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The Gout Dugout newsletter.Issue#011.Febuxostat & pegloticase latest news,Benjamin Franklin's gout,
November 01, 2008
A warm welcome to November's Gout Dugout, and to those gout interested folks who have signed up since the October edition. I'll begin with two items of real gout news.
FEBUXOSTAT'S FDA MEETING
Febuxostat is almost certainly the most widely studied gout drug in history. It was approved for member nations of the EU in May this year, but has not yet been approved for the U.S. and many other countries. Febuxostat has demonstrated that it is more potent than allopurinol, although in EU countries certain categories of gout sufferers cannot be prescribed it. More details are on the febuxostat page.
Its developers did apply to the U.S. FDA for approval, but I have been wondering for months why nothing has been heard from the FDA.
However, I am glad to report that the FDA is is working on it. The latest development is that there will be a day-long meeting of the FDA's Arthritis Advisory Committee in late November this year, solely to "chew the fat" about its approval.
The general public can attend. The meeting will be held at the Hilton Washington hotel in Silver Spring, Maryland. I doubt any reader would be able to attend, but if you are interested please email me for more details.
US FDA approval is very important of course to febuxostat. If this is obtained, it means that it will have been approved by both the European Medicines Agency and the FDA. With that kind of backing it's hard to see how many other countries would not approve it.
If any news can be reported from this meeting, I'll do so in the December edition.This is the kind of item that's always reserved for readers of the Gout Dugout first, as is the next item, and goes on the website later, so keep reading your monthly edition!
SAVIENT APPLIES FOR FDA APPROVAL OF PEGLOTICASE
Savient Pharmaceuticals, the developers of pegloticase, had said that they would apply to the FDA by the end of October. And this is what they have done, actually on October 31.
They presented more information about its progress at the recent American College of Rheumatology (ACR) meeting in San Francisco. (They had completed its Phase 3 trials and an extension trial). The extension trial showed a good continuing performance both against gout attacks, and especially for clearing up tophi.
Last week the problem was,at least as Wall Street saw it, that five people on pegloticase in the whole trial program died, two of which were from cardiac events. (Presumably heart attacks or strokes). Of course, if this happens there's always an immediate investigation. This concluded that pegloticase had not caused these deaths. And a few on a placebo (dummy drug) died too. But when Wall Street heard about it, Savient's shares plummeted, but are now maybe an excellent buy.
Opinion amongst financial analysts was divided as to whether this meant Savient won't get approval, or that extra trials will be called for, or that it will, or that it will but for a more restricted class of gout patients.
Part of the difficulty in sorting out the confusion, if that's really what it was, is that pegloticase was trialed on gout patients who have serious health problems. That's what this new drug for gout is all about. Febuxostat,which doesn't tackle such hard to treat patients, has been approved in EU countries, but is not recommended for those with heart disease.
Moreover, five other patients who had serious cardiac events, but not death, continued to receive pegloticase successfully. Other patients showed their favourable opinion of pegloticase by wishing to remain on it after their treatment ended. And most of the deaths had been reported by Savient earlier anyway.
The US FDA will take all of this into account of course. It's what they conclude that matters, not what Wall Street thinks. What can certainly be said is that pegloticase is in a new phase and it may be approved before the summer of 2009.
I will go into more details about what Savient reported about pegloticase in the extension trial in the December edition. If it's FDA approved,Savient will next apply to the European Medicines Agency, then to other areas of the world.
RDEA 594 and XOMA 594 also reported continuing progress at the ACR meeting, but these two are years away from approval.
THE GOUT AND VITAMIN C REPORT
For the past few months new subscribers to this newsletter have received a free Gout and Vitamin C report. If any readers who subscribed before this offer went live would like a free copy, please email me and I'll send it by email attachment. Since it was written I've collected more evidence that vitamin C lowers uric acid levels. Just one caveat, mega doses of vitamin C may not be a good idea.
BENJAMIN FRANKLIN'S GOUT
I've recently read a biography on Benjamin Franklin, that reluctant revolutionary whose image is on the US$100 banknote (bill). The author didn't say what his favourite foods were. Franklin did not guess exactly what caused his gout but in his fairly well known essay "a dialogue with gout", he revealed that he knew it was something to do with his diet and lack of exercise. (The role of uric acid was not known in his lifetime, although the MSU crystals were). He never dealt with it well, that is he never it seems bothered to diet, although he went through one five year spell without an attack.
