Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT?

A WSJ article on the financial condition of NY hospitals, and specifically a line by NY Mayor Bloomberg, caught my eye:

Wall Street Journal
Mar. 26, 2010
Hospitals Under the Knife
New York City System Aims to Cut 2,600 More Jobs as State Funding Drops
By MICHAEL HOWARD SAUL and SUZANNE SATALINE

NEW YORK—The nation's largest public hospital system plans to slash its work force—including doctors and nurses—by about 10% over two years as government aid drops and the number of uninsured patients jumps.

With its budget deficit set to top $1 billion, New York City's Health and Hospitals Corp. plans to eliminate 2,600 jobs in the fiscal year that begins July 1. That comes on top of 1,300 positions to be eliminated this year."No hospital system in the country is exempt from the crushing economics facing the health-care industry," said New York Mayor Michael Bloomberg. He noted that New York had been early to adopt electronic medical records but said that state budget cuts were hitting the system hard.

... Previous job cuts focused on trimming support staff, but the new measures will include physicians and nurses, Alan Aviles, the corporation's president, said in an interview.

"Early to adopt EMR's BUT the budget cuts were hitting the system hard?"

To the knowledgeable, this seems a non sequitur. Its message is clearly that yes, we spent hundreds of millions of dollars on EMR's, but the adoption of EMR's should have saved us jillions of dollars, helping insulate us from economic downturns.

Yet some very serious researchers say this is not the case.

For starters, there's, Ashish Jha’s research at the Harvard School of Public Health that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care. A New York Times story "Little Benefit Seen, So Far, in Electronic Patient Records" on those findings is here. Was anyone in the Governor's office or hospital governance reading their own newspaper?

Then, there's the Nov. 2009 “Hospital Computing and the Costs and Quality of Care: A National Study” (Amer J Med 123:1; 40-46) by Himmelstein and Wololhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs."

There's the June 2009 Wharton School of Business article "Information Technology: Not a Cure for the High Cost of Health Care" that I wrote about at this HC Renewal post. Senior Wharton professors wrote:

Technology could increase health care costs without markedly improving quality, according to experts at Wharton.

... "No one has done the careful research to indicate that if one health care system has information technology and the other doesn't, then the care is different. There are no controlled trials," says Mark Pauly, a health care management professor at Wharton. All that technology is no panacea, he warns. In fact, he believes IT could actually raise costs because of culture clashes, training, the implementation of the systems [I would say "the mayhem that often goes on during the implementation" - ed.] and the labor required to maintain the new technology.

"The best-case scenario is that information technology will improve quality but not lower costs. The worst case is that there's no difference at all."

... That opinion is echoed by other experts at Wharton and the University of Pennsylvania. "The focus on IT in health care is a good thing, but there's way too much hype about it and misunderstanding about what the benefits will be and how quickly they will come," says Peter Gabriel, medical director of clinical information systems at the University of Pennsylvania Health System.

[Kevin Volpp, professor of medicine and health care management] agrees that tracking real cost savings from health care IT is a difficult task, but he expects there to be some benefits from spotting and eliminating redundant care. But those benefits aren't likely to add up to big savings, says Lawton R. Burns, director of the Wharton Center for Health Management and Economics. "I agree that information technology is important, but it's not the slam dunk it's portrayed to be," he says. The chase to reduce costs, improve quality and expand coverage is deemed the "iron triangle of health care. A lot of us wince [at that goal]," Burns notes. "It's arguable that we can't do any of those things well."

David A. Asch, a Wharton health care management and economics professor, agrees that technology is a big part of reform. "No one is arguing against it, but that doesn't mean that it's not oversold," he says. Gabriel likens the fascination over IT in health care to a shiny new object that's easier to focus on relative to more daunting issues.

... In addition, it's unclear what cultural issues [a big theme in my writings - ed.] will emerge as information technology is adopted. These cultural issues are in the forefront of primary care physician relationships. Experts at Wharton and Penn say physicians are generally skeptical of the technology movement. How much will a technology overhaul add to operating costs? How much will it cost to retrain workers? What's the electronic record learning curve? And what happens when a doctor has a laptop between him and the patient?

