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Dear Reader,
Picture this:
You're the maker of a blockbuster painkiller. Sales are soaring ($2.5 billion in 2011); you're on top of the world.
Never mind that your painkiller could increase the risk of life threatening heart problems, including heart attack and stroke--and that the risk becomes greater if you use it long term.
And forget the finding that it may seriously harm the intestines, even causing bleeding or perforation (which can be fatal and can occur without warning).
Nah--those are just details. You're looking at the bigger picture.
That bigger picture involves widening your target to include kids. I mean, after all, kids get arthritis, too, so why should adults be the only ones reaping all the "benefits" of this top-selling drug?
And widening your pool of potential patients becomes even easier when the FDA gives you a free pass.
Of course, Celebrex was approved for use in children back in 2006 (around the same time it was suggested that long-term heart problems could come from use of the drug--lovely). The advisory panel that recommended approval also expressed concern that chronic use could introduce health risks. But in the "shoot first, ask questions later" world of drug approvals and the FDA, Pfizer didn't have to conduct a safety trial until after the drug was approved.
In a ridiculous twist, though, the FDA has released Pfizer from having to conduct the trial. So of course they've shut it down. Quit while you're ahead, right? Wouldn't want to uncover any problems with your cash cow.
Of course, there was another reason for the cancellation of the trial. It's kind of hard to get parents to sign their kids up as guinea pigs. No matter--Pfizer has gotten what they want--a seemingly magical assurance that their drug is safe. In the short period during which the study was active, they didn't see any major adverse effects, so why keep pushing for long-term results? They looked into their crystal ball and said they didn't expect to see any "clinically meaningful" results regarding adverse effects.
Maybe I'm missing something here, but isn't that sort of the point of a long-term study? Especially when advisors on an FDA panel have come right out and said they worry about long-term effects of a drug's use?
Besides, I'd like to think that drug execs have some semblance of concern for patients--especially kids. Wouldn't they rest easier if they had REAL proof that their drug is safe for long-term use, instead of just speculation?
But in the money-grubbing world that is the pharmaceutical industry, that's asking a lot. And meanwhile, only time will tell what's in store for kids who end up on an under-tested drug for pain management.
Yours in good health,
Christine O'Brien
The arthritis shocker that may make pain pills obsolete
Scientists have just made what may be one of the most startling revelations in medical history...
Arthritis pain doesn't start in your joints!
In fact, it goes much, much deeper. And now that they've uncovered exactly WHERE it begins, they've finally figured out how it may be possible to turn the tides on arthritis pain once and for all!
This discovery may very well make pain pills obsolete when it comes to arthritis relief...
That's right...You could vaporize your pain and get back your "get up and go" -- in as little as 30 minutes--without a single pill! Find out how you can put this cutting-edge breakthrough to work starting TODAY.
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Planning a family? Schedule this essential test
Q: My husband and I are hoping to start a family soon. We've been reading up on things to do to make sure we're both as healthy as we can be (so our potential baby is, too!). Is there anything we could have missed?
Dr. Wright: If you have any chance at all of becoming pregnant, there's an inexpensive but critically important blood test that's too often overlooked. Although it's simple, quick, and easy to do, many clinical laboratories don't do it because there's "no demand."
It's called the "neutrophilic hypersegmentation index." It is a mouthful to say, but for decades it has been--and still is--the best test of your personal folate status. Not how your folate level compares with other people's numbers, but how optimal your own level is.
Neutrophils, other circulating blood cells, and the cells that line our gastrointestinal tracts are the most rapidly dividing cells in our bodies. So if there's a shortage of any of the three key nutrients for keeping cell division normal--folate, vitamin B12, and/or zinc--these rapidly dividing cells are likely to show the effects first. So the "neutrophilic segmentation index" actually tells us whether the most rapidly dividing cells in our bodies have enough folate. If these cells do, then it's very likely that every cell in our bodies has enough folate.
One of the saddest test reports I've had to share with anyone was an NHI of 47 percent reported for a woman who was already pregnant. As you may have expected, her baby was born with a birth defect.
Every woman who has any chance at all of becoming pregnant should have this test done! If it's abnormal, and she's planning on a pregnancy soon, she should take a series of folinic acid injections right away, preferably with the methylcobalamin form of vitamin B12, so there's enough folate (and B12) immediately available for any newly conceived infant.
Why the rush? Well, the most common birth defect--neural tube defect--occurs on days 27–29 after conception, before many women are even certain that they are pregnant.
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 physician before acting on any recommendations contained herein.
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Sources:
"Pfizer Calls Early End To Celebrex Safety Study In Children," Fox Business (foxbusiness.com)
"Celebrex Information," Drugs.com (drugs.com)
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