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Lorcaserin: the Latest FDA-approved Obesity Drug

The FDA recently approved a new drug called lorcaserin (brand name Belviq) for the treatment of obesity.  Lorcaserin causes an average of 13 lbs (5.8 kg) of weight loss over a year, compared to 5 lbs (2.2 kg) for placebo (1), which is less than the other recently approved drug Qsymia (formerly Qnexa; topiramate/phentermine).

Learning about obesity drugs is always a good opportunity to gain insight into the mechanisms that underlie the development and reversal of obesity.  If you've been following this blog for a while, you already have a pretty good guess what organ this new drug acts on.  Make your guess and read on!

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Private Equity, Obfuscatory Advertising, and Making Health Care a Commodity: Lessons from Cerberus Capital Management

The use of advertising by Steward Health Care, currently a regional hospital system here in New England, continues to provide lessons about how public relations and marketing may be used to shape the health care policy debate.  Stand by because the story is convoluted.

Steward Promotes "New Health Care," Whatever That May Be

This week, Commonwealth reported on Steward's latest high profile advertising campaign in the Boston area,

Steward Health Care is using the Olympics to hone its image. The Boston-based chain of 10 community hospitals, many of which were on the verge of going under when Steward acquired them, is running a series of ads on WHDH-TV (Channel 7) during Olympics coverage that cast the company as a delivery system for a new type of world-class health care.

While visible, the advertisements are notably vague. One features

a Steward employee who says she believes 'world class health care is here.' Another of the initial ads features individual doctors and technicians pledging to be stewards of 'the new health care,' which is the tagline for all of the Steward ads.

What the 'new health care' means is never fully explained in the ads

One local health care expert

Paul Levy, the former CEO of Beth Israel Deaconness Medical Center, said he thinks the ads are part of a campaign by [Steward Health Care owner] Cerberus [Capital Management] to make Steward more attractive to would-be buyers. 'This has very little to do with anything other than establishing the image and the brand of the Steward hospitals so when the day comes when Cerberus sells the company it will be better received in the public markets,' Levy said.

The article had noted that

Cerberus Capital Management, a New York private equity firm, owns Steward,...

So it is possible that no one at Steward really has any idea what sort of "new health care" the organization is promoting

Steward's CEO Promotes Health Care as a Commodity

However, there is reason to think that the top leadership of Steward, and probably of Cerberus Capital Management, the private equity group that owns it, actually does have a clear idea what new health care they are promoting.

Almost simultaneous with the Commonwealth article and the Olympic advertising campaign an interview appeared with Steward's CEO in Fortune. CEO Dr Ralph de la Torre first pitched medicine as science,

A lot of us physicians went into medicine because we loved the art aspect of it. There wasn't a lot of real hard-core science when many of today's doctors went into medicine. It was your intuition, your abilities, the gestalt of what was going on. But something happened in medicine along the way. It started becoming a real science, and a lot of studies have come out that guide what we do and how we do it. We as a society need to understand that science has to guide our practice of medicine. Not everyone with a headache needs a CAT scan; not everybody with a sprained ankle needs an MRI.

This sounds like it could be an affirmation of evidence-based medicine, the approach that attempts to base medicine on systematic search for and critical review of the best clinical research, among other things. However, De la Torre takes it a big step further, citing:

In deference to those who love the individual hospital, you have to look back at America and the trends in industries that have gone from being art to science, to being commodities. Health care is becoming a commodity. The car industry started off as an art, people hand-shaping the bodies, hand-building the engines. As it became a commodity and was all about making cars accessible to everybody, it became more about standardization. It's not different from the banking industry and other industries as they've matured. Health care is finally maturing as an industry, and part of that maturation process is consolidation. It's getting economies of scale and in many ways making it a commodity.

Apparently Dr De la Torre does not see a distinction any longer between health care, or to use an old-fashioned word, medicine, traditionally considered an art or practice of caring for individual patients, and making automobiles on an assembly line. Dr De la Torre may be deeply misinterpreting evidence-based medicine, which is about evidence from clinical research, but also much more. Consider how the Cochrane Collaboration discusses it:

Evidence-based health care

Evidence-based health care is the conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors [1].

