Comments: J&J Called Clinical Trials Of Psychiatric Drugs For Kids "Growth Opportunities"
This diagnosing of children is pure greed.
The "illness" they have does not warrent medication.
Seven deadly sins Greed LINK
Bribery is in the description of greed, which goes well with Fred Goodwin and others who take money from Pharma Co.
Posted by mark p.s.2 at November 25, 2008 02:14 AM
I am not a mother, but every friend I know who is a mother of a baby, a toddler, a pre schooler, even a teenager, questions every shot, every drug the child gets, from the moment they find out they are pregnant.
For a mother (and father) to subject their children to be gunea pigs on something that could be as highly toxic as Rispardal, to me that is wrong. What would motivate a parent to do that? Money? Hell, if they needed money so bad, why don't THEY go on a paid pharma holiday (sarcasm) to test some "nice' new drug.
Kids need adult figures who love them. They need to develop a sense of self esteem. They need to play- whether it's sports or just skipping rope and hopscotch. Kids need love.
Kids don't need to be part of clinical trials, unless they are for the latest toys.
But then, what do i know folks? I'm still not a mother- yet I still hope that I will be someday.
Posted by susan at November 25, 2008 03:45 AM
Damn Phil, you really should be given a Knight Award! I'm constantly amazed at how much stuff you uncover and share with all of us. And though I'm sure there is frustration for you, I get a charge whenever you're able to say something like "Didn't I report and comment about that 1 or 2 or 5 years ago!".
I have to admit though, sometimes there is so much bad shit going on out there that it's overwhelming. I try to read you entries every day but sometimes it's hard.
On the upside, if I'm feeling sluggish I just need to read through your writings to get my blood pressure up!
Keep up the great reporting!
Posted by SallyT at November 25, 2008 04:12 AM
The problem I see with the whole Biederman story is that these people like Biederman might or might not be ousted and so they will come and go but this won't change anything very much. I am trying to look at the Big Picture here.
This Big Picture is that this is just a continuation of the saga that began with Prozac and then all of the SSRIs & SNRIs. There was the corruption of the head docs, the falsifications of the clinical trials, the sorrows and anger of the victim's loved one and what was the result? A Band-Aid. The SSRIs & SNRI antidepressants received a Black Box Warning for youth from the FDA and then it was promptly forgotten or attempts to refute it were made - some of which were successful. In the final anaylsis, the beat just went on. Although there are slighyly fewer children/adolescents taking antidepressants, it is more than made up for by the number of adults taking antidepressants.
So many of these people on antidepressants went insane on them, too, and then were labeled bipolar. So they just switched from Prozac to Zyprexa. Nothing was ever really solved.
Hate to be pessimistic about this but this is actually what I see happening.
Columbine, Red Lake MN, NIU, etc. - all these school shootings involving antidepressants and no one really cares. I remember when Michael McDermott went insane on a triple dose of Prozac and shot dead seven people in the personnel office of Edgewater Technology. He was only one of about 15 perpetrators of workplace violence listed on www.SSRIstories.com Yet nobody really cared because the media refused to report on the Prozac usage. It is the same with all of these terrible cases.
So we will see the same thing with Biederman. We will find in the end, although there might be some initial indignation & a few lawsuits & a few oustings of top docs, that nobody really cares.
Posted by Rosie at November 25, 2008 06:46 AM
Dear Philip:
Biederman should be in prison for all the crimes he has committed against medicine, children, and all reasonable ethical and professional principles.
But isn't it sad they haven't even pulled his license to practice medicine yet! What is the American Medical Association waiting for? What is the APA waiting for? What is Congress waiting for?I guess they are all too busy hiding in their own closets to scared they are next to get caught up in a bribe or scandal!
Yours Truly,
Stan
Posted by stan at November 25, 2008 08:54 AM
MGH Psych Hospital needs to be closed down and re-opened for the studing of withdrawals from these toxic med's. Only doctors without ties to pharma should be hired and it should be completly
funded by the drug companies.
