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Thursday, 15 October 2015

Princess Health and Phooled Again - More Settlements Suggesting Bad Behavior by Big Pharma/ Biotech. Princessiccia

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Once again, here is a roundup of cases showing big multi-national pharmaceutical and biotechnology companies are up to their usual tricks.

Presented in alphabetical order...

Bristol-Myers Squibb Settles Charges of Bribery of Chinese Hospitals.

The best version of this I could find was in USA Today, in early October, 2015,

Pharmaceutical manufacturer Bristol-Myers Squibb has agreed to pay more than $14 million in fines to settle charges that its joint venture in China paid cash and other benefits to state-owned hospitals in exchange for prescription sales, the Securities and Exchange Commission announced Monday.

After its investigation, the SEC found that the New York-based company violated the Foreign Corrupt Practices Act in its dealings with Chinese hospitals and doctors and 'reaped more than $11 million in profits from its misconduct.'

Bristol-Myers Squibb neither admitted nor denied the findings, the SEC said.

The details, such as they were:

Chinese sales representatives at BMS China, the Chinese joint venture that is majority-owned by Bristol-Myers, paid bribes � including cash, jewelry, meals, travel, entertainment, sponsorships and other gifts � to health care providers between 2009 and 2014 to generate more sales. And Bristol-Myers Squibb 'failed to respond effectively to red flags' indicating such practices, the SEC said.

Apparently, some lower level Chinese employees were fired, although it is not clear whether they were involved in bribery, or in whistle-blowing about it, but top company management did not look too hard to see who might have authorized or directed the bad behavior,

Several BMS China employees who were fired by the company made claims that faked invoices, receipts and purchase orders were widely used to bribe health care providers. But Bristol-Myers Squibb did not investigate their claims, the SEC said.

Bristol-Myers Squibb was aware of improper payments as early as 2009, when an internal audit highlighted the problem. But the company was 'slow to remediate gaps in internal controls' over dealing with Chinese health care providers and monitor payments to them, the SEC said.

Needless to say, no one who might have authorized or directed the bad behavior, and who conceivably might have personally gotten bigger bonuses based on the revenue it brought it, suffered any negative consequences. Despite the settlement, of charges of bribery, no less, company public relations produced the usual,

We have resolved this matter with the United States Securities and Exchange Commission, and are committed to the highest standards of business integrity, vigilance and ethics across our organization.

Well then, that clears it up.

I cannot find any information about what BMS allegedly bribed the hospitals to do, and hence can draw no conclusions whether patients may have been harmed by receiving inappropriate medications.

UK Judge Found Pfizer Threatened Health Professionals

The most thorough coverage of this was, amazingly, in a medical journal, namely the British Medical Journal (Kmietowicz A. Pfizer loses UK patent for blockbuster pain drug after threats to doctors.  Brit Med J 2015; 351: h4918.  Link here.)  The background was,

The patent for the use of Lyrica for epilepsy and generalised anxiety disorder expired in July 2014, and manufacturers of generic versions already have licences for these two indications. But the manufacturer, Warner-Lambert (a subsidiary of Pfizer), holds a 'second medical use' patent for the use of pregabalin to treat peripheral and central neuropathic pain, which expires in July 2017. A second medical use patent is one that relates to a new medical use for a known compound.

Lyrica is one of Pfizer�s most successful products, with global sales in 2013 of some $4.6bn (�3bn; �4.1bn).

So apparently Pfizer set out to scare physicians away from prescribing generic pregabalin [generic Lyrica].

In his 174 page ruling Mr Justice Arnold said, 'Since late September 2014, Pfizer has taken extensive steps to try to ensure that generic pregabalin is neither prescribed nor dispensed for the treatment of pain.' This included sending a letter to the BMA and pharmacists stating that doctors and pharmacists risked infringing the patent if they supplied generic pregabalin for the pain indication and that this would be an unlawful act.

