Thursday, 8 January 2015

Princess Health and Once More, the Hospital CEO as Scrooge -  Cape Cod Healthcare CEO Collected Millions in Severance After Laying Off Hundreds of Health Professionals, and Being Sanctioned by the State Medical Board . Princessiccia

Princess Health and Once More, the Hospital CEO as Scrooge - Cape Cod Healthcare CEO Collected Millions in Severance After Laying Off Hundreds of Health Professionals, and Being Sanctioned by the State Medical Board . Princessiccia

The theme of non-profit hospital CEO as Scrooge seems to be persisting in the media even beyond the holiday season.  (Our last post on this theme was in December, 2014).  The previous cases we discussed (also here) involved  marked contrasts between how well top hired managers of non-profit hospitals were doing, and how their institutions were doing.

Turning Around the Hospital, but Turning Away Employees

The background to this story comes from an article in the Cape Cod (MA) Times from January, 2014.  Cape Cod Healthcare, a regional non-profit hospital system, hired Dr Richard Saluzzo as CEO to turn around the system's troubled finances.

Cape Cod Healthcare had 'a pretty significant economic turnaround' under Salluzzo's stewardship, as well as accolades for quality of care, [board chairman Thomas] Wroe said.

'We were really in trouble. He was the architect and foundation of turning that around,' Wroe said.

In this case, the turn around seemed to be strictly financial,

During his tenure Cape Cod Healthcare's bond rating improved from one grade above junk status to BBB with a favorable outlook.

However, the turn around also involved turning away employees,

The financial turnaround came in part from cost-cutting measures such as layoffs for about 200 employees and improved billing.

More details about these layoffs were in a Cape Cod Times article from 2008,

A hospital chaplain and several psychiatric nurses are among the cuts emerging from Cape Cod Healthcare's announcement last month that it is eliminating 169 positions.

In particular,

the hospital's largest union is expected to begin the process of 'bumping' later this week, which allows employees with more years of service to move into jobs of junior colleagues.

Most of the layoffs announced last month are at Cape Cod Hospital.

Union jobs scheduled for elimination are going through a process of negotiation with management.

Seventy-six positions held by members of the 1199SEIU United Healthcare Workers East are slated for elimination.

Also still in negotiation is the fate of seven members of the Massachusetts Nurses Association, several of whom are employees of the psychiatric center located across the parking lot from Cape Cod Hospital in Hyannis.

Some of the nurses work part time, said Marilyn Rouette, president of the Cape Cod Hospital chapter of the association.

But the psychiatric services help 'a very vulnerable population,' she said.

So the hospital apparently did improve its financial performance during the reign of Dr Saluzzo, but at the expense of quite a few employees, including health professionals serving vulnerable patients.

CEO Compensation as the Gift that Keeps on Giving

CEO Dr Saluzzo earned pretty good pay during his last full year, as reported by the Cape Cod Times in 2014,

In fiscal 2010 � his last full year of employment at Cape Cod Healthcare � Salluzzo earned under $1 million, garnering $835,609 in salary and $23,967 in other compensation. He also received a benefit plan worth $78,618.

He did much better than did the previous CEO,

Salluzzo's most recent salary stands in striking contrast to that of his predecessor, retired Cape Cod Healthcare CEO Stephen Abbott, whose salary came to $621,225 in fiscal 2008, his last full year on the job. That year he also had a benefit plan worth $111,544.

However, CEO Dr Saluzzo's compensation did not stop when he left.  The 2014 article in the Cape Cod Times included,

Even as Dr. Richard F. Salluzzo abruptly left his CEO position at Cape Cod Healthcare more than three years ago, he was due to receive more than $2 million in compensation.

Reports filed with the state attorney general's office for fiscal 2012 and 2011 show that Salluzzo remained Cape Cod Healthcare's highest-paid employee those years, despite the fact that he left just two months into fiscal 2011.

Salluzzo earned $1,309,308 for fiscal 2011 and $1,095,342 for fiscal 2012, according to forms filed with the attorney general's nonprofit/public charities division. Cape Cod Healthcare's fiscal year starts Oct. 1.


This week, the January 5, 2015 Cape Cod (MA) Times updated the figures,

Three years after he abruptly left Cape Cod Healthcare, former CEO Dr. Richard Salluzzo continued to be one of its highest-paid employees, according to new financial reports filed with the state attorney general�s office.

Since departing the nonprofit organization in November 2010, Salluzzo has taken in more than $3 million in compensation, including $857,953 for the most recent fiscal year on file, 2013.

The compensation made Salluzzo the fourth-highest-paid employee at Cape Cod Healthcare for that period, which started Oct. 1, 2012, according to forms recently filed with the attorney general�s nonprofit/public charities division. The payout is less than what Salluzzo earned in fiscal years 2011 and 2012, which came to $1,309,308 and $1,095,342.

