I have been participating in the comment thread on the HisTALK heath IT industry news/gossip site at http://histalk2.com/2009/09/17/news-91809/ . At this time there are 34 comments - mine begin at #4. (I have also archived the thread in Word format here.)

It’s been quite interesting, demonstrating that many of the harmful attitudes of IT personnel about healthcare I observed more than a decade ago are still around.

An anonymous commenter under the title “Programmer” has been forthcoming with views I think are actually common in the health IT field about medicine, science, IT flaws and shortcomings, and physician involvement in HIT. I will let you read them for yourself at the above link.

Others have indicated in that comment thread and other threads that “Programmer” is an executive with a massive HIT company, but I can’t confirm this.

The crux of the issue came out towards the end where “Programmer” maintains in Comment #28 that I’m “just someone who likes to talk about IT” and he is a “real IT person.”

By extension, this is the “doctors (including medical informaticists) do not do things with personal” type of comment I’ve heard face-to-face from healthcare IT personnel since I entered the field in the early 1990’s, and commented upon a decade ago here.

“Programmer” also attacks (from the perspective of arrogant ignorance) the “Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop” white paper drawing together the thinking at a workshop attended by over fifty informatics experts from all areas of medicine and technology. The role of the medical informatics expert itself, and other issues as well relating to reasons for HIT failure and difficulty are attacked and dismissed.

I’ve emailed Tim, the proprietor of the HISTalk site [mr_histalk AT yahoo.com], to inquire if this poster was real or just a provocateur.

Tim’s response: “He is real and has been around for a while, even though lately he seems to be enjoying an escalated level of confrontation when he has the ability to create one.”

I maintain — based on personal experience and that told me by others — that this person’s views are not all that rare in the HIT vendor and hospital IS communities. (If the person is a fake, they are doing a might accurate approximation of my own real world experiences.)

I also opine that thinking such attitudes can be dealt with by logical argument and persuasion is a belief itself lacking in rigor.

IT personnel of views as in the HisTALK comments thread represent an older culture of data processing, dating from the days of card punch tabulators that ran businesses prior to personal. It is a culture that has failed to mature with the times.

As I wrote here, the unimaginative, process over results, tightfisted control, bureaucratic data-processing culture of the business IT (management information systems) world is the lineal descendant of IBM’s patchcord plug-panel programmed, card tabulating machines from which IBM made a huge portion of their profit in the days before the electronic computer:

Hollerith Type III Tabulator with its control panel exposed. Photo: MNRAS, Vol.92, No.7 (1932). Click to enlarge.

Fortunately, such personnel and their designer-centric, as opposed to user- and work-centric philosophies are starting to become obsolete. This can be observed (as an example) via the mission of the iSchool consortium, of which my organization, the Drexel College of Information Science and Technology, is a member:

The iSchools are interested in the relationship between information, people and technology. This is characterized by a commitment to learning and understanding the role of information in human endeavors. The iSchools take it as given that expertise in all forms of information is required for progress in science, business, education, and culture. This expertise must include understanding of the uses and users of information, as well as information technologies and their applications. [the order of these priorities is pertinent - ed.]

Unfortunately, the data processing culture and its adherents are not becoming obsolete quite fast enough. There are still too many in the upper echelons of management, including health IT vendors, hospitals and pharmaceutical R&D environments.

Finally, IT personnel with such attitudes as displayed in the comments, from the lowliest programmer to the CEO and Board, have no place anywhere near where patient care is conducted, or where information systems serving clinical medicine are designed and built.

In line with other character types one encounters in healthcare that are often discussed on Healthcare Renewal, clinicians should not accommodate such IT personnel and these types of views.

– SS

Addendum:

IT personnel of such views bring to life Lecia Barker’s paper “Defensive climate in the computer science classroom”:

“Defensive climate in the computer science classroom” by Barker et al., Univ. of Denver. Link here (subscription required). Might help explain the control-seeking culture of IT personnel. As part of an NSF-funded IT workforce grant, the authors conducted ethnographic research to provide deep understanding of the learning environment of personal science classrooms. Categories emerging from data analysis included 1) impersonal environment and guarded behavior; and 2) the creation and maintenance of informal hierarchy resulting in competitive behaviors. These communication patterns lead to a defensive climate, characterized by competitiveness rather cooperation, judgments about others, superiority, and neutrality rather than empathy.

