Tuesday, September 30, 2008

Walgreen Settles

Here is the next story in what seems like an endless succession of prominent health care companies settling lawsuits alleging improper behavior, via the Minneapolis Star-Tribune:

Walgreens has paid the United States and Minnesota and three other states nearly $10 million to resolve allegations of falsely billing Medicaid, the U.S. Justice Department announced Monday, with some of that money going to two Twin Cities pharmacists who turned in the industry giant.

Illinois-based Walgreens charged Minnesota, Florida, Michigan and Massachusetts as if some Medicaid recipients were uninsured, the Justice Department said, when those members were actually covered by Medicaid and by private insurance. The department said Walgreen was entitled to a copay, but instead, charged the difference between what the insurance companies paid for the drugs and what the Medicaid programs would have paid if the recipients were uninsured.

As a result of this improper billing, Walgreens received reimbursement amounts from the states' Medicaid programs that were higher than it was entitled to receive.

Walgreens spokesman Michael Polzin blamed the problem on 'inadvertent billing errors' because of a 'unique requirement for Medicaid billing when Medicaid is a secondary insurer.'

This is the second settlement of this kind we have discussed this week. Its immediate predecessor was the Cephalon settlement. Earlier this year we discussed settlements by Staten Island University Hospital, Amerigroup, UnitedHealth, Anthem Blue Cross and Blue Shield, and HealthMarkets, Express Scripts, Kyphon (Medtronic subsidiary) and Merck. Of course, to these could be added various other ethical lapses, including some involving guilty pleas to criminal charges (e.g., Biovail, and at UMDNJ)

Juxtaposing these events in a procession suggests there are serious systemic ethical problems in the leadership of health care organizations. Moreover, these problems likely have cumulative adverse effects on heath care costs, access and quality, and on the morale of health care professionals. However, outside of Health Care Renewal, there seems to be almost no discussion that so juxtaposes them. In particular, try to find any mention of them in the health services research, health care research and health care policy literature.

Furthermore, while these settlements serve to mark the unethical behavior of the organizations and individuals involved, they never seem to have a large enough monetary value to actually discourage such behavior. As long as health care leaders can shrug off the consequences of unethical behavior merely as acceptable costs of doing business, absent any serious attempts to get health care organizations to enforce internal codes of ethical behavior or to avoid hiring ethically challenged leaders, the procession will likely continue. The effects will be continually rising costs, declining quality, shrinking access, and rising numbers of demoralized health professionals.

Maybe at a time when many people see arrogant, greedy, and unethical executives as the main reason our financial system seems to be in incipient collapse, they will also realize that the same sorts of executives may be a major cause of our ongoing health care crisis.

What's a life worth to Cephalon and its stockholders?

Apparently, not very much, considering their off-label promotions of opiate-laced lollipops.

In what prosecutors called the largest health-care settlement in federal court here, Cephalon Inc. will pay $425 million to settle criminal and civil charges that it illegally marketed three of its drugs.

The Frazer company is expected to plead guilty in U.S. District Court to one misdemeanor criminal charge, the U.S. Attorney's Office in Philadelphia announced yesterday.

Cephalon, a biopharmaceutical company based in Chester County, previously announced last November an "agreement in principle" with the U.S. attorney and Justice Department over an investigation that began in 2003 of its "off-label" promotion and sales of pain medication Actiq, Provigil for sleep disorders, and Gabitril for epilepsy.

Cephalon said yesterday that it had reached separate agreements with attorneys general in Connecticut and Massachusetts to settle related probes.

The drug manufacturer will pay $6.15 million to Connecticut and $700,000 to Massachusetts.

That's the cost of "doing business" to unscrupulous drug marketering and salesforce leaders:

Cephalon's off-label campaigns were successful. Actiq sales jumped from $50.1 million in 2001 to $550.4 million in 2006.

Gabitril revenue rose from $24.6 million in 2001 to $87.3 million in 2004, and Provigil sales from $146.2 million in 2001 to $691.7 million in 2006, the government said.

What's the problem with the strategy of off-label advertising?

While doctors are free to prescribe medicines for any condition they believe appropriate, drug manufacturers can promote products in the United States only for FDA-approved uses.

Were leaders at Cephalon, I add, hired and trained and unleashed without that knowledge? Or did they deliberately flout the law? And if so, have the individuals involved been properly held accountable?

Law enforcement authorities began seeing misuse of Actiq by people who also abused OxyContin and other narcotic painkillers in 2004. Actiq had the street name "perc-o-pops."

Actiq, a berry-flavored cancer-pain treatment on a stick, is approved to treat bouts of severe cancer pain in patients who can tolerate opiods such as morphine. But Cephalon promoted it to treat migraines and backaches, prosecutors said .... acting U.S. Attorney Laurie Magid said at a news briefing "We know in the case of these drugs, patients were harmed, including death, when there was off-label use."

Treatment of migraines and backaches with a drug used to treat pain of metastatic cancer?? The former are just the complaints many addicts use in ED's and doctor's offices to get drugs.

I spent the early part of my career trying to convince public transit vehicle operators, police, fire, and other mission-critical personnel not to abuse drugs, and oversaw testing for same.

Now, here come the pharmas, encouraging physicians (some of them - a minority - unscrupulous themselves, but others naive or misled by drug reps and advertising) to prescribe questionable drugs resulting in harm to innocent patients, abuses by dishonest "patient-actors", and support of the street drug trade.

How did this practice come to light?

In January 2003, a former Cephalon sales representative in Ohio, Bruce Boise, contacted the FDA about Cephalon's sales practices. Boise wore an undercover wire to a company sales conference to help the government gather evidence, according to his Washington-based attorney, Peter Chatfield.

In November 2003, another Cephalon sales representative, Lucia Paccione, of Philadelphia, filed the first of four qui tam "whistle-blower" lawsuits. The complaints were unsealed yesterday.

In this case, four whistle-blowers will divide about $46.5 million plus accrued interest, prosecutors said.

The ultimate costs to the company?

News of the settlement, known to Wall Street for months, barely budged Cephalon's stock price. Shares closed down $1.31, or 1.64 percent, at $78.57. Cephalon had reserved the $425 million for the federal settlement last year.

In summary, the life of an unsuspecting patient who takes Cepahalon drugs for off-label uses that were illegally advertised and then suffers harm, and the life of those addicted to drugs, seem worth little to Cephalon and its stockholders.

In my opinion, as long as this pharma/stockholder/cost-of-doing-business dystopia continues, we can look forward to an unending stream of this type of situation.

The penalties for this type of conduct need to be escalated. Instead of just a fine of $425 million, how about the addition of long prison sentences and exclusion from any further involvement in biomedicine - for life - for the perps?

-- SS

Sunday, September 28, 2008

BLOGSCAN - Duplicate Publication about an SSRI

On the Clinical Psychology and Psychiatry Blog, the anonymous blogger described an interesting example of apparent dual publication on a selective serotonin reuptake inhibitor (SSRI) anti-depressant drug, duloxetine (Cymbalta, manufactured by Eli Lilly). Important aspects of the story include how both articles draw conclusions that go well beyond the (same) data in their enthusiasm for the drug in question, and how the second article incorporated an author not found in the first, an author who also happened to be the co-editor in chief of the journal in which the second article appeared, and the leader of an important medical society. This author has been the subject of previous posts (like this one), on Health Care Renewal.

