Where were the adults?

Along with Lilly and GlaxoSmithKline (see Drug companies use studies the way a drunk uses a lamppost), Pfizer created ghost suicidal acts on placebo. Other companies did further things that concealed the suicide problem. Did Pfizer?

In 2004, following the lead of the British Regulator (MHRA), the FDA put a Black Box warning about the risk of suicide on the pediatric use of antidepressants. The MHRA asked companies to submit the data from adult antidepressant clinical trials. FDA followed suit. Not all companies gave all their data to either regulator. MHRA published a report on antidepressants and suicide containing these figures in Table 1 for suicides and suicidal acts on Zoloft (sertraline – Lustral).

Two years later in 2006 FDA also published a report. It contained a quite different set of figures – see Table 1.

Table 1

 

Zoloft

Number Acts/Number Patients

Placebo

Number Acts/Number Patients

Relative Risk

Britain 2004Suicides

4/7169

0/5108

Suicides & Suicidal Acts

24/7169

8/5108

Zoloft twice as risky as Placebo

USA 2006Suicides

0/6561

1/5408

Suicides & Suicidal Acts

6/6561

8/5408

Zoloft nearly twice as safe as Placebo

 

The Zoloft 2006 data were not just different to the 2004 data – they were startlingly different to the data for Paxil, Prozac, Celexa, Lexapro, and the other drugs reviewed by FDA in 2006. The new Zoloft data played a key part in FDA not extending the Black Box warning to all ages. Indeed the data helped FDA argue there was an apparently beneficial effect of antidepressants in the elderly.

Two years later, Pfizer published an article containing yet another set of data (Vanderburg et al (2009). A pooled analysis of suicidality in double-blind, placebo-controlled studies of sertraline in adults. J Clinical Psychiatry 70, 674-683). See Table 2.

Table 2

Pfizer 2009

Zoloft

Number Acts/Number Patients

Placebo

Number Acts/Number Patients

Risk

Suicides & Suicidal Acts

25/10,917

14/9006

Zoloft 1 ½ times as Risky as Placebo

Over 65s

4/1037

0/823

Zoloft much Riskier than Placebo

 

On the basis of these data all ages would have had a Black Box warning.

If FDA had worked on the basis of these data in 2006, all ages would have had a Black Box warning and there would have been no question about some beneficial effect for the elderly.

So what is happening here? FDA has some scope for plausible deniability. They were hemmed in by company data management maneuvers – some of which have been outlined in my recent blogs – and perhaps in an effort to avoid these, asked the companies for short-term trials only and didn’t want any withdrawal periods. Exactly what they asked is the key issue; and with two years to think about the issues someone had plenty of time to come up with a form of words that would produce a “result.”

This someone is unlikely to have been the regulator. FDA in all this have shown no signs of being agile or creative. Quite the contrary, it seems FDA can be depended on not to spot something happening. Not to spot when cases of suicidality are coded as emotional lability, for instance. In this case FDA, companies, and their advisors somehow managed to find perhaps the only safe line through a minefield.

The myth has emerged that younger people are uniquely susceptible to suicide…when even on the data presented to FDA in 2006, 45-65 year-olds had the same risk as 18-25 year-olds.

The result was to concede some ground by extending the Black Box to cover 18-25 year-olds. All of a sudden the myth emerged that younger people were uniquely susceptible to the risk of suicide from these drugs — when even on the data presented to FDA in 2006, 45-65 year-olds had the same risk as 18-25 year-olds.

Another myth was also spun that the drugs were more likely to trigger suicidal ideation rather than suicidal acts, when in fact the 2006 data shows just the opposite.

It is hard to avoid the impression of companies and regulators tip-toeing through a data minefield. This might look like a modern version of the parting of the Red Sea allowing Moses and the Children of Israel to be miraculously saved from the towering walls of water on either side of them. It should look more like pillars of smoke being used to prevent those with a right to know getting access to the facts.

