Arguments with Pavlov's Dogs: Health IT Regulation Will "Harm Innovation"? How, exactly?

Health IT hyper-enthusiasts, when faced with the prospect of government regulations, react like Pavlov's dogs with the response "regulation of health IT will harm innovation."

Here's a soliloquy of critical questions that need be asked:

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

Now, Mr. (or Dr.)  Hyper-Enthusiast, you state HIT regulation will harm innovation.

What aspects of regulation, specifically, will harm innovation?

Good manufacturing processes (GMPs)?

Building a safety case for review and inspection?

Pre-market safety/fitness/quality/reliability testing?

Post-marketing surveillance?

What?

Innovations happen before regulatory evaluation, do they not?

What, exactly, are your objections to safety and quality testing of innovations?

Don't innovations need to be tested for safety and quality?

If innovations are not safe, should they not be used on live patients?

How can the industry with its conflicts of interest effectively regulate HIT?

Even if it could, again, how would additional regulatory oversight harm innovation?

----------------------- 

And perhaps this needs to be asked as well:

• Don't you really mean regulation would harm the bottom line?

-- SS

Hospital Retaliation Against Outspoken Physician Reaches New Levels - La Cosa Nostra Levels, That Is

Physicians, take note:

The Advisory Board Company
Feb. 14, 2013  
Hospital Framed Physician; Planted a Gun

A jury has ordered a California hospital chain to pay physician Michael Fitzgibbons $5.7 million after its former CEO allegedly framed him by planting a gun in his car.

In 2006, Fitzgibbons—an infectious disease specialist and former chief of staff at Western Medical Center—was arrested in the hospital parking lot after police found a pair of black gloves and a handgun in his car. Police questioned Fitzgibbons and searched his car after an anonymous 9-1-1 call claimed that the doctor had brandished the gun in traffic.

DNA evidence from the gloves and gun exonerated Fitzgibbons, and he was never charged.

However, the arrest followed a series of disagreements between Fitzgibbons and the leadership of Integrated Healthcare Holdings Incorporated (IHHI), which owned the Santa Ana hospital. Fitzgibbons and his attorney—Ted Mathews—alleged that IHHI's then-CEO, Bruce Mogel, had framed Fitzgibbons in an effort to silence him.

Specifically, Mathews said that the frame was part of Mogel's attempt to "humble" Fitzgibbons after the doctor won a legal victory over IHHI in June 2006.

During the trial, former IHHI President Larry Anderson testified that Mogel had instructed him to create a $10,000 contract for a "scary guy" named Mikey Delgado immediately after Fitzgibbon's legal victory. The contract was for unnecessary work on the health system's website. In his testimony, Anderson said he realized after Fitzgibbons was arrested that the contract was actually for the frame. Mathews told the jury that the $10,000 was used to "[get] Dr. Fitz set up."

IHHI's board learned of the $10,000 contract during Anderson's deposition in 2008. Instead of firing Mogel, the board awarded him an eight-month consultancy worth $43,750 per month, Mathews says. This showed that IHHI board "knew what Mogel did to Dr. Fitzgibbons," Mathews told the jury, adding, "They ratified it, and they gave him a golden handshake goodbye.

The article notes Board acquiescence.

Two questions come to mind:

1.  Have the involved people been permanently removed from positions of authority in healthcaree?

2.  Have the persons involved been charges criminally?

Shocking.  Positively shocking.

-- SS

Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's Center for Devices and Radiological Health director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows about health IT risks is the "tip of the iceberg" due to systematic impediments to knowledge gathering and diffusion.   See links to source here and to the FDA Internal Memo on HIT risk - labeled "internal document not intended for public use" and unearthed by investigative reporter Fred Schulte several years ago - here (PDF).

At my Feb. 9, 2013 post "A New ECRI Institute Study On Health Information Technology-Related Events" I opined that a new ECRI study was beginning to peer beneath the waterline of Jeff Shuren's iceberg tip, at what may reside underneath that waterline.  Iceberg tips, needless to say, are usually tiny compared to the iceberg's overall size.

Reporter Kevin O'Reilly at AMNews (amednews.com) has now written about that ECRI report.

The results of the report are concerning:

 Ways EHRs can lead to unintended safety problems

Wrong records and failures in data transfer impede physicians and harm patients, according to an analysis of health technology incidents.

By Kevin B. O'Reilly, amednews staff, posted Feb. 25, 2013.

In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly.

That is just one example of 171 health information technology-related problems reported during a nine-week period to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events.

Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.

