More Hospitals Settle, But Not for Much

In late February, there have been several notable legal settlements made by more or less prominent hospitals, discussed in rough order of size.

United Regional Health Care System

Per the Cypress Times,

The Department of Justice announced today that it has reached a settlement with United Regional Health Care System of Wichita Falls, Texas, that prohibits it from entering into contracts that improperly inhibit commercial health insurers from contracting with United Regional’s competitors. The department said that United Regional unlawfully used these contracts to maintain its monopoly for hospital services in violation of Section 2 of the Sherman Act, causing consumers to pay higher prices for health care services.

Note that this appears to be the first settlement involving the Sherman Anti-Trust Act that included a hospital system, or any health care organization which we have discussed. As the Times article mentioned,

This is the first case brought by the department since 1999 that challenges a monopolist with engaging in traditional anticompetitive unilateral conduct.

Here is more detail about the alleged offenses:

According to the complaint, United Regional is by far the largest hospital in Wichita Falls. Its share of general acute-care inpatient hospital services is approximately 90 percent, and its share of outpatient surgical services is more than 65 percent. It is the region’s only provider of certain essential services such as cardiac surgery, obstetrics and high-level trauma care. In Wichita Falls, United Regional’s average per-day rate for inpatient hospital services sold to commercial health insurers is about 70 percent higher than its closest competitor for the services that are offered by both hospitals.

The department said that in order to maintain its monopoly in the provision of inpatient hospital and outpatient surgical services, United Regional systematically required most commercial health insurers to enter into contracts that effectively prohibited them from contracting with United Regional’s competitors. United Regional’s contracts required these insurers to pay significantly higher prices if they contracted with a nearby competing facility. Since United Regional is a must-have hospital for any insurer that wants to sell health insurance in the Wichita Falls area, and because the penalty for contracting with United Regional’s rivals was so significant, almost all insurers offering health insurance in Wichita Falls entered into exclusionary contracts with United Regional. As a result, competing hospitals and facilities could not obtain contracts with most insurers and were less able to compete, helping United Regional maintain its monopoly in the relevant markets and raising health-care costs to the detriment of consumers.

As far as I could tell, however, for this apparently severe offense there will be no actual penalty. The settlement only appears to provide for a promised change in future behavior by the hospital:

The proposed settlement, which if accepted by the court would be in effect for seven years, restores lost competition by prohibiting United Regional from using agreements with commercial health insurers that improperly inhibit insurers from contracting with United Regional’s competitors. In particular, United Regional is prohibited from conditioning the prices or discounts that it offers to commercial health insurers based on whether those insurers contract with other health-care providers and from inhibiting insurers from entering into agreements with United Regional’s rivals. United Regional is also prohibited from taking any retaliatory actions against an insurer that enters into an agreement with a rival provider.

So if a hospital engages in actions that restrain competition and results in a de facto monopoly, all the hospital leaders must fear is that at some point it may have to change its monopolistic behavior, according to this settlement.

Catholic Healthcare West

Per the San Jose Business Journal,

Catholic Healthcare West, parent company to local Mercy hospitals, has agreed to pay $9.1 million to settle allegations that seven of its hospitals submitted false Medicare claims, U.S. Attorney Benjamin Wagner announced late Friday.

Here is more detail about the alleged offenses:

The hospitals include Community Hospital of San Bernardino, St. Bernadine Medical Center in San Bernardino and St. Elizabeth Community Hospital in Red Bluff.

The settlement also included allegations that O’Conner Hospital in San Jose, Seton Medical Center in Daly City and St. Joseph’s Hospital and Medical Center in Phoenix submitted inflated costs for their home health agencies and were overpaid. The agreement also resolves allegations that St. Joseph’s overstated how much was owed in disproportionate share funding for indigent patients.

CHW no longer owns O’Conner Hospital or Seton Medical Center.

The settlement resolves allegations that St. John’s Regional Medical Center in Oxnard was overpaid for treating a high percentage of patients with end-stage kidney disease for several years, including two when it was not eligible.

Note that while the amount of the payment assessed appears substantial, it will be made a very long time after the alleged bad behavior occurred:

All of the problems occurred in the 1990s. Federal investigators began looking into the matter in 2001, but it took years to compile evidence and reach a settlement. All of the hospitals had set aside money in a reserve account should they have to pay funds back to the government.

So if a hospital submits false claims to the US government, hospital leaders need not fear paying anything back for more than 10 years, according to this settlement.

By the way, this was not the first such settlement that Catholic Healthcare West has had to make:

In 1998, a whistleblower at Woodland Healthcare disclosed instances of alleged fraud by two medical groups affiliated with local Mercy hospitals, Woodland Clinic Medical Group and Medical Clinic of Sacramento.

Following an extensive investigation, former U.S. Attorney John Vincent announced a $10.25 million settlement in May 2001. The allegations included false claims to inflate reimbursement from Medicare, Medi-Cal and military health insurance programs.

Massachusetts General Hospital (Partners Healthcare)

Per the Boston Globe,

Massachusetts General Hospital has agreed to pay the federal government $1 million to settle potential violations of patient privacy laws, which occurred when an employee commuting to work lost patient records on the T’s Red Line two years ago.

Here is more detail about the alleged offenses:

Health information for 192 patients in Mass General’s Infectious Disease Associates outpatient practice was lost in the incident, including that of patients with HIV/AIDS. The documents included a patient schedule containing names and patient medical record numbers, as well as billing forms containing the name, birth date, medical record number, health insurer and policy number, diagnosis, and name of providers for 66 of those patients.

Note that Massachusetts General Hospital is not independent, but part of Partners Healthcare, which reported net patient service revenue of $1.5 billion in the most recent quarter, again per the Boston Globe. So this settlement amounted to about 0.00167% of the system's patient revenue.

So if a hospital engages in actions that violate the trust patients have that their information will be kept confidential, all hospital leaders have to fear is that their institution will eventually have to pay something much less than round-up error of their revenue, according to this settlement.

Summary

Again, the volume of participants in the ongoing march of legal settlements is a reminder of how pervasive bad behavior is in the US health care system. Remember that these settlements are in some sense the tip of the iceberg. They only indicate behavior that inspired legal action which was in turn was publicized. It is likely that for each behavior that eventually leads to a settlement, there are many behaviors that go unreported, or that cause no reaction.

It is interesting that sorts of bad behavior that formerly caused no official reaction are now leading to settlements. As noted above, there had been no recent legal actions against concentration of power in health care up to the United Regional Health Care System settlement.

However, like many of the settlements we have previously noted, the latest crop seem to have little deterrent power. The United Regional Health Care System settlement seemingly involved no monetary penalties whatsoever, only a promise of not to do it again. The Catholic Healthcare West settlement's monetary penalties were so delayed, occurring over 10 years after the actions in question, their deterrent power is highly questionable. The Massachusetts General Hospital (really the Partners Healthcare) monetary penalty was infinitesimal compared to the size of the institution's budget.