Saturday, September 27, 2008

Update on the NIH “Trial to Assess Chelation Therapy”

(Some of the following is identical to a post on Science-Based Medicine dated 9/26/08.)

A few days ago, while gathering information for a post on Science-Based Medicine about intravenous hydrogen peroxide, I noticed this:

ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false. ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.

I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:

The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

The “allegations of impropriety” mentioned in the ACAM press release had been made by my co-authors and me in a comprehensive article previously introduced on Health Care Renewal here. The article is available in its entirety here. In June, we made a formal complaint to the federal Office of Human Research Protections (OHRP), citing that article and additional information posted on Science-Based Medicine here. That our complaint was the instigating factor for the recent “decision to suspend patient accrual” is suggested by an email that I received last week:

I would like to know who is paying you guys off. Finally we have a chance to assess Chelation therapy and put the issue to rest and to find out whether or not it really works and you bozos screw it all up. I know that the trial was stopped and it is your fault. What are you afraid of? Why are you not decrying all of the injuries caused by medications and unnecessary surgeries? Why are we the citizens of the US deprived of a trial of EDTA so that we can judge for ourselves?

Anyone who is a thinking man, can only be disappointed in you. [sic]

Binyamin Rothstein, D.O.

Rothstein, unlike many of his fellow ACAM members, does not appear to be a TACT investigator. Like them, however, he touts chelation, intravenous hydrogen peroxide, and other baseless and dangerous treatments. He has harmed patients, his protestations nothwithstanding. His medical license was revoked in 2005, but that hasn’t hindered him from using smoke and mirrors in his relentless pursuit of profit from nonsense. He’s even managed to promote himself to the public without revealing key items from his resumé—one of the many reasons that even the most diligent regulation can’t always protect the public from scoundrels.

At least two reporters have recently covered the story (here and here). They mostly get it right. The AP report, however, states that chelation "is mainly used to treat lead poisoning." That is not technically false, but is misleading because disodium EDTA (Na2EDTA), the drug used in the TACT, has never been approved for lead poisoning and is considerably more dangerous than calcium EDTA, the drug that is so approved. Ironically, one of our objections to the TACT is that its literature---including protocols, consent forms, and subject recruitment pitches---conflates the two drugs so as to make the study drug appear safer than it is.

Indeed, the FDA has recently withdrawn its approval of Na2EDTA, citing "important safety information" and the possibility that it may be confused with the less dangerous CaEDTA:

As noted in the January 16, 2008, Public Health Advisory, there have been cases where children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate) or when edetate disodium was used for indications other than those approved by FDA.

Readers might remember that we at HCR have previously discussed the important distinction between the two EDTA salts, after a 5-year old boy was killed in Pennsylvania when a quack administered Na2EDTA to him as a treatment for autism. At the time a CDC expert was so surprised that anyone would infuse Na2EDTA that she concluded, erroneously, that it must have been a drug error: "a case of look-alike/sound-alike medications." The PA medical board's investigation subsequently confirmed that the practitioner had intended to give Na2EDTA, exactly as we had predicted.

The TACT should now be stopped altogether. Contrary to the ACAM press release, our objections to the TACT are scrupulously documented and not “of a political nature.” They are of a scientific and ethical nature. They will not be proven false, because the evidence for them is overwhelming.

Thursday, September 25, 2008

Did Mrs. Jones receive her off-label failed spinal implant via excellent informatics data, or via a surgeon's visit to a prostitute?

In a story that leaves me at a loss for what has become of medical ethics, I read that Medtronic stands accused of, among other marketing tactics, inducing surgeons to use its spinal implant devices via kickbacks and outings to a now-closed Memphis strip club whose owners pleaded guilty to dancers engaging in acts of prostitution.

Apparently the devices were being used extensively for off-label uses, resulting in unexpected adverse events, some quite serious in nature.

I could not have made up this rather sordid story if I tried:

Wall Street Journal
Sept. 25, 2008

Lawsuit Says Medtronic Gave Doctors Array of Perks

(subscription required)

A lawsuit brought by a former Medtronic Inc. lawyer alleges the big medical-device maker gave surgeons a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in. The previously undisclosed allegations involve Medtronic's spinal-devices unit, which has $3 billion in annual revenue. The unit's business relationships with doctors who use its spinal-repair implants are being investigated by Sen. Charles Grassley and have been the focus of lawsuits by other former employees.

Sen. Grassley has been looking into whether inducements for doctors, like those alleged in the lawyer's suit, have led to what surgeons say is widespread off-label use of Medtronic spine products.

... Ms Kelley's [whistleblower Ami P. Kelley, a former senior legal counsel for the spine unit] lawsuit says kickbacks were "pervasive" and "the culture and way of doing business" at Medtronic. Sales staff, she said, "routinely took physicians" visiting the spine unit's Memphis headquarters to the Platinum Plus strip club, and picked up the tab for the dancers' services during "VIP visits." In 2007, Platinum Plus's owner pleaded guilty to charges related to dancers engaging in acts of prostitution, and the club has closed.

Ms. Kelley's lawsuit sought to recoup damages for the federal government, which prohibits companies from giving doctors inducements to use products covered by Medicare or Medicaid.

Her lawsuit and a separate one that also accused the spine unit of paying illegal kickbacks to doctors were the basis for a $40 million settlement deal between Medtronic and the government in 2006, according to the settlement document.

"VIP Strip Club" visits for orthopedic surgeons and neurosurgeons? I'm certain that only the most advanced scientific discussions between company and client occurred at such venues.

My questions are:

  • Why would any physician allow themself to be taken by a vendor to a strip club? This is a questionable and unprofessional activity on its face, but in the context of vendor marketing to surgeons (presumably male), it is even more appalling. I personally would have rejected such an invitation out of hand as being sleazy and tawdry by its nature.
  • Was there a genuine data-driven attempt to evaluate the off-label uses?
  • What datasets were being collected by the company and the surgeons to support non-FDA-approved uses of the spinal implant devices?
  • Who designed those datasets?
Not to mention:

  • Did the wives and families of the surgeons know where their husbands and fathers were being taken on their "business trips to Medtronic?"

The names of the involved physicians are currently a closely-guarded secret:

The former Medtronic lawyer's allegations are contained in a 2002 suit filed in U.S. District Court in Memphis against Minneapolis-based Medtronic and 10 doctors. The lawsuit and other filings in the case remain sealed, except for a heavily redacted copy of the complaint, which contains none of the doctors' names nor specifics of the allegations.

Medtronic has refused repeated requests from the Senate Finance Committee's staff for an unredacted version. Sen. Grassley, an Iowa Republican, is the panel's ranking minority member.

... The Kelley lawsuit names several top spinal surgeons among the 10 doctor defendants and lists several others as receiving inducements.

The complaint clearly comes from the typical "disgruntled employee":

Ms. Kelley, who now works at another company, alleges she was dismissed by Medtronic after challenging improper payments.

One surgeon's name was apparently made available to the WSJ:

The suit says surgeon Jeffrey Wang, now director of the University of California at Los Angeles's Comprehensive Spine Center, "liked to be taken" to Platinum Plus and emailed Medtronic sales official Brad Hancock saying he was "looking forward to going" to the club with him.

Of course, UCLA has an air-tight explanation for this:

A UCLA spokeswoman said Dr. Wang, who isn't named as a defendant in the suit, "denies ever being entertained by Medtronic at the Platinum club" and doesn't recall sending any such email. If he did send it, she said, "it would have been done so in jest."

