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Jumat, 14 Januari 2011

Cyber-Puppeteering on Health IT by Dr. TruthHurts

While the specifics in this Xtranormal video "Dr. TruthHurts" on the Patient Protection and Affordable Care Act (PPACA) might be incorrect, and the political views expressed offensive to some, the scenes of "Dr. A.C.O." using a computer (starting at about time 4:09) might not be far from the future cybernetic "truth" we are headed towards.

While the computer-use scenes are mostly sound-based and somewhat hyperbolic, if physicians are not vigilant and outspoken, I fear the machines -- and their users -- will further become servants of bureaucratic control and of money.

Click to play the YouTube video.


Click image to play video


I also note that the diagram of the healthcare bureaucracy in this cyber-puppeteer video is real:


The coming Health Care Mega-Bureaucracy (click to download PDF from House.gov).

Somewhere, buried in that morass of healthcare facilitators, are quaint relics of the work of the healthcare enablers such as the doctor-patient relationship, informed consent, and private medical decision-making between physician and patient.

Oh wait...I forgot, there are computers to make the bureaucratic morass all work seamlessly.

-- SS

ONC Workgroup Document Misindentification - Just the Type of Computer "Glitch" That Can Kill People

A provocative title indeed.

The Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup recently had a meeting, Jan. 10-11, 2010.

They've posted the testimony and supporting documents here: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1482&&PageID=17128&mode=2 .

I've copied & pasted these document links directly from the site, at 12:45 PM EST 1/14/2011:


The problem is, some of the URL's are simply wrong, including several of the ones I've bolded.

For instance, I tried to download Dr. Willa Drummond's documents:


The links for "Collection of Problem Scenarios from Professional List Serve" and "Ten Commandments for Computerized Healthcare Information Systems" are simply wrong.

They lead to the incorrect documents as of this writing.

By experimentation (borne of experience!), I found I could locate the correct documents by manually altering a number in the URL.

For example, to locate the "Problem Scenarios" document whose URL is linked as:

http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf

I had to alter the number 949972 to 949973, like this:

http://healthit.hhs.gov/portal/server.pt/document/949973/drumexsum-imwg-11011_pdf

I further had to experiment to find the "Ten Commandments" document, also erroneously listed as at this URL ...

http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf

... but actually here at 949971:

http://healthit.hhs.gov/portal/server.pt/document/949971/drumexsum-imwg-11011_pdf

Presumably these erroneous indices will be fixed at some point. Are they due to computer and/or software error, or human error -- as in medicine, due to busy schedules, cognitive overload from a suboptimal IT user experience, and other factors?

I do not consider these errors "minor" or at all humorous. Leadership by example - through fine attention to detail - in a supposed "HITECH" paperless-medicine promoting government organization - is what I expect.

Similar "misidentification" errors in EHR systems can and do cause medications to be missed or given to the wrong patient - such as in the example at the Trinity Healthcare System as mentioned in my post "Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight" where an EHR "upgrade" caused considerable risk:

... Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]


Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

See the many questions I raised about this episode at the followup post "More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight." (I understand that the initial "fix" to the problem of "orders going to the wrong chart" was to prevent clinicians from opening more than one chart at a time, thus further interfering with clinicians' work.)

"Glitches" cause sometimes crucial data to be lost, and even patients to be harmed or killed (e.g., see the gray banner at top of my site on HIT failure, and my recent post "EHR Problems? No, They're Merely Anecodotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits" on this blog).

Ironically, the First Commandment in the mislinked Ten Commandments document above is:

"The Computer shall find and collate all data generated by other computers."

Perhaps it should read:

"The Computer shall find and correctly collate all data generated by other computers."

-- SS

1/14 addendum:

I looked specifically for those documents as my first retrievals on the HHS site due to past correspondence with Dr. Drummond. The pinball machine then tilted.

Perhaps it is simply those bad electrons and stale bits that follow me around once more.

Kamis, 13 Januari 2011

Who Undermined "These Wonderful Philanthropic Organizations?" - Evil External Swindlers or Their Own Leadership

The rise and fall of yet another esteemed health care institution provides another cautionary tale about health care dysfunction. 

The Tragic Fall of the Picower Foundation

Two years ago, a highly-regarded charitable foundation had to close its doors, apparently one of the biggest victims of the Bernard Madoff Ponzi scheme.  Here is the Boston Globe version of the story:
The unfolding scandal surrounding the alleged Ponzi scheme run by Bernard L. Madoff yesterday claimed as a victim one of the largest foundations in the country, which has funded groundbreaking brain research at the Massachusetts Institute of Technology and diabetes research at Harvard Medical School.

The Picower Foundation of Palm Beach sent an e-mail to 'colleagues and friends' late yesterday saying that it was a victim of Madoff's alleged scheme and that it would soon shut down. With assets of more than a half-billion dollars, it is believed to be the largest charity to have been forced to close by the unfolding scandal.

'It is with great sadness that I write to inform you that the Picower Foundation has ceased all grant-making, effective immediately, and will close its doors in the coming months,' wrote Barbara Picower, the foundation's president, who added that its money was managed by Madoff.

