The Case for the Food Reward Hypothesis of Obesity, Part II

In this post, I'll explore whether or not the scientific evidence is consistent with the predictions of the food reward hypothesis, as outlined in the last post.

Before diving in, I'd like to address the critique that the food reward concept is a tautology or relies on circular reasoning (or is not testable/falsifiable).  This critique has no logical basis.  The reward and palatability value of a food is not defined by its effect on energy intake or body fatness.  In the research setting, food reward is measured by the ability of food or food-related stimuli to reinforce or motivate behavior (e.g., 1).  In humans, palatability is measured by having a person taste a food and rate its pleasantness in a standardized, quantifiable manner, or sometimes by looking at brain activity by fMRI or related techniques (2).  In rodents, it is measured by observing stereotyped facial responses to palatable and unpalatable foods, which are similar to those seen in human infants.  It is not a tautology or circular reasoning to say that the reinforcing value or pleasantness of food influences food intake and body fatness. These are quantifiable concepts and as I will explain, their relationship with food intake and body fatness can be, and already has been, tested in a controlled manner. 

1.   Increasing the reward/palatability value of the diet should cause fat gain in animals and humans

Read more »

The Case for the Food Reward Hypothesis of Obesity, Part II

In this post, I'll explore whether or not the scientific evidence is consistent with the predictions of the food reward hypothesis, as outlined in the last post.

Before diving in, I'd like to address the critique that the food reward concept is a tautology or relies on circular reasoning (or is not testable/falsifiable).  This critique has no logical basis.  The reward and palatability value of a food is not defined by its effect on energy intake or body fatness.  In the research setting, food reward is measured by the ability of food or food-related stimuli to reinforce or motivate behavior (e.g., 1).  In humans, palatability is measured by having a person taste a food and rate its pleasantness in a standardized, quantifiable manner, or sometimes by looking at brain activity by fMRI or related techniques (2).  In rodents, it is measured by observing stereotyped facial responses to palatable and unpalatable foods, which are similar to those seen in human infants.  It is not a tautology or circular reasoning to say that the reinforcing value or pleasantness of food influences food intake and body fatness. These are quantifiable concepts and as I will explain, their relationship with food intake and body fatness can be, and already has been, tested in a controlled manner. 

1.   Increasing the reward/palatability value of the diet should cause fat gain in animals and humans

Read more »

Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure

Case 1. Tumult
October 5, 2011
New York Times
Patient Data Landed Online After a Series of Missteps

By KEVIN SACK

Private medical data for nearly 20,000 emergency room patients at California’s prestigious Stanford Hospital were exposed to public view for nearly a year because a billing contractor’s marketing agent sent the electronic spreadsheet to a job prospect as part of a skills test, the hospital and contractors confirmed this week. The applicant then sought help by unwittingly posting the confidential data on a tutoring Web site. [Got all that? - ed.]

In an e-mail sent to a victim of the breach, the billing contractor, Joe Anthony Reyna, president of Multi-Specialty Collection Services in Los Angeles, explained that his marketing vendor, Frank Corcino, had received the data directly from Stanford Hospital, converted it to a new spreadsheet and then forwarded it to a woman he was considering for a short-term job.

The position was with Mr. Corcino’s one-man shop, Corcino & Associates, Mr. Reyna wrote in the e-mail, which was authenticated by his lawyer, Ellyn L. Sternfield. The job applicant apparently was challenged to convert the spreadsheet — which included names, admission dates, diagnosis codes and billing charges — into a bar graph and charts, Stanford Hospital officials said.

Not knowing that she had been given real patient data, the applicant posted it as an attachment to a request for help on studentoffortune.com [I wrote about that earlier here - ed.], which allows students to solicit paid assistance with their work. First posted on Sept. 9, 2010, the spreadsheet remained on the site until a patient discovered it on Aug. 22 and notified Stanford.

My, how electronic data can travel when mishandled. Try that trick with 20,000 paper charts ...

