FDA Report Exposes Troubles at Merck Vaccine Plant

Thursday, May 01, 2008 by: Joanne Waldron
Tags: Merck, health news, Natural News

(NewsTarget) A new FDA report, obtained and brought to the attention of the public by Karl Stark of the Philadelphia Inquirer and available to anyone via the federal Freedom of Information Action Act (FOIA), reveals that a Merck vaccine plant located in Montgomery County, Pennsylvania was cited for 49 items, including failure to follow good manufacturing practices and some contaminated vaccines for children. Merck, the maker of the very controversial Gardasil vaccine, has been in the news quite a bit. Recently, they have also been under investigation for crafting numerous studies (a practice known as ghostwriting) for their Vioxx drug and then getting preeminent doctors to agree to allow them to use their names in conjunction with these studies.

Many of the details in the FDA inspection document are redacted, including lot numbers of vaccines and the names of various patients. The report indicates that Merck is required to investigate Product Quality Complaints (PQCs) for all deaths and life-threatening adverse experiences and perform lot checks and batch record reviews. The FDA notes that this procedure is not always followed by Merck and provides several examples in the report.

One example of this given in the report noted that an individual (name removed from the report) was vaccinated with Pneumovax (lot number removed from the report) on October 6, 2005. On November 1, 2005, the same individual was treated with IV antibiotics for an abscess at the injection site that had grown to the size of a half-dollar and was surrounded by redness. This was reported to VAERS, but Merck failed to conduct the required lot check and batch record review. A second example provided in the report involved an intrauterine death (victim's name removed from the report) after the receipt of Gardasil (lot number removed from the report). Again, Merck failed to conduct the required lot check and batch record review.

This is just the tip of the iceberg, so to speak. The report also notes that leaky Gardasil syringes have been a problem. Merck's packing methods for products shipped with dry ice permitted the ingress of some substance (the name of which was redacted from the report) to replace another substance (the name of which was also redacted from the report) in the head-space of vials of lyophilized product. The products involved included ProQuad, Varivax, Zostavax, M-M-R II, Mumpsvax, Attenuvax, M-M-VAX, and Meruvax. According to the report, Merck was aware of this ingress as early as 2003. Numerous issues concerning sterilization were also mentioned in the report. Another item in the report specifies that vials that were rejected by automated inspection equipment in the first pass had to be rejected once again in a second pass in order to be discarded. Many procedural deficiencies were also noted in the FDA report. Obviously, all of the problems that were found are too numerous to list here, but the report is available for anyone who would like to see it through the FOIA.

Most people would not want to feed their children in a restaurant if health department inspectors observed that the restaurant had contaminated food or a dirty kitchen or bathroom. Few parents would allow a child to eat with a dirty fork. This would be a surefire recipe for indigestion. Perhaps parents should show the same concern about vaccinations.

About the author

Joanne Waldron is a computer scientist with a passion for writing and sharing health-related news and information with others. She hosts the Naked Wellness: The Gentle Health Revolution forum, which is devoted to achieving radiant health, well-being, and longevity.