Latest Information On Arthritis Pain Relief!

[Guest guest]

F.D.A. Is Advised to Let Pain Pills Stay on Market

By GARDINER HARRIS

 

Published: New York Times - February 19, 2005

 

 

Most of the advisory panel's members said that the agency should do

the following: place warnings on the drugs' labels detailing their

heart risks; ban consumer advertising for the drugs; and require

each prescription to include a guide outlining the risks.

" I think physicians need to be more thoughtful about how they use

these drugs in the future, " the panel's chairman, Dr. Alastair Wood,

said after the meeting. " It would be a brave man or woman who

started a patient with a clear history of heart disease on these

drugs. "

Dr. John Jenkins, director of the Office of New Drugs at the F.D.A.,

agreed, saying the panel had made clear " that they felt that these

agents should maybe not be as widely used. "

Several panel members said that patients in need of pain relief

should first try naproxen, sold as Aleve by Bayer, before taking any

of the three painkillers known as cox-2 inhibitors - Celebrex and

Bextra, made by Pfizer, or Vioxx, made by Merck.

The panel voted 31 to 1 that Pfizer should be allowed to continue

selling Celebrex, which members said was safer than the other two.

The vote on Bextra was 17 to 13 with 2 abstentions, and 17 to 15 on

Vioxx.

Vioxx has been off the market since September, when Merck withdrew

it after a study showed that it doubled the risk of heart attacks

and stroke, but the company told the panel that it might reintroduce

the drug.

The F.D.A. is not bound to follow the advice of its panels, but it

usually does. Dr. Jenkins said that the agency would announce

regulatory decisions within weeks. Merck, he said, would not be

allowed to reintroduce Vioxx without coming to agreement with the

agency.

Though it is unlikely that the three painkillers will again approach

their previous combined sales of $6 billion a year, Pfizer and Merck

shares rose sharply, with investors apparently relieved that the

panel did not seek to ban the drugs.

Letting the drugs remain on the market, after a thorough review of

the clinical data, could also help the companies build their

defenses against lawsuits filed by patients or their survivors.

Merck is already a defendant in hundreds of such suits, with some

cases expected to go to trial this spring.

The panel was far more comfortable with the safety of Celebrex,

particularly at low doses, than with that of Vioxx or Bextra. Still,

it rejected Pfizer's insistence that there was little evidence that

either Celebrex or Bextra caused heart problems.

Dr. John LaMattina, Pfizer's president of global research and

development, said that all pain relievers, with the possible

exception of naproxen, seemed to increase the risk of heart attacks.

He said doctors should have a " good handle " on the risks of pain

medications after the advisory meeting.

Dr. LaMattina also pledged that Pfizer would not advertise Celebrex

or Bextra in the coming weeks.

" Then after that, " he said, " we will discuss with F.D.A. what we

should and shouldn't do. "

Most panelists were adamant that the drugs not be advertised unless

the advertisements were written by the F.D.A. or an independent

group.

Dr. Jenkins of the F.D.A. said it did not have the power to ban

advertising. But Dr. Wood said that it was unlikely a company would

defy the committee's wishes. " It would be a brave company that would

start an advertising campaign for these drugs, " he said.

Dr. Jenkins said that " we heard the message that the committee

thought Vioxx had a cardiovascular risk that was perhaps larger or

better documented than the others. " If Merck officials want to

reintroduce Vioxx, he went on, " we'll welcome them to come talk to

us about the various paths forward. "

The panel's divided votes on Bextra and Vioxx make interpreting its

advice on those drugs more difficult, Dr. Jenkins said.

The drug agency convened the panel in September after the Vioxx

withdrawal, in the face of concerns that Celebrex and Bextra might

have similar risks.

Celebrex, Bextra and Vioxx were developed because older pain pills

cause ulcers in 1 percent to 4 percent of users. Vioxx was

eventually shown to halve the risk of ulcers, compared with older

pills. Neither Celebrex nor Bextra have ever been proven to be

easier on the stomach.

But arthritis sufferers need something to ease their pain, and many

respond differently to different medications. Some patients told the

panel that Celebrex and Vioxx were the only medicines that allowed

them to live pain-free.

It is far from clear that older medicines, like ibuprofen and

diclofenac, have fewer effects on the heart. Several panel members

worried that by tarring the cox-2 drugs, they would encourage

physicians to prescribe older medications whose risks are not well

understood.

" We will by our actions today cause a shift in prescribing

practices, " said Dr. Steven Nissen, a cardiologist at the Cleveland

Clinic, " and I'm not sure it will be toward safer drugs. "

The panel's decisions were not good news for Pfizer, despite the

rise in its stock. The company had come into the advisory committee

with a strategy to deny almost entirely the notion that Celebrex

increased the risks of heart attacks and strokes and to suggest that

any evidence linking Bextra to such risks was shaky and irrelevant.

