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Shingles vaccine given OK by FDA advisory panel
Seattle Post-Intelligencer ^ | December 16, 2005 | JOHN J. LUMPKIN

Posted on 12/16/2005 8:42:38 PM PST by neverdem

ASSOCIATED PRESS

WASHINGTON -- Federal health advisers endorsed a proposed vaccine on Thursday to help prevent shingles, an often-excruciating disease that afflicts as many as 1 million adults every year.

The Food and Drug Administration's advisory panel on vaccines said the vaccine for shingles appeared to be safe and effective in people age 60 and older. However, panelists worried its effectiveness may not last, and said it appeared to be less effective in people over 80.

The vaccine, Zostavax, was developed by Merck & Co., which sought to have it approved for use in people aged 50 and older.

But Merck conducted trials mostly on people 60 and older, leaving the members of the FDA panel on vaccines uncertain whether it was safe or effective for those in their 50s.

Whether to approve the vaccine for sale is now in the hands of the FDA, which often follows the advice of its advisory panels. Even if the FDA approves it for use only in those 60 and older, doctors could still prescribe it for younger people.

People develop shingles as they age because their immunity to the chickenpox virus wanes. The condition usually starts with pain or itching in a band on the skin, followed by a rash or blisters that can last for days or weeks. It can sometimes cause long-term nerve pain.

"The need is there," Dr. Jeffrey Silber, a senior researcher with Merck, told the FDA panel.

Although they generally supported its use, panelists questioned how long the vaccination would be effective, or whether it would only stave off shingles for a few years.

If its effectiveness does decrease, a patient might have to get a booster or risk becoming more seriously ill with the condition after the vaccine wears off.

Silber said the trials showed the vaccine was effective for at least four years, and studies were ongoing to establish its long-term effectiveness, which remains uncertain.

"This is always a question with every new vaccine," he said.

Panelists wondered about data that suggested its effectiveness decreased in people 70 and older. Dr. Patricia Rohan of the FDA said the trial data showed some drop-off in effectiveness among people over 70 years old.

While most vaccines prevent the body from acquiring an illness, this vaccine is unusual in that it may prevent a flare-up of a virus already in the system.

Panelists called on Merck to conduct additional studies on the vaccine. Zostavax is based on the company's chickenpox vaccine, but is built around a much more potent dose.

The favorable vote is another boost for beleaguered Merck, which also won an endorsement of its new vaccine for rotavirus on Wednesday. Merck is facing thousands of lawsuits over its Vioxx painkiller.


TOPICS: Business/Economy; Culture/Society; Extended News; Government; News/Current Events; US: District of Columbia; US: Maryland
KEYWORDS: fda; shingles; vaccine
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1 posted on 12/16/2005 8:42:40 PM PST by neverdem
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To: neverdem

Just had a bout with that, still a tiny patch left. I never had them before. Don't run to get vaccines, but if they recur and are as severe as I've heard they can get, it's sure nice to know about it. Thanks for posting.


2 posted on 12/16/2005 8:45:50 PM PST by Aliska
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To: Aliska

My brother thinks he may be getting shingles. He has a tingly patch of skin on his back, and what feels like stabbing pain. He has some acclivir (sp?) coming tomorrow, but other than an antiviral-- anybody have any tips for him? I figure if he starts now, before a rash develops, the better.


3 posted on 12/16/2005 8:50:57 PM PST by emiller
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To: Aliska

My grandfather had it as well as another person I know. It can cause such discomfort! Far worse than worst case of chicken pox.


4 posted on 12/16/2005 8:54:17 PM PST by ozaukeemom (Nuke the ACLU and their snivel rights!)
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To: Aliska; emiller; ozaukeemom

http://search.nlm.nih.gov/medlineplus/query?DISAMBIGUATION=true&FUNCTION=search&SERVER2=server2&SERVER1=server1&PARAMETER=shingles


5 posted on 12/16/2005 9:06:07 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: emiller
My brother thinks he may be getting shingles. He has a tingly patch of skin on his back, and what feels like stabbing pain. He has some acclivir (sp?) coming tomorrow, but other than an antiviral-- anybody have any tips for him? I figure if he starts now, before a rash develops, the better.