The Board Continues its Defense of the Seemingly Endless CEO Compensation

According to the 2015 Cape Cod Times article, the new board chairman continued the defense of the continuing payment of a CEO who departed over three years ago,

This was a commitment made by the board years ago,' said William Zammer, chairman of the Cape Cod Healthcare Board of Trustees. 'The system was hemorrhaging money, and we were in a terrible position.'

'Salluzzo came onboard and did the job' of shifting the health care system from the red to the black,' Zammer said.


Never Mind the Questions Raised about the CEO Since 2008

This defense, admittedly not as strident as some other defenses by hospital board members of CEO compensation that we have discussed, was maintained despite some pretty significant questions about former CEO Dr Saluzzo since he was hired back in 2008.

Dr Saluzzo's Leadership of Wellmont Health System

This concern goes all the way back to 2009, as reported again by the Cape Cod Times,

Amid the good news, however, comes word from the Wellmont Health System in Kingsport, Tenn., that profits under Salluzzo were significantly less than first reported. A recent audit by a new firm found the system overstated its net earnings for fiscal years 2006 and 2007 by nearly $20 million and lost $4.6 million in 2008. The financial restatement came as a shock to Salluzzo, who said audits during his tenure always came back clean.

'This is a disagreement between auditors,' he said. 'I know my team and I did nothing wrong.'

Wellmont officials, who have not returned phone calls, said in a prepared statement that the audit turned up no evidence of criminal acts. The press release referred to errors in recording expenses, receivables and assets and said the system was imposing a new set of controls to reconcile accounts and strengthen internal auditing.

At that time, the board of Cape Cod Healthcare just seemed relieved that the issue was not criminal,

'There's no indication of fraud, manipulation of funds or personal gain,' [board chairman Thomas Wroe] ... said. 'They changed auditors. Any time you do that, you have a different translation of financial results. We have strong confidence in Dr. Salluzzo. He's been doing a great job for us.'

Saying that there is no indication that a person is a criminal seems like rather faint praise.  Never mind that it was still on CEO Dr Saluzzo's watch that these results, which now appear less than stellar, were produced, and that the belief, not apparently wrong, that CEO Dr Saluzzo produced stellar results at Wellmont was a reason to hire him as CEO of Cape Cod Healthcare.  Never mind that it was on CEO Dr Saluzzo's watch that the Wellmont hospital systems accounting was full of errors, yet it was Dr Saluzzo's financial leadership at Wellmont that apparently endeared him to the Cape Cod board.

Dr Saluzzo Sanctioned by the Massachusetts State Medical Board

In 2011, after Dr Saluzzo left his position as CEO, the Falmouth (MA) Enterprise reported,

Dr. Richard F. Salluzzo, former CEO of Cape Cod Healthcare, was disciplined by the state Board of Registration in Medicine this week for using drugs prescribed to others for his own use and prescribing drugs to family members without keeping proper records.

In particular,

Among the allegations in the board�s investigation of Dr. Salluzzo are that in 2008, before he started at Cape Cod Healthcare, he wrote four prescriptions for Valium for an employee working under him and then asked the employee to fill the prescriptions and give him the drugs. In 2009, while holding the top job at Cape Cod Healthcare, he wrote prescriptions for Zoloft for a friend and filled the prescriptions for his own use.

According to the board�s allegations, he also wrote prescriptions for controlled substances for his wife, his two adult children and his father but did not keep medical records for the family members.

In disciplining Dr. Salluzzo for those actions, the board cites the American Medical Association�s Code of Medical Ethics that 'physicians should not treat themselves or family members as professional objectivity may be compromised and issues of patient autonomy and informed consent may arise.'

In a consent order, Dr. Salluzzo agreed to the ruling and punishment, signing the document on November 1.

At that time, the Cape Cod Healthcare board of trustees responded to the disciplinary measures taken for unprofessional actions by the system's former CEO thus,

Cape Cod Healthcare�s board of directors, in a press release, stated, 'We became aware of a complaint and followed our established policies to ensure that the licensing board was involved in this matter on a timely basis. We then cooperated fully with the Board of Medicine�s investigation.'

The board notes that the Board of Medicine discipline concerns Dr. Salluzzo�s private practice and not his management performance.

'No complaint was ever reported or filed by any patients or physicians here regarding the quality of the clinical care provided by Dr. Salluzzo during his tenure on the medical staff of both CCHC hospitals,' according to the statement.

The board reiterated its statement last year about Dr. Salluzzo�s tenure at the hospital. 'He achieved the goals set for him as witnessed by our financial turnaround and improved relationships with our physicians, then decided to pursue other career challenges and professional interests.'

By the way, the January, 2014, Cape Cod Times article also noted,

On the basis of the Massachusetts disciplinary actions, Salluzzo also was fined and reprimanded in 2012 by medical boards in New York, Tennessee and Pennsylvania � all states where he has practiced medicine in the past.