In jest? They mean to say, a top surgeon who claims he never went to the club, doesn't recall sending the email --- but if he did actually send it and simply forgot (meaning he would have known a vendor takes doctors on "VIP visits" to strip clubs / houses of prostitution but refused to go himself) then it was just a joke?

On the MedInformaticsMD scale of credibility, that rates about a 0.3 out of 10. It's not even good spin.

All is better now:

Medtronic declined to comment on the lawsuit's allegations. It said it has changed many business practices since the suit was filed, and is "committed to reform and transparency in the industry."

How reassuring.

Actually, not, considering the posts about Medtronic's practices on this blog here, here, here and here, among others.

Also not reassuring was the simplest Google news search on "spinal implant problem medtronic" which returns items like this:

Medtronic Will Settle Accusations on Kickbacks
New York Times - Jul 19, 2006
Medtronic was the subject of two lawsuits filed in Federal District Court in Memphis by whistle-blowers on the actions of its spinal-implant division, ...
All 14 related - Related web pages

Medtronic to settle with doctor over spinal implant invention.
Free with registration - Saint Paul Pioneer Press - AccessMyLibrary.com - Apr 23, 2005
Spinal implant devices are part of a division that accounted for 20 percent of Medtronic's $9.09 billion in total sales last year. In 1999, Medtronic paid ...
Medtronic to Pay $1.35 Bln to End Spinal Doctor... - Bloomberg
Medtronic to buy spine patents, ends legal battle - USA Today
Forbes - San Diego Union Tribune - All 22 related - Related web pages

Medtronic Sofamor Danek's Patent Infringement Lawsuit Begins.
Free with registration - Commercial Appeal - AccessMyLibrary.com - Jun 4, 2004
Medtronic Sofamor Danek and Dr. Gary Michelson are disputing patent rights over the Los Angeles surgeon's inventions in spinal implants, instruments and ...
All 2 related - Related web pages

Medtronic Must Pay Inventor $109 Million, Jury Says (Update3)
Bloomberg - Sep 28, 2004
28 (Bloomberg) -- A US jury told Medtronic Inc., the world's biggest maker of spinal implants, to pay at least $109 million to an inventor for violating ...
Medtronic Must Pay Inventor $109 Million, Jury... - Bloomberg
Memphis, Tenn., jury awards surgeon $110 million... - Commercial Appeal - AccessMyLibrary.com (Free with registration)
All 12 related - Related web pages

Medtronic Must Pay Surgeon $400 Mln Punitive Damages (Update2)
Bloomberg - Oct 12, 2004
Minneapolis-based Medtronic doesn't break out sales of spinal implants. The unit that includes spinal products, as well as ear-nose-and-throat devices, ...
Medtronic ordered to pay $400 million to Los... - Saint Paul Pioneer Press - AccessMyLibrary.com (Free with registration)
$400 Million Judgment Against Medtronic - New York Times
Los Angeles Times - Star Tribune - All 11 related - Related web pages

I'm not even going to attempt to dig any deeper. I fear I may lose my breakfast as a result.

However, hopefully Sen. Grassley and his staff will dig deeper.

A lot deeper.

It's hard for Medical Informaticists and others to help usher in an era of data-driven healthcare when we are competing with strippers and prostitutes for the affection of our surgeons.

-- SS


I am increasingly coming to believe the executive resistance I faced to development of an advanced, very fine-grained, still-used Invasive Cardiology Clinical Database (ICCD) at a major heart center in Delaware late last decade was not based on scientific issues.

This information system could show whether a new device or treatment was effective or not in short order, affecting valuable orders for devices. In fact, in its first year it saved almost $1 million in expense through just that means.

Interestingly, the resistance was from administration and IT, not the doctors, who were the true cheerleaders of the system. Reading the increasingly common stories about the way business is conducted by such companies, I do wonder if cardiac device companies could have been in bed with administration in some way.

Additional addendum 9/28/08:

UC leadership is certainly aware of this issue as well as this posting, after reading it via a Google search on the terms "Medtronic" and "stripper." From the HCRenewal tracking logs:

Domain Name: ucsf.edu ? (Educational)
IP Address: 169.230.242.# (University of California San Francisco)
ISP: University of California, Office of the President
Operating System: Macintosh MacOSX
Browser: Firefox
Time of Visit: Sep 28 2008 6:35:33 pm
Last Page View: Sep 28 2008 6:35:33 pm
Referring URL: http://www.google.co...r&btnG=Google Search
Search Engine: google.com
Search Words: medtronic stripper
Visit Entry Page: http://hcrenewal.blo...eive-her-failed.html
Visit Exit Page: http://hcrenewal.blo...eive-her-failed.html

Wednesday, September 24, 2008

Brown University Student Journalists Dare to Report on Paxil/ Seroxat, Study 329 and GSK

We have published a few posts about the controversy about the clinical research supporting the use of paroxetine (Paxil, Seroxat in the UK, made by GlaxoSmithKline) in depression (here, here, here, and here.) This controversy includes allegations that clinical research funded by GSK was manipulated, and that the company's marketing for the drug was unsupported by clinical evidence. GSK settled a case alleging fraud in the marketing of Paxil by then NY Attorney General Eliot Spitzer in 2004. A recent article provided arguments and evidence that Study 329, a clinical trial of paroxetine for adolescents, was manipulated , allegedly at least with the acquiescence of Brown University Psychiatry Chair Dr Martin Keller. [Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008; 20: 73-81. Link here.] A book entirely devoted to this controversy, Side Effects by Alison Bass, who started reporting on the case in 1999 for the Boston Globe, was just published.

I am a still proud alumnus of Brown University (undergraduate and medical). I was a full-time faculty member at the University from 1994-2004, and am still a clinical faculty member. Despite Dr Keller's and the University's central role in the case, at least as alleged by Ms Bass and by Jureidini et al, there has only been silence about the case here in Rhode Island.

That just changed. Intrepid reporters from the Brown Daily Herald published two stories on the GSK/ Paxil/ Keller controversy. Both included some important original reporting, as well as providing clear summaries of the issues at hand.

The first article dealt mainly with Keller's alleged conflicts of interest. This article provided confirmation that Senator Charles Grassley (R-Iowa) and the US Senate Finance Committee is, in fact, investigating Dr Keller and Brown University in connection with the controversy. It also included other original reporting, including an acknowledgement from GlaxoSmithKline Director of US Media Relationships Sarah Alspach that the company had provided the committee with full information about the compensation it gave Dr Keller.

The second provided a quite clear explanation of the allegations about the manipulation of Study 329. This article also included results of an interview with Dr Jon Jureidini, the author of an article that dissected study 329, and suggested that it had been manipulated to enhance the apparent benefits of paroxetine, and diminish its apparent risks. The reporters noted that Jureidini was "confident that data in Study 329 were deliberately misrepresented." They were also able to obtain an internal GSK document that acknowledged that study 329 did not prove the efficacy of the drug.

The BDH reporters, Chaz Firestone and Chaz Kelsh, in my opinion, did a fine job, clearly explaining the issues, and digging out some new facts on the case.

Nonetheless, the BDH reporters were not able to get Dr Keller to talk to them, despite several attempts. They were not able to get anyone in the University administration to discuss any substantive aspects of the case. The highest ranking University official who would talk to them was Provost David Kertzer. He asserted that the University "can't discuss particular cases of possible claims of wrongdoing and what we do about them."