Evidence-based clinical practice is an approach to decision-making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best [2].

Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research [3].

[1] Cochrane AL. Effectiveness and Efficiency : Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972. Reprinted in 1989 in association with the BMJ. Reprinted in 1999 for Nuffield Trust by the Royal Society of Medicine Press, London, ISBN 1-85315-394-X.[2] Gray JAM. 1997. Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone.
[3] Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. 1996. Evidence based medicine: what it is and what it isn't. BMJ 312: 71–2 [3] [Full text]

Note the emphasis on making decisions for individuals based on what is best for each, and the integration of evidence from clinical research with clinical expertise. This is far from commoditization.

Nonetheless, Dr De la Torre seems to envision "new health care" like a 1930s automobile assembly line, with the physicians and other health professionals cast as assembly line workers, and the patients cast as automobiles.

Our next example may provide some explanations for this point of view.

Steward's Advertising Raises Questions of Whose Hands Should be on Health Care

As we discussed earlier, Steward Health Care has been working on acquiring a struggling local Rhode Island hospital system, and in doing so is in a dispute with the statewide non-profit Blue Cross health insurance company. Steward had been putting daily full-page advertisements in the local paper. A recent version (27 July, 2012), had this text:

RHODE ISLAND TO BLUE CROSS:
GET YOUR HANDS OFF OUR HOSPITALS

With 80% of the market under its control, Blue Cross & Blue Shield of Rhode Island thinks it can decide which hospitals survive or fail. The people of Rhode Island beg to differ.

For the past decade, they've watched Blue Cross starve Landmark Medical Center of its funding. And this year, when Blue Cross issued an ultimatum to terminate the hospital, Rhode Islanders heard enough.

In a poll conducted this week by John Marttila, a nationally recognized leader on public attitudes concerning health care, 76% of respondents said that Blue Cross shouldn't be allowed to use their monopoly to dictate the fate of Rhode Island hospitals. They also felt, by a 2-1 margin, that if Landmark did indeed close, Blue Cross would be to blame.

However, soon after, investigative reporting by the Providence Journal's Ms Felice Freyer revealed that maybe the poll should have been interpreted differently. Not unexpectedly, Ms Freyer revealed the poll to have been "commissioned by Steward." Its basic results were really:

Just over half the respondents knew that Landmark was being sold to Steward, and of those, 58 percent did not have an opinion, 29 percent supported the sale, and 13 percent opposed it. However, among those who knew about the sale and also live in northern Rhode Island, the approval rating was higher –– 37 percent support the sale, with 15 percent disapproving and 48 percent having no opinion.

The pollster than provided prompting, perhaps in an attempt to get results more favorable to its client:

One of the questions starts with this statement: 'Blue Cross Blue Shield provides health insurance to 80 percent of Rhode Island. By refusing to negotiate on reimbursement rates, Blue Cross can essentially determine if hospitals in the state stay open or if hospitals close.' Based on that statement, 76 percent of respondents agreed that 'Blue Cross should not be allowed to use its monopoly to dictate which hospitals stay open and which close their doors.'

Unfortunately, it appears that the prompting statement was perhaps not fully accurate:

In 2011, Blue Cross covered 66 percent of Rhode Islanders with private health insurance, not 80 percent, according to a report by the Office of the Health Insurance Commissioner.

Blue Cross denies that it has refused to negotiate.

'We have negotiated in good faith and have offered a fair contract to Landmark Hospital that is consistent with our reimbursement arrangements for other independent hospitals,' Blue Cross said in a statement. 'Unfortunately, Steward has been unwilling to enter into a contract under those conditions.'

While they touted probably methodologically biased survey results, Steward's local advertising campaign's headline might prompt some people to think about whose hands should really be on their health care. The advertising tries to limit this question to Blue Cross' influence. However, one might also ask whose hands control Steward Health Care?

Whose Hands are on Steward Health Care?

As the Commonwealth article above pointed out, Steward Health Care is a wholly owned subsidiary of Cerberus Capital Management, a New York based private equity firm.