I would guess that this means that actions uncovered by the Massachusetts board of medicine included some that took place in these other states.  

The real issue raised was not whether Dr Salluzzo's professional actions harmed patients, but whether a physician so sanctioned for unprofessional conduct deserved continuing payments, amounting to millions of dollars, for his previous employment as CEO of  Cape Cod Healthcare. 

The usual justification for extremely high compensation of hired health care managers is their brilliance. Recall that in 2014, well after CEO Dr Saluzzo departed from Cape Cod Healthcare, then chairman of the board of trustees Thomas Wroe gave him accolades for "quality of care."  It seems that one could question the quality of care produced by the leadership of a physician who wrote used subterfuges to obtain controlled substances for himself and his family.  Such questions did not occur to the former chair of the system's board of trustees even by 2014.

Summary

Note that the 2014 Cape Cod Times article quoted W. Michael Hoffman, executive director of the Center for Business Ethics at Bentley University, who called CEO Dr Saluzzo's cumulative compensation "outrageously lucrative."  The 2015 Cape Cod Times article quoted David Schildmeier, spokesman for the Massachusetts Nurses Association, who called it "obscene," and furthermore,

We're paying this failure of a CEO millions of dollars.

Nevertheless, heaven forfend that a hospital board of trustees would try to withhold pay for a CEO, even pay provided years after that CEO's departure, that might violate a previously written contract, even new information discovered might now provide reasons to challenge that contract.

So here is an amazing example in which a former hospital system CEO continues to be rewarded with millions of dollars after he actually left his employment as CEO.  These rewards started even though the financial turnaround he supposedly engineered required layoffs of health care professionals serving vulnerable patients  The hospital system board of trustees continued to authorize, and failed to question these payments even after subsequent revelations that the CEO's initial hiring was apparently based on a false impression of the financial performance of his previous hospital system generated by accounting problems within that system, and that the CEO had behaved unprofessionally in obtaining prescriptions of controlled substances for his family and for himself.

As we have said before, in US health care, the top managers/ administrators/ bureaucrats/ executives - whatever they should be called - continue to prosper ever more mightily as the people who actually take care of patients seem to work harder and harder for less and less. This is the health care version of the rising income inequality that the US public is starting to notice.

 Thus, like hired managers in the larger economy, non-profit hospital managers have become "value extractors."  The opportunity to extract value has become a major driver of managerial decision making.  And this decision making is probably the major reason our health care system is so expensive and inaccessible, and why it provides such mediocre care for so much money. 

One wonders how long the people who actually do the work in health care will suffer the value extraction to continue?

So to repeat, true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

Wednesday, 7 January 2015

Princess Health and Is Meat Unhealthy?  Part VI. Princessiccia

Princess Health and Is Meat Unhealthy? Part VI. Princessiccia

In this post, I'll examine the possible relationship between meat consumption and cancer risk.

Is cancer risk even modifiable?

Cancer is caused by the uncontrolled division of a population of rogue cells in the body. These cells essentially evolve by natural selection to escape the body's multiple anti-cancer mechanisms.

To a large extent, cancer appears to be a numbers game. The human body contains about 37 trillion cells. To get cancer, all you need is one cell that develops key mutations that allow it to shed its built-in restrictions on cell division. The older you are, the more time you have to accumulate mutations, explaining why cancer risk rises sharply with age.

Unlike other common non-communicable diseases, we don't know to what extent cancer is caused by modifiable diet and lifestyle factors vs. bad luck that's completely outside our control. Some cancers, such as lung cancer, are typically linked to lifestyle factors like cigarette smoking-- yet the majority of cancers aren't so easily understood.
Read more �

Monday, 5 January 2015

Princess Health and As the Hepatitis C  Marketing Frenzy Continues, a Reminder Not to Ignore the Evidence. Princessiccia

Princess Health and As the Hepatitis C Marketing Frenzy Continues, a Reminder Not to Ignore the Evidence. Princessiccia

The Hepatitis C Spin Cycle Continues

Since our last post in July, 2014, about sofosbuvir (Sovaldi, Gilead), the $1000 pill proclaimed to be a wonder drug for the treatment of hepatitis C, the marketing juggernaut for new antiviral drugs for this condition continues to roll along.

For example, I just got a notice to look at a Gilead website which proclaims 

HCV can be cured

In October, Gilead got permission so sell Harvoni, a new combination drug that includes sofosbuvir and ledipasvir, hailed as a once daily pill that can cure hepatitis C, for a mere $94,500 for a typical treatment course. (See this article in the Wall Street Journal.) Meanwhile, AbbeVie launched its own antiviral treatment for hepatitis C, Viekira Pak, (ombitasvir, paritaprevir, and ritonavir tablets plus dasabuvir tablets) priced just under sofosbuvir, but still very expensive.  (See this Bloomberg article.)