I had it several years ago, and it was some of the most severe pain I've ever experienced. And it took nearly a year before the pain completely went away, but that was probably because I was working way too much (I wasn't even able to take any time off during the initial outbreak). Because of the stress I was under, and a lack of sleep (every time I moved I would wake myself up. I think I averaged 2 or 3 hours of sleep a night during the week) it lasted far longer than it should have.

Your brother needs to do everything possible to build up his immune system as quickly as possible. Reduce levels of stress, and get plenty of rest.

Your brother needs to get on the anti-virals as quickly as possible. As far as pain goes, there are topical ointments (non-Rx) that helped me a little bit, with capsacin. Rx treatments are standard pain killers, like hydrocodone, but I couldn't take those during the week, only weekends, and believe it or not, certain anti-depressants. Since the pain is actually directly from the nerves, some anti-depressants can help control the pain.

FWIW, I've had some pretty painful conditions in the past, and Shingles was probably the worst.

Mark

6 posted on 12/16/2005 9:18:01 PM PST by MarkL (I swear by my pretty floral bonnet that I will end you!)
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To: MarkL

Capsacin is incredible stuff! Do not get any of it in any membrane. It is very hot pepper.I used surgical gloves to apply it.Shingles is like nothing I have ever seen befor.


7 posted on 12/16/2005 9:35:56 PM PST by ozaukeemom (Nuke the ACLU and their snivel rights!)
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To: neverdem

One of the people I knew did develop neuropathy. He was also told it is quite common to have a recurrence.


8 posted on 12/16/2005 9:40:52 PM PST by ozaukeemom (Nuke the ACLU and their snivel rights!)
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To: ozaukeemom

Some folks get a persistent postherpetic neuralgia that's a relentless agony. I didn't get it three years ago, maybe because I took Valtrex for 3 - 4 weeks.


9 posted on 12/16/2005 9:55:26 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem

I've treated many patiets with shingles. What a terrible thing to have. I really feel sorry for them.

This is good news.


10 posted on 12/16/2005 9:57:56 PM PST by Gamecock ("God does not look for men fit to be elected; he makes them so." Saint Augustine)
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To: Carolinamom

ping


11 posted on 12/16/2005 10:02:15 PM PST by kayak (Praying for MozartLover's son, all our military, and our President every day!)
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To: emiller

If he takes Valtrex within 72 hours of the outbreak, the course of the shingles will be greatly lessened. I had shingles several years ago, it was hands down the most painful thing I have ever experienced. And they were on the left side of my face, I looked like I had some terrible contagious disease. If your brother's dr is good, he will prescribe pain pills and sleeping pills and whatever else your brother needs for comfort. He has my sympathy.


12 posted on 12/16/2005 10:14:43 PM PST by Utah Girl
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To: El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; ..
FDA rules anthrax vaccine safe, effective

Congress agrees to set up cord blood bank

CDC recommends new blood test for TB

FReepmail me if you want on or off my health and science ping list.

13 posted on 12/16/2005 10:41:27 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem

I had shingles 2 1/2 years ago, and like others have said--it was the most excruciating pain I've ever experienced in my life, even more painful than going through labor and delivery.

One thing that helped relieve the pain for me was using a product called "Shingles No More" sold by Forces of Nature, www.fonoils.com. It contained the organic oils: Ravansara, Palmarosa, Lavender, and Cymbopogon. There are probably other things that will help, too. I gained the most relief, however, by putting ice on the affected part.


14 posted on 12/16/2005 11:39:06 PM PST by Nan48
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To: neverdem

Herpes Zoster killed my father. He was 85. This stuff can be deadly. It was not a good death.


15 posted on 12/17/2005 2:31:01 AM PST by Banjoguy (I will rot in Hell before I buy another Dell!)
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To: emiller; PoorMuttly; hiredhand

Dr Muttly clued me into L-lysine. Take 10 at a time, about three times a day along with the antiviral prescription and pain meds the doc will give ya.....