A letter sent to clinical commissioning groups in December 2014 was described by Arnold as 'calculated to have a chilling effect on the sales of Lecaent [the version of pregabalin made by Actavis].'

These letters would be seen by the recipients as a threat, said Mr Justice Arnold.

The Justice ultimately "overturned Pfizer's UK patent for pregabalin for pain control," in part because the "company made 'groundless claims' that its patent for Lyrica would be infringed if doctors did not specify Lyrica as opposed to a generic alternative when prescribing...."

This case was apparently only about the patent (and is subject to appeal), so it appears no one who apparently tried to authorize, direct or implement apparent intimidation of health care professionals with "groundless threats" will suffer any negative consequences.

This case does not seem to involve any obvious harms to patients.  However, "groundless threats" to health care professionals could have obviously demoralized them and clearly challenged their autonomy and professional values.

Sanofi Again Settles Charges of Misbranding Seprafilm

We discussed the first civil settlement the company made of this case in 2014 here.  A relatively clear summary of the new settlement was given by Reuters in September, 2015.

Genzyme Corp agreed to pay $32.59 million, admit wrongdoing and enter a deferred prosecution agreement to resolve U.S. criminal charges over its marketing of the surgical implant Seprafilm, the Department of Justice said on Thursday.

The biotechnology unit of French drug company Sanofi SA (SASY.PA) was accused of two misdemeanor counts of violating the federal Food, Drug and Cosmetic Act from 2005 to 2010 by allowing Seprafilm to be adulterated and misbranded while being sold. Sanofi bought Genzyme in 2011.

Seprafilm is a clear film used to reduce abnormal internal scarring that can cause organs and tissues to stick together following pelvic and abdominal surgeries known as laparotomies.

But the Justice Department said some sales representatives taught surgeons how to turn Seprafilm into a 'slurry' for use in increasingly popular laparoscopic surgery, even though U.S. regulators had never approved the film for that use.

According to papers filed with the federal court in Tampa, Florida, Genzyme admitted and accepted responsibility for the facts underlying the two criminal counts.

The two-year deferred prosecution agreement calls for improved oversight, and steps to halt Seprafilm sales for off-label uses. If Genzyme complies, the government will dismiss the charges.

Note that at least in this case, there was some admission by the company of the truth of the facts charged, and no protestation that "we adhere to the highest standards of integrity," or some such.

It seems possible that the use of the Seprafilm slurry in patients without clear evidence of its safety or effectiveness may have lead to patient harms, but I cannot find clear discussion of this.

Summary

So while big health care corporations, especially large drug and biotechnology companies, are always protesting how their main goal is to benefit patients, and how they support health care professionals, here are more cases in which it appears they at best set out to manipulate patients and health care professionals to maximize revenue.

Note that this is hardly the first time any of these companies have apparently misbehaved.  See our previous posts on BMS, on Genzyme (now a Sanofi subsidiary), and on Pfizer.  Note that our last discussion of the ever troubled Pfizer was only one month ago.

We have discussed endlessly how the march of legal settlements and other legal rulings affecting big health care corporations has raised questions about whether they are in it for patients and health care professionals, or just for the money.  That almost none of these legal actions has resulted in any real consequences for the individuals within the corporations who profited most from the misbehavior has allowed health care corporate managers' continued impunity, and has suggested how cozy health care corporate managers and goverment regulators and law enforcement officials have become, partially through the mechanism of the revolving door.