Media coverage of these developments suggests that there is no controversy about the curative, nay lifesaving properties of these new drugs.  For example, a Wall Street Journal article about how Express Scripts will only pay for the slightly less expensive Viekira Pak referred to Sovaldi, Harvoni, and the Viekira Pak as "lifesaving medicines," and later noted, "Both Gilead�s Harvoni and AbbVie�s Viekira Pak have been shown in clinical trials to cure as many as 90% of patients..."


Never Mind the Evidence from Clinical Research, or Lack Thereof

Nearly all cases of hepatitis C can be cured, and one of the best hopes for a cure is sofosbuvir, maybe plus ledipasvir?

Never mind that the prominent published studies of sofosbuvir plus ledipasvir(1-3) did not compare this combination to any other drugs.  They simply compared different durations of treatment with the combination, plus minus other drugs.  So whether this combination is better than any other treatment, and even whether the apparently high rate of "cure," really suppression of virus detectable in blood samples at 12 weeks, would apply to patients less highly selected than those in the study was unclear. 

Of course, like every other trial of antiviral drugs for hepatitis C, these studies only assessed whether the drugs causes a "sustained virological response," that is, made the virus undetectable in patients' blood for 12 weeks.  They did not assess whether the virus reappeared after that, and certainly did not assess whether the drugs affected the development of the dreaded complications of hepatitis C infection, that is cirrhosis, liver failure, liver cancer, and death.  In the absence of controlled trials that assessed these long term clinical outcomes, the assertions that these drugs are curative or lifesaving do not appear to be well substantiated.

It is not even obvious that the new sofosbuvir based regimens are better than the old peg-interferon based regimens.   As we noted here, there apparently has only been one published study that compared sofosbuvir to another antiviral drug, peg-interferon.  That study had multiple methodologic problems, most of which appeared likely to make sofosbuvir look better, but nonetheless did not show sofosbuvir to be clearly more effective or safer than this, or any other alternative. (See posts here and here.)

In October, a cost-effectiveness analysis appeared that was used to make the case that expensive drugs like sofosbuvir could nevertheless be cost-effective.(4)  It showed that the drugs increased quality adjusted life expectancy for a relatively modest cost.

Never mind that the analysis was based on the highly questionable assumption, that "treatment resulting in cure [presumably meaning sustained virological response] could leave patients with residual fibrosis consistent with their stage at the time but without additional progression." [Italics added.] This assumption was completely unsupported by randomized controlled trial data.  As Chavez-Tapia et al wrote in a December, 2014, letter to JAMA,(5) "SVR is poorly correalted with clinical outcomes in randomized controlled trials, and even though efforts have been made to correlate it with mortality, evidence to date is insufficient to assert that SVR will translate into improved quality of life or life expectancy."

Is the evidence supporting the Viekira Pak any better?

Not obviously.  The prominent November, 2014, New England Journal of Medicine study by Ferenci et al of the drugs within the Viekira Pak also equated 12 week SVR with cure, also failed to allow patients long-term, and also failed to assess clinically important complications of hepatitis C such as cirrhosis, liver failure, liver cancer, and death.  Furthermore, the study did not compare the Viekira Pak with any other treatment option, e.g., one containing sofosbuvir or peg-interferon, or to placebo.(6)   Thus, assertions that the Viekira Pak is curative or lifesaving also do not appear to be substantiated by evidence from well-designed long-term clinical trials.

However, the lack of evidence so far as not discouraged the breathless claims, and the acceptance of these claims in the media, and probably by many physicians.

Another Skeptical Review

However, one bit of common sense about all this just appeared in the form of a 2015 article in the French journal Prescrire International.(7)  The full article requires a subscription, but a summary is available on the web, and includes the following dry but telling language:


Sofosbuvir�s initial clinical evaluation includes several comparative trials. But these trials investigate its harm-benefit balance in a minimal way. Sofosbuvir has not been compared directly with a viral protease inhibitor in a randomised clinical trial. The evaluation of sofosbuvir in patients infected with a genotype 1 HCV and suffering from cirrhosis is very poor.

Clinical trials have shown that the addition of sofosbuvir to various drug combinations increases their virological efficacy, but there is no guarantee of success.

In practice, in patients with liver damage requiring antiviral drug therapy, sofosbuvir seems to be at least as effective and less harmful than viral protease inhibitors such as boceprevir. Its use makes it possible to reduce the duration of treatment by several months. But there is a great deal of uncertainty as to its adverse effects and its interactions. In genotype 1 cases, the addition of sofosbuvir to the peginterferon alfa + ribavirine combination is an option. In genotype 2 or 3 cases, sofosbuvir is an alternative to peginterferon alfa. However, given the slow progress of hepatitis C and the many unknowns surrounding sofosbuvir, it is a reasonable option to await further clinical evidence to be available.

