Tuesday, 26 April 2005

Princess Health and Ghosts Busted: Another Update. Princessiccia

Princess Health and Ghosts Busted: Another Update. Princessiccia

New World Association of Medical Editors Policy
The World Association of Medical Editors issued a new policy statement on ghostwriting. Its introduction states "The integrity of the published record of scientific research depends not only on the validity of the science but also on honesty in authorship." Furthermore, "The scientific record is distorted if the primary purpose of an article is to persuade readers in favor of a special interest, rather than to inform and educate, and this purpose is concealed." Thus, "WAME considers ghost authorship dishonest and unacceptable."
The policy declares that "Submitting authors bear primary responsibility for naming all contributors to manuscripts and describing their contributions." However, "Other parties, including companies�such as marketing, communications, and medical education companies who are paid to assist pharmaceutical and medical device companies in disseminating favorable messages about their products�may initiate the sequence of events for which the author is the final and most easily identified participant. These other participants are also responsible for ghost written manuscripts and addressing their roles should be part of the solution."
The policy includes the following possible sanctions for violations:
"1. publish a notice that a manuscript has been ghost written, along with the names of the responsible companies and the submitting author;
2. alert the authors' academic institutions, identifying the commercial companies;
3. provide specific names if contacted by the popular media or government organizations; and
4. share their experiences on the WAME Listserve and within other forums."
It all makes sense to me, but I wonder if any of the proposed sanctions are likely to have a powerful effect on the large health care organizations that sponsor the ghostwriting, nor the "medical education companies" that actually produce it.
Annals of Internal Medicine Announcement
Meanwhile, the Annals of Internal Medicine just put an announcement on its web-site that the journal editors are investigating the report of the ADVANTAGE trial, and "The editors will try to verify the number of cardiac events reported in The New York Times article. We will print a correction if we confirm that Lisse and colleagues reported patient outcomes incorrectly. " Sounds like a good idea, but this doesn't directly address the issue that the Times alleged that this trial was ghostwritten, and alleged that the true authorship of the trial was concealed from the journal editors and their readers. Let's see if there is more to come on this.
The Canadian Broadcasting Corporation Report on Ghostwriting
I found a fairly scary report that the CBC put out in 2003, which I wish I had seen then. It included an interview with a ghostwriter, one of three, in Vancouver, Montreal and Ottawa, that the reporters found. The anonymous ghostwriter declared:
  • "I'm given an outline about what to talk about, what studies to site. [sic] They want us to be talking about the stuff that makes the drug look good. There's no discussion of certain adverse events. That's just not brought up."
  • "You're being told [by the drug company] what to do. And if you don't do it, you've lost the job."
  • "I expect that all the drug companies are doing it with all the drugs."
  • "As long as I do my job well, it's not up to me to decide how the drug is positioned. I'm just following the information I'm being given."
  • "The way I look at it, if doctors that have their name on it, that's their responsibility, not mine."
Spooky. Read it --and weep if what their anonymous interviewee said was even an approximation of the truth.
Princess Health and  Ghosts Busted: Another Update.Princessiccia