So here are the questions:

  • We’ve seen how GlaxoSmithKline managed studies in a manner that concealed the problems — what exactly happened with the Pfizer data?
  • It is completely implausible that SSRIs don’t cause problems in the elderly. Pfizer’s 2009 data show this. Why has there been so little questioning of this point?
  • Why is there no apparent interest to find out how the clinical trial data could so misrepresent the risks these drugs pose to the elderly?

When she was a child, I read Exodus
To my daughter. ‘The children of Israel…’
Pillar of fire
Pillar of cloud
We stared at the end
Into each other’s eyes
Where
She said hushed
Were the adults?

— From George Oppen’s “Exodus”


Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

Dr. David Healy documents a riveting and terrifying story that affects us all.

University of California Press (2012)

Available on Amazon.com

 


RxISK: Research and report prescription drug side effects on RxISK.org.

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You and your meds. Give the real story. Get the real story.

Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. Suicidal ideation doesn’t happen with abrupt discontinuation from anti-depressants. There is no, ‘oh, I think I might try and hang myself today, tomorrow or next week.

    It is instant, fast, and effective. Like the hangman’s noose in day’s gone by; no escape, the floor disappears from under your feet. In a twinkle you are gone.

    Suicide and acts. If you escape because of that split second of sanity from a death from hanging, like I did, by the skin of my teeth, you are very, very lucky.

    That was Paroxetine in 2002. Eight weeks off Seroxat and psychotic and deranged. Not a drug has passed down my throat since 2003. I cannot complain about anything anymore because it’s a case of ‘look what you did’, don’t entertain any compassion from the medical profession.

    On to Citalopram and the elderly.

    My dear old mum became confused because she did not take her Citalopram for a few weeks. I knew exactly why she was in the most ‘bizarre’ state of mind and she is now organised to take her drugs on time every day. She is fine now, albeit hooked until the end of her days.

    I was 51, she is 91.

    Age doesn’t come in to the equation.

    • The trail of death and sveree physical disabilities from psychiatric drugs sadly grows longer. I praise this couple who had just a horrible, tragic loss, and who honored themselves, and their child by fighting back. They are brave people up against a uncaring foe. The pharmaceutical companies have made trillions pushing anti-depressant drugs which their own lab tests have shown to be no more effective than placebos in actually relieving depression.As money is all these corporate criminals are interested in, lawsuits are an effective action we can take to stop them?they certainly do not care what effects their drugs create! At some point I hope enough demand for justice is created to force the members of the Congress & Senate (who are all on the payroll/favors roll of pharmaceutical companies no exaggeration; check it out yourself) to pass legislation that stops the fraud these companies continue to push in every TV ad, every women’s magazine ad ,etc.that these drugs are safe and help people.

  2. There is no interest in the risk for these antidepressants for the elderly because there is no group who watches over these clinical trials. The trials are presented to the FDA who is owned by pharma. I am surprised the FDA got as far as the black box for 24 and under.

    Although 10% of the population are on these SSRIs and SNRIs, among women in their 30′s, 40′s and 50′s , it is 25%. There has been a definite increase in the number of suicides in this age group among women according to the latest stats from the CDC. Perhaps more women are taking these antidepressants because their birth control pills are making them “blue”. Whatever the reason, more women are now committing acts of violence and other bizarre behavior than previously noted.

