Now a labor union leader at Merck has responded to the Philadelphia Inquirer article "FDA report shows problems at Merck vaccine plant." He writes in a letter to the editor:
Concerns at Merck
The article "FDA: Problems at Merck's vaccine plant" (Inquirer, April 24) indicated the concerns raised after an inspection at our facility, Merck's West Point site. We, the United Steelworkers Union members, are dedicated to the creation of quality products through all phases of the manufacturing process. We are committed to following FDA guidelines, industry standards, and the FDA's Good Manufacturing Practices, all of which are the foundation for a successful pharmaceutical and vaccine production plant.
The company has implemented new ideas on how to function at our site. The expectation placed on our members is that they are required to do more with less. This business philosophy is not unique to large corporations but it is new to the pharmaceutical industry. Our members have worked diligently to ensure that the demands that have been placed on them have been met. They also want to ensure that their jobs are secure, but the article has raised concerns for them and their families about the future.
Phil Hughes
Vice president
United Steelworkers Local 10-0086
North Wales (PA)
This somewhat cryptic letter can be interpreted in a number of ways. A clear message is that the union members are being asked to "do more with less", implying overwork. This seems an explanatory theme in the FDA 483 Inspection Report referenced in the Inquirer article, a copy of which I have obtained. There are, in fact, phrases in paragraphs of that FDA inspection report that do not belong in the same paragraph, such as:
and
5. SOP 1330, Headquarters Review of Lot Numbers for Product Quality Complaints (PQCs), dated 14 May 2007, states that all deaths and life threatening adverse experiences [with vaccines] require lot checks with batch record review. This is not always performed.
Rejects from the first pass through the inspection equipment are sent through the inspection equipment a second time and only those that are rejected a second time are discarded. [Four examples involving vials of Varivax, Zostavax and ProQuad follow.]
What is most concerning about the union leader's letter to the editor, however, is this:
They [our union member Merck employees] also want to ensure that their jobs are secure, but the article has raised concerns for them and their families about the future.
I ask why an article such as the one published in the Inquirer would raise concerns for Merck unionized workers about their "future" (i.e., jobs).
Is the union concerned about retaliation in the form of layoffs for the substandard report? Since it's unlikely Merck vaccine sales will be affected by easily correctable FDA inspection problems, and since it's also unlikely Merck Vaccine Division will go out of business, being touted as it is by Merck management as a significant source of company income (e.g., via the new Herpes vaccine), the fear of layoff retaliation appears possible.
I can only say that if the unions are so concerned and so milquetoast in their approach to employee overwork via mild-mannered letters to the editor, imagine what the non-unionized employees must be feeling.
Finally, I once worked as Medical Programs Manager for the regional transit authority in Philadelphia. The leader of its biggest union, Transport Workers Union local 234, would likely have had quite a different response in the Inquirer to the problems caused by his employees being made to "do more with less" in a life-critical operation.
When I first met Mr. Lombardo it was at a medical department meeting where he was banging his fists on the table, shouting at the doctors for f***ing around with his employees via workers comp denials, drug tests, etc. At the time I thought this behavior frightening and unprofessional, but now I see its value.
I wish I'd had a union leader will testicles representing me in my past few positions.
-- SS
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