 Mar. 1, 2013 addendum.  From ECRI, the denominator is this:

Participating facilities submitted health IT related events during the nine-week period starting April 16, 2012, and ending June 19, 2012. ECRI Institute PSO pulled additional health IT events that were submitted by facilities during the same nine-week period as part of their routine process of submitting event reports to ECRI Institute PSO’s reporting program. The PSO Deep Dive analysis consisted of 171 health IT-related events submitted by 36 healthcare facilities, primarily hospitals.   [I note that's 36 of 5,724 hospital in the U.S. per data from the American Hospital Association (link), or appx. 0.6 %.  A very crude correction factor in extrapolation would be about x 159 on the hospital count issue alone, not including the effects of the voluntary nature of the study, of non-hospital EHR users, etc.  Extrapolating from 9 week to a year, the figure becomes about x 1000.  Accounting for the voluntary nature of the reporting (5% of cases per Koppel), the corrective figure approaches x20,000.  Extrapolation of course would be less crude if # total beds, degree of participant EHR implementation/use, and numerous other factors were known, but the present reported numbers are a cause for concern - ed.]

Sept. 2013 addendum: 

Health Leaders Media has more on the ECRI Deep Dive study at http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI:

HIT Errors 'Tip of the Iceberg,' Says ECRI
Cheryl Clark, for HealthLeaders Media , April 5, 2013

Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.

Computer programs truncated dosage fields, leading to morphine-caused respiratory arrest; lab test and transplant surgery records didn't talk to each other, leading to organ rejection and patient death; and an electronic systems' misinterpretation of the time "midnight" meant an infant received antibiotics one dangerous day too late.

These are among the 171 health information technology malfunctions and disconnects that caused or could have caused patient harm in a report to the ECRI Institute's Patient Safety Organization.

... The 36 hospitals that participated in the ECRI IT project are among the hospitals around the country for which ECRI serves as a Patient Safety Organization, or PSO.

The 171 events documented, break down like this:

• 53% involved a medication management system.
  • 25% involved a computerized order entry system
  • 15% involved an electronic medication administration record
  • 11% involved pharmacy systems
  • 2% involved automated dispensing systems
• 17% were caused by clinical documentation systems
• 13% were caused by Lab information systems
• 9% were caused by computers not functioning
• 8%. Were caused by radiology or diagnostic imaging systems, including PACS
• 1% were caused by clinical decision support systems

Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

As at the opening of this post, "tip of the iceberg" is a phrase also used by FDA CDRH director Jeffrey Shuren MD JD regarding safety issues with EHRs and other health IT.

Along those lines, at my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" I proposed a "thought experiment" to theoretically extrapolate limited data on health IT risk to a national audience, taking into account factors that limited transparency and thus reduced known injury and fatality counts. The results were undesirable, to say the least - but it was a thought experiment only.

Using the current data, coming from a limited, voluntary set of information over 9 weeks, I opine that the results of an extrapolation to a national (or worldwide) level, in an environment of rapidly increasing adopters (many of whom are new to the technology), on an annual basis, not a mere 9 weeks - would not look pretty.

The institute’s report did not rate whether electronic systems were any less safe than the paper records they replaced. The report is intended to alert hospitals and health systems to the unintended consequences of electronic health records.

Ethically, this is really not relevant towards national rollout, especially with penalties beginning to accrue to non-adopters of HHS "Certified" technology in a few years.

As I've written on this blog, medical ethics generally do not condone experimentation without informed consent, especially when the experimental devices are of unknown risk. Not knowing the risks of IT, it really doesn't matter, ethically, what the safety of paper is.  "Hope" is not a valid reason for medical experimentation.  (See below for what a PubMed search reveals about risks of paper records.)

The unspoken truth prevalent in healthcare today seems to be this:  the sacrifice of individual patients to a technology of unknown risk is OK, as long as - we hope -  it advances the greater good.    Perhaps that should be explicitly admitted by the HIT industry's hyper-enthusiast proponents who ignore the downsides, so the spin can be dropped and there can be clarity?

The leading cause of problems was general malfunctions [also known by the benign-sounding euphemism "glitches" - ed.]  responsible for 29% of incidents. For example, following a consultation about a patient’s wounds, a nurse at one hospital tried to enter instructions in the electronic record, but the system would not allow the nurse to type more than five characters in the comment field. Other times, medication label scanning functions failed, or an error message was incorrectly displayed every time a particular drug was ordered. One system failed to issue an alert when a pregnancy test was ordered for a male patient. [These 'general malfunctions' are thus not just computer bugs undetected due to inadequate pre-rollout testing, but also examples of design flaws due to designer-programmer-seller-buyer-implementer lack of due diligence, i.e.,  negligence - ed.]

