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
4/30/2008 Addendum:
Here is the word from the horse’s mouth on the inspection and a warning letter issued on April 28. 2008. (A PDF of the warning letter is here, and HTML version is here.)
Merck Warning Letter
http://www.fda.gov/cber/faq/merckqa.htmFDA’s Electronic Freedom of Information Reading Room - Warning Letters and Responses
When did FDA first become aware of issues with Merck and Co described in the April 28, 2008 Warning Letter?
FDA conducted an inspection of Merck and Co.’s West Point, PA, facility between November 26, 2007, and January 17, 2008.What issues did the agency identify during the inspection?
FDA investigators documented significant deviations from current good manufacturing practice in the manufacture of licensed vaccines, bulk drug substances and drug components. At the conclusion of the inspection, investigators issued a list of inspectional observations (FDA Form 483) to the firm, which included but was not limited to inadequate investigations of deviations and failure to maintain production and process controls. After determining that the firm’s response to the FDA Form 483 was inadequate to address the serious deviations noted, FDA issued the Warning Letter. FDA is continuing its discussions with the firm on an ongoing basis.
Why did FDA issue this warning letter?
FDA’s practice, depending upon the nature of a violation of regulations, is to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law.
Warning Letters are issued only for violations of regulatory significance. Significant violations may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving voluntary compliance with applicable laws and regulations.
What products are covered by this Warning Letter?
The Warning Letter covers U.S. licensed biologics manufactured by Merck at the West Point, PA facility, including but not limited to the following vaccines: Liquid PedvaxHIB®, RECOMBIVAX HB®, ProQuad®, Gardasil®, VAQTA®, and COMVAX®.
The FDA warning letter also addresses Merck’s CEO’s response to the inspection report and states:
… The deficiencies described in this letter are indicative of your quality control unit’s inability to fulfill its responsibility to assure the identity, strength, quality, and purity of your drug product and drug substance.
We acknowledge receipt of your written response dated February 15, 2008, which addresses the inspectional observations on the Form FDA 483 issued at the close of the inspection, and we have reviewed its contents.
Corrective actions addressed in your letter may be referenced in your response to this Warning Letter; however, we believe that your response(s) did not provide sufficient detail to fully assess the adequacy of the corrective actions. Our comments and requests for further information regarding corrective action are detailed below…
I should also note the FDA states “FDA does not believe that the issues identified will affect the safety of the vaccines manufactured by Merck. We will continue to review the progress made by the firm.”
Is everything OK at Merck? I report, you decide.
Fortunately, the vaccines in question are apparently OK. This time.
Will they be as lucky next time?
– SS