Your headline is misleading and disingenious. That takes away from the opinion in the piece.

Seroquel Killed FDA Panel Member's Son

Possibly. The fact is, however, we don't know. Margy Lawrence's son was taking Seroquel, and he died of sudden cardiac arrest. But correlation does not automatically equal causation, and to assume that it does is bad science.

the gooz is saying the panel smells of bias because it included this parent? this is who you are supposed to have on govt committess - govt is there to protect us little guys from the powerful who prey on our lack of power, including our lack of medical knowledge, lack of the original data, lack of teams of lawyers, lack of experts able to see how the powerful lie with statistics, etc.

the burden is in AZ, or whomever, to demonstrate safety. the burden is not on scattered interested ppl to develop such a mountain of tragic evidence that it eventually becomes absurd to believe that [fill in the blank - smoking doesn't cause cancer, thalidomide does not cause birth defects, prempro doe not cause breast cancer, SSRIs don't cause sucide, atypcail antipsychotics do not cause diabetes, etc.].

One has to wonder if the FDA knew for years that industry thought leaders with obvious biases were included on FDA advisory committees.

FDA's ode to industry thought leaders: http://www.mtv.com/videos/pinmonkey/59406/barbed-wire-and-roses.jhtml

"So anyone with a negative experience with a drug would have to recuse themselves?"
I thought the same thing.
Heads I win. Tails you lose.

Good one that an actual victim's parent showed up on the Committee....they sure turned me down. But the real news on that committee was that so many of the "regulars" were "outted" at the last minute due to conflicts-of-interest-made-public, that to get a quorum the FDA had to go OUT OF THE FIELD OF PSYCHIATRY to biostatisticians or whatever, who just looked at the science presented and voted NO for REAL REASONS such as "data inconclusive", "not enough data", "trial didn't last long enough", etc.

Very refreshing, even though Dr. Robert Temple badgered each no vote on one 4-4-1 vote split, trying to turn one into a YES. They all held the line. INTEGRITY saved the day.

Is it possible that the victim's Mom was a NAMI and the FDA thought every little thing would be okay? Just wondering.

"...especially to the consumer and patient slots..." Yeah, 'cause having professionals with long-term monetary/career-based bias is CLEARLY a better bet than consumer advocates who may be overzealous. Safer to overapprove behavioral meds with outrageous side effects for non-fatal diagnoses than underapprove, right? Bring on the antipsychotics for public speaking anxiety, and hell, why not fear of heights too. Those pesky concerned patients need to get out of the way of progress!

It's ridiculous. "'My son died of sudden cardiac arrest,' she said. 'Seroquel was part of his cocktail,'" becomes the headline, "Seroquel Killed FDA Panel Member's Son."

That kind of flaky reasoning calls into question every assertion by the anti-Seroquel people. I have yet to find a proven case of where Seroquel killed anyone. It's like SSRI Stories all over again, and the anti-Seroquel people are undermining themselves in the same way. Which is a good thing.

Philip Dawdy responds: ok so go ahead and write a better headline. use the exact same number of words or less.

You know what freaked me out that I just find out? I was looking through the old cabinet which had all my old meds and I saw an old bottle of Seroquel. So I think that it must be left over from the time I used to take Seroquel. Then I see the date on the bottle and the doctor who prescribed it and I'm first confused, then shocked. The date was from way back when I was 14. Back when I was 14, I was on Risperdal, had awful side effects, was on it for like eight months or so and then got off it with a different doctor. This Seroquel bottle was dated a few months after I got off Risperdal, it was during a time when things were amazing, one of the highest, most incredible parts of my life where things were just going so amazingly amazing, a time I'd love to go back to. Apparently, the doctor prescribed me Seroquel, the prescription was filled. That really scares me for a couple reasons. I did eventually go on Seroquel several years later, but by then I was on all sorts of meds that canceled out Seroquel's side effects. During that time, I wasn't on those meds, that was the time where I had been off Risperdal for a couple months and things were going so great. If I had been given the Seroquel then, my life could have been ruined. The script was filled and the bottle was right in front of me, but for some reason I didn't take it then. It scares the shit out of me how if I had taken the Seroquel at that point in time, it could have been what happened with Risperdal all over again and things could have gotten so messed up. I also wonder why the doctor had given me Seroquel during a time when things were going so amazingly well, just for the hell of it? I remember the doctors I went to kept trying to get me to stay on Risperdal, this doctor in particular, when I wasn't getting my period on Risperdla, said I could just stay on Risperdal and not get my period. Then the doctor apparently wanted to put me on Seroquel then? This scares me so much. I mean, my experience with Seroquel wasn't that bad when I finally went on it, it was nothing like the horrors of the Risperdal experience, but if I had had Seroquel at that point in time, just after getting off Risperdal, I just wonder what would have happened to me? Looking at that bottle of Seroquel was just weird, how huge a difference those little pills make. I was on Seroquel for two years, but I don't remember any of the side effects or stuff. I got off that cold turkey a long time ago. I have some psych med humor, maybe we can make a forum for it.

