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The Gout Dugout.Issue #034. FDA thumbs up for Krystexxa and be careful of cherries from heaven
November 01, 2010
THE EARLIER OCTOBER "ISSUE"
First of all a massive apology. The so-called last edition of The Gout Dugout newsletter you received was essentially the September edition repeated and you probably wondered what on earth had happened.
What happened was that my father died at 88 in late September. This meant I had of course to return to my native land, Britain, from the Philippines where I now live, for his funeral, and for the legal and financial stuff that has to be done after it.
Amidst all this I had no time or thought for anything else. And I completely forgot that I had set up the October Gout Dugout to be sent out on October 7 without actually writing much of it. So what you got was the September issue again, because I planned to use it as a basic template to write the October one! The program that handles the newsletter just sent it out!
This means this issue here is really the October one and I'll write and send out the November one in a couple of weeks.
We have a new gout drug. On September 14 the U.S. FDA approved Krystexxa (Pegloticase) for the two weeks course of intravenous infusions. This was the period that performed best in its trials. I won't repeat what I've already written about this on www.best-gout-remedies.com. There are two new pages about Krystexxa -
the upbeat page
and the page discussing
the side effects, expense and likely availability date.
Worth its weight in gold?
Ounce for ounce it wil probably cost more than gold. If you are a chronic gout sufferer, which in the world of conventional medicine means the other drugs don't work for you for some reason, you should be able (for the time being if you live in the U.S.) to get yourself on a course of Krystexxa, if some organisation (organization) will pay for it. Its price hasn't yet been announced but this isn't a cheap tablet like allopurinol, nor an expensive one like febuxostat.(Uloric, Adenuric,Feburic). Krystexxa is going to cost thousands of dollars for a year's treatment.
From the trials we learnt that most people will need at least 6 months, some a year and some over a year to get the desired results of an end to gout flares and maybe the end of tophi. And that is as long as they can take Krystexxa's side effects, which a majority of people can. Just how many dollars, will be announced when it's ready to be distributed. But it's not yet ready.
Unlike febuxostat, which was being marketed in the U.S. within a few days of FDA approval, it's not available yet because, whilst its developers, Savient Pharmaceuticals, have enough stock for a launch, they also wanted to sell their business as soon as they got approval.However, a few days ago Savient said they hadn't been able to sell their business, and they are still planning the Krystexxa launch.They had talked about their moral obligation to get the drug out asap. So we await developments.They think they can begin distribution in November. So, if you live in the U.S. and if you think Krystexxa is for you, you can start to make enquiries.
There's no doubt that Krystexxa can lower uric acid dramatically - in its trials, in some people, uric acid went from 10.0 mg/dL to below 1.0 mg/dL in a matter of hours or days. What has to be remembered is that uric acid is the most abundant antioxidant in the blood. There is much more in the blood, than Vitamins C and E and the carotenoids for example. I never read the effects of such a low level of uric acid on free radicals,(the aging compounds) in the Krystexxa research, and I poured over a lot of it, so you might care to discuss this with your doctor, if you do get on a Krystexxa course. He/she might say you need to take more of the antioxidant vitamins (including Glutathione and Selenium) plus the ones mentioned above.
Getting off Krystexxa
The second query in my mind is that we simply don't know what happens when you go off Krystexxa. Whoever's paying for it will want this to happen at some point. Let's asume it gets your uric acid down and the gout flares end and a couple of tophi dissolve away. That's great, but because it will cost so much, who is going to pay for it for years? It is, say Savient, patent protected in various ways until 2026 so no one can compete with it with a similar product till then, or around then. So there is no pressure for prices to fall for a long time.
Savient have said that people have been able to go back on it in the extension studies, but of course they said those who do must be very carefully monitored.
If any reader has experience of being infused with rasburicase for gout (Elitek or Fasturtec), which works in a similar way to Krystexxa (pegloticase), and has been aproved for children and adults in EU countries and the U.S. for a number of years - but only for gout caused by tumor lysis syndrome - please write in to pass on your own experience.
As usual with gout drugs it's what you do after success that's under stated. We all know that gout can self start again if you give it a chance by allowing your uric acid levels to rise.
I don't want to be dreary. Congratulations to Savient Pharmaceuticals, and to the drug's two inventors, for getting this fairly revolutionary treatment to FDA approval, and navigating through a few storms on the way. It's probably the most effective gout treatment ever, if you can take it for long enough, although there was one in the 19th century that is now almost forgotten, that was pretty good too according to one major expert at that time. Let's hope that the 170,000 gout sufferers in the U.S., who need Krystexxa can get it.
It will be very interesting to see what Britain's NHS (generally speaking, free heathcare for all Britons funded by general taxation) makes of this new gout drug, when it comes to decide if it is going to pay for it. That may be in about a year's time if you live in Britain or another EU country.