Similarly, the New York Times reported without question:
One of the nation’s leading philanthropies, the Picower Foundation, announced on Friday that it was shutting down.

Also,
Listed previously at $1 billion, the foundation’s assets were managed by Bernard L. Madoff, Mrs. Picower said in a statement, and his 'act of fraud has had a devastating impact on tens of thousands of lives as well as numerous philanthropic foundations and nonprofit organizations.'

A Blow to Medical Research and Academic Medicine

This appeared to be a major blow to philanthropy, and to medical research and academic medicine.  Per the Boston Globe:
[No charities that had suffered from the Madoff scheme] were near the size of the Picower Foundation. In its 2007 tax return, it said the market value of its investment portfolio was $955 million. The Foundation Center, a nonprofit that tracks philanthropy, ranks the Picower philanthropy as the 71st largest in the United States by assets. It finances medical research at many leading institutions, human rights and child advocacy programs, and arts and cultural operations.
In particular,
A portrait of the Picowers hangs in the Picower Institute for Learning and Memory at MIT. They gave the center $50 million in 2002, which was, at the time, the largest grant from a single foundation the university had ever received. The foundation gave MIT another $4 million in May to launch a fund for faculty to conduct high-risk neuroscience research activities.

'I am deeply saddened by the terrible news,' Susumu Tonegawa, the Nobel laureate for medicine who founded the center in 1994, said in an e-mail.

It is unclear from the foundation's statement whether it lost all its money or just enough to force it to cease operations.

The Picower Foundation also gives MIT $200,000 a year to fund scholarships for graduate students, in the name of Norman Leventhal, the famed Boston developer and philanthropist. Leventhal was a director of Picower Foundation until this year.

The Picower Foundation also awarded $1.5 million for diabetes and metabolism research to Dr. Jeffrey Flier, dean of Harvard Medical School.
In addition,
[Dean Flier's] research funded by the foundation 'is over,' he said, unless he finds another funder.

Added his colleague, Dr. Barbara B. Kahn, chief of the division of endocrinology, diabetes, and metabolism at Beth Israel Deaconess Medical Center, 'I think it's tragic for the Picower Foundation and for the public that a single individual could undermine these wonderful philanthropic organizations that support excellent causes such as biomedical research.'
So that was the story in 2008. By then, we all knew that the scope of Bernard Madoff's fraud was audacious, and that all sorts of people were victimized, but it seemed a particularly low blow that he could "undermine these wonderful philanthropic organizations that support excellent causes such as biomedical research."  The narrative was one in which a prestigious, well-intentioned charity was laid low by an evil act perpetrated by a wily criminal.

Should Madoff be Blamed?

Or not. Today the Wall Street Journal reported the latest update on this story, on that seems quite dissonant with the version above:
A federal judge signed off Thursday on a settlement in which the widow of a longtime investor with convicted Ponzi scheme operator Bernard Madoff will return $7.2 billion to the victims of Mr. Madoff's fraud.


The settlement by Barbara Picower, the widow of Jeffry Picower, brings to nearly $10 billion the amount that Irving Picard, the court-appointed trustee for Mr. Madoff's firm, has recovered for people cheated in the scheme.

Recall that Barbara Picower was the President of the Picower Foundation.

Anechoic Stories About the Conflicted Leadership of the Picower Foundation

In fact, the glowing description of that foundation in the Boston Globe did not square with stories that ought to have raised serious questions about this apparent bastion of health care philanthropy, but instead were quite anechoic.

In 2001, the St Petersburg Times had published an expose of the Picower Foundation which suggested that its Jeffrey Picower used it in a complex scheme involving self-dealing for the purposes of personal enrichment.  The story is a bit complicated, but I provide details below to underscore its verisimilitude.

A Foundation that Appeared Virtuous

On one hand, it acknowledged how the foundation was set up to appear virtuous. One of the largest recipients of its apparent charity was the Picower Institute.
Picower's wife, Barbara, was active in determining the charities that received Picower Foundation grants. In 1999, the foundation gave $250,000 to the National Abortion and Reproductive Rights Action League, $700,000 to public television station WNET-Ch. 13 in New York, $120,000 to the Children's Aid Society and $107,000 to the Boys and Girls Clubs of Palm Beach County.

By far, though, its largest grant was to the Picower Institute. The foundation's $5.5-million donation was 41 percent of the $13.3-million in grants it made in 1999.
The Institute's leader was a famous medical academic:
Dr. Anthony Cerami was at the peak of his career in 1991 when he dined with Picower to celebrate his new job as president of the Picower Institute for Medical Research.

A dean at New York's Rockefeller University, Cerami had just been elected to the elite National Academy of Sciences, about the highest honor for a scientist short of a Nobel Prize.

'Dr. Cerami is what we call a giant in the scientific community, and he's also very well liked personally,' said Michael Kent, a biotechnology investor.
A Focus on  Drug Development

But it appeared that the main purpose of the Institute was actually to develop drugs, through a vehicle called Cytokine Networks:
Cytokine Networks held the rights to certain discoveries of the Picower Institute. In an arrangement common for non-profit medical research charities, it was set up in 1993 to commercialize science discovered at the Picower Institute.