A quarter of incidents were related to data output problems, such as retrieving the wrong patient record because the system does not ask the user to validate the patient identity before proceeding. This kind of problem led to incorrect medication orders and in one case an unnecessary chest x-ray. Twenty-four percent of incidents were linked to data-input mistakes. For example, one nurse recorded blood glucose results for the wrong patient due to typing the incorrect patient identification number to access the record.  [Many of these are likely due to what NIST has termed "use error" - user interface designs that will engender users to make errors of commission or omission - as opposed to "user error" i.e., carelessness - ed.]

Most of remaining event reports were related to data-transfer failures, such as a case where a physician’s order to stop anticoagulant medication did not properly transfer to the pharmacy system. The patient received eight extra doses of the medication before it was stopped. [Due to outright software, hardware and/or network problems and defects - ed.]

I've been writing about such issues since 1998, not because I imagined them.  As a CMIO I saw them firsthand; as teacher and mentor I heard about them from colleagues; as a writer I heard about them via (usually unsolicited) emails from concerned clinicians; as an independent expert witness on health IT harms I've heard about them from Plaintiff's attorneys, but not from the Defense side of the Bar as yet.  Of course the reasons for that are understandable -  albeit disappointing.

In fact, robust studies of a serious issue - the actual risks of paper towards harm causation - and further, whether any of the issues are remediable without spending hundreds of billions of dollars on IT - seem scarce.  I've asked the PA Patient Safety Authority about the possibility of using data in the Pennsylvania Patient Safety Reporting System (PA-PSRS) database, just as they did for EHR-related medical events, to determine incidence of paper-related medical events.  They are pondering the issue.

As an aside, I note that it would be ironic if the relative risks of both IT and paper were not really robustly known.  (I note that in a PubMed search on "risks of paper medical records", not much jumps out.)  IT hyper-enthusiasts will not even debate the issue of studying whether a good paper system might be safer for patients in some clinical environments than bad health IT.

Considering the tremendous cost and unknown risk of today's health IT (and perhaps the unknown risk of paper, too), would it not make more sense, and be consistent with the medical Oath, to leave paper in place where it is currently used - and perhaps improve its performance - until we "get the IT right" in controlled, sequestered environments, prior to national rollout?

In other words, as I've asked before on these pages, should we not slow down the IT push and adhere to traditional (and hard-learned) cautions on medical research?

Even asking such questions brings forth logical fallacies such as straw arguments (e.g., UCSF's Bob Wachter in a recent discussion I initiated with several investigative reporters: "...where we part ways is your defense of paper and pencil. I understand advocacy, and you have every right to bang this particular drum"), ad hominem attacks, etc.

... It is not enough for physicians and other health care leaders to shop carefully for IT systems, the report said. Ensuring that systems such as computerized physician order entry and electronic health records work safely has to be a continuing concern, said Karen P. Zimmer, MD, MPH, medical director of the ECRI Institute PSO.

“Minimizing the unintended consequences of health IT systems and maximizing the poten­tial of health IT to improve patient safety should be an ongoing focus of every health care organization,” she said.

I recommended that clinicians take matters into their own hands if their leaders do not, as at the bottom of my post here.  This advice bears repeating:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

• Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).

• Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

• Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at http://www.jointcommission.org/report_a_complaint.aspx . Also consider writing the JC senior officers (link to officer's list), whose awareness of HIT issues I can personally attest to via our correspondences.

• Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. An example of such an adverse event report I filed myself (when the involved hospital refused) is at this link in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.

• Inform the State Medical Society and local Medical Society of your locale.

• Inform the appropriate Board of Health for your locale.

• If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."

• Inform a personal attorney.

• Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.

• As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:

"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."

• If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.

• As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These recommendations still stand, although after this recent story, my caution about retaliation should be re-emphasized:

The Advisory Board Company
Feb. 14, 2013
Hospital Framed Physician; Planted a Gun

-- SS

Another Reason for Hope? - Concern about Excessive Executive Pay in Health Care Goes Mainstream

Another recent case suggested that the problem of excess, disproportionate compensation of health care executives is becoming more of a mainstream concern. 

The Case of Eastern Connecticut Health Network

The case appeared in the Manchester (CT) Journal-Inquirer (link requires subscription).  Here are the basics:

ECHN Inc., which owns Mancester Memorial and Rockville General hospitals, reported to the IRS last year that the company paid its president and CEO, Peter J Karl, a total of $1,042,200 in salary and fringe benefits.  That's a 30.7 percent increase over Karl's compensation reported in the previous year,....

ECHN also reported that six other top executives were paid between $254,640 and $591,090, representing increases of as much as 20.6 percent. 

ECHN is yet another relatively small non-profit hospital system with a million dollar plus CEO.

For comment on this, I turn back to the Journal-Inquirer article.  One person the reporter interviewed

says the big salaries and bonuses paid to top officials at Eastern Connecticut Health Network are part of a national scandal over executive compensation propelled by the 'pursuit of talent for short-term gains.'

