Everything is fine at Merck?

At "The wages of treating employees in biomedicine as expendible assets" and "Pharma Union cowed into submission?" I called attention to an FDA inspection report showing forty nine deficiencies in vaccine manufacturing more consistent with an upstart company than the world's finest.

Seasoned experts opined that some of the issues were consistent with overwork, a theory corroborated by a Merck union leader's assertion that its members were being asked to "do more with less."

However, everything is just fine at Merck, according to John T. McCubbins, Senior vice president Global Vaccine Manufacturing and West Point Operations. It's just the evil Philadelphia Inquirer out to misreport the FDA's own FDA 483 inspection report:

Safety at Merck

... The article "FDA: Problems at Merck's vaccine plant" (Inquirer, April 24) does a disservice to public health by inappropriately characterizing a review process that has not yet been completed. Regulatory agencies around the world conduct regular inspections of our facilities, as they do with all pharmaceutical companies. We are committed to fully addressing each FDA observation to the agency's satisfaction. We want to stress that Merck does not distribute contaminated products.

... We also object to your article's implication that issues raised in the FDA report may have been due to our efforts to become more efficient. Merck introduced four new vaccines in the last three years. To do so, we significantly increased staffing, invested heavily in new equipment and buildings as well as employee training while continuously enhancing quality systems.

John T. McCubbins
Senior vice president
Global Vaccine Manufacturing and West Point Operations
Merck & Co. Inc. , West Point, Pa.

My first question is, what difference does it make if the "review process has not yet been completed?" Is Mr. McCubbins denying that the deficiencies that were found were real? Did the FDA inspectors make their report up from thin air?

My second question is, what is the meaning of "our efforts to become more efficient?" That sounds like corporate doublespeak for layoffs and working people harder. Were they not working hard enough over past years and decades?

My third question is, what is the definition of a "significant investment in staffing?" Does Mr. McCubbins care to provide numbers? Would rank and file agree with that assessment?

With all the supposed investments in staff, are the staffing levels adequate? One can "invest in staff" and still have inadequate staff to "do more with less", as the Merck union leader stated.

In fact, when I read headlines like this, I really wonder about the committment to adequate staffing levels vs. levels that seek to maximize apparent margin in the face of "doing business from an empty wagon", off the backs of overworked employees.

All the while, I am continually annoyed by the expensive helichopper rides I witness daily being taken by Merck executives to go from West Point, PA to sites at Rahway, NJ and Whitehouse Station, NJ (and perhaps to their estates).

That has got to cost just a little more than teleconferencing from a car and the tolls at the NJ Turnpike.

I knew Dr. Maurice Hilleman, inventor of many Merck vaccines, in his later years (see my post "The End of an Era: Maurice Hilleman, Ph.D."). Dr. Hilleman remained a scholar, writing review papers as a Merck emeritus. He was one of the best customers of the scientific library I ran in Merck Research Labs, ravenously seeking articles even in his mid 80's.

Dr. Hilleman was also well known for his very colorful, no-holds-barred language. In response to the letter to the editor as above, he might well have uttered a colorful, very politically incorrect epithet.

-- SS