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| 22 September 2011
UK Edition |
 Dear Reader,
Let's say you suspect a given drug shouldn't be on the market. You want to look into evidence of its safety... and potential harms. Well, you'd better hope everything you need has been recorded in the last 15 years.
Because if it's older than that, it's gone. Bizarrely, the policy of the drug regulator in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA), is to destroy all evidence about the benefits and harms of all of the drugs it approves after the data has been stored for 15 years.
A doctor who has been preparing an analysis of antidepressant medications ran into this policy when he was unable to get his hands on data concerning fluoxetine (more commonly known as Prozac). His access to some data was denied because it's simply been destroyed. (And he's of course had no luck getting anything at all from the manufacturers, Eli Lilly — you know whatever they have is locked up tight.)
Unless the data is needed for legal, regulatory, or business reasons or is considered to be of "lasting historic interest," out it goes.
How about public safety? Would that be a good enough reason? You know, I can't think of a single reason to NOT keep the data, but I can certainly think of plenty of reasons to keep storing it.
And especially now, in the year, 2011, I find it hard to believe that it would be difficult to hold on to this data... we're talking about the potential safety of a whole nation of people. No, actually... a world of people, considering how valuable studies from a variety of nations can be when it comes to drug safety.
The American Food and Drug Administration (FDA) has declined to comment on the situation in the UK... probably because their first thought was, "Why didn't we think of that?" Currently, they retain records for 30 years or until the data is no longer needed, whichever is latest — and they usually use the latter classification to effectively keep data "forever."
So, I guess we can take some comfort in knowing that the FDA is doing SOMETHING right...
Continues below...
Trouble sleeping?
You know what it's like…
You go to bed at a sensible time – and just lie there.
You hear the clock tick. You put the light on and try to read yourself to sleep. Why doesn't it work? Now its 2am, 3am, 4am – the light starts to filter through the curtains...
As the day starts to break into your bedroom you've just dropped off…
Then you're woken, a couple of hours later, by the alarm clock!
Click through to break the cycle.
Keeping the beat
Q: I've been diagnosed with having an irregular heartbeat. What can I do?
Dr Jonathan V. Wright: One of the most common treatments for a certain type of irregular heartbeat (technically known as atrial fibrillation) is a procedure called cardioversion.
Cardioversion involves applying an electrical shock to the heart to attempt to restore a normal heart rhythm. It sounds a bit frightening, but it's actually very safe and is often successful — at least in the short term. The problem is, the fibrillation frequently returns — sometimes after a length of time, but sometimes quite promptly, within just a few days. And when prompt recurrences happen, it can be quite upsetting. Patients are often understandably discouraged and don't want to undergo repeat treatment.
But just last month a group of Greek researchers reported that vitamin C — yes, that's just "regular" vitamin C — can significantly decrease recurrence of atrial fibrillation after cardioversion treatment.
In this study, 44 individuals with this problem were "randomized" evenly to take either no vitamin C, or 2 grams of vitamin C 12 hours before cardioversion, and then 500 mg twice daily for the next seven days. Only one of the patients given vitamin C had a relapse of atrial fibrillation, while eight (36 per cent) of the patients not given the vitamin had relapses.
The researchers also found two other positive changes in the group given vitamin C: both their white blood cell levels and fibrinogen levels fell significantly, but neither dropped in any of the control patients. Markers of inflammation were also significantly higher among patients who had a recurrence of atrial fibrillation, compared with those who did not.
So far, there's no longer-term follow-up to this research, but taking 2 grams (or perhaps a bit more) of vitamin C each day certainly can't hurt — and there are many other health benefits to it as well.
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
Nutrition and Healing
P.S. In the latest issue of Nutrition & Healing, Dr. Wright will explain how undiagnosed food allergies can contribute to poor health and reoccurring symptoms of almost any illness. Also learn about the 6 ways to identify a food sensitivity, the D-I-Y guide to allergy testing and how to treat food sensitivities... plus much, much more...
All new members who sign up will receive important updates like these in addition to receiving Dr. Wright's 7 Volume Library of Natural Healing.
Click here for full details.
Sources:
"UK Drug Regulator Destroys All Trial Data After 15 Years," Medscape News (www.medscape.com)
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