This strategy seemed to backfire. Panelists were incredulous that

Pfizer's presentation did not include any information about a large

federally sponsored trial in which patients taking Celebrex had more

than three times as many heart attacks as those given a placebo.

" You're telling us that you don't have data that you published two

days ago in The New England Journal? " Dr. Wood asked.

Dr. LaMattina said the panel's skepticism was unfair. In one case,

Pfizer excluded data from one study because the F.D.A. said that

that study would be discussed by someone else, he said.

Sales for Celebrex last year totaled $3.3 billion, and those for

Bextra totaled $1.3 billion. Sales of both drugs are now about half

what they were last fall.

Sales of Aleve, on the other hand, should receive a lift. Bayer was

forced to scramble in December when researchers suggested that a

large study showed that it, too, increased the risk of heart attack.

Dr. Constantine Lyketsos of Johns Hopkins Hospital, who helped to

oversee that trial, came before the panel to explain what happened.

He said the trial was stopped not because of problems with Aleve but

because of administrative worries.

Panel members criticized Dr. Lyketsos sharply.

" In that media frenzy going on at the time, this announcement was

inappropriate and led to some panic among the public, " Dr. Nissen

said. " It shouldn't have happened, and I hope it doesn't happen

again. "

Panel members largely concluded that naproxen was the safest pain

reliever.

Indeed, most concluded that drug makers wishing to market future

pain pills should compare their experimental drugs with it in

trials, including at least 10,000 patients over two years. Only then

would the drugs be proved to be safe, they said.

Shortly after the drugs' approvals, studies began to show that they

might cause heart attacks and strokes. The panel had to consider

which was worse. Ulcers, whose frequency has declined sharply in the

past 20 years, are fatal less than 5 percent of the time; heart

attacks are fatal in 40 percent of cases, the panel was told. Ulcers

usually heal entirely; heart attacks often cripple.

___________________

__

For Pain Management, Doctors Prescribe Caution

By MARY DUENWALD

 

Published: February 20, 2005

 

 

After a panel of medical experts gave a very cautious nod to the

continued use of the painkillers Celebrex, Vioxx and Bextra on

Friday, pain management experts said they expected to see the same

caution transform the way the painkillers are prescribed from now on.

The drugs, which had been hugely popular for people with both short-

term and chronic pain, will be prescribed much less readily, for a

smaller group of patients, at lower doses and for shorter periods,

the experts said.

" I am still very concerned about the cardiac risks of these

medications, " said Dr. David Campen, director of pharmacy services

at Kaiser Permanente in Oakland, Calif., who led an effort to shift

Kaiser patients off Celebrex and Vioxx and onto other

painkillers. " If you can get away with a safer medication, you ought

to. "

But doctors expressed relief that they are likely to still have the

drugs at their disposal.

" All of us have been reacting to the news as it comes forward, as to

whether some of our tools will be taken off the market, " said Dr.

Raymond Gaeta, an anesthesiologist who directs Stanford's pain

management clinic. " This is good news for patients over all. Clearly

there are side effects with every medication, but it's really

important to weigh the potential side effects versus the benefits

for an individual patient. "

On Friday the panel warned that all three drugs increased the risk

of heart attack and strokes, although Celebrex is less hazardous

than the other two, and recommended that the Food and Drug

Administration place new warnings to that effect on their labels.

But the experts also said the benefits to some patients outweighed

the risks and concluded that the drugs should remain on the market.

The agency usually follows the advice of its advisory panels.

While acknowledging the risks of the drugs, doctors pointed out that

no drug was perfect for every patient. " As a physician, I like to

have a choice of treatments, because people are different and some

respond well to them, " said Dr. James F. Fries, an arthritis

specialist at Stanford University.

Dr. Sudhir Diwan, director of the division of pain medicine at New

York-Presbyterian Hospital, said, " We all have found that these

drugs can be very, very good in pain control and easy on the

stomach, " adding, " But it is true that we must do a better job of

informing the public that these medications do have side effects. "

Before prescribing any of the three drugs, doctors should carefully

evaluate their patients' risk of heart problems, said Dr. Garret A.

FitzGerald, a cardiologist at the University of Pennsylvania medical

school, in Philadelphia, who was among those who spoke before the

F.D.A. panel to warn of the drugs' risks. " Obviously one of the

things to check is blood pressure, " Dr. FitzGerald said. " And it's

certainly wise to look at an echocardiogram to see if there is any

impairment in cardiac performance. " He said such drugs could help

some patients with chronic pain who are prone to stomach irritation.

