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 Post subject: Canadian panel says Vioxx OK for market
PostPosted: Thu Jul 07, 2005 9:28 pm 
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http://money.cnn.com/2005/07/07/news/fortune500/canada_vioxx.reut/index.htm

Panel concludes that Vioxx and Pfizer's Celebrex should be available despite cardiovascular risks.
July 7, 2005: 12:13 PM EDT

The panel also recommended that Pfizer Inc.'s (down $0.27 to $26.50, Research) rival pain medicine Celebrex be allowed to stay on the market but that Pfizer's Bextra, another arthritis drug, be kept off the market.

Shares of Merck (down $0.30 to $30.26, Research) were down 0.5 percent in early trading Thursday.

The panel met at the government's request last month to study the risks of the three drugs, known as COX-2 inhibitors, following reports of increased heart disease and stroke.

Health Canada, the federal agency responsible for drug regulation, must now decide whether to accept the panel's recommendations, according to Canadian Press.

Merck voluntarily withdrew Vioxx from the market last September because of concern about such reports.

On April 7, Pfizer Canada announced the suspension of its Bextra, following the United States' lead. It continued to sell Celebrex, but under restrictions.

The panel was unanimous on Thursday in recommending that Celebrex continue to be sold. It said the increased risk of cardiovascular disease was similar to that of other pain medicine while gastrointestinal harm appeared to be less.

"Patients benefit from having a variety of drugs to choose from for pain relief," the report said.

By a vote of 12 to 1, the body recommended that Merck's Vioxx be allowed back on the market, for the same reasons. The lone dissenter said evidence suggested that Vioxx had a higher risk of cardiovascular harm than Celebrex, especially at higher doses.

The vote was 8 to 5 against the reintroduction of Bextra, in part because there was not enough information available yet and because of a possible risk of a rare but serious skin disorder.

The panel recommended that warnings about the risks of Celebrex and Vioxx be added to the material given to patients.

Wednesday Merck picked up the license for a crucial schizophrenia drug from a Japanese company -- read more here.



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PostPosted: Thu Jul 07, 2005 9:30 pm 
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They voted 12 to 1 to let Vioxx back on the market in Canada.

:roll:

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PostPosted: Thu Jul 07, 2005 9:51 pm 
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See, this is why we can't trust prescription drugs from Canada. :P

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PostPosted: Thu Jul 07, 2005 10:05 pm 
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punkdavid wrote:
See, this is why we can't trust prescription drugs from Canada. :P


Damn you!!! I was trying to bait some people into a discussion about this but you ruined it. :x

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PostPosted: Thu Jul 07, 2005 10:06 pm 
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and yet one baseball player dies from xenedrine, and its off the market before you can say whut

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PostPosted: Thu Jul 07, 2005 10:08 pm 
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Peeps wrote:
and yet one baseball player dies from xenedrine, and its off the market before you can say whut


I'm sure you can get xenedrine without a prescription from Canada.

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PostPosted: Thu Jul 07, 2005 10:28 pm 
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I see no problems with this. If people and doctors are aware of the risks associated with drugs, they can make the educated decision whether or not to take it. The problem with Vioxx and Celebrex is that the increased CV problems weren't well known when they were first released. Pfizer and Merck should be punished for any missteps in reporting or research, but beyond that I don't think they did anything wrong.

If a an otherwise healthy individual with no predispositions to heart disease wants to take one of these medications, why should we stop them? Just don't give them to an 80yr old man who's had 2 heart attacks. All drugs have side effects. You just need to weigh the costs and benefits before deciding a course of therapy based on each individual's needs.

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PostPosted: Thu Jul 07, 2005 10:44 pm 
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Go_State wrote:
I see no problems with this. If people and doctors are aware of the risks associated with drugs, they can make the educated decision whether or not to take it. The problem with Vioxx and Celebrex is that the increased CV problems weren't well known when they were first released. Pfizer and Merck should be punished for any missteps in reporting or research, but beyond that I don't think they did anything wrong.