Meanwhile, more skepticism about the sky high pricing of these new antiviral drugs appeared in the form of a lawsuit by the Southeastern Pennsylvania Transportation Authority (SEPTA) for price gouging that allegedly violates antitrust laws.

But even the coverage of this lawsuit, like nearly all the other coverage of Sovaldi, Harvoni, and competing drugs, assumed that these drugs are miracle cures, e.g., see this Wall Street Journal article.  As we discussed in detail before (look here, here, here, here, here and here)  there is no good evidence that any of these new treatments prevents cirrhosis, liver failure, liver cancer, or death due to hepatitis C, and their long-term safety is unclear.  Similar points have been made by rigorous reviews in Germany, in the US, and now in France.  Yet the antiviral spin continues without regard to evidence, or the lack thereof, from good clinical research.  I would like to hope that each new added bit of skepticism, now including the Prescrire International review, will have some effect.  But that may be wishful thinking, since most of what goes on in the health care "industry" now seems less than fully reality based.

Summary

As we said before,  the Sovaldi (and now Harvoni, Viekira Pak, etc) case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will likely not buy us the promised miracles and triumphs.

It is disappointing that so many physicians and other health professionals have been caught up in this hype and spin, probably abetted by their wishful thinking about cures of hepatitis C, and perhaps also abetted by financial conflicts of interest.  Yet to protect the best interests of their patients, they should be rigorously skeptical of illogical or evidence-free arguments made to further vested financial interests.

As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.

References

1.  Afdhal N, Reddy KR, Nelson DR et al.  Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection.  N Engl J Med 2014; 370: 1483-98.  Link here.
2.  Afdhal N, Zeuzern S, Kwo P et al.  Lepipasvir and sofosbuvir for untreated HCV genotype 1 infection.  N Engl J Med 2014; 370: 1889-98.  Link here.
3.  Kowdley KV, Gordon SC, Reddy KR et al.  Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.  N Engl J Med 2014; 370: 1879 - 1888.  Link here.
4.  Liu S, Watcha A, Holodniy M et al.  Sofosbuvir-based treatment regimens for chronic genotype 1 hepatitis C virus infection in the U.S. incarcerated populations: a cost-effectiveness analysis.  Ann Intern Med 2014; 161: 546 - 553.  Link here.
5.  Chavez-Tapia NC, Barrientos-Gutierrez TB, Uribe M. Assessment of outcomes of hepatitis C treatment.  JAMA 2014; 312: 2570-2571.  Link here
6.  Ferenci P, Bernstein D, Lalezari J et al. ABT-450/r�Ombitasvir and Dasabuvir with or without Ribavirin for HCV. N Engl J Med 2014; 370:1983-1992. Link here.  
7.  Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete.  Prescrire Int 2015; 24: 5- 10.  Link here.

Thursday, 1 January 2015

Princess Health and2014 WINS.Princessiccia


We are a club with a strong focus on enjoying the sport, and pursuing a high level of health.  That being said, when you put a bunch of people together who support each other and have a blast doing so, something funny happens: hard work transpires without realizing it, consistency becomes easier than a lack thereof, and before you know it, results begin to pile up.


You don't have to be treated like you are hardcore, or declare you are hardcore, to race like you are hardcore.  We tried to have fun, but in the process we also won.  Now, I'm not talking age group wins, personal bests, or all the other ways our team excelled this year.  If I were to list all of those, this blog post would be never-ending.  This is simply a list of ways our team won overall (or placed 2nd).



The following performances were not our primary goals, but they are something to look back at, reflect on, and be proud of.  If you are an H+Per who does not have a name on this list, well it may as well be on there.  The success of these individuals is a direct reflection of the massive family of support and inspiration that we have assembled.

(Did we miss you?  Send us a link to your results page and we will add you to the list)


ROAD RACING

MEN

OVERALL WINS

April 26th, 2014. Guelph Avery's Bravery 5K. Robert Brouillette (18:45)
April 26, 2014. ENDURrace 8K.  Brendan Hancock (28:32) 
April 26, 2014. ENDURrace Combined  13K.  Luke Ehgoetz (47:51)
April 27th, 2014. Guelph Billy Taylor 5K. Robert Brouillette (16:03)
May 10th, 2014.  Baden 5K.- Sean Delanghe (17:20)
July 13th, 2014. Guelph Big Little trail 5K. Robert Brouillette (16:30) 
July 28th, 2014. Waterloo H+P Summer Time Trial 2.2K. Bredan Hancock (6:28)
 August 16th, 2014.  ENDURrun 10K.  Jordan Schmidt (35.49)
August 17th, 2014. Conestogo ENDURrun Marathon. Robert Brouillette (2:41:37) 
October 13th, 2014. Guelph Thanksgiving Day 10K. Robert Brouillette (34:45)
 September 13th, 2014. Wellesley Harvest Half-Marathon. Robert Brouillette (1:15:08) 
October 19th, 2014. Battle of Waterloo 23K (total)- Sean Delanghe (1:18:40)
November 23rd, 2014. Cambridge YMCA Jingle Bell 5K. Robert Brouillette(16:21)
December 13th, 2014.  Santa PurSuit 5K- Sean Delanghe (17:35)


