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 Dear Reader,
Let's say there's a new drug up for approval from the American Food and Drug Administration (FDA). It's going up against a popular drug for the same condition. The makers hope their new drug will cause fewer side effects.
But so far research shows it doesn't. Oh, and it's also less effective than that other drug. In fact, it's about half as effective.
See a problem there? Well, apparently the FDA didn't.
Because they approved the drug in 2009.
It's an anti-arrhythmic called dronedarone (Multaq). The drug's maker, Sanofi-Aventis, pitted it against amiodarone (Cordarone, used in treatment of arterial fibrillation) in research submitted during the FDA approval process.
Sanofi-Aventis specifically created the drug to have fewer side effects than amiodarone (which carries serious risks of thyroid and lung toxicity), but a new review of the drug says the studies submitted to the FDA don't confirm that at all. The review, published in the April 2010 Journal of the American College of Cardiology, also shows that dronedarone is only about half as effective as amiodarone.
The story gets more convoluted. This isn't the first time the drug has come under fire. Sanofi-Aventis sponsored a recent lecture that promoted off-label use of dronedarone for treating arrhythmia. So here you have a company pushing a drug that was (1) approved under shaky evidence, (2) not approved to treat the condition they're pushing it for, and (3) isn't even more effective than drugs already on the market in treating that condition!
Researchers concluded that dronedarone should be used as a second or even third-line drug for the conditions for which it's intended. They also said that doctors should be cautious about off-label uses, no matter how much the drug makers push them. But my question is, why should it be used at all? Why was this drug even approved?
Is there any kind of reasonable explanation the FDA could possibly spin for approving drugs that show absolutely no benefit over those already on the market?
It would cut down on a lot of confusion (not to mention market saturation) if one simple question were included in the FDA's review of new drugs: Is this drug safer and more effective than what's already out there?
If the answer is no, the drug doesn't get approved. It seems pretty simple to me.
Can you imagine if they tried that, though? Pharmaceutical giants would raise the battle cry immediately. How dare the FDA try to actually regulate anything!
I doubt we'll ever see a drug-approval process built on common sense. But it's nice to daydream about it.
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An easy way to be canker-sore free
Q: Is there a way to get rid of canker sores (mouth ulcers)? I get them pretty frequently and they just drive me crazy.
Dr. Jonathan V. Wright: If you wait long enough, canker sores usually go away on their own. But there may be an even easier solution that can help you from getting them in the first place: switching toothpastes.
In one study, 10 people with recurrent canker sores were given two different toothpastes to use, for three months each. One contained 1.2 per cent sodium lauryl sulphate (SLS) and the other was SLS-free. Otherwise, the toothpastes were identical. When researchers compared the three-month periods, they found that the group using the SLS-free paste had 64 per cent fewer canker sores than the other group.
The problem is, virtually all of the popular brands of toothpaste contain SLS. However, there are some lesser-known brands sold in natural health food stores that are free of the compound.
Bear in mind we are not addressing anyone's personal situation and you should rely on this for informational purposes only. Please consult with your own doctor before acting on any recommendations contained herein.
Wishing you the best of health,
Andrew Miller
UK Editor
P.S. In the latest issue of Nutrition & Healing, Dr Jonathan V. Wright tells you about the serious health threat lurking behind 'cosmetic conditions' like thinning hair and chipped nails. Also, learn about the mysterious disease that could cripple you – and the herbal treatment that works better than drugs. Plus, the alternative remedy that could help you get back your condidence in the bedroom.
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Sources:
"New Arrhythmia Drug Provides Only Modest Efficacy and No Clear Safety Benefits, Say Researchers," Science Daily (www.sciencedaily.com)
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