Sunday, 22 November 2015

Princess Health and Fat, Added Fat, and Obesity in America. Princessiccia

Princess Health and Fat, Added Fat, and Obesity in America. Princessiccia

In the last post, we saw that carbohydrate and particularly sugar intake have been declining in the US since 1999, even as our obesity rate has continued to climb.

In this post, let's look at another putative driver of obesity: our fat intake, and especially our intake of added fats like seed oils, butter, and olive oil. Like the graphs in the last post, the data underlying the following graphs come from USDA food disappearance records (not self-reported), and NHANES survey data (1, 2). Also like the last post, the graph of total fat intake is not adjusted for waste (non-eaten food), while the graph of added fat intake is*. As a consequence, the figures for total carbohydrate and total fat intake are higher than actual intakes, but still good for illustrating trends.

Here we go. First, total fat:
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Thursday, 19 November 2015

Princess Health and What Revolving Door?  - An Unprecedented Endorsement of a Political Appointment by the "Gold Standard" Medical  Journal. Princessiccia

Princess Health and What Revolving Door? - An Unprecedented Endorsement of a Political Appointment by the "Gold Standard" Medical Journal. Princessiccia

An Unprecedented Endorsement 

It's deja vu all over again.  In the spring of 2015, the New England Journal, the most prestigious US medical journal, published a remarkable series of opinion pieces extrolling physician-industry collaborations, and minimizing the significance of resulting conflicts of interest.  More remarkable was the extent that the articles' argument were bolstered by logical fallacies (look here).

Doubling down, the New England Journal of Medicine appeared to make its first ever endorsement of a nominee for federal office.  On October 28, 2015, the NEJM published an editorial with the almost campaign slogan like title, "Califf for the FDA," which enthusiastically endorsed the current presidential nominee to be Commissioner of the US Food and Drug Administration (FDA). (1)   It began, [with italics added for emphasis]

Robert M. Califf, M.D., has been nominated to be the next head of the Food and Drug Administration (FDA); he currently serves as Deputy Commissioner for the Office of Medical Products and Tobacco. We think his confirmation as commissioner should proceed as quickly as possible. Because the FDA oversees the safety and, in some spheres, the efficacy of products that constitute about 25% of our economy, the country needs a strong and experienced leader who can keep the FDA focused on its mission.

And the editorial concluded,

Califf's experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpased qualifications for the post of commissioner of the FDA; we strongly endorse his nomination and urge the Senate to act favorably on it. 

I have never seen this journal, known primarily for publishing research and scholarly opinion on medicine and health care, publicly render an opinion about a nomination for a federal position, let alone such an enthusiastic one.  A quick search of the journal revealed that it had taken no position and made no comment about the nominations of the last three US FDA Commissioners, (Dr Margaret Hamburg, Dr Andrew von Eschenbach, Dr Lester Crawford, and Dr Mark McClellan, look here) who were nominated by one Democratic and one Republican President.

Dismissing Concerns about Conflicts of Interest

This fervid endorsement came in the face of some controversy about the nomination, particularly about Dr Califf's previous ties to industry (see this post ).  He has participated in many industry sponsored clinical research projects.  For example, a 2013 JAMA disclosure statement included 13 commercial research sponsors of his work.  It also noted his consultative relationships with 32 commercial firms.  We discovered he also had a "board level" conflict of interest, having been a director of Portola Pharmaceuticals, for which he received over $250,000 in 2014 (see this proxy statement).  He also had been paid for "educational activities" in previous years, possibly including "drug talks," at least per one blogger.  So in my humble opinion, the nomination of Dr Califf could potentially become one of the most significant health care revolving door cases to affect US government.


Such consideration may have influenced Senator Bernie Sanders (I - Vermont), who is currently running for President.  In early October he announced he would oppose the Califf nomination.

Furthermore, since our post but before the publication of the NEJM editorial, there have been new revelations.   Dr Califf twithdrew as authors from several papers that had been accepted for publication, seemingly violating norms for declaring authorship of scholarly works, (see the Boston Globe here).   Dr Califf was revealed to have been a board member of and consultant to Faculty Connection LLC, which advises academic researchers "who want to work with industry" about regulatory submissions (see Intercept.com here)

Yet the Editor of the New England Journal of Medicine dismissed concerns about Dr Califf's industry relationships,

a few concerns have been expressed about his associations with industry, and these concerns may have caused some to withhold support for his nomination.

