What’s New? – Alliance for Human Research Protection


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Infomails

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At FDA, Graham is still the whistle-blower

Loss of Trust: Big Drug Makers See Sales Decline With Their Image

War hero’s death in clinical trial follows years of FDA neglect

European perspective: Bird Flu / Rumsfeld Tamiflu stock $5 to $25 million

Big Pharma’s Shameful Secret–Bloomberg/ Clinical Trials Stopped Early for perceived benefit later turned out false–JAMA

Twin Pharma Give-A-Ways: Biodefense Vaccine Development Act /Bird Flu Plan

FDA May Require Longer Studies Before Approving Psych Drugs

Former FDA Commissioner says FDA lost public trust

Jones reveals TMAP drug scam linked to then Governor George W. Bush

20% Drop in Psych Drugs Prescribed for US Children

Epidemiologist: Most Published Research Findings False – Psychiatrist: Credibility Crisis

A Taxpayer-Funded Clinical Trial Registry Exists!

Medicaid may shrink $5.5 Bill spending on Schizophrenia Drug

TIME inquiry: top officials at vital gov agencies lack credentials for the job

What the FDA Isn’t Telling You – SLATE

FDA Commissioner Crawford Resigns

Federal Study Finds No Benefit of New Antipsychotic Drugs

Joint Commission on Accreditation of Healthcare Orgs & NCQA

Anatomy of an Epidemic – Whitaker

Universities Misappropriate Federal Grants – Cornell Doctor Blows Whistle Alleging Phantom Studies

Cymbalta Contract: How Lilly Influences What Prescribers Learn

Congress Bars EPA from accepting human pesticide data

US Epidemic: Controlled Prescription Drug Abuse

Jury awards $635,177 Damages for Memory Loss from Electroshock

Concealed NIH Review Substantiates Fired Expert’s Concerns

AMA Serves Pharma Marketing Priority/ FDA To Add Warnings on ADHD drugs

1/3 US Scientists Admit Unethical Research Practices

Suicide Rate Unchanged in 10 Years / AMA Considers Stand Against Warning Labels

Most Americans Will Be Mentally Ill – NIMH / Harvard Study Says

Treating children as young as 4 for bipolar – WSJ

A National Scandal: AIDS Drug Experiments on Foster Care Children

A Serious Drug Problem – The Medicare Prescription Bill of 2003

The Power of $4 bill Drug Ads: Doctors Respond with Diagnosis & Prescription

Drugmakers Go Furthest to Sway Congress: 1,274 Lobbyists – USA Today

Depressed? NYC Screens for People at Risk

UK: Drugs firms ‘creating ills for every pill / US ‘Bioshield’ Drug-Patent Plan Draws Fire

NIH Scientists Caught Concealing Millions in Royalties

Intimidation, Politics and Drug Industry – FDA Permits Graham to publish Vioxx Report

Credibility Crisis: Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA

Sen Grassley to Offer Mandatory Drug Data Registry Bill

Just Say No – Forbes

Prescription Drug Industry: The Insiders – AARP Bulletin

Dr. Loren Mosher, 1933 – 2004

Pharma Influence: Penn Whistleblower Lawsuit – Medicare Chief Lied

Scientists Decode Secret of NIH Grants

Bush Plans to Screen Whole US Population for Mental Illness

More than 100 gov officials represented industry

Doctors Without Borders: Why you can’t trust medical journals

FDA Bad Faith – Daniel Troy’s pre-emption defense

Ethics Policy Announced for NIH Officials – LAT

Drug Companies and Research at NIH

view infomail archive

 

AHRP Speaks Out

AHRP Statement on MH Screening – FDA Hearing Re: Drug Advertising

AHRP Testimony: Protections for Foster Children Enrolled in Clinical Trials

Statement Opposing the SACHRP Children’s Committee Recommendations

Statement by Vera Hassner Sharav, Anthrax Band Reunion Press Conference

AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine

Testimony of Meryl Nass, MD – Senate HELP Committee, Subcommittee on Bioterrorism

