You are wrong that the FDA has to approve a drug no matter what the degree of efficacy.

Approvals have to be made in the context of the balance of efficacy and risk, i.e. safety.

Thalidomide was efficacious for what it was submitted for.

If insufficient information has been submitted to judge safety then the law requires that an application not be approved, regardless the evidence for efficacy.

The information required includes all reasonable information which includes not only clinical studies but things such as receptor binding information etc..

You wouldn't want another phen-fen simply because the company refused to submit information on whether Seroquel or its metabolites stimulated the 5HT2B receptor would you?

Philip Dawdy responds: i believe i made my original statement within the context of safety considerations and really don't feel like being nitpicked by anonymous know it alls today.

"Personally, I hope the FDA finds the drug non-approvable for any new indication due to its teensy efficacy and rotten side effect profile."

I agree with you, Philip, but I also oppose its approval for one additional reason. Frankly, I've never seen an "antidepressant" response to Seroquel in any of my patients, and I'll be quite livid if one of AZ's lackeys (er, sales reps) tries to convince me that it's more effective than anything else already at my disposal.

OK, so maybe I'm not using it on the "right" patient, but that just begs the question: Since when does the FDA approve something for the "right" type of depression? Simply putting the "approved for depression" label opens the floodgates for a lot of uninformed (and impressionable) psychiatrists and others to throw this drug at a lot of patients to see if it "sticks."

I'm sorry, but that's not the way I was trained to practice medicine.

Maybe you should fact check first and not keep repeating lies that are being fed you by the FDA and the drug companies about the standards for approval.

Philip Dawdy responds: the fda approval process has been explained to me at length by both fda officials, including tom laughren himself, and various academics, including some who take not a single dime from pharma. so i've done the appropriate level of fact checking and please refrain from insinuating that i haven't.

as to the lies you allude to, please specify. i haven't the faintest about how any of these people may or may not be lying to me about the fda approval process.

SteveBMD, that was certainly my experience with the drug. Seroquel did nothing at all to help my depression but my doctor appeared to be quite taken with the drug.

You think Tom Laughren, the head of the FDA's Psych division, isn't going to lie to you?

Isn't that part of what an investigative reporter does, check that what you're being spoon fed, by people who may have a hidden agenda.

The standards for approval are in the Food Drug and Cosmetics Act (if you take the time to check what the wording actually means), as well as the history Congress's approval with their congressional intent, and testimony before congress by Commissioner Kessler. So there's plenty of independent easily verifiable sources.

Now check these sources vs. what Bob Temple said (from FDA transcripts) about the standards for approval during the PDAC meeting for Pediatric Bipolar in June:

DR. TEMPLE: "Well, that's not the legal test. The legal test is whether it's effective and whether it's safe. And, incidently, safe always means safe for its intended use, benefits outweigh the risks; that's what it's always meant, even though the law doesn't say it that way."

This is blatantly false. It's not for the intended use alone. It includes safety for off-label use, or even what's implied in the labeling. A few years ago Laughren headed up an AC meeting about duration of studies for antidepressants. Even though the standard of care is put everybody on 6 months minimum, the AC said NO to anything longer than 3 months. Poor Tom cried crocodile tears over this. Well his job is to supposedly enforce the law regardless of what a rigged AC says and believe me there isn't a single AC meeting I've gone to where I knew the inside scoop that I couldn't see the FDA as well as the company was trying to rig things.

At the last PDAC Laughren said even though the approval for the drug would only be for up to 3 weeks in bipolar and 6 weeks in schizophrenia he wouldn't include in anything in the labeling to discourage longer use because no one is going to switch medications. So that's an implied use in the labeling especially since they're reporting in the press some misleading longer term data.

I read you and generally don't comment on all the things that you get wrong because I can't expect you as a reporter to know how things really work or the real facts.

I wasn't trying to be nitpicking but rather correct a mistake that I've heard from others who work for patient's rights which is something the FDA and the drug companies want us to believe. So when someone like you who has the ear of so many who have been harmed by certain parties repeat the lies being put forward by those parties it carries a gravitas and helps perpetuate problems.

Philip Dawdy responds: i think your beef is with the fda not me. take it up with them.

Evergreening is done with the support of FDA;
Halcion is still on the market;

"Sen. Chuck Grassley, R-Iowa, says the FDA was worse than passive. Investigators for the Senate Finance Committee, which Grassley chairs, met Thursday with FDA researcher David Graham, lead scientist on a study presented in August at a medical meeting in France."

"Graham told the finance committee investigators that the FDA was trying to block publication of his findings, Grassley said in a statement. "Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,' " Grassley said. Graham gave Grassley copies of e-mail that appear to support his claims that his superiors suggested watering down his conclusions."

http://justana-justana.blogspot.com/2009/08/do-you-know-of-any-drug-that-was-taken.html

Don't tell me that FDA is really doing a good job and protecting US citizen's health.

How many years Vioxx blah blah blah...

FTA:

Personally, I hope the FDA finds the drug non-approvable for any new indication due to its teensy efficacy and rotten side effect profile.

Actually, I kind of hope the FDA does approve it. When more and more members of the general public experience the hellish side effects of these drugs and understand what happens to psychiatric patients who are force fed them, maybe they'll realize that what the crazies are saying is true and come over to our corner to support us.

I'm 73 and have been on Paxil, Trazadone, and Sonata for over ten years. Before I was on Elavil and other meds since I was 33. I was always able to function even in my worst periods of depression but as I grew older I have had more difficulty with "will." After being put on Seroquel about a year ago I've had no serious depressive episodes and my ability to self start has returned. I have had serious weight gain do to increased appetite. I am concerned about diabetes. My diagnoses include depression, anxiety, and sleep problems. An uncle committed suicide, and an aunt was hospitalized and given ECT. She died in her nineties. I've weighed the risks and decided to continue this regimen. Dot