Like Califf, we believe that our actions should be driven by data, not innuendo. Since 2005, Califf has reported, as an investigator, the outcomes of seven clinical trials sponsored solely by industry in primary publications in major general medical journals. Of these trials, four had a negative outcome (i.e., not favoring the intervention), two favored the intervention, and one, with a factorial design, had a mixed outcome. Given this performance, it is impossible to argue that Califf has a pro-industry bias.

This opinion may yet carry the day.  The New York Times reported that

Dr Robert M Califf ... coasted through a confirmation hearing on Tuesday, with  most members of a Senate committee - including some who have been skeptical about his ties to the pharmaceutical industry - seeming set to support his candidacy.

This occurred despite one more major revelation that appeared since the editorial was published, but before the hearing.  A large pharmaceutical company clinical trial which Dr Califf ran had been criticized as biased in favor of the company's drug by the FDA's own staff and consultants. (see POGO here).  And it occurred despite calls by various organizations for the nomination to be turned down, including by Public Citizen and the AIDS Healthcare Foundation (see Medscape here).

Missing the Main Point

However, the NEJM editorial seemed to miss the main point.  It revolved around the claim that


It is impossible to argue that Califf has a pro-industry bias.

This was based apparently on an informal evaluation by Dr Drazen of seven of Dr Califf's 1200 publications.  So at best this was about the question of pro-industry bias in research publications. 

However, the controversy is about Dr Califf's nomination as the head of the US government agency that oversees the pharmaceutical, device and biotechnology industries, among others, and tries to assure the safety and effectiveness of drugs, biologics and medical devices, among other responsibilities.  The overriding issue is about the risk that his decision making in these capacities could be biased.  The real issue is the revolving door, not bias in research.

As we have repeated very recently, the revolving door can be veiwed as a species of conflict of interest.   Government officials who can look forward to extremely lucrative employment in health care industry may be much more inclined to seem friendly to the industry while in office.  Government officials who were previously paid by industry, and who benefited from financial interactions with industry, are likely to maintain their industry mindset and be mindful of their industry friends.  But the concern here is not that this risks biasing future research.  The risk is that a person who previously enjoyed close ties, including close financial ties to industry is at risk of putting the interests of industry over those of citizens and patients while running a US government agency charged with regulating that industry and protecting the health and safety of those citizens and patients.

Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,
The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
  Dr Drazen's editorial never directly addressed that issue.  It is one that should still be a concern.

Mission-Hostile Management?

Finally, the effect of the Califf nomination on the FDA has generated considerable public comment.  The effect of the New England Journal of Medicine's unprecendented editorial endorsement of the nomination has generated almost no discussion.  Only on the 1BoringOldMan blog was there note of the past industry ties of the current NEJM editor inspired their own controversies, and asked "since when is the editorship of the NEJM a position from which to weigh in on such matters?" (look here).

Using the editorship to so weigh in could not only obfuscate the debate about the nomination.  It could threaten the mission of a proud medical institution. The NEJM claims a

reputation as the 'gold standard' for quality biomedical research and for the best practices in clinical medicine.

It claims its editorials are

thoughtful, carefully reasoned analyses and interpretations [which] help you crystallize your own opinions on current topics and findings

Yet the blanket and unprecedented endorsement of the current FDA nominee appears otherwise.  We have previously argued that the earlier NEJM opinion pieces on conflicts of interest were based on logical fallacies more than "thoughtful, carefully reasoned analyses and interpretation."  In the Editor's apparent haste to defend industry-physician relationships, he risks the reputation and mission of once what was really a gold standard.

 Reference

1.  Drazen JM. Califf for the FDA.  N Engl J Med 2015;  DOI: 10.1056/NEJMe1513828 (link here)  

Wednesday, 18 November 2015

Princess Health and HOW TO HELP YOUR CHILDREN HAVE A POSITIVE BODY IMAGE. Princessiccia