Cerberus' top leadership includes
- CEO Steven A Feinberg, who, as we noted previously, was listed as number 21 on a list of the 25 most powerful businessmen in 2007 by Fortune, at that time running through Cerberus 50 companies with total revenues of $120 billion.  On Wikipedia, his net worth was estimated as $2 billion in 2008.
- Chairman John W Snow, who, as we noted previously, resigned as Treasury Secretary in the administration of President George W Bush "in 2006 only because it was revealed that he had not paid any taxes on $24 million in income from CSX, which had forgiven Snow's repayment of a gigantic loan that the company had made to him," according to Chareles Ferguson in Predator Nation.
- Chairman, Cereberus Global Investments J Danforth Quayle, the controversial former US Vice President during the George H W Bush administration.

Furthermore, Cerberus Capital Management, which wholly owns Steward Health Care, owns several other businesses.  As we noted here, these include, DynCorp (see their web-site), which has been called one of the "leading mercenary firms," by an article in the Nation.  As reported by Bloomberg, DynCorp, and hence indirectly about Cerberus, and Steward Health Care, in 2011 settled accusations that it overbilled the US government for construction work in Iraq.   Furthermore, as we noted here, Cerberus also owns the biggest manufacturer of firearms and ammunition in the US. As reported by BusinessWeek in 2010, Cerberus owns 13 brands of fire-arms and munitions under the umbrella Freedom Group.

So while Cerberus Capital Management would like us to believe that Rhode Island residents question the hands of Blue Cross Blue Shield of Rhode Island on a struggling local hospital system, it seems to be trying to avoid questions about whose hands would be on the hospital system were Cerberus Capital Management's subsidiary Steward Health Care to acquire it. 

Summary

So, to recapitulate this winding story....   A regional hospital system has been pushing its "new health care" idea.  However, its former surgeon CEO promotes new health care as commoditized health care, assembly line health care, in which doctors become assembly line workers and patients become widgets.  This seems bizarre until one realizes that the CEO actually works for a huge private equity firm whose goal is to make a lot of money in the short-term.  Standardized, commoditized health care is likely to be cheaper to provide than individualized health care.  Private equity firms thrive by cutting their subsidiaries' costs, and then selling them quickly, sometimes before the long-term consequences of these cuts become apparent.  (Look here.)

So there are two lessons.

To repeat the lesson from our earlier post, everybody, doctors, other health care professionals, health policy makers, patients, and the public ought to be extremely skeptical of the marketing and public relations efforts of big health care organizations.  Based on the examples above, they ought to be particularly skeptical of organizations that are overtly for profit, and/or have a clear focus on short-term revenue generation.  As a society we need to think about how to best counter these biased, incomplete, sometimes grossly deceptive efforts to manipulate public psychology and opinions through our rights to free speech and a free press.

To add a lesson, everybody, doctors, other health professionals, health policy makers, patients and the public ought to be extremely wary of the ongoing corporatization of medicine and health care.  Corporate leaders who often get large incentives for maximizing short term revenue are likely to be enthused about turning our health care into a commodity.  Doctors and health care professionals should not want to be assembly line workers, and patients surely should not want to be widgets. 

Two Great Quotes About Obesity (technical)

By Dr. Hans-Rudolf Berthoud, from a recent paper, "The Neurobiology of Food Intake in an Obesogenic Environment" (1).  I came across it because it cites my review paper (2).  My perspective on obesity is similar to his.  From the abstract:

The modern lifestyle with its drastic changes in the way we eat and move puts pressure on the homoeostatic system responsible for the regulation of body weight, which has led to an increase in overweight and obesity. The power of food cues targeting susceptible emotions and cognitive brain functions, particularly of children and adolescents, is increasingly exploited by modern neuromarketing tools. Increased intake of energy-dense foods high in fat and sugar is not only adding more energy, but may also corrupt neural functions of brain systems involved in nutrient sensing as well as in hedonic, motivational and cognitive processing.

And a nice one from the conclusions:
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Fitness Bucket List

By Stephanie of Infinite Life Fitness

When talking with clients, the first and main reason they want to get healthier and fit is so that they can look and feel good. There is NOTHING wrong with that…BUT why not set some other goals to go along with that?

