Later On

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Archive for August 9th, 2019

Why Are 96,000,000 Black Balls on This Reservoir?

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Written by LeisureGuy

9 August 2019 at 5:15 pm

Republicans for the Rule of Law have a new commercial regarding Moscow Mitch

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Written by LeisureGuy

9 August 2019 at 4:36 pm

The Low-Carb Community Is Its Own Worst Enemy

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I followed a low-carb high-fat diet for 5 years with good success in controlling blood glucose and, once I added WW Freestyle tracking, with good success in weight loss. I particularly like DietDoctor.com as a resource, and I still prefer his ketchup recipe to any commercial ketchup (because it tastes really good, because I enjoy cooking in general and making condiments in particular, and because it does not include any refined sugar such as high-fructose corn syrup). Still, I eventually became concerned, and I did switch to my current whole-food plant-based diet.

But because I had enjoyed the LCHF diet, I read with interest this article in Medscape by Yoni Freedhoff, MD:

Physicians have been recommending low-carb diets to patients since at least the 1860s, when Dr William Harvey encouraged the British royal family’s undertaker, Mr William Banting, to adopt one. He in turn penned the world’s first known blockbuster diet book — the not particularly excitingly named Letter on Corpulence, Addressed to The Public.

And yet today, one of the loudest laments of low-carb-promoting physicians is that the medical community, as a whole, purposefully eschews their favored diet. Perhaps one of the reasons for this is the low-carb community itself.

Self-righteous, Indignant Vitriol

Unfortunately for physicians who appropriately see low-carb diets as one of many reasonable options for their patients, the larger medical community may struggle to take them seriously. For instance, it took until 2019 for the American Diabetes Association to include low-carbohydrate diets as a therapeutic option in its nutrition therapy consensus report, and JAMA recently published an opinion piece designed to pour cold water over a diet that has and is helping many people manage weight and various diet-responsive comorbidities.

I would argue that at least part of the blame here lies with the ways in which low-carb diets’ loudest champions promote them. In virtually every other area of medicine, physicians are comfortable with the existence of multiple treatment options and modalities, and they also recognize that each patient responds differently to different treatments. When it comes to diets, however, for many vocal low-carb MDs, there can suddenly be only one.

And it’s not just the overzealous promotion of one diet at the exclusion of all others that the low-carb community bizarrely champions. Their self-righteous and often indignant vitriol is frequently on display, whether it’s trotting out the tired trope of medical organizations and dietary guideline committees purposefully manipulating or ignoring evidence (see the extensive corrections and clarifications for this piece), described by a prominent low-carb physician as being representative of a “conspiracy by a ‘matrix of agendas’ to promote a plant-based diet“; or asserting that the overwhelmingly unfollowed low-fat dietary guidelines are responsible for the obesity epidemic (refutation available here); or stating that older dietary guidelines posters will one day appear in “museums recording history of human genocide“; or publicly fat-shaming dietitians and researchers with obesity; or even food-shaming a chemo-receiving cancer patient who posted online that she enjoyed (gasp) an ice cream cone.

And it’s not just random, angry public trolls pushing these narratives. Some of the low-carb community’s most visible and vocal physicians drive these very messages, along with others that may be dangerous and/or incredibly misleading. From stating that fruit should be treated like a poison, to publishing op-eds promoting statin denialism (a thoughtful discussion on this topic can be read here), to coauthoring books with marginalized medical conspiracy theorists with large platforms (more on Dr Mercola here), to stating that sugar is eight times more addictive than cocaine, to producing and selling tea purported to improve weight loss outcomes, to even amplifying anti-vaccination messaging in order to imply that low-carb, high-fat diets treat “vaccine-damaged” autistic children, the low-carb medical community makes it exceedingly easy to not take them — and by extension, their chosen diet — seriously.

That’s a shame, of course, as low-carb diets are just as good as other diets when it comes to weight management, whereby those who enjoy them enough to adhere to them can maintain large, clinically meaningful losses and may also see benefits beyond those attributable to simple weight loss, including improved glycemic control in patients with type 2 diabetes.

Less Hyperbole, More Collaborations

If the low-carb community wants to make inroads into the medical community as a whole, I have two recommendations for them. First, . . .