US Gov Pesticide Exposure Experiments: Target Children–$970 per child – Wash Post

AHRP Press Briefing 9/14/04: Antidepressants & suicide-related risks for children

Open Letter to NIMH re Prozac & Concealed Suicide Attempts

Open Letter to Officials at NIMH

AHRP Briefing 2/2/04: Scientists present suicide evidence

Conflicts of Interest policy – New York Times

Phase I Drug Trials Used Foster Care children in Violation of 45 CFR 46.409 and 21 CFR 50.56

AHRP Testimonies re: Fatal ARDS lung experiment

AHRP Comments: DHHS COI Guidance for Human Subject Protection

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

“Should the EPA Accept Human Pesticide Experiments?", testimony by Vera Sharav before Committee of The National Academies of Science

AHRP Comments on Smallpox Vaccine Testing on Children 2 to 5 Years of Age

AHRP Press Release Children Policy Recommendations

AHRP Replies to OHRP Response re Surrogate Consent.

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

Media interviews Dr. Meryl Nass re: anthrax vaccine and anthrax attacks

Critique: U.S. to Vaccinate 500,000 Workers Against Smallpox (7/7/02)

Memorandum in opposition to California AB 2328

"Conflicts of Interest In Clinical Trials", a presentation by Vera Hassner Sharav before the US Army Medical Department and Henry M. Jackson Foundation for Advancement of Military Medicine

Congressional Testimony re: Protecting Children in Research

more

 

Congressional Investigations

Featured News

NEW:

Drugs, Devices & Doctors – Krugman
Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble
AHRP Comments Re: EPA Proposed Rule for Human Pesticide Research

Unethical Experimentation on Foster Children

Timeline and Links – Unethical Experimentation on Foster Children
Letters Challenge NY Times Report re: AIDS drug/ vaccine experiments on foster children
OHRP preliminary findings fault Columbia University Medical Center
Congressional Hearings – Testimony by Roberta Harris, Deputy Secretary, Wisconsin Dept. of Health / Family Services
Congressional Hearings – AHRP statement and recommendations for the record
A National Scandal: AIDS Drug Experiments on Foster Care Children – AP
AHRP Letter of Complaint: Phase I AIDS Drug/Vaccine Experiment on Foster Children

Safety of Depression’s ‘Wonder Drugs’ Investigated After a Decade of Lies, Deception and Cover-up

Mark Miller, whose son, Mat, committed suicide while on Zoloft, has trumped Pfizer in his rendition of their new Zoloft advertisement published in Oprah magazine. See the parody on DrugAwareness: http://www.drugawareness.org/pdf/zoloftad.pdf

Mosholder Report: Suicidality in Pediatric Clinical Trials
GSK Internal Memo
Analysis of Prozac/Paxil/Zoloft use in US, 1988-2002 (pdf)
US Paxil Suicide Calculations, 1993-2002