If a an otherwise healthy individual with no predispositions to heart disease wants to take one of these medications, why should we stop them? Just don't give them to an 80yr old man who's had 2 heart attacks. All drugs have side effects. You just need to weigh the costs and benefits before deciding a course of therapy based on each individual's needs.


It underminds what the FDA is controlling in the US. If Vioxx is banned here than people will just go online and order it from Canada. Where's the regulation?? Oh there isn't any, then what happens is the widow from North Dakota sues Merck anyway. Perfect.

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PostPosted: Thu Jul 07, 2005 10:46 pm 
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Zutballs wrote:
Go_State wrote:
I see no problems with this. If people and doctors are aware of the risks associated with drugs, they can make the educated decision whether or not to take it. The problem with Vioxx and Celebrex is that the increased CV problems weren't well known when they were first released. Pfizer and Merck should be punished for any missteps in reporting or research, but beyond that I don't think they did anything wrong.

If a an otherwise healthy individual with no predispositions to heart disease wants to take one of these medications, why should we stop them? Just don't give them to an 80yr old man who's had 2 heart attacks. All drugs have side effects. You just need to weigh the costs and benefits before deciding a course of therapy based on each individual's needs.


It underminds what the FDA is controlling in the US. If Vioxx is banned here than people will just go online and order it from Canada. Where's the regulation?? Oh there isn't any, then what happens is the widow from North Dakota sues Merck anyway. Perfect.


Yeah, but that's our government's problem. I don't see anything wrong with Canada making their own decisions about drugs. If the real reason is some underhanded way to sell Vioxx to Americans, then I'd have a problem.

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PostPosted: Thu Jul 07, 2005 10:54 pm 
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Go_State wrote:
Zutballs wrote:
Go_State wrote:
I see no problems with this. If people and doctors are aware of the risks associated with drugs, they can make the educated decision whether or not to take it. The problem with Vioxx and Celebrex is that the increased CV problems weren't well known when they were first released. Pfizer and Merck should be punished for any missteps in reporting or research, but beyond that I don't think they did anything wrong.

If a an otherwise healthy individual with no predispositions to heart disease wants to take one of these medications, why should we stop them? Just don't give them to an 80yr old man who's had 2 heart attacks. All drugs have side effects. You just need to weigh the costs and benefits before deciding a course of therapy based on each individual's needs.



It underminds what the FDA is controlling in the US. If Vioxx is banned here than people will just go online and order it from Canada. Where's the regulation?? Oh there isn't any, then what happens is the widow from North Dakota sues Merck anyway. Perfect.


Yeah, but that's our government's problem. I don't see anything wrong with Canada making their own decisions about drugs. If the real reason is some underhanded way to sell Vioxx to Americans, then I'd have a problem.


I agree Canada can do what it wants, but I still see the problem of how to regulate this in the US.

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PostPosted: Thu Jul 07, 2005 10:57 pm 
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Zutballs wrote:
Go_State wrote:
Zutballs wrote:
Go_State wrote:
I see no problems with this. If people and doctors are aware of the risks associated with drugs, they can make the educated decision whether or not to take it. The problem with Vioxx and Celebrex is that the increased CV problems weren't well known when they were first released. Pfizer and Merck should be punished for any missteps in reporting or research, but beyond that I don't think they did anything wrong.

If a an otherwise healthy individual with no predispositions to heart disease wants to take one of these medications, why should we stop them? Just don't give them to an 80yr old man who's had 2 heart attacks. All drugs have side effects. You just need to weigh the costs and benefits before deciding a course of therapy based on each individual's needs.



It underminds what the FDA is controlling in the US. If Vioxx is banned here than people will just go online and order it from Canada. Where's the regulation?? Oh there isn't any, then what happens is the widow from North Dakota sues Merck anyway. Perfect.


