FDA = Fu**ing Dumb Asses

[Monster]

Ephedrine is banned by these idiots, but heres a few drugs that got these dumb fucks approval and the consequences of taking them (which has finally come to light).
******************************

During a Senate hearing Thursday regarding Vioxx, the arthritis blockbuster pulled off the market in September over concerns about increased risk of heart attacks and strokes, FDA scientist David Graham dropped a bombshell about five other drugs on the U.S. market. Graham, associate director for science in the FDA's Office of Drug Safety, said the five drugs pose serious safety concerns:


• Abbott Laboratories' weight-loss drug Meridia can cause high blood pressure, Graham said. When he raised a question about the drug's usefulness in a report, though, Graham said he was forced to delete it. Abbott spokeswoman Laureen Cassidy defended Meridiaby saying it has been studied in morethan 100 studies and has been used by 15 million patients worldwide.

• AstraZeneca's Crestor is the "only cholesterol-lowering drug that causes acute kidney failure," Graham said. Emily Denney, a spokeswoman for AstraZeneca, says the drug has been prescribed to more than 3.5 million people worldwide and has been extensively tested.

• Roche's drug Accutane, approved to treat severe acne, is a "20-year regulatory failure," Graham said. Accutane can cause serious birth defects if taken by pregnant women, he said, and the agency's efforts to prevent this problem are ineffective. He said the FDA should institute a system that would restrict the distribution of the drug. Carolyn Glynn, a Roche spokeswoman, said the company will now require all patients - as well as their doctors and pharmacists - to register with an independent agency that will track patient use.

• Pfizer's arthritis medicine Bextra is in the same drug class as Vioxx. A recent study showed that the incidence of heart attacks and strokes among Bextra patients was more than double that of patients taking sugar pills. Pfizer spokeswoman Susan Bro says an analysis of previous studies found no increase in "serious cardiovascular events" in nearly 8,000 arthritis patients.

• GlaxoSmithKline's drug Serevent treats asthma and chronic obstructive pulmonary disease. Before the FDA approved this asthma drug, a British study found with 90% certainty that it increased the risk of death from serious asthma complications, Graham said. There have been reports of patients "found dead clutching their Serevent inhaler," he said. GlaxoSmithKline issued a statement defending the medication, saying the FDA "fully considered" safety concerns last year when it issued a black box warning in the medicine's label.

It was clear Thursday that Graham was not speaking on behalf of the FDA. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, told committee members there's no evidence that these five drugs are any more dangerous than others.

*******************************

How can this be true? They all have such great TV commercials?

-------------------------


"You can kill the revolutionary,
but you can't kill the revolution."


I used to not believe in god, till I realized he was me.

[archive_xtinct]

It's a big mistake to through Accutane in there along with the other drugs. The other drugs will harm you even if taken as directed. With Accutane, Roche as well as the doctors prescribing it go to rediculous lengths to tell women not to take it if pregnant. Have you ever seen a US retail packaging of Accutane? There must be 20 different, highly conspicuous, very clear warning labels on there. So unlike the other four drugs that were mentioned, taking Accutane of the market would just be another example of the government taking away everyone's right (the right to an effective treatment for a very serious indication, in this case) just to protect the most ignorant and the most careless people in our society. That is precisely what I resent so much about our government.

[archive_Mr. Nobody]

Since when is ephedrine banned? Maybe this is one of the few perks in Dumbfukistan, that Dumbfukistanis can buy ephedrine in just about any truck stop (and we have one around ever corner here)


PS: Monster, can you tell me what my avator looks like, I still can't see half of them including the one you selected for me

<BLOCKQUOTE class="**-ubbcode-quote"><font size="-1">quote:</font><HR>
You have not been given the security rights to access this page. You require the rights to view WebSpace files. For a full list of any special rights you have on this site, see your profile. If you want to be given this access right, contact your administrator and ask for the 'View WebSpace Files' right.
<HR></BLOCKQUOTE>

This is what I get when right-clicking to view the avator (since it does not show).....and I call myself a moderator.....Special Guest Star my ass.....cant even see bushes and other pics, dammit....grumble, grumble

__________________________________________________ __________________________________
Any society that would give up a little liberty to gain a little security will deserve neither and lose both.
Benjamin Franklin

Disclaimer:
Mr. Nobody is presenting fictitious opinions and does in no way, shape or form encourage, use nor condone the use of any illegal substances or the use of legal substances in an illegal manner, especially thongs and vibrators.
The information discussed is strictly for entertainment purposes only and shall not take the place of qualified medical advice.