Furthermore, as in nearly every other case we have reported, no person who authorized, directed or implemented the actions in question had to pay any penalty, or suffer any negative consequence, or was even identified.

So while there seems to be some increased interest in addressing some kinds of bad behavior, like monopolistic practices, that heretofore generated no official reactions, regulatory authorities still seem loathe to even slap the wrists of the people whose aggregated actions are making our health care so expensive, so inaccessible, and probably of such mediocre quality.

Thus, in recent years, health care leaders, like leaders of financial service companies, seem to have impunity,  Up to now, they have been able to preside over all sorts of bad behaviors that help support their exorbitant remuneration without fearing any personal penalties.  As Charles Ferguson, the director of Inside Job, said when accepting his Academy Award last night, per MarketWatch,

Forgive me, I must start by pointing out that three years after a horrific financial crisis caused by fraud, not a single financial executive has gone to jail — and that’s wrong

After a slow-motion health care train wreck over the last 30 years, hardly any health care executives have even had to pay a fine, much less go to jail.

So I repeat, and repeat, and repeat: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Electronic Medical Records: Two Weeks, Two Reams

Electronic medical records in the pioneering years were about helping clinicians better understand a patient. They were about easing the clinicians' work in evaluating and caring for a patient, or in performing a consult on a patient being cared for by a colleague.

The commercial electronic medical record is another beast entirely.

Thanks the the imperative to document anything and everything to drive up billing, and due to the "computer as a data warehouse", early 20th century programmable card-tabulator culture of mercantile, manufacturing and management computing specialists (A.K.A. the MIS personnel in most hospitals and health IT vendor development shops), these systems have become a distraction and an error-promoting nightmare.

In the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:

... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.

In the Feb. 26, 2011 New York Times Op-ed "Treat the Patient, Not the CT Scan", Verghese also observed that:

... the complaints I hear from patients, family and friends are never about the dearth of technology but about its excesses. My own experience as a patient in an emergency room in another city helped me see this. My nurse would come in periodically to visit the computer work station in my cubicle, her back to me while she clicked and scrolled away. Over her shoulder she said, “On a scale of one to five how is your ...?”

The electronic record of my three-hour stay would have looked perfect, showing close monitoring, even though to me as a patient it lacked a human dimension. I don’t fault the nurse, because in my hospital, despite my best intentions, I too am spending too much time in front of the computer: the story of my patient’s many past admissions, the details of surgeries undergone, every consultant’s opinion, every drug given over every encounter, thousands of blood tests and so many CT scans, M.R.I.’s and ultrasound images reside in there.

One of the reasons he and other physicians are spending too much time in front of the computer is because the computer EMR application is poorly engineered, presenting a mission hostile user experience and characterized by "clickorrhea" in order to navigate the perfect storm of informational disarray and chaos. The systems also cannot support clinician's cognitive processes properly, as was the original intent of these systems (See, for example, the 2009 National Research Council report on health IT.)

Another is due to the computer technician and billing department's fetish with massive detail.

All of these issues are easily illustrated via one picture:

Two weeks of hospitalization of one patient generated about 1000 pages, or two reams of paper (one ream = 500 pages, as sold at office supply stores everywhere) that another physician who sent this photo needed to wade through:

Two weeks, two reams. More stunning full-sized. Click to enlarge.

The content of these reams, rather than being learned medical prose, is what can be more accurately referred to as "legible gibberish." These "records" have all the fluency of a computer programmer's grasp of Shakespeare, or, as one commenter here colorfully put it, "cloistered coding gnomes.

It could have been worse. In the case of a relative, just over two and a half weeks of the initial phase of their hospitalization for an EMR-caused medical catastrophe generated approximately 2,900 pages of legible gibberish - six reams (or three reams, double-sided) for which I had to pay about $1000 to obtain.

This 'paper-orrhea', needless to say, is reckless and a medical information science absurdity. It is crazy stuff.

... Anyone who thinks these systems in their present form benefit clinical medicine needs to have their head examined. Preferably, by a psychiatrist not suffering from irrational exuberance himself or herself, and not taking notes into a computer facing away from the examination couch.

Perhaps a psychiatrist like this?

[/satire off]

-- SS

Addendum: it occurs to me I may have selected the wrong body part for examination. Those who gleefully and uncritically push this experimental technology for national rollout, even in the face of literature such as I aggregated at "An Updated Reading List on Health IT", perhaps (metaphorically speaking) should have the contents of their hip pocket or purse examined:


-- SS

"Replace the RUC!"

We have frequently posted, first here in 2007, and more recently here and here, about the little-known group that controls how the US Medicare system pays physicians, the RBRVS Update Committee, or RUC.

Since 1991, Medicare has set physicians' payments using the Resource Based Relative Value System (RBRVS), ostensibly based on a rational formula to tie physicians' pay to the time and effort they expend, and the resources they consume on particular patient care activities. Although the RBRVS was meant to level the payment playing field for cognitive services, including primary care vs procedures, over time it has had the opposite effect, as explained by Bodenheimer et al in a 1997 article in the Annals of Internal Medicine.(1) A system that pays a lot for procedures, but much less for diagnosing illnesses, forecasting prognoses, deciding on treatment, and understanding patients' values and preferences when procedures and devices are not involved, is likely to be very expensive, but not necessarily very good for patients.

As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.

To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation. Their names do not appear. A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95 (although now with the notation that the product has been "discontinued.") However, the book is not on the web, or in my local or university library, and I have no other way to easily access it. Thus, the RUC membership is at best relatively opaque.

To expand on the ultimate point, as Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."

The fog surrounding the operations of the RUC seems to have affected many who write about it. We have posted (here, here, here, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC. Up until 2010, after the US recent attempt at health care reform, the RUC seemed to remain the great unmentionable. Even the leading US medical journal seemed reluctant to even print its name.

That changed in October, 2010.  A combined effort by the Wall Street Journal, the Center for Public Integrity, and Kaiser Health News yielded two major articles about the RUC, here in the WSJ (also with two more spin-off articles), and here from the Center for Public Integrity (also reprinted by Kaiser Health News.) The articles covered the main points about the RUC: its de facto control over how physicians are paid, its "secretive" nature (quoting the WSJ article), how it appears to favor procedures over cognitive physician services, etc.

So the RUC became less anechoic.  Now, four months later, there is more news.  A new site called "Replace the RUC!" has now appeared, with the following introduction:

This site has been developed - see here for our backgrounds - to help primary care physicians and other interested individuals obtain verifiable background from reputable sources on:

* The evolution and structure of the US' medical payment system.
* How it came to devalue primary care and favor specialty services.
* How that has translated to lower quality care at far greater expense in the US.

We believe the overwhelming majority of American primary care physicians are deeply frustrated with the differences in how primary and specialty care are valued by the current system, and the havoc that system has wrought throughout health care and the nation.