'To bring science more quickly to the bedside -- that was their avowed mission,' Massey said of the institute.

Cytokine Network's largest shareholders were the New York-based Picower Foundation and the Picower Institute, which had each invested $2.5-million in the venture and held a combined ownership stake of 62.5 percent.

[Jeffrey Picower] owned no shares of the company.

Cytokine Networks held the rights to a drug labelled CNI-1493:
CNI-1493 has shown great promise in reversing Crohn's disease, a devastating inflammation of the intestine that is treated, though not always effectively, by injections. A small molecule can be taken in pill form and is cheaper to manufacture.

However, Jeffrey Picower, the husband of Barbara Picower, seemed to indirectly control Cytokine Networks:
he ran the board meetings, which were held at the New York offices of the JMP Group, Picower's investment holding company, said [Dr Glenn] Rice, the former Cytokine Networks executive.

'He was involved with every major decision,' Rice said. 'He'd get into minutia -- the capitalization of the company, screening potential new investors, personally reviewing the clinical trials. Virtually everything a chairman of the board would do, he did.'
Picower Foundation Sells Cytokine Networks to Picower (the Person)

And here comes the trick. Observe closely:
In 1999, [Cytokine Networks] ... merged with another private pharmaceutical company, PharmaSciences Inc., in which Picower was the majority shareholder.
So
When the merger was completed in 1999, Picower's non-profit organizations' equity stakes were diminished from a combined 62.5 percent of the old company to 24.5 percent of the new company.

Picower owned nearly 47 percent -- making him the largest shareholder in the company that had obtained the rights to CNI-1493.

An evaluation by Merrill Lynch put the merged company's fair-market value at $15 to $25 a share, making Picower's stake worth an estimated $40- to $67-million.

This is a pretty good trick:
Rice contends that by wearing all the hats in the merger, Picower had a conflict of interest.

In any business negotiation, each side tries to get the best deal. Yet in this merger, the interests of Picower's non-profit organizations were pitted directly against Picower's personal interests.

On one side were shareholders of Cytokine Networks, mainly the Picower institute and foundation. On the other side were the shareholders of PharmaSciences, primarily Picower.

Picower called the shots at the institute and foundation. So, Rice said, the question is this: On whose behalf was Picower working? His own? Or his non-profit organizations?

'The valuation here would be crucial,' said George Cowperthwaite Jr., a certified public accountant who specializes in preparing private foundation returns and has no connection to Picower.

By that, Cowperthwaite means the relative values assigned to each company for purposes of the merger. The shareholders of Cytokine Networks would be expected to push for the highest value possible assigned to their company. A higher value would give them more ownership in the new, merged company.

Yet Rice, who also was a shareholder in Cytokine Networks, questioned whether Picower had any incentive to push for a higher valuation of Cytokine Networks because it would mean that he would end up owning less of the merged company.

Indeed, a 1997 valuation by Lehman Brothers concluded that Cytokine Networks shareholders should own 47 percent of the combined company. They ended up with 36 percent.

In 2009, ProPublica published a report on the Picower Foundation which summarized this transaction thus:
Picower used both his foundations and a private corporation called PharmaSciences, of which he was the majority shareholder, to gain control of a potentially lucrative medical discovery. In 1999, Picower merged PharmaSciences with a for-profit spinoff of his institute called Cytokine Networks, essentially negotiating with himself. The merged company called Cytokine PharmaSciences had the rights to develop a new drug that could help minimize such illnesses as arthritis and multiple sclerosis. The newspaper raised the question of whether Picower had shortchanged his nonprofit in the deal.
So it appeared the Jeffrey Picower used the Picower Foundation, which was lead by his wife, and the Picower Institute, which was ostensibly an independent not-for-profit organization funded by the the Foundation, to set up a deal which could have markedly enriched Jeffrey Picower.

Picower's Previous Anechoic Financial Peccadilloes

In fact, it appeared that Jeffrey Picower had a long history of questionable business deals.  In 2002, Forbes ran a profile of Jeffrey Picower that asserted:
has been battle-hardened from years of legal disputes over his dealings. In the 1980s he sold to clients of his old accounting firm Laventhol & Horwath shaky tax shelters involving computer leases. When the Internal Revenue Service realized the computers were virtually worthless, it challenged the deductions. That spelled trouble for longtime client Peter Davidson of Brooklyn, N.Y.'s Davidson Pipe, who had put at least $30 million in Picower's leases after an introduction by Laventhol accountant William W. Schneck, who happens to be a former boss of Picower. Davidson sued Laventhol and Picower for $90 million. He claimed that Picower had bribed Schneck to betray him. Picower denied that, and his lawyer says he testified that the $50,000 he'd given Schneck was a loan. After hearing the opening arguments, he and Laventhol paid Davidson to drop the case on condition that Davidson keep his mouth shut about the settlement. Davidson later settled with the IRS.