The hospital, located on the campus of Stanford University in Palo Alto, demanded that the spreadsheet be removed, and the Web site quickly complied. Pressed for time, the job prospect wound up completing the assignment herself and, in the end, did not get hired, Ms. Sternfield said.

Ironically, this was all for naught.

Mr. Corcino, in his first public statement, attributed the breach to “a chain of mistakes which are far too easy to make when handling electronic data.”

Far too easy to make - especially by the dyscompetent.

... Breaches of private medical data have become distressingly commonplace, with two substantial ones disclosed in the last week alone. [We don't know the details of those yet; that's for next week - ed.]

Case 2: Pandemonium
(from same NYT article)

In Orlando, officials with Florida Hospital reported that three employees had improperly combed through emergency department records of 2,252 patients, apparently to forward information about accident victims to lawyers. The employees were fired, and law enforcement officials are investigating.

Trolling for Torts - is this a new EMR TV game contestant show? Perhaps it could be followed by "Trolling for Tarts?"


Case 3: Bedlam (from the same NYT article)

Meanwhile, Science Applications International Corporation disclosed that computer backup tapes containing medical data for 4.9 million military patients [that number also amounts to almost 2% of the total U.S. population - ed.] had been stolen from an employee’s car in San Antonio. The data included Social Security numbers, clinical notes, laboratory test results and prescriptions. The company said the risk of harm was low because retrieving data from the tapes would require specialized knowledge, software and hardware. [Who's to say the theft was not by someone with that specialization, or someone paid by same to steal the tapes? - ed.]

The Texas breach is by far the largest since September 2009, when a new federal law began requiring disclosures of medical privacy violations involving at least 500 people. Some 330 such episodes have been tallied, including four others that affected more than one million people each.

We'd all be buried in stray clinical paper by now if it weren't for computers. Thank god for them!

Officials at the Department of Health and Human Services said the new reporting requirements had exposed deep vulnerabilities and encouraged renewed vigilance.

Exposed to whom? The blind, deaf and dumb?

“We’re moving in the right direction in terms of a culture of compliance,” said Leon Rodriguez, director of the department’s Office for Civil Rights, which investigates medical privacy cases. “Are there still a lot of problems out there? Yeah, my sense is there are still a lot of problems.”

The Titanic was moving in the right direction - towards New York Harbor, in fact, when it met a little unexpected obstacle. Perhaps a culture of brains would be better than a culture of compliance...

The Stanford breach was notable for the duration of public exposure, and for spotlighting the vulnerability created by a medical provider’s business relationships with outside parties.

Last week, lawyers filed suit in state court in Los Angeles, seeking certification as a class action and $20 million in damages from Stanford Hospital & Clinics and Multi-Specialty Collection Services, which is known as MSCS.

$20 million might hurt a bit, and might help motivate the organization to hire better and/or more appropriate clinical information management expertise - in house where it belongs (see below).

The threat of liability set off a predictable round of finger-pointing.

In written responses to questions, Lisa Lapin, Stanford University’s assistant vice president for university communications, said, “MSCS bears the complete and sole responsibility for the breach.”

It's their fault, not ours.

Ms. Lapin said the hospital had sent the data in encrypted form to Mr. Corcino, who requested it on behalf of MSCS to analyze a strategy for improving billing collections. She said Mr. Corcino had regularly represented himself as MSCS’s executive vice president and had been Stanford’s “primary contact” during a seven-year relationship. MSCS, a five-person firm that audits hospital accounts to maximize reimbursement, possessed the passwords to unencrypt the data, she said.

It was all about money and outsourcing.

“This mishandling of private patient information was in complete contravention of the law and of the requirements of MSCS’s contract and is shockingly irresponsible,” the hospital said in a statement.

It is foolish to believe that someone else can run critical aspects of your business, and it is even more foolish to believe that it is OK for someone else to run critical aspects of your business.

Ms. Sternfield, Mr. Reyna’s lawyer, said Mr. Corcino had never been an MSCS employee, but rather was paid a monthly fee to drum up business, typically in face-to-face meetings with health care executives. Mr. Reyna, she said, had no knowledge that the Stanford data had been sent to Mr. Corcino, or that he had passed it on.