'The hospital industry is emblematic of what's happened in executive compensation in the United States, where the multiple of the lowest- paid employee to get to the salary of the highest-paid employee has just exploded over the last 30 years,'....

Furthermore, the person interviewed noted that hospital executives were bemoaning decreases in payments to their institutions by state government "while making 10 to 20 times as much money as" the state governor makes.  In this case, the CEO, Mr Karl's "compensation package was 6.9 times [Governor Daniel P] Malloy's salary of $150,000."

A second person interviewed said

Salaries have gotten to the point where they have skyrocketed and are out of control.

He also raised an issue about conflicts of interest affecting the ECHN board

he agreed with state health care advocate, Victoria Veltri, who told the Journal Inquirer last week that nearly $1 million in business deals between ECHN and five members of its board of trustees require further scrutiny

Criticism from the Mainstream

I have been coy about who the commentators were, but bear with me.

So we see in this one somewhat obscure newspaper article about one small regional hospital system points that we have been raising for years about the perverse incentives generated by excess executive compensation in health care.  We have frequently discussed how such compensation is often completely untethered to the organizations' financial results, much less its positive effects on patients' and the public's health.  Compensation often rises faster than inflation, faster than revenue (and sometimes when revenue declines and deficits loom), and even when the organization is facing financial, clinical, or ethical challenges.  Thus it often seems that the primary goal of the organization has become enriching top executives (look here for a recent example).  As the first commentator noted above, this seems to arise out of the business school dogma that puts short-term revenue ahead of all other goals (which we discussed here, and can be termed financialization.)

But our concerns do seem to be getting more mainstream.  The first commentator above was actually the Governor of Connecticut, Dannel P Malloy, himself.  The second commenter was Connecticut state Senator Steve Cassano.  So prominent politicians are beginning to see the perversity of excess executive compensation in health care at a time of still burgeoning health care costs and still threatened health care access and quality. 

So maybe some more people will listen this time when we repeat....  Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Seth MacFarlane: An Oscar Host who is Harmful to Comedy and the Public’s Health

This week’s post for Pop Health was co-written by Beth Grampetro, MPH, CHES. Beth has been working in college health promotion for 7 years and her interests include feminism online and in popular culture. You can follow her on twitter @bethg24. 

The role of society is important in public health.  Health is not just influenced by individual decisions and behaviors.  It is also influenced by our interactions with the world around us- our communities, our families, our workplaces, our schools, entertainment, celebrities, and the media.  These interactions can have a very strong influence (good or bad) on the public’s health.

With that in mind, we were horrified to witness host Seth MacFarlane’s monologue and ongoing commentary during Sunday night’s Oscars.  According to Nielsen ratings, approximately 40.3 million viewers tuned in to the Oscar telecast.  This broad audience watched MacFarlane, a widely known celebrity, make jokes about domestic violence, female actresses’ bodies, and various forms of discrimination.

In the opening number, MacFarlane sang a song entitled “We Saw Your Boobs”, about the scenes in various movies where actresses in the audience had appeared topless. While it has been reported that the actresses were in on the joke, it is nonetheless disturbing that this number passed muster- especially given that several of the scenes he referenced were from movies where the actresses he named portrayed rape victims.

Other jokes included a reference to Jennifer Aniston’s past as a stripper, a congratulatory statement about how great all the actresses who “gave themselves the flu” to lose weight looked in their dresses, and a comment about how Latino actors (in this case Javier Bardem, Salma Hayek, and Penelope Cruz) have difficult-to-understand accents “but we don’t care because they’re so attractive.”

MacFarlane also tried some jokes that had men as their targets but still managed to get mud on a few women in the process. He joked that Rex Reed was going to review Adele’s performance (a reference to Reed’s recent movie review in which he called Melissa McCarthy a “hippo”) and made a joke about 9-year-old nominee Quvenzhané Wallis dating George Clooney. Some defenders of MacFarlane’s performance argued that these jokes were meant to be about the men in question, but ignored the fact that they were made at the expense of women and girls.

The Oscars are billed as “Hollywood’s Biggest Night”, and it’s incredibly disappointing to see what is the biggest event for the entertainment industry turned into the worst office party in history, complete with a leering coworker who’s creating a hostile environment.  If MacFarlane succeeded at anything, it was reminding women that they’re expected to always be thin, be pretty, and be willing to shut up and take it, lest they spoil the whole evening.