I'm sure if we were privvy to all the emails from all the psychiatric ties to the drug companies we would find this same shit occurred with adult psych med's and ECT device makers.
I think it is safe to say these medications would have never made it to the public had the truth about the shrinks and drug company ties been known. These medications have been killing and destorying lives for far to long. It is mind bloggling to think that these people actually fall asleep at night.
Yet, we will allow this behavior to continue because for some reason we as a society beleive it is better to make people sicker and kill them with approved medications because a few believe they were saved and by god it is much better to say we are "treating" someone and kill them then it is let them work out life difficulties.
Posted by Jane at November 25, 2008 10:06 AM
I WANT ANSWERS AND TRUTH. I want the drug company CEO's and people responsible for cutting those paychecks to Biederman, I want Biederman, and all of them to tell me WHY.
WHY they chose to push forth a personal agenda that caused my daughter personal bodily harm and injury.
Risperdal was given to my daughter in 1999 and I was not told what the hell the drug was, her eyes rolled up, she turned so pale and her breath slowed down I had to find a nurse I thought she was dying!
I want to know WHY my daughter is gravely disabled now as a 20 yr old.
I want answers and people jailed, and placed on trial.
Johnson and Johnson? I may stack these new findings up and file a lawsuit on behalf of my daughter and innocent child, who has suffered at the hands of Biederman's personal agenda to create a diagnosis that psychiatrists were also duped by. If I never took her to a doctor for bed wetting this wouldn't have happened to her!
God!
Posted by Stephany at November 25, 2008 10:09 AM
I agree with Rosie. The beat just goes on. Furthermore these revelations about Biederman and Goodwin and their conflicts of interest are reputedly almost welcomed by big pharma because it takes the media's eye off the real problem which is the corruption of the whole scientific process. The conflicts of interest are wrong but what is far worse is the concealment of the raw data that is behind all these clinical trials that are published. No one has a clue whether these studies are actually good science or not, but given that "anecdotes" and narratives out there in the real world seem to be totally at odds with what's "concluded" in clinical trials and written up in journals, it does seem that maybe they are not good science at all but very bad science indeed. Anecdotes and science should really be consistent with each other, not completely at odds. Patients who agree to be in clinical trials deserve to have the information they are providing disclosed to anyone who wants to see exactly how conclusions are reached, not just the data that suits the purpose of the people funding the trial or writing it up. With a nod to David Healy who makes this point in lectures quite often.
Posted by Sara at November 25, 2008 10:46 AM
This is a little story about the power of the Net.
Back in late 1998 a new Website was born called www.drugawareness.org Since there were so few Website devoted then to people having problems with Prozac/SSRIs, this became the stomping grounds for people who had lost loved ones to SSRIs & SNRIs. Anyone who was having problems with Prozac, Zoloft, Paxil, Luvox, Effexor, Celexa, etc., contacted this site. A few of these people were hang-overs from the Old Prozac Survivors Support Group which did its thing by snail mail from 1991 to 1997.
These people posted their personal stories on this site and soon almost everyone came to know everyone else. And what was the result?
When the FDA announced their Advisory Committee meeting in late 2003 for a look at suicidality & antidepressants and gave the Feb. 2nd 2004 date for the meeting, the word flew fast among the drugawareness.org group. The FDA, which was required by law to announce the meeting in one newspaper, put it in the Arlington, Virginia newspaper.
The FDA initially said they would allow 5 [five] minutes for the presentation of each speaker in the Open Public Hearing. Then, gasp, they were inundated with requests to be heard. Next they announced that each speaker could have only 3 minutes and they were still swamped. So they finally announced a limit of two [2] minutes for each speaker.
The FDA couldn't believe it when all of these parents showed up at the meeting. They had expected maybe three or four parents - tops I would say five.