Princess Health and Ghosts Busted: Another Update.Princessiccia

New World Association of Medical Editors Policy
The World Association of Medical Editors issued a new policy statement on ghostwriting. Its introduction states "The integrity of the published record of scientific research depends not only on the validity of the science but also on honesty in authorship." Furthermore, "The scientific record is distorted if the primary purpose of an article is to persuade readers in favor of a special interest, rather than to inform and educate, and this purpose is concealed." Thus, "WAME considers ghost authorship dishonest and unacceptable."
The policy declares that "Submitting authors bear primary responsibility for naming all contributors to manuscripts and describing their contributions." However, "Other parties, including companies�such as marketing, communications, and medical education companies who are paid to assist pharmaceutical and medical device companies in disseminating favorable messages about their products�may initiate the sequence of events for which the author is the final and most easily identified participant. These other participants are also responsible for ghost written manuscripts and addressing their roles should be part of the solution."
The policy includes the following possible sanctions for violations:
"1. publish a notice that a manuscript has been ghost written, along with the names of the responsible companies and the submitting author;
2. alert the authors' academic institutions, identifying the commercial companies;
3. provide specific names if contacted by the popular media or government organizations; and
4. share their experiences on the WAME Listserve and within other forums."
It all makes sense to me, but I wonder if any of the proposed sanctions are likely to have a powerful effect on the large health care organizations that sponsor the ghostwriting, nor the "medical education companies" that actually produce it.
Annals of Internal Medicine Announcement
Meanwhile, the Annals of Internal Medicine just put an announcement on its web-site that the journal editors are investigating the report of the ADVANTAGE trial, and "The editors will try to verify the number of cardiac events reported in The New York Times article. We will print a correction if we confirm that Lisse and colleagues reported patient outcomes incorrectly. " Sounds like a good idea, but this doesn't directly address the issue that the Times alleged that this trial was ghostwritten, and alleged that the true authorship of the trial was concealed from the journal editors and their readers. Let's see if there is more to come on this.
The Canadian Broadcasting Corporation Report on Ghostwriting
I found a fairly scary report that the CBC put out in 2003, which I wish I had seen then. It included an interview with a ghostwriter, one of three, in Vancouver, Montreal and Ottawa, that the reporters found. The anonymous ghostwriter declared:
  • "I'm given an outline about what to talk about, what studies to site. [sic] They want us to be talking about the stuff that makes the drug look good. There's no discussion of certain adverse events. That's just not brought up."
  • "You're being told [by the drug company] what to do. And if you don't do it, you've lost the job."
  • "I expect that all the drug companies are doing it with all the drugs."
  • "As long as I do my job well, it's not up to me to decide how the drug is positioned. I'm just following the information I'm being given."
  • "The way I look at it, if doctors that have their name on it, that's their responsibility, not mine."
Spooky. Read it --and weep if what their anonymous interviewee said was even an approximation of the truth.
Princess Health and Former Fletcher Allen Health Care CEO Sentenced for Conspiracy. Princessiccia

Princess Health and Former Fletcher Allen Health Care CEO Sentenced for Conspiracy. Princessiccia

As reported in the Rutland Herald and the Burlington Free Press....
William Boettcher, the former CEO of Fletcher Allen Health Care, an academic medical center affiliated with the University of Vermont, was sentenced to two years in jail for federal conspiracy. He was convicted of misleading the Vermont state legislature about the true cost of the "Renaissance Project," a massive hospital renovation project ostensibly budgeted for $173 million, but actually costing $367 million. Boettcher kept two sets of books on the project, one for the legislature's benefit, and one that reflected the true cost.
As the judge put it:
  • "'You're here because you orchestrated a scheme to lie to state regulators,' Judge Sessions scolded Boettcher. 'That goes to the heart of purpose and functions of state. How would government function when it is treated so dismissively and with such deceit? 'Most of us approach our jobs with a keen sense of humility and pride," Sessions continued. "Mr. Boettcher approached his job with arrogance and deceit.'"
Furthermore,
  • "In court Monday, Boettcher was hardly recognizable as the man whom prosecutors have portrayed as a boss who bullied and intimidated his managers into doing his bidding. In a nearly 50 minute statement, the former CEO wept openly, apologizing for his and his co-conspirators' lies to state regulators. "
David Demers, a former Fletcher Allen Senior Vice President, described Boettcher in this way:
  • "He controlled those around him and managed those around him by fear and intimidation and I would say that as a manager he's a 'Theory X,' a management style that assumes people need to be frightened and threatened in order to perform."
Is this the sort of manager that rises to a leadership position in today's large health care organizations? Before dismissing this case as an aberration, consider a story in yesterday's New York Times about the excessive number of beds in Buffalo, NY. When asked for an explanation, William D. McGuire, CEO of Kaleida Health, commented about his peers,
  • "But an awful lot of the obstacle is CEO ego. We're kingdom builders as a group: 'I've got to have more beds than you do. I've got to have more hospitals than you do. I've got to have the biggest empire."
Again, this suggests that the new corporate culture of health care often attracts as leaders the sorts of people least suited to run organizations whose goal is taking care of individual patients.
Princess Health and  Former Fletcher Allen Health Care CEO Sentenced for Conspiracy.Princessiccia

Princess Health and Former Fletcher Allen Health Care CEO Sentenced for Conspiracy.Princessiccia