There is evidence to show that (unfortunately) these types of jokes and messages that devalue women are believed and internalized within our communities.  For example, a 2009 study by the Boston Public Health Commission found that over half of teens surveyed blamed the singer Rihanna after she was beaten by her boyfriend Chris Brown.  In addition, research shows that a mere 3-5 minutes of listening to, or engaging in, fat talk can lead some women to feel bad about their appearance and experience heightened levels of body dissatisfaction.

Research also tells us that these internalized messages and social norms are correlated with serious public health outcomes.  For example, the CDC outlines the risk factors for sexual violence perpetration.  Under society level factors we find (among others):

• Societal norms that support sexual violence
• Societal norms that support male superiority and sexual entitlement
• Societal norms that maintain women's inferiority and sexual submissiveness
• Weak laws and policies related to gender equity

So the issue is much bigger than if Seth MacFarlane was funny or made a good Oscar host.  The issue is about the quality of the role models we choose to represent our communities and the messages they send.  These messages can have a broad and long lasting influence on public health.  We hope the Academy will choose wisely next year.

Reason for Hope? - Novartis Rescinds Vasella's Golden Parachute

Enormous compensation of hired health care executives, out of all proportion, if related at all to whether their work had any positive effect on patients' or the public's health, has long been a concern on Health Care Renewal.  For example, back in 2006, we posted repeatedly (look here for links) about the billion dollar plus fortune amassed by the then CEO of UnitedHealthcare which vividly contrasted with the company's avowal to "make health care more affordable."

We have posted many such stories.  Yet maybe there is a whiff of change in the air.  For the first time that I can recall, a gigantic pay package to a top health care executives has been rescinded after public protest.

Novartis' Golden Parachute for Vasella

This is how the New York Times described the huge golden parachute that was initially proposed:

A plan by Novartis, one of Switzerland’s biggest drug makers, to pay its departing chairman $78 million to keep him from sharing his knowledge with competitors has added fuel to an already heated debate about executive pay.

The announcement of the payment to the chairman, Daniel Vasella, was made last Friday, just two weeks before a Swiss referendum to give shareholders more power to determine executive compensation. Mr. Vasella, who had previously said that he would step down as chairman at Novartis’s annual shareholder meeting on Friday, is to receive the sum, 72 million Swiss francs, over six years. 

In a statement, Mr. Vasella said that 'it has been very important to Novartis that I refrain from making my knowledge and know-how available to competitors and to take advantage of my experience with the company.'

Unprecedented Resistance by Shareholders, Politicians and the Public

The plan to provide this "golden parachute" met stunning resistance from Swiss citizens and company shareholders.  As the Times reported,

Swiss lawmakers and shareholder activists criticized the company over the weekend for not making the amount public earlier. They also contended that the planned payment was just the latest of several bad decisions by Novartis on executive pay.

Ethos, a Swiss group of investors, on Monday called on Novartis to immediately cancel the contract with Mr. Vasella and take back any money already paid.

Christophe Darbellay, president of the Christian Democratic People’s Party, told a Swiss newspaper, SonntagsZeitung, that Mr. Vasella’s compensation was 'beyond evil.' Simonetta Sommaruga, the Swiss federal justice minister, told another newspaper, SonntagsBlick, that the payment was an 'enormous blow for the social cohesion of our country' and that such 'help-yourself mentality' was damaging confidence in the economy. 

Even Swiss identified as pro-business or right-wing joined in the criticism.  As reported by the Swiss Broadcasting Company, 

Philipp Müller, president of the centre-right Radical Party which traditionally has close links with the business community, is quoted as saying Vasella was 'taking liberal Switzerland to the henchman'.

Other politicians described the latest figure as 'disgusting' and denounced the recklessness of top managers.

The director of the Swiss Business Federation, which has been leading the fight against the initiative, said he was surprised by the 'dimension of the payment' to Vasella.

A Golden Parachute Despite a Past Record of Misadventures

Maybe there would have been even more outrage if those in Switzerland had known about Novartis' track record of misadventures, at least in the US, while Vasella had been leading it.  In particular,

-  In 2011, as we noted here, a company subsidiary paid $150 million to settle charges by several US states that it had misrepresented pricing information

-  In 2010, as we noted here, the company settled US federal civil and criminal charges in connection with its marketing of multiple drugs for $422.5 million.  The charges included giving kickbacks to physicians disguised as speakers' honorariums and fees for serving on advisory boards.  

-  In 2010, as we noted here, the company settled separate US charges that it made false claims to support off-label marketing of its drug tobramycin for cystic fibrosis for $72.5 million. 

- In 2008, as we noted here, the company settled charges in the US state of Alabama that it defrauded Medicaid for $33.7 million.

However, these legal escapades were not mentioned in the recent media coverage of the proffered and then withdrawn parachute. 

The Company Backs Down.