The link between body image and depression, low self-esteem, social anxiety, and eating disorders has been studied as a personal psychological problem for well over fifty years. Because the prevalence of eating disorders and body image based problems have skyrocketed over the last 20 years, the discussion of body image is now being looked at not strictly as a personal psychological problem, but rather an indication of a social problem. This is great news for us parents! As the body image epidemic grows culturally, we can recognize the problem and prevent it from spreading to our own children. But first, we need to recognize it in ourselves, and we need to understand what body image is.
What is body image?
Body image is defined as a person using his or her body to construct a sense of self. The image of who she is becomes psychologically constructed by how she looks, her attractiveness, her sexuality, how her body performs (athletically), or if her body is healthy. In short, body image is used as a gold standard of worth for people who are able-bodied. Are you attractive enough, thin enough, sexy enough, athletic enough, or healthy enough? I like to refer to these as sacred body-righteous standards. They are sacred because they are believed as unquestionable truths, and righteous because the body is used to define the individual morally. If, however, an individual has the misfortune of a disease, a disfigurement, or an accident that leaves her disabled, none of the body image rules apply and the person is free to be and to love herself without condition. But if you are able-bodied, you are held to an incredibly high standard in order to feel good about your body and for it to be approved.
Once an individual internalizes and believes a body-righteous standard is important and required, he is held to the ideal and compared to it in order to define and prove his worth. When he compares himself to the able-bodied gold-standard, the difference between what he believes is ideal and his actual body creates feelings of dissatisfaction and discontent. But if his body matches the ideal he can feel proud, a sense of power, accomplishment, and safety. Either way, someone who uses body image to define his value, sense of worth, or to construct his sense of identity is at high risk for eating disorders, as well as exercise addiction. But again, for all of this to take hold, an image of what the ideal body is must be recognized, understood, and internalized as an unquestionable �sacred� requirement.
The role of media
Corporate-driven media has been a huge contributing factor to the definition of the idealized body image. They use perfected and airbrushed pictures as examples of what should be aspired to. The diet, beauty, and health industries use perfected body images as their main selling point and motivation behind what they are selling. These businesses send a powerful message that beauty, health, fitness, and thinness are the most important measures of life, worth, happiness, control, and success, and the media they use captures the perfected body-righteous standard in such a way that has stigmatized anything other than the ideal. But corporate media only has power if the consumer actually believes the message behind the body image symbol, and that�s where parents have a key role in either contributing to or preventing the problem.
Positive and negative parenting examples
Parents and family can play an important contributing factor when they, too, have internalized, believed, and encouraged these sacred body-righteous standard
s. Most people are aware that making your teen�s weight and diet a focus is an obvious contributor to negative body image and eating disorders. But, they don�t necessarily understand that how parents feel about themselves and how they treat their own bodies can be just as influential.
Parents who openly discuss their �battle with weight,� who openly judge and criticize parts of their body, who publicly talk about their diets, who describe food as �bad/good� or �clean/dirty,� who feel the need to excuse eating, who have to justify what they eat, or who negotiate for food�all of these positively teach moral importance and values of body-righteousness.
Conversely, powerful contributors to poor body image are the parents and people who believe they actually have the power and righteousness of the ideal body that others aspire to have. Many of these people are in the diet, nutrition, health, and fitness industry and they use themselves as the example. They tend to use their ideal body as a measure of their success and have a higher, more righteous standard for themselves and their children.
Children of these �ideal body� parents are often held to a stricter body-righteous standard, have food restricted needlessly, are forced to exercise for fitness, and they often hear their parents criticize, judge, and even shame other people who are fat, unhealthy, or who don�t believe or prioritize the same body-righteousness. The internal family perfectionism without grace inevitably results in their children�s fear of shame and disapproval if their body doesn�t match the family standard. Essentially, these children are held captive by the strict requirement of their parent�s egotistic standard of righteousness.
These parents are more likely to over-criticize their children�s bodies and make them diet out of their own projected fear of being judged for having an overweight child. These children tend to resent their parents, feel bad about who they are, hide food, over-criticize themselves and their body, and, unfortunately, are at a high risk for eating disorders. But this type of body image captivity and fear mongering doesn�t have to come from a parent. It can come from a spouse, friend, significant other, or society.
While parents and families can certainly contribute to the body image problem, they are just as powerful in preventing it as well. When you find a sense of worth that forgives and eliminates body image, you will have more power to teach your children how to do it for themselves.