Mr. Corcino was not authorized to use an MSCS title, Ms. Sternfield said, but she declined to say whether Mr. Reyna was aware of the practice. She acknowledged that Mr. Corcino sometimes used an MSCS e-mail account.

In his e-mail to the breach victim, who shared it with The Times, Mr. Reyna wrote that Stanford had sent the file to Mr. Corcino “for a potential MSCS project that would audit paid accounts to verify that the reimbursement was correct.”

For his part, Mr. Corcino said in a statement that he was an independent contractor but was “the marketing face of the company,” and that MSCS “allowed me to use the title of executive vice president.” He wrote: “Stanford sent the file to me at MSCS, and I imported the data into a spreadsheet that was forwarded to the job applicant as part of a skills test. I did not intend to provide any personal health information in the file. This was a marketing project.”

Without explaining how or why he sent the data to the applicant, Mr. Corcino said MSCS had not trained him properly and faulted Stanford for sending him private information that he did not need. That, he said, was the “first link in a chain of mistakes.”

“I regret that Stanford released a file containing unnecessary information,” Mr. Corcino said, “that MSCS did not have an appropriate training and audit system for the handling of electronic data and that I was not more careful with the file. While Stanford and MSCS left the information in the file I received, it was my mistake to not catch its inclusion and remove the data.” ... The hospital has terminated its relationship with MSCS, and Mr. Reyna has done the same with Mr. Corcino.

Even I can't follow all that. This will be one convoluted court case...

Stanford Hospital has reassured affected patients that the posted spreadsheet did not contain Social Security numbers, birthdates or credit card numbers, and has offered free identity theft protection services. The hospital said it had not uncovered any misuse of the exposed data.

Yet, that is. (Is it no wonder that sedatives are among the most highly-prescribed medications?)

Moving from the NYT article:

Case 4: Tumult (I'm running out of descriptors)

A large class action lawsuit again Health Net and IBM:

California Legal
Westlaw Journal Insurance Coverage

Health Net’s, IBM’s negligence compromised medical data, suit says

June 7 (Westlaw Journals) - Health Net Inc. and IBM face a class-action lawsuit seeking $5 million in damages over the loss of computer storage devices that held the medical histories, financial data and Social Security numbers of 2 million people.

Health Net Policyholder Alana Bournas’ class-action complaint in the U.S. District Court for the Eastern District of California alleges that the insurer and IBM breached their duty of confidentiality and negligently allowed the release of highly personal and confidential information of millions of Health Net employees and policyholders.

The complaint alleges violation of California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56; Cal. Civ. Code § 1798.2, which concerns the unauthorized disclosure of customer records; Cal. Bus. & Prof. Code § 17200, the state’s unfair-competition law; and public disclosure of private facts.

Companies will either pay the going price for competent employees, or pay for the mistakes of incompetent ones. It would probably be better for society, however, to do the former habitually.

The suit says IBM agreed to manage Health Net’s information technology database for five years beginning in 2008.

IBM informed Health Net Jan. 21 that it had lost nine disk drives containing the confidential information of 2 million people, including Health Net policyholders and employees.

Health Net failed to alert the victims of the breach until March 14, the complaint says.

IBM allegedly also failed to encrypt the data, thereby enabling anyone who possesses the hard drives to easily access the confidential information. This puts the victims at an increased risk of identity theft and “other unauthorized uses of plaintiff and class members’ personal information” the suit says.

Encryption, a feature now built into mainstream OS's by Microsoft and Apple? (Oh wait...IBM...)

Health Net’s attempt to compensate the victims by providing two years of free credit monitoring services through TransUnion is an inadequate remedy for the defendant’s conduct, Bournas says. This “remedy” fails to address unauthorized disclosures of medical information, and the monitoring services only protect against new account fraud but do not address fraudulent activity with existing accounts, the suit says.