Thankfully you made it through, Princess. I have a didn't-happen-but-could-have horrible Seroquel story as well. After my oldest child died from Zyprexa, my surviving child went to (among others) a psychiatrist from the Stanley Research Foundation (we thought at the time we were getting The Best). That doctor, with the coldest of hearts, convinced my remaining child that going on Seroquel was the Best Thing. Together, and with severely painful thoughts and hearts, we went along with it briefly but then it became emotionally intolerable...plus weight gain began immediately, and that was that for the Seroquel Experiment. Done and off.

Somebody here said, "correlation does not automatically equal causation, and to assume that it does is bad science." Well, this is exactly the science that physicians used to say that smoking causes lung cancer. Scientists tried to give lung cancer to dogs & other animals [poor pets] and they never could. So they had to go by "correlation equals causation" and this is where we still stand today.

As for Seroquel and death, it is a given that any drug which has listed as a side effect "myocardial infarct' and a person in their 20's dies of a heart attack, the assumption should be that the drug caused or heavily contributed to the death. In fact, for Seroquel, "myocardial infarct" is not even listed as a rare reaction.

As for SSRI Stories, it is my understanding that they simply read the insert to Prozac back in 1992 and when they saw that "mania" and "psychosis", "abnormal thinking" and "paranoia", "hostility" and "agitation' were listed as adverse reactions [and not rare ones, at that], they assumed, when millions of people began taking Prozac and then the other SSRIs and SNRIs, that there would be plenty of murders, suicides, murder-suicides and rampage shootings. It didn't really take much to figure that out. In fact it was a no-brainer.

It is all such a National Tragedy. Even the soldiers are committing suicide more than they are being killed in combat. Have mercy on our souls.

Philip Dawdy responds: ok so go ahead and write a better headline. use the exact same number of words or less.

The word-count requirement isn't important, as the headline for the post before this one has more than twice as many words. But here are a couple:

Panelist Implicates Seroquel in Son's Death

or

Panelist Says Seroquel Killed Her Son

That meets the word-count requirement. Adding one word will give you:

FDA Panelist Implicates Seroquel in Son's Death

or

FDA Panelist Says Seroquel Killed Her Son

Any of these is truer to the facts as they are presented in the linked article.

Philip Dawdy responds: wow very good lkhllwd. now do 2200 blog posts and get the headlines perfect for each one. bet you can't

Try this thought experiment:

A company files a new drug application for a new label indication for a particular drug. The FDA impanels an advisory committee to evaluate its suitability for approval. Would you rather an advisory committee where two of 15 members came from patients/relatives of patients/consumers who suffered horrible fates at the hands of that drug company and its drug, but the other 13 were on the payroll of the company? Or would you prefer two patient/consumer reps who understand that perspective, are not from some astroturf patient advocacy group, but have no personal experience while the other 13 have zero financial ties to any drug company?

I prefer the latter. But if you want the FDA to adopt the former policy, then be prepared to accept pro-industry biased clinicians on every advisory committee since the Federal Advisory Committee Act, which governs this area, not only requires absence of conflicts of interest (unless they are waived because the conflicted person's expertise cannot be found elsewhere), but requires balance as to points of view. The issue people should focus on is how to eliminate pro-drug, pro-"we need another alternative" clinicians who don't have obvious conflicts of interest from these advisory committees and replacing them with objective people, or at least balancing their point of view with more objective practitioners. The FDA, even when they eliminate conflicted physicians, still does a poor job on this score.

FYI: I am no longer with the Center for Science in the Public Interest.

Scientists tried to give lung cancer to dogs & other animals [poor pets] and they never could. So they had to go by "correlation equals causation" and this is where we still stand today.

This just isn't true. By the mid-70s, scientists had induced lung cancer in dogs (which breaks my heart, actually) and rats, cancer of the larynx in hamsters, and smoke-induced skin cancer in mice and rabbits.



Tobacco and tobacco smoke - Seminars in Oncology, March 1976

I am wondering why the response I posted before my post about scientists inducing cancer in lab animals hasn't appeared.

Philip Dawdy responds: because i chose not to approve it.