Nonetheless, what was really surprising was that the outrage made the company back down.  Per the Wall Street Journal, 

Novartis AG on Tuesday abandoned a 72-million-Swiss-franc ($78 million) exit package for its chairman, bowing to pressure from shareholders and Swiss politicians after four days of increasing criticism.

The Swiss drug maker said its board and Chairman Daniel Vasella agreed to cancel a six-year noncompete and related-compensation agreement designed to prevent him from joining or advising rivals and which would have paid him 12 million francs a year.

The agreement was scheduled to take effect on Friday, when Dr. Vasella, 59 years old, is planning to leave the Basel-based company at its annual shareholder meeting

Furthermore,

In the Novartis statement on Tuesday, Dr. Vasella acknowledged that his offer hadn't soothed public opinion: 'I have understood that many people in Switzerland find the amount of the compensation linked to the noncompete agreement unreasonably high,' he said. 

In addition, as Reuters noted, Vasella actually admitted he made "mistakes,"

'The fierce reaction and reproaches that were made as a consequence of the many-sided discussions about my compensation did leave its mark on me,' 59-year-old Vasella said in his opening address to 2,688 shareholders gathered at Novartis's annual general meeting in Basel.

'I made two avoidable mistakes: the first was to even negotiate this contract. And the second to believe that giving up this individual payment to charities would be considered as something positive by society.'

Of course, it is hard to believe that Novartis had previously paid him as lavishly as it did  - the New York Times had reported that his pay just prior to resignation was 12.4 million francs, "about $13.4 million a year" -  without securing an agreement to protect trade secrets.  Many businesses routinely add confidentiality clauses, trade secret protection, and non-compete clauses to contracts of many employees.  Thus adding a $78 million golden parachute ostensibly just to protect trade secrets and defection to the competition seems like impossibly gilding the lily.  Furthermore, if Novartis really thought that Vasella was likely to run to another firm at the drop of a hat, it would have made no sense to entrust someone thought to be at risk of such disloyalty with top leadership positions.

Reason for Hope

At least Chairman Vasella admitted "mistakes," and at least the ridiculous pay package was rescinded. This incident does show that it is possible for public and shareholder outrage over gargantuan payments to executives to have some effect.  That seems like real progress, and a reason to hope. 

Of course, executives of public for-profit corporations are supposed to be working for shareholders.  Thus their general impunity from shareholders' control up to now remains inexplicable.  Furthermore, executives of pharmaceutical companies and other health care corporations seemingly should be responsible for putting patients' and the public's health ahead of their own enrichment.  Thus their ability up to now to ignore public concern about their companies' actions, and to avoid personal responsibility for their companies' bad actions also remains inexplicable.

But progress may now be possible.  In and outside of Switzerland, shareholders of publicly-held for-profit health care corporations should demand accountability from the executives who are supposed to be working for them.  In and outside of Switzerland, health care professionals, policymakers, and the public at large should demand accountability from leaders of health care organizations for the effects of their organizations on patients' and the public's health. 

Could the low testosterone problem be a mirage?

Low testosterone (a.k.a. “low T”) is caused by worn out glands no longer able to secrete enough T, right? At least this seems to be the most prevalent theory today, a theory that reminds me a lot of the “tired pancreas” theory () of diabetes. I should note that this low T problem, as it is currently presented, is one that affects almost exclusively men, particularly middle-aged men, not women. This is so even though T plays an important role in women’s health.

There are many studies that show associations between T levels and all kinds of diseases in men. But here is a problem with hormones: often several hormones vary together and in a highly correlated fashion. If you rely on statistics to reach conclusions, you must use techniques that allow you to rule out confounders; otherwise you may easily reach wrong conclusions. Examples are multivariate techniques that are sensitive to Simpson’s paradox and nonlinear algorithms; both of which are employed, by the way, by modern software tools such as WarpPLS (). Unfortunately, these are rarely, if ever, used in health-related studies.

Many low T cases may actually be caused by something other than tired T-secretion glands, perhaps a hormone (or set of hormones) that suppress T production; a T “antagonist”. What would be a good candidate? The figure below shows two graphs. It is from a study by Starks and colleagues, published in the Journal of the International Society of Sports Nutrition in 2008 (). The study itself is not directly related to the main point that this post tries to make, but the figure is.



Look at the two graphs carefully. The one on the left is of blood cortisol levels. The one on the right is of blood testosterone levels. Ignore the variation within each graph. Just compare the two graphs and you will see one interesting thing – cortisol and testosterone levels are inversely related. This is a general pattern in connection with stress-induced cortisol elevations, repeating itself over and over again, whether the source of stress is mental (e.g., negative thoughts) or physical (e.g., intense exercise).

