AntidepressantInduced Suicide and Tort Reform

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Antidepressant-Induced Suicide and Tort Reform

• Joseph Glenmullen, MD
• Congressional Hearing Energy and Commerce
  Committee February 10, 2005

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Joseph Glenmullen, MD

• Psychiatrist at the Harvard University Health
  Services
• Psychiatrist in private practice
• Clinical Instructor in Psychiatry,Harvard
  University
• Author of Prozac Backlash (2000)
• Author of The Antidepressant Solution (2005)

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A Moderate in the Antidepressant Debate

• I prescribe antidepressants to countless patients
  who have reported their benefits
• I have been a critic of the drugs being
  over-prescribed for mild, even trivial conditions
• And of patients not being adequately warned about
  their side effects

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FDAs Historic 2005 Black Box Warning

• Antidepressants can make children and adolescents
  suicidal especially at the beginning of therapy
  or when the dose either increases or decreases,
  i.e. whenever the dose changes

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FDAs Historic 2005 Black Box Warning

• The over-stimulating side effects of
  antidepressants that can make children suicidal
  include anxiety, agitation, panic attacks,
  insomnia, irritability, hostility, impulsivity,
  akathisia (severe restlessness), hypomania, and
  mania

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According to the FDA

• Antidepressant-induced suicidality is beyond the
  suicidality as a result of the disease.

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The FDA Warning on Adults

• Adults may also be vulnerable to
  antidepressant-induced suicidality but the FDA is
  not yet finished studying the adult data
• Much of the FDA warning applies to adults, but
  the black box only applies to children and
  adolescents

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Numerous Families Testified at the 2004 FDA
Hearings on Antidepressant-Induced Suicide

• Many of the families have lost children to this
  side effect
• Others have children who survived
• The testimony was dramatic, moving, and
  demonstrated that distinct pattern of
  over-stimulating side effects leading to suicide
  and violence

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I Have Witnessed This Side Effect First Hand in
Patients Who I Treat With Antidepressants
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Doctors Need to Be Well Educated about
Antidepressant-Induced Suicidality in Order to
Distinguish it from the Suicidality of Depression
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FDAs Historic 2005 Warning

• Covers all 32 antidepressants currently on the
  American market including
• Prozac, Zoloft, Paxil, Celexa, Lexapro, Effexor,
  Cymbalta, Wellbutrin, Remeron, Luvox

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The FDA and Pharmaceutical Industry Knew About
This Side Effect Over a Decade Ago
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In the Early 1990s Shortly after Prozac Was
Introduced
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American Journal of PsychiatryNew England
Journal of MedicineArchives of General
PsychiatryJournal of Family PracticeJournal
of the American Academy of Child and Adolescent
PsychiatryHuman PsychopharmacologyJournal of
Family Practice
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FDA Held a September 1991 Hearing on
Prozac-Induced Suicide
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But

• The FDA waived its own standards for
  conflicts-of-interest for 5 of the 9 committee
  members and 4 of the 6 consultants because of
  their ties to the pharmaceutical industry

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Despite the Conflicts-of-Interest

• One-third of the committee members voted for a
  warning back in 1991

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The 1991 Committee Repeatedly Called for More
Research
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Eli Lilly Agreed to Do the Gold Standard Research

• May 13, 1991 internal Eli Lilly memo
• On meeting with FDA and agreeing to do the
  research
• Obtained in Prozac suicide lawsuit

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Lilly Developed the Study Protocol

• March 29, 1993 internal Eli Lilly memo
• Full protocol for the study
• Obtained in Prozac suicide lawsuit

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Lilly Submitted the Protocol to the FDA

• Deposition of Dr. Charles Beasley, Lilly
  scientist
• In Prozac suicide lawsuit
• November 8, 2000

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Lilly Involved as Many as 100 Scientists

• Deposition of Dr. Charles Beasley, Lilly
  scientist
• In Prozac suicide lawsuit
• November 8, 2000