OVERALL RUNNER UPS

February 23rd, 2014.  Re-Fridgee-8er 8K.  Sean Delanghe (27:54)
April 26th, 2014. ENDURrace Combined  13K.  Aron Mailman (49:32)
April 26th, 2014. ENDURrace 8K.  Luke Ehgoetz (29:39)
May 10th, 2014.  Baden 7M. Luke Ehgoetz (43.52)
 July 28th, 2014. Waterloo H+P Summer Time Trial 2.2K.  Robert Brouillette (6:32)
 August 10th, 2014.  ENDURrun Half 21.1K.  Sean Delange (1:16:58)
September 13th, 2014. Wellesley Harvest Half-Marathon.  Brendan Hancock (1:15:39)
September 13th, 2014. Wellesley Harvest 1/4-Marathon. Nick Burt (40:43)
Octobeber 13th, 2014. Oktoberfest 5K.  Chris Goldsworthy (18:00)
October 19th, 2014. Battle of Waterloo 23K (total).  Brendan Hancock (1:20:53)
December 13th, 2014.  Santa PurSuit 5K.  Nick Burt (19:01) 




WOMEN

OVERALL RUNNERS UP

February 23rd, 2014.  Re-Fridgee-8er 8M.  Gillian Willard (55:32)
May 10th, 2014.  Baden 5K.- Kailey Haddock (21:10)
April 26, 2014. ENDURrace 8K.  Jessica Kuepfer (33:12)
May 10th, 2014.  Baden 7M.  Jessica Kuepfer (49:07)



 TRAIL RACING 

MEN


OVERALL WINS

September 6th, 2014. Haliburton Forest 26K. Dave Rutherford (2:23:30)
October 25, 2014.  Horror Hill 10K.  Aaron Mailman (43:01)

OVERALL RUNNERS UP

July 5th, 2014. Creemore Vertical Challenge trail 25K.  Robert Brouillette (1:47:03)
September 13th, 2014. Muppuppy 8K.  Greg Dyce (31:54) 
October 25, 2014.  Horror Hill 25K.  Dave Rutherford (1:49:26)

 
WOMEN

 OVERALL WINS

June 8th, 2014.  Yankee Springs Trail Half. Jessica Kuepfer (1:50:08) 
July 5th, 2014. Creemore Vertical Challenge 25K. Jessica Kuepfer (2:20:20)
October 25th, 2014.  Horror Hill Trail Run 6 hour. Vicki Zandbergen (61.04K)

OVERALL RUNNER UPS

July 5th, 2014. Creemore Vertical Challenge 25K. Vicki Zandbergen (2:20:56)
July 6th, 2014.  Dirty Dash 8K. Vicki Zandbergen (40:57)




ULTRA RACING 

MEN


OVERALL WINS

January 18th, 2014.  Beast of Burden 100M. Steven Parke (17:40:35)
September 20th, 2014. That Dam Hill 12H. Steven Parke (122.047K)

OVERALL RUNNERS UP

Janurary 6th, 2014.  Run4Kids 6 Hr.  Steven Parke (64.64K)
May 24th, 2014.  Sulpher Springs 100M.  Steven Park (18:07)


  WOMEN

 OVERALL WINS

May 7-13th, 2014.  EMU 6 DAY Ultra.  Charlotte Vasarhelyi. (734K- New Canadian Record)
July 26-27th, 2014.  Montour 24 Hour Ultra.  Charlotte Vasarhelyi (170K)
August 2nd, 2014.  Epic 8 Hour Adventure Race. Jessica Kuepfer.

 CYCLING

MEN
 OVERALL WINS

March 23th, 2014.  Runny Nose 34K.  Bill Frier (1:28:22)

OVERALL RUNNER UPS

September 14th, 2014.  Centurtion C50 90K.  Sean Delanghe (2:23:27)


