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03/21/2011 - 9:54am

I’d like to say I was shocked when a colleague sent me the warning letter from Eli Lilly relaying results of a French study that indicate a 30 percent increased risk of death among children treated with recombinant human growth hormone (rhGH) in attempts to make them taller.

For years, when I had run into them in meetings, I’d been asking scientists who study growth hormone what they thought might be negative long-term affects of the pediatric use of rhGH. They consistently told me two possibilities: an increase in type 2 diabetes and an increase in cancer. Then they’d shake their heads and say something like, “This is so bad. This is so nuts.” And they’d review what we all already knew:

There’s no evidence that there is any medical need to treat short kids with rhGH. There’s no evidence such children are at increased risk of psychosocial problems by virtue of being short, and no evidence that being made a couple of inches taller (which is all rhGH achieves) will leave them any better off.

We do have evidence that, psychologically, these treatments leave treated children either no better off or worse off. The evidence is nicely presented in two books: Size Matters: How Height Affects the Health, Happiness, and Success of Boys and the Men They Become, a book aimed at adults, by Stephen S. Hall; and Short: Walking Tall When You’re Not Tall at All, a book written to be accessible to tween-and-up children and their parents, by John Schwartz.

And should we really be surprised that some kids might be left worse off psychologically? Let’s see: for three years or more, you inject a kid every day with this message: “You’re short and that’s bad; you’re short and that’s bad.” Then thanks to the drug they turn out . . . a tiny bit less short. (Psst: that’s bad.)

So even before the French data, we had reason to believe this scene to be a case of vertical cosmetics run amok. Now the French study suggests not an increase in diabetes and cancer, but an increase in brain bleeds and cancer: “abnormally high death rate due to the occurrence of vascular cerebral complications (such as intracerebral hemorrhages) and bone tumours.”

The FDA promptly issued a warning on this, noting (reasonably) that the French data still needs to be crunched. But, as I noted yesterday in a Chicago Tribune op-ed, the weird thing about the FDA warning is this claim: “At this time, FDA believes the benefits of recombinant growth hormone continue to outweigh its potential risks.” Huh? What benefits?

Wondering whether this line amounted to boilerplate or my missing something important, I wrote to a few specialists in the field and asked them their thoughts. They all agreed it had to be boilerplate, because none knew of any demonstrated benefits. I then wrote to a physician friend who had worked at the FDA to ask her if it was boilerplate. She responded that she was sure the FDA would not have approved this indication without evidence of real benefit, something other than a mere height change.

Oh, really? In an excellent plain-language review for Atrium (starting on p. 15 of this PDF), University of Michigan pediatric psychologist David Sandberg explained how Eli Lilly pulled off a real coup in getting the FDA to approve “idiopathic short stature” (aka “just plain short”) as a medical indication for rhGH:

“Eli Lilly’s presentation to the FDA was logical, even elegant; there was little to no mention of the psychological ‘suffering’ that children and adolescents with SS [short stature] experience or the potential romantic and occupational disadvantages of being a short adult. Good thing, because the data would not support such claims. Instead, representatives of Eli Lilly argued that since healthy children can be as short as those who receive [already FDA-approved] rhGH when their height was stunted by a medical condition, healthy children should receive the hormone for their appearance as well.”

Sandberg continues:

“In response to one question put forth by the FDA, ‘Should psychological or quality of life benefits be required outcomes of growth hormone treatment?’, Dr. Charmian Quigley, Senior Clinical Research Physician at Eli Lilly and Company responded, ‘While this is a relevant question, I would point out that this has not been conclusively demonstrated for either growth hormone deficiency or for any other growth disorder that is currently approved for treatment.’ She was right – the FDA had descended the slippery slope years earlier by approving new uses for rhGH without identifying endpoints other than height for gauging success.”

As an interesting historical aside, Dr. Quigley – the Eli Lilly pediatric endocrinologist who sold this “appearance-benefitting” indication to the FDA – is now the author of the warning letter mentioning possible risk of death.

One can only hope that, as the FDA reviews the French data, it also reviews the question of why it approved rhGH for vertical cosmetics in the first place.

And hey, as long as I’m dreaming, I’m also going to dream that this little scare (which I hope doesn’t turn out to be a big horror) causes a minor revolution in pediatric endocrinology, towards a focus on what the evidence tells us about what is medically necessary, safe, and effective for children. Perhaps after this, pediatric endocrinologists will have more shame than they did a couple of years ago when they invited the drug companies to literally sit at the table with them as they came to a consensus on care for short children.

I think a revolution is possible. When I was invited to give the Lawson Wilkins Lecture to the Pediatric Endocrine Society in 2007, and I blasted the use of rhGH for stature, about a third of the audience of pediatric endocrinologists burst into applause, with some of them actually standing to applaud. I was told later no one had ever seen such a thing at the Pediatric Academic Societies meetings. Now, it concerned me that most of those standing and applauding seemed notably young. (Would these folks have the power to change the system? Would they become more like their elders as they aged?) On the other hand – and this makes me hopeful – they were also pretty short.

Alice Dreger is a professor of clinical medical humanities and bioethics at Northwestern University Feinberg School of Medicine.