NIMH Grants to Study SSRI Suicidality – FDA to Examine SSRI-Suicide in Adults
SC Supreme Court To Hear Christopher Pittman Appeal
FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks
Two Court Rulings Reject Pfizer-FDA Preemption Claim in Zoloft “failure to warn”
FDA Public Health Advisory: SSRI-Suicide link in adults
Traci Johnson driven to suicide by anti-depressants? Trade secret
SSRI Defects: Infants Suffer Drug Withdrawal / Adults risk GI bleeding
FDA Slaps Pfizer on Zoloft Ads After AHRP Files Complaint
Petition FDA to Investigate
if SSRI Induced School Shootings
Zoloft Warnings to Canadian Doctors – FDA Caves In to Lobbying
Eli Lilly Prozac Documents: What do They Reveal?
Prozac Suicide Risk
– CNN Posts long concealed Eli Lilly Internal Documents
Contracts Keep Drug Research Findings Concealed
FDA Orders Black Box Warnings – Suicide risk
Psychiatry on the Ropes–WP / Evidence-based Psychiatry
BBC – Taken on Trust – 13 years-Medical Deception
Janssen Admits Hiding Risperdal Risks / TMAP & Illinois Mental Health Screening
Effexor warnings added: neonatal effects and suicidality
Forest Labs Admits Data Concealment – Cong. Probe Expands
NY Times Editorial: When Drug Companies Hide Data
FDA role in suppressing damaging data – WSJ
Bristol Myers Squibb Takes Serzone off the market
Recycled drugs: failed antidepressants
Unpublished Trials
Suggest Most SSRIs Unsuitable for Children
Expert FDA Report: SSRI Suicide risk
Rate of Preschool Kids Prescribed Antidepressants Skyrockets
Antidepressant Controversy: Media Conflicts of Interest
What GSK really thinks
about Paxil for Children
Lilly duloxetine drug trial–19 Quit after a suicide
Healthy 19 year old volunteer suicides at Eli Lilly laboratory
Prescription for Suicide?
Time Magazine
Drug report barred by FDA Scientist links antidepressants to suicide in kids
Antidepressant Makers Withhold Data on Children
UK doctors told: No Prozac for kids; No Prozac for PMDD
Medscape Cites AHRP Concerns Re: New Law
Wyeth Pharma Warns Doctors Against Rx Effexor to Kids
74% children prescribed SSRI suffer adverse effects
GlascoSmithKline Paxil Warning letter to UK Healthcare Professionals
UK Government Bans Paxil for children

New Presentations, Publications, and Testimonies

Cheaper than Chimpanzees Statement re: Revisions to DHHS Regulations on Protection of Prisoners Involved in Research – Sharav
Protecting People with Mental Disabilities & Impairments Against Biomedical Research Abuse – Noble & Sharav
AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine
Testimony: Senate HELP Committee, Subcommittee on Bioterrorism – Dr. Meryl Nass
The Impact of the FDA Modernization Act – Vera Sharav article
Best Pharmaceuticals for Children’s Act of 2002 – AHRP Comments
Broken Brains or Flawed Studies? – Dr. Cohen & Dr. Leo
Children in Clinical Research: A Conflict of Moral Values – Vera Sharav
AHRP Letter in NEJM re ARDS Investigation
Interview with Dr. Loren Mosher – San Diego Reader
AHRP Testimonies re: Fatal ARDS lung experiment
AHRP Children Policy Recommendations

Major Ethical Violations: No Informed Consent

Why did OHRP SHRED informed consent documents
China Daily update: Harvard genetic research in rural China
China Daily challenges US genetic experiments on poor farmers
OHRP Found NHLBI / ARDS Lung Experiments Violated Informed Consent
Research dispute prompts patient-trials debate – Seattle Times
OHRP Letter to ARDSNetwork re: Investigation of ARDS Study
EPA Opens the Door to Testing Bug Killers on People: Spoon-Feeding Poison Artificial Heart experiment without informed consent?
Research at US Veterans Hospitals Nationwide Under Investigation – NYT
Anthrax Vaccine Consent Form / Should You Roll Up Your Sleeves – WSJ


AHRP is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to ensure that the human rights, dignity and welfare of human subjects are protected, and to minimize the risks associated with such endeavors.


Children at Risk of Harm

SAMHSA Backs Away from TeenScreen & TMAP

212% Increase in Prescription Drug Abuse by US Teens – Australian critics challenge loose prescribers

EPA Exceptions Allow Pesticides experiments on Children

New Evidence Re AIDS Drug/Vaccine Experiments on Foster Care Infants & Children

The Rutherford Institute Takes on TeenScreen Case in Indiana

Treating children as young as 4 for bipolar

A National Scandal: AIDS Drug Experiments on Foster Care Children

Calls for Transparency- Accountability – NYC Foster Children AIDS drug trials

NGO Probe to Look at Foster Kids in AIDS Drug Trials – NYC

Mental Health Screening: Children Drugged Without Parental Consent

Ritalin Chromosome Abnormalities / High school prescription drug abuse

91 Merck Memo Warned of Mercury in Baby Vaccines

US Gov Pesticide Exposure Experiments: Target Children–$970 per child – Wash Post