In my opinion, and as I said to the reporters, one of the most distressing aspects of this case is the refusal of Dr Keller or anyone in the University to deal with the content of the case. Very serious allegations have been made. If they can be refuted, they should be. If not, stonewalling only increases the impression that the University administration has something to hide.

Furthermore, the case raises important issues about science and clinical medicine. Universities are supposed to be where people can conduct free enquiry. There seems to be no free enquiry at Brown into the issues raised by this case. University administrators should be encouraging free enquiry. Here, they seem to be doing their best to avoid, if not stifle it.

Today, the BDH published its own editorial on the case, suggesting that Dr Keller's "actions directly affect the integrity of the University." If so, the University community should, at the very least, be discussing these actions, how they affect this integrity, and what ought to be done about it. Unfortunately, I am not optimistic that there will be an open discussion of these issues, even after the brave publication of these articles. The University administration seems to have some reason they want to clamp a lid on this case, and I am afraid they will continue to do so. The medical school faculty, lacking tenure and remembering what happened to previous dissenters like Dr David Kern, are likely to be too scared to push that lid away. Woe unto Brown.

See also comments on the Alison Bass Blog, PharmaGossip, and Pharmalot.

ADDENDUM (29 September, 2008) - See also this post on the Alison Bass blog, with links to some of the original documents relevant to study 329.

Failed "Masters of the Universe" Running a Renowned Teaching Hospital

The Wall Street Journal Health Blog recently reported about some New York City hospitals worried about the current financial/ economic crisis, but for interesting reasons:

To give you a sense of how the crisis on Wall Street is affecting New York hospitals, we need only provide the names of some financial execs who are on the board and donor list of of New York-Presbyterian Hospital.

The chairman of the board is John Mack, Chairman and CEO of Morgan Stanley — you know, that big investment bank that just scrapped its business model? Serving alongside him was Richard Fuld, CEO of Lehman Brothers, the one that’s now reorganizing under bankruptcy protection. Another board member is John Thain, CEO of Merrill Lynch, which is selling itself to Bank of America. The hospital’s chairman emeritus is Maurice “Hank” Greenberg, former chairman and CEO of AIG, the insurance titan effectively taken over by the government.

Hospital execs worry that now just might not be the time to call their friends on Wall Street to ask for donations.

I will make a bet that if one were to get lists of the top current and recent former leaders of all the financial corporations that have just failed, one way or the other, in particular, Bear Stearns, Lehman Brothers, Merrill Lynch, Fannie Mae, Freddie Mac, and AIG, you would find quite a few who also have leadership positions (often as board members) of important health care organizations, both for-profit and not-for-profit. For example, we noted that the former CEO of Fannie Mae, James A Johnson, who was forced out after an accounting scandal that presaged the current plight of the company, was also a board member of UnitedHealth, and had approved the outlandish compensation given to now prematurely retired UnitedHealth CEO Dr William McGuire.

But the board members of a not-for-profit teaching hospital are not just supposed to be a group of the largest contributors. The board of directors or trustees of a not-for-profit institution provides the highest and final layer of oversight for the organization. Hospital executives are supposed to answer to, and are hired and fired by the board. The board has ethical, and in some states legal responsibilities to uphold the mission of the organization, and when making decisions for the organization, to put the mission and the interests of the organization ahead of personal interests.

So it seems reasonable that all the board members of not-for-profit hospitals should be devoted to the mission of the hospital, and the values that underlie it. Furthermore, it seems reasonable that all board members should at least either have substantial knowledge about the health care context, and/or have considerable intelligence and leadership abilities.

However, the board of this one illustrious teaching hospital included four corporate executives who had no particular knowledge of health care. They have now been shown to have lead spectacularly failed corporations, corporations whose failures have contributed to what some people now call the biggest economic crisis since the great depression. This is not a great testament to the intelligence and leadership abilities of these former "masters of the universe," although it is perhaps a testament to their ability to promote themselves.

So whoever is now responsible for leading the hospital, and beyond that, all those who are concerned about the reputation of the hospital and its ability to fulfill its mission should be wondering why in the world these people were on the board? Furthermore, they should be wondering what was and is wrong with the process that appointed such leaders to this level?

We have frequently discussed how leaders of health care organizations have often proved to be autocratic and "imperial," ill-informed about health care, indifferent to the values of health care, isolated and insulated, self-interested, conflicted, or even corrupt. We have contended that such bad leadership is a major, but rarely discussed cause of what has gone wrong with health care.

That arrogant and over-paid CEOs of some of the most spectacularly failed financial corporations of this century were also leading one of the country's (formerly?) great teaching hospitals says something major about what has gone wrong with the leadership of health care.

ADDENDUM (24 September, 2008) - the US Federal Bureau of Investigation (FBI) is now investigating four of the above firms, Fannie Mae, Freddie Mac, Lehman Brothers, and AIG, according to the New York Times.

Monday, September 22, 2008

Are You Ready for Some Football? - St Louis University Hospital Pays to be Official Hospital of the St Louis Rams

The St Louis Post-Dispatch reported on the latest fashions in hospital marketing:

St. Louis University Hospital calls itself the 'official' hospital of the St. Louis Rams on billboards and signs.

But its doctors provide no medical care for the Rams' team.

Team doctor Matt Matava and his colleagues from Washington University School of Medicine since 1995 have provided that service at BJC HealthCare facilities.

SLU Hospital defends the sponsorship deal. 'We're not out there trying to say we take care of the Rams,' said Laura Signaigo, its marketing and communications director. 'This is a marketing agreement.'

Sports teams have sponsorship arrangements with nearly every industry — from banks to breweries. Still, if a hospital calls itself the 'official' hospital of a sports team, do patients — and prospective patients — assume its physicians treat the players?

'Do I think it's clear to the general public (that this is a marketing agreement)? I don't know,' Signaigo said. 'I think the Rams have a product to sell, and I bought it.'

At one time, professional sports teams paid top dollar so their athletes could be treated by the best physicians. Then, the tables turned. Doctors and hospitals began paying teams — at times more than a $1 million a year — for the privilege of treating players.

A survey in 2004 by The New York Times found about half the teams in the four major North American professional leagues were tied contractually to a medical institution, and the numbers were growing. Those arrangements had varying business models. Few, if any, had an arrangement like the Rams and SLU Hospital, where the 'official' hospital did not provide care.

The advertisements never say the hospital's doctors are the Rams' physicians or that the hospital provides care, said Matt Marchal, who at the time was a sales manager for the Rams. He recently changed jobs and now works in insurance.

'They're leveraging the relationship … being associated with a professional football team carries a lot of weight,' Marchal said.

Signaigo also points out the term 'official hospital' is the Rams' terminology. It is supposed to signify a level of sponsorship, not a clinical relationship, she said.

'The purpose from a marketing perspective, in my opinion, is to tie into the positive perceptions that these organizations have with the public,' Signaigo said.

In my humble opinion, the most likely interpretation of a statement that the hospital is the "official" hospital of a sports team would be that the team gets their care at the hospital. The wording on its surface does not suggest that the hospital paid the team for the designation. Thus, this seems to be a particulary cynical way to market a health care institution. But what else should we expect from marketers in health care?

There was once a time when hospitals (and doctors) did not advertise. Those pushing for advertising argued it would lead to more informed patients. To often, however, it seems mainly to lead to deception.