	ASS Nelson Montana

[DREXX]

I agree with xtinct about the Accutane, it shouldn't be bunched in there with the others.

Every pill has a symbol that says not for pregnant women.

http://www.kellyandbrian.com/assets/images/accutane.jpg

If it's not hard it's not worth doing...

[archive_Killer]

When I was taking accutane, by GF looked at the little labels "the crossed out pregnant lady" and asked if I was taking birth control

[PQ]

That's priceless LMAO!!

[archive_the truth]

Agreed about the Accutane--if people choose to disregard a mnufacturer's warning then the onus is on them. Kinda like the furor a few years back over FDA approval of Thalomid (thalidomide). People were letting emotion override their reason. Although, the regulatory bodies in countries where thalidomide was prescribed in the 50s/60s (it was never available in the US) were pretty fucked up to allow it to be marketed as a morning sickness pill.

BTW, ephedrine is not banned by the FDA.

[Monster]

Well, Im sure you guys are taking Accutane, which accounts for your defensiveness. BUt in any case, the point with Accutane is that the government has failed to CONTROL the drugs distribution.

The man quoted is talking about safty concerns, and the concern is not that the bottle is not marked, its that the regulation of the drug has failed.

I misspoke about ephedrine, I meant the control of it and removal from supplements...

-------------------------


"You can kill the revolutionary,
but you can't kill the revolution."


I used to not believe in god, till I realized he was me.

[archive_the truth]

<BLOCKQUOTE class="**-ubbcode-quote"><font size="-1">quote:</font><HR>Originally posted by Monster:
Well, Im sure you guys are taking Accutane, which accounts for your defensiveness.
<HR></BLOCKQUOTE>

Defensiveness is a side effect of Accutane?

Unless you were joking, this is an ad hominem and without merit.

I've never taken, or needed to take, Accutane, and I'm unclear as to how either post was defensive.

Does my statement about thalidomide mean that I have Hansen's Disease and am defensive about it?

[archive_Bjaarki]

These are all pretty much tiny increases in risk, are they not? These "side effects" are still pretty damned rare, aren't they?

For 17 years, I have sat on the IRB (Institutional Review Board, or human subjects review board) for a major medical school where most of the protocols we review are med trials of various sorts. You guys would be amazed at the extreme care that goes into most, nearly all, such research.

I don't see much of this as an FDA failure, but rather I see it as the difficulty inherent in detecting changes in baserates of rare events that are on a long time-delay.

BTW Frackal, let's not hijack this thread, but I fail to see the connection between regulators being beholden to pharmaceutical interests (which they aren't in any case) and "big govt." I would say the problem would be "big business," and "under-regulated big business" at that, wouldn't you? I mean, who's the villain in this: the regulatory agency that becomes beholden to an industry, or the industry with the deep pockets willing to corrupt a government agency?

Bjaarki

"First, say to yourself what you would become.
Then, do what you have to do."

[archive_xtinct]

<BLOCKQUOTE class="**-ubbcode-quote"><font size="-1">quote:</font><HR>Originally posted by Monster:
BUt in any case, the point with Accutane is that the government has failed to CONTROL the drugs distribution.
<HR></BLOCKQUOTE>

You are correct. I am taking Accutane and it's working better than anything else I have ever tried. That is why is pisses me off that some pencil pusher wants to mess with the drug's availability.

I don't really understand what your point is about how the Accutane is not regulated enough. What do you suggest should be done? Make it a CII drug so that there is a written record of every Rx? It's one thing to protect people from inherently dangerous drugs (I support that) but it's a totally different matter to create all kinds of unnecessary hurdles for a drug that is save and effective if used correctly. I bet there are MANY more cases of people causing severe damage to their health with OTC drugs like aspirin, acetominophen, etc. Does that mean that these drugs need to be more regulated?