Where did these parents come from - the majority came through the website drugawareness.org
My husband even spoke to a man at the Advisory Meeting [we, thank the dear Lord, did not have a child who had lost his/her life] whose son had committed suicide on an SSRI. He told my husband that he was amazed so many people from all over the country had showed. He, himself, was from Arlington, Virginia and had seen the annoucement in the newspaper.
The upshot was that the FDA Advisory Committee had no intentions of placing a Black Box warning. They had even suppressed the evidence of their own in-house top doc, Dr. Andrewe Mosholder, and were prepared for business as usual. But a funny thing happened on the way to the forum. The media, slight as they were, began broadcasting the parent's story at noon on Feb. 2nd and there stood the FDA with egg on their face.
So the FDA hummed and hawed and finally agreed that Columbia University should do a study of the clinical trials for children/adolescents and then they would make a decision. Well, guess what - when the FDA came back on Sept. 13, 2004, they had the stats from the Columbia study and it read that children/adolescents were 2 to 3 times more likely to have suicidal behaviors on SSRIs & SNRIs. They kept emphasizing that no child had committed suicide during the clinical trials but I have my doubts about this because I am privy to information that there was a murder during one of the adult clinical trials on an SSRI and it was never reported. So a child suicide might not have been reported, either, but, instead, kept secret during one of those "secret settlements" the drug companies were always making.
Anyway, the up shot is that the FDA did put a Black Box on antidepressants and that the power of the Web is what did this.
So, all you who have websites like furiousseasons, paxilprogress, the effexoractivist, ssristories.com, etc., keep this in mind when it comes time to take a deep look at this bipolar issue, this epidemic which can't be halted yet. Somehow these websites are going to be important. I can't tell how or when but I know they will play a part.
Posted by Rosie at November 25, 2008 11:34 AM
"Why doctors never learn from the past is beyond me. Could we have some judiciousness, please?"
Posted by Philip Dawdy at November 16, 2005 10:13 PM
Posted by Ana at November 25, 2008 11:55 AM
I was proud to learn that the source of these documents is a class-action lawsuit, under the RICO racketeering statute no less, led by three unions in the Philadelphia area. (They are filing as health plans, to recoup the money spent on medically inappropriate Risperdal prescriptions and the costs of caring for the victims.) This will be a crucial part of any fight for health care for all: taking on the profit-driven private health care corporations that are driving up costs and endangering our health into the bargain.
Details and documents on the website of one of their law firms:
http://www.finkelsteinthompson.com/new_cases/risperdal.php
Posted by Johanna at November 25, 2008 04:20 PM
The internet will bring change..
In the pre internet days , pharmaceutical companies and psychiatry had a nice little fucked up business, creaming the profits from the "mental illness" industry. The internet is Global public discourse , the truth always resonates, the truth always surfaces and history will document it all.. (just these days the shit comes out faster than ever before)
The days of deceitful drug company propaganda and psychiatric lies are nearing their end..
The internet is something they cannot control..
Posted by truthman30 at November 25, 2008 04:51 PM
Truthman, I have agonized at the slow pace between knowledge and action, even with the Internet at our disposal. It was interesting to read how the SSRI parents/spouses came together: There has been no similar site strictly for the atypicals, except for one run by CCHR. Many of us, me included have testified, blogged, etc., but it has been a fractured effort. Thus, no black box warning and many children being moved over from SSRIs to atypicals. The MSM has given a share of exposure to the problems of Zyprexa and the others but still - no bans, only one blackbox warning (seniors with dementia). I was there in 2004 and testified and remember my friend Allen Routhier practically leaping over the podium at Tom Laughren and finally the SSRIs got their warning and a medguide. It doesn't mean I'll quit but atypical families don't have a similar hangout; a place to plot and scheme and moan and cry.
Posted by Sorrowful at November 25, 2008 06:29 PM
Rosie wrote:
Well, guess what - when the FDA came back on Sept. 13, 2004, they had the stats from the Columbia study and it read that children/adolescents were 2 to 3 times more likely to have suicidal behaviors on SSRIs & SNRIs.
