The wages of treating employees in biomedicine as expendible assets: FDA report shows problems at Merck vaccine plant

In "P for Poor Management" and "Tax Break Used by Drug Makers Failed to Add Jobs" I postulated that many of pharma's difficulties stem from understaffing, poor morale and overwork caused by the abandonment of the idea of employees as valuable partners - as opposed to "expendible assets."

I further postulated that many of Merck's problems were not due to deliberation but to demoralization of the workforce via the continuing spectre of layoffs. Layoffs artificially jack up the stock price in the short term but have long term detrimental effects.

Others apparently agree with this assessment.

In "FDA report shows problems at Merck vaccine plant", it appears Merck's vaccine manufacturing processes are suffering from significant problems. A company that has been manufacturing vaccines for decades, and with a relatively new state-of-the art facility, is now found to be experiencing problems more characteristic of an upstart:

FDA report shows problems at Merck vaccine plant

By Karl Stark, Inquirer Staff Writer

April 24, 2008

Federal inspectors documented unwanted "fibers" on the stoppers of vaccine vials at Merck & Co. Inc.'s vast vaccine plant in Montgomery County. They also found instances of contaminated children's vaccines and complaints that were not always investigated at the West Point plant.

Inspectors from the U.S. Food and Drug Administration spent 30 days at the plant between November and January and cited 49 areas of concern, including a failure to follow good manufacturing practices.

The findings are detailed in an unpublished 21-page FDA report obtained by The Inquirer under the federal Freedom of Information Act. Independent experts who reviewed the report say it documents serious concerns in one of the country's premier vaccine plants.

Of note:

[Independent experts] suggested the problems could be a symptom of Merck's cost cutting [i.e., layoffs - ed.] in the face of rapid growth of its vaccine business.

"I would fault the management for not providing enough resources to do the work that needs to be done," said Scott M. Wheelwright, a biotech manufacturing expert and chief executive officer of the biotech consulting firm Strategic Manufacturing Worldwide, of Saratoga, Calif.

... Wheelwright, a consultant with 25 years' experience in vaccine manufacturing, suspects that the workload could be overwhelming. "I would not judge the plant as being out of control," he wrote in an e-mail. "There are numerous issues where they failed to comply with their own documentation and SOP [standard operating procedure] requirements. This suggests insufficient staff.

There are other instances where the validation was insufficient. This also looks to me like overwork of the available crew. Sometimes in a plant where everyone feels overburdened . . . they give up trying to do everything and just try to keep their heads above water."

And then there's this:

That Merck would be having problems with FDA inspectors surprised several longtime company observers. Sammie Young, a retired FDA deputy director, inspected the West Point plant early in his career and for many years oversaw vaccine-plant inspections for the entire agency.

"There are a lot of violations there [in the report]," Young said, after reading the report. "I'm surprised."

He said vaccine-makers were supposed to investigate vaccine lots if their use was associated with a death or a life-threatening event.

Merck failed to investigate two such cases, the FDA report said. A patient treated with the pneumococcal vaccine Pneumovax developed a half-dollar-size abscess and needed intravenous antibiotics to contain the infection. A pregnant woman who took the HPV vaccine Gardasil lost her baby, the FDA report noted. The Gardasil packaging warns against its use for pregnant women.

"I am concerned about the adverse-event reporting system," Young said. "It looks like the people didn't know when they were supposed to report. I find that hard to believe."

Of course, Merck denies all of this:

John T. McCubbins, who heads Merck's Global Vaccine Manufacturing and WestPoint Operations, disputed that assessment. He maintained that the division's employment had kept pace with vaccine production. He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems.

As the Inquirer reporter notes:

Merck is a fabled name in vaccines. It was at Merck that microbiologist Maurice Hilleman developed many of the most common childhood vaccines, which are credited with saving millions of lives."

As I had noted in this post (or, more correctly, as one state government's bureau of unemployment had noted):

The stress of losing a job is like the stress of a death in the family or a divorce. It involves loss of wages and benefits, role as worker and provider, dignity and self esteem, loss of the "American Dream", loss of trust, loss of control over your life, loss of the pattern of daily life, and loss of the "work family."

... Many of these employees carry corporate wisdom with them that is lost ... Remaining employees become overworked, burned out, extremely unhappy and put in a position of fear and uncertainty.

I don't believe overwork, burnout, extreme unhappiness and fear and uncertaintly make for the best compliance with procedures in difficult manufacturing processes. (Nor in R&D for that matter, in areas such as discovering new drugs.)

For the premier "fabled name" in vaccines to be found with a failure to follow good manufacturing practices and other problems, I think it more likely the company is reaping that which it sowed, with the reaping being represented by a grim, hooded figure with a scimitar - in the form of mass layoffs that began in 2003, breaking with century old traditions in this once fabulous company.

I offer this advice to pharmas:

If you enjoy mass lawsuits, and wish to continue to do try to do business from an empty wagon, continue to treat your employees as expendible assets.

(Full disclosure: I am a laid-off employee myself. After lobbying for and partially ending rationing of advanced scientific literature searching tools available to only a minority of discovery scientists, and filling critical unmet needs for scientific information by increasing the supply of scientific articles supplied to the research labs tenfold compared to decade-long norms, I found myself laid off in Nov. 2003. I was replaced by personnel lacking clinical and biomedical informatics credentials, i.e., they possessed the inferior credentials that led to the information-scarcity problems in the first place. I'm not sure how that will help the company. Borrowing a line I saw on the HISTalk blog recently, this brings to mind the adage "No company ever shrank to greatness." )

-- SS