Picower also had a run-in with the Securities & Exchange Commission. In 1983 the SEC rebuked him for being months late disclosing that he had exceeded a 5% position in Fidata, a financial services firm that he later merged into what is now Alaris, a medical device maker. Shades of the Cytokine Pharma merger: Picower was on both sides of the table.

Two years ago Picower had to put up $21 million from another one of his pet companies--Physician Computer Network in Morris Plains, N.J.--to appease other shareholders who'd lost everything when it went bankrupt after it came out that his executives had cooked the books. It is hard to imagine how a smart guy like Picower could have been oblivious to all of that while chairing the board and controlling 45% of the stock, but he was never charged with a thing.

There have been other trips to the courthouse. Fourteen years ago he refused to pay the final bill for renovations on his New York offices. When the interior design firm sued to collect, he sued them for $17 million, taking the stand at trial in an effort to convince the jury that sloppy work had left him in squalor. The judge made a surprise visit to the office with the jury in tow. The place turned out to be sumptuous, and the judge decided not to let it go to the jury at all, rendered a directed verdict and ordered Picower to fork over $178,000, including legal fees.
So by 2002, there were plenty of reasons to worry about the integrity of any organization lead by Picower.  Yet when the Picower Foundation went bankrupt in 2008, the public narrative was of a noble pillar or health care philanthropy done in by an evil confidence man.

One year later, the story was very different

Picower as a Beneficiary of Madoff
So maybe it should have been no surprise when ProPublica chronicled how the Picower Foundation seemed to have made huge profits from the Madoff Ponzi scheme that had victimized so many others.
It now appears that the biggest winner in Madoff's scheme may not have been Madoff at all, but a secretive businessman named Jeffry Picower.

Between December 1995 and December 2008, Picower and his family withdrew from their various Madoff accounts $5.1 billion more than they invested with the self-confessed swindler, according to a lawsuit filed by the trustee who is trying to recover money for those Madoff defrauded.
Jeffrey Picower died in October, 2010.  As noted above, just today, the settlement that would return $7.2 billion from Picower's operations to the Madoff  trustee.

Summary

The big question is why people can be so easily fooled? 

Why were a Chief of Endocrinology, the Dean of one of the country's most prestigious medical schools, and a Nobel Prize winner not the least bit skeptical of a foundation whose leadership was accused of conflicts of interest and self-dealing, and had been involved in a series of questionable business deals over the previous 20 years?  All this was public by six years before the collapse of the foundation.  Why was the media so eager to spin a narrative that labelled the apparent perpetrators as victims?  A simple Google search on "Picower" would have suggested other explanations.

Certain health care institutions seem to held in such high esteem that almost no one thinks to question what goes on behind their walls.  This makes it possible for unscrupulous leaders to subvert the missions of such institutions for personal gain.  It even makes it possible for scam artists to create institutions that appear as if they ought to be held in high esteem as vehicles for chicanery.

We have now seen so much ill-informed, incompetent, mission-hostile, conflicted, and criminal leadership of health care organizations that no one should accept the word of someone just because he or she is in the leadership of an institution with a fancy name.

Just because a health care organization has an impressive name, or even an impressive history does not mean that its current leaders should be immune to questions, inquiry, skepticism, or even investigation.  In fact, in this day and age, the leaders of large health care organizations with historically good names should be scrutinized especially carefully. 

If not, expect so see more collapses of "wonderful" organizations.

Google CEO Eric Schmidt on Healthcare IT Once Again

At the Jan. 11, 2011 WSJ health blog, in an article entitled "JP Morgan Healthcare: Google’s Schmidt on Open Source and Health IT", Google CEO Eric Schmidt is cited as saying:

... One solution to the problem may be to take the electronic-medical record architecture out of the hands of the corporate world, suggested Google CEO Eric Schmidt at the JP Morgan Healthcare Conference last night.

“If I were not doing what I’m doing and I wanted to do something in health care … I would go to all of the research universities and would try to figure out where the best, interesting IT software is that can be open-sourced,” he said at a health-IT panel discussion. “My guess is that a platform like that would be remarkably different from the platforms that we are using today,” he said.

First, a comment on language, which perhaps I should more accurately describe as a critique of IT culture:

“A platform like that?”

As at my post "Does the CEO of Google Use Google? - And: Platform, Platform, Who's Got The Platform?" early last year Schmidt also said

“As computer scientists, this [that is, why docs haven’t embraced databases to help them sort through medical information] is a platform database problem, and we do these very, very well, as a general rule. And it befuddles me why medicine hasn’t organized itself around these platform opportunities.”

At that post I also pointed out that the successful practice of medicine is not a 'platform database' or any other reductionistic information retrieval problem, and that such a "platform opportunity" was seized upon decades ago:

DXplain was developed starting in the mid 1980's by medical informatics researchers who actually know this domain, and which offers this explanation and warning: "DXplain uses an interactive format to collect clinical information and makes use of a modified form of Bayesian logic to derive clinical interpretations ... DXplain does not offer definitive medical consultation and should not be used as a substitute for physician diagnostic decision making."

I note that IT personnel like to refer to “platforms”, “solutions” – a rather presumptuous term – “paradigms”, and other buzzwords to mask the fact that what they’re referring to are more commonly known as “hardware” and “software” and arrangements thereof.