03/21/2011 - 9:23am

Motives, especially corporate ones, are hard to figure. Some people, of course, are skeptical about the notion that an abstract entity like a corporation can have motives (or intentions or beliefs of attitudes or any of those sorts of things), even though we all have a tendency to talk about corporations as if they are capable of having them. It’s pretty common to talk about a company “expecting” profits to rise next year, or “wanting” to increase its market share, and so on. But even if we’re not so skeptical about attributing motives (etc.) to companies, their motives can be pretty elusive. We may not be ready to believe corporate spokespersons when they tell us what their company’s motives are, and besides, even if everyone within a company agrees that a certain course of action is the right one to take, it’s entirely possible that different parties within the company all have different motives for doing so.

This question of determining motives came to mind when I read a story about an age discrimination case at 3M: “3M settles age-discrimination suit for up to $12M”....

03/21/2011 - 8:46am

In an inevitable posthuman world, which ethical theory will triumph: The Categorical Imperative, Utilitarianism, Existential Ethics, Normative Intellectualism or Technoprogressivism?

Firstly I think it would be a good idea to go over what a “concept” is. A concept is basically a theory, or a unit of knowledge about the universe and ourselves.  Concepts are apt to change like theories are, but some concepts remain prominent throughout history. The question then, is, will concepts change or be enhanced as the mind becomes enhanced? For example the mental representation of the category of dogs come with it many different abstract ideas and information.  Will the posthuman know everything about dogs and think of dogs so differently then we do that their concept of dog doesn’t even closely resemble ours? Simply put, one thinks of different breeds, colors, temper, and so on, reinforced through language of the particular culture one is from.(1) Concepts, in philosophy, described by Encyclopedia Britannica are...

03/21/2011 - 7:58am

1987 was the first year in which one billion people boarded airline flights.  In that year the world’s population hit 5 billion, meaning approximately 20% of all people experienced a fantastic luxury not available to history’s wealthiest monarchs.  By 2005 two billion people were boarding airliners each year, and the world’s population had grown to 6.5 billion.  In the short span of years between 1987 and 2005, airline flight grew from being a right of 20% to a right of 31% of humanity, from barely a fifth to almost a third.  Even assuming more frequent flights by the wealthier, this is startling evidence of the democratization of technology.

1987 was also noteworthy as the first year mobile phone sales hit one million units.  A tool for the rich?  Twenty-two years later, in 2009, half the world’s population owned their own mobile phone.  From one million to three billion in 22 years.  Even assuming some rich people have two or more mobiles, this is undeniable evidence of the democratization of technology....

03/21/2011 - 7:31am
Natasha Vita-More’s talk at Humanity+ @ Caltech
03/21/2011 - 5:49am

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03/20/2011 - 10:46am
Bradley Cooper and Robert De Niro star in Limitless, a paranoia-fueled action thriller about an unpublished writer whose life is transformed by a top-secret smart drug that allows him to use 100% of his brain and become a perfect version of himself. His enhanced abilities soon attract shadowy forces that threaten his new life in this darkly comic and provocative film.
03/19/2011 - 10:29pm

In May 2011, at the Pediatric Academic Societies meeting in Denver:  “Futility Controversies: Ethical and Legal Considerations”  Here is the program description:

1:00 PM -  Background of the Futility ControversyJohn  D. Lantos...

03/19/2011 - 9:05pm

Surgeon Richard Thompson has a brief article in the February 2011 British Journal of Hospital Medicine titled "Medical Futility: A Commonly Used and Potentially Abused Idea in Medical Ethics."  It is an elementary overview of the concept using a narrow range of dated sources.  But Thompson does helpfully remind us that patients have treatment goals other than the "obvious biological goals of most treatments."  These include:

...

03/19/2011 - 8:39pm

Francis Heylighen started his career as yet another physicist with a craving to understand the foundations of the universe – the physical and philosophical laws that make everything tick.  But his quest for understanding has led him far beyond the traditional limits of the discipline of physics.  Currently he leads the Evolution, Complexity and COgnition group (ECCO) at the Free University of Brussels, a position involving fundamental cybernetics research cutting across almost every discipline.  Among the many deep ideas he has pursued in the last few decades, one of the most tantalizing is that of the Global Brain – the notion that the social, computational and communicative matrix increasingly enveloping us as technology develops, may possess a kind of coherent intelligence in itself.

I first became aware of Francis and his work in the mid-1990s via the Principia Cybernetica project – an initiative to pursue the application of cybernetic theory to modern computer systems.  Principia Cybernetica began in 1989, as a collaboration between Heylighen, Cliff Joslyn, and the late great Russian physicist,  dissident and systems theorist Valentin Turchin.  And then 1993, very shortly after Tim Berners-Lee released the HTML/HTTP software framework and thus created the Web, the Principia Cybernetica website went online.  For a while after its 1993 launch, Principia Cybernetica was among the largest and most popular sites on the Web.  Today the Web is a different kind of place, but Principia Cybernetica remains a unique and popular resource for those seeking deep, radical thinking about the future of technology, mind and society.  The basic philosophy presented is founded on the thought of Turchin and other mid-century systems theorists, who view the world as a complex self-organizing system in which complex control structures spontaneously evolve and emerge....