"Individual physicians just don't know where the money is going to come from," says Pauly. "If IT is tied to reimbursements it could work, but [many] are skeptical." Burns adds that the physician-patient relationship can also be altered. "Technology adoption changes the way you practice. What happens when your primary care physician is looking at his screen instead of you?"

There are the concerns of Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, who wrote in the Wall Street Journal in a June 2009 article "The Myth of Prevention" that:

... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.

Finally, this is an experimental technology whose benefits and risks are not well known.

In the article "Electronic Health Record Use and the Quality of Ambulatory Care in the United States" (Arch Intern Med. 2007;167:1400-1405), the authors examined electronic medical records use throughout the U.S. and the association of EMR use with 17 basic quality indicators. They concluded that “as implemented, EMRs were not associated with better quality ambulatory care.”

Further, the FDA recently testified that this technology can actually harm and kill patients, but the extent is unknown. Existing FDA data is likely the "tip of the iceberg", testified FDA official Jeffrey Shuren MD, JD at the HIT Policy Committee, Adoption/Certification Workgroup, special meeting on health IT safety on February 25, 2010.

I described Shuren's testimony in my HC Renewal post "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'." Considering FDA is nearly unknown as the go-to for such reports, and the low reporting of medical errors related to computing noted by Koppel at the same meeting, the actual rates of injury and death could be much, much larger.

In effect, NY hospital physicians, nurses and support staff will lose their job due to budget shortfalls, at the same time the NY hospitals have been spending hundreds of millions of dollars on the extravagance of experimental clinical IT systems whose benefit is still an unknown.

Perhaps some of those millions could have been better spent on human beings, such as employees or better yet, patient care.

As I've written before, the health IT industry seems to be staging an invasion of healthcare to its own benefit. Now, clinical personnel are losing their jobs as a result, and patient care is likely to suffer.

While I'm supportive of EMR experimentation when finances are stable (when performed with patient safety considerations as paramount, of course), this is not the time for such extravagance in NY, especially when jobs - both support and clinical - are threatened.

Irrational exuberance in technology is bad enough - it's far worse when you can't afford the objects of your affection.

One suggestion is that the healthcare IT experiments be put on hold as unaffordable under current conditions, and resumed when finances are more stable. The money could be diverted to keeping physicians, nurses and support staff employed. The risks could also be studied further. However, this might cause some executives somewhere to have to forgo their pet contracts with their friendly HIT vendors and management consultant companies.

Computers are more important than people, after all.

At a time of massive international economic difficulty, "Blood for Computers!" can be the new rallying cry.

Since many of the layoffs will involve union members of District Council 37, the city's largest municipal employee union, perhaps the rallying cry "Computers for Union Busting!" could also apply.

(Some people would have no problems with that, but these are real, live hospital staff being put out of work, and the patients they care for being affected.)

-- SS

3/26/10 Addendum:

The advice above may apply to an entire country, the UK, that seems to have spent about £13 billion (about $19 billion U.S.) on health IT that doesn't work.

Per the Telegraph article today "Hospital wards to shut in secret NHS cuts":

Tens of thousands of NHS workers would be sacked, hospital units closed and patients denied treatments under secret plans for £20 billion of health cuts.

... The proposals could lead to:

• 10 per cent of NHS staff being sacked in some areas.
• The loss of thousands of hospital beds.
• A reduction in the number of ambulance call-outs.
• Medical professionals being replaced by less qualified assistants.

At least the IT industry is alive and well.

-- SS

Post Title → Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT?

Abbott's TriCor Fails To Beat A Sugar Pill in Diabetics - And In Pharma's Current Death Spiral, Forget About a Drug That Will

In numerous national publications today, we are once again reminded that lowering the risk of diabetics for vascular events (MI/heart attack, CVA/stroke etc.) and death is far more complex than lowering measures such as cholesterol and blood pressure.

Note these articles:

Abbott's TriCor Fails To Beat A Sugar Pill
March 14, 2010 - 9:58 am
Matthew Herper
Forbes.com

ATLANTA -- A popular triglyceride-lowering drug that has been taken by millions of Americans failed to prevent heart disease in a big federal study being presented today.