– SS

[Source : Health Care Renewal]

Ghostwriting is a topic covered extensively at Healthcare Renewal, including at my post “Wyeth: Ghostwritten Papers Fake, But Accurate” here, Roy Poses’ “Wyeth’s Industrial Scale Ghost-Writing” here, and many others about Wyeth and other pharmas that can be viewed via this link: http://hcrenewal.blogspot.com/search/label/ghost writing.

A story in the Philadelphia Inquirer yesterday about Wyeth and ghostwriting brought to mind my medical school days at Boston University, in a metaphorical and rather negative way, regarding an oddity reflecting this day’s pharma industry.

In those years I lived next to Boston City Hospital on the top floor of a 29-story high rise at 35 Northampton Street, at that time one of the toughest and highest crime neighborhoods in the region if not the country (I was careful and lucky, and only got mugged at gunpoint once). I had an excellent bird’s-eye view of the urban decay in the area, reflective of ethical decay in the community.

35 Northampton St., next to Boston Medical Center (formerly Boston City Hospital)

Across the street from the high rise was an oddity - a very huge liquor store named Blanchard’s. Inside Blanchard’s was a very small grocery department of all things. Have a snack with your booze! (I went in only twice; once to see what it was all about, and again during the Blizzard of ‘78 to get some needed food when all transit in the city was shut down and several feet of snow — and neighborhood guns — inhibited foot travel.)

The area has much improved in the past three decades, but according to Google street view the liquor store is still there:

In the 1970’s “Liquor Land” was a big liquor store with a small grocery department named “Blanchard’s.” Click to enlarge.

Why does this odd store remind me of Wyeth, and more generally today’s pharmaceutical industry?

Because that industry has turned from what used to be a biomedical research & development industry with decent ethics and a small marketing arm, to huge marketing industry with poor ethics and a small R&D arm.

(Or, perhaps more accurately, a massive marketing industry with poor ethics and a busywork section disguised to look like R&D. As a colleague noted in my post “Pfizer/Wyeth Merger And Sacrificing The Future: Laying Off Scientific Staff All Over The Place” here, a small fraction of prime scientist intellectual horsepower and time is actually spent on true R&D today, the rest wasted on feeding the bureaucratic corpulence that is the modern pharma research lab. He observed that “what we this day call pharmaceutical R&D is in reality busywork disguised to look like R&D, in effect a well engineered, well managed, massively pricey failure.”)

Here is what led to my “pharmas have become big marketing firms with a small R&D effort” metaphor. It was a story in the local newspaper on ghostwriting.

The glib quotes from Dr. Joseph Camardo, Wyeth’s senior vice president of global medical affairs, on the practice of ghostwriting are simply stunning:

Philadelphia Inquirer

Ghosts in the medical machine

Was drug research infected by ghostwriters? With Paxil suit in court, a Chadds Ford firm states it was ethical.

Sun, Sep. 20, 2009

By Miriam Hill

Inquirer Staff Writer

When GlaxoSmithKline P.L.C. marketers looked for doctors to promote the antidepressant Paxil, they called the project CASPPER. The name was more than just an offbeat tribute to the friendly cartoon ghost. It was a wink and a nod to “ghostwriting,” a questionable practice in which scientists put their names on research written by someone else, usually a writer paid by a drugmaker.

Ghostwriting critics say it disguises marketing material as scientific research.

Charges of ghostwriting have been lobbed against many companies in recent years, including Glaxo, Wyeth, AstraZeneca P.L.C., and Merck & Co. Inc., often arising in lawsuits from consumers claiming a drug injured them.

… Documents released in connection with 8,000 lawsuits filed against Wyeth over Premarin and Prempro show that the company, which employs several thousand people in Collegeville, paid a medical-writing firm to produce articles from 1998 to 2005 that allegedly downplayed the risks of hormone treatment and emphasized benefits.

In 2002, researchers stopped a landmark federal study after finding that menopausal women who took certain hormones had an increased risk of breast cancer, heart disease, and stroke.

“Ghostwriting was used to sway doctor opinions to favor hormone use as disease prevention long after that was a scientifically defensible position,” Fugh-Berman [writer Adriane Fugh-Berman - ed.] stated.