2/3 foster care children in MA on psych drugs

Government sanctioned Assault on Children and Pregnant Women

Cong Hearing Re: Disclosure Pediatric SSRI Trials

No evidence that screening reduces suicide

NYU Students Drugged

HIV Foster Babies, Children Used to Test Safety of Experimental Drugs

What to do about the ADHD epidemic

A growing Crisis: Aggressive Marketing of drugs for children

Drugging Our Kids – New American

Brain Development & Teen Mood Swings

Senate Passes Pediatric Research Equity Act

2,000 children to get experimental malaria vaccine

Psychiatry and Preschoolers

FDA Statement Regarding Antidepressant Paxil for Children

GlaxoSmithKline issued letter to UK Healthcare Professionals Re Paroxetine (Seroxat, Paxil) in children.

Suffer the Little Children in the Research for Cures

Children in Clinical Research: A Conflict of Moral Values

FDA Warning Letter: child died from overdose during clinical trial

Psychiatric Drugs Pushing Children to Crisis Units

Failed Experiments: Child-Rearing Experts– Visions and Revisions

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

Death of Baby Prompts Scrutiny of Research Risks

Dr. David Healy: Testing Psychotropic Drugs in Children – problems and prospects

more children

 

Risks: Drugs / Vaccines

Lilly is Hiding Negative Information About Zyprexa

ADHD drug Cylert withdrawn from market due to Liver Toxicity

Finkelstein Letter to FDA about FDA’s Failure to Warn about Neurontin-Suicides

New Diabetes Drug Increases Mortality / Morbidity

Suicide Warning: Strattera

UK Doctors told to stop giving antidepressants to children – Glaxo Warns of Paxil Birth Defects

In the UK & Canada, but NOT the US Eli Lilly Warns about Zyprexa Lethal Side Effect

Zyprexa – Risperdal – Abilify – Clozaril Kill Elderly

Pfizer Statements RE: Bextra, Celebrex, Neurontin Lies

UK Parliament Report Re: Pharma Influence / US Regulators Comatose as 258 Fatal Suicides Linked to Neurontin

Antipsychotic drugs may be bad for your heart/ Clozaril and Zyprexa

Canadian Regulators Withdraw ADD Drug Linked to 20 Sudden Deaths

Officials at NIH Knew of AIDS Drug Risks and Failed to Inform White House

How Did the Vioxx Debacle Happen? USA Today / Lancet

Time for a Drug Test Registry: Marcia Angel

All pesticides pose serious health risks to humans

Safety of Smallpox Vaccine among Military Recipients Questioned_JAMA

FDA Accepts Adverse Drug Reaction Reports from Consumers

FDA Statement Regarding Antidepressant Paxil for Children

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

GlascoSmithKline PAXIL Warning letter to Healthcare Professionals

Bayer Documents: Tainted Blood Killed Thousands of Hemophiliacs

BBC Panorama: Unprecedented public response to SSRI drug harm

Leading Antipsychotic Drugs Come Under New Scrutiny – NYT

Risperdal Linked to Stroke; Zyprexa linked to Diabetes

Bayer/ Baycol on Trial in Texas_- NYT

Internal Documents: Bayer Knew of Baycol Dangers – NYT

18 Deaths Linked to Serzone – Removed from European market

Clinical Psychiatric News. Analysis of Psych Drug Trials, 1985-2000, Reveals High Suicide risk.

Duke Warning: Zyprexa-Diabetes Link

more

 


There is no law that protects children in clinical trials comparable to the Animal Welfare Act of 1966 that protects laboratory animals.

The Boston Globe reported that in 2001:

  • 45,000 children were in medical experiments, vs. 16,000 in 1996.  
  • Researchers got $5,000 referral fees to recruit children for drug trials.  
  • Parents — who are uninformed about the actual risks involved — were offered financial incentives — $200 to $1,000 — to volunteer their children for such experiments.

Would you volunteer your child to be among the "risk-bearing children" in drug trials?


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