Anyone who has had a stroke or who has existing heart disease should

be kept off the drugs, said Dr. Gaeta of Stanford, as should someone

with obvious heart disease risk factors, like a diabetic smoker.

Unfortunately, many patients who are candidates for Celebrex, Vioxx

and Bextra, because they are prone to stomach bleeding, are the same

ones who are at risk for heart attack, said Dr. Campen of Kaiser

Permanente. These patients tend to be older or have other health

problems.

Doctors should also stick to low doses of the medications, said Dr.

Fries, the Stanford arthritis specialist, noting that in the studies

that have shown heart risks, patients took relatively large amounts.

Patients should take 10 milligrams of Bextra a day, rather than 20,

he said, and 200 milligrams of Celebrex, rather than 400. And if

Vioxx comes back on the market, it should be prescribed in 25-

milligram doses rather than 50, Dr. Fries said.

 

 

___________

 

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__________

[Guest guest]

Are there any natural or holeopathic remedies for arthritis pain relief?

 

 

Thanks.

 

mary

For the Lord God helps Me; therefore have I not been ashamed or confounded. Therefore have I set My face like a flint, and I know that I shall not be put to shame. Isa 50:7

Search presents - Jib Jab's 'Second Term'

[Guest guest]

yes i think homoeopathic medicine would be the excellent choice without any side effects.

rgds,

sameena

 

 

 

 

Mary Reilly <setlikeflint wrote:

Are there any natural or holeopathic remedies for arthritis pain relief?

 

 

Thanks.

 

mary

 

For the Lord God helps Me; therefore have I not been ashamed or confounded. Therefore have I set My face like a flint, and I know that I shall not be put to shame. Isa 50:7

 

 

Search presents - Jib Jab's 'Second Term' ********************************************* WWW.PEACEFULMIND.COM Sponsors Alternative Answers-HEALING NATURALLY- this is the premise of HOLISTIC HEALTH. Preventative and Curative measure to take for many ailments at:http://www.peacefulmind.com/ailments_frame.htm__________-To INVITE A FRIEND to our healing community, copy and paste this address in an email to them:http://www./members_add _________To ADD A LINK, RESOURCE, OR WEBSITE to Alternative Answers please Go to: http://www./links___________Community email addresses: Post message: Subscribe: - Un: - List owner: -owner _______Shortcut URL to this page: http://www.

[Guest guest]

22.2.05

 

yes it is there. in the files section in mudra folder , you will find one joints pain mudra ( yogic hand posture system) which clears it within few weeks.

 

with light & love

d.k.kothari

 

-

Mary Reilly

Tuesday, February 22, 2005 7:47 PM

Re: Latest Information On Arthritis Pain Relief!

 

Are there any natural or holeopathic remedies for arthritis pain relief?

 

 

Thanks.

 

mary

 

For the Lord God helps Me; therefore have I not been ashamed or confounded. Therefore have I set My face like a flint, and I know that I shall not be put to shame. Isa 50:7

 

 

 

 

 

Version: 7.0.300 / Virus Database: 266.1.0 - Release 02/18/2005

[Guest guest]

Whilst not a remedy as such, as I have found Reiki

treatments to useful in managing arthritic pains in

joints.

trgards

Paul

[Guest guest]

Yes. Although pain is not something one can claim to relieve unless safely in the camp of the powerful few. However, if it is true that it disrupts the free flow of energy and that strength and endurance becomes less, what would it mean if strength and endurance became more. Now, you begin to see how you can see beyond what is said.

 

Much Love in Spirit,

 

Stephen A.Brown, PhD

 

www.lifewave.com/drsabrown

 

 

Mary Reilly [setlikeflint] Tuesday, February 22, 2005 9:17 AM Subject: Re: Latest Information On Arthritis Pain Relief!

 

Are there any natural or holeopathic remedies for arthritis pain relief?

 

 

Thanks.

 

mary

 

For the Lord God helps Me; therefore have I not been ashamed or confounded. Therefore have I set My face like a flint, and I know that I shall not be put to shame. Isa 50:7

 

 

Search presents - Jib Jab's 'Second Term' ********************************************* WWW.PEACEFULMIND.COM Sponsors Alternative Answers-HEALING NATURALLY- this is the premise of HOLISTIC HEALTH. Preventative and Curative measure to take for many ailments at:http://www.peacefulmind.com/ailments_frame.htm__________-To INVITE A FRIEND to our healing community, copy and paste this address in an email to them:http://www./members_add _________To ADD A LINK, RESOURCE, OR WEBSITE to Alternative Answers please Go to: http://www./links___________Community email addresses: Post message: Subscribe: - Un: - List owner: -owner _______Shortcut URL to this page: http://www.