.

A spokeswoman for the university said it owns the intellectual property rights to Branch's patents and that royalties generally are split with 35% to the individual and 65% to the university. None of those royalties involved BMP-2, university media relations manager Bonnie Davis said in an e-mail.

She said Branch and Wake Forest were getting royalties at the time the paper was published, but not when the trial was going on.

In a separate e-mail, Branch said use of the term 'encouraging' in the paper 'was not a strong endorsement,' but, rather, recognition that patients getting BMP-2 had superior results to those receiving a traditional bone graft.

Summary

So here we go again.  Once again we see an example of a single medical device company paying heroic amounts, hundreds of thousands to over a million dollars a year, to surgeons ostensibly as royalties for their intellectual property.  The company and the surgeons were all rather cagey about the nature of the intellectual property for which the money was paid, and about the justification for the size of the payments.

While it is likely that the payments have been going on for a while, previous influential articles written by some of the surgeons receiving the payments contained at best minimal disclosure of their financial relationships with Medtronic, and gave no hint about the magnitude of these relationships.  These previous influential articles seemed more enthusiastic about a Medtronic product than was justified by their results.  Of course, maybe getting hundreds of thousands or millions of dollars a year from a commercial health care firm could lead to some excess enthusiasm about its products.

It seems that every drug, biotechnology, and device company has its stable of highly paid physicians and surgeons who can be counted on for their enthusiasm about the companies' products, and their reticence about their financial relationships with the companies.  We have often discussed the pervasiveness of the web of conflicts of interest that seems to link most commercial health care firms with most influential medical academics and practitioners.  The web seems even more pervasive than we once imagined, and the conflicts seem even more intense. 

Those who laud ties between academic medicine and industry may perseverate about how collaboration leads to innovation, while denying that mere money can influence professional judgement.  However, it is difficult to imagine how even the most well-intentioned professional would not be influenced by hundreds of thousands or millions of dollars a year.  When professionals hide the magnitude of such relationships, it only raises more suspicions that they know they have something to hide because they realize they have been bought.

The ever increasing revelations about conflicts of interest pervading academic medicine should inspire extreme skepticism about clinical research or clinical teaching supported in any way by commercial interests.  At the very least, these revelations justify the need for detailed and complete disclosure of all financial relationships among commercial health care firms and academic and practicing physicians, and others who make or influence health care decisions. 

I suspect that if such full disclosure took place, physicians, other health care professionals and the public, at least those who had not been paid themselves, would be so aghast that such relationships would not remain legal for long. 


References
1.  Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M.  Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med 2009; 361:1466-1474.
2. Haid RW, Branch CL, Alexander JT, Burkus JK. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cates. The Spine Journal 2004; 4: 527-539.

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How Marketing Mixes Into Medical School Curricula - an Example from Canada

Misery loves company, so here is an interesting case reported by the Canadian Press, via CTV News, about how students in a pain management course at the University of Toronto complained that marketing seemed to have been mixed into their curriculum:

The complaint centered around students being provided a book on managing chronic pain that was funded and copyrighted by the maker of the prescription pain killer OxyContin. The book had been brought in by a non-faculty lecturer with financial ties to the drug company.

It turned out that:

From 2002 to 2006, the pain course was funded by donations, included $117,000 in unrestricted educational grants from four drug companies -- Merck-Frosst, Purdue Pharma, Pharmacia Canada and Pfizer -- although they had no input into course content. Since 2007, the program has been funded solely from faculty budgets.

[Dean of Dentistry Dr David] Mock said Purdue's copyrighted book on pain management had been brought in by Dr. Roman Jovey, an unpaid guest lecturer and co-author of the book who left copies 'for anyone to take.' Jovey, medical director for a chain of clinics called the Centres for Pain Management, is a member of Purdue's speakers' bureau, paid by the company to conduct workshops and lectures.

Dr Jovey defended handing out the free book produced by his part-time employer:

Jovey confirmed he had left copies of the 371-page book, entitled 'Managing Pain: The Canadian Health Care Professionals Reference,' for students.

'It was a gift from Purdue. I'm not at all embarrassed or ashamed. I think it's a darn good book.

"If we all want to be politically correct and have the appearance of being politically correct, then I guess I get it, that nothing that has any kind of pharma logo or name or ownership should be given out to medical students,' he said Wednesday.

'But the losers are the medical students because I think it's a high-quality book, it's very readable and they're deprived of it this year because of this controversy. And I guess they will be in the future.'

However, it appeared that the "darn good" book's content was biased in favor of Purdue's product, Oxycontin:

Dr. Irfan Dhalla said he has concerns about the content of the book, which a medical student taking the course brought to his attention.

'There are definitely things that are not consistent with the evidence,' said Dhalla, a staff physician at St. Michael's Hospital and a lecturer at the university. 'For example, oxycodone ... is listed as a moderate-potency opioid, when I think everybody agrees it's a very strong opioid, up to twice as strong as morphine.'

While it's appropriate to prescribe oxycodone for severe acute pain or cancer pain, Dhalla said the book suggests that physicians can prescribe the drug for chronic non-cancer pain with relative safety for the patient.

'And I think people with experience know that that is just not the case. When you prescribe to people with chronic non-cancer pain, it's very difficult to do that safely,' he said, noting that the book pays little attention to issues of addiction and deaths from overdose.

'The book in several places makes reference to a claim that the rates of addiction if opioids are used for chronic non-cancer pain are very low. And they're not nearly as low as is claimed in the book.'

In fact, a study by Dhalla and colleagues published last year showed prescription rates for opioids -- including OxyContin, a long-acting form of oxycodone -- soared in Ontario over the last two decades, as did the number of deaths linked to the narcotic.

A subsequent inquiry has recommended revising the curriculum and dispensing with the drug company funded book.

This is another example of how marketing has infiltrated medical education. It suggests that market influenced education likely includes not only opinions in favor of the specific product being marketed, but distortions of fact to support the product that are hardly evidence-based.

Furthermore, it shows how conflicts of interest facilitate marketing influenced medical education. Note that the bringer of the biased textbooks in this case was being paid honoraria to speak on behalf of the pharmaceutical company, but presumably not to teach the particular course in question. However, his enthusiasm readily carried over to his work in that course.

We have discussed how pharmaceutical marketers regard the "key opinion leaders" whom they pay to speak as salespeople. One would expect salespeople to be enthusiastic for their product even outside of their normal working hours. In my humble opinion, this is why no medical academic should be allowed to simultaneously be a commercially paid "key opinion leader."