And the relationship between cortisol and testosterone is strong. Roughly speaking, an increase in cortisol levels, from about 20 to 40 μg/dl, appears to bring testosterone levels down from about 8 to 5 ηg/ml. A level of 8 ηg/ml (the same as 800 ηg/dl) is what is normally found in young men living in urban environments. A level of 5 ηg/ml is what is normally found in older men living in urban environments.

So, testosterone levels are practically brought down to almost half of what they were before by that variation in cortisol.

Chronic stress can easily bring your cortisol levels up to 40 μg/dl and keep them there. More serious pathological conditions, such as Cushing’s disease, can lead to sustained cortisol levels that are twice as high. There are many other things that can lead to chronically elevated cortisol levels. For instance, sustained calorie restriction raises cortisol levels, with a corresponding reduction in testosterone levels. As the authors of a study () of markers of semistarvation in healthy lean men note, grimly:

“…testosterone (T) approached castrate levels …”

The study highlights a few important phenomena that occur under stress conditions: (a) cortisol levels go up, and testosterone levels go down, in a highly correlated fashion (as mentioned earlier); and (b) it is very difficult to suppress cortisol levels without addressing the source of the stress. Even with testosterone administration, cortisol levels tend to be elevated.

Isn't possible that cortisol levels go up because testosterone levels go down - reverse causality? Possible, but unlikely. Evidence that testosterone administration may reduce cortisol levels, when it is found, tends to be rather weak or inconclusive. A good example is a study by Rubinow and colleagues (). Not only were their findings based on bivariate (or unadjusted) correlations, but also on a chance probability threshold that is twice the level usually employed in statistical analyses; the level usually employed is 5 percent.

Let us now briefly shift our attention to dieting. Dieting is the main source of calorie restriction in modern urban societies; an unnatural one, I should say, because it involves going hungry in the presence of food. Different people have different responses to dieting. Some responses are more extreme, others more mild. One main factor is how much body fat you want to lose (weight loss, as a main target, is a mistake); another is how low you expect body fat to get. Many men dream about six-pack abs, which usually require single-digit body fat percentages.

The type of transformation involving going from obese to lean is not “cost-free”, as your body doesn’t know that you are dieting. The body “sees” starvation, and responds accordingly.

Your body is a little bit like a computer. It does exactly what you “tell” it to do, but often not what you want it to do. In other words, it responds in relatively predictable ways to various diet and lifestyle changes, but not in the way that most of us want. This is what I call compensatory adaptation at work (). Our body often doesn’t respond in the way we expect either, because we don’t actually know how it adapts; this is especially true for long-term adaptations.

What initially feels like a burst of energy soon turns into something a bit more unpleasant. At first the unpleasantness takes the form of psychological phenomena, which were probably the “cheapest” for our bodies to employ in our evolutionary past. Feeling irritated is not as “expensive” a response as feeling physically weak, seriously distracted, nauseated etc. if you live in an environment where you don’t have the option of going to the grocery store to find fuel, and where there are many beings around that can easily kill you.

Soon the responses take the form of more nasty body sensations. Nearly all of those who go from obese to lean will experience some form of nasty response over time. The responses may be amplified by nutrient deficiencies. Obesity would have probably only been rarely, if ever, experienced by our Paleolithic ancestors. They would have never gotten obese in the first place. Going from obese to lean is as much a Neolithic novelty as becoming obese in the first place, although much less common.

And it seems that those who have a tendency toward mental disorders (e.g., generalized anxiety, manic-depression), even if at a subclinical level under non-dieting conditions, are the ones that suffer the most when calorie restriction is sustained over long periods of time. Most reports of serious starvation experiments (e.g., Roy Walford’s Biosphere 2 experiment) suggest the surfacing of mental disorders and even some cases of psychosis.

Emily Deans has a nice post () on starvation and mental health.

But you may ask: What if my low T problem is caused by aging; you just said that older males tend to have lower T? To which I would reply: Isn’t possible that the lower T levels normally associated with aging are in many cases a byproduct of higher stress hormone levels? Take a look at the figure below, from a study of age-related cortisol secretion by Zhao and colleagues ().



As you can see in the figure, cortisol levels tend to go up with age. And, interestingly, the range of variation seems very close to that in the earlier figure in this post, although I may be making a mistake in the conversion from nmol/l to ηg/ml. As cortisol levels go up, T levels should go down in response. There are outliers. Note the male outlier at the middle-bottom part, in his early seventies. He is represented by a filled circle, which refers to a disease-free male.

Dr. Arthur De Vany claims to have high T levels in his 70s. It is possible that he is like that outlier. If you check out De Vany’s writings, you’ll see his emphasis on leading a peaceful, stress-free, life (). If money, status, material things, health issues etc. are very important for you when you are young (most of us, a trend that seems to be increasing), chances are they are going to be a major source of stress as you age.