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Written by LeisureGuy

9 August 2019 at 4:34 pm

Posted in Food, Low carb, Medical

t’s Complicated! — Systems Science And Obesity

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Amanda Raffoul, a PhD Candidate in the School of Public Health and Health Systems at the University of Waterloo, writes at Obesity Canada:

Although some of us recognize that weight is about more than how much you eat or how often you move, this remains a dominant theme throughout much of our daily lives. We make assumptions that with the “right diet”, a “gruelling exercise program”, and “willpower”, anyone can lose and maintain weight loss.

But it is not that simple! Weight is an incredibly complex phenomenon, influenced by many factors that are often out of our control. Check out the image below – in 2007, a team of researchers mapped out the dozens of contributors to weight and the complex interconnections among them (1). Since then, physicians, researchers, and policymakers have increasingly turned to systems science to help address the complexity underlying weight, and more specifically, obesity.

You might be asking yourself, what is systems science? How can I use it? I’m just a student or practitioner or regular non-scientific person – what does it matter? Systems science may revolve around complexity, but it can be fairly simple to gain a surface-level knowledge of why it is important to apply to obesity.

A system is an interconnected set of parts that are dynamic, always changing, and together, create a complex whole (2). Another term we may use to capture more complex systems is wicked problems, which includes issues that are nearly impossible to resolve because of the complicated system underlying them (think of climate change or poverty).

There are different ways that we can use a systems perspective to envision, capture, and even help resolve some elements of wicked problems, including:

  • Systems thinking, through which we can recognize that complex problems must have complex solutions. We can incorporate systems thinking into our everyday lives by resisting the urge to oversimplify things and looking at them through multiple perspectives. This requires us to work with others who hold different perspectives, knowledge, and skills that can help us better understand the complexity driving wicked problems (3).
  • Systems mapping, as seen in the Foresight map above (1), in which we can visualize a system and its drivers and interconnections. We can even map smaller wicked problems – so don’t be overwhelmed by the obesity map above! Systems maps are a great first step to help us understand how complicated problems can be, and can provide early foundations for our final method…
  • Systems modelling, which includes different complex, computational models that can help us understand, and even predict (!) the behaviour of a system (4).

Systems science is incredibly important in helping us understand the complexity underlying obesity. Using a systems perspective can help physicians recognize the multitude of factors that contribute to their patient’s weight gain, researchers acknowledge that many factors outside of an individual’s “choices” influence their behaviour, and policymakers identify how to best promote health and wellness without unintentionally doing more harm than good.

Most importantly (in my humble opinion!), using a complex systems perspective can help everyone recognize that obesity is not simple, and that weight cannot simply be changed with the “right diet”, a “gruelling exercise program”, and more “willpower”. The idea that weight change is simple and within an individual’s control is the central idea underlying weight bias, which has negative health consequences for people’s mental, social, and physical wellbeing (5). Obesity is so much more than calories in and calories out – it’s complicated!

References

Written by LeisureGuy

9 August 2019 at 2:09 pm

Posted in Daily life, Medical

Congress is Accepting Price Gouging By Defense Contractors

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Congress now seems completely divorced from protecting the public and representing the interests of the public. Charles Tiefer writes in Forbes:

On May 15, the House of Representatives Committee on Oversight and Reform held a  hearing about contract pricing practices of Transdigm, a sole source supplier of parts to the Pentagon.  The Department of Defense (DOD) Inspector General (IG) found that Transdigm overcharged the government by as much as 4,451 percent for items purchased.  The hearing produced what passed for bipartisan outrage, and Transdigm eventually agreed to refund $16 million to DOD.

Left unstated was that Transdigm violated no laws, regulations or DOD policies.  Transdigm simply got overly aggressive at the wrong time, and was singled out for criticism when the prices DOD paid became public.  But what about all the companies that engage in the same type of perfectly legal pricing practices as Transdigm, but are more subtle about it?  This includes every major defense contractor, since virtually all of them are using the same type of pricing transparency disclosure exemptions employed by Transdigm.

Over the past two decades, government contractors, primarily those that supply to DOD have used their political clout to have traditional pricing laws changed – sort of the government contracting equivalent of repeal of the Glass-Steagall Act.  Instead of supplying cost or pricing data to the government for negotiation of contract prices, Congress has largely exempted contractors from these long standing pricing transparency requirements by a form of legal jiu-jitsu that labels goods and services as “commercial.”  But, what does “commercial” mean under this new paradigm?  For decades, it was goods and services sold to the general public at market prices.  Sounds reasonable.  But that was not good enough for  contractors who want to claim that everything the government buys, including specialized goods and services for military use on a sole source basis are “commercial” (and thus not have to justify their prices).