These executives apparently can't even get the fix straight.

Moreover, the complaint says, Health Net has previously been accused of a similar breach of confidential information. In 2009 it lost the same types of records of nearly 1.5 million people and waited six months before notifying the victims. In settling the state of Connecticut’s lawsuit stemming from that security breach, the company promised “to enhance security procedures and training,” the suit says.

What can I say?

The current breach could have been avoided had Health Net and IBM taken proper precautions and implemented security policies to maintain consumers’ confidential data, according to Bournas. Therefore, the protections granted under California law require that Health Net be penalized for its negligence, she says.

The plaintiff notes that millions of people entrusted Health Net with their private data.

“At best, defendants’ actions allowed this private information to go astray. At worst, the private information is being viewed, sold, resold, and used for illegitimate and illegal purposes,” the complaint says.

The suit is seeking injunctive relief, compensatory damages, declaratory relief, and attorney fees and costs.

Bournas v. Health Net Inc., No. 2_11-CV-01262, complaint filed (E.D. Cal. May 11, 2011).

I would revise that to say "The current breach could have been avoided had Health Net and IBM hired personnel in adequate numbers with the qualifications and true gravitas (and not laid them off, of course) to maintain consumers’ confidential data."

Case 5: Maelstrom (I am reaching to the bottom of the barrel for such descriptors).

Wellpoint recently settled class-action suit in CA.

AMA news
By Pamela Lewis Dolan, amednews staff.
Posted Aug. 1, 2011.

WellPoint reaches tentative accord in data breach suit

It is the second settlement to come from lawsuits claiming that the company failed to protect the privacy of individual insurance applicants online.

WellPoint has reached a preliminary settlement that will, if approved, bring an end to a class-action lawsuit filed more than a year ago.

The lawsuit, filed in the Superior Court of the State of California, involves the potential exposure of data belonging to more than 600,000 individual health insurance applicants on a company-run website that allowed insurance applicants to track their applications.

The situation came to light when an applicant to WellPoint-owned Anthem Blue Cross of California sued the company in March 2010. The applicant was able to manipulate the web address within the site to gain access to other applicants' information, including names, addresses, dates of birth, Social Security numbers and health and financial information.

In other words, probably changing a simple number in the URL brought up someone else's records. Good going there, Wellpoint. What were the programmers thinking? (Were they thinking?)

When the suit was filed, the company said an upgrade to the system caused the information to become exposed. The company said a third-party vendor validated that all security measures were in place when, in fact, they were not. Changes were made to the system soon after the situation was discovered.

Blame someone else, yet again.

In addition to the class-action suit, the company was sued by Indiana Attorney General Greg Zoeller in July 2010. The suit, filed in Marion County Civil Superior Court, alleged that the company violated the Indiana Disclosure of Security Breach Act by failing to notify Zoeller, and the 32,051 Indiana residents affected by the incident, in a timely manner. That suit was settled in early July, when WellPoint agreed to pay a $100,000 fine. As part of the settlement, WellPoint admitted it had a security breach and failed to properly notify the attorney general's office as required by law.

Gevalt.

Under the preliminary settlement in the California class-action matter, WellPoint agreed to offer credit monitoring for two years to all affected individuals. Class members are eligible to receive reimbursement for identity theft losses of up to $50,000 per incident, as well as additional time to file identity theft claims until May 31, 2016. Those making identity theft claims are eligible for an additional five years of credit monitoring. The company also will donate a total of $250,000 to two nonprofit organizations whose efforts are directed at protecting consumers' privacy on the Internet.

It might have been cheaper and better for goodwill not to outsource a vital function...those third-party vendors can really hurt you. (I'd really like to know - was this "third party vendor" domestic, or overseas?)

WellPoint did not admit wrongdoing in the case, nor was it found guilty. A fairness hearing is scheduled for November, and the courts then will decide whether to approve the settlement.

Large corporations are immune from such formalities as admitting wrongdoing or being found guilty.

-----------------------

But don't worry. Your medical data's safe.