The first step to remedying this situation is for the primary care medical societies to visibly and loudly withdraw from participation in the RUC, de-legitimizing the process.

That said, this effort is most decidedly NOT primarily about getting primary care physicians more money, but bringing our health system back into homeostasis.

We have previously noted that there are many unanswered questions about the RUC:

• How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
• Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
• How did the RUC become de facto in charge of this process?
• Why does the AMA keep the membership of the RUC so opaque, and give no input into the RUC process to its general membership?
• Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
• Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?

We welcome this new site as a way to answer these questions, and more importantly, as a way to develop more rational incentives within the health care system.

Note that "Replace the RUC!" will be added to our link list.

References



1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.)
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (Link here.)

Send Mercenaries, Guns, and Money? - Cerberus Tries to Buy Jackson Health

The latest twist in the tale of one of the US great safety-net public hospitals raises some interesting questions.  As reported by John Dorschner in the Miami Herald, Jackson Health System has had some bad times:

the system, ... has served for a century as Miami-Dade County’s safety net healthcare system for the poor and uninsured. But money and management woes in recent years have pushed the system to the brink of failure time and again. Last week, its executives said it would run out of cash in July unless drastic measures are taken.

The Bid for Jackson Health

The latest drastic measure proposed was a take-over by a for-profit corporation, one that we have heard of before:

A Massachusetts hospital chain led by a Cuban American heart surgeon with family ties to Miami has sent Jackson Health System a non-binding 'expression of interest' letter, offering to take over the financially troubled public hospitals, invest $600 million in capital and assume $500 million in debt.

The $1.1 billion offer from Ralph de la Torre of Steward Health Care System was delivered Tuesday morning to members of the capital committee of the Public Health Trust, Jackson’s governing body.

Questions Appear Immediately

The proposed deal immediately raised questions and concerns. The very nature of the deal was unclear:

Trust member Ernesto de la Fe said he wasn’t sure if the company was proposing a straight-out sale, while other board members said they thought the offer envisioned 'a public-private' partnership.

Also, in a follow-up story by the same reporter, there were questions about the rapid time-table,

Jackson is in such difficult financial conditions – its executives warn it may run out of cash in July – that many leaders are willing to consider a sale, but they wondered whether the 90-day timetable set by Steward Health Care System is realistic and what the deal might mean for the 500,000 uninsured persons in Miami-Dade County.

There were questions about the company which proposed to buy Jackson:

'We need to know a lot more about this company,' said Sal Barbera, an adjunct professor at Florida International University and a former hospital executive.

Steward has existed only since November, when Cerberus Capital Management finalized a $895 million deal to turn six Catholic hospitals into a for-profit entity. Steward has since bought two other small hospitals. Altogether, the Steward system has 1,565 licensed beds. Jackson has 2,100. De la Torre has been a hospital executive for less than three years.

That’s 'a very short track record,' said Mark Rogers, a Trust member and former chief executive of the Duke University Hospital.

Would the Mission be Upheld?

The issue of whether a private, for-profit company would respect the mission of a safety-net hospital came up quickly,

Alan Sager, a health policy professor at Boston University, said some Steward facilities are money losers in poor neighborhoods. 'Some of us had a lot of questions' about the Cerberus take-over and how the investment company could squeeze returns for investment out of hospitals that were struggling as nonprofits.

'We asked repeatedly. We never received answers,' Sager said.

He said his fear is that patient care will be reduced to make profits. 'I think there should be concerns about preserving essential patient care in Dade County' if Steward took over Jackson, he added.

'If the object is merely to cut costs to make money … then that is not the right approach for Jackson,' said Rogers, the former Duke executive. 'Clearly some costs have to come out, but we have to invest in new programs to maintain the quality of medical care that Jackson has always provided.'

One day later, John Dorschner again writing for the Miami Herald raised more questions about why a large private equity company would want to buy a money-losing public hospital system? First he noted,

While the human face on the $1.1 billion bid to buy Jackson Health System is a Cuban-American heart surgeon with strong family ties to Miami, a vast and powerful entity looms in the background: Cerberus Capital Management.

The company, named for the mythological three-headed dog that guards the gates of Hades, is one of the biggest private investment firms in the United States, and it is the owner of Steward Health Care, the Boston hospital group that this week said it is interested in buying Miami-Dade’s public hospitals

So,

The question that perplexes some Trust members is why such a big-time investment firm would be interested in a healthcare system with three public hospitals that lost $244 million in fiscal 2009, is expected to lose $105 million in fiscal 2010 and is projected to run out of cash in July unless drastic measures are taken.

The concern, again, was whether Cerberus would uphold the current mission of the hospital system:

Trust Treasurer Marcos Lapciuc said Thursday that Cerberus is 'in the driver’s seat' on this deal, not Steward. 'They are going to expect some return on their investment. This is not going to be charitable donation,' he said.

Of course, the central mission of the current Jackson Health System would seem to be charitable.

To build the health of the community by providing a single, high standard of quality care for the residents of Miami-Dade County

The implication of "single, high standard" is that applies to all residents, regardless of financial status or ability to pay.

More Questions

The CEO's Short Term Focus

There is good reason to question whether Steward Health Care, formerly Caritas Christi, and now owned by Cerberus Capital Management would uphold that mission. As we noted recently, the Steward Health Care CEO seems to have a very short-term focus, suggested by the track record of the Cerberus CEO, who quickly left an organization he had aggressively promoted, suddenly switched from the Republican party to become a big contributor to the Democratic party, abandoned his medical license after developing a good reputation as a cardiovascular surgeon, and famously was quoted, "burn the boats on the beach, baby." Would he support the long-term commitment needed to make both the Massachusetts based and now the proposed Florida based hospitals, most of which are safety net hospitals, succeed?

"Leakage Reduction" - a Threat to Physicians' Professionalism?

As we also noted recently, the main tenet of his business plan seemed to be to reduce "leakage," to make sure patients who start within the system are referred within the system and do not "leak" elsewhere. The problem with this is that physicians are supposed to decide how to manage patients, and specifically to decide where to refer patients in the patients' interests, not just to keep money flowing to the health care system. "Leakage reduction" may possibly threaten physicians' first commandment, to make decisions to maximize benefits and minimize harms to individual patients, before all other considerations. Also, as we noted earlier, since Steward Health Care purchased not only some Massachusetts hospitals, but a big network of physician practices, there could be a risk that the physicians who are now employed by a private equity group would be pushed to make referral decisions for financial reasons, rather than in the best interests of the patients.

Note that a recent (posted 9 February, 2011) advertisement for a Senior Medical Director (physician leader) of the Caritas Christi Network Services, the physician group owned by Steward Health Care LLC, said the Director's first goal would be:

This position will have a leadership role in all aspects of the CCNS system, including responsibility and accountability for:
- Lead/Mentor/Support IPA based Medical Directors (at both the IPA and Pod level) to achieve Medical Management goals and objectives in Quality, Leakage, Utilization, and Risk performance

Keeping Company with Gun and Ammunition Manufacturers and "Mercenaries"

There are also questions about whether the corporate culture of Cerberus Capital Management would be compatible with the management of safety-net hospitals. Cerberus has some current investments in firms whose operations seem oddly askew from providing medical care to patients regardless of their ability to pay.