Until 1980, the American Medical Association warned, "the practice of medicine should not be commercialized, nor treated as a commodity in trade."(1) According to Dr Arnold Relman, it was forced to change that position after a 1975 US Supreme Court decision that decreased anti-trust protection for physicians, effectively treating them more as trades people than professionals. Maybe it is time to urge reconsideration of that decision, and more appreciation of the old AMA policy.


1. Relman AS. Medical professionalism in a commercial health care market. JAMA 2007; 298: 2668-2670. Link here.

Sunday, September 21, 2008

More Lucrative Payments to Orthopedic Surgeons: This Time Consulting Fees By Medtronic to Spine Surgeons

Starting last year, 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. Our last post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.

This month, the Minneapolis Star-Tribune published a series of reports on its investigation of payments made to orthopedic surgeons by medical device maker Medtronic. Unsealed documents from an ongoing lawsuit suggested that this company also made some strikingly large payments to orthopedic surgeons who perform spine surgery. The Star-Tribune's first article focused on a single surgeon:

Dr. David Polly's reputation precedes him and it's worth a lot. Among spine surgeons, this rather unremarkable-looking 51-year-old is a rock star.

Arrayed before him as he spoke at the annual Design of Medical Devices Conference at the University of Minnesota were two dozen doctors, engineers, students and medical device company representatives, some furiously scribbling notes. In this reverential group, Polly's mention of a particular surgical technique or medical device would be golden.

They already knew much about this man with a 29-page résumé. The head of orthopedic spine surgery at the university, Polly has led close to 80 research studies and co-written at least 90 scientific papers on repairing aging, injured and contorted spines. In an era of active baby boomers, many with ailing backs, Polly's specialty is a growth industry.

Polly's paid consulting relationship with Medtronic Inc., the global leader in medical devices, was not a focus of discussion that muggy April day. The Fridley-based firm makes the plates, screws, cages, neurostimulators and bone grafts that largely comprise the toolbox of spine repair.

A recently unsealed whistleblower lawsuit, and Congressional and Justice Department investigations, are finally bringing into public view the practice of handsomely reimbursing top doctors to consult for medical device companies.

The $344,375 in consulting fees Polly allegedly received from Medtronic in 2006, and similar amounts in 2004 and 2005, are only emerging because of a complaint filed in a whistleblower lawsuit by two former Medtronic employees in U.S. District Court in Massachusetts.

Another article focused on another surgeon:

Dr. Kenneth Burkus is quite confident his eight-year relationship as a paid consultant for Fridley-based medical device maker Medtronic Inc. hasn't compromised his patients' care.

The Columbus, Ga., surgeon said he receives royalties for helping to develop the company's artificial neck disc and other products. A whistle-blower lawsuit filed in Massachusetts federal court alleges that he was paid $416,775 for consulting work in 2006.

I thought it might be useful to examine the extent that these two surgeons have disclosed their relationships with Medtronic in their published work.

Dr Polly is by far the more prolific writer. Most of his recent work is in Spine. So I looked at a 2008 review article on treatment of scoliosis for which he was senior author.(1) This is what was disclosed in the article:

Although one or more of the author(s)has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of the manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other non-profit organization which the author(s) has/have been associated. One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That was really specific, wasn't it. The disclosure does not identify which author received payments, what company made the payments, how much they were, or what their purpose was.

I found two recent articles authored by Dr Burkus, both again in Spine. The most informative disclosure statement was from an article by Dimar et al(2)

One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That wording seems familiar, and presumably is the boilerplate favored by Spine. Of course, it is no more specific here than it was before.

The new investigations by the Star-Tribune suggest that huge payments to orthopedic surgeons by medical device companies are hardly confined to those related to hip and knee prostheses, and that spine surgeons seem no more eager to disclose these payments in any detail to the readers of their research articles than were surgeons who specialized in hip and knee replacement.

So I get to repeat myself. In my humble opinion, a disclosure that a journal article's author received some sort of "benefits" from a company does not quite have the impact of a disclosure that the author received hundreds of thousands of dollars in consulting fees. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons' enthusiasm for spine surgery, especially involving the use of specific products, might just have been a bit influenced by making hundreds of thousands of dollars a year in consulting payments from the manufacturers of those products.

Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from consulting fees almost enough to make a doctor rich? Inquiring minds want to know.

This is another argument for requiring full and detailed disclosure of all payments made to physicians, and to health care academics, and health care decision makers, beyond their usual salaries or fees, and that could have any bearing on their clinical or health care decision making.


1. Lenke LG, Kuklo TR, Ondra S, Polly DW. Rationale behind the current state-of-the-art treatment of scoliosis (in the pedicle screw era). Spine 2008; 33: 1051-1054.

2. Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistance matrix versus iliac crest bone graft. Spine 2006; 31: 2534-2539.

Thursday, September 18, 2008

Staten Island University Hospital Settles, Again

From the New York Times comes the latest installment of the sorry story of Staten Island (NY) University Hospital:

Staten Island University Hospital has agreed to return $88.9 million that prosecutors say it fraudulently obtained from government health insurance programs, one of the largest settlements of such a claim ever paid by a single hospital.

The settlement, which prosecutors announced Monday, represents the third time in a decade that the hospital, which is the borough’s largest, has paid millions of dollars to resolve civil charges that it knowingly overbilled the government for treatment costs. Prosecutors had accused the hospital of conducting a collection of schemes from 1994 to 2005 that spanned many aspects of its operations, including substance abuse detoxification, inpatient psychiatric care, cancer treatment and the number of residents it had in training.

Two of the charges included in the settlement stemmed from separate whistle-blower lawsuits filed by a former doctor at the hospital and the widow of a cancer patient. Dr. Miguel Tirado, a former director of chemical dependency services at the hospital, accused the hospital of fraudulently billing the state Medicaid and the federal Medicare programs for inpatient alcohol and substance abuse detoxification treatment. Investigators determined that from July 1994 through June 2000, the hospital submitted claims for 12 more beds than it was licensed to use, and hid those beds from state inspectors. To settle those charges, the hospital agreed to return $11.8 million to the federal government and $14.8 million to New York State.

The other whistle-blower suit, filed by Elizabeth M. Ryan of Florida, accused the hospital of using the codes of a cancer treatment covered by Medicare to receive payments for treatment to her husband that was not covered. Investigators determined that the hospital used incorrect billing codes in cancer treatment from 1996 through 2004 to Medicare and Tricare, the United States military’s health insurance program. The hospital agreed to return $25 million to the federal government.

The settlement also resolved two other claims that were not yet the subject of lawsuits. Federal prosecutors said that from 1996 to 2003, the hospital had deliberately inflated its count of residents in training, which resulted in the hospital receiving reimbursements for which it wasn’t entitled. The hospital agreed to return $35.7 million.

Finally, the settlement resolved what prosecutors said were wrongful billings to Medicare and Medicaid for treatment of psychiatric patients in unlicensed beds from July 2003 through September 2005. The hospital agreed to repay the federal government nearly $1.5 million to settle that claim.

In 1999, the hospital entered a settlement with Eliot Spitzer, then the attorney general, to repay $45 million to Medicaid and to provide $39 million in free care for indigent patients. Mr. Spitzer had charged that from 1994 through 1998, the hospital provided therapy to developmentally disabled adults in rooms at group homes, but billed the services as outpatient hospital treatments, which Medicaid reimburses at a rate 10 times higher.