Sort of. See also:


-- SS

Enabled by the Revolving Door, Corporatistic US Trade Policy Seems to Put US Drug Companies Ahead of Global Public Health

We just discussed how leaders of big health care corporations with histories of ethical and legal missteps want to export our supposedly "wonderful technology, wonderful approaches" to the rest of the world.  A story on the Huffington Post showed how big health care corporations, partnering with the US government, have already been doing that with not very pretty results.  The article discussed two cases, connected by a single person who transited the revolving door from government to the pharmaceutical industry and then back to government.

The US Dispute with Brazil, on Behalf of Merck and Pfizer, About HIV Drugs

When [William] Daley was commerce secretary in the later years of the Clinton administration, Brazil rankled U.S. drug companies by opting to provide its citizens with a generic version of another HIV drug. Like Thailand, Brazil declared a public health emergency in an effort to lower the cost of treating roughly a half-million HIV infections. The U.S. government responded by sending Daley to Brazil with executives from U.S. pharmaceutical giants Merck & Co. and Pfizer to try to pressure the Brazilian government into reversing its decision.
Thus the US government appeared to be putting the revenues of US corporations ahead of the public health, at least in Brazil.
Daley soon made the transition to the private sector:
In a speech at Johns Hopkins University before leaving for Brazil, Daley encouraged students to enter the revolving door between big business and public policy-making. 'Let me say this: As one of the only members of the president's Cabinet to come from business, it's good when you mix both government and business in your careers,' he said. 'It makes better public servants, and it makes better businesspeople.'

It has certainly been good for Daley's career. His effort to twist arms in Brazil failed, but drug companies apparently took note. It was after leaving the Clinton administration that Daley was hired by Abbott, where he raked in more than $1.3 million as a board member from 2004 to 2010, according to Securities and Exchange Commission filings. Over the same period, he served on Boeing's board and was a top lobbyist for JPMorgan Chase.
Abbot's Dispute, Supported by the US Government, with Thailand About Kaletra

Soon Abbot was involved in a similar dispute.

The background is:
[HIV drug] Kaletra costs more than $10,000 a year for a patient living in the United States, a price that is reflective of the highly protective American patent system. The U.S. is the only country that grants long-term monopolies on life-saving medicine without regulating the price of monopolized drugs.

In addition
In countries that negotiate with companies on drug prices, the cost of medicine is often far lower. But though American pharmaceutical companies do supply drugs to developing nations at rates below those charged in the U.S., those discounted prices are still too high for many poor or hard-hit nations to afford.

'In many developing countries, it's a death sentence,'said Nobel Prize-winning economist Joseph Stiglitz, referring to high drug prices.

The core of the dispute:
In 2007 negotiations with the Thai government, Abbott Labs wouldn't budge below a price of $2,200 per person, per year for Kaletra. At the time, Thailand was classified as a 'lower-middle income' country by the World Bank -- the second lowest of four categories. With more than a half-million citizens living with HIV, Thailand considered that price beyond its budgetary capacity. So it declared a public health emergency and began importing a vastly cheaper generic version of Kaletra from India.

And then, by international trade standards, all hell broke loose.

'When countries declare the health emergency, they face a huge backlash, particularly from the USTR [US Trade Representative] and the drug companies,'said Tim Boyd, policy research coordinator with the AIDS Healthcare Foundation, a U.S. nonprofit dedicated to eradicating HIV.

Abbott responded by withdrawing pending applications to register drugs in Thailand, cutting its citizens off from other medications. The move was unprecedented: Never before had an American drug company attempted to punish a country during drug price negotiations by cutting off the supply of other medicines.

At the time, Brook Baker, a law professor at Northeastern University and a member of the board at the Health Global Access Project, called the move a 'ruly appalling example of corporate hubris'that 'irectly violates any conceivable norm of corporate responsibility.'