    • I too believe the birth control pill should be closely studied as being linked to so much depression among women. I did a campaign to create awareness of the risk of depression caused by the drug Dianette also know as Diane-35. This is licensed for acne and contains the contraceptive drug ethinyl-estradiol as well as the anti-androgen – cyproterone-acetate Women have self harm and some told me they attempted suicide. I have over 150 reports and most women complained their doctors prescribed antidepressants without telling them to stop taking Dianette. The manufacturers have been asked to include more warning about the risk of depression but the information is not standardised.
      Millie Kieve founder of APRIL http://www.april.org.uk

  3. Beware the DSM-V
    Autism Spectrum Disorder (ASD) is a proposed revision to the DSM-5.This new diagnosis will include autistic disorder, Asperger syndrome, childhood disintegrative disorder, and PDD-NOS – which includes anything and everything found unacceptable by teachers and others. It is thought that individuals with ASDs are best represented as a single diagnostic category and includes collapsing social and communication deficits into one class. Thus, an individual with an ASD diagnosis will be described in terms of severity of social communication symptoms, severity of fixated or restricted behaviors or interests and associated features. And what will this mean?
    The National Institute for Mental Health publishes the following:
    “A Parent’s Guide to Autism Spectrum Disorder
    Autism is a group of developmental brain disorders, collectively called autism spectrum disorder (ASD). The term “spectrum” refers to the wide range of symptoms, skills, and levels of impairment, or disability, that children with ASD can have. Some children are mildly impaired by their symptoms, but others are severely disabled.
    ASD is diagnosed according to guidelines listed in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition – Text Revision (DSM-IV-TR). The manual currently defines five disorders, sometimes called pervasive developmental disorders (PDDs), as ASD:
    Autistic disorder (classic autism)
    Asperger’s disorder (Asperger syndrome)
    Pervasive developmental disorder not otherwise specified (PDD-NOS) – (So that takes care of all other “unacceptable” behaviours)
    Rett’s disorder (Rett syndrome) – (Why a genetic disorder such as Rett syndrome should be included defies explanation.)
    Childhood disintegrative disorder (CDD). (Whatever that may be.)
    NIMH goes on: “Some medications can help reduce symptoms that cause problems for your child in school or at home. Many other medications may be prescribed off-label, meaning they have not been approved by the U.S. Food and Drug Administration (FDA) for a certain use or for certain people. Doctors may prescribe medications off-label if they have been approved to treat other disorders that have similar symptoms to ASD, or if they have been effective in treating adults or older children with ASD. Doctors prescribe medications off-label to try to help the youngest patients, but more research is needed to be sure that these medicines are safe and effective for children and teens with ASD.
    At this time, the only medications approved by the FDA to treat aspects of ASD are the antipsychotics risperidone (Risperdal) and aripripazole (Abilify). These medications can help reduce irritability—meaning aggression, self-harming acts, or temper tantrums—in children ages 5 to 16 who have ASD.
    Some medications that may be prescribed off-label for children with ASD include the following:
    Antipsychotic medications are more commonly used to treat serious mental illnesses such as schizophrenia. These medicines may help reduce aggression and other serious behavioral problems in children, including children with ASD. They may also help reduce repetitive behaviors, hyperactivity, and attention problems.
    Antidepressant medications, such as fluoxetine (Prozac) or sertraline (Zoloft), are usually prescribed to treat depression and anxiety but are sometimes prescribed to reduce repetitive behaviors. Some antidepressants may also help control aggression and anxiety in children with ASD. However, researchers still are not sure if these medications are useful; a recent study suggested that the antidepressant citalopram (Celexa) was no more effective than a placebo (sugar pill) at reducing repetitive behaviors in children with ASD.
    Stimulant medications, such as methylphenidate (Ritalin), are safe and effective in treating people with attention deficit hyperactivity disorder (ADHD). Methylphenidate has been shown to effectively treat hyperactivity in children with ASD as well. But not as many children with ASD respond to treatment, and those who do have shown more side effects than children with ADHD and not ASD.
    All medications carry a risk of side effects. For details on the side effects of common psychiatric medications, see the NIMH website on Medications”.
    Parents, faced with this apparently authoritative information and the power of the American Academy of Child and Adolescent Psychiatry, are more than likely to accept as gospel that a) their child has a significant disorder simply because it has a “scientific” name and b) there is a “magic pill” that will cure.
    How does one fight this widely held perception?

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