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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 8 of 8. This is the beginning of the thread.
Posted by kazoo on February 15, 2000, at 1:20:52
Whatta say we get a petition going BANNING the FDA; or, better yet, disbanding it
all together from government. Run these idiots out of town, if necessary (I have tons of chicken feathers!)
What good are these people anyways? Who hires them? How much money do they make?
Kessler had the right idea: stick with analyzing the pulp content in orange juice (the idiot!).(a very sad) kazoo
Posted by S. Suggs on February 15, 2000, at 5:03:30
In reply to Re: FDA-Rebox. doesn't look too promising, posted by kazoo on February 15, 2000, at 1:20:52
I think dr bob's suggestion we focus on contacting our state legislators, and do it across the board (nation). Right now, I have no need for this drug (taking parnate), but you never know, I might in 6 months etc... Networking is the key and have everybody fill email boxes with suggestions for the FDA to review another one of it's ignorant examples of poor logic in it's decision making process.
blessings to all
S. Suggs
Posted by Dr. Bob on February 16, 2000, at 1:06:27
In reply to Re: FDA-Rebox. doesn't look too promising, posted by S. Suggs on February 15, 2000, at 5:03:30
> I think dr bob's suggestion...
Just to set the record straight, that wasn't my suggestion.
Bob
Posted by PattyG on February 16, 2000, at 7:51:15
In reply to Re: FDA-Rebox. doesn't look too promising, posted by S. Suggs on February 15, 2000, at 5:03:30
How about if someone would draft somewhat of a form letter that we might utiilze in order to write to whomever we need to contact to further our "cause?"
Posted by Leighwit on February 16, 2000, at 15:15:11
In reply to Re: FDA-Rebox. doesn't look too promising, posted by PattyG on February 16, 2000, at 7:51:15
I'm in the US and taking reboxetine through my Pdoc who orders it from a pharmacy in London. I consulted with a psychopharmacologist also before starting this drug.
Drugs (at least those from the UK) without FDA involvement, have minimal labeling. You would not believe how vague the package insert is. Someone in the UK on reboxetine commented on another ng about how sophomoric the labeling information is on all of their drugs. "Pathetic" was the term I believe he used.
I'm not defending the slow approval process by any means. But I do have a new appreciation for the information the FDA requires the pharmaceutical companies to provide to the public.
I have juvenile-onset (Type I) insulin-dependent diabetes. The contraindications for ADs matter a great deal to all of us; particularly those with chronic medical conditions.
If I lived in the UK, I'd be researching FDA information to make safe choices.
Just some thoughts about the flip side of the coin.
LW
Posted by Noa on February 16, 2000, at 17:26:09
In reply to Re: FDA-Rebox. doesn't look too promising, posted by Leighwit on February 16, 2000, at 15:15:11
Interesting. Good to read different perspectives.
Posted by Adam on February 16, 2000, at 17:27:14
In reply to Re: FDA-Rebox. doesn't look too promising, posted by Leighwit on February 16, 2000, at 15:15:11
From what I've heard through my job, the FDA isn't really influenced by anyone from the outside as far as their decision-making goes, unless compelled to do so by new laws. I'm not sure that writing to your congressman/woman would make any difference one way or another for the particular case of reboxetine. Besides, what does your average legislator know about drugs (or mental illness, or much else, for that matter)?At an internal R&D meeting my employer holds every year, a VP gave a long talk about the arduous journey of a particular drug through the regulatory process, a drug that took an especially heroic effort to get approved. The FDA kept asking over and over for more information, rewrites, more experiments, etc. Some regulators would literally zero in on real or percieved problems with grammar or semantics in the mounds of submitted paperwork that would set the process back weeks. It took three major attempts before the drug was finally approved, and my employer still isn't certain how long it will require to recover the money spent to get it out the door. It's close to a zero-sums game at this juncture, even though the drug has been proven to be quite useful.
At one point the VP put up a slide of Fred Astaire. He stayed silent for a few seconds, and then said "Once you done all that it is possible to do, perhaps then it's time to try a little song and dance. I was tempted."
The FDA does a good job of keeping us from being poisoned. However, I have the distinct feeling that it is widely populated by litigious nitpickers who are more concerned that you dot all your i's and cross all your t's than about real issues of safety or benefit. It also seems this branch of the government is beholden to none unless something dangerous is approved. Given near zero consequences for denying safe and effective drugs (one can always find something wrong), and dire consequences for approving unsafe and/or ineffective ones, there is an obvious preference for hypervigilance these days, and a desire to cover one's own ass when the time comes to give the green light or the red.
You can try to suggest legislation to change the way the FDA operates. Even better, one can try to enact legislation that puts realistic limits on liability. Safety and efficacy are only one part of the equation in the USA. It's a battle of the lawyers as much as anything. Why should one have to spend $200 million+ to get a drug approved unless the threat of a class-action lawsuit is even more expensive?
> I'm in the US and taking reboxetine through my Pdoc who orders it from a pharmacy in London. I consulted with a psychopharmacologist also before starting this drug.
>
> Drugs (at least those from the UK) without FDA involvement, have minimal labeling. You would not believe how vague the package insert is. Someone in the UK on reboxetine commented on another ng about how sophomoric the labeling information is on all of their drugs. "Pathetic" was the term I believe he used.
>
> I'm not defending the slow approval process by any means. But I do have a new appreciation for the information the FDA requires the pharmaceutical companies to provide to the public.
>
> I have juvenile-onset (Type I) insulin-dependent diabetes. The contraindications for ADs matter a great deal to all of us; particularly those with chronic medical conditions.
>
> If I lived in the UK, I'd be researching FDA information to make safe choices.
>
> Just some thoughts about the flip side of the coin.
>
> LW
Posted by Abby on February 17, 2000, at 13:27:12
In reply to Re: FDA-Rebox. doesn't look too promising, posted by Leighwit on February 16, 2000, at 15:15:11
> I'm in the US and taking reboxetine through my Pdoc who orders it from a pharmacy in London. I consulted with a psychopharmacologist also before starting this drug.
>
> Drugs (at least those from the UK) without FDA involvement, have minimal labeling. You would not believe how vague the package insert is. Someone in the UK on reboxetine commented on another ng about how sophomoric the labeling information is on all of their drugs. "Pathetic" was the term I believe he used.
>
> I'm not defending the slow approval process by any means. But I do have a new appreciation for the information the FDA requires the pharmaceutical companies to provide to the public.
>
> I have juvenile-onset (Type I) insulin-dependent diabetes. The contraindications for ADs matter a great deal to all of us; particularly those with chronic medical conditions.
>
> If I lived in the UK, I'd be researching FDA information to make safe choices.
>
> Just some thoughts about the flip side of the coin.
>
> LWUK labeling is rather patronizing and simplistic. I was on Lustral for a while, their name for Zoloft. I don't think that Europeans, and certainly not Britons, are any easier on drug manufacturers on truly substantive matters. We have i-dotting and t-crossing obsessed bureaucrats.
The UK has problems too. The chairman of Glaxo-Wellcome was threatening to abandon clinical trials and early launches there--too much work for the size of the market. To illustrate my point that the way we are harder on pharmaceutical firms is only so much paperwork production and not true safety concerns, I'll mention a drug which is approved for use here but not in the UK--bupropion (Wellbutrin).
A fair number of psychiatrists disagreed, but the UK regulatory body believed that the risk of seizure was too great. In that particular case, given the same data, they were "tougher" than our beloved FDA.Abby
This is the end of the thread.
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