Joseph Camardo, Wyeth’s senior vice president of global medical affairs, called Fugh-Berman’s view “baseless.” Medical opinion evolves, he said, and the papers in question reflected scientific understanding then. He also said the authors alone controlled the content and writing of the papers, though some did have outside help paid for by Wyeth.

“It’s really being misrepresented as something we wrote and paid for that said what we thought it should say,” Camardo stated. “But the authors weren’t paid, and the authors had the final say.”

… Studies on ghostwriting have suggested that anywhere from 8 percent to 75 percent of articles in medical journals may involve the practice.

Aside from the point I raised in my post “Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?” here regarding possible severe contamination of the literature and therefore of “expert knowledge” as it exists today, Camardo’s response raises a cornucopia of questions.

Regarding “Medical opinion evolves, he stated, and the papers in question reflected scientific understanding then”:

• Whose scientific view do they reflect, exactly?
• Does Camardo believe these ghostwritten papers, usually written by party “A” but with authorship claimed by party “B” (usually prominent academic doctors often nurtured by the industry into the role of “key thought leaders”, KOL’s) are objective?
• Does Camardo actually believe most of the content comes from party “B” rather than party “A” in these papers?
• Does Camardo understand that paying a MECC (Medical education & communications company) or other firm to write scientific papers puts the author(s) of those papers in a conflict of interest position relative to the paying sponsor, injurious to objectivity?
• Is Camardo that naive to believe a paid writer would “diss” the holder of his or her paycheck?

Regarding “the authors alone controlled the content and writing of the papers, though some did have outside help paid for by Wyeth”:

• Which authors is he referring to?
• The ghostwriters?
• Wyeth scientists?
• Academics claiming authorship?
• Was the “outside help” from Wyeth “authors” to the ghosts, or from the ghosts to Wyeth “authors”, or from Wyeth to the academics claiming authorship, or what?
• Can Camardo produce statistics on what % of article content on ghostwritten articles Wyeth sponsored were written by the ghost vs. written by Wyeth scientists and/or the claimed academic author? If not, why not? And if not, why should any intelligent person not assume the papers are, state, 99% the product of the hired guns?

Regarding “the authors were not paid, and the authors had the final state”:

• Again, which author(s) is he referring to?
• In terms of the ghosts, I assume they weren’t working for the MECC’s for free.
• In terms of the academics and KOL’s claiming authorship, they (maybe!) were not paid in money, but instead in the valuable academic currency of a publication in a major biomedical journal.

To claim the KOL’s were “not paid” is disingenuous. In fact, I find his entire argument disingenuous, a play on words, PR “spin” totally callous to the needs for scientific objectivity, the advancement of science, and ultimately to patient’s lives.

This is marketing, with poor ethics, in the extreme.

Being somewhat familiar with authorship issues as former Director of Published Scientific Information Resources and The Merck Index (of Chemicals, Drugs & Biologicals), 13th ed. at Merck Research Labs, I further pointed out in my post “Wyeth: Ghostwritten Papers Fake, But Accurate” here, that:

… in addition to the violation of accepted practices of authorship, such as specified by NIH and the International Committee of Medical Journal Editors, among others, such lucky authors [i.e., those who claim authorship of ghostwritten papers] get to “count” such papers in their academic portfolios, presumably also in violation of their own institutional policies and guidelines for fair attribution and intellectual honesty, e.g., here [Harvard - ed.]

These industry practices and Camardo’s position might be based on:

• Ignorance of accepted practices of authorship of the NIH, the International Committee of Medical Journal Editors, and most academic institutions, or perhaps:
• Cavalier dismissal of these practices for pecuniary reasons.

Is Camardo informed and upfront? Inept? Disingenuous and dishonest? That is up to the reader to decide.

In my aforementioned post “Wyeth: Fake but Accurate” I’d also noted Wyeth attorney Stephen Urbanczyk acknowledging that the ghostwritten articles were part of a marketing effort. But he said that they were also “fair, balanced, and scientific.” More spin.

This raises the following observation. It is said that you can judge a person by the company they keep. I also believe that:

You can judge a company by the persons it keeps.

This raises the following very serious questions:

• Is the presence of a senior vice president of global medical affairs and a lawyer with such views on ghostwriting representative of the senior executive leadership’s views on dissemination of biomedical scientific information?
• Is their presence reflective of the views of Wyeth’s Board of Directors?