TAKE the L-lysine the prescription powerful pain meds, take the seven day therapy prescription AV meds and lots of the L-Lysine vitamin.....more than ya would think is safe.

Wish this illness on not even your worst enemy.....I've been shot, dropped, cut, broke, burnt, beat , blown up and talked bad about yet can tell ya those hurts were childs play compared to the shingles....first sign get yor hiney to the doc ASAP !!!

Felt like a kidney stone combination gall bladder attack after someone had beat me in the back, ribs and gut with a louisville slugger baseball batfor a few hours. I was down and out for 4+ weeks and am still taking pain meds as it is very painful folks.....a world of hurt. Avoid at all cost. If ya have a choice of losing a limb or shingles fess us the limb gladly !


16 posted on 12/17/2005 5:40:15 AM PST by Squantos (Be polite. Be professional. But, have a plan to kill everyone you meet. ©)
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To: neverdem

Shingles is a living hell. I hope this vaccine is not destroyed by the crooked trial lawyers and the anti-vaccine whackjobs.


17 posted on 12/17/2005 8:08:31 AM PST by FormerACLUmember
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To: Squantos; All

To make a long story shorter, I found out about cold sores from some actors doing close-up shots. They had eaten Reeses Pieces the day before, and developed problems the next day...and then someone explained it to us...it was the chocolate and peanuts! Really!

This is the deal....viruses multiply by taking some of their own DNA and putting it into a protective Protein Coating, like a test tube. It is made out of the amino acid Arginine, the thing in chicken soup which is said to help prevent colds, and strengthen the immune system. The problem occurs when a virus has already gotten a foothold...then it feeds them. So, theoretically, if one starves the system of Arginine, which is found in POULTRY, CHOCOLATE, and NUTS, they say, and floods the system with the amino acid L-Lysine, especially in powder-capsule form, the virus must choose the inferior building material L-Lysine, or not reproduce. It does, and when the white blood cells (I think) attack the new viruses, the protein shell fails, and the new virus dies.

I recall that dairy products and Flounder, especially steamed flounder, is full of Lysine. The actors went out to dinner that night, and the next day, it appeared that the sores were going away. Then an incredible thing happened. One of their friends said she had an idea, went to the health food store and returned with a small bottle of Grapefruit Seed Extract. She placed a drop on each spot, with an eyedropper, waited a minute, then wiped it off with a moist tissue. By that night, the stuff was GONE! I mean, really not even there, gone.

I had a cold sore when I was very, very little, and I still remember that it hurt like hell. I haven't had one since, but if I ever do....

It is said that chicken pox, cold sores, herpes 1 and 2, and shingles are pretty much the same thing, and all viruses, like some other pretty nasty ones running around these days. I would imagine that they all would respond to roughly the same treatments, which is why I changed into my white lab coat with headlamp and stethescope, and advised my friend Squantos to give it a try, since he was suffering so. I use the stethescope to search for engine knocks, so had to wipe the motor oil off of it, but fortunately I did not have to use it. That would have required soaking in marvel mystery oil, as we medical professionals do with almost everything, except our baloney sammiches.

Trust me. I once played a surgeon in a school play.


18 posted on 12/17/2005 11:14:49 AM PST by PoorMuttly ("He is a [sane] man who can have tragedy in his heart and comedy in his head." - G.K.Chesterton)
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To: PoorMuttly

Hmmmm Grapefruit Seed Extract.....fergot about that goop !

I'm on my way to GNC to restock the voo doo locker errrr medicine cabinet w/ l-lysine anyway....will get the extract too just in case .


19 posted on 12/17/2005 11:24:20 AM PST by Squantos (Be polite. Be professional. But, have a plan to kill everyone you meet. ©)
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To: Squantos

I understand it can stun the Screaming Mimis, and if spilled, burn a hole to China.

Guess I shoulda mentioned that earlier.

Uh...sorry....I plum fergot!

I think NASA uses it to kill intergallactic microbes too. They have a glass lined vat of it in Area 52.


20 posted on 12/17/2005 6:29:19 PM PST by PoorMuttly ("He is a [sane] man who can have tragedy in his heart and comedy in his head." - G.K.Chesterton)
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