In 2005, Mr. Spitzer’s office negotiated a second settlement with the hospital that required it to return $76.5 million to Medicaid. Mr. Spitzer, who accused the hospital of overbilling through part-time community clinics, said at the time that the hospital’s own lawyers had warned its executives to stop, but the illegal billing continued nonetheless.

We had posted twice before on the 2005 settlement (here and here). It turned out that the former executive vice president of the hospital had been hailed as a leader with "gravitas" after he moved to his next job, which he subsequently quickly quit after his connection with the troubles at Staten Island came to light.

This story again reminds us how often the self-proclaimed leaders with "gravitas" of health care organizations are weighed down with other baggage. This is particularly pertinent during the week when the high priests of finance, the most exalted of the exalted leaders of business, have been shown to have foolishly and arrogantly over-reached. The push to break the medical guild and put managers without health care experience into the leadership of health care organizations unfortunately came at a time when such managers were growing up in a culture of greed, arrogance, and self-interest. So while high-paid chiefs of investment banks are brought low, it is time to rethink whom we have put in charge of health care.

Tuesday, September 16, 2008

MHRA Report on Influence of Healthcare Blogs

Below is a link to an MHRA-sponsored report (Medicines and Healthcare products Regulatory Agency, the UK equivalent of the FDA) on the "top influencers" in healthcare thinking, including blogs such as this one, Healthcare Renewal.

The MHRA report is here: 
link (PDF)

The report is based on data collected regarding seroxat. The results are possibly reflective of, or proportional to, influence on other biomedical topics as well.

It was prepared for the MHRA by Market Sentinel, a company specializing in:

... measuring, monitoring and benchmarking influence in relation to issues, brands and companies. This includes social media monitoring (blogs and messageboards) but is not limited to it. We provide clients in the public and private sector with hard facts that enable them to better understand the playing field; more effectively bring their messages to market and increase their influence ...

... in addition to services such as reputation and crisis management, and optimization of customer targeting in advertising campaigns.
The MHRA report became became publicly available after a UK Freedom of Information request, apparently by someone concerned about the seroxat controversy. The full Freedom of Information release containing the report is here (also PDF). The report begins at page 215 of the release, after a somewhat curious, identity-redacted email that states:
"Our intention is not so much to track retail opinion so to speak - the opinion of random unqualified individuals - but to track the opinions of those who matt[er], those with a demonstrated following. Our hypothesis is that it is these "influencers" whose opinions will reach the rest of the world.

have not so far made recommendations as to who to target amongst these stakeholders, preferring to speak first about the message you wish them to receive."

I presume the "Our" and the "We" refer to Market Sentinel, and the "you" to someone at MHRA or perhaps seroxat manufacturer GlaxoSmithKline in an attempt at "reputational repair" over the seroxat controversy, but this is unclear.

In any case, it appears the Market Sentinel Report was not prepared as a purely academic exercise.

Health care bloggers appear to be doing well, a finding that does not surprise me, aware as I am of the growing influence and power of the political blogs.
That healthcare bloggers in general appear to be doing well is a desirable observation, considering the increasing distortion of the biomedical literature by commercial interests that makes attainment of true "evidence based medicine" more difficult.

It is also desirable from the perspective of the "group think" aspect of the peer review process that makes publication of opinion, even well-documented opinion, sometimes impossible if the opinion is "politically incorrect" and/or runs contrary to the collective wisdom, collective exuberance - or the collective pocketbook.

My posts on Medical Informatics and healthcare IT problems, for example, would probably never make it through peer review in the informatics community. They challenge the dominant paradigms and what I believe to be the irrational exuberance over the technology.

I do not write about that issue lightly or without evidence. The American Medical Informatics Association, as just one example, recently decided it would not publish a book on HIT difficulty by several members of the Clinical Information Systems Workgroup in a style similar to my website on that topic (i.e., anonymized, fine-grained case examples), itself a resource that would have been impossible before the Web. The group had to go elsewhere.

I also highly doubt the posts of my colleagues about healthcare corruption and loss of core values would make it past peer review in most mainstream journals, especially in a fashion that would form an "anti anechoic effect" repository or aggregation of such cases.

Healthcare Renewal came out relatively high in influence on the MHRA-commissioned report on seroxat:

... Mainstream media accounts for 30% of the top 100 stakeholders. Media coverage of MHRA is neutral to mildly negative, with the force of emotion mainly targeted at GSK.

The second largest group is bloggers who account for 23% of the 100 most influential stakeholders. The blogs are either written by insiders in the pharmaceutical industry (Doctors, Researchers, Journalists etc) or by individuals who have experienced the effects of Seroxat first hand. Of the industry bloggers, 72% are from the USA and the rest are UK based. For the personal experience bloggers, 60% are based in the UK and the remainder is in the USA.

78% of blogs in the top 100 are written by industry insiders. The most influential industry blog is the American based Health Care Renewal blog. Contributed to by a group of health care professionals, it tackles issues which call into question the values of the health industry.

A highly influential industry blogger is Aubrey Blumsohn who writes the Scientific Misconduct Blog. Not only is he ranked high in influence, but his blog ranks the highest in terms of betweeness’ which measures how many different paths go through a specific stakeholder. Blumsohn is what Malcolm Gladwell would call a “connector”. His old blog, thejabberwock, is still often cited, despite the fact that it is no-longer regularly updated.

Blogger Bob Fiddaman is dedicated to raising the profile of the side effects of Seroxat and regularly posts comments on other blogs, which in turn increases his on-line sphere of influence. A further individual blogger who is highly influential is the author of the Seroxat secrets blog. The entire blog is dedicated to discussing and publishing any issues surrounding the drug, MHRA and GSK.

After Mainstream media and Bloggers, distribution of influence is shared between 12 groups, some of which exist to support those working in the health care industry by supplying information and support ...

Of interest is the citation analysis-like "stakeholder analysis" method used to rate the influence of various Old and New Media outlets. Here is a "stakeholder map" of the top influencers, showing connectedness and information flows (see the MHRA report linked above for a full explanation):

(click diagram to enlarge)

Healthcare Renewal is the red circle at the mid-right network border; size of each node reflects relative influence.
Some stats from the report as highlighted by colleague Roy Poses:This blog ranked as 13 in the table of "top influencers." Other highly influential blogs included some cited by us, and/or are on our side-bar list of links. On the ranking of top influencers, Health Care Renewal outranked the Wall Street Journal, Reuters, the UK Times, Nature, Forbes the UK Telegraph, the Annals of Internal Medicine, the Canadian Medical Association Journal, and ABC News, among well known publications. On the ranking of "popular stakeholders," Health Care Renewal came in at 27. We out-ranked Reuters, the UK Times, Nature, CNN, Forbes, the UK Telegraph, and the Canadian Medical Association Journal.

Considering there were only a few posts here on the seroxat controversy, this may have to do with "trustedness" -- i.e., "goodwill" of a sort generated by the plain language, sunlight-as-best-disinfectant coverage of many other issues -- on the hyperlink-driven access patterns and information flows.

The stakeholder analysis shares some aspects of the longitudinal citation analysis methodology such as used to trace the flow of ideas here, but in a hyperlinked web context:

Citation analysis is the examination of the frequency, patterns and graphs of citations in articles and books.[1] [2] It uses citations in scholarly works to establish links to other works or other researchers. It is one of the most widely used methods of bibliometrics. Automated citation analysis has changed the nature of the research allowing millions of citations to be analyzed for large scale patterns.