I encourage people to create a “Fitness Bucket List”. This list is fitness and health tasks that they would like to work towards completing.

For example: Run a marathon (this can include a 5K or 10K or any other types of marathons that can be offered). Some people want to be a part of these kinds of competitions so they have something to work towards when they are in the gym. Working to complete a race like this is great motivation! Being able to train and set a time you would like to finish allows you to push yourself through training and also through the event when you get there!

Your bucket list can include ANYTHING health and fitness related that you would like.

What was on my bucket list? To give up fast food. And YES I have been fast food free for almost 3 years now! I was tired of being lazy and not caring about the food I was putting into my body. I was able to be more self-conscious of the food I was eating. AND it allowed me to save more money! Creating and planning my meals for the week allow me to shop smart at the grocery store so it cut my food budget almost in half when I stopped eating out so much!

You can create goals like “Not drinking carbonated beverages for a month” or “Only having Starbucks once a week”. YOU can set the limits and the rules on your bucket list! This is a great way for you to take control of your health and fitness habits and it also allows you to stay accountable for the things you want to achieve!

Need more ideas?

Here are a few others that may be great for you to add to your list:

• Do a swim race
• Learn to surf
• Run a triathlon
• Compete in an iron man competition (or half competition)
• Compete in charity races
• Compete in charity athletic events (like football or basketball or any other sport)
• To be able to fit in your old wedding…prom…or any other dress you have hidden in the back of your closet
• Go on a fitness cruise
• Kayak down a river
• Do a fitness competition
• Walk part of the Appalachian Trail
• Be able to run 1…2…3 miles
• Be able to do multiple pull ups (because they are VERY hard to do!)
• Go rock climbing
• Go running on the beach
• Be able to do 25…50..100 push ups
• Master some yoga poses without falling
• Be able to hike on trails (Like in Yellow stone national park or the Grand Canyon!)
• Complete a spin class

Like I said, your Bucket List can contain ANYTHING you have wanted to do physically that you know you cannot do now. All it takes it a little motivation and a lot of hard work! If you stay focused and stay motivated you can achieve your health and fitness goals!

This is Stephanie from Infinite Life Fitness. Please feel free to stop by my blog for more health and fitness tips!

More "Visionary" Leadership That Turned Out to be "More Interested in Flash than Substance" - Continuing Troubles at the University of Miami

Over the last 20 years or so, health care organizational leaders somehow ceased to be mere mortals, and became visionaries.  The latest example of how their visions turned out to be cloudy appeared in the Miami Herald.

Background: Donna Shalala as "Visionary" President of the University of Miami

Donna Shalala, formerly the US Secretary for Health and Human Services, became President of the University of Miami in 2001 (see her official biography).  She has since been hailed literally for her "visionary leadership" (as recipient of the Health Leadership Award from the National Hispanic Medical Association in 2005).  In 2008, then US President George W Bush awarded her the US Medal of Freedom, the highest US civilian award, as "one of our nation’s most distinguished educators and public officials. She has worked tirelessly to ensure that all Americans can enjoy lives of hope, promise and dignity.")

At the University of Miami, as described in a detailed investigative report by Paul Basken in the Chronicle of Higher Education in 2011, Ms Shalala pursued a grand strategic vision to " bring the University of Miami into the ranks of the nation's elite research universities."  In an interview at that time, she claimed to have had "a very disciplined strategic plan to make this place much, much better, to move into the top ranks of American universities."

Cracks in the Wall Appear in 2011

However, Mr Basken reported that by 2011, that strategy was showing signs of failure.  He noted problems including rising deficits and a worsening credit rating; allegations that the university was failing to meet the needs of the poor patients for whom its doctors had traditionally cared for at Jachson Memorial Hospital while favoring paying patients at its newly acquired medical center; and concerns about conflicts of interest affecting top leadership of the university, including Ms Shalala (see our post here).  At the time, university leadership scoffed at the importance of these problems.  For example, Ms Shalala ridiculed doctors "who gripe" that the university had become over-extended by pushing research over patient care as "these people complaining they want to live their little lives without being researchers." 