While these latest three cases have appeared, the mainstream media have begun to feature more discussion about how widespread managerial and corporate misbehavior is fueling the decline of the global economy, and perhaps of global society.  For example, as discussed in srticles in The Guardian, and more recently in the New York Times, Nobel Prize winners Robert Shiller and George Akerlof's new book, Phishing for Pfools: The Economics of Manipulation and Deception, suggests that widespread bad behavior in supposedly "free," and mainly unregulated markets can cause all sorts of evil.  In the Guardian, Shiller used the examples of how

 Most of us have suffered 'phishing': unwanted emails and phone calls designed to defraud us.  A 'phool' is anyone who does not fully comprehend the ubiquity of fishing.  A phool sees isolated examples of phishing, but does not appreciate the extent of professionalism devoted to it, nor how deeply this professionalism affects lives.  Sadly, a lot of us have been phools - including Akerlof and me, which is why we wrote this book

As Shiller wrote in the NYT, while he is a "free market advocate,"

we both believe that standard economic theory is typically overenthusiastic about unregulated free markets. It usually ignores the fact that, given normal human weaknesses, an unregulated competitive economy will inevitably spawn an immense amount of manipulation and deception.

Shiller and Akerlof believe that various kinds of manipulation and deception are enabled by technological advances, and that they are contagious,

When you realize that your competitor has used sophisticated and effective marketing tricks, then you will fall behind if you don�t follow suit.

This is really not a new idea,

In 1918, Irving Fisher, the Yale economist, argued that what people maximize in their actions is something that could better be described as 'wantability' rather than utility, for they are subject to temptation and mistakes in the vast array of purchases they make, leading profit-maximizing marketers to take advantage of them on a systematic basis.

In the first half of the 20th century, such critiques were of general interest. But they are little discussed today.

In the Guardian, Shiller warned that failure to address this problem in the financial sector could lead to "a new Dark Age." I fear that we are already close to a dark age for health care.

Similarly, in the Wall Street Journal, of all places, Charles Moore, the authorized biographer of Margaret Thatcher, and former editor of the conservative UK Daily Telegraph, wrote:

The relationship between money and morality, on which the middle-class order depends, has been seriously compromised over the past decade.  Which means that the mass bourgeoisie (a phrase that Marx and Engles would have thought a contradiction in terms) start to feel like the new proletariat.

Furthermore,

To the extent that people cheat in markets, they are not real markets, any more than antifreeze labeled 'wine' is real wine.  Too many advocates of markets have allowed themselves to be suborned into becoming apologists for business.  And too many businesses now operate as if their responsibilities are only to themselves and not to consumers.

See the above examples, and all we have written about bribery, kick-backs, fraud, other crime, and corruption to show how prevalent cheating is in health care.

Shiller concluded,

Marx did have an insight about the disproportionate power of the ownership of capital. The owner of capital decides where money goes, whereas the people who sell only their labor lack that power. This makes it hard for society to be shaped in their interests. In recent years, that disproportion has reached destructive levels, so if we don�t want to be a Marxist society, we need to put it right.

I would add that if we do not put these things right in health care, ending up with a Marxist system will be the least of our worries.

So as a start, to quote Shiller, we need more

heroic effortsw of campaigners for better values, both among private organizations and advocates of government regulation

Who will step up?

Our musical diversion, "Won't Get Fooled Again," the Who, 1978 live version:


Wednesday, 14 October 2015

Princess Health and Oktoberfest Rosters.Princessiccia

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The 2015 Oktoberfest 5 and 10K is almost upon us.  Last year we had a blast with the Sean vs. Gill challenge, where we had 5 separate runners break 17mins in the 5K for the first time as a team!  We are sending a competitive roster to STWM on the same day this year, but we are still fielding one of our largest teams ever to take advantage of this new and faster-than-ever course.  Here is how our teams shape up:


Health and Performance (10K)
Emily Hunter
Nick Burt
Luke Ehgoetz
Valery Hobson
Dragan Zubac
Andrea Sweny
Paul Gonsalves
Craig Kingston

H+P Women
Gillian Willard
Vicki Zandbergen
Kailey Haddock
Laura Hewitson
Cari Rastas Howard
Maddie Hobson

H+P Masters Women
Manuela Jones
Heidi Engelhardt
Candice Shrigley
Gail Delanghe
Tracey Kuchma
Louise Martin