[1] Rubin, Richard E. Foundations of Library and Information Science 2nd ed. New York: Neal-Schuman, 2004.
[2] Garfield, E. Citation Indexing - Its Theory and Application in Science, Technology and Humanities Philadelphia:ISI Press, 1983.

Although the MHRA-sponsored study has its limitations, blogs can indeed be quite influential. This is a lesson painfully learned by some prominent mainstream media newspeople, politicians, and others.

Perhaps HC blogs should not be dismissed as the work of pajama-clad novice journalists dabbling in their bedrooms.

(The existence of firms specializing in "social media monitoring" suggests that this is starting to be understood in some sectors.)

-- SS

Monday, September 15, 2008

University of Minnesota Courts McGuire - "We Don't Really Care About the Stock Options"

We have posted quite a bit about leadership problems at one of the US biggest for-profit managed care organizations/ health care insurers, the UnitedHealth Group (UHG), most recently here.

UHG has not always been known for being particularly patient-, employer-, or physician-friendly. For example, as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."

We have previously discussed how UHG promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here); allegations that the UHG acquisition of Pacificare in California lead to a "meltdown" of its claims paying mechanisms (see post here); charges that the UHG acquisition of Sierra Health Services would give it a monopoly in Utah, and that UHG was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here); and numerous violations of Nebraska insurance laws by UHG (see post here).

Such anecdotes conflict with the UHG mission statement, as recently revised. The company pledged to:

* Enhance the performance of the health care system, and improve the overall health and well-being of the people we serve and their communities.
* Work with health care professionals to expand access to high-quality health care so people get the care they need at an affordable price.
* Support the physician/patient relationship and empower people with the information, guidance and tools they need to make personal health choices and decisions.

One hypothesis is that UHG has trouble adhering to its idealistic mission because of the shortcomings of its leadership.The story of the fall of its recent CEO, Dr William McGuire, was strikingly instructive. As we have previously discussed, (see these posts here, here, and here from 2006 with links backward) Dr McGuire received outrageously lavish remuneration, which stood in stark contrast to the previous UHG mission's pledge to "make health care more affordable."

Controversy has swirled over the timing of huge stock option grants given to Dr McGuire (see post here), leading to his resignation in October, 2006 (see post here). More recently, McGuire agreed to pay back some of those options, although that would reportedly leave him with more than $800 million worth of options (see post here).

Most recently, as reported by Bloomberg,

UnitedHealth Group Inc.'s former chief executive officer William McGuire agreed to pay $30 million to settle a lawsuit brought against the company and individual defendants over backdated stock options.

Under the deal, which needs court approval, McGuire will also return to UnitedHealth 3.68 million shares of stock options. The class-action, or group, lawsuit was brought over options that were backdated during McGuire's tenure at the helm of the company, the largest U.S. health insurer.

The settlement may be the largest cash recovery obtained from an individual defendant in a securities class-action lawsuit, Calpers said.

The company remains under a criminal probe of backdated stock options.

But at the same time, the Minneapolis Star-Tribune reported, Dr McGuire seems to have found ways to keep busy,

The University of Minnesota is courting William McGuire, the health insurance executive who lost his job in a stock options scandal, as "executive in residence" at its business school.

Stephen Parente, director of the Medical Industry Leadership Institute in the Carlson School of Management, said the school had given him the go-ahead to explore the idea with McGuire, former chief executive of Minnetonka-based UnitedHealth Group.

'We are courting him to be an executive-in-residence at Carlson,' Parente said, adding that McGuire's immense experience in health care is what appealed to the university.

Parente said he first reached out to McGuire in August 2007, inviting him to be the keynote speaker at an invitation-only event attended by 70 to 80 guests at the Lafayette Club in Minnetonka Beach. The subject of McGuire's talk was the future of health care.

McGuire hit familiar themes during the hourlong speech, including the need for universal access to health care and the need to track the quality of care by physicians and to pay them accordingly.

Parente said his approach to McGuire was along the lines of: 'We don't really care about the stock options. You know stuff. Tell us what you think.'

Since then, McGuire has attended two seminars at the Carlson school, including one where he arrived unannounced.

There was some discussion within the school, Parente said, on whether it was appropriate to engage McGuire, given the lawsuits and investigations in which he was embroiled. The conclusion was that it was.

'It's one thing if you're bringing in a criminal to speak. But if someone's under investigation, that's fair game,' he said.

Since then, McGuire has acted as "ad hoc kitchen-cabinet adviser" to him, Parente said.

In June, when Parente presented a paper titled 'Is Consumerism at Odds with Prevention?' at the American Society of Health Economics at Duke University, he listed McGuire as one of six co-authors.

Sometimes, you just can't make this stuff up. Under CEO McGuire, UnitedHealth became a poster child for the hypocrisy of managed care, promising affordable care while stuffing the pockets of its top managers. The company was reported to have committed numerous instances of unethical behavior that contradicted its lofty ideals. It had to re-state its earnings. McGuire was forced into early retirement. Both he and the company have had to settle lawsuits, and the company is reportedly still under criminal investigation.

So then, a prominent business school is "courting" McGuire? Its leadership invites him to speak about universal health care, after he managed to steer a billion or so dollars out of the health care system into his pocket (at least for a while)? It invites him to speak about the quality of physicians' medical management, after he managed his company in stark contrast to its lofty ideals?

Its leaders "don't care about the stock options." Anyone who has not (yet) been convicted of a crime has ethics good enough for them?

That's a pretty good way for the business school to tell its students that the health care management slogan should be "take the money and run."

With business schools setting these kinds of ethical examples for their students, no wonder the business-oriented leaders of health care have turned out so bad.

ADDENDUM (18 September, 2008) - Now it appears that the University of Minnesota is disavowing any plans to make McGuire a faculty member, per the Star-Tribune.

BLOGSCAN - FDA Hires Pharmaceutical Marketing Agency to Educate Consumers About Drug Advertising

On the GoozNews blog, Merrill Goozner posted about how the US Food and Drug Administration (FDA) set up a program to educate consumers about direct-to-consumer (DTC) advertising. It seems that the organization the FDA hired for this purpose is nominally a not-for-profit, but not registered as such with the federal government, and is run by the president of a pharmaceutical marketing agency. The not-for-profit was funded mainly by the marketing agency, and its leadership all have connections with pharma. Sometimes, you just can't make this stuff up.

Meanwhile, on the PostScript blog, this post assessed the content of the web-site provided by this program. The site is, shall we say, not terribly skeptical about how the pharmaceutical industry advertises drugs. But what did we expect, given who provided the content?

Saturday, September 13, 2008

Correcting historical information from the recruiter component of the Health IT Ecosystem

In the seemingly unending quest to correct inaccuracies and misinformation regarding clinician leadership of health IT and medical informatics, I wrote the following letter.

It is in response to an article entitled "The Chief Medical Informatics Officer: Past, Present and Future" by two well-known healthcare IT recruiters (I know the latter from her time at Hersher Associates) in the Sept. 2008 edition of "Advance for Health Information Executives", a non-technical journal for those involved in management of HIT.

