# Presentation: 656406

## Antidepressant-Induced Suicide and Tort Reform

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

## 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)*

## 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

## FDA’s 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 *

## FDA’s 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”

## According to the FDA

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

## 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

## 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

## I Have Witnessed This Side Effect First Hand in Patients Who I Treat With Antidepressants

## Doctors Need to Be Well Educated about Antidepressant-Induced Suicidality in Order to Distinguish it from the Suicidality of Depression

## FDA’s Historic 2005 Warning

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

## The FDA and Pharmaceutical Industry Knew About This Side Effect Over a Decade Ago

## In the Early 1990s Shortly after Prozac Was Introduced

## American Journal of PsychiatryNew England Journal of MedicineArchives of General PsychiatryJournal of Family PracticeJournal of the American Academy of Child and Adolescent PsychiatryHuman PsychopharmacologyJournal of Family Practice

## FDA Held a September 1991 Hearing on Prozac-Induced Suicide

## 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

## Despite the Conflicts-of-Interest

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

## The 1991 Committee Repeatedly Called for More Research

## 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

## Slide 20

## Lilly Developed the Study Protocol

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

## Slide 22

## Lilly Submitted the Protocol to the FDA

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

## Slide 24

## Lilly Involved as Many as 100 Scientists

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

## 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

## Slide 27

## Once the Media Attention Died Down Lilly Never Did the Study

## Lilly Claimed the Study Was “Mooted” by the 1991 FDA Hearing

- Eli Lilly interrogatory
- Obtained in Prozac suicide lawsuit

## Slide 30

## FDA Failed to Get the Study Done

## FDA Failed to Have Other Companies with New Antidepressants in the Pipeline Adopt the More Sensitive Scale for Assessing Antidepressant-Induced Suicidality

## Countless Internal Pharmaceutical Company Documents

- Obtained in lawsuits involving antidepressant-induced suicide and violence
- Are responsible for the momentum leading up to the FDA’s historic 2005 warning in which the agency finally admitted this side effect

## 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

## The Internal Company Documents

- Have saved people’s lives
- Because they have changed the way doctors like myself diagnose and treat these severe antidepressant side effects

## In 2003 the FDA Lagged Behind the British MHRA Which Virtually Banned Many Antidepressants for Children and Adolescents

## Without Lawsuits Against the Pharmaceutical Industry, a Vital Avenue for Protecting the Public Would Be Lost

## The FDA Has Still Not Done Enough to Protect American Children

## The FDA’s 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

## 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

## 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”

## Only Prozac Is Approved by the FDA for Depressed Children

## All Other Antidepressants Studied Have Failed to Be More Effective than Placebo (Dummy) Pills for Depressed Children

## The FDA Failed to Tell Doctors in the Drug Labels that They had Been Studied and Failed

## One Million American Children Are on Antidepressants for Everything from Shyness to School Anxiety to Headaches to Attention Deficit Disorder

## How Can the FDA  Allow This to Happen When It Has Acknowledged That the Drugs Can Make Children Suicidal?

## 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

## The  Most Dangerous Scenario: When Neither the Doctor Nor the Patient Knows How to Recognize Antidepressant-Induced Suicidality

## 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 day’s doses may throw patients into severe withdrawal that can lead to suicidality and violence

## 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?

## 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