The drug, TriCor from Abbott Laboratories, has been used for over a quarter of a century to lower levels of fatty particles in the blood called triglycerides. The presumption has been that doing so would prevent heart attacks or heart-related deaths. TriCor has annual sales of more than $1 billion.

But the new study being presented at the American College of Cardiology meeting casts doubt on this. In the study, funded by the National Heart, Lung and Blood Institute, 5,500 patients with diabetes got either TriCor or a placebo. After five years, there was no difference in the rate of heart attacks, strokes and deaths in the patients who got Tricor versus those who took a sugar pill.

and

Search for Better Diabetes Therapy Falls Short
Mar. 14, 2010, 9:39 P.M. ET
Ron Winslow
Wall Street Journal

Current Treatments, While Effective, Failed to Also Help Prevent Heart Attacks and Stroke

ATLANTA—New strategies to prevent and treat diabetes and heart disease failed to improve care in two major studies, frustrating researchers' efforts to find more-effective approaches to the world's burgeoning diabetes epidemic.

The studies are among the first large trials to test whether treatments recommended for diabetes patients also reduce the risk of heart attacks and strokes. Diabetics are between two and four times as likely to die of cardiovascular causes as nondiabetics. The lack of data on whether strategies to treat diabetes actually lower heart risk is of growing concern to physicians, researchers and regulators.

One new study, called Accord, found that treating blood pressure to lower levels than recommended in current practice doesn't further reduce risk of death, heart attack and stroke among people with diabetes. The same study also found that the drug Tricor, marketed by Abbott Laboratories, failed to prevent such events even though it lowered levels of blood fats called triglycerides that are associated with high diabetes risk.

In the other report, dubbed Navigator, a diabetes drug called Starlix failed to prevent people at high risk of diabetes from progressing to the disease. The blood-pressure medicine Diovan did modestly reduce risk of developing diabetes in the same study, but neither drug significantly cut the risk of heart-related deaths, heart attacks and strokes. Both pills in this study are sold by Novartis SA of Switzerland.

There is a meta-issue I wish to bring up:

It's clear there are many phenomena going on in diabetes and other metabolic disorders that we simply do not understand.

It's also very likely that there are new drugs, yet undiscovered, that could be developed and that would improve mortality and morbidity.

It's too bad the pharmaceutical industry is now largely run by dyscompetents, incompetents, and other management charlatans, not to mention those responsible for questionable or outright criminal behaviors (such as here, here).

This privileged class has apparently so demoralized pharma rank and file including the very soul of drug discovery (chemists) - based for example on "layoff thread" comments on a very popular blog for medicinal, synthetic and other chemists such as here - that these new drugs are increasingly unlikely to be developed at all.

The industry in its current anti-intellectual, "lay them off and watch the stock price rise", short-term narrow-minded idiocy-driven death spiral is basically good for nothing except money games.

Pity.

-- SS

Post Title → Abbott's TriCor Fails To Beat A Sugar Pill in Diabetics - And In Pharma's Current Death Spiral, Forget About a Drug That Will

Pharma Union cowed into submission?

In various posts including this one, I've commented on the environment of cutbacks, quality issues, and fear that seems to permeate pharma.

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:

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.

and

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

Post Title → Pharma Union cowed into submission?

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

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

'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.

Permalink

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.

Post Title → 'P' is for Poor Management?

Lawyers to have cholesterol feast: lawsuits target Vytorin's makers - and, who is responsible for the "confusion?"

In today's news we find that Merck and Schering Plough are coming under lawsuits as a result of the ezetimibe/Vytorin controversy. This was perhaps to be expected:

Lawsuits target Vytorin's makers
Plaintiffs contend the firms knew the drug didn't work.
Sat, Jan. 26, 2008

By Karl Stark
Inquirer Staff Writer

First came the negative publicity, then the lawsuits.

Merck & Co. and Schering Plough Corp., makers of the cholesterol-lowering combination drug Vytorin, are getting hit with a wave of lawsuits asserting the companies knew its product didn't work and delayed telling the public about it.