By the way, note that this case also suggests how the issues we discuss on Health Care Renewal are relevant globally, not just to the US. I tend to be wary of blogging about cases in other countries, since there may be subtle difference in context across countries that might make interpretation of cases more difficult when viewing them from abroad. However, I think that the facts and language here are straightforward enough for me to be fairly confident about what was going on. Nonetheless, if any Canadian think I have got this wrong, please let me know.

Meanwhile, if anyone is blogging about similar issues from beyond the US shores, please let me know so I can add their work to our blog roll.

Hat tip to Prof Margaret Soltan on the University Diaries blog.

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Hackensack University Medical Center CEO's $5 Million Golden Parachute: "the Public Will Perceive the Institution as a Kind of Insider's Group"

Last year was an embarassing one for Hackensack University Medical Center (HUMC), a large academic medical center affiliated with the University of Medicine and Dentistry of New Jersey.  In April, former state senator Joseph Coniglio was convicted of fraud (against the public) and extortion for a scheme that involved him being paid $5000 a month for undefined consulting work for HUMC while he promoted the hospital's interests in the state legislature (see post here).  A subsequent investigative report revealed widespread self-dealing on the part of the HUMC board (see post here).  Soon after, the HUMC CEO, John Ferguson, announced his retirement, per the Newark Star-Ledger.

Scandal Leads to Apparent Reforms

So when I read an article from last week on NorthJersey.com entitled "Hackensack University Medical Center works to revamp reputation hurt by trial" I hoped that these travails lead to some real improvements in the leadership and governance of the institution.  Hope springs eternal, and the article did describe some apparent progress.

The medical center's board of trustees was streamlined:

the hospital's board of governors — once a 57-member behemoth run by a core group of powerful and politically connected members — was whittled to less than half its former size and is now overseen by what the hospital is calling a 'reinvigorated' parent company, Hillcrest Health Service System Inc.

Conflicts of interest and self-dealing were apparently banned

Members of the two boards may no longer do business directly with the hospital — a significant change because some of them own or work for companies that have been paid millions of dollars by Hackensack. In 2009 alone, these companies were paid $13.2 million by the hospital, according to its federal tax filings. They were paid $17.4 million in 2008.

The Devil in the Details
Although the board was reduced in size, it gained almost no new members, and the politically-connected members who previously were accused of self-dealing remained:

Serving as chairman of the board of governors is Joseph M. Sanzari, a construction magnate, multimillion-dollar donor and longtime board member. His company, a joint venture with former board Chairman J. Fletcher Creamer Jr., has been one of the highest-paid independent contractors at the medical center.

Also,

There were no new board members until Tuesday, when two were appointed. Many who held influential positions on the board of governors — including Sanzari, Creamer and Joseph Simunovich — are still in key roles.

Furthermore, there was a big loop-hole in the apparent ban on conflicts of interest and self-dealing:

members of both the board of governors and Hillcrest can still do business with the hospital as long as they work as subcontractors or move to the foundation board or a newly created advisory panel that doesn't have voting or fiduciary powers.

Also,

Members of the board of governors and Hillcrest still can be hired as subcontractors.

The ban on doing business with the hospital also doesn't cover members of the advisory panel or the board that oversees the foundation. About a dozen members of these two groups are affiliated with companies that have made money — millions, in some cases – in work with the hospital.

As one outside expert noted,

'They may have changed the structure, but if you don't change the people, you don't change the culture,' said Jamie Orlikoff, a governance expert who advises the National Hospital Association.

Furthermore,

'People who had influence and clout when they were members of a fiduciary board will still have influence and clout even if they are moved to an advisory board,' Orlikoff said.

So,

'The concern is that the public will perceive the institution as a kind of insider's group and things are being done to benefit them,' said Daniel Borochoff, president of the American Institute of Philanthropy.

The CEO's Golden Parachute

Hope spring eternal, but is too often crushed.  However, at least the former CEO is gone. But it turns out he got quite a going away present. As described in a companion article,

John P. Ferguson received a severance package of more than $5 million when he was forced out as president of Hackensack University Medical Center last year, bringing his total compensation for 2009 to $7.7 million, according to recent federal tax filings.

The other executives who presided over HUMC in 2009, the year that its former consultant was convicted, also did very well for themselves,

His senior vice president for operations, Doreen Santora, received $2.6 million — including more than $1.5 million in severance — when she left in the executive reshuffling that followed, the documents show.

In all, seven top executives at the non-profit hospital each received more than $1 million in total compensation in 2009, up from five the year before.

This extremely generous compensation could not be related to the financial success of the hospital at the time:

The compensation packages came in a year in which tax filings show the 775-bed medical center employed 317 fewer staff and Moody's Investors Service downgraded its credit rating to Baa1, leading to higher interest payments when new debt is issued.

If this was pay for performance, by what measure these executives' performance was measured was not clear. Actually, who even decided to award them such sumptuous pay was unclear:

only a handful of board members were aware of the millions of dollars in pay and perks that had been handed out to executives over the last few years. Several employees saw their overall compensation double or triple.

Board members expressed 'sticker shock' when they first learned of the compensation numbers at a fall 2009 meeting, said J. Fletcher Creamer Jr., who completed his term as chairman of the board of governors in March.

'We went through every single executive' whose salaries must be disclosed on the IRS form for non-profit institutions, Creamer said in an interview earlier this year. 'It's the first time they actually saw it. … We always made the numbers available if they wanted to come see it, but not everyone looked.'

Keep in mind that per the first NorthJersey.com article, Mr Creamer will still be in a "key role" at HUMC, his failure to think that top executives' compensation was something his fellow board members needed to consider notwithstanding.

Summary

Is this any way to run a hospital "which has a national reputation for quality care?" The hospital leadership did and still appears to be an "insider's group" which works to promote its own self-interest.

As we have said before, far too often the leaders of not-for-profit health care institutions seem more interested in padding their own bottom lines than upholding the institutions' missions. They often seem entirely unaware of their duty to put those missions ahead of their own self-interest. Like the financial services sector in the era of "greed is good," health care too often seems run by "insiders hijacking established institutions for their personal benefit." True health care reform would encourage leadership of health care who understand health care and care about its mission, rather than those who see a quick way to make a small fortune.

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BLOGSCAN - Are electronic medical records a health care cure or a disease?

This doctor writing at Cleveland.com really doesn't like EMR:

... Our practice implemented EMR about three months ago, and it has not been a downhill sleigh ride thus far. Here's the scorecard.

• It saves time. It doesn't.

• It saves money. It hasn't.

• It promotes office flow and efficiency. Hardly.

• It improves staff morale. Are you joking?

• Patients prefer it. None that I know.

• It's been a bonanza for document-scanning companies. Bingo!