Yes, it is true that scientists have not been able to give lung cancer to animals. There was only one experiment where they were able to give one case of lung cancer to one animal and then they could never replicate the finding.

However, they used that one case to "prove" that they had found tobacco causes lung cancer. Actually, I believe that tobacco smoking does cause lung cancer becaue I believe that "correlation proves causation".

Here is an article which explains all this about the failed experiments of dogs, etc. and tobacco .

http://www.lcolby.com/b-chap9.htm

I am curious to know how many paid Astras are on this comment section objecting to headlines that they believe are misleading or disengenuous.??

Let's move on to the BEHAVIOR at the meeting - forgetting for a moment the objectivity(more than usual thanks to all those subs) and moving on to the TREATMENT OF THE PUBLIC SPEAKERS. Each of the fifteen were given three minutes with the mike turned off mid-sentence if they went over. Not one person on the Adv. Committee, nor the FDA, nor the twenty or so Astras sitting in a row directly (DIRECTLY) behind the Advisory Com (public spkrs. placed in peanut gallery behind the press) gave the tiniest indication that they were listening to people whose young vet sons - or other sons killed by related atypical antipsychotics -the families basically had had to stand up and BEG the FDA to LISTEN TO THEM. The only word said to any of us was "NEXT" as in "WHOEVER IS NEXT TAKE YOUR TURN". AS in AN ORDER....NEXT!!!! NOW!!!!!

The tragic video of a vet so out of it on Seroquel that he could barely sit in a chair; his head drooped over, food falling out of his mouth, illegible speech..a vet who soon thereafter was found dead in his bed, as explained by his sobbing young widow...even this elicited NO RESPONSE. This is our federal government at work. The FDA needs to be torn down.

it just dawned on me that the seroquel defenders that we are seeing here are probably attorneys for astra zeneca, which is now being sued by ?? 15 or 20 thousand people or their next of kin for such conditions as diabetes and death from hyperglycemia, cardiac arrest, and whatever other lethal side effects the drug may have.

talk about a vested interest. talk about the depths to which this country has fallen as we weigh life and death based on a bottom line.

I'd like to know first hand information if CABF professional board advisory member, Barbara Geller was there in person as a temp FDA advisory committee member....and remark now that she was part of the Paxil study fame. That doesn't give me much hope in the temporary members voting that day being without conflict of interest, and an interest in pro-drugs!

The FDA, in my opinion is not the public safety watchdog we all might hope it could be; in fact it's bought and owned by pharma and it's influence. Bringing these atyipcals into approval has already proven that, because of the buried data, the lies, etc. the fact that AstraZeneca is in court at the same time as this approval meeting is proof I need the FDA is defunct.

The FDA drug approval process is tainted, their committee members are conflicted--remember Laughren was part of the CABF pharma funded study same as Geller part of the FDA. There's a corrupt agency approving drugs that are risking the health of citizens and I personally believe that agency should be held accountable for injuring people as a result of the drugs they approve with such data skewed/cooked, hidden...take Seroquel off the market, and same goes for Zyprexa.

Someone is here defending Seroquel, based on the argument that smoking does not cause cancer? These AZpologists are pretty good at accepting any kind of defense for AZ.

For those who are posting some of the story about what that FDA hearing was like: thanks! Please post some info on where the rest of us could find a full, accurate description.

I am wondering why the response I posted before my post about scientists inducing cancer in lab animals hasn't appeared.

Philip Dawdy responds: because i chose not to approve it.

I gathered that. I was wondering why.

Philip Dawdy responds: because you had already made your point and were getting excessive with me. you aren't going to walk me through a journalism 101 class on my own website. got it?

From Rosie:

Yes, it is true that scientists have not been able to give lung cancer to animals. There was only one experiment where they were able to give one case of lung cancer to one animal and then they could never replicate the finding.

This isn't true either. If you'll review actual scientific literature instead of a book with a specific axe to grind, you'll see that.

This from Anon.:

I am curious to know how many paid Astras are on this comment section objecting to headlines that they believe are misleading or disengenuous.??

and this from SICK AT HEART:

it just dawned on me that the seroquel defenders that we are seeing here are probably attorneys for astra zeneca

I'm not a "paid Astra" (whatever that is), nor am I an attorney for AZ. I think Seroquel is useful in treating schizophrenia and bipolar disorder, but I don't think it should be approved for anything else. In the interest of full disclosure, I do take Seroquel at a very low dose and have found it helpful, but I don't carry any particular torch for it.