H+P Men
Sean Delanghe
Mike Piazza
Brendan Hancock
Martin Chmiel
Aidan Rutherford
Brian Wetzler
Michael Hewitson
Kyle MacKenzie
Tim De Visser
Sam Lalonde
William Spaetzel

H+P Masters Men
Jonathan Fugelsang
Graham Dunn
Don Macleod
Jan De Visser
Dave Rutherford
Harold O'Krafka
Ed Shrigley
Jeff Martin

Here we go!
#cantwonstop

Thursday, 8 October 2015

Princess Health and Will You Fill Out This Paleo Diet Survey?. Princessiccia

Princess Health and Will You Fill Out This Paleo Diet Survey?. Princessiccia

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This week, I received an e-mail from a graduate student at Humboldt State University named May Pati�o.  She asked me to share her online research survey targeted to Paleo dieters.  Here are the goals of her research, in her words:
The main objective of my study is exploring how the Paleo diet is being implemented in practice.  I would like to assess the health outcomes of these practices, as well evaluate how closely they conform to, or deviate from ways this diet is being described in theoretical literature, and implemented in controlled diet trials. I also want to be able to use the data collected to help explain what is driving the popularity of the ancestral health movement. Ultimately, I would like this information to be used to better inform protocols for controlled diet trails.
The survey took me about 40 minutes to complete.  You're welcome to participate whether or not you're on the Paleo diet.  Please consider taking the survey, for the love of science!

Research Survey: The Paleo Diet in the US

Tuesday, 6 October 2015

Princess Health and H+P on Strava.Princessiccia

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H+P is all about finding new ways to keep training fun.  Sure, it's easy to go hard during our team workouts, but what about finding reasons to get in those off day runs?  WELL, Sam Lalonde, our data specialist has done a great job of making fun challenges based on Strava, and tracking it on our stats page.

Looking to get in on the fun?  Here are your options!

Top 80


The Strava Top 40 and Next 40 are a list of the top 80 most frequently attempted segments.  Some segments have been omitted due to safety reasons (crossing busy roads) and consistency (i.e. GPS watches can't handle tracks).

Our goal is simple:  To own both the female and male course record in these 80 most visited segments.  We want work together and use our numbers to take down non-H+P segments.  Find one you can get, and go for it!  H+P on H+P violence is not the priority, although attacking and defending CRs is not prohibited.

Long story short, don't hurt yourself, have some off day fun, and let's work together as a team to own these 80 and to keep the fitness rolling when not at practice!

Conquests


Not looking to hammer on your off day (probably smart), but simply want a reason to run more at an easy pace?  The conquests feature is for you!  This one is simple: complete as many of the Top 80 segments as possible.  Runners are ranked based on total # completed. When tied, average speed for each segment is the tie breaker.  Can YOU run all 80?

That's it, happy off day running team!

#cantwontstop
Princess Health and Fatal Fraud? - More Settlements by Commercial Hospices of Allegations They Enrolled Non-Terminal Patients . Princessiccia

Princess Health and Fatal Fraud? - More Settlements by Commercial Hospices of Allegations They Enrolled Non-Terminal Patients . Princessiccia

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Introduction - Commercialized Hospices

We have occasionally written about the rise of the commercialized hospice industry, and concerns that commercialized hospices may not be providing the compassionate care they promise.  As we have discussed before, the hospice movement began with small, non-profit, community based organizations meant to provide compassionate palliative care to the terminally ill.  However, in the US, the hospice movement has been co-opted by commercial hospices, often run by large corporations, which may put profit ahead of compassion.

In the Washington Post series "Aging in America," Peter Whoriskey explored problems affecting the contemporary "industrialized" model of hospice.  He noted in August, 2014,

The hospice industry in the United States is booming and for good reason, many experts say. Hospice care can offer terminally ill patients a far better way to live out their dying days, and many vouch for its value.