Tips to encourage a positive body image
What can we do as parents to raise children to have positive relationships with their bodies? Here are a few suggestions that might help.
1. Find a sense of human-worth that is not defined by body image, physical attractiveness, or any cultural ideology.
2. Love and appreciate your body without condition.
3. If the body you are in is alive, it is perfect.
4. Expose the extreme perfectionism used in the media to manipulate our concepts of body image.
5. Expose the body-righteousness and health-righteousness used in the diet industry and body image culture.
6. Recognize that as an able-bodied human, you don�t actually have a problem.
7. Give yourself the freedom to live life as if the ideal body isn�t possible, as if it doesn�t exist and it never will.
8. Exercise for pleasure, not for an image or an illusion of health.
9. Eat a variety of food and eat pleasurably.
10. Do not diet, and do not encourage your children to diet.
11. Do not weigh yourself or measure yourself in front of your children.
12. Do not body-shame others or body-praise others.
13. Do not discuss your judgment of yourself or others in front of your children.
14. Do not make your children�s looks important or worthy of praise/criticism.
15. Eat when you are hungry and avoid excessive fullness, and encourage your family to do the same.
16. Do not judge food morally.
17. Do not food-shame.
18. Give your children the breathing room to express and dress themselves.
19. Take the seriousness out of your own dress code.
20. Get professional help if you believe you or your child struggles with disordered eating or an eating disorder.
By following these tips, you can improve your own healthy body image and serve as a powerful role model to your child.
* * * * * *

Tuesday, 17 November 2015

Princess Health and Health Care Renewal Bloggers in Print on Conflicts of Interest and Health Care Corruption. Princessiccia

Princess Health and Health Care Renewal Bloggers in Print on Conflicts of Interest and Health Care Corruption. Princessiccia

Not to toot our own horn too loudly, but in the last week, Health Care Renewal bloggers have appeared in print three times.

Prevalence of Board Level Conflicts of Interest

We recently posted on a British Medical Journal article on the prevalence of what we originally termed "a new species of conflicts of interest," that is, conflicts of interest involving membership in boards of directors of for-profit health care corporations.  A shortened version of this just appeared as a (not very) "rapid response" in the BMJ here.  (Note though that the official date of the response was October 3.)

The New England Journal Series Calling for Rethinking the Problem of Conflicts of Interest

After the New England Journal of Medicine published an editorial and three commentaries earlier this year suggesting that concerns about conflicts of interest in health care may have been overblown, we pointed out that many of their arguments were supported by logical fallacies.  The Canadian Medical Association Journal has been publishing a series of news articles about the issue.  The latest one, published on November 17, 2015, ended by quoting HCR blogger Roy M Poses MD.

Health Care Corruption

On November 16, 2015, the Corporate Crime Reporter published a front page interview, "Roy Poses on Corruption in American Healthcare,"  The interview is listed here,  and summarized here but the full transcript apparently is not available online, but only in print and via subscription.  (Link to interview updated on 19 November, 2015).  

Monday, 16 November 2015

Princess Health and Carbohydrate, Sugar, and Obesity in America. Princessiccia

Princess Health and Carbohydrate, Sugar, and Obesity in America. Princessiccia

We like explanations that are simple, easy to understand, and explain everything. One example of this is the idea that eating carbohydrate, or sugar, is the primary cause of obesity. This lets us point our finger at something concrete and change our behavior accordingly. And it's true enough that it has practical value. But the world around us often turns out to be more complex than we'd like it to be.

The CDC recently released its latest data on the prevalence of obesity in the US, spanning the years 2013-2014 (1). These data come from its periodic National Health and Nutrition Examination Surveys (NHANES). Contrary to what many of us had hoped for after a slight decline in obesity in the last survey, the prevalence has once again increased. Today, roughly 38 percent of US adults have obesity. As a nation, we're continuing to gain fat, which is extremely concerning.

I decided to examine the relationship between obesity prevalence and our intake of carbohydrate and sugar over the years. The food intake data come from the USDA's Economic Research Service (2). For some reason, the data on carbohydrate don't extend beyond 2010. This probably relates to funding cuts at the USDA*.

Let's have a look at the data for carbohydrate:

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Thursday, 12 November 2015

Princess Health and "Dreaming On" - The Illusions of the Leaders of Large Health Organizations, as Illustrated by Medtronic's Founder. Princessiccia

Princess Health and "Dreaming On" - The Illusions of the Leaders of Large Health Organizations, as Illustrated by Medtronic's Founder. Princessiccia


On Health Care Renewal, we have posted story after story about amazingly well paid leaders of big organizations presiding over amazingly bad organizational behavior (including subversion of mission, conflicts of interest, deception, fraud, kickbacks, various other crimes and outright corruption).  Yet the leaders often seem curiously disconnected from what occurs on their watches, while they are sometimes hailed as "visionaries," and at times exude messianic confidence.