Regarding Merrill's comment, in an ideal world we would have an objective committee without too many biases one way or the other. But I just thought it was ridiculous that he picked up on the patient rep's bias when the entire FDA is riddled with drug industry biases and favoritism; he didn't even mention those when critiquing the patient rep's bias. What a thing to focus on when it's literally a miracle ever to get those advisory committees to think outside the box about victims and people who have been harmed, especially in psychiatry. All they care about are the dangers of some hyped up "disease" that can't even be objectively diagnosed and promoting the so-called benefits of bogus treatments.

Someone is here defending Seroquel, based on the argument that smoking does not cause cancer?

No. If you'll read closer, you'll see that's not the case.

These AZpologists are pretty good at accepting any kind of defense for AZ.

What exactly makes one an AZpologist?

The FDA sells, after the fact, and for ?? bucks, a filmed accounting of the Hearings. I personally have never seen one as I am sure the only buyers are pharms involved AND their competitors, parsing what happened like football coaches on game films. Heaven knows if they film the public speakers like us or only AZ and the Advisory Committee and FDA badgering of same.

That is the best I can do for you, unless you wish to have personal anecdote.

It was, personally, one of the most compelling, infuriating, heartbreaking, and anger-producing days I think I will ever have in my lifetime.

If you have some downtime, google Dr. Joshua Sharfstein at the Baltimore Health Department and tell him to get the lead out and get over to the terrible FDA and throw people out on the street immediately.

The sadism and manipulation shown by the two FDA staffers in charge of the meeting, Drs. Temple and Laughren, will forever be burned into a memory bank I really wish I didn't have...it's called the FDA File.

However, the solidarity felt with the vet families, and others I knew who testified, will always be in a Good File of People I Love and Will Never Forget for their Bravery and Tenacity in the Face of Scorn by Our Government.

Busy directing "outside" reporters to the content of "inside reporter" Phil's blog and this thread in particular.

This is the stuff that NEVER SHOWS UP IN A STORY.
I read at least twelve stories on the meeting, all in the Business Section of major papers, and only ONE mentioned the dramatic testimony given by people who had lost family members to this or other atypicals. ONE.

I spoke with one of them today who found me and called him on it......he at least has the intellectual curiosity and perhaps a green light from his boss to follow up on what he heard the public speakers saying at the meeting. One family who lost two sons - he is the Commanding General of Fort Carson, CO - is going VERY PUBLIC, however. One son killed in the Iraq War, and the other ???a suicide while on/off an SSRI/SNRI. Given for PTSD from the War I don't know. Check SSRI Stories....maybe they know.

Steamin'

Here is the tragic story of General Mark Graham as it appears on SSRI Stories. I have copied and pasted part of the story, also.

---------------------------
Paragraph 27 reads: "Gen. and Mrs. Graham say the program's rigorous workload and unrelenting pressure started getting to Kevin. He was diagnosed with depression, they say, and doctors in Kentucky put him on Prozac . Gen. Graham says he encouraged Kevin to take time off from the ROTC program and offered to pay back his scholarship. Kevin told his father he didn't want to be a quitter."

http://online.wsj.com/article/SB123819242229860775.html
BUSINESS
MARCH 28, 2009
A General's Personal Battle

The military is facing a sharp spike in suicides, and Maj. Gen. Mark Graham is leading the fight to reduce them. His mission is close to the heart: His own son, a young ROTC cadet, killed himself six years ago.

By YOCHI J. DREAZEN
Fort Carson, Colo.

Maj. Gen. Mark Graham is on the frontlines of the Army's struggle to stop its soldiers from killing themselves. Through a series of novel experiments, the 32-year military veteran has turned his sprawling base here into a suicide-prevention laboratory. Photo illustration by John Kuczala

One reason: Fort Carson has seen nine suicides in the past 15 months. Another: Six years ago, a 21-year-old ROTC cadet at the University of Kentucky killed himself in the apartment he shared with his brother and sister. He was Kevin Graham, Gen. Graham's youngest son.

Rosie, thank you for the info. about the Graham family's horrendous tragedies. Are you telling me or implying that both boys killed themselves while on SSRI's? I thought one of them was killed in Iraq. Please set me straight...I like to keep the beloved dead sons and daughters straight in my reeling mind and furious broken heart.

Has anyone gotten through the maze of the FOIA to get the latest count of the dead from atypicals off the FDA's hilarious Medwatch System???? I did this three or four years ago but lordy only knows what the numbers are up to now - now that we add in all the seniors, kids, vets, polypharmacy, MDD, GAD, off-label, whatever....

Ilky, I have yet to see a CREDIBLE study that showed that any atypicals helped people with manic depression (let alone schizophrenia) except, perhaps in an acute, psychotic state.

Can you provide sources for your statements? Most particularly for manic depression. Thanks.