First, Cerberus owns the biggest manufacturer of firearms and ammunition in the US. As reported by BusinessWeek last year,

Cerberus had more than DPMS [Firearms] in its sights. From April 2006 to January 2008 it bought three other firearms companies: Bushmaster, Remington, and Marlin. And it kept adding to its collection. Cerberus now controls 13 brands in a holding company it created, Madison (N.C.)-based Freedom Group. With sales of $848.7 million in 2009, Freedom Group is the largest gun and ammo maker in the U.S. That means Stephen A. Feinberg, Cerberus' founder and managing member, is the country's top civilian gun magnate.

In addition,

Luth, the rifle maker, says that when he arrived at Cerberus' Park Avenue offices to negotiate a deal in 2007, he discovered that Feinberg and several of his partners 'are real gun guys.'

Also, as reported by the New York Times, Cerberus recently bought one of the biggest "private military contractors,"

DynCorp International, the private military contractor, said on Monday it has agreed to sell itself to Cerberus Capital Management for $1.5 billion, as the private equity industry continues to return to its core business of deal-making.

Cerberus will pay $17.55 a share for DynCorp, a 49 percent premium to Friday’s closing price of $11.75. DynCorp now has 28 days under a 'go-shop' provision within the deal agreement to find a higher and better offer.

While DynCorp has continued to win new contracts from the federal government, it has also been the subject of controversy over the years for its assignments in Iraq.

That controversy was amplified in an article in The Nation by Jeremy Scahill, entitled "The Mercenary Owners, They Are a Changin' (Sort of)

Blackwater and DynCorp, the two leading mercenary firms servicing the US wars in Iraq and Afghanistan have both undertaken steps toward significant structural changes over the past month. In the case of DynCorp, the ownership of the whole business seems to be changing hands, while Blackwater is dumping its private air force.

Cerberus Capital Management, one of the largest private equity firms in the US announced April 12 it was buying DynCorp, the massive, publicly traded company, which is akin to the Wal-Mart of the private security industry, for $1 billion in cash. Cerberus counts among its big wigs former vice president Dan Quayle, who often represents the company internationally. DynCorp has had its share of scandals over the years, including whistle blower allegations that personnel have engaged in organized sex-slave trading with girls as young as 12 and allegations its personnel have assaulted journalists. It has been rebuked by the State Department for its 'aggressive behavior' in interactions with European diplomats, NATO forces and journalists in Afghanistan. A 2007 US government audit of DynCorp's work in Iraq found that the State Department 'does not know specifically what it received for most of the $1.2 billion in expenditures under its DynCorp contract for the Iraqi Police Training Program.' More recently, the company was in the news facing allegations its training of the Afghan National Police was shoddy, including allegations its trainees didn't know how to adjust the sights on their AK-47s. If the Cerberus deal goes through, it will mean that the publicly-traded DynCorp will go private, meaning that it will be infinitely more difficult to get information on the company.

Cerberus seems to have had a dream of owning its own mercenary business for at least a few years. In April 2008, the company was reportedly looking to buy Blackwater. The deal apparently fell through because of concerns over Blackwater's reputation.

Summary

So we have come a long way from 1980, when the US American Medical Association gave up the rule that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  (See posts here and here.)   Now we have private equity firms buying or trying to buy formerly non-profit safety net hospital systems to be included in portfolios that can include gun and ammunition manufacturers and private armies.  Now we have physician networks owned by private equity firms focused on choking off "leakage."  Such ownership may initially inject lots of money into the system, and may eventually profit the new private owners, but what will we give up in this brave new world of commercial safety-net hospitals and for-profit physician practices?

As we said before,.... Deals that turn not-for-profit hospital systems into privately held for-profit systems ought to be scrutinized with extreme skepticism. Furthermore, once such deals are made, the results ought to be watched extremely closely to make sure they do not put private gain ahead of individuals' and the public's health. For-profit hospitals have generally not lived up to the promises they made to provide quality, accessible health care at a cheaper price.  It is yet to be seen whether private equity running for-profit hospital systems (and physicians networks) will do any better.

Coda

The title requires apologies to Warren Zevon, who famously performed "Send Lawyers, Guns and Money."

Colin Herd - A treasure trove of razzle-dazzle stylings, superfine wit, charismatic discretion, and a vacuuming tenderness

Colin Herd, too ok, BlazeVOX, 2011.

"Colin Herd is invincible in lemon, wants to be famous in two years—à la Charles Henri Ford—and his dad dresses like Roland Barthes. He’s not scared to introduce Simple Minds to Schopenhauer, nod to Oulipian lists, or throw in ‘old .at’ puns with real ones: ‘4 Lorne Street.’ That’s not a joke. Colin’s words, not mine (the poems are so engaging, and rooted in the poet’s life, that you feel able to use his forename). This playful first collection is a faux-real wide-eyed stare at the normal and the uncanny in everyday life. Herd evokes Brautigan when he writes ‘crumple this.’ Don’t. At least, read it first." — nick-e melville

"Colin Herd's 'too ok' is a treasure trove of razzle-dazzle stylings, superfine wit, charismatic discretion, and a vacuuming tenderness. Herd's gift for words is exquisite and adventurous and armed to the teeth, and these poems are its perfect measurements.' — Dennis Cooper

Colin Herd, Like, Knives Forks and Spoons Press, 2011.


"• I LIKE the way found-texts are written which aren’t quite found-texts
• I LIKE the voice
• I LIKE the alleviated status of the trash written about without that puke-ingusting feeling that you are ‘viewing everyday objects in an extraordinary way’
• I LIKE the condemnation of capitalism
• I LIKE the grotesque & squiggy imagery; esp the mushyness of George Bush Sr. Do sculptures at Madame Tussaud’s get melted down like the Wicked Witch of the West or do they go into storage at the Tate Gallery?
• I LIKE the way the art criticism is done here
• I LIKE the juxtaposition of magik and humanism: see Franz Kline poem
• I LIKE Franz Kline any day of the week
• I am sorry Denise Levertov was so mean to Colin Herd but kinda glad also
• I enLIKED to hear him growl. Thank you so much for teaching me how to growl
• There is this woman I LIKE a bit (she’s so naff), who I’ve seen advertising non-aging cream, but I had never heard of Jane Rafter before but I am GLAD that I have done now
• Just LIKE Colin Herd I enjoy watching crap TV sometimes and I LIKE to satirise it. Crap TV is one of many things that needs to be satirised and is evidence enough to agree with Adorno’s threadlike arguments
• I LIKE Colin Herd’s poem about Eva Longoria even though I don’t know who the hell she is: I’m not going to google her but will no doubt get told who she is subsequent to this review
• I LIKE to laugh; laughter is both the happiness and sadness of the people, our escapism and our warning
• I LIKE the way Colin Herd does détournement
• I LIKE to start my day with Nescafe (LIKE hell I do)
• I LIKE ‘LIKE’" - James Davies


read my lips

i’m such a fan of madame tussauds
that i have a favourite wax-sculptor

and could recognize his work in a
tv-style police lineup. i think i might

anyway. his name’s paul bainbridge
and he did ringo and george but not

paul or john. the way mrs t works, it’s
a team-project, but paul’s input is
distinctive. if the person is shifty, he
sure as anything makes them look

shifty. you should see his al gore.
his princess juliana of the netherlands
is excellent too but his masterwork is

george bush sr and i would rate it
as one of the finest works of political

art, the way the lip slides up at the right
as if he’s saying, like you just did:
my throat’s now closing up, fantastic.


