Research Protection for Children

AHRP Campaign to Protect Children from Harm

Oct 15: FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk

Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception

Sep 30: GSK Sales Reps told NOT to Divulge Paxill Data / Merck Withdraws Vioxx

Sep 22: Will Cong Oversight / Investigations Committee Ask FDA Tough Questions?

Sep 21: 18% decrease SSRI use in Youth – NYT / Suicide Risk Not New – Globe / Prozac no different

Sep 19: Govt Prozac study Recommends MANDATORY Screening & Drugs – “Overdosed America”_OpEd NYT

Sep 16: Black Box Warnings for Antidepressants – What’s Next?

Sep 16: Tell the Truth About Antidepressants On Drug Labels & in Medical Journals

Sep 14: AHRP Press Briefing Re: Antidepressant Drug Risks

Sep 8: FDA Forced Wyeth to REMOVE Suicide Warning from Effexor Label

Sep 2: Antipsychotic Drug Use Doubled since 1996 in Tennessee Children – Why?

Aug 11: Two-thirds foster care children in Mass on psych drugs_Globe
Psychiatry: Soviet Experience–American Fallacy

Aug 10: Prozac in Drinking Water / Prozac in Streams Hurt Frogs fish / Newborns suffer Withdrawal

Aug 5: Spitzer Expands drug Probe: Johnson & Johnson / New FDA analysis Confirms SSRI Risks to Kids – WSJ

Aug 4: Sen. Grassley (Finance Committee) letter (416 K pdf) to 8 drug companies requests list of all antidepressant tests on children (1/1/1990–7/23/2004)

Aug 4: FDA Approves Lilly’s Cymbalta for Depression Despite Risk of Suicide

Aug 3: Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data

Jul 26: Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT

Jul 24: Janssen Admits Hiding Risperdal Risks / TMAP & Illinois Mental Health Screening

Jul 23: Government sanctioned Assault on Children and Pregnant Women

Jul 22: Concealed Drug Trial Results Mislead Doctors & Put Children’s Lives at Risk – NYT

Jul 19: Clinical Trials Controversy Spotlights Flawed System – Psychiatric News

Jul 16: Congressional Hearing: What did drug companies & FDA hide?

Jul 9: Paxil for Children: Safety, Efficacy Aren’t Established – Letter WSJ

Jul 7: Cong Hearing Re: Disclosure Pediatric SSRI Trials

Jul 1, 2004: Harvard Study: Multivitamins Effective in Thwarting AIDS progress

Jun 30, 2004: NYS AG Expands Pharmaceutical probe – Forest Labs

Jun 29, 2004: FDA Alert: Effexor warnings added for neonatal adverse effects and suicidality risk

Jun 23: AHRP: Published NIMH Funded Prozac Trial Report Concealed Suicide Attempts by Teens

Jun 21: Antidepressants – USA Today Editorial / AHRP OpEd/ WSJ Editorial Bashes Spitzer

Jun 14: Guardian Reports: MHRA to Issue New SSRI Restrictions / Warnings for Adult Use

Jun 10: Antidepressant drug induced Suicides: Evidence of “Iceberg effect” Revealed

Jun 6, 2004: NY Times Editorial Gets it Right: When Drug Companies Hide Data

Jun 3: Spitzer’s Lawsuit Will Shake Up the Drug Industry – Full Disclosure is the Goal

Jun 2, 2004: NYS Attorney General files suit against GlaxoSmithKline

May 26: Australian Judge blames Paxil & Effexor: mom free of murder attempt

May 25: FDA role in suppressing damaging data – WSJ

May 21: No evidence that screening for suicide reduces suicide

May 10, 2004: “The scariest thing is that nobody knows” risks of depression drugs for children

May 8, 2004: Comprehensive scientific review concluded: All pesticides pose serious health risks to humans–especially children