After the 2011 report came out, Ms Shalala ridiculed  it in print as "a shocking example of irresponsible and lazy reporting."

Note that on Health Care Renewal, we had previously raised questions about Ms Shalala's conflicts of interests, particularly her role on the board of UnitedHealth at the time its CEO was receiving hundreds of millions in back-dated stock options (in 2006, look here); and about her priorities, including the contrast between her lavish compensation, which encompassed her residence in a fully-staffed mansion, and how the university treated its low level workers, particularly its janitors who did not receive health insurance (also in 2006, look here). 

The Cracks Widen in 2012

In retrospect, Mr Basken's article appears quite responsible and accurate.  Last week the Miami Herald reported that Ms Shalala's "ambitious moves vaulted UM’s medical school to the national stage — but they may also have seriously damaged it."  Soon after Ms Shalala ridiculed the Chronicle of Higher Education article, already internal reports showing even more trouble were appearing. 

As far back as October, billionaire car dealer Norman Braman wrote in a memo to fellow UM trustees that he and colleagues had been receiving anonymous letters for months 'outlining a host of wrongdoings, mostly at the medical school. Braman and others closely tied to the school warned UM officials the medical school was spending too much, too fast in the push to build a world-class medical center.

There were problems beyond those described by the CHE article:

The medical school also had major problems of its own. According to internal documents, the school suffered from bloated staffing, a faulty billing system and prices that sometimes ran much higher than at other South Florida hospitals. Internal controls apparently were weak at best: A whopping $14 million in expensive cancer drugs disappeared from a UM pharmacy over three years before an employee was charged with theft in June 2011.

The medical school’s difficulties even began to impede its relationship with the ailing, taxpayer-financed Jackson Health System, endangering a decades-long partnership with the public hospital system.

The Herald article includes substantially more detail to support these assertions.

Trustee Braman summarized it thus:

Poorly conceived decisions by the medical school administration have put the university at significant risk and, at the same time, injured Jackson Memorial Hospital.

As we noted, earlier this year the university's financial problems lead to layoffs, but at the same time, the university was building an even fancier mansion for President Shalala. After the lay-offs, Braman said they were:

a real tragedy that never should have happened. ... The people at the top were very much more interested in flash than substance.

Summary

Since the early 1990s we have suffered the rise of extremely confident, extremely well-paid, "visionary" health care leaders. Anyone within the organization who doubted their visions risked being labeled a malcontent or worse. Any skeptic outside the organization might be met by a barrage of propaganda from the organization's well financed public relations operation. Yet the visions these leaders produced often appeared to be clouded at best.

One of the most striking early examples remained anechoic for a long time. The then CEO of the Allegheny Health Education and Research Foundation, Sharif Abdelhak, was publicly labeled a "visionary" and "genius" for assembling a large, vertically oriented health care system, which eventually went bankrupt. Abedlhak went to jail. (Look here for summary). In the greater business world, whose culture now seems to rule health care, there are other examples of such failed visionaries (look here).  Yet this case, and other since, have largely been ignored.

However, as the case of the leadership of the University of Miami now seems to show in retrospect, many people seem to fall again and again for the now tired hucksterism of the "visionary," or "genius" leader selling grandiose and often self-serving pipe dreams.

Maybe it would be enough in health care to simply aspire to good patient care, responsible education, and honest research.

Meanwhile, health care professionals, health policy leaders, and the public at large should start showing appropriately pointed skepticism of our current self-proclaimed "visionary" leadership.

Protective Style Lookbook || Double Dose Twist Updo (Short Hair)

By popular demand, this is a series showcasing various protective hair styles.  Protective styling does not have to be boring. :o)

**This segment contains two styles.**

Model: Iknowlee

Style description: Style #1 - twist updo with pompadour.  Style #2 - twist updo with classy roll.

Difficulty level: Style #1 - 3/5. Style #2 - 3/5.

You can now find HHB on Facebook. Share with your friends:

http://www.facebook.com/healthyhairandbody.