It is a word that implies lack of knowledge about the complexities and realities of medicine – including that health IT problems will not be solved via a “platform.”

I wrote more on “platformania” at this link.

I do agree strongly with Schmidt on the following from the recent WSJ posting:

Schmidt said that using such an open-source strategy — giving programmers the freedom to modify and distribute software [an agile computing methodology - essential to health IT development and lifecycle - ed.] — is a proven way to fix disparate software architectures. It’s the same development strategy that brought about the modern internet and “all the other technologies that you use every day.” ... Part of the problem in designing and discussing a new standard is that the current focus is on the companies involved rather than the patients.

That's been done, too, as in the OpenVista /WorldVista efforts.

I merely add that an erroneous approach to "focusing on the patients" (and the clinicians using the IT, i.e., a user-centric approach in the terminology of Social Informatics) will have results just as suboptimal as the current designer-centric approach to health IT. Designing health IT that "focuses on the patients" and that eliminates unintended consequences - i.e., "doing health IT well" - is wickedly harder than it sounds.

Most importantly with regards to Mr. Schmidt's most recent thoughts on academia:

The National Research Council did study a number of the best academic centers and in a 2009 report found quite clearly that even there, “Current Approaches to U.S. Health Care Information Technology are Insufficient.” See http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572

They did recommend the solution, and it's not a "platform":

“In the long term, [Health IT] success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.”

That means forgoing the current national rush to EHR, which is decidedly a medical experiment without patient consent.

In any case, I am impressed that a major information technology CEO has recommended a patient centered approach to health IT, agile methodologies, open source, etc. - true sacrilege towards today's health IT ecosystem.

(Note to Google and Mr. Schmidt: In "Who Can Solve Healthcare IT's Challenges? Part 1 - Google" I wrote that:


... This [HIT] dysfunction takes the form of corporatization of HIT, creation of myths about its magic bullet capabilities in "revolutionizing healthcare" ... In "A Biomedical Informatics Manifesto" I addressed the domain expertise I feel is most needed.

I did not, however, address the "who" as in "what organization(s)." What organizations, that is, have the resources (e.g., financial and infrastructure) to make useful, usable, national, interoperational HIT happen? What organizations have the innovative track record to effectively engage the best specialists to make it happen?

One example comes to mind immediately. It was suggested by an expert in IT and bioinformatics I correspond with, Felix Fulmer.

Google.

These folks are innovative. Their services are reliable, fast (when is the last time Google was down or took a long time to provide query results?), widely available, cost effective (many services available for free!), and a true technological tour de force.


Google, I am available should you seek true competitive advantage, and avoidance of paths that lead to health care IT failure such as you once attempted here. However, somehow I am sure your HR department would probably find my sometimes "edgy", critical-thinking approach to matters of national import "disruptive."

Disruptive to what, exactly, I'm not sure, but disruptive to - something - is good enough in today's "PC", outcomes-be-damned corporate culture.)

-- SS

Selasa, 11 Januari 2011

The Curious Case of Pfizer's Asbestos Claims

Here is a very strange and long-running story that raises some questions about how health care organizations are lead, but seems to have bee covered only in the business press.

Pfizer Goes Into the Asbestos Business (in 1968), Faced Hundreds of Thousands of Lawsuits (in the 1980s), Promised to Settle (in 2004)

Here is the background, per a 2004 report by the Associated Press, per Fox News:
Pfizer Inc. (PFE) Friday said it has agreed to pay $430 million to settle all lawsuits against it alleging injury from insulation products made by a subsidiary.

Pfizer and its Quigley Co. subsidiary were named, along with several other defendants, in 171,611 lawsuits claiming personal injury caused by exposure to asbestos, silica or mixed dust.


Pfizer acquired Quigley Co. in 1968. It sold some products containing asbestos until the early 1970s.

Pfizer will establish a trust for the payment of pending claims as well as any future claims. It will contribute $405 million to the trust over 40 years through a note, and about $100 million in insurance. Pfizer will also forgive a $30 million loan to Quigley.

Since 1982, Quigley's main business has been to manage the asbestos lawsuits.

As part of the settlement, Quigley will file for Chapter 11 bankruptcy. Its reorganization plan must be approved by the bankruptcy court and confirmed by a vote of 75 percent of the claimants.
That seems like the end of a long story, but it was not.

Bankruptcy Proceedings Go On Through 2009, No Claims Paid

By 2009, nothing had really been settled. Apparently, the bankruptcy of Pfizer's subsidiary, which was set up as if Quigley was an independent corporation, had not resulted in any resolution to the multiple lawsuits and the large claims. As reported in December, 2009, by Bloomberg:
At issue in the trial is whether Quigley, a former maker of asbestos-containing products, can confirm a plan of reorganization, ending more than five years in bankruptcy. The trial pits the U.S. government and asbestos victims against Pfizer, the world’s biggest drugmaker, with claims that its $450 million contribution under a settlement isn’t enough to satisfy its liabilities.
At the trial, the lawyer for the asbestos victims claimed that Pfizer was using the bankruptcy of its subsidiary to avoid liability:
Edward Weisfelner, a lawyer for an ad hoc group of so- called asbestos victims that represents 30,000 individuals, told Bernstein today that the plan can’t be confirmed because the purpose of the bankruptcy law being used to channel asbestos claims is to 'scrub' a viable company of liabilities.