Apr 22, 2004: What’s in a Warning? Antidepressants and Risk of Suicide – FindLaw

Apr 21, 2004: Data from Unpublished Trials Suggest that Most SSRIs Unsuitable for Children

Apr 19, 2004: NYU Students Drugged – NY Post

Apr 19, 2004: Antidepressant Use in Children Soars Despite Efficacy Doubts – Washington Post

Apr 10: Meta-Analysis: Efficacy & Safety of Antidepressants for Children – BMJ

Apr 2, 2004: Rate of Preschool Kids Prescribed Antidepressants Skyrockets – Cong Investigates FDA

Apr 1, 2004: Congress & the White House must remedy a prescription for danger

Feb 29, 2004: HIV Foster Babies, Children Used to test safety of Experimental Drugs – NY Post

Feb 11, 2004: Update: 19 year old volunteer suicided in Eili Lilly laboratory

Feb 10, 2004: Healthy 19 year old volunteer suicides at Eli Lilly laboratory

Feb 6, 2004: Prescription for Suicide? TIME MAGAZINE

Feb 4, 2004: Advisory Committee tells FDA: strengthen warnings on SSRI drug labels now

Jan 10, 2004: What Parents Aren’t Being told about their Kids Antidepressants – A Suicide Side-Effect? – SF Chronicle

Jan 9, 2004: Zolft pediatric study in JAMA challenged by peers – JAMA letters

Dec 19, 2003: UK doctors told: No Prozac for kids; No Prozac for PMDD

Dec 18, 2003: National Assoc School Psychologists Communiqué Re: Paxil, SSRIs

Dec 17, 2003: Medscape Cites AHRP Concerns Re: New Law Mandates More Testing of Drugs in Children

Dec 15, 2003: Antidepressant Ban for Kids Puts Pressure On U.S. / Canada

Dec 13, 2003: ABCNEWS.com: Worried About Antidepressants? E-Mail Us

Dec 4, 2003: Bush signed Pediatric Research Equity Act

Nov 1, 2003: TIME – Medicating Young Minds with Mood / Behavior Altering Drugs

Oct 29, 2003: FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald

Oct 14, 2003: Appeals Court reinstates Nigerian research case against Pfizer

Oct 14, 2003: WSJ: Court Revives Suit Against Pfizer On Nigeria Study

Oct 3, 2003: A growing Crisis: Aggressive Marketing of drugs for children – Lou Dobbs-CNN

Oct 1, 2003: Lead author of JAMA article rethinks positive Zoloft report – Guardian

Sept 24, 2003: Babies given mind altering drugs in Florida / 68 Paxil Withdrawal Victims File Lawsuit

Sept 21, 2003: UK issues ban on second SSRI antidepressant for children

Sept 2, 2003: Wyeth Pharma Warns Doctors Against Rx Effexor to Kids

Aug 26, 2003: Connecticut Dept of Children & Families Bans Paxil

Aug 25, 2003: Drugging Our Kids – New American

Aug 24, 2003: Brain Development &Teen Mood Swings – ABC

Aug 22, 2003: NIMH-Harvard study: 74% children prescribed SSRI suffer adverse effects

August 18, 2003: Comments submitted by The Alliance for Human Research Protection
Re: Best Pharmaceuticals for Children’s Act of 2002

July 29, 2003: Senate Passes Pediatric Research Equity Act

July 22, 2003: 2,000 children to get experimental malaria vaccine – Nature / BBC

June, 2003: What to do about the ADHD epidemic – William B. Carey, M.D.

June 19, 2003: GlascoSmithKline PAXIL Warning letter to Healthcare Professionals

June 19, 2003: FDA Statement Regarding Anti-Depressant Paxil for Children

June 18, 2003: GlaxoSmithKline issued letter to UK Healthcare Professionals – Paroxetine (Seroxat, Paxil) linked to serious undesirable effects in children.