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Lilly Developed a More Sensitive Scale for
Assessing Antidepressant-Induced Suicidality

• As part of the study protocol
• March 29, 1993 internal Eli Lilly memo on the
  protocol
• Obtained in Prozac suicide lawsuit

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Once the Media Attention Died Down Lilly Never
Did the Study
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Lilly Claimed the Study Was Mooted by the 1991
FDA Hearing

• Eli Lilly interrogatory
• Obtained in Prozac suicide lawsuit

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FDA Failed to Get the Study Done
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FDA Failed to Have Other Companies with New
Antidepressants in the Pipeline Adopt the More
Sensitive Scale for Assessing Antidepressant-Induc
ed Suicidality
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Countless Internal Pharmaceutical Company
Documents

• Obtained in lawsuits involving antidepressant-indu
  ced suicide and violence
• Are responsible for the momentum leading up to
  the FDAs historic 2005 warning in which the
  agency finally admitted this side effect

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The Internal Company Documents

• Have allowed researchers like myself who were
  writing about this side effect long before the
  FDA finally acknowledged it in 2005

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The Internal Company Documents

• Have saved peoples lives
• Because they have changed the way doctors like
  myself diagnose and treat these severe
  antidepressant side effects

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In 2003 the FDA Lagged Behind the British MHRA
Which Virtually Banned Many Antidepressants for
Children and Adolescents
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Without Lawsuits Against the Pharmaceutical
Industry, a Vital Avenue for Protecting the
Public Would Be Lost
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The FDA Has Still Not Done Enough to Protect
American Children
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The FDAs Warning Does Not Adequately Spell Out
the Link to Antidepressant Withdrawal Reactions

• The warning describes changes in the dose as the
  most dangerous period but falls short of spelling
  out the link to antidepressant withdrawal
  reactions

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Mosholder Report

• Internal FDA report originally suppressed in 2004
  by the FDA but leaked to the media
• Specifically said the link to antidepressant
  withdrawal reactions needs to be further
  investigated
• The FDA has apparently not pursued this key link

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The FDA Has Not Done Enough to Limit Off-Label
Prescribing of Antidepressants to Children

• A recent study showed that as many as 89 of
  antidepressant prescriptions for children are
  off-label

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Only Prozac Is Approved by the FDA for Depressed
Children
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All Other Antidepressants Studied Have Failed to
Be More Effective than Placebo (Dummy) Pills for
Depressed Children
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The FDA Failed to Tell Doctors in the Drug Labels
that They had Been Studied and Failed
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One Million American Children Are on
Antidepressants for Everything from Shyness to
School Anxiety to Headaches to Attention Deficit
Disorder
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How Can the FDA Allow This to Happen When It Has
Acknowledged That the Drugs Can Make Children
Suicidal?
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The FDA Has Failed to Adequately Educate Doctors
and the Public

• Family doctors write 70 of prescriptions for
  antidepressants and know little about how to
  diagnose and treat antidepressant-induced
  suicidality

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The Most Dangerous Scenario When Neither the
Doctor Nor the Patient Knows How to Recognize
Antidepressant-Induced Suicidality
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This Side Effect Can Happen to Anyone, Even
People Doing Well on a Stable Dose

• The research shows the majority of patients
  routinely forget to take their antidepressant
• Missing just one or two days doses may throw
  patients into severe withdrawal that can lead to
  suicidality and violence

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What if Doctors Were Considering an
Antidepressant for Your Child or Grandchild?

• Would you want the doctors to be informed about
  this side effect and how to keep your child safe?
• Or, would you want pharmaceutical companies to
  control all the information and keep it out of
  public view?

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If You Would Want Doctors to Know

• Please do not vote along partisan lines
• Instead, use your power as legislators to
  preserve lawsuits against pharmaceutical
  companies, a vitally important check and balance
  in the system

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