Dying for Some Standards: Broken Medical Systems as Revealed by a New FDA Warning
Alice Dreger, 03/21/2011

Dying for Some Standards: Broken Medical Systems as Revealed by a New FDA Warning

(Medicine) Permanent link

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.

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