At least 10 lawsuits have been filed in federal courts, with half the filings in New Jersey, where both parent companies are based. Other federal suits have landed in California, New York, Ohio and Colorado.

The drugmakers "reaped billions of dollars in profits" by failing to release negative results, asserted a class-action complaint filed by a Philadelphia firm on behalf of Lionel D. Galperin of Washington state. The companies also caused patients to spend more money on Vytorin, which sells for more than $100 for 30 pills, compared with a lower-cost generic, the suit alleges.

Here is where I step off the alleged "anti-pharma" bandwagon ... sort of.

While I have criticized Merck's and Schering's mammoth marketing campaign for these drugs here ("Merck and Vytorin ... Who, Exactly, is Confused?") and here ("Full page ads in major newspapers: Does pharma really spend twice on marketing what it spends on R&D?"), I believe lawsuits with the slant of "Bush lied, people died" (i.e., the firms knew the drug didn't work but withheld the information) are both unmerited and especially unhelpful to those attempting to advance medical science.

This claim is in part based on the following:

The companies completed the [Enhance] study [on these drugs] in April 2006 but did not release preliminary results until a press release was issued on Jan 14 [2008]. That was more than a month after congressional investigators had written to company executives, asking about the delay and demanding documents.

The implication is that actual knowledge of the results were withheld from the public to protect the drug. I do not believe this to be the case. I recall genuine excitement at Merck about Zetia's cholesteral-lowering effects, and great confidence that it was a true breakthrough drug that would generate much needed revenue after multiple drug failures and patent expirations. Clinical medicine, however, is full of surprises.

While such excitement could motivate a company to withhold negative new information, I have a different interpretation of why such delays occurred. Pharma is in a state of downsizing. At Merck, a company that carried on a succcesful business for over 100 years without downsizing, the mass downsizing that began in Nov. 2003 and continues to this day was a major cultural "hammer over the head."

Such social changes tend to sink morale very severely. While Catbert the Evil HR Director might find this amusing, most productive poeple do not. It's also something that cannot be "massaged away" with HR propaganda and "employee appreciation days." As I noted in "Happy Accidents in pharma doubtful: Tax Break Used by Drug Makers Failed to Add Jobs" here, the stress of losing a job is like the stress of a death in the family or a divorce, and the stress of fear of losing a job is also pretty darn bad. As the Alaska state government piece on "surviving a layoff" cited in the above posting states, "remaining employees become overworked, burned out, extremely unhappy and put in a position of fear and uncertainty." It doesn't exactly take a rocket scientist to realize this.

Anecdotally, I reside in a Merck community and hear as much about morale from my local car dealer, haircutter, family medicine physician, restaurant waiters, and others. In fact, I don't believe clinical trials information was withheld deliberately. I believe morale is low, departments are understaffed, and people are playing "CYA" like their lives depended on it (as their careers and ability to pay mortgages and support families depends on their jobs, this is actually not unwise).

Taking morale issues into account, and adding in the three late-stage pre-launch drug failures of 2003, resulting cultural shift to mass layoffs, and the Vioxx debacle, extra long "CYA" to make sure the data and conclusions are correct is understandible in context.

In such an environment, where overworked, stressed out people basically give themselves (effectively speaking) hourly pay raises via doing less per hour, and return to seeing jobs as a value-for-value proposition where an employee in a mirrorlike fashion gives a company what it has earned (i.e., deserves) in terms of their committment and willingness to make sacrifices, long delays in handling complex clinical trials results sets - this study, of course, being just one of many - is not at all surprising.

In addition, politics being what they are in any corporate layoff, many good people (the movers and shakers) get laid off, and other good people can't stand the environment and leave for greener pastures. This leaves behind many less capable colleagues to pick up the slack. I believe the cause of the delays in data release are more likely to be found attributable to low morale, a lesser % of "stars" among the workforce than necessary for optimal effectiveness, dysfunctional self protection-style politics, and resultant lowered productivity.

