GlaxoSmithKline's $3 billion fraud settlement with the DOJ in 2012 remains the largest healthcare fraud case in U.S. history — this page documents GSK's vaccine products, clinical trial record, and regulatory violations.
GlaxoSmithKline (GSK) is one of the four major pharmaceutical companies ("the big four") that sell vaccines on the CDC's childhood schedule. It is the manufacturer of Engerix-B (Hepatitis B vaccine), which was licensed after a trial monitoring safety for only 4 days.
Role in Vaccine Policy
Engerix-B: GSK's Hep B vaccine; pre-licensure trial monitored safety for 4 days per injection (see Pre-Licensure Safety Testing). Plotkin claimed during deposition that safety data beyond 4 days must exist, but was never able to provide it — and moved to quash the subpoena seeking proof.
One of the "big four" vaccine manufacturers alongside Merck, Pfizer, and Sanofi
Key People (pharma ties)
Stanley Plotkin — consulting; board roles; expected future payments
Tina Tan — consultant; advisory board member; speakers' bureau
Kathryn Edwards — research funding (listed as SmithKline Beecham in study disclosures, predecessor to GSK)
What was GlaxoSmithKline's $3 billion fraud settlement about?
In 2012, GSK paid $3 billion to settle the largest healthcare fraud case in U.S. history with the Department of Justice. The settlement covered illegal promotion of drugs for unapproved uses, failure to report safety data, and paying kickbacks to physicians. This is the same company that manufactures multiple childhood vaccines including Engerix-B (hepatitis B), Infanrix (DTaP), Havrix (hepatitis A), and Hiberix (Hib).
Which vaccines does GSK manufacture for the CDC childhood schedule?
GSK manufactures Engerix-B (hepatitis B, licensed with 4-day safety monitoring), Infanrix (DTaP, tested against DTP which increases infant mortality), Havrix (hepatitis A, tested against Engerix-B), Hiberix (Hib, tested against ActHIB), Pediarix (combination DTaP+HepB+IPV), Fluarix and Flulaval (influenza), and Priorix (MMR). None were tested against an inert placebo.
What happened with GSK's "Big Bad Cough" pertussis advertising campaign?
GSK ran an advertising campaign depicting grandmothers as wolves who would harm grandchildren by not being vaccinated for pertussis. ICAN's firm brought a class action lawsuit against GSK for consumer fraud and false advertising, since scientific consensus shows the acellular pertussis vaccine does not prevent transmission. The entire campaign was pulled by mid-September 2020 following service of the lawsuit.
Which vaccine advisors have financial ties to GSK?
Stanley Plotkin has consulting, board roles, and expected future payments from GSK. Tina Tan serves as a consultant, advisory board member, and speakers' bureau participant for GSK. Kathryn Edwards received research funding from SmithKline Beecham (GSK's predecessor). These individuals simultaneously served on FDA and CDC committees that voted on GSK's vaccine products.
How was GSK's Engerix-B hepatitis B vaccine tested before licensure?
Engerix-B was licensed with only 4 days of safety monitoring after each injection and no control group. Stanley Plotkin claimed during his 2018 deposition that safety data beyond 4 days must exist, but admitted "that's speculation based on experience." ICAN sued the FDA demanding clinical trial reports showing safety review beyond one week — the FDA never produced a single such document after years of litigation.
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