If so, then the objectivity of any article about Wyeth drugs is called into question, and doctors and patients should utilize Wyeth drugs (and literature on them) with great caution.

– SS

[Source : Health Care Renewal]

It’s almost World Series time in the US, so here’s a baseball story, courtesy the Pittsburgh Business Times,

University of Pittsburgh Medical Center lobbyist Leslie McCombs used Pittsburgh Pirates baseball tickets bought by UPMC’s insurance arm to entertain film executives and others to promote the creation of a state film tax credit, according to the Say Ethics Commission.

The commission fined McCombs $5,025 for failing to promptly register as a lobbyist for Lions Gate Entertainment Corp. and omitting a daytime phone number in registering as a lobbyist for UPMC, according to a commission ruling reached on July 22. The confidential decision was disclosed Sept. 9 by The Associated Press.

McCombs, who works for UPMC as a consultant, received permission from UPMC President and CEO Jeffrey Romoff to lobby on behalf of Lions Gate, which she described in a February 2007 e-mail to him as the, ‘largest independent producer and distributor of motion pictures and TV in the country.’

Romoff cleared her work with Lions Gate after consulting with UPMC legal counsel and assured by McCombs in the e-mail that, ‘UPMC signs will be prominently featured throughout the (‘Kill Pit’ TV) series.’

Filming for the eight-part miniseries, which was renamed ‘The Kill Point,’ began in March 2007 in Pittsburgh. Gov. Ed Rendell signed the Film Production Tax Credit bill into law in July 2007, which provided for a 25 percent film tax credit to offset production expenses.

Also,

From 2005 to 2006, McCombs was director of public relations for UPMC Health Plan, a for-profit subsidiary of the nonprofit hospital network. She was then named senior consultant with UPMC’s government relations department.

The Say Ethics Commission lists 18 baseball games where McCombs treated Lions Gate and government officials using UPMC tickets.

In addition, she attended a June 15, 2007, matchup against the Chicago White Sox with Rendell and his wife, Marjorie, and Romoff and his wife, Stefania, according to the commission.

It’s not clear from the commission report whose interests McCombs was representing at that game, but Rendell later reimbursed $960 for the tickets to the five games that he attended, which was returned to the health plan.

In 2007, UPMC Health Plan purchased $61,440 worth of Pittsburgh Pirates tickets, which were available to employees of the insurer ‘in the performance of their duties,’ the report says. The sum included a $20,000 seat license.

So did you get all that? The director of public relations for the UPMC Health Plan, the managed care subsidiary of UPMC, a big academic medical center, lobbied the state governor for the enactment of a tax credit for television and movie production, partially so that the UPMC logo would appear in a television series, and entertained the governor using a few of the more than $60,000 worth of baseball tickets the medical center bought for employee use. Amidst the complication, the public relations director violated state lobbying rules. None of these shenanigans had anything directly to do with health care, or medical education and research. The only conceivable advantage accruing to the institution would be the appearance of the UPMC logo in a television series. But most likely everyone had good times at the ball game.

This story again suggests that managers of health care organization are more focused on playing marketing and political games than on health care, and generally are more focused on benefiting themselves than upholding their organizations’ mission. The amounts of money involved in this case may be small, but don’t underestimate the collective effects on health care access, cost and quality of managers who have their eyes on the wrong balls.

UPMC has provided grist for the Health Care Renewal mill before, see earlier posts here, here, here and here.

[Source : Health Care Renewal]

At Healthcare Renewal we often write of the dangers of financial conflict of interest towards medical research and practice.

Here’s a plea from a father of an 18 year old patient whose death became a cause célèbre against conflict of interest, only to then be swallowed up in the sea of silence known as the “anechoic effect.” The plea is in our local newspaper, but deserves much wider attention:

Philadelphia Inquirer

Posted on Thu, Sep. 17, 2009

Seeking justice for my son

He died in a gene-therapy trial. Penn and the FDA should release the records.

By Paul Gelsinger

Ten years ago this day, my 18-year-old son, Jesse Gelsinger, died at the University of Pennsylvania in a gene-therapy trial. Who is responsible? Could his life have been saved? Are other patients at risk? These questions have yet to be fully answered.

Jesse lived with a rare metabolic disease. The point of the research trial was to see if an adenovirus (a cousin of the cold virus) could safely deliver corrective genes to Jesse’s liver. Instead, the adenovirus killed Jesse.

