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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by Bill L on June 27, 2002, at 12:43:40
That's the word I got today from Forest Labs when I called their customer service number 800-678-1605 (ext 7301). The reason is simply that they need to wait for the FDA.
The pill will come out first. The liquid form should follow about 6 months later.
Posted by Bob on June 27, 2002, at 13:19:17
In reply to Lexapro delayed until late summer/early fall, posted by Bill L on June 27, 2002, at 12:43:40
> That's the word I got today from Forest Labs when I called their customer service number 800-678-1605 (ext 7301). The reason is simply that they need to wait for the FDA.
>
> The pill will come out first. The liquid form should follow about 6 months later.
Don't hold your breath on this. All of these drugs seemed to get delayed or otherwise at the last minute. A few of the recent debacles are:Reboxetine - it has basically fallen into a black hole.
Selegeline patch - FDA denied.
Duloxetine - was supposed to be out by now, but has been FDA delayed for at least a year.
And now it looks like Lexapro has been delayed. Do not at all be suprised if it turns out that you don't see Lexapro until next year, or the year after that... or maybe never.
Posted by pharmrep on July 31, 2002, at 3:29:38
In reply to Re: Lexapro delayed until late summer/early fall » Bill L, posted by Bob on June 27, 2002, at 13:19:17
Delays suck....in February..eta was June,
in May...eta was July, in July...eta is August. I want it as bad as everyone, but what I do know, is that clinical trials are approved, that only the "legalese" on the Package insert...(you know, that small paper folded up like a fortune cookie you need a magnifying glass to read)is what's left. The FDA is finishing now....then that's it.
Posted by Geezer on July 31, 2002, at 14:29:20
In reply to FDA is the DMV in the pharm world, posted by pharmrep on July 31, 2002, at 3:29:38
> Delays suck....in February..eta was June,
> in May...eta was July, in July...eta is August. I want it as bad as everyone, but what I do know, is that clinical trials are approved, that only the "legalese" on the Package insert...(you know, that small paper folded up like a fortune cookie you need a magnifying glass to read)is what's left. The FDA is finishing now....then that's it.Lets not forget:
1) Tort lawyers go for the deepest pockets. Not only the doc's insurance company gets sucked in but frivolous multi-millon dollar legal settlements impact the drug company as well. Lets add that to the cost, shall we. Can anybody say TORT REFORM?
2) Meaningful drug testing (human subjects-not rats), in terms of a significant test population over an adaquate period of time, are conducted in EUROPE not the US. These test results are not admissible (by FDA regulation) for qualifying the drug for approval in the US but the results do tell the drug companies and docs a good deal about safety and efficacy.
3) The bureaucratic "brown shirts" at the FDA protect us from nothing......they are a LABELING AGENCY.
I agree drugs are too expensive but I am getting damn fed up with the "greedy drug company....dishonest sales rep.....poor duped doctor" crap. After 30 years in the medical device business (same rules as the drug companies) I am now completely disabled, paying out-of-pocket for all drugs. I would rather suffer the pain of capitalism than the oppression of socialism......there ain't no free lunch....pay now or pay later.
With all civility intended; IMHO only.
End of topic for me Dr. Bob - no further comment.
Geezer
Posted by bubblegumchewer on August 2, 2002, at 12:31:05
In reply to Re: FDA is the DMV in the pharm world » pharmrep, posted by Geezer on July 31, 2002, at 14:29:20
This is of special interest to me, because I am pregnant. In 1981 all approved prescription medication for nausea of pregnancy ceased being available because of some (unsuccessful) lawsuits against the makers of Bendectin. Bendectin's maker could not support the costs of defending itself and found it cheaper to stop production. Anyone familiar with pregnancy will know that there is a fixed incidence of birth defects that is fairly constant: about 6% I think, (the figure changes depending on what birth defects are counted, major or minor and what kind.)
Anyway, in our lawsuit-happy country, of course a certain number of parents of children born with "defects" are going to sue whomever they can, and the maker of a medicine taken during pregnancy would be a prime target. Bendectin was a combination of doxylamine, and old common antihistamine, and vitamin B6. It was never found to be responsible for any birth defects.
In fact, it has been the most widely studied drug during pregnancy and has found to have no correlation whatsoever with birth defects. Apparently every other country in the world markets this drug; in Canada for example it is called Diclectin. My doctor who is from Australia told me to go get ahold of the stuff over the counter. Doxylamine is sold as Unisom and of course, vitamin B6 is sold as vitamin B6.
Pregnancy of nausea can be debilitating and cause massive misery. Sure, some women are lucky and get only mild cases or none at all. But I have read (sorry, any source freaks; I don't have sources at hand) that voluntary terminations of pregnancy were found to increase when/where this effective anti-nauseant was not available, and in fact I've seen a graph that shows the rising # of hospitalizations (yes, it can be severe enough to require IV and other measures) for nvp (nausea and vomiting of pregnancy) right after 1981 when America's prescription access to Bendectin was cut off. In contrast, with the subsequent availability of Diclectin (the same stuff, remember) in Canada, hospitalizations dropped dramatically. (Canada had also been without anything for a while as Bendectin was not available in Canada, either, in 1981 and shortly thereafter until they "created" Diclectin.)
Well, there's my rant, and I'm sure you already got the point. Sometimes it makes me pretty mad that in this country people suffer while other countries seem more sensible. I can't give a profound comment on the source of this discrepancy except that I think there is so much liability-consciousness here that we pay for it one way or another. Either in money or in personal suffering.
Posted by pharmrep on August 2, 2002, at 12:51:27
In reply to pharmrep and geezer, are you aware of this?, posted by bubblegumchewer on August 2, 2002, at 12:31:05
Good one...I'm happy for your pregnancy and hope you can tough out the naseua.
Posted by Geezer on August 2, 2002, at 13:30:51
In reply to pharmrep and geezer, are you aware of this?, posted by bubblegumchewer on August 2, 2002, at 12:31:05
Hi Bubblegum,
Good point.....let's hope they don't make aspirin illegal.
Geezer
This is the end of the thread.
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