Sunday, 18 October 2015

Princess Health and 2015 STWM.Princessiccia

While a majority of the team tackled the Oktoberfest 5 and 10Ks, we still had a very quick squad competing at STWM.



Half Marathon
Rankings

Adam had a great performance, running 1:08, good for a new club record and second place OA!

Coach Dyce also had an amazing performance, running a massive new PB of 1:19:51.

Tracy continues to be one of our best masters runners.  She ran a strong 1:39:46, just off her PB.

Val battled injury coming into this race, but still competed hard and finished with a solid 1:40.

Payton had a great debut in the half, running 1:40:27!

Helen Broom achieved an outstanding new PB and one of her fastest races ever with a 1:42:51 finish time.

Kim Chan showed she's staying fit during her work term, coming in with a 1:45.

Kristin achieved a massive new PB, running 1:49, over 3 minutes faster than last year.

Erica Hall ran a strong 2:39.

Marathon
Rankings

Runner Rob was the only H+P athlete in action.  He posted a stellar new PB and club record of 2:37!



Road 2 hope is up next!  If we missed your results, let us know!

#cantwontstop

Princess Health and 2015 Oktoberfest 5K and 10K.Princessiccia



H+P had one of our best races ever, once again PACKED with PBs.  The new course was fast, conditions were even better, and the team took advantage.  Here are the full results:



5K:
Rankings

Brendan came in 1st OA with a massive new PB of 15:34.

Sean came in 2nd OA with a new PB of 15:58.

Graham was in next for the team, running an outstanding 17:47 PB, good for 11th OA, 3rd in his AG and 1st on our masters team.

Dave, the 50-yo all star was in right behind Graham running 17:51 and handily winning his AG.

Mike had a massive PB performance of 17:58, placing 5th for the team and 3rd in his AG.

Kailey had an outstanding PB performance of 18:09, coming in just 1s off the club record, and placed 3rd OA!

Jon Fugelsang crushed a new PB of 18:21, placing 4th in a very competitive AG.

Aidan ran a solid new PB of 18:27 off of next to no training, good enough to win his AG.

Martin Chmiel ran an amazing 18:37, a massive PB and 20 minutes faster than his PB from last year!

Gillian Willard became the 3rd H+P female ever to break 19, running 18:41 and placing second in her AG.

Don MacLeod continues to improve, breaking 20 for the first time with a 19:42 PB.

Sam ran a great new PB of 20:13- that sub-20 is within reach!

Brian Wetzler ran a very solid 20:31, one of his fastest times ever.

Vicki Zandbergen ran a great new PB of 21:16, which brought her in 3rd on our women's team and 1st in her AG.

Manny was right behind VZ with a new PB and masters club record of 21:26; good enough to win her AG as well!

Howie was in right behind with a PB by almost 1 minute, finishing in 21:51.

Dan Nukluski ran a strong 21:37, a new PB!

Jose Perez ran a very solid 22:56 in his H+P debut!

Tracey Kuchma ran an amazing new PB of 22:37, good for 2nd masters overall!

Ed ran a great time of 23:46, one of his better times in recent years.

Mike Hewitson ran a strong 23:47, but out-kicked Ed at the line!

Candice Shrigley had a great showing, finishing in 24:13 - a new PB!

Cari managed to edge out Laura in the Cari vs. Laura challenge, running a solid 24:24 PB.

Kyle continues to be one of our best up-and-coming runners, with a great 24:37 finish.

Laura ran a strong PB of 24:45!

Maddie Hobson ran a solid 25:23, good for 4th in her AG!

Gail Delanghe ran 27:26, good for 1st in her AG.

Will and Derek both enjoyed fun runs/walks as they work their way back into competitive running.

5K Teams
Full Results

The H+P Men's team finished 1st with an average time of 17:19.  This included times from Brendan, Sean, Mike, Aidan and Martin.

The H+P Masters Men's team really had a strong race despite missing some of their best runners.  Their two top runners (Dave and Graham) were in our OA team's top 5.  The next 3 to make up the roster was Jonathan, Don and Harold to give an average time of 19:11.

The H+P women's team was led by two sub-19 minute performances from Kailey and Gill.  Vicki, Cari and Laura also scored for the team, giving them an average pace of 21:29.

The FIRST EVER H+P Masters women's team had a great performance.  Manny lead the squad with a new masters club record.  Tracey, Candice, Gail and Louise made up the rest of the top 5, giving them a 25:35 average pace.  This was fast enough to beat all non-H+P teams, wow!

10K:
Rankings

Nick Burt was in first for the team with a new PB of 35:23, good for 3rd in his AG and 6th OA.

Luke came in right behind Nick with a great new masters club record of 36:12, good for the AG win
and 7th OA!

Andrea had a great 10K PB of 39:42, placing 3rd on the team, 2nd OA for females and winning her AG.  Not bad for just 1 week removed from her 3:07 CR in Chicago!

Craig was in next for the team with a great 41:05, placing 3rd in his AG.

Emily came in next for the team with her 2nd best performance ever, running 41:08 and placing 2nd in her AG.

Val Hobson posted a stellar new maters club record of 41:13, placing 2nd in her AG.

Dragan was in next for the team with a great new PB of 44:36.

Heidi continues to improve as she ran a new PB of 53:51, winning her AG.

10K Teams:
Full Results

H+P had one team in this event, winning with an average time of 38:43.  This team was comprised of Nick, Luke, Andrea, Craig and Emily.  Great work!

Battle of Waterloo:
Updated Results

This is the second stage of 3 in the battle of Waterloo.  Through 10K of competition:
- Sean sit first with a time of 33:09
- Martin sits 4th, just off the podium in 38:38.
- Gill is in 1st OA for females, in 5th OA just 4 seconds back of Martin in 38:42.
- Brian is ninth in 42:43.
- Ed is 11th, 2nd in his AG with a combined time of 48:42
- Candice sits with a time of 50:25, also 2nd in her AG.
- Cari has a time of 51:22, Laura is just behind her with a total time of 51:53!

Up next for the team..... Road 2 Hope and the RememberRun 5/8K!

#cantwontstop

Friday, 16 October 2015

Thursday, 15 October 2015

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

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


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

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