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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by Phillipa on October 1, 2010, at 5:27:20
FDA rejects GHB by Jazz Pharmaciticals for fibromyalgia and various other psych conditions. Phillipa
Posted by Phillipa on October 1, 2010, at 5:27:20
In reply to FDA Rejects GHB For Fibro And Other Conditions, posted by Phillipa on September 28, 2010, at 12:23:45
Posted by Christ_empowered on October 1, 2010, at 5:27:21
In reply to FDA Rejects GHB For Fibro And Other Conditions, posted by Phillipa on September 28, 2010, at 12:23:45
so, they have data that shows its effective, but they're so worried about drug abuse/misuse that they vote to reject? Ummm...OK. Adderall and the other stimulants are schedule II drugs, and they're being handed out to people from the age of 4 on up. Where's the concern about abuse there?
Also...how can the FDA approve so many "me-too drugs," then demand that this company show that their drug is not only effective, but more effective than already available options? I just don't get it.
The FDA is powerfully lame.
Posted by linkadge on October 1, 2010, at 5:27:21
In reply to FDA Rejects GHB For Fibro And Other Conditions, posted by Phillipa on September 28, 2010, at 12:23:45
I think its silly too. People will abuse anything and everything. I don't think GHB is *that* much more abusable than say ambien, valium or xanax.
Linkadge
Posted by linkadge on October 1, 2010, at 5:27:21
In reply to Re: FDA Rejects GHB For Fibro And Other Conditions, posted by linkadge on September 28, 2010, at 15:43:42
I understand the FDA has been under heavy criticism in the last two decades, for approving drugs either a) based on incomplete evidence and b) turn out to pose major health risks.
However, I think the FDA has swung the other way. Now, it seems, that a lot of good drugs are being rejected for reasons that are a bit irrational IMHO.
Linkadge
Posted by Christ_empowered on October 1, 2010, at 5:27:21
In reply to Re: Has FDA swung the other way?, posted by linkadge on September 28, 2010, at 15:51:26
I just don't get why this drug was rejected. The FDA just approved Fanapt and Saphris for bipolar and schizophrenia, even though they're no better than other drugs already on the market and they have some pretty serious health risks (saphris, for instance, can cause death. DEATH.)
They approve a re-mix of dexedrine for ADHD. Now this stuff comes out for an under-served patient population, and they're like "Nope, abuse potential way too high--no can do." Where was this concern for the public when Xanax got approved? Or Bextra, Vioxx, etc.? Avandia?
Posted by bulldog2 on October 1, 2010, at 5:27:22
In reply to Re: Has FDA swung the other way?, posted by linkadge on September 28, 2010, at 15:51:26
The problem is its reputation as the date rape drug. The FDA is probably taking this position to avoid a slew of public outrage it its approved for the above conditions.
Posted by Phillipa on October 1, 2010, at 5:27:22
In reply to Re: Has FDA swung the other way?, posted by bulldog2 on September 28, 2010, at 16:41:54
You know stopped to get vitamins today and the man working there had back surgery and they refused to give him pain meds as addictive so he had to get accupuncture. Pain meds impossible to get here. Phillipa
Posted by bulldog2 on October 1, 2010, at 5:27:22
In reply to Re: Has FDA swung the other way?, posted by Phillipa on September 28, 2010, at 19:58:42
> You know stopped to get vitamins today and the man working there had back surgery and they refused to give him pain meds as addictive so he had to get accupuncture. Pain meds impossible to get here. Phillipa
The hand percocet out like candy here! Practically force it on you for pain.
Posted by Phillipa on October 1, 2010, at 5:27:22
In reply to Re: Has FDA swung the other way?, posted by bulldog2 on September 29, 2010, at 15:06:54
Seriously? Trick or treat like? Phillipa
This is the end of the thread.
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