Colin's blog

Llorenç Villalonga - A testament to the eternal attractiveness of the libertine, and the lengths to which we go in justifying our own worst impulses

Llorenç Villalonga, The Dolls' Room (Catalan Literature Series), Trans. by Deborah Bonner, Dalkey Archive Press, 2010.


"A classic of contemporary Catalan literature, and a haunting and satirical portrait of a vanishing age, Llorenç Villalonga's The Dolls' Room concerns the decline of Don Toni and Dona Maria Antònia Bearn: aristocrats, cousins, husband and wife, and members of the decadent, age-old ruling class of a town that bears their name. Their story is told by the naïve family priest, Don Joan, who was taken under Don Toni's wing as a schoolboy. Describing the shabby grandeur of his benefactors’ lives in their ancient, rundown family mansion, their grand but ruinous excursions to Paris and Rome, and the mysterious events that lead to their deaths, the humbly devote Joan is continually challenged, and perhaps titillated, by Don Toni’s impious personality, his defiance of church authority, and his scandalous affairs. Partly condemning and partly admiring his devilish mentor, the pure-minded Don Joan’s lurid "biography" of the Bearns is a testament to the eternal attractiveness of the libertine, and the lengths to which we go in justifying our own worst impulses."


"It is a puzzle that this masterpiece has been so long in reaching the English-speaking world." - Publishers Weekly


"Villalonga is surely one of the best-loved writers in the Catalan language." - World Literature Today


Excerpt:

"Since you never came to Bearn, I must explain that it is a mountain estate located near a small village of about four hundred souls also called Bearn. Whether the estate took the name of the village or the village that of the estate remains unknown. Year after year, on the day of Sant Miquel, the patron saint of Bearn, the preacher mentions that these lands have belonged to the Senyors since the Conquest. It may be true, although there are no documents to prove this fact. 'Our lineage', Don Toni said, 'is so old that it can't be dated. It's lost in the darkness of time.' However, the oral tradition that made them respectable and irreproachable has had no official recognition. There is a good reason: the documents are missing. All the Senyors except for Don Toni, who was a francophile, were always quite indifferent as far as erudition was concerned. Even within the past century and a half, one of his great-great-grandfathers, also called Don Toni, was such a primitive soul that he was the object of many tales of mischief, although they probably exaggerate what he actually did. The old people remember the following rhyme:

Our Lord Jesus is in Heaven

and in Moorish lands, the heathen.

The Devil lives deep down in Hell

and in Bearn Don Toni dwells.

The Senyor found it all very amusing. 'At least,' he said, 'he didn't waste any time.' His other ancestors were more sensible. They lived in the country, and either ignored or looked down upon the refinements of city life. The City, in turn, ignored them.

From the village to the estate is about an hour's walk, but due to the mountainous terrain one cannot see the estate until one is practically on top of it. Bearn is thus, figuratively speaking, a lost cause. The land is poor, with only pine and oak growing between jagged rocks. It will soon be thirty-eight years since I came into this world, the son of a labourer and a farm girl. I have no recollection of my parents. I have heard that my mother was very beautiful and had jet-black eyes. When I was seven, I was sent to work as a swineherd, but the Senyor decided almost immediately that I was to be sent to school in the City. I can remember it as if it were this very moment. It was a summer afternoon and I had taken the herd over to S'Ull de Sa Font when the Senyors went by. They would spend long periods in the City, and when they returned, my respect, my fear or my embarrassment made me run off and hide every time I saw them. I barely dared to look at them anywhere but in the village church, on the day of Sant Miquel, when they sat in two red velvet-covered chairs next to the altar.

Dona Maria Antònia was very beautiful, and Don Toni, thin, graceful, and rather slight, resembled her despite his ugliness. They were first cousins. Although they almost always smiled, they were imposing because they appeared to be made of a different substance from that of the peasants, something newer and more luminous; not even now could I explain it. The way they dressed undoubtedly had something to do with it, but I do believe it was a less material, almost magical quality that surrounded the feudal and pastoral name of Bearn, revered every year from the pulpit on the holiday. Usually around Sant Miquel it rains in the mountains, and the history of the old family is as closely associated with the beginning of the cool weather and the joyful green of the first pastures as it is with the deeds of the conquerors in the battlefield.

'Look at that boy, Tonet,' said Dona Maria Antònia. 'Have you noticed his eyes?'

The Senyor stared at me and did not reply. Dona Maria Antònia was lost in thought.

'He reminds me of someone . . . I'm not sure who,' she said.

He remained silent. The following day I was sent to the Theatine school. I returned for the Easter vacation. My benefactors were not at the estate. Madò Francina told me that 'the Senyor was off travelling' and that Dona Maria Antònia was at the townhouse of Bearn, a stone house by the church. I thought I sensed some mystery in her words. Indeed there was: everybody was talking about it, whispering to each other, and no matter how much I listened, I could not understand a thing. Besides, whatever I could have understood would only have been the outside appearance of the matter. Years later, the Senyor, who was unreserved with me and with almost everyone, unveiled the psychological mechanism behind it in a series of long conversations which truly resembled a confession. Although I do not know to what degree they could be considered as such, despite their sincerity, and I understand that you may be shocked, as I myself am, to think that to this date, after all my years as the family priest, I cannot honestly state that he ever made a single confession.

His soul was as transparent and ever-changing as glass. Precisely because he was such a sincere man, you could never know what he was really like, just as you cannot know what images will be cast by a piece of crystal. It is strange that those people who refuse to lock themselves into a system, perhaps so as not to neglect any aspect of reality, are the ones who appear to be most dishonest. If you add to that the fact that noblemen are trained from an early age in the art of kind words that are not to be taken literally, and yet always are by those less educated, we find another reason why people mistrusted Don Toni. Ordinary people believe that only the tactless are sincere, because they are incapable of interpreting the conventional values and the things that are taken for granted in good manners. For example, I believe I already told you that he used to wear a white wig and the habit of a Franciscan. Those who compared his past and his conversation, not always edifying, with those robes, saw nothing but the disparity which undoubtedly existed, but they might also have seen the similarities (his secluded life, his love for matters of the soul) that were no less real. People who only spoke one language admired this man who spoke several. The Senyor was basically well-meaning, although some of his actions may have been disastrous; he believed that disasters were caused by errors of intelligence rather than by voluntary evil, which he refused to accept.


