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        New Message Board Archives >> 2004 Posts >> The FDA is Your Friend !!
        
(Message started by: floridian on Dec 16th, 2004, 4:29pm)
Title: The FDA is Your Friend !!
Post by floridian on Dec 16th, 2004, 4:29pm
Approximately two-thirds of the US public has faith that the Food and Drug Administration is adequately regulating drugs and protecting their safety.  

In a separate study, approximately two-thirds of the scientists who work at the FDA expressed the opposite opinion ... they are not very confident that the agency does a good job in protecting the public.  Twenty percent of the scientists said they had personally been pressured to approve a medicine when there was insufficient data on its safety or effectiveness.  

http://www.usatoday.com/news/health/2004-11-23-fda_x.htm
http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=7116527

 
Title: Re: The FDA is Your Friend !!
Post by Jeepgun on Dec 16th, 2004, 4:35pm
Blind faith in the government, any government, will get you killed in this day and age. *sigh* People are so gullible.
Title: Re: The FDA is Your Friend !!
Post by ExplodingEyeBall on Dec 16th, 2004, 4:47pm
The FDA is your FIEND

Fiend [n]  a cruel wicked and inhuman person
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 16th, 2004, 5:13pm
The FDA is being squeezed by an administration that DOES NOT want them to do their job.
Title: Re: The FDA is Your Friend !!
Post by Charlie on Dec 16th, 2004, 5:17pm
The FDA has become way too political. Just today they got caught in sloppy testing on birth control pills. They said they could cause heart attacks. Turns out not to be true. Sorry but with the current ridiculous abstinance policies and its horror at morning aftter pills, I'm a tad suspicious.  >:(

I don't much care for their trying to scare us about Canadian drugs. That's entirely political.

Charlie
Title: Re: The FDA is Your Friend !!
Post by Langa on Dec 16th, 2004, 8:52pm

on 12/16/04 at 16:29:17, floridian wrote:
Approximately two-thirds of the US public has faith that the Food and Drug Administration is adequately regulating drugs and protecting their safety.  

In a separate study, approximately two-thirds of the scientists who work at the FDA expressed the opposite opinion ... they are not very confident that the agency does a good job in protecting the public.  Twenty percent of the scientists said they had personally been pressured to approve a medicine when there was insufficient data on its safety or effectiveness.  

http://www.usatoday.com/news/health/2004-11-23-fda_x.htm
http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=7116527

 



This is so true Floridian...
One of my main jobs at the company I work for now is working very closely with the FDA...so many times they approve stuff for market because they felt pressured to do so or because they're "friends" with the people on the other end.  Frankly, I don't even know how they sleep at night.

I just had a huge clinical trial done for a test on an analyzer we want to get approved for market.  The clinical trial failed, but they wanted to cut corners.  I refused.   Right now i'm in the process of another clinical trial.  If it passes, then i'll agree.  

I mean do they not see that a lot of patients out there will get false positives because the test they approved isn't working up to par?...I just don't get it, but it goes on all the time...  [smiley=huh.gif]

Langa
Title: The Story Continues....
Post by Ueli on Dec 21st, 2004, 3:42am
The story continues with Celebrex.

Pfizer pulling advertising for Celebrex (http://www.azcentral.com/arizonarepublic/business/articles/1221pfizer21.html)

NIH suspends study of Celebrex, naproxen (http://seattlepi.nwsource.com/national/apscience_story.asp?category=1500&slug=Study%20Halted)

FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex (http://www.fda.gov/bbs/topics/news/2004/new01144.html)

FDA: Consider 'alternative' to Celebrex (http://www.cnn.com/2004/HEALTH/conditions/12/17/celebrex.heart/)

I read a note this morning, that in Germany the heath authorities think it's no longer reasonable to give Celebrex to patients with an increased risk of cardiac problems.

But the good news is: The young and healthy can still use Celeberex for their osteoarthritis and rheumatoid arthritis.  ::)

PFNADs, Ueli                 [smiley=smokin.gif]
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 9:33am
The benefit of the Cox-2 inhibitors for arthritis was that it didn't bother the stomach, like the other NSAIDs... So there are choices, the heart or the stomach.
Title: Re: The FDA is Your Friend !!
Post by floridian on Dec 21st, 2004, 9:53am

on 12/21/04 at 09:33:00, vig wrote:
The benefit of the Cox-2 inhibitors for arthritis was that it didn't bother the stomach, like the other NSAIDs... So there are choices, the heart or the stomach.


Yeah, were not going to find meds without risks and side effects.  Treat one problem and it will sometimes create another.  That doesn't bother me too much. What gets my goat is when the companies or regulators hide information about the risks.  
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 9:59am
One of the big journals, I forgot which, New England Journal of Medicine or Journal of the American Medical Association just came out and said they would no longer publish studies unless they were told about them BEFORE the study was conducted.  So that the companies couldn't just submit the GOOD ones.

that's a little progress.
Title: Re: The FDA is Your Friend !!
Post by Lizzie2 on Dec 21st, 2004, 10:06am
I assume you all saw the news stories on Aleve possibly being pulled that came out this morning?

IMHO, the FDA is off the hook - and not in a good way!