What I find most troubling about EMR is that it is "point and click" medicine. It radically disrupts the doctor-patient relationship. Taking the patient's medical history -- the bedrock of doctoring -- is reduced to a sterile data-entry process. Taking the history, the conversation that physicians and patients have had since Hippocrates tended to the sick, is our opportunity to reach out and bond with our patients. During this time, we forge human-to-human connections with patients who are seeking our help. This is the scaffold upon which a sturdy doctor-patient relationship develops. EMR is taking a chainsaw to this structure.

Those who champion the technology are usually not practicing physicians. They are the insurance industry, billing personnel, medical coding specialists, the government, various bean counters and, of course, EMR vendors. Because these folks are not physicians, they do not appreciate how EMR affects doctoring at ground zero in our exam rooms ...

Read the whole thing.

-- SS

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Inpatient or outpatient and the battle to control costs: The truth about the push for electronic medical records?

Electronic health records have been pushed like opiates on a run-down inner city street corner for some years now; yet the evidence does not support the aggressive national push currently underway.

I'd thought wishful thinking, hope, government naivete, industry aggression and lobbying, and other similar factors were a major explanation.

A candid article today, however, in my local newspaper, about the ER of a hospital where I did my residency years ago (pre-EHR), seems to offer the most potent driver behind the current push - real-time money games:

Inpatient or outpatient? The battle to control costs

By Michael Vitez
Inquirer Staff Writer
Sun, Dec. 26, 2010

Randy Klein had a lovely vacation, three weeks in Europe with her husband, Stephen, for their 36th anniversary.

They went to Paris, Rome, Venice, even took a cruise to Monte Carlo. On the last day, they ate oysters in Normandy.

Her stomach started cramping on the airplane. The diarrhea didn't hit, thank God, until she got home, in Rydal, on Oct. 17, but it landed with a fury.

"Doesn't even give you a shot to get to the bathroom," she said.

She went to the emergency room at Abington Memorial Hospital, where they took cultures and she spent the night. She began to feel better and went home the next day.

A few days later, a violent diarrhea slammed her even worse than before. She went back to the ER and soon was on a gurney and hooked to a morphine drip.

Klein, 56, was too sick to know or care, but she was the subject of a conversation taking place down the hall between her ER doctor and an admission review nurse:

Should Klein be admitted to the hospital or treated there but as an outpatient, in what is known as observation? [That is, "short-stay", or "one-day" fast-tracked admissions - ed.]

This may sound bureaucratic, even benign. But this question - and where it leads - tells a lot about the state of health care today, the tension between hospitals and insurers, the impact on patients.

The tension is strong indeed:

Abington wants to avoid treating Klein as an inpatient, then getting paid only an outpatient rate from the insurer - half as much.

Insurers see themselves as good citizens, responsible parents [I think their principle motivation is, rather, to be good parents to their profits - ed.], doing the difficult job of holding down health-care costs, in part by refusing to pay for what they view [from a distance, post hoc - ed.] as unnecessary care.

Doctors see this as second-guessing by insurers and an erosion of the doctor's role.

[I don't "see it" as second guessing. It *IS* second guessing, on first principles - ed.]

And hospital finance people say these cuts in reimbursement will affect the care of Randy Klein, thousands like her, and eventually all of us.

And some will be injured and die as a result...but it's all for money:

... These skirmishes over reimbursement take place gurney by gurney, patient by patient, like a thousand paper cuts, but the dollars add up.

Abington says it will lose $12 million a year because of this. Hospitals around the state and nation are feeling the same financial pressure.

Observation status, created by Medicare, has existed for years, but was infrequently used by area hospitals until last year, after a crackdown by Medicare auditors.

The idea is basic: If a patient arrives in the emergency room, and it isn't immediately clear whether the patient should be admitted, the patient can be placed in observation - treated in the hospital but as an outpatient.

The statement "treated in the hospital but as an outpatient" shows George Orwell's concepts of language manipulation are alive and well.

... Steve Fisher is one of 40 emergency-room doctors at Abington. He likes to say, "I'm paid to be paranoid."

On Monday, Oct. 25, before he went to see Randy Klein, he saw that she had been in a few days earlier for the same problem, and that immediately raised concern.

The results of cultures taken the previous week showed she had two parasites, campylobacter and giardia, infections one gets from contaminated food and fecally contaminated water. Fisher knew giardia, which he felt was causing her trouble, is rarely life-threatening, but he is paid, as he says, to be paranoid.

On examination, Fisher felt Klein's belly was incredibly tender, and he contemplated a CT scan of her colon, but decided against subjecting her to the radiation.

He didn't think she had a blockage or anything that would need surgery. But considering the extreme inflammation, a rupture was possible, and he was confident she would need subsequent abdominal exams in the hospital, in the days to come.

ER doctors need to be "paranoid" because they ultimately are responsible for outcomes. They also develop a keen sense of judgment towards potential trouble. This patient was admitted for several days, but soon the claim for inpatient care was denied.

Based on a cookbook known as "InterQual", Blue Cross would pay at an observation rate, an outpatient rate, even though Abington provided inpatient care. Read the article or the link above for more on that cookbook.

Now about the denial and the second guessing of doctors:

"Respectfully," [senior medical director at Independence Blue Cross Donald Liss] added, "I'd say, jeez, this is the perfect case for observation. Is she going to respond, get better in six, eight, 12 hours from now and perk up? That's the one where you would want to keep an eye on her, responding to therapy or not."

[How does he know? He was not present. He did not perform an exam. He did not get a "sense" of the patient. - ed.]

Liss wanted to emphasize that "I have a personal interest in the continued existence of Abington. My wife and I delivered our kids there. I live within a mile.

That's very nice, but irrelevant. What is relevant is this:

"We don't intend to tell the ER doc how to practice medicine," he added. "I appreciate the conundrum and challenge that creates at the point of care.

"But unashamedly our job is to be a good steward of the dollars our customers entrust us [such as patients just like Randy Klein? - ed.] to spend on health care."

This is bull. It is a lie. I find this statement offensive and insulting to my intelligence. I am indeed tired of the lying and the spin.

Of course the insurance company representatives are telling the ER doctor how to practice medicine.

Patient disposition decisions are part of an ER physician's practice of medicine. Insurance company interference in those decisions is precisely a matter of telling ER docs how to practice medicine.

Their profits depend on it.

Now for the EHR angle:

... Joanne Mainart and Donna Tobin are nurses and case managers at Abington who review admissions. Mainart was hired for this job a year ago; Tobin joined her in March.