As an aside, it would not surprise me if recent chemical spills of "liquid mustard gas" into the creeks in my community had at its roots a similar cause:

Pharmaceutical giant Merck has agreed to pay $20 million in assorted fines, environmental improvements and cleanup costs to make up for killing untold fish, fouling drinking water supplies and spoiling a season of recreation on the Wissahickon Creek in Pennsylvania with a toxic "liquid mustard gas," the Philadelphia Inquirer is reporting. The massive impact came from an old-school problem: Dumping toxic chemicals down the drain at a vaccine plant, from which they reacted with chlorine disinfectants and washed into the creek, wreaking havoc downstream for miles.

I do not believe the company would deliberately withhold clinical trials data, and therefore do not believe a "deliberately withheld" charge is reasonable with regard to the ENHANCE clinical trial results on ezetimibe (Zetia) and ezetimibe-Zocor(Vytorin) . If there is a good basis for a lawsuit, perhaps the people who should be sued are those in management and in consulting organizations that recommended layoff strategies and stole the soul of such a once-stellar company.

The newspaper also notes the following:

...The drugmakers aren't the only ones facing scrutiny. Both the American College of Cardiology, which represents most cardiologists, and the American Heart Association echoed the companies' assurances and urged patients on Vytorin not to panic after a major test of Vytorin was released on Jan 14. But their stands have drawn criticism from congressional investigators and others because both groups take in substantial sums from pharmaceutical firms.

I'm not going to comment further on this other than to say "that sounds familiar", as the conflict of interest issue affecting medical professional societies has been well addressed by my Healthcare Renewal colleagues.

I will, however, comment on this:

W. Douglas Weaver, president-elect of the cardiologists, echoed those concerns. "We really had huge numbers of patients calling physicians' offices and not knowing how to interpret this information," Weaver said. "People were discontinuing statins because of the confusion."

The unstated but not-so-subtle implication (to those who understand marketing and "spin") appears to be that the big, bad, "anti-pharma" zealots and their allies in the media have gotten the poor public all confused, and the public is stopping their lifesaving meds as a result.

Having been involved in drug nomenclature activities at Merck as well as being familiar with the work of groups such as the Institute for Safe Medication Practices, one major goal in drug naming is to prevent confusion regarding the drug's nature and purpose. One creates drug names to assure that one drug is not confused for another, by healthcare professionals, patients, and others. Information scientists and others work very hard to select names for drugs that do not "resemble" others in spelling, phonetics, etc.

Now, just who is responsible for the confusion among patients "discontinuing statins because of the confusion?"

It seems to me the brainiacs who came up with the marketing scheme of giving a combination drug consisting of a newly-generic drug and a newly-approved one an entirely new name to milk more income out of a drug going generic -- and effectively discourage doctors/patients from simply prescribing/taking two pills (the generic and the new one) -- are largely responsible.

How many patients really understand that their wonder drug has two parts, one old, one new, that they could purchase and take separately likely for less cost than the combination, and that only the "new" part has come under scrutiny? How many understand that if the statin part of the new combination drug doesn't agree with them, they would have to discard the drug instead of simply replacing the statin? In addition, do busy general practice physicians understand this? One wonders.

It therefore seems the marketing folks as well as the drug naming approval organizations and the FDA carry significant blame for the "confusion." Perhaps this is a case of the unexpected (or should I say the predictable but undesired?) happening that provides evidence drug combinations should not be given snappy new names or approved as expensive "new" drugs.

Finally, I cannot but think it ironic that just as VIOXX and other similar drugs may have caused platelets and/or blood vessel walls to become more "sticky" and create vascular side effects, so ezetimibe might cause cholesterol and/or blood vessels to be more "sticky" for reasons not yet understood and negate some of the cholesterol lowering effects. It would be ironic indeed, as the newspaper article suggests by the observation "the combination drug failed to provide any benefit and even performed slightly worse than Zocor alone", if long term studies show ezetimibe to create more harm than good.

However, clinicians, the company and the regulators should be prepared if this occurs to get the data out ASAP when it is available fron ongoing studies - low morale or not.

-- SS

Post Title → Lawyers to have cholesterol feast: lawsuits target Vytorin's makers - and, who is responsible for the "confusion?"