At that time, the US government went along with Abbott:
As for the USTR, it seemed to support the company, placing Thailand on its 'Priority Watch List 'of nations that do not respect U.S. intellectual property rights. 'In late 2006 and early 2007, there were further indications of a weakening of respect for patents, as the Thai Government announced decisions to issue compulsory licenses for several patented pharmaceutical products,' wrote the agency in its report announcing that Thailand had been added to the priority list.

Although the USTR blacklist is little known domestically, it is a major economic indicator abroad and can affect a country's ability to import everything from software to DVDs to automobiles. Thailand's new status as an international rogue sparked concern among the country's economic policy officials and corporate leaders. And 35 members of Congress wrote to the USTR to protest Thailand's blacklisting, noting, 'The move is being interpreted in the public health community as a warning and a threat to other countries.'

Note that:
Abbott Labs declined to detail Daley's involvement in the Thailand episode, but as a member of the board, he should have been well informed about the strategy.

US Government Pressure to Protect Drug Companies' Patents

William Daley has transitioned the revolving door again in the other direction:
As commerce secretary under Bill Clinton, William Daley worked with U.S. pharmaceutical giants to curb the use of cheaper generic drugs abroad. As a board member for Abbott Laboratories, he had a front-row seat on a brutal clash between a major drug company and a developing nation over access to life-saving medication. And as White House chief of staff today, Daley has President Barack Obama’s ear.

In his new government job,
Add up Daley’s power and experience, and experts who follow public health policy suspect his influence in the U.S. stance in negotiations over a major international trade deal -- a stance with hugely profitable implications for giant American drugmakers.

The United States is in talks with eight other Pacific nations to establish the Trans-Pacific Partnership, which the administration hopes will serve as a template for other trade pacts. According to leaked documents from the negotiations, the Obama administration is using the deal to push hard-line intellectual property standards that could drive up medicine prices overseas, boosting the bottom line for U.S. drugmakers like Abbott Labs at the expense of public health.

Public health advocates are worried. 'If the point of the trade policy is not just to protect the interests of our companies, but the public health benefit and burden of research, then [the United States] is doing this all wrong,' said James Love, director of Knowledge Ecology International, a nonprofit that focuses on how patent laws affect the poor.

A White House spokesman said only that the negotiations -- which are being conducted behind closed doors with input from corporate lobbyists -- are being 'ably led' by the United States Trade Representative (USTR) and that Daley is 'not directing or participating in those negotiations.'

Note that the USTR leadership includes other travelers through the revolving door:
Daley's personal history with drug access is not unique among top-tier government officials with trade responsibilities. McCoy lobbied on intellectual property issues at the influential D.C. law firm Covington & Burling before moving to the USTR in 2006. His top deputy, Kira Alvarez, was a lobbyist for drugmaker Eli Lilly before joining the agency.

Summary

Per Zach Carter, the author of the Huffington Post article:
Daley, who previously lobbied for JPMorgan Chase, is a prominent examplar of a bipartisan phenomenon in American government in which corporate insiders, and the profit-driven perspective of the boardroom, have come to dominate formal and informal debate over public policy.

Another way to describe this is corporatism. The corporatism in this case is partly enabled by the continuation of the revolving door, the free transit of individuals from leadership positions in top corporations and in government. The government and big corporations have teamed up to produce solutions that may seem beneficial to the people making the decisions, and may benefit their long term career strategies, but may not be good for the US public, for patients' and the public's health in this case, and for the ability of the country to conduct foreign policy based on some ethical and moral principles.

By the way, note that combined with other cases we have discussed, this shows that the revolving door pheonomenon, and other aspects corporatism affecting health care are not linked with any one political party.

So,
There is no evidence that any of these players, including Daley, have done anything illegal or explicitly corrupt during the Trans-Pacific trade negotiations. But public health doesn’t seem to be their first priority.

'The real concern is that the U.S. is using its international power and prestige to force poor countries to enforce our intellectual property standards, and the result of that is that access to medicine is denied and people are dying,' said Joseph Stiglitz.
Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders.
xx

There Are Still Some Medical Watchdog Organizations That Call a Spade a Spade

Seeking justice for healthcare errors is often a disconcerting, if not sordid affair. This can be gleaned from recent posts such as here, here, and here.