Contractors pushed through a willing Congress a government contracting definition that literally qualifies anything imaginable as “commercial” provided it is “of a type” relating to something that exists in the commercial world.  Under this Orwellian definition, military aircraft, combat vehicles, specialized electronics, even rockets, and virtually every other product or service potentially qualifies as “commercial” and contractors are relieved of the necessity to submit cost or pricing data to justify their prices – even in sole source situations.

For contractors, not submitting cost data makes perfect sense.  No one wants to empower a buyer with information that could make them drive a harder bargain.  For the buyer, the government in this instance, not getting the cost data has been a disaster, leading DOD and other agencies to pay inflated, but perfectly legal prices.  Transdigm is just the tip of the defense pricing iceberg.

Even when DOD does not recognize an item or service as “commercial,” other statutory changes made by Congress have effectively neutered much of the law that used to provide for pricing transparency, the “Truth in Negotiations Act.”  The effect is that government contract pricing has become a “Wild West” with much less meaningful disclosure to ensure that prices paid using taxpayer dollars are fair and reasonable.

Meanwhile, the Cost Accounting Standards (CAS) Board, a part of the Office of Management and Budget that sets accounting rules for cost-reimbursement contracts, and other contracts awarded without competition, is quietly, but actively trying to “deregulate,” i.e., allow contractors to use whatever accounting principles they feel like when pricing contracts and seeking payment.  The CAS Board, the brainchild of the legendary Admiral Hyman Rickover, father of the nuclear Navy, has been estimated to save the government from 5–10% on all contracts to which it is applied.  That’s a 5–10% margin that contractors would like to see pad their bottom line.

The situation has gotten so bad that the recently departed Director of the DOD Pricing and Contracting Office wrote to the DoD IG in late 2018 stating, “The reality is that the only true defense against companies that exhibit unconscionable greed is to avoid doing business with those companies whenever possible through competitive means, ensure that there are statutory provisions that address ‘war profiteering’ and price gouging, and ensure the existence of a legislative provision that compels companies to provide cost data …”  He added that current defense contractor “value based pricing” concepts “… are no more than an industrial code word for unfettered price gouging.” . . .

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Written by LeisureGuy

9 August 2019 at 10:48 am

How Big Pharma Was Captured by the One Percent

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Alexand Zaitchik writes in the New Republic:

Donald Trump’s plan to lower prescription drug prices, announced May 11 in the Rose Garden, is a wonky departure for the president. In his approach to other signature campaign pledges, Trump has selected blunt-force tools: concrete walls, trade wars, ICE raids. His turn to pharmaceuticals finds him wading into the outer weeds of the 340B Discount program. These reforms crack the door on an overdue debate, but they are so incremental that nobody could confuse them with the populist assault on the industry promised by Trump the candidate, who once said big pharma was “getting away with murder.”

With his May 11 plan, Trump is, in effect, leaving the current pharmaceutical system in place. Increasingly, its most powerful shareholders are the activist managers of the hedge funds and private equity groups that own major stakes in America’s drug companies. They hire doctors to scour the federal research landscape for promising inventions, invest in the companies that own the monopoly licenses to those inventions, squeeze every drop of profit out of them, and repeat. If they get a little carried away and a “price gouging” scandal erupts amid howls of public pain and outrage, they put a CEO on Capitol Hill to endure a day of public villainy and explain that high drug prices are the sometimes-unfortunate cost of innovation. As Martin Shkreli told critics in 2015 of his decision to raise the price of a lifesaving drug by 5,000 percent, “this is a capitalist society, a capitalist system and capitalist rules.” That narrative, that America’s drug economy represents a complicated but beneficent market system at work, is so ingrained it is usually stated as fact, even in the media. As a Vox reporter noted in a piece covering the May announcement of Trump’s plan, “Medicine is a business. That’s capitalism. And we have seen remarkable advances in science under the system we have.”

This is a convenient story for the pharmaceutical giants, who can claim that any assault on their profit margins is an assault on the free market system itself, the source, in their minds, of all innovation. But this story is largely false. It owes much to the rise of neoliberal ideas in the 1970s and to decades of concerted industry propaganda in the years since.