Yes, but what are the absolute percentages of the number of people affected. If the rate is very low to begin with then the number need to harm (NNH) is so large, even with a doubling or trebling of the risk, it is still worth trying an SSRI or SNRI. It sucks being the one who is harmed by one of these medications, but over all they are still worth trying.
Just stating a two or three times increase in suicidal behavior is very misleading.
Posted by A Believer at November 26, 2008 03:44 AM
A Believer,
I don't know how many [the numbers] were involved in the Columbia study of the clinical trials for children/adolescents.
I do know that in the Zoloft study for children/adolescents, there were 133 youth taking Zoloft alone [no CBT] and two of these had homicidal ideation. So this would be a number of approximately 1 in 66 children taking Zoloft alone who had homicidal ideation.
This, then, would be considered a Frequent adverse reaction according to the standards of the Physicians Desk Reference. Between 1 - 100 patients having an adverse reactions is considered Frequent.
Posted by Rosie at November 26, 2008 06:14 PM
Rosie:
I read the 2008 NEJM study that you cited that found 2 subjects in the Zoloft alone arm having homicidal ideation compared to 0 subjects in the CBT and placebo arms. The chart on p. 11 says that the difference wasn't statistically significant, meaning that the homicidal ideation could have been due to random chance and not the Zoloft.
Take care.
Posted by dguller at November 26, 2008 08:01 PM
dguller,
Of course they would say "random chance". One out of 66 children is a very high rate for "homicial ideation" and what would happen to Pfizer's Zoloft and all the other SSRIs if it was not 'random chance'. It is all about money.
Get with it, dguller. Use your brain.
I have seen studies where the stats showed one thing and the conclusions showed another. Don't you know this yet? You evidently haven't read very many Journal Articles.
I hope you have a nice Thanksgiving anyway.
Posted by Rosie at November 26, 2008 09:19 PM
Rosie:
The authors explicitly state in the article that the differences between Zoloft, CBT and placebo in terms of suicidal and homicidal ideation are not statistically significant.
Here's the quote:
"Rates of adverse events, including suicidal and homicidal ideation, were not significantly
greater in the sertraline group than in the placebo group" (p. 11).
You can even see the p-values on the chart on the same page, and none of them are
Now, you may not like that result, and claim that this is part of a conspiracy to make money, but the actual numbers and the text agree that you are wrong in this case.
And yes, I have read many journal articles (why the capitals?), which is why I always read the discussion LAST, after I have looked at the methodology and statistics sections first to see what the actual figures showed. The discussion is where the authors usually try to fudge things to go their way!
Take care.
Posted by dguller at November 26, 2008 09:59 PM
I'm fond of the phrase "there's a journal for every article". Just because it's published, just because they give assurances, does NOT mean they aren't full of shit. Homicidal/suicidal ideation is not to be taken lightly, there have been enough suicides and school shootings that you ought to be ashamed.
Just the other day I had to redirect a student presenting articles in which the methodology was as solid as a wet tissue AND the results were simply not what was concluded. P-values aside, there are countless ways this study could have manipulated to minimize problematic data. Consider the number who started the trial, the number who finished the trial, and the multitude of tricks in between to screen out unfavorable numbers. I can't be bothered to go into listing all of it. Read some of Phil's breakdowns of various studies. You might learn something
Posted by Jordan at November 28, 2008 02:36 PM
Jordan:
First, I never said that every published study is automatically valid. We have to read the methodology, statistics, and results to see if it is sound, assuming no underlying manipulation of the data.
Second, so, anything that doesn't accord with your wealth of anecdotal data should be tossed aside as obviously manipulated? Or should we actually examine the studies individually to find methodological or statistical flaws?
Feel free to look at the article that Rosie cited and critique it. :)
Posted by dguller at November 28, 2008 03:30 PM