They sit at their own computer in the ER [i.e., with their own access to the EHR - ed.], away from patients, and when they see a black ball beside a patient's name [signifying the insurer may deny an inpatient claim and pay at aforementioned "outpatient inpatient" rates - ed.], their job is to examine medical records and treatments and determine if the patient meets criteria for inpatient admission.

Doctors still make the decision. These nurses only advise. But their mission is to make sure patients get put in the right category - inpatient admission or observation [so the hospital can be paid appropriately - ed.]

Assigning Mainart and Tobin to the ER was Abington's response to the push toward observation.

And this:

... Blue Cross has its own team of utilization review nurses, all of whom, it says, have at least five years experience and have received special training in utilization review.

One of the nurses, working at the Blue Cross offices in Plymouth Meeting, got access to Abington's computers through a secure logon [they can see the EHR too! - ed.] and reviewed the same records Tobin had the previous evening.

[Note the centrality of the computers in this payment "poker game" process - ed.]

The Blue Cross nurse did not feel Klein met InterQual.

[Since nurses cannot unilaterally make these decisions, a physician later reviewed the case and concurred - ed.]

So, there we have it.

Physicians' work is interfered with by EHR's ostensibly put in place to "help them", but in reality a behind-the-scenes cybernetic game of financial chess is going on, worth billions to hospitals and the insurers.

If that is not a compelling driver for EHR technology, I don't know what is.

Unfortunately, it does not benefit patients or doctors clinically (my relative was nearly killed earlier this year by the unintended adverse consequences of an ED EHR system), and it looks like the upper hand financially now lies with the insurers.

Hospitals like Abington estimate they "will lose $12 million a year because of [the denials]." Hospitals around the state and nation are feeling the same financial pressure.

Per Abington Chief of Staff Jack Kelly, a former director of my Residency program there:

John J. Kelly, [now] Abington's chief of staff and top doctor, said: "It actually costs us more money to do observation. You might say that doesn't make any sense."

He said Abington has had to hire more staff and "compress everything" - in other words, try to provide the same care it gives an inpatient but squeeze that into 24 hours of observation.

Kelly also said staff was required to do more documentation "because you're paid by the hour for observation. It's craziness."

"What they're asking us to do sometimes is dangerous, I think," said Kelly, speaking for himself and not the hospital.

"The 'retrospectacope' is the most powerful instrument known to man," he added. [That sounds like vintage Jack - ed.]

"Part of the reason we spend so much of our resources in training physicians is to develop that sense of judgment about who needs what. And we're being second-guessed by everybody strictly on the basis of costs.

"I understand the need to be sensitive to costs, yet they're going to cripple us, the insurers [and] the government."

Note his statement:

"Part of the reason we spend so much of our resources in training physicians is to develop that sense of judgment about who needs what."

I concur with his assessment, and from personal experience. I was one of the physicians he trained.

A plague of our current culture is the permitting of second guessing by people who both lack the expertise of the experts, and/or lack the crucial benefit of direct, concurrent observation of the patient.

In conclusion:

First, it is increasingly apparent that clinical information technology has been hijacked from its inventors and pioneers. It has been morphed from a tool that was supposed to help clinicians in their private doctor-patient relationship, into a cybernetic control mechanism for bureaucrats.

Second, until this culture takes away the power from ill informed bureaucrats, people need to bring a bodyguard (medical advocate) with them to any hospital encounter.

"If you are second-guessed wrong, your patient's dead" seems an apropos motto for this era.

-- SS

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Study highlights 'lurking question' of measuring EHR effectiveness: The science in Medical Informatics is dead

The science in Medical Informatics is dead.

I'm not going to even use academic fabric softener in my assertion, e.g., "may be", "appears to be", or "is it?" (as a question) dead.

It's dead.

When HIT experts recommend changing the study goalposts when existing studies don't give results they'd like to see, rather than first and foremost critically and rigorously examining why we're seeing unexpected results, science is dead.

Study highlights 'lurking question' of measuring EHR effectiveness

December 22, 2010 | Molly Merrill, Associate Editor

WASHINGTON – Hospitals' use of electronic health records has had just a limited effect on improving the quality of medical care nationwide, according to a study by the nonprofit RAND Corporation.

The study, published online by the American Journal of Managed Care, is part of a growing body of evidence suggesting that new methods should be developed to measure the impact of health information technology on the quality of hospital care.

[In other words, we're not getting the results we thought and hoped we'd get with "Clinical IT 1.0", so let's alter the study methodologies and endpoints --- rather than using the results we have to identify the causes and improve the technology to see if we can do better with "Clinical IT 2.0."

Further, it's not as if there's no other data on why health IT might not work as hoped - ed.]

Most of the current knowledge about the relationship between health IT and quality comes from a few hospitals that may not be representative, such as large teaching hospitals or medical centers that were among the first to adopt electronic health records.

[This implies "other" "representative" hospitals are either not doing it right, or the technology is ill suited for them and may never work. Which is it? We really need to know before we proceed with hundreds of billions more in this "Grand Experiment" - ed.]

The RAND study is one of the first to look at a broad set of hospitals to examine the impact that adopting electronic health records has had on the quality of care.

The research included 2,021 hospitals – about half the non-federal acute care hospitals nationally. Researchers determined whether each hospital had EHRs and then examined performance across 17 measures of quality for three common illnesses – heart failure, heart attack and pneumonia. The period studied spanned from 2003 to 2007.

The number of hospitals using either a basic or advanced electronic health records rose sharply during the period, from 24 percent in 2003 to nearly 38 percent in 2006.

[How many billions of dollars diverted from patient care needs does that represent? - ed.]

Researchers found that the quality of care provided for the three illnesses generally improved among all types of hospitals studied from 2004 to 2007. The largest increase in quality was seen among patients treated for heart failure at hospitals that maintained basic electronic health records throughout the study period.

However, quality scores improved no faster at hospitals that had newly adopted a basic electronic health record than in hospitals that did not adopt the technology.

[In other words, the improvements or lack thereof had little to do with electronic vs. paper record keeping - ed.]

In addition, at hospitals with newly adopted advanced electronic health records, quality scores for heart attack and heart failure improved significantly less than at hospitals that did not have electronic health records.

[In other words, the clinical IT was probably impairing doctors compared to simpler paper methods and good HIM personnel - ed.]

EHRs had no impact on the quality of care for patients treated for pneumonia.

Researchers say the mixed results may be attributable to the complex nature of healthcare.

[That is likely true, but maybe the mixed results are also -- and even more likely in major part -- due to poorly designed and/or poorly implemented IT - ed.]

Focusing attention on adopting EHRs may divert staff from focusing on other quality improvement efforts.

[That speaks to poor EHR overkill, poor usability, unfitness for purpose, and other issues that may or may not be remediable in short or even long term - ed.]

