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Skull & Bones: What the FDA would rather you didn’t know
By Jenny Thompson on 07/16/2010
At what point do you start labeling something as a poison?
How about if it increases stroke risk by 27 percent?
Or increases heart failure risk by 25 percent?
Or increases risk of either heart attack or stroke by 14 percent?
Or increases risk of death by 13 percent?
What if you could predict that one out of every 60 people who took this so-called "medicine" would be harmed in one of these ways?
And what if that meant that over a decade, more than 100,000 people have probably experienced one of these "excess events" after taking the medicine?
At what point do you put skull and crossbones on the label so people will know to keep this dangerous junk on a high shelf in the basement where no one can accidentally ingest it?
Nothing exceeds like excess
The stats above all come from an FDA report about a drug that helps control blood sugar. And the dreadful irony here is that diabetics take this medicine hoping to avoid the common dangers of their disease, such as increased risk of heart attack, heart failure, and stroke.
The drug is Avandia. And as I've mentioned before, Avandia's link to heart problems is so well known that if this were a different era, we'd be lighting torches and hoisting pitchforks as we stormed the gates of the factory where this very dangerous stuff is made.
But we don't go in much for violent mob rule these days. We don't have to because here in the 21st century we have professionals on duty at the FDA who help the public avoid drugs like Avandia.
I'm kidding, of course! Look up "drug company enabler" in the dictionary and you'll find a photo of FDA headquarters.
But then we have Dr. David Graham.
He's one of the very few guys at the FDA who genuinely keeps a sharp watch on dangerous drugs. Dr. Graham was the one person at the agency who shook the world awake to the dangers of Vioxx and a number of other dangerous drugs. And it's Dr. Graham who is leading the charge to inform the public about the "excess events" linked to Avandia.
But I don't think you'll be surprised to learn that he believes FDA officials are trying to suppress his very damaging Avandia report. Apparently, the Journal of the American Medical Association is standing by, ready to publish Graham's findings. But some higher ups at the agency are dragging their heels, delaying the green light to publish.
This matters because once the report is validated by JAMA, it has a good chance of making the evening news.
But you and I know better than to wait for the FDA and JAMA to get their acts together. You can act right now by forwarding this e-mail to anyone you know who may have diabetes.
Someday the evening news might catch up, and someday GlaxoSmithKline (the maker of Avandia) might take their very risky drug off the market.
Till then, it's just us and the power of the forward button.
Printer-friendly versionAbout the author
Jenny Thompson is the Director of the Health Sciences Institute and editor of the HSI e-Alert. Through HSI, she and her team uncover important health information and expose ridiculous health misinformation, most notably through the HSI e-Alert.
Visit www.hsionline.com to sign up for the free HSI e-Alert.
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Comments
Anonymous
I am a 59 year old woman who was diagnosed with Type 2 diabetes in 2007 and am presently taking Metformin and Glimepride. After my last doctor's visit, he prescribed Actos to see if we could lower my A1C that was at 7. I took the drug for 6 weeks and then started seeing some reaction. One ankle started to swell - - and then the other ankle also swelled dramatically. Bad timing as it was on Mother's Day and I was hosting a family BBQ at my home - - and my ankles literally disappeared - - turning into cankles. :) I contacted my doctor's office - - my doctor was not on call, but the doctor I spoke to told me to stop taking Actos immediately - - which I did. I started reading up on Actos and most of the warnings and side effects of that drug are also 'heart' related issues. Is Actos safe? In your link to another article, it recommends Avanadia users stop taking it and instead try Actos. Are you sure that Actos is safe?
Anonymous
I just wish Avania were the only thing the FDA is ignoring the dangers of.
What about High Fructose Corn Syrup? or the side effects of drugs that only cover up the problem? What ever happened to curing the disease by fixing the problem and not the symptoms? Is there any drug out there that is addressing the root cause of the imbalance that causes diabetes? I have yet to hear of one!
Unfortunately, the FDA is focal point of a problem largely caused by the drug companies and their multi-billion dollar business. If all their profits were combined, they could probably pay off the $13 trillion deficit and not really miss it.
The People Of America!
im commiding on the drug avandia,im sure its not safe for most people,but the FDA dont care about the people.they only how imported they look for the companys,were just the geine pig that are tested on.if you dont know that by now. then i hope yous people out their open up your eyes,and think about it.im a diabetic myself and dont touch those drugs.God gave us this earth to live in,and look around you.he aslo gave us everything to take care ourselfs.clean water,pure fresh air,plants to heal ourselfs,and plenty of room to grow and live well until it came time to pass on,all he asked one thing from us,to worship him.and we cant even do one simple thing.now thats whats bad.and we can even take care of our own planet.so lets start a new year by voting for people that can take care of us,and can be start doing the job they know they can do for the united states of america.until next time my citizens of a great nation. The people of america has spoken!
Mr. Sirajul Islam
I like Dr. Thompson's HSI e-alerts. She, and her organisation is a whistle blowing organisation, and informs us about many things we need to know. This includes 'what' and 'how' we should take to keep our health sound, and what should we avoid. There are many other drugs (even vitamins) that are believably risky. I read about those on her e-alerts. That's fantastic! I think, Dr. Jenny will write on those, as well, like on the NSAIDs, statins, ACE Inhibitors, ARBs. And diabetics, you need not to live on medicines only. There are many simple foods like eggs, herbs and spices that can do the tricks, e.g. Gymnema, cinnamon, fenugreek, Turmeric, ginger. Chromium appears to be the most useful mineral in the prevention of Type II diabetes. The list included Niacin and niacinamide, both forms of vitamin B3, biotin, CoenzymeQ10 etc. Doctors are not especially talking about vitamin C or vitamin E, although both of those vitamins have been shown to be essential in helping to prevent kidney disease in diabetics. According to research from the American Journal of Clinical Nutrition, vitamin D may play a key role in glucose metabolism. Ref: Vieth R et al. Vitamin D supplementation, 25-Hydroxyvitamin D Concentrations, and Safety. American Journal of Clinical Nutrition 1999; 69: 842-856.
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