Under bankruptcy law, courts shouldn’t approve Chapter 11 reorganizations where the primary purpose is to shield a third party, such as Pfizer, Weisfelner said.

'Courts are instructed to avoid the possibility that parties use bankruptcy to protect a third party that’s not submitting itself to the jurisdiction of the court, and that’s exactly what’s going on in this case,' Weisfelner said.
The US government also objected to what Pfizer was doing:
Opposition to the plan also comes from the U.S. Trustee, an arm of the Justice Department that monitors bankruptcies, which has said was improperly orchestrated to shield the drugmaker from liability.
t the time, Pfizer (through its Quigley subsidiary) also was attempting to keep the whole thing quiet, but not successfully:
The U.S. Trustee has fought to keep the trial open to the public, and said in court documents that some of Quigley’s requests to keep information confidential failed to meet legal standards for protecting 'commercial' information.
Of course, at that time, the opinions of the plaintiffs' lawyer and the US Trustee were just that, opinions.

By 2010, Judge Found that Pfizer "Manipulated" the Bankruptcy

But by September, 2010, according to Bloomberg then:
Pfizer Inc.’s Quigley unit, a former asbestos maker, was denied permission to exit bankruptcy by a judge who found the world’s largest drug company manipulated the bankruptcy process to benefit itself.

U.S. Bankruptcy Judge Stuart M. Bernstein in New York today rejected Quigley’s fourth reorganization plan and said parties should discuss dismissal of the case. He said the plan was filed in 'bad faith' by Pfizer and cited testimony that asbestos claims directed at Quigley could total $4.45 billion over the next 42 years.
No Progress by the End of 2010

Apparently despite the judge's opinion, the case still remained tied up in court. By December, 2010, no progress had been made. According to Bloomberg then:
Pfizer Inc., the world’s largest drug company, should have the bankruptcy of its Quigley unit which has protected it from asbestos-related health problems since 2004 dismissed, lawyers for the U.S. Trustee said.

While the bankruptcy has been pending, creditors with alleged asbestos-related health problems have been unable to sue New York-based Pfizer, and many have died, wrote lawyers for the U.S. Trustee, an arm of the Justice Department that oversees bankruptcy. A hearing to decide the U.S. Trustee’s request is set for Jan. 13, according to court papers filed Dec. 23.

'The harm in delaying the inevitable dismissal of this case is to the individuals who have filed asbestos claims against the Debtor and Pfizer,' lawyers for acting U.S. Trustee Tracy Hope Davis wrote in court papers. 'For some of those individuals, time may be of the essence.'
So Pfizer had stalled for so long that some of the plaintiffs had died off.

Summary

So let us summarize. For reasons that are unclear, Pfizer Inc, primarily a pharmaceutical company, bought out a company that made asbestos products in 1968. The health hazards of asbestos were soon recognized, and many people filed lawsuits against Pfizer's subsidiary, alleging they had been harmed. Pfizer promised to settle the matter in 2004, about 30 years since the exposures occurred. Yet by setting up a bankruptcy of its subsidiary as if it were an independent company, Pfizer stalled any resolution of the case for at least another six years, using what a Judge termed "manipulation." Now it is 2011, and the cases are still unresolved.

So for a company that claims it is
committed to applying science and our global resources to improve health and well-being at every stage of life.
and boasts
Pfizer Inc: Working Together for a Healthier World
This does not look good.

So question number one is should not the leaders of a company whose main business is ostensibly making people healthier be more sensitive to claims about the health effects of its products? Specifically, why did Pfizer's leaders not try to more speedily come up with a cleaner and more timely solution to this problem that would appear more sensitive to the health problems of the claimants?

It would be interesting if Pfizer's top leaders were to try to answer that question.

My policy observation is now familiar.  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.

Senin, 10 Januari 2011

EHR Problems? No, They're Merely Anecdotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits

My mother, who suffered an iatrogenic cerebral hemorrhage in May contributed to by an EMR's interference with clinicians, fell the other day in the bathroom.

Her fall was hard; she struck her back and knocked out one of the mounting posts for the bathroom tissue - completely out of the wall, the wallboard now with a large gaping hole in it.


In an elderly person, falls can result in injuries such as this one, a painful hematoma on her back.

She went to a local hospital where x-rays were done; aside from a large bruise and hematoma (collection of blood under the skin) over her back at the point of impact, miraculously nothing was broken.

At triage I went over her medication list in great detail, ensuring both the data input and the triage printout record of her meds were complete and precise. She went home.

The very next day, in mid afternoon she had sudden onset of speech difficulty (expressive aphasia) and right sided weakness, symptoms of loss of blood flow to the left side of the brain, while sitting in a chair talking on the phone. (The aphasia was the same symptom that led to her May 2010 presentation and travails, resulting in left carotid stenting, but with accidental cessation of a critical medication and severe complications, domino-style.)

