Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, June 23, 2014

Critics Slam New Antidepressant-Suicide Study

A new study has recently been slammed by fellow professionals in the field of medicine and a top US law firm.

The study, "Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study", was published in the British Medical Journal [BMJ ] last week and, basically, makes outrageous claims based on findings that seem to be based on bizarre methodology.

I had to look up the word 'quasi'  as I didn't know what it meant. I'd assumed for many years it was a shortened version of Quasimodo [ The Hunchback of Notre Dame]

The authors have, it would appear, cherry-picked studies in an attempt to manipulate the outcome.

In a nutshell the authors are suggesting that teenage suicide increased after the FDA toughened antidepressant warning [Black Box Warning]

Two things strike me here.

1. The BMJ is widely read by doctor's, many of whom have been fence-sitting for years regarding the off-label prescribing of antidepressants to children and adolescents. This study is the proverbial splinter up the backside for those doctors, with a sharp prick to the the buttocks they fall from their fence on to the side of the pro-antidepressant brigade.

2. The media reporting of this particular study is worrying. Retired psychiatrist Mikey Nardo, who writes the 1 Boring Old Man blog, breaks the media coverage down...

First the Washington Post (Dennis) reports:
As a result [of the FDA warnings] antidepressant prescriptions fell sharply for adolescents age 10 to 17 and for young adults age 18 to 29. At the same time, researchers found that the number of suicide attempts rose by more that 20 percent in adolescents and by more than a third in young adults.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE

According to NBC News (Raymond) :
New research finds the warning backfired, causing an increase in suicide attempts by teens and young adults. After the FDA advisories and final black box warning that was issued in October 2004 and the media coverage surrounding this issue, the use of antidepressants in young people dropped by up to 31 percent.
Comment from a non-study affiliated expert? NO 
How many limitations are discussed? NONE

Reuters (Seaman) reports that:
Antidepressant use decreased by 31 percent among adolescents, about 24 percent among young adults and about 15 percent among adults after the warnings were issued. At the same time, there were increases in the number of adolescents and young adults receiving medical attention for overdosing on psychiatric medicines, which the authors say is an accurate way to measure suicide attempts. Those poisoning increased by about 22 percent among adolescents and about 34 percent among young adults after the warnings. That translates to two additional poisoning per 100,000 adolescents and four more poisoning per 1,000 young adults, the researchers write.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? ONE (limitation #5)

According to USA TODAY (Painter):
Warnings that antidepressant medications might prompt suicidal thinking in some young people may have backfired, resulting in more suicide attempts, new research suggests.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE

Forbes (DiSalvo) reports:
Antidepressant use fell 31 percent among adolescents and 24 percent among young adults after the FDA warnings, according to the study. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults in the same time period. Suicide attempts tracked in the study were largely the result of drug overdoses.
Comment from a non-study affiliated expert? NO
How many limitations are discussed? NONE

NPR (Stein) also reports on the story:
Antidepressant use nationally fell 31 percent among adolescents and 24 percent among young adults, the researchers reported. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? ONE (limitation #5)

Finally, the Boston Globe (Freyer) concludes that...
instead of declining as hoped, suicide attempts over the next six years showed a “small but meaningful” uptick among people ages 10 to 29, according to a study published Wednesday in the journal BMJ. That increase followed a substantial drop in the use of antidepressants.
Comment from a non-study affiliated expert? YES
How many limitations are discussed? NONE

A perfect proxy for advertising the safety of antidepressant use in kids.

The study, which is open to opinion has, thus far, received a number of comments from fellow-professionals.

Gerald W Gaines, who owns Depression Recovery Centers in Arizona, writes...

" The study presents a statistical association and proposes a causal relationship with no proof and three key assumptions that anti-depressants have efficacy, increases in overdose were due solely to suicide attempts and the two were somehow linked. The study does not demonstrate causality and the preponderance of secondary evidence would suggest there is no causality at all in the way implied."

Worryingly Gaines uses the horse tranquilizer Ketamine to treat his depressed patients.

Peter C Gøtzsche of the Nordic Cochrane Centre in Denmark is highly critical of the study...

"The FDA’s large meta-analysis of 100,000 patients who had participated in placebo-controlled randomised trials found that antidepressants increase suicidal behaviour up till about the age of 40, and in young people, the risk was doubled"

He adds, "The findings in the report by Lu et al. should be ignored. SSRIs don’t decrease suicidal behaviour in young people, as they claim. SRRIs increase it, and it seems that the risk increases with dose, as would be expected."

Associate Professor, Dept. of Family Medicine, McMaster University Dee Mangin,  hits the nail on the head with...

"Almost none of these drugs are licensed for use in depression in this age group. This article could by its implications endorse off-label use."

Psychiatrist Bernard J Carroll of California adds input to the controversial study with, "I won’t even bother to critique the special pleading and the tendentious tone of this report. The decision to publish it was not the BMJ’s finest hour."

While David Healy, Professor of Psychiatry Bangor University, adds, "There is in summary so little basis in the data presented here for the argument being made that this paper perhaps offers better evidence of an agenda than anything else."

It's a pity the mainstream media chose not to ask any of the above professionals for their expert advice, opting instead for sensationalism and eye-catching headlines.

The lead author [instructor] of the study is one Christine Y Lu.

Lu is a  a pharmacist, pharmacoepidemiologist, and health policy researcher. She also mentors students and fellows through the Harvard Medical School Fellowship in Pharmaceutical Policy Research.

Her findings, along with her co-authors, must be a kick in the teeth for the parents who have lost children and other family members to antidepressant induced suicide. Their findings border on moronic given that the methodology used was just a means to widely promote using this group of medications on children and adolescents. At least that's the way I see it... hey I'm an old cynic approaching 50, what do I know?

Even if the study has been criticized they have successfully spread the word without actually lifting a finger.

The BMJ publish it, doctor's read it.

The mainstream press run with it with very few opposing views - the public read it.

Your average family may have been considering their family doctor's offer of an SSRi to help treat their child.

"But don't these drugs cause suicide?"

"No, in fact a new study has shown that suicides have increased since the warning came out... your child is perfectly's a prescription for Paxil, Zoloft, Celexa, Lexapro, Prozac." [delete where applicable]

I've not yet witnessed a study [so fresh] that has caused so many fellow-professionals outrage. To my knowledge I've never witnessed a law firm come out and chastise the findings of a study so soon after its publication.

Step forward Baum Hedlund, a top US law firm operating out of Los Angeles, Washington, D.C, New Orleans, Philadelphia, and Tallahassee.

They've taken the unusual step of issuing a press release via their webpage.

You can read their full press release here.

In the meantime it's job done for the pro-antidepressant crowd. Their goal may not have been to change the opinion of the FDA, it may have been much simpler. Get the story in a journal widely read by white-coated prescription pad bearers and convince the public [via shoddy journalism] that it's okay to give antidepressants to kids [albeit off-label]

The FDA have issued a statement saying that they have no plans to change the black box warnings [See the Baum Hedlund article for more details.]

Christine Lu has, in my opinion, unleashed a sugar-coated turd. One only has to scratch at the surface to smell the stench. Pinch your nose when going through the study.

Bob Fiddaman.

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