Medtronic's Founder on its Sacred Mission

A recent article appearing in an unexpected place provides an example of leaders' excess confidence in their own righteousness.  In the IEEE (Institute of Electrical and Electronics Engineers) Institute was a commentary by Earl Bakken, the founder of medical device/ biotechnology giant Medtronic, modestly proclaiming the "secrets of corporate success."

Keep in mind that while Mr Bakken founded the company, at age 91, while no longer its leader, he proclaimed, " I stay involved with my company."  As such, he remains proud of its mission statement,

In 1960, when corporate mission statements were rare, I wrote one that has never changed. It remains the company�s guiding principle. There are six tenets, but the first one is the most important: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.

Starting in the 1970s, I met with all new employees, explained our history and mission, and in each of their hands I placed a medallion imprinted with the mission statement. I encouraged them to live by it�at work and at home.
Note that the official mission also includes,

To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service. [ital added]

Apparently, he believes that under the "visionary leadership" and "astute direction" of the current, this mission remains central to the organization.

At Medtronic, we live our mission. It�s the basis for how we behave in relationship to our stakeholders, each other, our communities, and the world. But it also guides our relationships with ourselves. We live the Medtronic Mission every day in truly genuine ways by serving others. I am proud to have a mission that is so deeply woven into the fabric of this company that improves millions of lives throughout the world.

Here�s to dreaming on.

Honesty? Integrity? - the Company's 10 Year Track Record 

I hate to disillusion a 91-year old, but in light of the company's last 10 year track record, as discussed on Health Care Renewal, he does appear to be in a dream world.


Medtronic has provided our blog with lots of material, including some amazing stories about conflicts of interest (starting in 2006, here, here, here, here, here, here, here, here, nad here,) and revolving doors  (here, here, here, and here). 

The company has also made a series of legal settlements of various allegations of infamous behavior, in chronological order...
 
2006

- We discussed detailed and vivid allegations that Medtronic had been paying off doctors starting in 2003.
 - Medtronic subsidiary Sofamor Danek settled for $40 million allegations that it gave kickbacks to doctors in the form of sham consulting fees and lavish trips (look here).

2007

As Bloomberg summarized in 2014,
Medtronic agreed in 2007 to pay about $130 million to settle consumer suits accusing the device maker of hiding defects in its defibrillators.
 2008

- Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link here)

2010

Per the Bloomberg 2014 summary again,
The company agreed to a $268 million settlement of suits in 2010 over allegations that fractured wires in another line of defibrillators caused at least 13 patient deaths.


2011

-  Medtroinic settled for $23.5 million two other federal lawsuits alleging it paid kickbacks to encourage physicians to implant its devices (look here).

2014  

In June, we discussed a settlement Medtronic made of allegations that  Medtronic gave kickbacks (that is, bribes) to doctors to get them to use its cardiac devices.

2015

In April, 2015 we discussed three settlements made by Medtronic:
- Its subsidiary EV3 settled old allegations that it coached hospitals how to overbill the US government for procedures using its products
- The company settled allegations it gave kickbacks to physicians to induce them to use its neuromodulation devices.
- The company settled allegations it lied to the US military about US origins of its devices.

(And by the way, we will not belabor the contrast between the statement's committment to "recognize the personal worth of employees," and the gargantuan payments made to certain employees, that is, the top managers, all who got over $3.5 million in 2014, and the "visionary" CEO, who got over $12 million, look here. )

Summary

Someone needs to wake up Mr Bakken.  He may still believe in the mission statement, and wish that it is central to his company.  However, the track record seems to suggest that the mission statement has been honored often in the breach.

Perhaps the problem is that Mr Bakken is really much more detached from the company he founded than he now admits.  However, I worry that this immensely positive spin suggests that he, like many other health care oragnizational leaders, live in some sort of bubble into which no negative karma is allowed to penetrate.  Thus convinced of their own innate goodness, they can provide no check on continuing manifestations of corporate greed, most likely with the solace of the own fortunes they build up. 

IMHO, we need to break up these huge health care organizations which have become so big that those who run them cannot be in touch with what really goes on.  We need to reestablish the accountablity of leaders, and no longer allow them to get credit for all the good that happens, and dodge responsibility for all the bad.  True health care reform would entirely transform health care leadership, so that it can become well-informed, supportive of the mission, unconflicted, less self-interested, honest, and certainly law abiding.