"Llorenç Villalonga (Palma de Mallorca, 1987-1980), was a writer who had also studied medicine, specialising in psychiatry (1919-1927).
He worked as a doctor in Palma, first as a private consultant and subsequently in the city's Psychiatric Hospital. He was also Secretary of the Balearic Islands Medical College.
Villalonga began his literary career by writing for the Palma-based newspaper Día with a series of articles that were notable for their clear anti-Catalanist and anti-republican sentiments. Not long afterwards, he published his first novel Mort de dama (Death of a Lady, 1931), under the pseudonym of Dhey. This work, which is markedly caricaturesque, caused a huge controversy in the provincial society of Mallorca, whose members felt they had been unkindly lampooned. With time, the book became a classic of Catalan literature, along with another work, Bearn o La casa de les nines (which was published in Catalan in 1951 and in English, in the translation of Deborah Bonner, as The Dolls' Room (London, Andre Deutsch, 1988)), winner of the National Critics' Prize and undoubtedly one of the most widely-translated novels of twentieth-century Catalan literature. Besides these two emblematic novels, he wrote a number of other works that gave shape to the myth of Bearn, especially after the 1960s. In these books, Villalonga intelligently and nostalgically portrays the swansong of the old Mallorca aristocracy. Hence his work, Bearn in particular, has been compared with Il gattopardo (The Leopard) by the Sicilian writer Giuseppe di Lampedusa, which Villalonga translated into Catalan in 1962.
Also of note are his plays, Fedra (Phaedra, 1932), Silvia Ocampo (1935) and Desbarats (Defeats, 1965), and the collection of articles Centro (Centre, 1934)."


Read it at Google Books

MedInformaticsMD in WSJ again: No Patient Will Ever Say, 'Quick, Watson, the Needle!'

Following along the lines of my Jan. 2011 post IBM's Watson, Jeopardy, and "Revolutionizing Medicine" , the Wall Street Journal published this Letter to the Editor by me today:

Wall Street Journal

LETTERS
FEBRUARY 25, 2011

No Patient Will Ever Say, 'Quick, Watson, the Needle!'

Regarding Ray Kurzweil's "When Computers Beat Humans on Jeopardy" (op-ed, Feb. 17): Librarians often receive requests for information as cryptic as "Jeopardy!" clues, from people who are sometimes not even sure what they're seeking. Watson is, in essence, a librarian that retrieves facts.

Regarding natural language processing and fact-retrieval systems like IBM's Watson, medicine is about cognition. It's about human judgment born of experience in dealing with ambiguity, not just of language but also, and this is critical, of observations, findings, lab data, image interpretation, etc. It is about human intuition, assemblage and the integration of a huge amount of disparate information in ways not well understood even by its practitioners. The end result is not just the recall of a piece of information, obscure as the information might be.

I consider predictions of Watson spearheading cybernetic miracles in medicine to imply just as grandiose a valuation to the technology as the statements I heard two decades ago about the health information technology of the day, or even today, "revolutionizing medicine." That has not happened.

A cybernetic librarian is no physician. As for me, for now I'll stick to people in my own medical care. Let Mr. Kurzweil see the machine for his ailments.

Scot Silverstein, M.D.

Philadelphia

I am pleased that my counter-marketing-hype opinion on the meme of health IT "revolutionizing medicine" was deemed fit to print by the Journal.

Those in senior leadership positions, as are included in the WSJ's readership, need to see that meme challenged.

-- SS

Polyphenols, Hormesis and Disease: Part II

In the last post, I explained that the body treats polyphenols as potentially harmful foreign chemicals, or "xenobiotics". How can we reconcile this with the growing evidence that at least a subset of polyphenols have health benefits?

Clues from Ionizing Radiation

One of the more curious things that has been reported in the scientific literature is that although high-dose ionizing radiation (such as X-rays) is clearly harmful, leading to cancer, premature aging and other problems, under some conditions low-dose ionizing radiation can actually decrease cancer risk and increase resistance to other stressors (1, 2, 3, 4, 5). It does so by triggering a protective cellular response, increasing cellular defenses out of proportion to the minor threat posed by the radiation itself. The ability of mild stressors to increase stress resistance is called "hormesis." Exercise is a common example. I've written about this phenomenon in the past (6).

The Case of Resveratrol

Resveratrol is perhaps the most widely known polyphenol, available in supplement stores nationwide. It's seen a lot of hype, being hailed as a "calorie restriction mimetic" and the reason for the "French paradox."* But there is quite a large body of evidence suggesting that resveratrol functions in the same manner as low-dose ionizing radiation and other bioactive polyphenols: by acting as a mild toxin that triggers a hormetic response (7). Just as in the case of radiation, high doses of resveratrol are harmful rather than helpful. This has obvious implications for the supplementation of resveratrol and other polyphenols. A recent review article on polyphenols stated that while dietary polyphenols may be protective, "high-dose fortified foods or dietary supplements are of unproven efficacy and possibly harmful" (8).

The Cellular Response to Oxidants

Although it may not be obvious, radiation and polyphenols activate a cellular response that is similar in many ways. Both activate the transcription factor Nrf2, which activates genes that are involved in detoxification of chemicals and antioxidant defense**(9, 10, 11, 12). This is thought to be due to the fact that polyphenols, just like radiation, may temporarily increase the level of oxidative stress inside cells. Here's a quote from the polyphenol review article quoted above (13):

We have found that [polyphenols] are potentially far more than 'just antioxidants', but that they are probably insignificant players as 'conventional' antioxidants. They appear, under most circumstances, to be just the opposite, i.e. prooxidants, that nevertheless appear to contribute strongly to protection from oxidative stress by inducing cellular endogenous enzymic protective mechanisms. They appear to be able to regulate not only antioxidant gene transcription but also numerous aspects of intracellular signaling cascades involved in the regulation of cell growth, inflammation and many other processes.

It's worth noting that this is essentially the opposite of what you'll hear on the evening news, that polyphenols are direct antioxidants. The scientific cutting edge has largely discarded that hypothesis, but the mainstream has not yet caught on.

Nrf2 is one of the main pathways by which polyphenols increase stress resistance and antioxidant defenses, including the key cellular antioxidant glutathione (14). Nrf2 activity is correlated with longevity across species (15). Inducing Nrf2 activity via polyphenols or by other means substantially reduces the risk of common lifestyle disorders in animal models, including cardiovascular disease, diabetes and cancer (16, 17, 18), although Nrf2 isn't necessarily the only mechanism. The human evidence is broadly consistent with the studies in animals, although not as well developed.