In addition, performance on existing hospital quality measures may be reaching a ceiling where further improvements in quality are unlikely.

[That speaks to a low ROI or even negative for the hundreds of billions of dollars being diverted to the IT sector - ed.]

"The lurking question has been whether we are examining the right measures to truly test the effectiveness of health information technology," said Spencer S. Jones, the study's lead author and an information scientist at RAND. "Our existing tools are probably not the ones we need going forward to adequately track the nation's investment in health information technology."

["Probably" not the ones we need? How can the authors know this? This is not science, it is speculation. Further, I'd say the scientific imperative before we design "the right measures" to "truly" test the effectiveness of HIT is to understand why the measures we're using now are not showing the desired results, because perhaps they are perfectly adequate and are revealing crucial flaws, overestimations and false assumptions that need to be dealt with, now, not after another round of billions is spent - ed.]

New performance measures that focus on areas where EHRs are expected to improve care should be developed and tested, according to researchers.

[In pharma clinical trials, this is akin to what is known as "changing the study methodologies and endpoints" - a form of manipulating clinical research, usually with the true ultimate endpoint of money - ed.]

For example, EHRs are expected to lower the risk of adverse drug interactions, but existing quality measures do not examine the issue.

[I believe the studies that have been done of CPOE have not been consistently supportive, and in fact show CPOE might create new med errors - ed.]

"With the federal government making such a large investment in this technology, we need to develop a new set of quality measures that can be used to establish the impact of electronic health records on quality," Jones said.

[This is truly putting the cart before the horse as I wrote here. The studies showing the benefit should have long preceded the "large investments" that were decided upon - ed.]

Support for the study was provided by RAND COMPARE (Comprehensive Assessment of Reform Efforts). RAND developed COMPARE to provide objective facts and analysis to inform the dialogue about health policy options. COMPARE is funded by a consortium of individuals, corporations, corporate foundations, private foundations and health system stakeholders.

Other authors of the study are John L. Adams, Eric C. Schneider, Jeanne S. Ringel and Elizabeth A. McGlynn.

The overarching assumption is that the metrics are wrong, not the quality and fitness for purpose of the technology, the 'wrongness' of which is painfully obvious from the aforementioned other literature, e.g., link, link, link, and the many posts at this blog referring to other literature. Are the authors unaware, one might ask? I know they are not. (Or - blinded? That is, could there be external pressures affecting the thought processes? The arguments might not unreasonably be construed to be skewed from that perspective.)

Recognizing the atrocious user experience and mission hostile nature of the technology (link), how disruptive it is (link, link), how poorly implemented it is often by domain amateurs to support financial battles of the payers, not cognitive processes of clinicians, I am amazed there's any signs of improvement at all, not outright deterioration. (That there is not outright deterioration of care displays if anything the results of the hard mental labor and ingenuity of clinicians to work around the technology's deficits.)

I note that the last time RAND looked at such matters there were problems with pro-health IT bias, among other issues (see my Feb. 2009 post "Heartland Institute Research & Commentary: Health Information Technology").

Carl Sagan wrote that science is a candle in the dark in a demon haunted world.

It seems the demons are winning.

-- SS

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BLOGSCAN - Charles Ferguson, "Inside Job," and Parallels and Interlinks with the Health Care Crisis

On the Naked Capitalism blog, there is a video clip of an interview with Charles Ferguson, who directed Inside Job (see this post).  It is highly recommended, if as disturbing as the movie.  Look for the parallels with health care, and think about how the health care crisis is interlinked with the global financial crisis.  See the movie if you haven't already.

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These Pharma-Paid "Key Opinion Leaders" Know Better

At "The Lancet Emphasizes the Threats to the Academic Medical Mission" Roy Poses summarized the major categories of ills affecting healthcare today.

The list reads like a list of the Ten Plagues of Egypt visited upon the Pharaohs (actually thirteen categories are listed, but plagues they are indeed to patients and conscientious medical practitioners).

This list, with keyword-hyperlinked examples, can serve as an index to the threats to healthcare's core values covered at the Healthcare Renewal blog:

• 1. Abandonment of traditional prohibitions of the commercial practice of medicine
• 2. Making money takes precedence over education
• 3. The medical school re-imagined as a biotechnology company
• 4. Faculty become employees of industry
• 5. Academics become "key opinion leaders" paid to market drugs and devices
• 6. Control of clinical research given to commercial sponsors
• 7. Conflicts of interest allow manipulation and suppression of clinical research
• 8. Academics take credit for articles written by commercially paid ghost-writers
• 9. Whistle blowers are discouraged, or worse, and academic freedom is damaged
• 10. Leadership of academic medical centers by businesspeople
• 11. Leaders of teaching hospitals and universities become millionaires
• 12. Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations
• 13. Leaders of failed finance firms become stewards of academic medicine

Today in my local newspaper, the Philadelphia Inquirer, an article that focused on plagues #4 and #5 was published entitled "Faculty still paid by drug firms." The article contains a personal reminder to me that the "faculty" know of the dubiousness of their deeds from long ago. More on that momentarily.

Posted on Fri, Dec. 24, 2010

Faculty still paid by drug firms

Medical-school policies often fail to keep doctors from lecturing on Big Pharma's dime.
By Tracy Weber and Charles Ornstein
PROPUBLICA

Officials at the University of Pennsylvania believed they had a strong tool to prevent pharmaceutical-company money from corrupting the medical faculty.

In 2006, they acted to keep drug marketers out of their hospital and clinics, to ensure that treatment decisions were made for the right reasons. In one of the country's first policies of its kind, Penn also told its physicians that they "should not participate in industry marketing activities."

Penn's chief medical officer, P.J. Brennan, said he thought the policy was clear: Company-paid lectures are forbidden. "It flies in the face of what a professional ought to be," he said.

[Perhaps the policy would have been clearer to the esteemed academic faculty if written in Latin, as in "Vexillum pensus lectures es inconcessus", or perhaps Greek "εταιρεία πληρωμένος διάλεξη είναι απαγορευμένος"? - ed.]

But an investigation by ProPublica found that 20 of Penn's doctors have delivered such lectures since 2009. Five, including one who left Penn last month, were paid more than $40,000.

$40,000 can buy a lot of opinions, or skew the opinions of otherwise scientific personnel. Those who deny this are either deluded or overly enamored by the hot sports car they plan to have in their garage...

What's the big deal with giving pharma-sponsored and paid "educational talks", anyway, when you can then more easily afford one of these?

