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Honesty: a new policy for drug companies?

I was struck by two different news stories today – one in the New York Times, and the other in the Washington Post.  Although the topics were different, the underlying theme was unified: drug companies (particularly Glaxo Smith Kline?) are coming clean with research data and marketing messages.  Sure, it might have taken a law suit by Eliot Spitzer to shine a light on the common practice of witholding negative research information from scientists… and it also may have taken a costly failure of an over-hyped diet pill by a competitor drug company to cause GSK to take the honest marketing track with Alli… But I like this new honesty, however we got to it.

Did you know that drug companies spend billions of dollars to research the safety and effectiveness of their drugs, but then are under no obligation to share what they learn with the general scientific community?  No, they share what they want to – generally the studies that show the largest effect or the greatest safety profile.  But now, physicians have been given access to the raw data collected in all the trials (showing benefit, no benefit, or harm) conducted by GSK.  And they’re having a field day!  A new study published in the New England Journal of Medicine is based on an analysis of GSK’s research, where they have found that Avandia (a popular diabetes drug) may put people at higher risk for heart attacks and heart related death.

Now here’s the devil in the details (as Dr. Charles rightly points out): the potential harm has been blown way out of proportion – the media has been citing “a 43% increase in heart attacks/myocardial infarctions and a 64%
increase in death from cardiovascular causes” when another way of stating what the authors found is that 86/14,371 patients or 0.598% of the patients taking Avandia had a heart attack, while 72/11,634 or 0.619% of people
not taking Avandia also had a heart attack.  Gee… which sound bite seems more scary?

Honestly, I feel worried for the general public who are now (with the new full disclosure of drug company data) sure to be victims of an onslaught of media hype around all sorts of small differences found in research studies.  Believe me, it’s important to sift through all this data to look for early signs of potential drug related health risks – but I think we should be careful before we terrify our patients with scary statistics.

Maybe in the midst of all this new honesty – we can have medical bloggers like Dr. Charles and the Revolution Health team help patients get to the bottom of things without having to have a PhD in biostatistics.  We need a voice of reason to translate research data for public consumption.  I’ll do my part – but since there are ~6000 research studies published per day in this world… I need some back up.  Any takers?This post originally appeared on Dr. Val’s blog at

The right balance for good health

I realize that my last post has probably left you wondering what on earth bulldozers and ballerinas have to do with medicine.  Well, let me lead you down my little mental garden path here and explain.

The dancing event took place right next to the National Academy of Sciences, where the Institute of Medicine (IOM) holds its regular meetings.  It was all the more humorous to see these bulldozers (with rose petal-filled buckets) participating in this awkward dance – right in front of the hallowed halls of medicine’s most prestigious scientific body.  As I thought about what the IOM stands for – the pursuit of truth through objective scientific analysis – and what these ballerinas were up to (reveling in the whimsy of life) it struck me that good medicine might actually combine the two.

Clearly, there are aspects of a healthy life that cannot be well defined by science.  Love, peace, and joyfulness are all nourishing to the mind and body – but quantifying them is rather difficult.  The things that grandma taught us – get your beauty rest, be kind to others, get lots of fresh air, marry a loving man (or woman) – are great medicine, and should be the foundation for a life in balance.

However, the science of medicine is also critically important.  The media thrives on exaggeration and controversy.  If there were a mountain of sand in front of us, and we had the choice to move it with a bulldozer or a teaspoon – the media would have us convinced that the spoon was equally effective.  And this is why we are constantly misled about treatments – we hear about efficacy, but we don’t hear about the relative effectiveness compared to other therapies.  So cinnamon, for example, is touted as a great new treatment for diabetes, when in fact it is only a teaspoon compared to the bulldozer of insulin.

And so I guess I would summarize my musings this way: good health is a dance near the IOM, with bulldozers instead of teaspoons.This post originally appeared on Dr. Val’s blog at

Bulldozers and ballerinas

“Bulldozers and Ballerinas” is the whimsical name of the event I attended this past weekend.  A dance troupe decided to pair themselves with some small bulldozers (propane powered) to do some interpretive work to the tune of Tchaikovsky’s Swan Lake.  There were about 8 dancers and two bulldozers on a city street closed off to traffic.  Large speakers blasted the classical music, as construction worker gear-clad ballerinas danced around the moving bulldozers.  This was about as funny as a Monster Truck rally hosted by Luciano Pavarotti.  I watched with  amusement and enjoyed the humor of the contrasts.

In my next post I’ll explain the connection between bulldozers and medicine.

This post originally appeared on Dr. Val’s blog at

Sun Therapy for Tuberculosis?

I was interested to see this news piece about how Vitamin D may improve the body’s ability to fight off Tuberculosis.  Vitamin D is found in some foods, but can also be created in your body when it’s exposed to UV light.  In the 1940’s Tuberculosis sanitoriums used “heliotherapy” (sun exposure) as a modality to treat TB.  I had often wondered about the utility of such treatments – with this photo etched in my mind.  And now it seems that they had it right.