This question also comes to mind:
can you get the future right when you have the past wrong - and were wrong in the past?
On having the past wrong:

To: firving@advanceweb.com, rmitchell@advanceweb.com, dolsen@advanceweb.com, shatfield@advanceweb.com
Date: 09/13/2008 12:53PM
cc: lhodges@wittkieffer.com, aanschel@wittkieffer.com
Subject: Re: "The CMIO: Past, Present and Future", Sept. 2008
Dear Advance for Health Information Executives,

I enjoyed reading the article "The CMIO: Past, Present and Future" by Linda Hodges and Arlene Anschel (Advance for Health Information Executives, Sept. 2008, p. 45-46). It was reasonably well done.

The following paragraph, however, contains factual errors:

"Prior to 1997 no true CMIO roles existed . Physicians as executives were part of a broader set of roles such as CMO or CEO. The physicians dabbling in health care delivery information systems lacked C-suite awareness and sponsorship; beyond a defined initiative, they also lacked specific responsibilities, expectations and accountabilities. They worked on a limited part-time basis in IS, often uncompensated for systems endeavors."

In fact, such roles did exist. I held one at Medical Center of Delaware in 1996, later Christiana Care Health System, hired by the CEO and reporting to the CMO, after holding a managerial role in a major municipal quasi-governmental organization. My colleagues held similar CMIO roles in other healthcare systems, some as early as 1991 and before. We had quite well-defined and fully-developed job descriptions and accountabilities with clear expectations.

In fact, through "dabbling" (by utilizing significant computer expertise dating to the early 1970's combined with clinical expertise) we were able to reverse projects that had turned into organizational nightmares and/or were threatening patient well-being, the latter being due to the clinical IT inadequacies of the identified IS leadership (see example case studies on this issue here and here).

It was puzzling to us that IT leadership was generally opposed to clinician involvement at a leadership level. Just as psychiatry and neurosurgery are two different specialties dealing with the same organ (brain), clinical computing is a very different specialty than management information systems. Both involve IT, but the commonalities in development, implementation, lifecycle and management diverge widely after that point.

We were, in fact, CMIO pioneers. An early version of my current website "Common Examples of Health IT Difficulties" that I began in 1998 was entitled "Medical Informatics and Leadership of Clinical Computing" and called for an expansion of roles such as ours, and empowerment of the CMIO role as a strategic imperative. My 1998 web site (and now the current site as well), have been read by thousands of healthcare and IT professionals worldwide.

I believe it and other writing by myself and others in the role pre-1997 helped fuel a shift in thinking about the strategic nature of the CMIO (e.g., "Strategic value of Informaticists", Healthcare Informatics, Nov. 1997, and "Broken Chord", Healthcare Informatics, Feb 99 , and a section of "Medical Informatics: Friend or Foe", Advance for Health Information Executives, May 2002 as examples of my own writings). The "strategic value" essay had been noted by The Advisory Board Company at the time of its publication and led to a long discussion with them on an issue of which they had been unaware.

In fact, access patterns to my current web site on HIT difficulty, tracked via a public web logging facility at extremetracking.com, show many direct queries on "healthcare IT failure" or similar concepts (see my 2006 poster here). Worldwide interest in this topic, and the need for more effective clinical IT leadership, is accelerating.

Finally, I continue my informatics advocacy writing at the multi author blog "Healthcare Renewal ." A recent MHRA-sponsored research project (MHRA is the Medicines and Healthcare Products Regulatory Agency, the UK's FDA-like agency) shows the thought-leadership impact of healthcare blogs to be significant, and that of Heathcare Renewal itself to be higher than several mainstream medical media outlets. The MHRA report is at this link (PDF).

I shall continue to call for leadership roles for healthcare informatics professionals, especially those with rigorous graduate and post-doctoral credentials from accredited organizations of higher learning (as opposed to the pseudocredentials offered by organizations such as HIMSS and others, see my essay "Is the HIMSS CPHIMS stamp substantive, or just alphabet soup?" at the Healthcare Renewal blog site at this link).

Finally, considering how the healthcare system can ill afford healthcare IT misadventure which can actually waste funds needed to care for the underprivileged, I ask the healthcare system "what took so long?" to realize that it takes a doctor to properly lead the creation of virtual clinical instruments.

I would argue that "what took so long" was obstructionism to progress caused by the territorial conceits of the IT and other components of the health IT ecosystem, for reasons both psychological and pecuniary.

These battles were and are waged, of course, at patient expense.

I am also concerned about the use of the term "
dabbling" to describe the activities of the pioneering informatics physicians and nurses. That is a pejorative term indeed for the challenging and patient-centered efforts of many brilliant cross-disciplinary clinicians.

A more appropriate term that might indicate a more genuine "evolution" of views by the headhunters would have been "explorer", "pathfinder" or something similar.

If anyone was "dabbling" it was the
hospital IS directors and IS personnel, entirely devoid of clinical education, knowledge and experience, who were dabbling with clinical medicine. They were uncritically importing their card punch tabulator mentality from the early days of data processing (explanation here) under the ill-conceived and bizarre (and opposed by the "pathfinders") notion that that mentality was appropriate for clinical medicine.

In fact, that mentality and all that went with it, tactically, stategically and operationally, was quite harmful. In my own direct observations as a CMIO, I watched in horror as "IS dabblers"
put the sickest patients in an ICU at great risk of iatrogenic infection with airborne pathogens (link), and caused chaos in an invasive cardiology facility performing the majority of cardiac procedures in an entire state, Delaware (link). I should not fail to mention the waste of resources and money that also occurred. 

The people behind these atrociously mismanaged clinical projects, some the "darlings" of the aforementioned recruiting companies and of the glossy HIT journals of the time, were never held accountable and in fact moved on to other organizations.

This style of clinical IT mismanagement continues to this day, and is an international phenomenon, at both the local level and the national, e.g., UK (link) and Australia (link).

Finally, on HIT recruiters being
wrong in the past in addition to having the past wrong:

Here is what prominent HIT recruiters wrote approximately at the time I was a CMIO.
From an article "Who's Growing CIO's" in the journal “Healthcare Informatics”:

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.

These were not helpful attitudes towards clinical leadership of HIT. In fact, the HIT recruiters were effectively serving as
enablers of clinical IT failure and potential patient harm through such "degree doesn't get you anything" ideologies, stunningly alien to biomedicine.

One wonders just how many "
from the school of hard knocks" HIT leaders were pushed by these recruiters onto healthcare organizations, and the harm such leadership may have done to healthcare and to patients.

These attitudes are definitely "not where the money is" today in HIT recruiting, but one wonders if the biases linger.

Have the recruiters truly learned their lesson? Perhaps, but perhaps not. Having been sent by the second author of the ADVANCE article last year into this unpleasantness -- incidentally while discussing with her the need for an article about the changing roles of CMIO's and giving her ideas for same - and then being chastised by her as "unprofessional" for writing my interview experience up in an anonymized fashion so that others might learn from it, I can only wonder.
[Translation of unprofessional: "your writing this up could get back to the employer or other candidates and hurt my future recruiting business. Education, knowledge sharing, and ultimately patient care be damned." - ed.]

It seems medical professionals who dabble in patient-centered activism to bluntly point out deficiencies in the lively, profitable HIT industry are simply acting unprofessionally, according to these experts.

My attitude is somewhat different, along the lines of the wise words of my early medical mentor, cardiothoracic surgery pioneer Victor P. Satinsky, MD at Hahnemann Medical College. Dr. Satinsky's simple mantra was:

"Critical thinking always, or your patient's dead."

-- SS