One of the most interesting effects of hormesis is that exposure to one stressor can increase resistance to other stressors. For example, long-term consumption of high-polyphenol chocolate increases sunburn resistance in humans, implying that it induces a hormetic response in skin (19). Polyphenol-rich foods such as green tea reduce sunburn and skin cancer development in animals (20, 21).

Chris Masterjohn first introduced me to Nrf2 and the idea that polyphenols act through hormesis. Chris studies the effects of green tea on health, which seem to be mediated by polyphenols.

A Second Mechanism

There is a place in the body where polyphenols are concentrated enough to be direct antioxidants: in the digestive tract after consuming polyphenol-rich foods. Digestion is a chemically harsh process that readily oxidizes ingested substances such as polyunsaturated fats (22). Oxidized fat is neither healthy when it's formed in the deep fryer, nor when it's formed in the digestive tract (23, 24). Eating polyphenol-rich foods effectively prevents these fats from being oxidized during digestion (25). One consequence of this appears to be better absorption and assimilation of the exceptionally fragile omega-3 polyunsaturated fatty acids (26).

What does it all Mean?

I think that overall, the evidence suggests that polyphenol-rich foods are healthy in moderation, and eating them on a regular basis is generally a good idea. Certain other plant chemicals, such as suforaphane found in cruciferous vegetables, and allicin found in garlic, exhibit similar effects and may also act by hormesis (27). Some of the best-studied polyphenol-rich foods are tea (particularly green tea), blueberries, extra-virgin olive oil, red wine, citrus fruits, hibiscus tea, soy, dark chocolate, coffee, turmeric and other herbs and spices, and a number of traditional medicinal herbs. A good rule of thumb is to "eat the rainbow", choosing foods with a variety of colors.

Supplementing with polyphenols and other plant chemicals in amounts that would not be achievable by eating food is probably not a good idea.


* The "paradox" whereby the French eat a diet rich in saturated fat, yet have a low heart attack risk compared to other affluent Western nations.

** Genes containing an antioxidant response element (ARE) in the promoter region. ARE is also sometimes called the electrophile response element (EpRE).

Three Years Later, A Congressional Investigation of the Deadly Adulterated Heparin

Slightly more than three years ago, we first posted about the case of the deadly adulterated heparin.  (A case summary is appended to the end of this post, and nearly all our posts are here.)  The case is of fundamental importance because it involves the failure of pharmaceutical companies to fulfill their core mission, to supply pure, unadulterated drugs.   Three years later, how the heparin was adulterated, and who was responsible are still unknown.

So now, it seems, there will actually be an official investigation.  As reported by Alicia Mundy in the Wall Street Journal,

The House Energy and Commerce Committee is conducting a formal investigation into the contaminated-heparin crisis of 2008, saying it wants regulators to figure out who was responsible for adulteration linked to 81 U.S. deaths.

The panel's chairman, Rep. Fred Upton (R., Mich.), and two colleagues sent a letter Wednesday to the Food and Drug Administration asking for documents on whether the agency pursued possible culprits in China and pushed the Chinese government for more information.

'The committee is investigating the unsolved case of who contaminated the U.S. supply of heparin,' a blood thinner used by about 12 million Americans annually, said Mr. Upton, joined by Reps. Clifford Stearns (R., Fla.) and Michael Burgess (R., Texas).

Better late than never, I suppose. In March, 2008, I called the case "outrageous," and called for an investigation. You really did hear it here first on Health Care Renewal. So three years later, an investigation has actually begun.

The latest WSJ article noted:

'There is substantial public interest in solving this case' because more than 80% of the standard heparin supply in the U.S. today comes from China, the lawmakers wrote. About 16% of all pharmaceutical ingredients in the country are imported from China, they wrote.

Also,

'There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain, and pose a continuing threat to pharmaceutical products imported to the U.S.,' the lawmakers wrote.

However, why this "substantial public interest" and the existence of "a continuing threat" did not lead to an investigation earlier is still completely obscure.

The article hinted at some partisan discord in the committee that will do the investigation:

Over the last two years, Mr. Burgess and the Energy and Commerce Committee's then-top Republican, Rep. Joe Barton of Texas, pressed the FDA for information on the agency's inspections of Chinese heparin facilities and on the extent of cooperation from national and local Chinese authorities.

At the time, Republicans were in the minority. Their inquiries didn't constitute a committee investigation, and they couldn't demand nonpublic information from the FDA or call hearings. They now are in the majority and have those powers.

The implication is that the Democrats on the committee blocked the investigation. Why they would have blocked an investigation when the executive branch was in Republican hands, and why the matter could not have been investigated in another congressional committee, or by some other organization, is unknown.

So, again, better late than never. An investigation could at least be the beginnings of accountability for the very well paid pharmaceutical company leaders who up to now have denied all responsibility for failing their most important responsibility, to provide pure, unadulterated drugs.

As we have said again and again, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.

To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

Case Summary

- We have posted several times, recently here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.


- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.

- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."


- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).

- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post here).

- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)

-  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)

Hat tip to the Postscript blog.

Windows 7 Service Pack 1 "Glitches": Why Personal Computers are Problematic, and Perhaps Should Not Be Mission Critical Components in Hospitals

A technical note on computer unreliability, and a series of followup critical questions relative to health IT:

I run Windows 7 Professional on one of my computers, a very unspecial 4-5 year old Micro Center machine, the PowerSpec 6001, using conventional components. The machine was upgraded with 2 Gb RAM and an ATI Radeon 9600 series video card, to run the Aero "eye candy."

It has run satisfactorily since I installed Windows 7 Professional (32-bit version) on it last year.

I am not a computer amateur. [I do, however, admit to being a Radio Amateur - Extra class - ed.] Further, I meticulously keep the machine current with Microsoft security patches, use Symantec anti-virus which I also keep updated, check my disk for errors, and only visit major well-known, nationally prominent websites using the machine.

So yesterday, Windows 7 Service Pack 1 appeared in my "Software updates" list from Microsoft, after being released to the general public.

It was explained that this Service Pack improves performance, reliability and security [i.e., it is intended to update all the many, many bugs, unreliabilities and security holes of the operating system since its inception - ed.]

I confirmed my machine met the specs for it, and allowed the computer to download and install Service Pack 1.

That was my mistake.

After installation, the machine could no longer reboot Windows.

The flying color patches of the first screen appeared ... and then the machine suffered a hard reboot (going back to the BIOS-initiated memory checks and screens, etc.), as if I'd pressed the front panel hardware RESET button this machine has.

An automated "wizard" that came up and tried to figure out why the machine would not restart failed to do so.

I asked the machine, therefore, to roll back to the state it was in prior to the Service Pack 1 (SP1) "upgrade" via a "Restore Point", a feature Windows permits using the "system restore" capability. The SP1 installation automatically creates a Restore Point (image of the prior state of the OS) on the machine just before installing itself.