A couple of years ago or so, the British NHS analysed Febuxosat's costs v its benefits very carefully with an expert loaded committee plus a statistics wizard, before it decided it would make it available, but only if absolutely necessary. Krystexxa will cost much more than Febuxostat.
Competition on the horizon?
Krystexxa may get some competition in the not too distant future. 400 mg of RDEA594 combined with 40 mg of febuxostat has lowered uric acid to very low levels too - a mean serum uric acid level of 1.2 mg/dL in one trial. RDEA594 is still a few years from approval possibility. It's been tested as a tablet, capsule and in a solution. So it won't be an expensive biologic like Krystexxa, and I think without the number and type of side effects that Krystexxa causes. But it may not be as good against tophi.
CHERRIES FROM HEAVEN?
Cherries for gout is an old remedy. In September I told the story of the fellow who could usually stave off gout attacks by eating some cherry pie. And if you have read a lot about cherries for gout you'll know there are many other ways of eating them, or drinking their juice. A few days later a little bell rang in my mind with a warning. It's the complacency, such delicious ways of dealing with gout successfully could easily cause. It's a similar sort of complacency you have when, in my opinion, alcohol is decreed not to be a cause of gout. This is sometimes said despite all the studies and stories to the contrary. So what is the complacency?
You must always keep in mind that gout is a progressive disease, that's only really controlled if you keep uric acid levels down. Whilst you may have a period of the rest of your life when
cherry juice or celery and the rest work, that may not always be the case and shouldn't be relied on. In other words don't assume these substances will always work. Staving off gout attacks like this is wonderful, but in the end, it's constant concentration on the uric acid level that matters and I don't think any gout sufferer should forget this.
One of the major lifestyle changes you have to make after you've had a first gout attack is a change in what you eat. The foods you have enjoyed in the past have probably contributed to your gout. If you really want a dietary solution to gout, a lot of former assumptions, beliefs and pleasures have to go out of the window, if you are going to be mentally equipped to win the dietary struggle ahead. And struggle it will be if you are to make a successful transition to new foods.
As you know, there are at least four diets which can get uric acid down, plus probably even a restricted calories diet will too if you lose enough weight on it. These are: a low purine diet if excess purines is your cause of gout; both the Zone diet (proven in one study) and the Atkins diet, if insulin resistance is the main cause; and an alkaline diet if you wish to raise blood pH and thus make uric acid less likely to crystallise (crystallize) and be more soluble.
And shedding old habits, means too ignoring the books, articles and T.V. programmes (programs) of celebrity chefs, most of whom I would guess do not know the difference between purines and peas. From now on, if you've been a celebrity chef follower remember, their focus is not yours. Your focus is only on foods for health. Or as Barry Sears of the Zone diet would put it, food is the most powerful drug you can put in your mouth. I'm not sure I completely agree with that in all cases, but his books explain how you can get amazing results from the right food intake.
The cookbooks you consult should only be those related to the diet you're trying and not eating just what you feel like.
I'll now mention one book about food I recommend for all gout sufferers. A library copy won't be any good because this one is so packed with information you'll want to consult it time and time again, if it interests you.
The chef's cook book
This is the book its covers' sales copy says is the one the chefs use if they really want to find out more about how to gain extra culinary refinements and about the food's origins. Plus hundreds of other facts, opinions and tips. In a gout sufferers case it is not essential to understand all this about food. Just follow the diets and learn as much as you can about gout.
But if you are genuinely interested in food, you'll enjoy owning it, and deepen your understanding of what's healthy and what isn't. So what am I writing about? It's by an American who has so much knowledge about food globally that you aren't buying an American cookbook. You are buying one of the world's best sources of information about food, and what's more one that is fairly easy to understand.
The book is Harold McGhee's On Food and Cooking; The Science and Lore of the Kitchen. Get the latest 2004 edition.
science and chemistry is such as big subject that although there's over 800 pages, he doesn't mention purines, list purines tables or mention uric acid, but you aren't buying it to learn about purines. There are frequent references to pH throughout the book. And it's well explained so you do have the chance to deepen your understanding of pH. But if you want to sharpen your pencil for knowing what's really what about food (and maybe get somewhat depressed occasionally in supermarkets) this is an excellent book.
FREE pH FOODS CHART AND RECIPES
As mentioned above, many diets are capable of getting the uric acid level down. One is an alkaline (pH) diet. If you want a free pH food chart with 45 alkalizing recipes, click on this link to phionbalance.com and when the home page arrives, the download link for the chart is on the right. You can then print out the food chart, so that you can take it with you when you go shopping for food.
John Mepham BA.(Econ).
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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