In the US, hospice care is funded by Medicare, and the funding at times may seem generous. As more hospices are taken over by for-profit corporations, that money may be irresistible. Whoriskey noted,

But the boom has been accompanied by what appears to be a surge in hospices enrolling patients who aren�t close to death, and at least in some cases, this practice can expose the patients to the more powerful pain-killers that are routinely used by hospice providers.

Whoriskey presented a case in which a non-terminally ill patient was admitted to hospice, and died possibly due to aggressive use of narcotics.

Clinard 'Bud' Coffey, 77, a retired corrections officer, did the crossword in The Charlotte Observer after breakfast every morning, pursued his hobby of drawing cartoons, talked seven or eight times a day to his son Jeff and, just two weeks before his death, told a pal that he still felt 'like a teenager.'

He did, however, have some chronic back pain, and in late March he was enrolled in hospice care 'essentially for pain management,' his doctor said. Over a two week period, he received rising doses of morphine and other powerful drugs, grew sleepy and disoriented, and stopped breathing, dying peacefully at home, according to his family and medical records they provided.

While hospices tend to use very aggressive pain management strategies, they also by design do not attempt to cure patients who develop new acute problems. So if a non-terminally ill patient enters hospice, such a new acute problem could be fatal. For example, we discussed a case in which a person admitted to a commercial hospice for "debility" but apparently not defined terminal illness, died from untreated sepsis. It is possible that timely use of antibiotics could have contained her initial infection, or possibly even cured her sepsis.

Yet evidence continues to accumulate that modern industrialized hospices, especially those owned and run by large for-profit corporations, may enroll patients who are not terminally ill to increase revenue. The regulatory response to such behavior continues to be spotty, and seems focused on enrollment of non-terminal patients as a form of fraud, not as a danger to patients.

So far in 2015 two commercial hospice chains settled charges that they enrolled patients who were not terminally ill.

Good Shepherd Hospice

Early in 2015, there was very abbreviated news coverage of the settlement made by Good Shepherd Hospice. A Department of Justice press release noted,

Today, Good Shepherd Hospice Inc., Good Shepherd Hospice of Mid America Inc., Good Shepherd Hospice, Wichita, L.L.C., Good Shepherd Hospice, Springfield, L.L.C., and Good Shepherd Hospice � Dallas L.L.C. (collectively Good Shepherd) agreed to pay $4 million to resolve allegations that Good Shepherd submitted false claims for hospice patients who were not terminally ill. Good Shepherd is a for-profit hospice headquartered in Oklahoma City which provides hospice services in Oklahoma, Missouri, Kansas and Texas.

The press release specifically stated,

The government alleged that Good Shepherd knowingly submitted or caused the submission of false claims for hospice care for patients who were not terminally ill. Specifically, the United States contended that Good Shepherd engaged in certain business practices that contributed to claims being submitted for patients who did not have a terminal prognosis of six months or less, by pressuring staff to meet admissions and census targets and paying bonuses to staff, including hospice marketers, admissions nurses and executive directors, based on the number of patients enrolled. The United States further alleged that Good Shepherd hired medical directors based on their ability to refer patients, focusing particularly on medical directors with ties to nursing homes, which were seen as an easy source of patient referrals. The United States also alleged that Good Shepherd failed to properly train staff on the hospice eligibility criteria.

However, it suggested that the behavior was fraudulent, not dangerous,

'Health care fraud puts profits above patients, and steals from taxpayers,' said U.S. Attorney Tammy Dickinson of the Western District of Missouri. 'In this case, company whistleblowers alleged that patients received unnecessary hospice care while Good Shepherd engaged in illicit business practices to enrich itself at the public�s expense.'

Note that as is usual in cases of health care fraud, Good Shepherd Hospice did not admit wrongdoing, and no individual who authorized, directed or implemented the alleged bad behavior suffered any negative consequences. The minimal media coverage of this case did not discuss the possibility of any risks to patients. (For example, look here.)

Good Shepherd Hospice is part of a for-profit corporation. I could find nothing about its ownership, who its leaders are, or its financial status.  So who particularly benefited from the alleged behavior was not clear.