The article continues:

[Penn] was not the only [school] caught off-guard. ProPublica checked on 12 medical schools and teaching hospitals and found that faculty at half also lectured for drug firms in the last two years, despite restrictions on such speeches. Among them, Stanford University, the University of Pittsburgh, and the University of Colorado Denver have initiated reviews.

Conflict-of-interest policies have become more important as academic medical centers worry that promotional talks undermine the credibility not only of the physicians giving them, but also of the institutions they represent.

[Asking a physician about conflicts of interest who is recommending some relatively new therapy or device, or novel use of an existing treatment, should now be considered standard patient operating procedure - ed.]

Yet when it comes to enforcing the policies, schools have allowed permissive interpretations and relied on the honor system. [In other words, the academic old boy's club turns a blind eye to abuses - ed.] ProPublica's review shows that approach isn't working: Many doctors are in apparent violation, and ignorance or confusion about the rules is widespread.

As a result, some faculty stay on the pharmaceutical lecture circuit, where they can net tens of thousands of dollars in extra income.

I find this doubly troubling. When I was a pharma research lab middle manager, a careful analysis I'd conducted over several months with the key scientific stakeholders demonstrated a $4 million+ annual gap in funding for provision of drug scientists with the information assets and informatics tools they needed to optimally perform their work.

Yet, I was only able to secure about a third of that (much of which was later rescinded after several late-state drugs in develpoment were withdrawn) while massive amounts of money was spent on marketing activities. (Even worse, the decisions were made by non-science-grounded computer personnel, further insulting my intelligence...and insulting the pocketbooks of investors and stockholders.)

The article then notes something we've noted frequently at this blog:

Critics of the practice say delivering talks for drug companies is incompatible with the job of teaching future generations of physicians. That's because drug firms typically pick the topic of the lecture, train the speakers, and require them to use company-provided presentation slides.

"You're giving someone else's messages, someone else's talk, someone else's judgments," said Bernard Lo, a medical professor at the University of California, San Francisco, who chaired a national panel examining conflicts of interest in medicine.

Lo then delivers the coup de grâce in a single sentence:

"We don't allow our students to use someone else's work."

Indeed, my students are now required by our university to attest to the originality of every assignment of submission, with penalties up to and including failure of a course and/or expulsion. In the face of the plagiarism made possible by new information and communications technologies (e.g., the Web), this policy will become more common.

Yet, it seems that some esteemed academic faculty, due to desire for money, cannot "keep it in their pants" and practice the morals their organizations preach. (The oldest profession suffers a similar vice.)

Then there's this startling finding:

Reporters compared the names of faculty members at a dozen medical schools and teaching hospitals with ProPublica's Dollars for Docs database of payments to doctors publicly reported by seven drug companies. Lists of the physicians whose names matched were provided to the universities and hospitals for verification and comment.

... "For God's sake, if the media can look at these websites, why can't we?" said David Rothman, president of the Institute on Medicine as a Profession at Columbia University. "Why trust if you can verify?"

I would suggest the answer to that question has to do with will, as opposed to lacking a way.

Now the personal angle:

At Penn, the top paid speaker, according to Dollars for Docs, was Corey Langer, director of thoracic oncology at Penn's Abramson Cancer Center. He made nearly $70,000 speaking for Eli Lilly & Co. in 2009 and the first half of 2010.

Langer also received unknown amounts from other firms, such as Genentech Inc., OSI Pharmaceuticals Inc., and Bristol-Myers Squibb Co., according to his disclosure for a medical education program this month.

By e-mail, Langer said he was "now fully aware" of Penn's policy and was "taking measures to curtail speaking for pharmaceutical companies.

I find this very sad.

This is a former medical school classmate at Boston University School of Medicine, Class of '81; in fact for a year we stood at adjacent tables in Gross Anatomy dating back to 1977. I knew him to be a brilliant student, and in several interactions with him in the early 1990's when I worked at an adjacent hospital to his, felt he had become an excellent clinician.

Interestingly, there was, in fact, a significant brouhaha in the class over gifting by pharmaceutical companies offering stethoscopes, black bags, and other accouterments of practice ca. 1978 or 9 as clinical rotations began. Several in the class were actually militant about the class setting a "no gifts from pharma" policy due to its potential effects on medical judgment and practice, and I recall the vigorous debates in the BU lecture halls vividly. This was in the late 1970's, I note, not 2010.

That one of my former classmates claims to only now be "fully aware" of pharma-related anti-conflict of interest issues in 2010 (like many others as in the article appear to become - after they are caught red handed) is a sad reminder to me of the state of healthcare and the corrosive influence of money.

The phenomenon is not just at a few organizations. The article continues:

UC Denver's experience was mirrored at other schools where officials discovered their policies were not working as expected.

The University of Pittsburgh's 2008 policy bans paid speaking in many cases, said Barbara Barnes, an associate vice chancellor in charge of industry relationships. Yet ProPublica found 22 Pitt doctors in its database.

At Stanford University, ProPublica found that more than 12 of the school's doctors were paid speakers, in apparent violation of its 2009 policy. Two had earned six figures since last year.

Philip Pizzo, the dean of Stanford's medical school, sent an e-mail to all medical school staff last week calling the conduct "unacceptable." Some doctors' excuses, he wrote, were "difficult if not impossible to reconcile with our policy."

[I'll bet those "excuses" would have made superb case studies in logical fallacy as well - ed.]

At least some are willing to own up to their behavior, although probably under duress:

Some Stanford doctors said they were in the wrong.

Among them was Alan Yeung, vice chairman of Stanford's department of medicine and chief of cardiovascular medicine, who has been paid $53,000 by Lilly since 2009. In an e-mail, Yeung said he quit speaking for the company this fall.

"I take full responsibility for this error," he said. "Even though I felt that these activities are worthwhile educational endeavors, the perceived monetary conflict may be too great."

While this is stated with typical academic fabric softeners and odor removers ("perceived", "may be", etc.), it's a start.

Finally, ethical simplicity itself:

[Stanford Medical School dean] Pizzo compared some doctors' explanations to what a police officer might hear after catching a motorist running a late-night stop sign.

"You can give 1,000 reasons: 'There was nobody around. It's safe,' " he said. "The reality is, it's still a stop sign."

Perhaps universities need to develop a suitable "stop sign" for posting outside their faculty offices.

May I suggest the following version:

(click to enlarge)

-- SS

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Mylan Settles, Merck KGaA Pays the Fine

The parade of legal settlements involving large health care organizations accused of wrong-doing just gets more and more crowded.  Here is the latest, courtesy the Pittsburgh Tribune-Review:

Mylan Inc., a generic-drug manufacturer in Cecil, agreed to a $280 million settlement of allegations that its Dey Inc. specialty-drug subsidiary cheated the government out of millions of dollars by reporting falsely inflated payments for several drugs, the Justice Department said.

