When you make drugs or other medical products, unwanted contaminants can fall into the mix — say, beetle parts (in baby formula) or glass flakes (in anemia drugs).
The latest pharma world example of wow-that-really-shouldn’t-be-in-there comes from Merck. As the WSJ reports, the company says charred bits of plastic shrink wrap have been found in vials of vaccines made at a big plant in West Point, Pa.
Affected products include Gardasil, used against the human papillomavirus, as well as shots against shingles, measles/mumps rubella, pneumococcal disease and chicken pox.
How’d this happen? It seems pieces of the wrap weren’t removed during vial washing and were charred during a sterilization process. Merck says there are no reports of adverse health problems, though theoretically the particles could cause a reaction at the injection site. The problem is very rare, according to the company.
The FDA has been tracking problems at the plant since 2008, according to the WSJ. A series of inspection reports have chronicled the issues — most of which have been resolved, Merck says. Here they are:
An April 2011 report cited the shrink-wrap particles, saying there were a dozen company-submitted reports about the problem since November, 2009 — eight due to customer complaints. The report noted that while plastic boxes replaced shrink-wrapped vials in some cases, some product vials were still being shipped in the wrap, raising the possibility of further problems. (Merck tells the WSJ it will end the use of shrink wrap on incoming vials by the end of the year.)
A report from August, 2010, found that an undisclosed number of adverse event reports involving drugs made at the plant weren’t submitted to the FDA in a timely fashion — that is, within 15 days.
An inspection report from January and February of 2009 identified problems including stainless steel particles in certain vaccines and a treatment for black widow spider bites, and cracked vaccine vials.
Sunday, July 31, 2011
Extraneous materials in vaccines is an old story. Many have been shown to contain unwanted viruses or even bacteria such as mycoplasma. (I used to have the abstracts posted on my website showing examples.) Anthrax vaccines had flecks of stopper material and fungi in them, noted on visual inspections by FDA in the late 1990s. Today Merck's West Point, PA plant has been cited for problems. From the WSJ blogs and WSJ:
Posted by Meryl Nass, M.D. at 2:13 PM