After his first gout attacks, he continued so it was said, to drink two bottles of wine a day, sometimes per meal! It was a habit that cannot have been discouraged by living in France for eight years when he was under considerable pressure trying to get military supplies to American revolutionaries, and bring the French into the war. He knew that about half his household were working for the British Intelligence organization of that time – copying his letters, noting his visitors and probably listening through keyholes. (i.e. Stress plus alcohol causing and aggravating gout).
Franklin also spent about 18, mainly happy and not especially stressful it seems, years of his adult life in Britain. He drank his two daily bottles there too, so perhaps it was the pleasurable habit and not the stress.
True to form, his gout worsened as he aged. He had also developed a paunch so he was over weight. Attacks became longer and laid him up, on one occasion for up to two months, but usually for two or three weeks.
Any prominent present day politicians who suffer from gout? I can think of two who have been reported to suffer it, although I haven't asked them personally. One is the U.S. Vice President Dick Cheney, and the other is the British politician and once Deputy Prime Minister, Michael Heseltine. Heseltine suffered gout attacks, he said, from heart medications he was given during/after a heart attack.
USEFUL ADDITIONS TO THE WEBSITE
The only diet that has been studied against gout, (apart from the low purine diet) is the one I described on the gout sufferers diet page and wrote about in the February 2008 issue of the Gout Dugout. The diet had a lot of success against gout – it was based on Barry Sears' Zone diet. It worked against some markers of insulin resistance, (aka the metabolic syndrome) another leading cause of hyperuricemia (excess uric acid) according to at least three studies. I personally think it is a bigger cause of gout these days than purines or genetic factors. It also reduced or ended gout attacks in a decent per cent of patients, and lowered blood uric acid (UA) levels. UA was normalised in 7 of 12 patients. No other natural remedies were used. If that isn't a pretty good result, I don't know what is.
The study tested only 13 people, which is not many, but they were all gout sufferers. And their average starting blood uric acid level was high, almost 10.0 mg/dL. In the febuxostat trials I recall that people at this initial level had more difficulty getting it down to 6.0 mg/dL.
The study was conducted in South Africa as long as nine years ago, and it has not been followed up with a much larger one. The mind boggles at this omission, but in this case we have to deal with the world as it is, not as we would like it to be. (If any member of a rheumatology association, anywhere, reads this please take note).
Looking at this page the other day, I realised that I hadn't included a link for readers to actually download the study for themselves, although I did describe it in some detail. You can get the study free, courtesy of the British Medical Journal. As gout studies go, it's not the most difficult for a layperson to understand, and is six pages long. Email me if you have any questions.
The uric acid amounts are in mmol/L. To convert to mg/dL divide the mmol/L amount by 0.059. Read it three times with full concentration and you will have mastered it. The Zone diet itself of course takes longer to master.
The British Medical Journal require you to register with them, but don't require much personal information. The link is now on the gout sufferer's diet page.
Potassium citrate and Chromium Picolinate There are now pages on the website about potassium citrate (which alkalizes urine and has lowered uric acid levels) and chromium picolinate (which may help in cases of insulin resistance, hyperinsulinism, and hyperglycemia. i.e. high blood sugar).
http://www.best-gout-remedies.com/potassium-citrate http://www.best-gout-remedies.com/chromium-picolinate Or visit www.best-gout-remedies.com/vitamins-for-gout.html and www.best-gout-remedies.com/chromium-picolinate-for-gout.html
TRAVERSE BAY FARMS OFFER STILL ONGOING
I have written before about the quality of the Fruit Advantage
Supplements from Traverse Bay Farms. Their free shipping on
many good for gout supplements such as cherries and blueberries
is still ongoing, also the Gout-Haters cookcooks.But you have to live in the continuous U.S.More details on the cherries page.
In next month's issue, among other items, I am afraid I shall have to be a potential spoilsport and discuss two foods you shouldn't eat at Christmas. One study has shown that one of them, in its juice form at least, raises urine uric acid levels, and it's not a high purine food. The other is not well known as a high purine food, but some say it is. They are both easily passed up and are not turkeys. All the best,
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 remedies with your doctor or other health care professional before implementing any treatment.
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