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| 7 December 2010
UK Edition |
 Dear Reader,
When I first read the news, I thought it was too good to be true.
And, as it turns out... it was.
Silly me, thinking the American Food and Drug Administration (FDA) was actually going to start putting consumer protection at the top of their list.
Recently, the news hit that the FDA was pushing to withdraw ProAmatine, a blood pressure drug from Shire Laboratories that's been on the market since 1996.
Back then, the drug was approved based on preliminary research that showed promise in treating low blood pressure. A follow-up study proving its long-term benefits was promised.
But that study never came. So for 14 years the drug has ridden on the results of early research, and nobody's ever proven it actually helps anyone.
So not much of a story there — we're used to this kind of stuff, right?
Except this time, the FDA actually got a little tough. For about a minute. Last month, they proposed withdrawing ProAmatine (and five generics) from the market, giving Shire Laboratories the option to schedule a hearing to discuss the issues with the drug.
It was — get this — the first time the FDA actually threatened to pull a drug from the market due to missing follow-up research, though they have had the power for a long time now. Despite the fact that only 64 per cent of follow-up studies requested since 1992 have been completed, the FDA hasn't bothered holding anyone accountable.
Seems pretty basic, doesn't it — especially to anyone who's ever dealt with children — you don't threaten a punishment and not follow through — unless you want the children to walk all over you.
So this turn of events was pretty refreshing.
Except nothing really happened. Rather than make an example of Shire, the FDA released a statement saying they haven't received any studies that verify the clinical benefit the drug is supposed to have but oh my goodness so many people say it works so it must be okay! Hooray, Shire!
They also say their announcement threatening to remove the drug doesn't mean they actually were going to remove it — it's just a step in the process they had to follow and they have to see the studies so people can understand who benefits from the drug and they hope they haven't hurt anyone's feelings.
Okay, I made that last bit up. But seriously — here the FDA had an opportunity to show consumers they're actually looking out for us — instead they puffed up and then backed down almost immediately. All of the focus has been on letting everyone know that this is all just part of a process and that ProAmatine is probably just fine!
So what could have marked a sea change for the FDA — and for us — has turned out to be business as usual.
How disappointing.
Continues below...
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Are low-fat diets bad?
Q: Are low-fat diets bad for you?
Dr. Jonathan V. Wright: I'm not a big fan of low-fat diets since most of our ancestors never ate that way. Even so, there are researchers who have shown that low-fat diets can be beneficial in some circumstances. But the media makes it sound otherwise with headlines like this one: "Low-fat diets do not protect women against heart attacks, strokes, breast cancer, or colon cancer."
No one bothered to mention (or didn't notice) that none of the low-fat studies measured the amount of trans fatty acids in the overall fat intake. Even medical authorities know that trans fatty acids are bad and can actually promote chronic inflammation, atherosclerosis, and cancer. In fact, medical authorities have gone so far as to require that labels state the amount of trans fatty acids in food products. The researchers also didn't report the proportions of monounsaturated fats (generally health-promoting), nor did they check the balance of omega-3 (anti-inflammatory) to omega-6 (generally pro-inflammatory) fatty acids.
And it gets worse: Only 14.4 per cent of the women in these studies met the researchers' own criteria for a low-fat diet, and the average fat reduction (whatever type it was) was only 8.2 per cent.
In contrast, the studies done by Dean Ornish that indicated the benefits of low-fat diets, reduced total fat consumption considerably more than that. And he paid attention to both "good" and "bad" fats.
Even though the mainstream research discussed in the articles you've seen cost you and me (as tax-payers) multiple millions of dollars, it shows no sign of intelligent design of any sort and should be consigned to the trashcan.
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
In the latest issue of Nutrition & Healing, Dr Jonathan V. Wright will tell you how to get your type 2 diabetes under control… without a single drug! Also, learn about the herbal oil that can help relieve irritable bowel syndrome. Plus, find out how you can get the most out of Bio-Identical Hormone Replacement Therapy.
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:
"FDA moves to withdraw unproven blood pressure drug," Yahoo! News (news.yahoo.com)
"Midodrine Update," FDA (www.fda.gov)
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