Lizzie
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 10:18am
Imagine trying to police the pharmaceutical industry...
WITHOUT weapons...
Title: Re: The FDA is Your Friend !!
Post by becky8 on Dec 21st, 2004, 10:26am
I hope they don't pull Aleve off, thats the only pain reliever that works for me when my neck is sore and such.
Title: Re: The FDA is Your Friend !!
Post by Lizzie2 on Dec 21st, 2004, 11:58am

on 12/21/04 at 10:26:11, becky8 wrote:
I hope they don't pull Aleve off, thats the only pain reliever that works for me when my neck is sore and such.


Good one for menstrual cramping, too!  hehe
Title: Re: The FDA is Your Friend !!
Post by marlin on Dec 21st, 2004, 2:52pm

on 12/21/04 at 09:53:37, floridian wrote:
Yeah, were not going to find meds without risks and side effects.  Treat one problem and it will sometimes create another.  That doesn't bother me too much. What gets my goat is when the companies or regulators hide information about the risks.  

Uh floridian, do you read the paper?  Within 2 days of Merck withdrawing Voixx the ambulance chasers had full page ads in every major newspaper including the lamest one, USAToday.   That's why.  They simply can't afford to come clean.  They can't afford to bring new marginal distribution drugs to market because of the liability laws -- CH meds for example.  Someone needs to bring some sanity to the whole process. Get the FDA to do real quality trials and if a drug passes all legal liability is transferred to the government with limits. The system if all F'ed up.  I hope dubya can get something meaningful done in this area as his purse-strings aren't directly connected to the attorneys' lobby. Instead of concentrating on faith based initiatives he should concentrate on sanity based ones.  We can only hope he alters course and invests more time in thinking than praying...
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 2:59pm

on 12/21/04 at 14:52:12, marlin wrote:
Someone needs to bring some sanity to the whole process. Get the FDA to do real quality trials and if a drug passes all legal liability is transferred to the government with limits. The system if all F'ed up.  

Agreed!

I hope dubya can get something meaningful done in this area as his purse-strings aren't directly connected to the attorneys' lobby. Instead of concentrating on faith based initiatives he should concentrate on sanity based ones.  We can only hope he alters course and invests more time in thinking than praying...

Unfortunately, dubya's purse-strings are attached to the pharmaceuticals lobby and they want NO government intervention so don't look for ANYTHING from him in this battle.  I think he's going to stick to his guns, prayers, and the faith-based world.
sad
my $.02
Title: Re: The FDA is Your Friend !!
Post by marlin on Dec 21st, 2004, 3:10pm
vig, I hope you're wrong.  Otherwise we just get deeper in the quicksand pit and try to pray our way out.

Right now lunatics are in charge of the assylum.
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 3:17pm
I hope so too Marlin, but on this, I'm not optimistic.
Title: Re: The FDA is Your Friend !!
Post by floridian on Dec 21st, 2004, 3:22pm

Quote:
Uh floridian, do you read the paper?  Within 2 days of Merck withdrawing Voixx the ambulance chasers had full page ads in every major newspaper including the lamest one, USAToday.


Yeah, I saw some of those.  But on one news show on TV, they went into how the pharmaceutical company trained their sales people to mislead doctors who asked about the risks for heart attacks.  They also did something like 9 studies, but only published 2 or 3 that were favorable to their product.  To me, that makes them guilty of murder.  I think their company should get the death penalty - jail the individuals that are responsible and let the courts divide the assets among the victims and their families.  Then next time, we might prevent 72,000 heart attacks instead of covering them up.  If 1/4 of the heart attacks caused by Vioxx were deadly, that would make 18,000 fatalities - that company did more damage than bin Laden, yet nobody is upset, little is being done.
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 3:26pm
I saw that one too Floridian, it was pretty nauseating.
They knew it caused this and it's when they heard the crunCH of the lawyers' shoes, they pulled the product.  It wasn't because of the people dying.  It was because of the new lawsuits.
Title: Re: The FDA is Your Friend !!
Post by marlin on Dec 21st, 2004, 3:34pm
OK, so my point was take the job of providing clinical proof out of the hands of the drug companies and move it to the FDA.  We don't need less drug comapnies we need more.  We need sanity in Washington.  We need a President that presides over the country not prayer sessions or fundraising ceremonies.  Those the jobs of the clergy and the party chairmen.

This country can't sue its way out of its problems.
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 3:40pm

on 12/21/04 at 15:34:04, marlin wrote:
OK, so my point was take the job of providing clinical proof out of the hands of the drug companies and move it to the FDA.  We don't need less drug comapnies we need more.  We need sanity in Washington.  We need a President that presides over the country not prayer sessions or fundraising ceremonies.  Those the jobs of the clergy and the party chairmen.

This country can't sue its way out of its problems.

agreed.
and give the FDA some balls.
Title: Re: The FDA is Your Friend !!
Post by marlin on Dec 21st, 2004, 3:54pm
vig, I checked your web page -- really nice stuff!  If I get a good shot it's purely by coincidence.  I wish I were better at it and had good equipment.  I love electrical storms and the area I live in is the source for some of the best lightening shots in the world.  I need to figure out how it's done... and then get lucky.
Title: Re: The FDA is Your Friend !!
Post by vig on Dec 21st, 2004, 3:58pm
Hey thanks Marlin,
Trick one is to take LOTS of shots, then statistically, the odds of getting lucky increase!!!


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