Letter of Complaint to FDA Commissioner, 2007

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Complaint about a surge of FDA administrative approvals for expanded use of highly toxic antipsychotic drugs for children. Approvals were determined by Dr. Thomas Laughren after secret deliberations–without disclosure of scientific data, without  an advisory panel or open public discussion.  Continue reading →

FDA Internal Document: Use of Placebo-Controls in Life Threatening Diseases

The efficacy and safety of a new drug that treats a serious and life threatening illness in premature infants will be studied versus sham/placebo in Latin America. The sponsor plans to apply for FDA approval, in addition to local and European registration. There are approved therapies (surfactants) for this illness (Respiratory Distress Syndrome, or RDS) in those countries where this trial is proposed to take place, and surfactants are even used in some of their hospitals. However, surfactants are completely unavailable to infants at many other hospitals, secondary to rationing or economic limitations. Continue reading →

ADDENDUM: Scientifically Invalid SSRI Study

When scientists are for sale and "peer reviewed" journals publish planted commercial pronouncements masquerading as "science" news reports, the public is advised to disregard those "news" reports and wait for the evidence to be independently examined and either corroborated or refuted.  Continue reading →