When Challenged by ICAN, the FDA Lifts Redactions to Reveal More Information About the Varicella (Chicken Pox Vaccine) Clinical Trials Data
ICAN sued the FDA in November 2019 in order to obtain copies of the clinical trials relied upon to license the varicella vaccine in 1995. Over 9 months later, the FDA completed production of the documents, many of which contained numerous unnecessary redactions. ICAN pushed back on the agency and, except for 12 dates of death, the FDA lifted all of the challenged redactions demonstrating a tendency by the agency to over-redact information that should be available to the public.
The CDC vigorously promotes the varicella (chickenpox) vaccine. ICAN, therefore, submitted a FOIA request to the FDA in September 2018 for copies of the clinical trials relied upon to license the varicella vaccine in 1995. ICAN wanted to review and share with the public the clinical trial reports and safety data relied upon when the FDA licensed this vaccine.
More than a year later, the FDA had failed to produce the clinical trial reports sought by the FOIA Request and so ICAN brought suit. The agency’s counsel and ICAN’s attorneys, led by Aaron Siri, then conferred and reached agreement on a schedule by which the FDA would produce all of the responsive clinical trials. On January 9, 2020, FDA made its first production to ICAN and completed its 9-part production on August 31, 2020. The large production contained many redactions for items including dates of vaccination, dates of adverse events, and date of medical treatment.
Given that most of these dates were at least 30 years ago and no identity of any trial participant was disclosed (or requested), ICAN pointed out to the FDA that redactions applied to protect personal information were inappropriate. It requested that the agency re-review portions of the production and produce the selected pages again without the redactions. The agency did so last month and the agreement was So Ordered by the Court.
The additional unredacted pages further support that, as explained in a prior legal update, this product should never have been licensed. Indeed, only one trial relied upon to license this vaccine included a placebo control. Buried deep in the reports, however, it admits that this “placebo” is an injection of lyophilized stabilizer containing approximately 45 mg of neomycin per milliliter. This is not a placebo! A placebo is an inert substance like saline — it is not another drug! Worse, this trial only contained 956 children, of which 491 received VARIVAX and 465 received the alleged “placebo.” Compounding its fake placebo and miniscule number of participants, these children were only monitored for clinical complaints for 56 days and then for an additional 14 days thereafter for serious adverse reactions.
Nonetheless, even in this shoddy, underpowered study, four serious adverse events (including seizure and viral enteritis) were reported in the group of children receiving VARIVAX and none were reported in the group receiving the alleged placebo. That differential was deemed acceptable by the FDA because Merck’s paid investigator did not consider these serious adverse events to be related to VARIVAX. The rest of the trials produced by the FDA were not blinded, not randomized, nor did they include a control group. These trials could therefore not provide scientifically valid data to support the product’s safety for licensure.
The FDA’s basis for licensing VARIVAX is incredible when considering that: (i) states mandate by law that millions of children receive VARIVAX every year; (ii) Merck cannot be sued for most injuries caused by this product under federal law; and (iii) Merck’s sales of this product, alone or in combination with another of its products, was $2.275 billion in 2019. But yet, the FDA licensed this product based on one fake “placebo” controlled trial, with only 956 children, and that reviewed safety for only around 2 months!
ICAN will continue to put the power of scientifically researched health information in your hands, with full transparency, even when it means suing and challenging public health authorities. When it comes to our children, we will chase down even the smallest details in order to provide complete information to parents in order to empower them to make educated decisions.
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