Guardian Hospice and AccentCare, Owned by Oak Hill Capital Partners

In early October, 2015, a brief news item in the Atlanta Journal Constitution described the settlement by Guardian Hospice.

A Georgia hospice company has agreed to pay $3 million to resolve allegations it billed taxpayers for patients who were not terminally ill,...

In particular,

Guardian Hospice set aggressive targets to recruit and enroll patients it knew were not in the last months of their lives so it could collect Medicare payments, the federal government alleged.

The article noted the settlement arose from a whistle-blower law suit, and that the whistle-blowers

alleged they routinely saw non-terminal patients being treated but were told it was necessary to keep the hospice�s 'census' up,...

The AJC article did quote their attorney as saying,

the practice was 'doubly cruel' because when unqualified patients are put on hospice, they are forced to forego regular medical care that could help cure their illness.

But it provided no further detail. The official news release only quoted an agent of the Department of Health and Human Services (DHHS) Inspector-General's office:

Hospice care is only medically appropriate � and reimbursed by Medicare � for terminally ill patients who are in the last months of their lives

Again, there were no admissions of culpabality, and no actions taken against any individuals.

The $3 million penalty seems paltry, given that we do know something about the owners of Guardian Hospice and the depth of their pockets.  One brief news article about a June, 2015, settlement made by Guardian Hospice for underpaying its nurses, did mention that Guardian Hospice is owned by AccentCare.  A little more digging found this press release from 2010 made by Oak Hill Capital Partners, a large private equity firm.

Oak Hill Capital Partners announced today that following the closing of their acquisition of AccentCare, Inc. ('AccentCare'), a premier provider of home healthcare services, including nursing and attendant care services, they intend to combine it with Guardian Home Care Holdings, Inc. ('Guardian'), a leading homecare and hospice service provider in the Tennessee, Georgia and Texas markets. The terms of the transaction were not disclosed.

The combination of AccentCare and Guardian creates one of the largest operators in the industry, with an expanded geographical footprint and highly diversified service offerings. The new company will operate over 130 branches across 10 states, serving more than 30,000 patients.

Since private equity firms have minimal reporting requirements, we do not know who owns Oak Hill Capital Partners, and hence who owns AccentCare and Guardian Hospice. We do know from the Oak Hill Capital Partners web-site that their portfolio is prodigious.

Summary and Discussion

There are more cases being reported in which hospices, particularly those owned and run by for-profit corporations, have enrolled patients who were not terminally ill.  These enrollments may be motivated by the desire for more money, but they put patients at risk.  Hospice patients may receive large doses of psychoactive drugs and narcotics, which may lead to adverse effects up to and including death.  Hospice patients may not, however, receive treatments for new acute problems, even if those problems are potentially curable.  Therefore, hospice patients may die from untreated infections that otherwise might respond to antibiotics.  Aggressive pain medication and withholding treatment of infections make sense as part of palliative care for terminally ill patients, e.g., those with terminal cancer.  But they make no sense for patients with longer life expectancy.

Nonetheless, such abuses by hospices get little press coverage, seemingly are ignored by health care regulators and law enforcement, and are almost completely anechoic in the health care, medical and health policy literature.

If a measure of society is how it cares for the most vulnerable patients, the US laissez faire approach to for-profit hospices suggests a society in decline.

To repeat what I wrote the last time for-profit hospices were (barely) in the news for enrolling the wrong patients,...

 In my humble opinion, we should return control of direct patient care, especially of the most vulnerable patients, to health care professionals and if necessary small non-profit community organizations.  We ought to give strong consideration to banning corporate hospices, and banning all forms of the corporate practice of medicine and corporate health care "delivery."

Given how many insiders make so much money from the current version of laissez faire capitalism in health care, however, I would expect strong resistance should such apparently "radical," but actually conservative proposals actually get any mainstream attention.    

Monday, 5 October 2015

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