May 29, 2003: Suffer the Little Children in the Research for Cures_USA Today

May 7, 2003: New AJOB InFocus article Examines Children in Clinical Research

May 5, 2003: FDA Warning Letter: child died from overdose during clinical trial

April 2003: American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav

April 29, 2003: Cong. to act on GAO Finding: Families Give Up Kids to Get Treatment

April 15, 2003: Psychiatric Drugs Pushing Children to Crisis Units_Tampa Tribune

April 9, 2003: Smallpox Vaccine Testing on Kids Blocked_LAT

April 6, 2003: Failed Experiments: Child-Rearing Experts– Visions and Revisions

March 27, 2003: Children are Humans: Don’t Sacrifice their Rights, Dignity & Welfare

March 10, 2004: AHRP Calls for Federal Investigation of Drug Trials Using Children in Foster Care in Violation of Federal Regulations

February 16, 2003: Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch

January 14, 2003: Instead of a War against Drugs, Children Riddled with Psych Drugs

December 2, 2002: AHRP Comments on Smallpox Vaccine Testing on Children 2 to 5 Years of Age

November 2002: Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children

November 27, 2002: US Gov Asks Court to Seal Vaccine Records

November 08, 2002: Investigative series finds kids drugged without cause – Journal News

October 21, 2002: AHRP Press Release Children Policy Recommendations

October 18, 2002: Court Strikes Down FDA Pediatric Rule

October 18, 2002: Pediatric Drug Tests – CNN / NYT Editorial

September 28, 2002: Smallpox Vaccine to be tested in children – why hasn’t CDC released their vaccine data?

August 21, 2002: AHRP Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth"

August 20, 2002: Medical Science Violating Children – 450 healthy children targeted – redflagsweekly

July 26, 2002: Cancer Trials: 60% to 70% of subjects are children

July 26, 2002: 2,610 Infants died of preventable hospital-acquired infections

July 25, 2002: US Drug Usage Explodes_327% increase in Children

July 12, 2002: Babies Exposed to Toxic Vaccines

July 9, 2002: Oregonian Editorial: Stop Drug Research on Oregon Kids

May 31, 2002: Children in "Hot Demand" for Clinical Trials

May 14, 2002: Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406)

May 13, 2002: Experimentation on Newborns: Is it Ethical?

April 30, 2002: Dr. David Healy: Testing Psychotropic Drugs in Children

April 23, 2002: AHRP Congressional Testimony submitted by Dr. John H. Noble, Jr. and Vera Sharav to U. S. Senate re: Protecting Human Subjects in Research: Are Current Safeguards Adequate?

April 21, 2002: Hundreds of Viennese Child Victims of Nazi "Experiment" in WWII are Buried

March 26, 2002: Lab animals used in research are protected by laws; children are not.

January 28, 2002: Linguistic Tinkering with Regulatory Terminology Increases Risk of Harm for Children

October 10, 2001
Maryland Court of Appeals Denies Motion by Johns Hopkins, Kennedy Krieger, EPA, et al. to Reconsider Ruling on Using Children in Lead Paint Poisoning Experiment

October 1, 2001 AHRP Amicus Brief Supporting Maryland Court of Appeals Landmark Decision in Higgins v Kennedy Kriger Institute

September 21, 2001
Human values vs. $$$_ Children at Risk in Research

August 24, 2001
Federal Agency begins Investigating KKI / Hopkins Study of Lead paint Hazard

August 16, 2001
Maryland Court of Appeals’ Landmark Decision (Higgins v. Kennedy Krieger Institute) Prohibits Non-Therapeutic Experimentation on Children

August 6, 2001

FDA: regulatory protections for children. Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP

July 25, 2001
Dissenting Opinion: Against Waiving Parental Permission for Research

April, 2001
Comments Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc.

February – March 2001 Boston Globe series by Alice Dembner documents harm to children in clinical trials

February 27, 2001
Would you volunteer your child to be a "risk-bearing" subject in drug experiments?