'The government paid millions of claims for far greater amounts than it would have if Dey had reported truthful prices,' the Justice Department said.

Mylan acquired Dey when it purchased Merck KGaA's generic-drug business in October 2007 for $6.8 billion. The government's action began before Mylan acquired Dey.

Dey said in a statement that Merck KGaA is responsible for paying the full amount of this settlement as well as all costs and other expenses associated with pending and future related Medicare and Medicaid reimbursement lawsuits involving Dey.

It all gets so tiresome, doesn't it. However, before one starts yawning, remember how such settlements are markers of the prevalence of bad behavior by major health care organizations. The continuing parade of settlements thus is a big clue that there is something very rotten going on in health care, that the leadership of health care is increasingly amoral, greedy, and lawless.

Here again is our generic statement on the phenomenon:  As in many previous cases, note that the monetary cost of the above settlement, while it seems large to normal humans, would be just slightly more than round-up error for a large multi-national company.  As I have said repeatedly,  penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue.  As long as the bad behavior continues, expect health care costs to continue to rise, while access falls, and quality suffers.  True health care reform requires accountability, integrity, and transparency of health care organizational leadership.

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Exactech Settles, Its Regional Sales Director Pleads Guilty

The march of legal settlements by health care organizations continues.  Here is a curious story in two parts.  The first part was reported in the most detail by the Gainesville (FL) Sun:

Gainesville-based Exactech must pay $3 million and submit to a year of federal monitoring under a settlement to avoid prosecution on charges that resulted from an investigation into whether orthopedic implant manufacturers were paying kickbacks to surgeons to use their products.

The company announced the deferred prosecution agreement Tuesday after three years of an expanded federal probe.

The U.S. Attorney's Office for the District of New Jersey agrees not to prosecute charges of conspiracy to violate federal anti-kickback laws if the company avoids any violations for a year.

What did Exactech do to wind up in this pickle? It is not really clear. The article noted:

What the U.S. Attorney calls kickbacks Exactech calls consulting fees to surgeons to help develop better products — a common practice in the medical product field.

One can get a little better idea of what was going on by seeing what changes the company agreed to make:

Exactech will continue using surgeons as consultants, but under a more rigorous process that verifies that the work is needed, tracks the surgeons' work and pays them fairly.

The article went out of its way to say:

In accepting the agreement, Exactech does not admit to any wrongdoing and the U.S. Attorney acknowledges that the company's conduct did not hurt patient health or patient care.

Meanwhile, however, a short article appeared in the Parsipanny (NJ) Daily Record:

A salesman from Chester pleaded guilty to conspiring to violate a federal anti-kickback statute by entering into illegal financial deals to get surgeons to use his company's products, the US Attorney's Office said Tuesday.

Douglass Donofrio, 45, director of sales for Exactech Inc.'s northeast region, entered his guilty plea Tuesday before District Judge Garrett E. Brown in Trenton.

Exactech, a publicly traded, Gainesville, Fla.-based national manufacturer and distributor of orthopedic implant devices and supplies, simultaneously agreed to 12-month deal with the justice department to federal monitoring.

'This is a reasonable resolution, giving Exactech credit for positive steps it has taken while requiring continued reform and compliance to avoid more serious consequences,' acting U.S. Attorney Gilmore Childers said in a statement released by his office. 'The agreement does not erase the past, but supports a future corporate culture that will not tolerate kickbacks as business as usual. Unlawful consulting relationships compromise the integrity of our healthcare system, and we will continue to hold institutions and individuals accountable who are willing to put profits over patients.'

Exactech is charged in a criminal court complaint with conspiring to violate the federal anti-kickback statute.

The complaint alleges that from 2002 through late 2008, Exactech entered into consulting agreements with certain orthopedic surgeons — deals which were designed and implemented, in part, to induce the surgeons to use, and cause the purchase of, Exactech's hip and knee reconstruction and replacement products, according to Childers' office.

Note that probably because this case was small in monetary terms, reporting about it was fragmented and brief, making it very difficult to get a sense of what really was going on. 

So, while Exactech did not admit to any wrong-doing, one of its mid-level managers admitted to apparently just the sort of wrong-doing of which the company was accused. If that manager was only a lone loose cannon, why would the company have been pushed to change how it uses surgeon consultants, and why would it need "support" for "a corporate culture that will not tolerate kickbacks as business as usual?"

Nonetheless, only that one mid-level manager admits he did anything wrong.  If anyone else did anything wrong, who they were, and what they did remains unclear, hidden within a swirl of legalese.  Maybe unethical practices occurred, and maybe the new deferred prosecution agreement will prevent further unethical practices, but who can tell? 

If anything unethical did happen, there seems to no longer be any mechanism in health care to find out and  do something about it. 

This case appears to be a good example of how language can be tortured by legalistic parsing that avoids the fundamental ethical problems that now plague health care. As Dr Bernard Carroll posted recently, "legalistic charges and defenses are not the right way to go in exposing and ejecting bad actors from our field," because this approach "favors the bad actors, who flaunt their constitutional protections with the taunt, prove it."  Instead, as Dr Carroll implied, the standard in health care should require more than just avoiding felony convictions.

Even though the current case is small in monetary terms, it is a marker of unethical behavior.  The ongoing parade of legal settlements and criminal pleadings and convictions involving health care organizations, when viewed in its entirety, should convince professionals and policy-makers that health care is undergoing an ethical meltdown. 

The fines imposed by the settlements have never been large enough to be more than costs of doing business, and hence are unlikely to change behavior.  The legalistic approach has not resulted in more than a few people who authorized, directed, or implemented the bad behavior that lead to the settlements paying any personal penalties.  If we want the bad behavior to stop, we clearly need some other way to deter it.  Until we come up with one, expect it to continue, and to continue driving up costs, driving down access, and making patients' outcomes worse.

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Unintended errors with EHR-based result management: a case series, and a special pleading for health IT

As I wrote at "Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT", articles in the premier journal of Medical Informatics, the Journal of the American Medical Informatics Association (JAMIA) on real and potential downsides of health IT appear to be becoming a trend.

Another article just appeared in JAMIA as the result of a study of healthcare IT related errors: "Unintended errors with EHR-based result management: a case series"; Thomas R Yackel and Peter J Embi; JAMIA 2010 17: 104-107; doi: 10.1197/jamia.M3294.

The article presents a series of health IT-related errors and categorizes them systematically, and thus adds to our knowledge on the issue of cybernetic clinical test results management. It also makes recommendations for increased vigilance and remediation.

The abstract is below (access to the article itself requires a JAMIA subscription.)