The civil justice system is slow, subject to legal stalling tactics, and not exactly easy to navigate.

Fortunately there are medical watchdog organizations that are not simply figureheads, rubber-stampers or puppets for large healthcare organizations. They call a spade a spade.

I had filed, at the request of my mother when she was still lucid and living, a complaint in Dec. 2010 with the Medicare Quality Improvement Organization (QIO) in the region where my mother was treated and injured earlier that year, related to an EMR system's deleterious effects on care continuity.

A critical heart medication of appx. eight years simply vanished from the EMR system, whose output was then taken as gospel throughout an ED stay of several hours, ICU admission, and transfer to floor several days later. This was despite the explicit history given by patient and family (me), resulting in catastrophe.

The QIO investigated and the records were reviewed by an independent expert physician of the appropriate specialty. The QIO's findings are as follows, redacted of names, places and dates; emphases mine.

It's regrettable that my mother left this earth several months ago, due to the injuries she sustained, before seeing this report's findings:

July ##, 2011

Dear Mr. Silverstein, [Dr., actually - ed.]

... In response to your initial written concern, a QIO physician has reviewed the medical records concerning the services your mother received on 05/##/10 at [YY Hospital].

You are concerned about the following:

Concern:

Your mother was admitted at [YY Hospital] on May ##, 2010. You are concerned regarding the failure of the staff to properly conduct medication reconciliation which resulted in denial of a critical heart rhythm maintaining medicine, Sotalol, to your mother who had been taking it for approximately 8 years.

Response:

A QIO physician reviewer has reviewed the complete medical record for this admission and previous admissions ... Appropriate medication reconciliation of this medication appears not to have been performed. Therefore, a quality of care concern has been identified and confirmed.

[The reconciliation failure resulted in rapid atrial fibrillation, an extremely high-risk scenario in a patient with tight bilateral carotid stenoses who in fact presented with an almost-stroke, i.e., transient ischemic attack or TIA. Needless to say, all the clinicians in this case should have exercised the highest levels of caution - ed.]

Concern:

You are concerned that this failure resulted in lack of continuity of care and many medical complications your mother suffered which include, permanent CNS and cardiac injury as well as increased risk for CVA.

Response:

The QIO physician determined that there is a lack of continuity of care based on the review of the medical records submitted. It appears that the failure to administer Sotalol resulted in the recurrent atrial fibrillation on 5/##/10 and other subsequent medical complications. Therefore, a quality of care concern has been identified and confirmed.

[Those 'subsequent complications' included need for high-risk IV heparinization and electrical shock of the chest to stop the fibrillation after Sotalol restart, iatrogenic brain hemorrhage of the cerebellum from IV heparin requiring emergency brain surgery, brain stem compression causing months of swallowing paralysis, permanent atrial fibrillation untreatable with coumadin after forced Sotalol withdrawal post-bleed due to widened electrical intervals, need for TPN-total parenteral nutrition (nutrition via IV) and surgically-placed feeding tubes in the stomach, muscle wasting, prolonged agitated delirium resistant to treatment, progressive memory deficits, seizures, sepsis, hypoglycemia, hyponatremia, hypothermia (that themselves could have caused death), need for extensive rehab, permanent gait problems requiring a walker ... and others, and finally - wrongful death, apparently of aspiration pneumonia. She suffered greatly, and so did I, taking care of her at home and not putting her in a nursing home (as I'd promised her I would not do before her mind went) - ed.]


... After a thorough review of your medical records and any additional information provided by the facility, we determined that the services your mother received did not meet applicable professionally recognized standards of health care. [That phraseology might be considered a technical description of malpractice - ed.]

... We share your concern about the quality of service your mother received and have initiated appropriate action as warranted by our review findings.

[I was told by QIO representatives that the hospital was required to develop and/or follow a remediation plan to prevent further errors of this kind, and report back to the QIO for several quarters on their progress - ed.]