Think about individual property accumulation, as it is practiced in modern urban environments, and how unnatural and potentially stressful it is. Many people subconsciously view their property (e.g., a nice car, a bunch of shares in a publicly-traded company) as their extended phenotype. If that property is damaged or loses value, the subconscious mental state evoked is somewhat like that in response to a piece of their body being removed. This is potentially very stressful; a stress source that doesn’t go away easily. What we have here is very different from the types of stress that our Paleolithic ancestors faced.

So, what will happen if you take testosterone supplementation to solve your low T problem? If your problem is due to high levels of cortisol and other stress hormones (including some yet to be discovered), induced by stress, and your low T treatment is long-term, your body will adapt in a compensatory way. It will “sense” that T is now high, together with high levels of stress.

Whatever form long-term compensatory adaptation may take in this scenario, somehow the combination of high T and high stress doesn’t conjure up a very nice image. What comes to mind is a borderline insane person, possibly with good body composition, and with a lot of self-confidence – someone like the protagonist of the film American Psycho.

Again, will the high T levels, obtained through supplementation, suppress cortisol? It doesn’t seem to work that way, at least not in the long term. In fact, stress hormones seem to affect other hormones a lot more than other hormones affect them. The reason is probably that stress responses were very important in our evolutionary past, which would make any mechanism that could override them nonadaptive.

Today, stress hormones, while necessary for a number of metabolic processes (e.g., in intense exercise), often work against us. For example, serious conflict in our modern world is often solved via extensive writing (through legal avenues). Violence is regulated and/or institutionalized – e.g., military, law enforcement, some combat sports. Without these, society would break down, and many of us would join the afterlife sooner and more violently than we would like (see Pinker’s take on this topic: ).

Sir, the solution to your low T problem may actually be found elsewhere, namely in stress reduction. But careful, you run the risk of becoming a nice guy.

Tips For Overcoming The Effects Of Cold Weather

Action Plan For Overcoming The Effects Of Cold Weather:

* If you wash your face, do so at least half an hour before
   you go outdoors. This gives your skin a change to dry
   thoroughly. If your face is slightly damp, the wind has
   an extra-drying effect.  

* Wear a richer moisturizer.

* Apply night cream to replenish moisture lost from the
   skin during the day.

* If your skin is flaking, avoid abrasive scrubs. Use a very
   gentle complexion exfoliator.

* Remember to take care for your hands and nails, too,
   as the skin here can also suffer in cold weather.

* Always apply waxy lip salves or balms to your lips which
   are especially vulnerable to dehyration.

* Add oils and moisturizing gels to your bath and apply
   body-lotions every day.

* Never come in from ice cold weather and immediately
   roast yourself in front of a hot fire, as you will dry your
   skin excessively;  the rapid contrast in temperature can
   also break capillaries, leading to red thread veins.

* If you are skiing or are outside in sunny, but cold weather,
   apply protective lotions on every part of exposed skin.

Boils - Symptoms, Causes, and Treatment

Boils

The boils, known as furuncle in medical parlance, are tender
swelling in the skin surrounded by large red areas. They are
infections of the sweat glands or hair follicles of the skin.
They commonly occur during summer. 

Symptoms

* Boils can occur anywhere on the body, but they appear most
   often on the face, eyelids, back of the neck, upper back, and
   buttocks.

* Boils occurring round the eyes and nose are especially serious
   because their poisons can spread to the brain.

Causes

* Boils are mainly caused by stapphylococcus germs which enter
   the sweat glands or hair follicles.

* They can be transmitted from one person to another .

* The essential cause of this disorder is thus bacterial.

Treatment

* A thorough cleansing of the system is essential to the treatment
   of boils.

* Take exclusive diet of fresh juicy fruits for two or three days.

* A warm-water enema should be administered daily, if possible,
   during this period to cleanse the bowels.

* Avoid tea, coffee, starchy, and sugary foods especially, cakes,
   pastries, sweets, chocolates, white sugar, and white bread.

Home Remedies For Boils

* The use of garlic and onion has proved most effective among
   the several home remedies found beneficial in the treatment of
   boils.

* The juice of garlic or onion may be applied externally on the boils
   to help ripen them and also to break them and evacuate the pus.

* Bitter Gourd is an efficient home remedy for boils.  A cupful of fresh
   juice of this vegetable, mixed with a teaspoon of lime juice,
   should be taken, sip by sip, on an empty stomach daily for
   few days in treating this condition.

* Cumin seeds (jeera) are beneficial in the treatment of boils. The seeds
   of black cumin should be ground in water and made into a paste.
   This paste can be applied to boils with beneficial results.