So into the hospital she went via ambulance again. The ambulance crew copied her meds off a list I keep on my mother's refrigerator onto a scrap of paper. In the hospital the ED nurse reviewed the meds with me from the scrap, but I informed the ED nurse that doing so was not necessary since I'd just carefully checked the ED EMR med list at triage less than 24 hours earlier at the triage station.

The ED nurse then replied - "we're not using the ED EHR med lists right now, the system's been 'glitchy' today."

Me - " 'Glitchy?' What does that mean?"

ED nurse - "Sometimes the EHR pulls up the patient's meds, sometimes it doesn't." (direct quote).

Needless to say, these were not exactly words I enjoyed hearing.

My mother was having a repeat of the ischemia to the brain or "TIA" (transient ischemic attack, i.e., threatening to have a stroke), only this time the ED EHR itself was also having a TIA.

In this progressive "paperless" setting, I was the sole conduit of accurate information about her meds. However, not every elderly patient has an advocate with my background...

My mother's TIA symptoms improved somewhat and she went to ICU, and was set up for a slew of tests to see what should be done, but these "every time I enter a hospital" EHR problems are getting a bit beyond what I consider as mere personal bad luck.

She was then transferred to a tertiary care hospital's critical care floor for neurological problems. Before transfer, I asked to see the results of her neck and brain scans.

A doctor brought them up on the computer screen, but rapidly scrolled down to the impression section. The doctor hoped I didn't see what was at the top of the radiological report. But I did. I saw a statement like this:

"A duplicate medical record number, previously unknown, was discovered for this patient."

Out of exasperation, I did not raise a commotion, but I can only wonder what data might have gone into that "previously unknown" silo.

After transfer to the tertiary hospital, the commercial EHR on a cart on wheels ("COW") outside my mother's room was displaying the EHR main screen, with a "patient worklist" window also open in the screen's center.

(The GUI appeared, by the way, to be that of obsolete Windows 2000 or NT 4.0, although possibly it could have been XP set to display the older GUI appearance, but the icon appearance suggested the former possibility).

Superimposed over the central patient worklist window, though, was a dreaded Microsoft crash window, exactly like this one from the Web:


An error window like this was superimposed on the EMR screens being used to manage my mother's care. Click to enlarge.

In asking the RN about this, I was told this window popped up a lot, and was simply dismissed by users with one of the two buttons. The IT dept. had told clinical staff the problem was due to users "loading illegal software on the hospital computers." (This COW, incidentally, lacked any portals for thumb drives, floppies, etc.) It sounded like IT would fix it when they managed to get around to it. The nurses went about their business, ignoring this screen when it popped up unpredictably but regularly.

Somehow, this did not inspire within me great confidence in the integrity of that EHR and its data.

As an aside, I remember hearing a story like this over ten years ago in a past life as CMIO of a large hospital, in the Cath Lab as I detailed here:

... The informaticist [a.k.a. me - ed.] first asked to see what had been installed in the cath lab by MIS. The informaticist found workstations running the application under Windows 3.1, an unreliable platform especially unsuited for critical care environments, because "Windows NT and other OS's such as UNIX were not supported by MIS." When shown a short demo of data entry by a nurse after a cardiac cath case, the workstation crashed, displayed a "general protection fault" error and hexadecimal debugging data. It had to be rebooted, with resultant time and data loss.

The informaticist asked the nurse about the crash and was told it happened frequently, up to several times per day per workstation. When the informaticist asked if MIS had requested a detailed log be kept of the crashes and error messages to help resolve the problem, the answer was no. MIS felt diagnosis and repair was the vendor's responsibility. When the informaticist asked the nurse exactly what had been explained to clinicians about the crashes, the nurse replied that cath lab staff had been told by MIS "don't worry about it, you can't understand it, we'll make it better."

The informaticist remembered, from medical school and residency, being told never to say such a thing to patients as it was considered inappropriate and too paternalistic in the modern age of medicine, especially with the elderly. This was an ironic and somewhat perverse scenario for a critical care area, the informaticist thought.

I find the repeat of a story like this simply stunning.

As probably 2/3 of my healthcare-worker students have related stories of EHR-induced clinical problems in their organizations in the past several courses I've taught [typical
examples of student stories are at this link], and other mentees with worse tales in their CMIO roles, and now with my own experiences getting more and more theatre-of-the-absurdish, I offer this thought:

Perhaps my experiences are merely anecdotal, due to some bad karma that causes me to attract bad electrons and stale bits, disrupting EMR operations.

Yes, that must be it.

-- SS

Executive Compensation at Non-Profit Hospitals: Pay for ... Fraud?

We have often discussed executive compensation at US hospitals and academic medical centers, which seems to run from generous to outrageous.  The usual explanation by organizational spokespeople, and occasionally boards of trustees is that this is the sort of compensation needed to attract the best and the brightest, a variation of the "pay for performance" meme that resounds throughout business schools and executive suites.  However, almost never does anyone at any hospital or AMC acknowledge that their leaders are not the best and brightest, although outside of Lake Woebegone, all cannot be above average.