In truth, the pharmaceutical industry in the United States is largely socialized, especially upstream in the drug development process, when basic research cuts the first pathways to medical breakthroughs. Of the 210 medicines approved for market by the FDA between 2010 and 2016, every one originated in research conducted in government laboratories or in university labs funded in large part by the National Institutes of Health. Since 1938, the government has spent more than $1 trillion on biomedical research, and at least since the 1980s, a growing proportion of the primary beneficiaries have been industry executives and major shareholders. Between 2006 and 2015, these two groups received 99 percent of the profits, totaling more than $500 billion, generated by 18 of the largest drug companies. This is not a “business” functioning in some imaginary free market. It’s a system built by and for Wall Street, resting on a foundation of $33 billion in annual taxpayer-funded research.

Generations of lawmakers from both parties bear responsibility for allowing the drug economy to become a racket controlled by hedge funds and the Martin Shkrelis of the smaller firms. The current crisis in drug prices and access—as well as a quieter but no less serious crisis in drug innovation—is the result of decades of regulatory dereliction and corporate capture. History shows there is nothing inevitable or natural about these crises. Just as the current disaster was made in Washington, it can be unmade in Washington, and rather quickly, simply by enforcing the existing U.S. Code on patents, government science, and the public interest.


In 1846, a Boston dentist named William Morton discovered that sulfuric ether could safely suppress consciousness during surgery. The breakthrough revolutionized medicine, but when Morton filed a patent claim on the first general anesthesia, one doctor huffed to a Boston medical journal, “Why must I now purchase the right to use [ether] as a patent medicine? It would seem to me like patent sun-light.”

The response reflected a longstanding belief that individuals shouldn’t be able to claim monopolies on medical science. Breakthrough discoveries, unlike the technologies inventors would design to apply those discoveries, should remain open and free to a global community of doctors and researchers, with the backing of the government if necessary.

These norms persisted into the postwar era. In 1947, U.S. Attorney General Samuel Biddle argued that the government should maintain a default policy of “public control” over patents. This, he said, would not only advance science, public health, and marketplace competition, it would also avoid “undue concentration of economic power in the hands of a few large corporations.” When asked on national television in 1955 why he didn’t patent the polio vaccine, Jonas Salk famously borrowed the quip leveled a century earlier against the Boston dentist who invented ether. “Could you patent the sun?” he asked.

By then, though, the economics of medicine had begun to shift, and with them the medical ethics surrounding patents. The public university at that time had become a giant laboratory where government and industry scientists worked together designing missiles, inventing medicines, and engaging in basic-science futzing under the “Science of the Endless Frontier”—a concept promoted by New Deal science-guru Vannevar Bush, who believed that the government should fund the open-ended pursuits of the most gifted scientists. Out of this new world arose new interests and new questions: What happens to the inventions spinning out of government-funded labs? Who owns them, who can license them, and for how long?

Toward the end of the 1960s, new mechanisms hatched out of the National Institutes of Health would transform the industry and drastically expand the opportunities for private profit at the expense of the public interest, ushering in a post-Biddle age of virtually unrestricted industry access to taxpayer-funded science.

In 1968, the NIH’s general counsel, Norman Latker, spearheaded the revival and expansion of a program that had, in the years before the government spent much on science, permitted nonprofit organizations—universities, mainly—to claim monopolies on the licenses of medicines developed with funding from NIH. Called the Institutional Patent Agreement program, it effectively circumvented rules that had been in place since the 1940s, not only making monopolies possible, but also greatly expanding their terms and limits, giving birth to a generation of brokers whom universities relied on to negotiate newly lucrative exclusive licensing and royalty deals with pharmaceutical companies.

In an industry where active ingredients are often bulk-purchased for pennies and sold in milligrams for dollars, the patent is more than just the product. It is a license to print money. An awful lot of money.

Before 1968, inventors had been required to assign any inventions made with NIH funding back over to the federal government. Now, those inventions were being sold to the highest bidder. “Nineteen-sixty-eight was the year the NIH threw its support behind a drug development market based on patent monopolies,” says Gerald Barnett, an expert on public-private research who has held senior licensing positions at the University of Washington and University of California. “It’s kept it there ever since.”

Watching these developments closely was the group of nominally libertarian economists, business professors, and legal scholars at the University of Chicago, known collectively as “The Chicago School.” The industry’s regulatory travails and the new opportunities to commercialize science that had emerged in the late 1960s were of particular interest to the economist George Stigler, a founding member of the Chicago School and its most celebrated theorist after Milton Friedman. Stigler is remembered today as the father of “capture theory,” which holds that because industries have a bigger stake in policy than individual citizens, they will exert greater control over shaping that policy. Industry, he argued, will seek to use their power to hamper competition and shore up their position in the market. Regulation never benefits the public, he believed; instead, it benefits the very industry being regulated. There is a lot of merit in this theory. But instead of arguing for more democratic control over regulation, Stigler argued for its elimination.

