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The Gout Dugout. Issue #020.Krystexxa not approved by FDA,health information;gout & kidney disease
August 03, 2009
A warm welcome to the August 2009 edition of the Gout Dugout newsletter, and to new readers who have signed up since the June edition.
KRYSTEXXA FOR GOUT? NOT YET.IT HAS NOT BEEN APPROVED BY THE US FDA
Yesterday, August 2, the developers of Krystexxa (Pegloticase) announced that the US FDA has not approved Krystexxa. After the June arthritis committee meeting recommendeded its approval by a large majority, and after some Wall Street analysts said that they thought it would be approved, hopes were high that it would be.
What seems to have gone wrong from Savient Pharmaceuticals (the developers) point of view, not to mention the thousands of potential chronic gout suffering beneficiaries, is that the FDA announced what it called deficiencies with the chemistry, manufacturing and controls section of the application. And the FDA was not clear about a change in the proposed process for manufacturing from the trial period. The FDA also said Savient need to produce a medication guide for patients, a communication plan for healthcare professionals and a plan for monitoring the use of both.
I haven't been able to read Savient's application, but my feeling is that none of the FDA's reasons for not approving the application are insurmountable. Savient will meet with the FDA to clarify these issues. They have said they expect to re-apply by early 2010 and that they can address the FDA's concerns.
GET GOUT INFORMATION AT HEALTH FOOD SHOPS
About 10 years ago, when I was living in Singapore, I had re-read one of the best vitamin books ever written IMO - Dr.Atkins' Vita-Nutrient Solution, and had decided to use one of its formulas. I do highly recommend it, although I think Dr.Atkins' account, in this book, of the cause of gout is a bit vague. What a pity we don't know what success he had in treating gout.
My wife had been suffering from painful and powerful migraines for a long time. I thought I'd make a determined effort to use the anti-migraine formula in Dr.Atkins' Vita-Nutrient Solution to attempt a natural cure. I studied his anti-migraine formula, wrote it down and took it to a Singapore health food shop. I'd ask the staff what they thought of it, whether others bought these vitamins for migraines, and what they reported, if anything.
I'd never tried this idea before and wasn't sure whether I'd get accurate and informed replies - the staff could be new, poorly trained, exaggerating to make a sale, or not talking to customers and recording their replies accurately.
I was encouraged by two staff in the shop making the confident assertion that the formula was good for migraines. Pretty soon after I was in Manila, Philippines where my wife was working. I went to a branch of the same chain as in Singapore to double check. The reply was the same, whereupon I bought the rest of the main part of the formula.
My wife took the Atkins formula, which centres around the herb feverfew but has other constituents. Within a day or two she reported feeling better and within a few weeks there had been no more migraine attacks. She occasionally still gets a mild one, which doesn't bother her for long, but nothing on the scale of the former ones, which included the dreadful auras. And the cure has been much much cheaper than the drug medication brand leader in this field. I have used this book successfully for other cures too.
Here's a similar story...and this one is about gout. Last year I was living in The Philippines on the outskirts of the financial district of the capital city, Manila. There is an excellent chain of health food shops in Manila which I frequented just about weekly. Enough to become a familiar face to the sales staff in more than one branch. The chain stocks the excellent U.S. Knudsen pure cherry juice - it's just squeezed cherries, nothing else - and tastes delicious even if in this case, it's been transported a long way from the United States.
Did gout sufferers buy it I asked? Did they say it helps? Oh yes was the unequivocal reply. You can't get many better testimonials than that.
Moral of the stories? If you don't know and follow this practice already (i.e. chatting about gout at health food shops) you can
get very useful health food information from the staff. They talk to lots of customers. Of course you must judge the quality of the answers and observations. But in the absence of research about so many foods, vitamins, minerals and other substances for gout, doing this is one way forward.
You know that the best known home remedy for gout is baking soda (bicarbonate of soda) but why it's helpful in so many cases is not really understood from study based knowledge. My own view, as expressed on the baking soda page, is that it raises pH levels,(the body becomes more alkaline), makes uric acid more soluble and therefore more easily excreted.
Definitive baking soda and gout treatment research is urgently needed. And so it was in 1805 when, I've read, baking soda (bicarbonate of soda) was used in gout treatment. So not much is known and you think that's crazy? It took over 250 years to treat scurvy properly.
But in July the results of a study into baking soda and kidney disease were published in the Journal of the American Society of Nephrology. It was good to read of research into baking soda. Gout and kidney disease are related because poorly functioning kidneys mean less uric acid is excreted. The study, of 134 kidney disease sufferers conducted at the Royal London Hospital, Whitechapel, London, U.K. proved hopeful and intriguing.
When given a small amount of sodium bicarbonate, patients with kidney disease progressed less rapidly to more serious kidney disease than those who were not given it. And they were less likely to reach the stage when they required dialysis.
COFFEE FOR GOUT - GOOD OR BAD?
I had an email from a bgr.com visitor from South Africa about coffee causing gout. This visitor believes too much coffee causes his gout attacks. We know it's possibly true that niacin (nicotinic acid) in espresso coffee, if you drink too many espressos or take a lot of niacin, inhibits uric acid excretion. Therefore uric acid levels rise and so does the risk of a gout attack.
On the other hand, a very large study found the risk of gout is lowered when you drink plenty of coffee. So what's your experience ? Do you think that coffee causes gout, or lowers the risk of it? Hit the reply button to email me, or click on the Contact Us button on www.best-gout-remedies.com home page.
The FDA did approve one gout drug last month - it was Colchicine!
- the 2,000 years old gout remedy. Colchicine is already widely used throughout the world of course, but now its use in the U.S. is official. The research into Colchicine, prior to this approval, threw up some interesting pointers about the safest dose. One item that I'll discuss next month.
John Mepham BA (Hons)
165,Union Street, Maidstone, Kent, United Kingdom ME14 1EY
P.S. You may distribute this newsletter freely and free-of-charge, providing any links in it remain unchanged and it remains intact. Partial copying is not allowed.
NB. The contents of this newsletter contain medical information, not medical advice. Please always discuss gout remedies with a doctor or other health care professional before implementing any treatment.
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