Here are two recent stories about hospital executives whose compensation contrasted with their performance.

Danbury Hospital

We previously posted about how the former chief financial officer (CFO) of Danbury Hospital, now part of Western Connecticut Healthcare, was found in violation of a no-contact order that arose after he was charged with multiple counts of fraud.  It turns out that the William Roe, the former CFO, previously was paid $267,990, per the Danbury News-Times

This month, again according to the News-Times, he pleaded guilty:
William Roe, the former chief financial officer of Danbury Hospital arrested in August and charged with defrauding the hospital out of more than $100,000, pleaded guilty Tuesday to one count of wire fraud.

The plea reduces the charges against Roe. In September, in addition to the wire fraud charges, federal prosecutors charged him with two counts of interstate transportation of stolen money. Those charges have been dropped as part of the plea deal.

Along with the guilty plea, Roe has agreed to reimburse Danbury Hospital more than $140,000. He also will reimburse St. Rita Hospital in Lima, Ohio, where he worked as CFO before coming to Danbury Hospital, an additional $75,000 for funds he allegedly stole there.

Archbold Memorial Hospital

This is one of those cases it would be hard to make up. The Dow Jones News Service originally reported in December, 2010:
A Georgia hospital paid $13.9 million to settle allegations it submitted false claims to the state's Medicaid program, the Justice Department said Wednesday.

The settlement resolves allegations that between November 2002 and July 2008, Thomasville, Ga., John D. Archbold Memorial Hospital Inc. made false representations to the Georgia Department of Community Health, the state agency that administers the Medicaid program in Georgia, that it was a public hospital for Medicaid purposes in order to increase the amount of funds provided to the hospital.

Under Medicaid rules, only public hospitals may participate in the Medicaid Upper Payment Limit, or UPL program. Contrary to its state certification, Archbold Memorial was in fact a private hospital, the Justice Department said, and as a result received millions of dollars in funds to which it was not entitled.
A private not-for-profit hospital claimed to be a public hospital to Medicaid?  And it took years for anyone to figure out that was not the case?  It would have been hard to make that one up.
Two executives took the rap:
in early 2008, then-Chief Financial Officer William Sellers resigned after a three-month suspension and pleaded guilty to charges related to his role in the matter. Former Chief Executive Ken Beverly, who also resigned in February of that year, was recently convicted on charges regarding his involvement.

The Albany (Georgia) Herald reported that Mr Beverly did quite well between the time of his resignation and his conviction:
Former CEO Ken Beverly resigned from his post in 2008 and walked away with more than $6.1 million in compensation and benefits. He was later indicted by a federal grand jury.

Convicted Dec. 8, 2010, of six felony counts related to an indictment alleging he was part of a scheme to defraud Medicaid, Beverly remains free on bond and is awaiting a sentencing hearing.

So is that $1 million per felony count? At least we can be assured it was not a "golden parachute,"
Archbold Spokesman Mark Lowe said that the figure as noted in the hospital’s Form 990 for 2009 as filed with the IRS on August 2010 is the sum of Beverly’s deferred compensation and benefits package as it has accumulated over the course of his 30-plus year career with the hospital and was not a 'golden parachute,' as described in some media reports.

'The ‘other compensation’ is from his retirement program that accumulated deferred compensation over the entire term of his employment. In his case, that was in excess of 30 years of deferred compensation. It’s not severance; rather, it’s compensation that was earned but not paid out until retirement,' Lowe said.

Well, that is reassuring.  Of course, regardless of what you call the payment, a lump sum of $6.1 million is far more than most citizens ever will get for their retirement from any employer.  Having $6.1 million in one's retirement account would fit most peoples' definition of "rich." 

Summary

Again, almost all hospital and academic medical center executives seem to be well-paid, even if they work at small institutions, or at those with shaky finances. When their pay is noticed by the news media, the usual explanation is the executives' general brilliance and excellence, with little more than more vague adjectives supplied in justification.

Given the lack of clear evidence for most executives' large compensation, I believe it is reasonable to cite anecdotes where generous compensation was obviously, if retrospectively coupled with poor performance to challenge the rationale for ever-increasing executive compensation in health care. The two cases above are not of merely poor, but criminal performance, and so stand out.

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.

BLOGSCAN - Attention to Medtronic's Payments to Spine Surgeons in the Main Stream Media

On the HealthBeat blog, Maggie Mahar takes up the case of huge royalty and consulting payments to spine surgeons by medical device company Medtronic.  We had discussed the case recently here, followed by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog (see link in this post).  Ms Mahar was notably optimistic because of the continued attention to this case by the main stream media.  She argued that the increased emphasis on aspects of health care dysfunction shown by the media means "health care reform is moving ahead on the ground."  I hope she is right, but I would feel more hopeful if ill-informed, mission-hostile, self-interested, conflicted, and corrupt health care leadership was less anechoic, if health care dysfunction actually got some attention in the medical/ health care/ health services research/ health care policy literature , and if I could identify at least one prominent politician or policy-maker who talks about these issues.