Though members of the Chicago School opposed monopolies, Stigler and his colleagues hated the government, not to mention the burgeoning “consumer-rights” pro-regulation movement of the 1970s, even more. If forced to choose between private and public power, there was no contest. Stigler developed his openly un-democratic ideas as chair of the Business School’s Governmental Control Project, whose name reflected a double meaning at the core of the project it served: Advancing the “free market” against government control of the economy can be achieved not only by rolling back the state and eliminating its agencies (the approach Milton Friedman favored—and promoted in the Newsweek column he wrote between 1966 and 1984), but by the invasion and colonization of politics on multiple fronts, especially patent law, regulation, and antitrust and competition policy.

“Pharma was the perfect test case for a neoliberal project that celebrates markets, but is fine with large concentrations of power and monopoly,” says Edward Nik-Khah, a historian of economics who studies the pharmaceutical industry at Roanoke College.  “Stigler and those influenced by his work had very sophisticated ideas about how to audit and slowly take over the agencies by getting them to internalize [their] positions and critiques. You target public conceptions of medical science. You target the agencies’ understanding of what they’re supposed to do. You target the very thing inputted into the regulatory bodies—you commercialize science.”

In 1972, Stigler organized a two-day event, “The Conference on the Regulation 
of the Introduction of New Pharmaceuticals.” Major drug makers like Pfizer and Upjohn pledged funds and sent delegates to the conference—a first and fateful point of contact between Pharma and the organized movement to undo the New Deal and radically remake the U.S. economy to serve an ideology of unfettered corporate power.

Born of this meeting was the echo chamber of ideas, studies, and surveys that the pharmaceutical industry has used to buffer an increasingly indefensible system against regular episodes of public outrage and political challenge. Organized and initially staffed by alumni of the Chicago conference, its hubs are the American Enterprise Institute’s Center for Health Policy Research, founded 1974, and the Center for the Study of Drug Development, founded in 1976 at the University of Rochester and later moved to Tufts. Their research has succeeded in producing and policing the boundaries of the drug pricing debate, most successfully propagating the myth that high drug prices are simply the “price of progress”—carrots that drug manufacturers need to entice them to sink hundreds of millions into research and development, because drugs cannot be developed or tested any other way. In the early 2000s, these think tanks gave us the deceptive meme of the “$800 Million Pill,” a dubious claim about the “real” cost of developing a single drug, which has provided cover for, among other things, George W. Bush to sign away the government’s right to negotiate drug prices in 2004. (The same think tanks now talk about the “$2.6 Billion Pill.”)

“The point of pharma’s echo chamber was never to get the public to support monopolistic pricing,” says Nik-Khah. “As with global warming denialism, which involves many of the same institutions, the goal is to forestall regulation, in this case by sowing confusion and casting doubt about the relationship among prices, profits, innovation and patents.”


While Stigler was marshaling researchers in the think tank world, the market was evolving to include more opportunities for speculative investments and bigger IPOs. Venture capital firms in the 1970s began investing heavily in biotech; soon, young biotech firms, established drug makers and Wall Street were pushing for changes in licensing and patent law to make these investments more profitable. They were aided in this by Edward Kitch, a law professor, Chicago School protégé of Richard Posner, and veteran of the ’72 conference, who worked with AEI’s Center for Health Policy Research. In 1977, he published “The Nature and Function of the Patent System” in The Journal of Law and Economics. It enumerated the many advantages of patents and IP rights, not least their role as bulwarks against the “wasteful duplication” of competition. Patents create the conditions for increased profits that, in turn, increase private sector R&D and spur innovation. (If this sounds familiar, it’s because the paper helped press the record for what has since become the industry’s favorite tune, “Price of Progress,” sung over the years in a thousand variations, including the strained aria of Michael Novak’s Pfizer-funded essay on the moral and Godly bases of monopoly patents, The Fire of Invention, The Fuel of Interest.)

These efforts contributed to a revolution in biomedical IP law during  . . .

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Written by LeisureGuy

9 August 2019 at 10:44 am

Which foods increase happiness?

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Written by LeisureGuy

9 August 2019 at 10:39 am

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