The machine works again, but ... (and that is a big "but"):

• The Service Pack is not installed. Therefore I am not running the latest protections, and do not know what will happen in the future with respect to patches and upgrades. Maybe the Service Pack will get its own Service Pack at some point to fix it, so it can fix my computer;
  

• The Service pack installation, without warning and rather rudely, erased my prior computer Restore Points of the past few weeks, leaving only the Restore Point it created just before inflicting itself on my machine. Just to thumb its nose at me, it also left two Restore Points from back in November, which would require me to then re-install a lot of software and updates at the very least. I cannot even try a Restore Point of, say, last week after other updates;

• I attempted to view the system error logs to determine what caused the failed Service Pack Install. Surprise! The Event Viewer and Task Scheduler management consoles I use to review system operation no longer operated, instead producing this lovely, extremely explanatory message: "MMC cannot initialize the snap-in", followed by hexadecimal gibberish that any doctor or citizen can easily decipher:

Such explanatory error messages! "MMC cannot initialize the snap-in. The snap-in might not have been installed correctly. Name: Event viewer. CLSID: FX: {b05566ad-fe9c-4363-be05-7a4cbb7cb510}." Click to enlarge.

• Attempts to look up the error on the Web produce gobs and gobs of amateurish "legible gibberish", indirection, misdirection, guesswork, and speculation, some of it from Microsoft itself;

• To add insult to injury, typical of poor user interaction design, I could not copy-and-paste the error, but had to type it (partially, fortunately, thanks to Google);
  

• Much of the material was in very broken English (where's those language translators promised to us for some 50 years now by computer scientists?)

• My attempts at repairing the damage by running the command "SFC /scannow" (system file check) to check and repair critical windows files showed that the Service Pack "Upgrade" also corrupted a number of critical Windows system files - despite the "Restore Point" rollback. Great Scott!
  

• SFC repaired the files and produced a log of gibberish that's thousands of pages long for me to ferret out what got damaged (ironically, just like the records from a few weeks of a relative's EMR-error-related hospitalization, at appx. 2,900 pages of legible gibberish);
  

• The repair did not restore the missing functionality;

• Attempts to reinstall supporting packages such as .Net framework also do not restore the functionality;

• Attempts to reinstall the Service Pack produce the same results, a crash on initial restart after the installation and need to roll back, erasure of several Restore Points I manually created, along with re-corruption of the critical system files previously repaired by the SFC /scannow command.
  

• I have no way of knowing what else is broken or may malfunction;
  

• While not rigorous, reports on the web show a significant percentage of others having problems with the "Service Pack" as well. Russian Roulette, anyone?
  

Russian Roulette, anyone?

All this was after many months of Microsoft "Beta testing" the Service Pack. (Perhaps it was really "Alpha testing?")

Similar issues occurred with the former Microsoft OS, Windows XP (now in its third major service pack since its release in 2002, with patches still coming on an almost weekly basis).

Fortunately, I have backup images of my entire disk, but the inconvenience and time wasted is quite irritating - and I will still not have the latest security patches after I roll back my machine to my latest disk image.


One should note that these "glitches" are just in the Operating System (OS) itself. Third-party applications (such as EMR and CPOE sytems, middleware, interfaces, etc.) suffer the same type of problems...for instance, the life-and-limb-threatening "glitches" that occurred at Trinity Healthcare after an EMR "upgrade."

Further, OS "glitches" can cause unexpected application "glitches", and vice versa. Complexity on top of complexity...

Note that machines running similar software are on the "servers" that are the heart of major enterprise systems such as EMR's and CPOE's, that communicate with enduser workstations.

Now, several simple questions:

• Who knows what other "glitches" the Service Pack introduced to my machine, that will "bite me" (or patients) later?

• Are these the machines we want our doctors and nurses to depend upon, since they increasingly regulate every medical transaction that occurs?

• Has the software become too complex to be entirely reliable, maintainable and secure?

• Does the average hospital have the staff to effectively deal with issues such as the above?

• Do these "glitches" raise the risk and the cost - therefore reducing the ROI, already low (see reading list) - of experimental health IT to even more unsatisfactory levels?

Finally:

• Would the average person tolerate such behavior from their car? In their aircraft? (Oops, the brakes don't work properly in 13.5% of cars after the parts upgrade, and that altimeter is simply crazy ...)
  

-- SS

Feb. 24 late night addendum:

Deciding to play with this mayhem, and knowing I was going to be wasting a lot of time, I first backed up my deranged machine to an external disk (~ half an hour) to preserve my files. I then restored my machine from an external disk backup image to its condition in mid-Nov. 2010 [thinking perhaps something more recent caused the SP1 to fail]. That took another half an hour. I then attempted to install the SP1 again. That took another hour or more.

Same results - machine crash after the "circling window panes" display.

I let the "Startup Repair" wizard run. It failed with the following informative messages. In a superb example of poor user design, I had to jot the messages down on paper, as it made no offer to print them, or load them into a thumb drive, etc. - although it did offer to send the error messages to Microsoft, a neat trick as the software components to drive the computer's wireless network adapter were not loaded:

Problem details - System Repair
Problem signature:

1- 6.1.7600.16385
2- 6.1.7600.16385
3 - unknown
4 - 21201077
5- AutoFailure
6 - 3
7 - BadPatch

OS version - 6.1.7600.2.0.0
Local ID - 1033256.1
Root cause - a patch is preventing the system from starting [no fooling - ed.]
Repair Action
System file integrity check and repair
Result = Failed.
Error code = 0xa

Then for added fun, I started the machine up in 'Safe Mode' (using the F8 key at startup). It came up, but told me it was doing a System Restore due to the failure to configure the Service Pack. After about 20 minutes of frantic disk activity, the machine rebooted - and immediately crashed as before.

I am rerunning the Startup Repair wizard again, asking it to restore my system, but I predict it will do so with the original remaining problems of non-functioning components that started this whole mess - if it works at all.

This is all absurd. It is a massive waste of time, a result of poor programming, uninformative, cryptic error messages (what? computers don't have enough storage for useful error messages?), poor (nonexistent) documentation, inadequate attention to the user experience, condescension of the user, inability to report the problems back to HQ automatically due to lack of forethought about a compromised machine's ability to access the network, software unreliability, and probably a host of other issues I haven't thought of yet because I'm tired after all this fritter.

Not to mention, it is potentially destructive of data to those who suffer this problem but did not keep backups. They warn you beforehand - but the installation agreement you "sign" is of the Ross Koppel/David Kreda "hold the vendor harmless" variety.

This experience is a metaphor for the state of health IT (with "glitches", "workarounds", unexplained errors, etc.), and of the dangers of computer worship.

-- SS

Feb 25 addendum - further experimentation based on web comments about SP1, such as running a pre-SP1 readiness checking utility by Microsoft, emptying the /temp folders, renaming the "software distribution" folder, clean booting, etc. all produce the same result: crash of the machine on reboot.

And there's no computer doctor to call for an appointment to fix the problem.

-- SS