TEAM WINS


February 23rd, 2014.  Re-Fridgee-8er 8M Open (Ahmed, Luke, Aaron, Nick, Gill)
Feburary 23rd, 2014.  Re-Fridgee-8er 8K Open (Sean, Dave, Brendan, Greg, Mike)
April 12th, 2014.  ENDURrace 5K Open (Luke, Mike, Aaron, Holger, Nick)
April 13th, 2014.  Toronto Yonge Street 10K Open (Sean, Rob, Brendan, Ahmed, Jordan)
April 26th, 2014.  ENDURrace Combined (Luke, Aaron, Nick, Vicki, Dan)
April 26th, 2014.  ENDURrace 8K Open (Brendan, Luke, Nick, Aaron, Jessica)
June 15th, 2014.  Waterloo Classic 5K Open (Aaron, Steph, Kailey, Gill, Holger)
June 15th, 2014.  Waterloo Classic 10K Open (Rob,Greg, Ahmed, Chris, Dave)
August 17th, 2014. ENDURrun Relay (Sean, Ahmed, Jordan, Brendan, Greg, Rob, Luke)
October 19th, 2014.  Oktoberfest 5K Open (Ahmed, Jordan, Greg, Dave, Gill)
October 19th, 2014.  Oktoberfest 10K Open (Nick, Aaron, Emily, Sam, Speedy)
December 13th, 2014.  Santa PurSuit 5K Open (Sean, Nick, Aaron Vicki, Mike)




The win is not why we do it.  We do it to enjoy the hunt.  And enjoy it we did.  See ya in 2015 other guys.  The hunt is on!

 #cantwontstop


Monday, 29 December 2014

Princess Health and How the Anechoic Effect Persists: The Case of the Continued Punishment of Dr Elliott . Princessiccia

Princess Health and How the Anechoic Effect Persists: The Case of the Continued Punishment of Dr Elliott . Princessiccia

We have frequently discussed the anechoic effect, how evidence and opinions that challenge the dysfunctional status quo in health care, and that might discomfit those in power in benefit from it, have few echoes.  One major reason for the anechoic effect is that people are afraid to speak up because thus disturbing the powers that be may have bad consequences for the speakers.   

A December 21, 2014 article in the Minneapolis Star-Tribune updated an ongoing example of how the leaders of health care may seek to silence their critics.  The article updated the career trajectory of Dr Carl Elliott, a psychiatrist physician and bioethicist at the University of Minnesota who dared challenge the university's handling of the untimely death of a patient in a university run clinical trial.

Background - the Dan Markingson Case

We first blogged about this case in 2011.  The case itself dates from 2003, and first got media attention in 2008.  A good quick summary appeared in the Center for Law and Bioscience blog out of the Stanford Law School. 
Dan Markingson � a vulnerable, psychotic young man � was forced to choose between enrolling in a Pharma-funded drug study or being involuntarily committed (in other words, locked up).  A UMN [University of Minnesota]  doctor enrolled him in the study despite having just determined that Dan 'lack[ed] the capacity to make decisions regarding [his] treatment,' rendering it highly unlikely that Dan could have given valid informed consent to participate.  As Dan's mother, Mary Weiss, observed his mental condition deteriorating, she repeatedly tried to have Dan removed from the trial � at one point asking  'Do we have to wait until he kills himself or someone else before anyone does anything?'  But the UMN co-investigators in the drug study refused to terminate his participation.  Shortly after Ms. Weiss made her desperate plea, Dan Markingson killed himself by cutting his own throat.
Dr Elliott, an expert in bioethics who had concentrated on issues such as the effect of conflicts of interest and commercial influences on clinical research, started probing the death of Mr Markingson after the 2008 media reports.

Some of what Dr Elliott found appeared in a May 23, 2014 article in Science. He concluded that previous efforts to investigate the death of Mr Markingson were flawed.

 Elliott came to believe that every investigation�not only by FDA but also by the Minnesota Board of Medical Practice, the university's IRB, and its general counsel's office�had been flawed or incomplete. FDA did not seek Weiss's perspective, the views of Markingson's caseworker, or interview staff at the halfway house who had interacted with Markingson, for instance. (FDA would not comment on the Markingson case for this story.) Nor did the agency examine conflicts of interest. Weiss's lawsuit was dismissed not on its merits, but because the university's IRB and Board of Regents were deemed immune from liability thanks their role as state employees. (The judge did argue that informed consent was obtained appropriately, because Markingson had signed the consent form and had not been declared mentally incompetent by a court.)

Furthermore, he found reasons to think that the problems with the trial in which Mr Markingson died were not unique.  He and a colleague

heard from other individuals who insisted that they had been harmed in UMN psychiatric drug trials or had witnessed others' mistreatment. One man said he had worked in the psychiatric units of the hospital where Markingson was treated. Another identified herself as a counselor for teenagers. Elliott heard from parents, who said their son or daughter had enrolled in a study under pressure.

Thus, Dr Elliott and others concluded that the university should do a thorough investigation of the case,

In November 2010, eight faculty members, including Elliott and [McGill University bioethicist Leigh] Turner, wrote a letter to the university's Board of Regents, requesting an independent, university-commissioned investigation into the Markingson case.

The Punishment of a Dissident

As the Science article noted, former Minnesota Governor Arne Carlson said that the

university hired Elliott because it 'found him to be one of America's most outstanding bioethicists. The moment he comes up with something that is sensitive to them, he becomes the village idiot.'