ABSTRACT

Test result management is an integral aspect of quality clinical care and a crucial part of the ambulatory medicine workflow. Correct and timely communication of results to a provider is the necessary first step in ambulatory result management and has been identified as a weakness in many paper-based systems. While electronic health records (EHRs) hold promise for improving the reliability of result management, the complexities involved make this a challenging task. Experience with test result management is reported, four new categories of result management errors identified are outlined, and solutions developed during a 2-year deployment of a commercial EHR are described. Recommendations for improving test result management with EHRs are then given.

The article begins:

Over a 2-year period from 2005 to 2007, coinciding with the first 2 years of a planned 3-year deployment of the ambulatory EHR to multiple practice sites, the vast majority of laboratory result routing events functioned as intended. However, seven error types were identified as causing a substantial delay or disruption in result delivery to providers’ electronic inboxes [no statement is made about patient harm or "close calls" that may have resulted - ed.] and led to further investigations and case finding by our group.

Upon analysis, these seven error types were logically grouped into four distinct error categories: (1) interface and results routing logic errors, (2) provider record issues, (3) EHR system settings, and (4) system maintenance.

This was at OHSU, a leading institution in medical informatics, not at some organization that's a newcomer to health IT.

Each of the "error categories" is described in some detail. The article then makes recommendations for improved systems, which sound simple, but are going to be far more resource intensive on a national scale than meets the eye:

1. Develop fault-tolerant systems that automatically report delivery
failures.
2. Use robust testing to find rare errors that occur both within and between systems.
3. Implement tracking mechanisms for critical tests, such as cancer screening and diagnostics.
4. Deliver results directly to patients.

I find myself uncomfortable with the possible human resource costs of implementing the recommendations, especially on a national scale. These costs would be over and above the hundreds of millions per institution and the hundreds of thousands per private doctor already spent, or planned to be spent.

My other issue regarding the article (my main issue, actually) is its editorializing for a product, health IT, in a scientific article, and making a special pleading for the technology.

The next to last paragraph of the article appears more of an editorial, perhaps to make vendors comfortable, than a scientific statement of fact supported by the article:

Finally, while it might be tempting to attribute the errors noted above to the use of a particular health information system or even Health IT in general, an examination of the cases reveals that most of these errors actually resulted from local configuration and implementation decisions rather than to the technologies themselves. Indeed, the authors believe that these cases further support the emerging truism [wow! This is news to me - ed.] that errors related to Health IT are in most cases the result of human error in the implementation of new information and communication systems into our existing complex healthcare environments.[10] Therefore, we contend that the main lesson arising from these cases is that care must be taken by those responsible for implementing health information systems to remain aware of the kinds of errors that might occur and monitor for the unexpected consequences that will undoubtedly take place, but not to avoid use of such systems that likely have the capacity for far greater benefit than harm, if implemented and monitored properly.

In this paragraph the authors state: "... while it might be tempting to attribute the errors noted above to the use of a particular health information system or even Health IT in general, an examination of the cases reveals that most of these errors actually resulted from local configuration and implementation decisions rather than the technologies themselves."

Sept. 2011 addendum: the article was written before Dr Jon Patrick's expose of examples of the internal flaws of commercial health IT, as here: link, link.

As for "rather than the technologies themselves", technologies themselves are never a problem by themselves, even the atomic bomb. In a reductio ad absurdum, which is maybe not so absurd, it took a B29 Superfortress to drop two A-bombs; the bombs could have been deactivated and put in a museum instead.

However, consider a poorly designed A-bomb that could unpredictably go "BOOM" - now that would be a problem.

While I agree some errors are due to mismanaged implementation, in the article, no differentiation is made of design issues vs. implementation (i.e., local configuration and implementation decisions). Yet fundamental design is crucial, according to industry leaders and non-industry experts, in areas that cannot be vastly improved by local configuration decisions:

HIMSS's former Chairman of the Board admits the technology remains experimental:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better;

While HIMSS itself admits in this 2009 PDF that

"Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available";

While the National Research Council (the highest scientific authority in the U.S.) last year reported that:

"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt);

It is very difficult if not impossible to make a clinical IT silk purse out of a poorly designed sow's ear, no matter how many sound "local configuration and implementation decisions" are made.

Further, it is stated in the JAMIA article that human errors in implementation as the cause of health IT woes are an "emerging truism".

Making the case that some observation reflects a "truism" is a powerful claim. Such a claim deserves more than one reference, but here's what we have:

"... the authors believe that these cases further support the emerging truism that errors related to Health IT are in most cases the result of human error in the implementation of new information and communication systems into our existing complex healthcare environments" [10].

10. Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc 2004;11:104–12.

Perhaps the term "truism", emerging or otherwise, should be avoided in 2010 regarding errors related to health IT.

The authors contend, presumably from the above observations that:

... we contend that the main lesson arising from these cases is that care must be taken by those responsible for implementing health information systems to remain aware of the kinds of errors that might occur and monitor for the unexpected consequences that will undoubtedly take place

"Might occur?" How about "that do occur" - as in the paper? Above all, these involve patients.

Unexpected consequences - these involve patients, too.

My relative was nearly killed by "unexpected consequences:" of health IT in May 2010. Perhaps that makes me less cavalier about health IT.

In fact, the certainty that UC's will "undoubtedly take place" reaffirms that these are still experimental technologies.

I remind that it might be best to focus on fundamental design issues before expensive systems are put into place that can cause errors and unexpected consequences, because these are mission critical systems involving live patients who have not, incidentally, been afforded informed consent to the use of these medical devices in their healthcare.

Another editorial comment follows:

[the lesson is that those responsible should remain aware] but not to avoid use of such systems that likely have the capacity for far greater benefit than harm, if implemented and monitored properly

Once again, this is an editorial and value judgment. Who knows if ultimately health IT has a capacity for far greater benefit than harm? If these systems will have predictable, unexpected consequences, how do we know that? Why should critical-thinking practitioners not avoid such systems for now until a better understanding of how to design them to improve usability and support clinician cognition is achieved?

Why put patients at risk en masse as part of a national experiment when studies even at advanced HIT sites show fundamental problems that could harm or kill?

I argue this paper and others that are "emerging" on the downsides and lack of ROI of health IT make the case for great caution and slowness (i.e., avoidance) in their adoption.

Yet the authors seek special accommodation for this technology, something that is perhaps unprecedented with (unregulated) medical devices of unknown risk.

The lesson is actually that we need to slow down with HIT; reboot and start to solve the problems of this technology before national rollout attempts.

This is the ethical position regarding any experimental medical technology that is proving risky at a level not clearly known.

-- SS

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