Yeah, but that's our government's problem. I don't see anything wrong with Canada making their own decisions about drugs. If the real reason is some underhanded way to sell Vioxx to Americans, then I'd have a problem.


I agree Canada can do what it wants, but I still see the problem of how to regulate this in the US.


I don't argue with you there. Although, if some idiot is dumb enough to order this online without consulting his doctor after all the publicity this has received, I almost think they deserve what they get.

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PostPosted: Thu Jul 07, 2005 11:03 pm 
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Zutballs wrote:
It underminds what the FDA is controlling in the US. If Vioxx is banned here than people will just go online and order it from Canada. Where's the regulation?? Oh there isn't any, then what happens is the widow from North Dakota sues Merck anyway. Perfect.


Can you sue someone if you illegally obtain their product?

"Vioxx hurt me."
"Well, the FDA told you not to take it."
"But I don't trust the FDA."
"Well, next time, you will."

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 Post subject:
PostPosted: Thu Jul 07, 2005 11:34 pm 
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the FDA is usually miles ahead of Canada in approving prescription drugs. There are many drugs that were pending in Canada for over 12 months that were already accepted in the US i.e Remicade. Canada approving Vioxx and Celebrex before the FDA does is a reversal.


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PostPosted: Fri Jul 08, 2005 12:05 am 
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I personally don't think any prescription drug should be forbidden from the market, so this ruling is fine by me.


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PostPosted: Fri Jul 08, 2005 12:13 am 
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I think it should be available here after some additional research on all side effects and should be prescribed with stricter warnings. Informed consent. Every medication has side effects and as long as you know what they are, then so be it.

The Vioxx problems occurred after long term use. Before it went off the marked, we used Vioxx for 2-3 days after a woman had a c-section to reduce inflammation at the operative site and reduce pain. It worked great and significantly reduced the amount of narcotics the pt would require for pain management.

There are ways that the drug can be used positively. Just don't use it long term. They should do more short term use studies to validate it's safety, and then bring it back to market to be used that way. Don't give up on it forever.

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PostPosted: Fri Jul 08, 2005 12:16 am 
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I think drug companies should have to tell the truth about the risks of their drugs, but it's clear we're never going to be that lucky, so, whatever!

Eliminate lawsuit caps on drug companies that hide test results and end up hurting people.

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 Post subject:
PostPosted: Fri Jul 08, 2005 12:19 am 
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B wrote:
I think drug companies should have to tell the truth about the risks of their drugs, but it's clear we're never going to be that lucky, so, whatever!

Eliminate lawsuit caps on drug companies that hide test results and end up hurting people.


or maybe have a system where the government can take the rights to the medication after the manufacturing company has proven itself to be irresponsible with the data (okay, in a perfect world where the government wasn't gonna lie to us either).

that way we punish the drug COMPANY and not the drug itself.

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PostPosted: Fri Jul 08, 2005 5:27 am 
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Green Habit wrote:
I personally don't think any prescription drug should be forbidden from the market, so this ruling is fine by me.


As long as all current research and possible side effects are published, I don't disagree with you. My sister-in-law who's an oncology RN raved about the benefits of Celebrex to me immediately after it was yanked off the market. Obviously anyone with heart disease risks should avoid it, but why pull it for those who don't have those problems or are willing to risk it for the benefits of the drug?

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PostPosted: Fri Jul 08, 2005 5:31 am 
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Boomer wrote:
the FDA is usually miles ahead of Canada in approving prescription drugs. There are many drugs that were pending in Canada for over 12 months that were already accepted in the US i.e Remicade. Canada approving Vioxx and Celebrex before the FDA does is a reversal.


Well, I don't know as much about human drugs, but when it comes to veterinary drugs the FDA is often miles behind the rest of the world. There are plenty of effective medications that have shown to be useful in real world settings with limited side effects in Europe that for some reason can't pass regulations here.

Anyone familiar with Deramaxx? It's been used in Europe for ages, shown far less side effects than many other drugs in it's class, and has only recently been introduced into the USA.

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