Jesse became the poster child for what not to do in human-subjects research. Neither he nor I was warned that, as the Washington Post later reported, monkeys had died in a prior trial. And the Wall Street Journal reported that the researcher who developed the adenovirus, James Wilson, had a seven-figure financial interest in the trial’s outcome, as did Penn.

I stood by Penn, Wilson, and the two principal investigators, Mark Batshaw and Steven Raper, until I understood the extent of Wilson’s financial ties and the extent to which Jesse was misled about the dangers and efficacy of the therapy. I eventually sued and ultimately settled. The amount of the settlement was sealed; the documents were not.

The federal government also sued, claiming that the researchers blew through clinical stop signs in conducting the trial, ignoring evidence that Jesse was not well enough to receive the adenovirus and failing to sufficiently alert the Food and Drug Administration about severe incidents involving prior patients. The researchers disagreed, saying they had the discretion to proceed despite Jesse’s test results, and that they’d alerted the FDA. The government also reached a settlement, which restricted the researchers’ activities for a period of years.

Before the government settled, I urged federal officials to make the documents they collected public. They refused, saying this is simply not done.

I believe a better understanding of what happened to Jesse could improve practices. So I gave the documents collected for my lawsuit to a law professor, Robin Wilson, who instructs at Washington and Lee University in Lexington, Va. They appear in her new book, Health Law and Bioethics: Cases in Context.

While they’re incomplete, the documents show a chilling pattern. They show that a lot of good people inside Penn raised alarms about Wilson’s financial ties from the get-go, but that Penn approved the deal anyway. The documents also show misleading disclosures to Jesse about the risks posed to him. For example, although animals died in prior trials, we were told that “animals have not shown toxic effects … at the dosage of virus that’s needed to transport the gene in this study.”

I thought the lawsuits brought by me and the government would change research practices and the rules governing research. When I settled, real reform seemed likely. The Senate had held hearings, the FDA was investigating whether mistakes were made in the trial, and influential medical bodies such as the Association of American Medical Colleges had begun to examine disclosure practices and financial ties.

But, sadly, we’ve not yet learned enough from Jesse’s death. The shroud of secrecy that envelops legal settlements has helped hinder reform. No one has publicly accounted for the mistakes that led to Jesse’s death.

We do not know whether the FDA was misled or dropped the ball. We do not know whether the researchers’ claims of efficacy had any basis in fact or were just wishful thinking. We do not know why Penn approved the deal despite warnings. And we do not know whether the researchers’ decision to administer the virus to Jesse was reasonable or reckless.

Ten years ago this day, my son died in a science experiment. A complete record of what the researchers and FDA regulators knew is the best precaution against future tragedies like Jesse’s death.

I am asking that the University of Pennsylvania and the FDA finally do the right thing and release their records. If they did nothing wrong, let us see the proof. If they made a mistake, let us all learn from it and do superior in the future. We owe it to Jesse to make his life and death mean something.

[Emphases mine - ed]

Other than stating that I strongly concur that these records should be released for others to learn from, I don’t think additional commentary is necessary.

– SS

[Source : Health Care Renewal]

On the University Diaries blog, Prof Margaret Soltan picked up on an article on the privileges now given to university leaders, using the example of the President of the University of Washington (which includes a medical school, academic medical center, etc). At a time when the university budget was being cut, President Mark Emmert refused to take a voluntary cut in his greater than $900,000 total annual compensation. This included a $12,000 vehicle allowance and free use of the university mansion.

From the original article comes this key quote:

How could this happen? It happened for the same reason that Wall Street types, with acquiescence of their boards and public officials, saw no reason to make any personal sacrifice at a time when others are sacrificing greatly. The UW Board of Regents, as most others at public universities, is not made up of scholars and altruists. It consists mainly of governor-appointed businessmen, lawyers, and other high-income types who themselves live insulated from the daily travails of ordinary say taxpayers.

As Froma Harrop put it, the ethos among leaders of the finance sector now seems to be “heads, I win, tails, I am bailed out.” That ethos has now infiltrated the leadership of many kinds of organizations, perhaps because in many cases the Masters of the Universe from the finance sector now lead the boards of these organizations. The result may be leaders of academia more focused on enriching and empowering themselves than on their organizations’ high-minded missions.

[Source : Health Care Renewal]