[archive_xtinct]

<BLOCKQUOTE class="**-ubbcode-quote"><font size="-1">quote:</font><HR>Originally posted by Bjaarki:
I mean, who's the villain in this: the regulatory agency that becomes beholden to an industry, or the industry with the deep pockets willing to corrupt a government agency?
<HR></BLOCKQUOTE>

There was a poll on cnn.com about who is to blame for the Vioxx mess. Can you believe that one of the choices was "trial lawyers"?!

[archive_the truth]

Glad someone mentioned acetominophen. I'm amazed by how casual many people are about its use; they'll just pop them like candy.

[~ JP ~]

Well, I know that most people jumped to defend Accutane, but I will take a different tact.

GlaxoSmithKline's drug Serevent is not an evil killer either. In fact it has been proven in several US studies to be safe and beneficial (hence its US approval) though there are recent studies that call these into question. I personally have taken it for asthma, and while others are better it does work. In fact, what I currently take, Advair, is a blend of 2 drugs and salmeterol (Serevent) is one of them. And this is one of the most effective drugs I have taken in a long time.

One thing that you might not realize about people with severe asthma is how they take their medicine. Many inhalers, Advair included are meant to be preventative measures, taken on a regular basis, and not to be used to stop an attack. However, what do asthmatics do? They start having trouble breathing and they reach for the inhaler and take a few puffs. Instant overdose, but many times this can actually stop the attack. So we do it.

When I was younger Asthma paralized me. I could not run, I could not participate in sports, I could literally do nothing. Now that it is under control I can run, I can work out and I am in control of my life. So in the most recent study, 13 out of 13,000 died on the medicine and only 4 out of 13000 died on placebo, adjusted statistically, there is not a big difference there. And those extra 9 people difference? Ask them what there quality of life is going in and out of the hospital, being hooked up to oxygen, unable to exercise. And ask them whether they would be willing to take on an extra 0.1 percent chance of death to have their life back. I can tell you what they will chose.

Ok, I am done now.

[Monster]

<BLOCKQUOTE class="**-ubbcode-quote"><font size="-1">quote:</font><HR>Originally posted by xtinct:
I don't really understand what your point is about how the Accutane is not regulated enough.<HR></BLOCKQUOTE>

It was David Grahams point.

<BLOCKQUOTE class="**-ubbcode-quote"><font size="-1">quote:</font><HR>Juicepimp:
Ask them what there quality of life is going in and out of the hospital, being hooked up to oxygen, unable to exercise. And ask them whether they would be willing to take on an extra 0.1 percent chance of death to have their life back. I can tell you what they will chose.
<HR></BLOCKQUOTE>

Again, not my original statement, nor my article. But in any event, no one is saying anyone should go back to suffering with asthma, but perhaps a safer choice of drug would be appropriate?

<BLOCKQUOTE class="**-ubbcode-quote"><font size="-1">quote:</font><HR>Bjaarki:
You guys would be amazed at the extreme care that goes into most, nearly all, such research.
<HR></BLOCKQUOTE>

I would... my wife is in the final stage human trials for an implant she has resting on a nerver for her bladder to treat ISC and painful spasms. There are 50 in the world, and 17 in the U.S. She is the youngest in the world. I can attest to the meticulousness of the research, but also to the very slight manipulation that goes on to be sure certaqin aspects of it go the way they want.



All I meant on defensivness is that people are going to jump to defend the drugs they are taking. Out of a subconscious fear and desire to convince themselves that nothing will happen, or whatever. It isnt an attack on anyone.
My wife takes (and has taken for quite a while) Bextra, which is prominantly on the list with some of the worst potential side-effects of the list.
All those people taking Phen-Fen scoffed, too.

But that doesnt mean anything will neccesarily happen to anyone taking these things, its just something worth mentioning.

I would like to believe this is just due to the difficulty in detecting baserate changes over the long haul, but Im critical of government agencies and have never felt the FDA solely had our interests at heart.

-------------------------


"You can kill the revolutionary,
but you can't kill the revolution."


I used to not believe in god, till I realized he was me.