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#15196 - 07/22/01 05:35 AM Accutane not approved by FDA until 1982
kat27_2000 Offline
Member

Registered: 06/30/01
Posts: 10
I noticed that some of you posted that you took Accutane before 1982. One posted that she took it in 1976. Accutane was approved amid controversy within the FDA on the "fast-track"--it only took 9 months to approve it vs. a year or more as a standard approval time. Were you aware that you were testing Accutane if you took it before 1982? Did you sign forms stating that you were participating in clinical trials?

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#15197 - 07/22/01 08:42 PM Re: Accutane not approved by FDA until 1982
Laura Phillips Offline


Member

Registered: 07/31/08
Posts: 12
Loc: Detroit, MI
Kat,

I'm not sure exactly what you're suggesting. "Fast track" approvals simply means that the administrative/bureaucratic delays are minimized. It does NOT mean that those drugs are subject to less testing or scrutiny. And no, I don't recall any controversy over the approval.

Yes, I took Accutane as part of a clinical trial. At the risk of sounding condescending, OF COURSE I knew I was in a clinical trial. The risks were well explained to me. I participated in the LAST clinical trial that Roche did prior to approval. I was invited to participate in earlier trials and declined, as I wasn't ready to be that much of a guinea pig and wanted to see several years of established results first. You can't POSSIBLY be part of a clinical trial and NOT know it. Many forms, much counseling, much consenting. Anyone who claims that they were somehow duped into participating in a clinical trial and didn't realized it was either completely asleep at the wheel or has some kind of amnesia (of course, no one would ever lie about something like that).

I think everyone knows that treatment using retinoids has risks. So long as you understand the risks (and rewards) and make an informed decision to proceed using a retinoid, I don't see what the problem is. My heart goes out to everyone who has serious. lasting side effects that they attribute to Accutane. However, I consider myself sort of an "Accutane success story." I took it for over 13 years, and I've had NO lasting side effects, and experienced no side effects during treatment that I would characterize as anything other than an annoyance.

So, if anything, I'm slightly biased in a positive way toward Accutane. However, I have decided that I'd rather not take it anymore (I'm totally paranoid about bone changes, of which I currently have none).

But I do think it's important that people get balanced information about Accutane. At this point, I think there's more than an abundance of "horror stories" out there. So, if you come out here and say nothing but negative scary stuff about Accutane, it puts me in a position to feel like I have to balance it.

Laura Phillips

P.S. I don't know what your personal experience is with Accutane (I'm judging from your comments on this Board that it's negative). For the most part, I'll let anyone post anything relevant to ichthyosis they want on these boards. However, there are some limits. Please stick to the topics (don't start posting under everyone's questions/problems, 'hey, do you or have you taken Accutane? you might want to consider that as the source of you problem'). And be careful making accusations that could be construed as libel. What you posted above actually borders on libel, implying that Accutane somehow shortcut the approval process and that there was doubt about it's approval. I'm going to let the post stand right now (and your other posts that are borderline off-topic). But play nice.

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#15198 - 07/22/01 11:38 PM Re: Accutane not approved by FDA until 1982
kat27_2000 Offline
Member

Registered: 06/30/01
Posts: 10
"Accutane was approved in 1982 by the FDA after nine months of review. The average review time for the 28 drugs approved in 1982 was 29 months." Also published on July 14, 1996, Columbus Dispatch, another article---Memos bare FDA split over Accutane.
A series of articles were written about Accutane from April, 1996 to May 22, 1996.
Section of paper: News, Local and National
They were written by Mark Somerson and Jill Riepenhoff, medical reporters for the Columbus Dispatch newspaper. Mark Somerson is still employed by the Columbus Dispatch.
He has been promoted within the company.
Don't know about Jill. These articles are posted in various places on the internet.
Or you can call the Columbus Dispatch for the set of articles. They will mail them to you for a nominal charge.
Ed Silverman of the Star-Ledger newspaper has also written a series of articles on accutane beginning in 1999 through 2000.

[This message has been edited by kat27_2000 (edited July 22, 2001).]

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#15199 - 02/20/02 06:04 AM Re: Accutane not approved by FDA until 1982
JohnArick Offline
Junior Member

Registered: 02/20/02
Posts: 2
Loc: Grand Rapids, MI, USA
I think I would call myself another Accutane success story. I started on the drug in 1978 at NIH. I was the youngest person taking it at that time and I think it's great stuff.

This medicine got a lot of goverment testing before 1982. I am living proof. I do however have some bone spurs but nothing really changed since about 1982 as I have been on a lot lower doses of the medicine. If you take Accutane, go for a really low dose. It will really reduce the side effects.

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