In fact, as we noted in 2013, in a 2012 post in the Center for Law and Bioscience blog, not only did university officials rebuff the call for a new, thorough investigation of the untimely death of Mr Markingson, but the university general counsel, who had been operating at the heart of this case, appeared to threaten the leading bioethicist dissident, Dr Carl Elliott:


 After Carl Elliott, the University of Minnesota bioethicist, refused to drop the matter, [university chief counsel] Rotenberg asked the university�s Academic Freedom and Tenure Committee to take up the question of '[w]hat is the faculty[�s] collective role in addressing factually incorrect attacks on particular university faculty research activities?' � a question that appeared both to accuse Elliott of 'factually incorrect attacks' and to call for some unspecified action to 'address' them.  Other faculty, including the president of the Minnesota chapter of the American Association of University Professors, viewed this as an attempt to intimidate Elliott into silence.  If so, it backfired.  The story ended up in the press, putting the Markingson case back in the public eye and once again making the University of Minnesota look really bad.
The December 21, 2014 Star-Tribune article reported that university administrators seem to be out to get Dr Elliott once again. First, it interviewed the university's chair of psychiatry,

[Dr S Charles] Schulz, the department chair, says he can�t even bear to read Elliott�s published accounts anymore. 'It�s too painful,' he said.

Both he and Olson say that Elliott gives only one side of the story and that he ignores the facts that don�t support his case.

'I think [people] believe that because Carl Elliott is a professor of bioethics and a member of the Center for Bioethics, that he must be telling the truth,' said Olson. But 'he�s not pursuing this in an academic way. I don�t think it�s conduct that becomes a faculty member and a peer.'

What is not academic or unbecoming about investigating the death of a vulnerable psychiatric patient during a clinical trial is not clear. Then,


University officials have not been amused. They accuse Elliott of whipping up hysteria with 'false and unfounded' allegations, and undermining research efforts in the process. And while the university hasn�t tried to fire him, it has reprimanded him for 'unprofessional conduct,' a move that he�s now challenging under the tenure code.

Again, rather than investigating the death of Mr Markingson, or at least responding to specific allegations, university administrators have set about to punish their own distinguished faculty member who wondered why a vulnerable patient died during a university run clinical trial. 

Finally,


So far, academic freedom has protected Elliott�s job. But last winter, the university claims, he crossed a line. It accused him of using a 'fabricated letter' in a speech about the Markingson case at Hamline University and demanded that he issue a retraction.

The 2004 letter, addressed to Weiss, Markingson�s mother, appears to be from a university lawyer disputing her right to her son�s medical records. The U says it�s a forgery; Elliott says he doesn�t believe it, and he refused to issue a retraction. He called it an attempt to discredit Weiss, adding: 'I won�t be part of it.'

Elliott received a letter of reprimand in August from Dr. Brooks Jackson, the current dean of the Medical School, citing him for 'significant acts of unprofessional conduct.' The reprimand is on appeal.

The evidence that the letter was a forgery was not apparent.  Yet while they pursue their own faculty member for his investigation of Mr Markingson's death, university managers still apparently have not addressed the many problems in the university's version of the story of Mr Markingson's death, from the fragmentary nature of previous investigations to the problems just revealed in a Scientific American blog with the knowledge of an expert witness for the university in the lawsuit brought by Mr Markingson's mother against it.  

Summary

Dr Carl Elliott is a respected physician bioethicist who has uncovered problems with commercial contract research organizations doing human research (see our blog posts here and here), and has written a critically acclaimed book, White Coat, Black Hat (reviewed here by Dr Howard Brody on his blog.)  Yet his previous work counted for naught when he dared look into possibly unethical clinical research done at his own university.  As noted in the Star-Tribune article,

Within the U�s Center for Bioethics, where he has worked since 1997, he says the tension is so palpable that he dreads setting foot in his office. He does most of his work from coffee shops.

In my humble opinion, it appears that top university managers have put their personal interests ahead of the mission of their university, the role of their faculty members in upholding that mission, and even the welfare of patients who put their trust in the university's academic medical center.  The hard life that Dr Elliott has lead since he started to challenge his own university's administrators show how the anechoic effect is generated.  As long as leaders of academic medical institutions, and other health care organizations can put their own interests ahead of the mission, health care professionals and other academics who object are likely to have their lives made miserable, possibly lose their jobs, or worse.  How many will have both the courage, and the resources to stand up for what is right under such a threat.

True health care reform would turn leadership of health care organizations over the people who understand and are willing to uphold the mission of health care, and particularly willing to put patients' and the public's health, and the integrity of medical education and research when applicable, ahead of the leaders' personal interests and financial gain.

ADDENDUM (30 December, 2014) - Post corrected.  Dr Elliott trained as a physician but is not a psychiatrist.

ADDENDUM (30 December, 2014) - also see comments on the 1BoringOldMan blog

Friday, 26 December 2014