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The findings are detailed in an unpublished 21-page FDA report obtained by The Inquirer under the federal Freedom of Information Act.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

'P' is for Poor Management?

An editorial entitled 'P' is for Profit appeared yesterday about the latest Merck scandal that was mentioned in posts "What Are Those Consulting Fees and Speakers' Honoraria Really For?" and "Healthcare scandal-of-the-week: Merck settles Medicaid lawsuits." This company has a large presence in the Philadelphia region, and the editorial contains an important message:

Philadelphia Inquirer - editorials

'P' is for profit

Tue., Feb. 12, 2008

In 1952, Time magazine put Merck & Co. Inc. president George W. Merck on its cover, along with his quote: "Medicine is for people, not for profits." That admonition supposedly has guided Merck ever since. But the drug maker has run into a string of legal troubles that raise questions about the application of Mr. Merck's mantra.

... just last week, Merck agreed to pay $650 million to settle charges that it routinely cheated the federal government by overbilling Medicaid for its most popular drugs. Merck didn't admit any wrongdoing. The agreement was one of the largest health-care fraud settlements ever.

... The Medicaid case arose out of a whistleblower suit filed by a former Merck sales manager, H. Dean Steinke, who will get about $68 million. He first complained to Merck, but said his supervisor told him: "I don't care how you do it, but get the damn business."

That sure doesn't sound like putting people before profits.

I agree with that assessment; however, in the field of social informatics, we analyze social and organizational issues underlying behaviors, primarily around information and communications technologies. More broadly speaking, but in that same vein, this episode raises several social questions:

• Is the company being wrongly blamed, as opposed to an individual?
• Might the individual's actions have been based on some other motivation(s) besides greed?
• Is the company at fault in any way for this type of behaviors in employees?

Let's answer those questions.

First, I believe it is wrong to condemn an entire company for the actions of one individual, or group of individuals. Many fine, ethical people work in pharmas, including my former colleagues at Merck, who did and do take George Merck's words to heart.

Second, what might motivate a middle manager to instruct a sales manager to "get the damn business" [by any means possible]?

How about fear of layoffs and the fear of the demoralization, instability and insecurity that engenders? (Also see the post "Do Demoralizing Pharma Personnel Practices Contribute to Unsafe Drugs?")

One of Merck's strengths in promoting ethical conduct by its employees was a "social contract" that worked as follows: if you perform well, you have a secure career. In fact, prior to 2003 when a drastic cultural shift occurred, Merck had not had a mass downsizing in its 100+ year history. People could live by the George Merck creed and be assured of stability.

In November 2003, the "Equinox layoff" program of 4,400 occurred, marking a major cultural shift and a quite marked decimation of the "social contract" with employees. (Frequent announcements of further layoffs have appeared regularly in the press, and up to ~ 10,000 people have apparently been separated since the 2003 social contract termination.) In the post-layoff counseling sessions at an outplacement firm in my case, I observed a multitude of highly intelligent, capable adults up to VP level sitting at a table, highly demoralized, worried about mortgages (and foreclosure), paying tuition for kids in college, etc.

One separatee in 2003 was a former medical instructor who taught me during my residency days who was a few years older than I; his wife was ill with cancer and he had significant other expenses as well. He remained unemployed for several years until I lost touch of his whereabouts. In my own case, mid 2003 was a very bad time for hiring nationally. At age 46 at the time, it took me a full 18 months to secure new employment and all I had received was a few month's severance. I believe age discrimination is quite real. (My new position was in academia where that phenomenon is probably less common.)

Now, like most major pharma corporations, the company has reserves of billions of dollars. The endowments of major universities pale in comparison. In reality, executives do not have to continually "re-engineer" the corporation through layoffs, except to please Wall Street (and coincidentally raise their own compensation higher into the stratosphere). If greed exists, it begins in the executive suite.

Imagine a middle manager or sales representative watching senior manager shred the social contract with employees. Imagine them watching former colleagues led out the door and humiliated, to face the spectre of unemployment because "their services were no longer needed." Imagine them watching the senior executives arrange lucrative contracts and golden parachutes, while shuttling daily between PA and NJ sites and to provincial homes in a fleet of luxurious corporate heli-choppers (it costs million to maintain such a fleet), or in some cases in weekly corporate jet flights for executives who live cross-country, such as in the midwest. I am certainly annoyed by the daily sight of these choppers over my neighborhood.

Telecommunications-equipped limos are not good enough to travel the ~80 miles on the NJ turnpike or PA/NJ interstates in this culture.

In such a culture, it is perhaps understandible why a family man with a good track record might feel compelled to stretch ethical boundaries to "make the numbers" -- not out of pure greed, but in an attempt to avoid the layoff axe. As I cited from one state's Bureau of Unemployment in the post "Happy Accidents in pharma doubtful: Tax Break Used by Drug Makers Failed to Add Jobs", 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."

While I do not at all condone unethical behaviors, such behaviors by line employees to avoid a stress equivalent to a death in the family are at least understandible, contextually, outside the sphere of pure greed and/or criminality.

So, in answer to the third bulleted question above, yes, a company's sick culture does contribute to an employee's behavior. A system of dehumanizing personnel practices and perverse incentives [which can be for personal gain, or for basic social stability] affects not just senior people, but everyone.

To put people under the duress of frequent "restructuring" while senior management live it up, and expecting people to hold the line ethically is simply bad human engineering. It is a perfect setup for mayhem.

'P' is as much for Poor Human Engineering and its root causation - Poor Management - as it is for profit.

Lastly, one final provocative question:

• Can non-medical business executives who've never actually sacrificed for patient care, as any physician or nurse has, truly understand -- at a gut level -- the creed of George Merck that "Medicine is for people, not for profits?"

-- SS

Addendum: thanks to reader Steve Lucas for pointing out the extremely unfortunate story in the WSJ health blogs below. I was unaware of it when I wrote the post above. Would it be too far off the mark to suggest a connection? A 47-year-old research chemist is likely to be someone with a fair amount of seniority - and a lot to lose:

A Chemist Found Dead at a Merck Plant
Posted by Jacob Goldstein

Tue., Feb. 12, 2008

A Merck chemist was found dead this weekend, apparently after swallowing “a bit of white powder from one beaker and some liquid from another,” the Star-Ledger reports. A co-worker came across the 47-year-old man on sprawled on the floor of the research library at a company plant in Rahway, N.J. The beakers were found near his body.

A hazmat team said the substances smelled of “bitter almonds and chlorine,” according to the article. Cyanide can smell of bitter almonds, but officials have yet to determine the chemicals involved in this case.

Police are investigating the possibility of a suicide, and a Merck spokesman told the paper that the death wasn’t work-related. The man’s name hasn’t been released, and police wouldn’t say whether he left a note. About 4,300 people work in manufacturing, research and development jobs at the Rahway plant, which is open 24 hours a day, seven days a week, the Star-Ledger wrote.

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I also note this in the linked Star Ledger story:

"Merck spokesman Chris Garland emphasized today that the death was not work-related. " ... Two glass beakers containing the unknown substances were found on the floor near the man's body, [Police Capt.] Mikajlo said. He added the man, who lived in Middlesex County, appeared to have swallowed the chemicals in succession.

I should add that if this occurred in the research library (building 86, above the cafeteria), this was not a place where chemicals and beakers were present or allowed to be taken. This would seem a very deliberate act in any case. To say the death is not "work related" seems very premature.