Of course, we don’t know how many of those patients developed skin cancers later in life…  (Always a trade off, isn’t there?)  In the US, milk and orange juice are fortified with Vitamin D – however in Britain they have no such requirement and they are seeing an increase in TB cases.  “Got Milk?” only works if it’s “Got Vitamin D Fortified Milk?” I guess…This post originally appeared on Dr. Val’s blog at

References for HRT post

These are the references for the post about HRT and “chemo brain:”


1. Gross J. Lingering fog of chemotherapy is no longer
ignored as illusion. New York Times April 29, 2007 p1.

2. Paganini-Hill A, Henderson VW. Estrogen replacement
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3. Tang MX, Jacobs D, Stern Y, Marder K, Schofield P,
Gurland B, Andrews H, Mayeux R. Effect of oestrogen during menopause on risk
and age at onset of Alzheimer’s disease. Lancet 1996;348:429-32.

4. Manly JJ, Merchant CA, Jacobs DM, Small SA, Bell K, Ferin
M, Mayeux R. Endogenous estrogen levels and Alzheimer’s disease among
postmenopausal women. Neurology 2000;54:833-7.

5. Chung SK, Pfaff DW, Cohen RS. Estrogen-induced
alterations in synaptic morphology in the midbrain central gray. Exp Brain Res

6. Jones KJ. Steroid hormones and neurotrophsim:
relationship to nerve injury. Metab Brain Dis 1988;3:1-16.

7. Nilsen J, Diaz Brinton R. Mechanism of estrogen-medicated
neuroprotection: regulation of mitochondrial calcium and Bcl-2 expression. Proc
Natl Acad Sci USA 2003;100(5):2842-7.

8. Nilsen J, Brinton RD. Mitochondria as therapeutic targets
of estrogen action in the central nervous system. Curr Drug Targets CNS Neurol
Disord 2004;3(4):297-313.

9. Alvarez-de-la-Rosa M, silva I, Nilsen J, Perez MM,
Garcia-Segura LM, Avila J, Naftolin F. Estradiol prevents neural tau
hyperphosphorylation characteristic of Alzheimer’s disease. Ann NY Acad Sci

10. Singh M, Meyer EM, Millard WJ, Simpkin JW. Ovarian
steroid deprivation results in a reversal learning impairment and compromised
cholinergic function in female Sprague Dawley rats. Brain Res. 1994;644:305-12.

11. McEwen B, Alves S. Estrogen actions in the central
nervous system. Endocrin Rev 1999;20:279-307.

12. Kampen DL, Sherwin BB. Estrogen use and verbal memory in
healthy postmenopausal women. Obstet Gynecol 1994;83(6):979-83.

Shaywitz SE, Shaywitz BA, Pugh KR, Fulbright RK, Skudlarski P, Mencl WE,
Constable RT, Naftolin F, Palter SF, Marchione KE, Katz L, Shankweiler DP,
Fletcher JM, Lacadie C, Keltz M, Gore JC. Effect of estrogen on brain
activation patterns in postmenopausal women during working memory tasks. JAMA

14. Duff SJ Hampson E. A beneficial effect of estrogen on
working memory in postmenopausal women taking hormone replacement therapy. Horm
Behav 2000;38(4):262-76.

LeBlanc ES, Janowsky J, Chan BKS, Nelson HD. Hormone replacement therapy and
cognition. Systemic review and meta-analysis. JAMA 2001;285(11):1489-99.

Zandi PP, Carlson MC, Plassman BL, Welsh-Bohmer KA, Mayer LS, Steffens DC,
Breitner JC. Hormone replacement therapy and incidence of Alzheimer’s disease
in older women. The Cache County
Study. JAMA 2002

MacLennan AH, Henderson VW, Paine BJ, Mathias J,
Ramsay EN, Ryan P, Stocks NP, Taylor
AW. Hormone therapy, timing of initiation, and cognition in women aged older
than 60 years: the REMEMBER pilot study. (Research into Memory, Brain function
and Estrogen Replacement). Menopuase: The Journal of the North American
Menopause Society 2006;13(1):28-36.

Shumaker SA, Legault C, Rapp SR, and the WHIMS investigators. Estrogen plus
progestin and the incidence of dementia and mild cognitive impairment in
postmenopausal women: The Women’s Health Initiative Memory Study: A randomized
controlled trial. JAMA 2003;289(20):2651-62.

Shumaker SA, Legault C, Kuller L, et al. Conjugated equine estrogens and
incidence of probably dementia and mild cognitive impairment in postmenopausal
women: Women’s Health Initiative memory Study. JAMA 2004;291(24):2947-58.

This post originally appeared on Dr. Val’s blog at

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