In medical parlance, my mother was turned into a clinical train wreck.

So, there are in fact organizations that will not tolerate substandard medical care.

These organizations need to receive increased influence and authority.

Further, more patients need to be aware of them, and use them.

Patients would have remained at risk without a remediation plan put upon the hospital by Medicare's QIO after an injured patient's complaint. This is in the face of the hospital's having been warned in writing about serious problems in their electronic systems in April 2010, yet its recipients conspiring to ignore that warning (was their Board informed, I wonder?) - resulting in medical disaster just a month later. (See "A Diary of EHR-Initiated Tragedy.")

Of course, I mentioned early in this post that seeking justice is not a linear process.

It seems part of the problem is that many hospitals have problems with basic honesty, accountability, and medical common sense.

Exhibit one in that regard is the statements from the hospital's representatives even after Medicare found them to have not met applicable professionally recognized standards of health care:

"Defendant is unable to determine what plaintiff's claims are."

Hear that, Medicare? Let me emphasize:

Defendant - is - unable - to - determine - what - plaintiff's - claims - are.


The claims are not exactly rocket science. The Complaint states in relatively plain English:

Count (4) This is a professional liability action involving the failure of the defendant's EMR system to properly identify and report a patient's medications to ensure continuity of treatment.

and

Count (23) As a result of the failures to continue the Sotalol treatment identified above [i.e., earlier counts - ed.], plaintiff has suffered the complications as identified herein and as in the medical records.

Let me emphasize:

The - failure - of - the - defendant's - EMR - system - to - properly - identify - and - report - a - patient's - medications - to - ensure - continuity - of - treatment.

and

Plaintiff - has - suffered - the - complications - as - identified - herein - and - as - in - the - medical - records.

--------------------

The Defendant's claim that "Defendant is unable to determine what plaintiff's claims are", if not made perjuriously, raises the question: can the hospital and defense team read their own medical records?

Medicare's quality improvement people apparently can.

It's not as if the hospital doesn't have access to the same records as Medicare. In fact, the hospital originated those records.

Perhaps they cannot understand the thousands upon thousands of pages of legible gibberish output by their EMR systems (2,900 pages alone - almost six reams - in just the first two and a half week portion of months of hospitalization/rehab, plus recurrent rehospitalizations; do the math), whereas Medicare had me to summarize the history for them?

On issues of health IT's role in the errors, the Defendant's response is Blame the Vendor:

"Claims are more appropriately brought against the software manufacturer."

[Which could likely have a "hold harmless" agreement with the hospital; cf.
Koppel and Kreda in JAMA - ed.]

This is reminiscent of the legal hemming and hawing in the aforementioned cases linked at the beginning of this post, and leads me to conclude many hospitals are, through legal games and technicalities, burying their cybernetic mistakes with little accountability.

Of course, the hemming and hawing nets defense attorneys probably $400+ per hour of the hospital's money. (In view of the July 2011 QIO report, some might consider that as defrauding the hospital...)

When Medicare finds you provided care that "did not meet applicable professionally recognized standards of health care", perhaps it's not best to throw wads of good money after bad on legal expenses to defend that you "don't know what the claims are, and it's the computer company's fault anyway."

I submit that if after Medicare finds hospitals to have not met applicable professionally recognized standards of health care resulting in severe patient injury and then death, yet the hospitals profess they "cannot determine plaintiff's claims", and seek to pass blame to vendors of medical devices they themselves willingly purchased and implemented that contributed to the harm, and other legerdemain, then ...

Those hospitals needs to find themselves new medical and Board-level leadership.


This is especially true when experts have forewarned them about medical device deficiencies that could result in patient harm.

-- SS

Addendum Oct. 13, 2011:

The Defendant's lawfirm in this story just yesterday searched Google on the phrase "Quality Improvement Organization Civil Litigation." One might wonder if they were doing such searching - back in July when the QIO report was released to me, and presumably their client hospital.

Perhaps they should also check on "QIO criminal litigation."

-- SS