As reported in the Rutland Herald and the Burlington Free Press....
William Boettcher, the former CEO of Fletcher Allen Health Care, an academic medical center affiliated with the University of Vermont, was sentenced to two years in jail for federal conspiracy. He was convicted of misleading the Vermont state legislature about the true cost of the "Renaissance Project," a massive hospital renovation project ostensibly budgeted for $173 million, but actually costing $367 million. Boettcher kept two sets of books on the project, one for the legislature's benefit, and one that reflected the true cost.
As the judge put it:
  • "'You're here because you orchestrated a scheme to lie to state regulators,' Judge Sessions scolded Boettcher. 'That goes to the heart of purpose and functions of state. How would government function when it is treated so dismissively and with such deceit? 'Most of us approach our jobs with a keen sense of humility and pride," Sessions continued. "Mr. Boettcher approached his job with arrogance and deceit.'"
Furthermore,
  • "In court Monday, Boettcher was hardly recognizable as the man whom prosecutors have portrayed as a boss who bullied and intimidated his managers into doing his bidding. In a nearly 50 minute statement, the former CEO wept openly, apologizing for his and his co-conspirators' lies to state regulators. "
David Demers, a former Fletcher Allen Senior Vice President, described Boettcher in this way:
  • "He controlled those around him and managed those around him by fear and intimidation and I would say that as a manager he's a 'Theory X,' a management style that assumes people need to be frightened and threatened in order to perform."
Is this the sort of manager that rises to a leadership position in today's large health care organizations? Before dismissing this case as an aberration, consider a story in yesterday's New York Times about the excessive number of beds in Buffalo, NY. When asked for an explanation, William D. McGuire, CEO of Kaleida Health, commented about his peers,
  • "But an awful lot of the obstacle is CEO ego. We're kingdom builders as a group: 'I've got to have more beds than you do. I've got to have more hospitals than you do. I've got to have the biggest empire."
Again, this suggests that the new corporate culture of health care often attracts as leaders the sorts of people least suited to run organizations whose goal is taking care of individual patients.

Sunday, 24 April 2005

Princess Health and "Passionate CEO" Who "Fights the Dragons". Princessiccia

Princess Health and "Passionate CEO" Who "Fights the Dragons". Princessiccia

The Philadelphia Inquirer for Sunday 04-24-2005, features an interesting piece by Thomas Ginsberg on the CEO, Sir Tom McKillop, at AstraZeneca, which has its US HQ near me, in the Delaware Valley. The article will probably be available here for a week or so after the above date, then I expect may disappear into the giant maw of pay-per-view and sundry search engine caches.

Recall that AZ is one of the recent drug companies--Merck is another--alleged to have participated in "ghost authoring," a practice the ethics of which many have questioned both in this blog and elsewhere. Hence, before returning to Sir Tom and the Inquirer, I suppose I'd like to ask the remedial question: should there be a "bright line" between scientific authorship, interpreted in plain old old-school fashion as "something I worked up, researched it myself, and then wrote it up," on the one hand, and some investigator lightly buffing a Medical Education Company's prose and proclaiming him/herself "first author"?

(The MEC in the AZ case advertises itself here. They were founded on "a vision of excellence.")

If there's a bright line, how is crossing it to be prevented? What sanctions can or should be imposed? (The Journal of General Internal Medicine may have recently come up with one, at least one that will give pause to this particular putative author.) And what can the old-school "gentlemen's clubs" journals, many of them run by collegiate societies, do to make that bright line as, well, bright as it clearly needs to be?

In the case of AstraZeneca, I doubt its approach was any different than many other pharmas. (Not sure which is more chilling: this is anomalous, or this is business-as-usual.) And I doubt, though cannot truly know yea or nay, whether Sir Tom knew about the "attempted plant" in JGIM, on which Dr. Adriane Fugh-Berman recently blew the whistle.

Yet some of the Inquirer reporter's notes and observations, in an article that sports the headline "Aggressive Stance," bear repeating here, since the last time I checked with Jack Welch, CEOs of large companies set the tone for the organizational behavior under them.

Here are some of the "dragons" that this gentleman, in a recent interview, sought to "lance."
  • "Drug safety advocates are sputtering 'nonsense.'"
  • "Regulators are creating 'imbalance' in risk-vs.-benefit decisions."
  • "Americans are catching 'the European disease' of excess caution...."
And so on. I have many good friends who work, or have worked, in pharma. It is completely understandable how pharma top management comes to think unflatteringly about FDA hold-outs, Sid Wolfe, and even this blog. Fish gotta swim, birds gotta fly. We're all just doing our jobs.
But a couple big questions linger.
One, where do authors, in academia or the private sector either one, get the idea that it's de rigueur to slap their name on a MEC-authored paper? Put another way, do they have no idea what might happen to them if someone like Dr. Fugh-Berman blows the whistle?
And two, what are we to make of the last quotable quote from the Inquirer piece on Sir Tom?
  • A favorite book is Konrad Lorenz's classic tome, On Aggression....
Let's not stop quite there, though. In point of fact, that AZ's Sir Tom, chemist-turned-CEO, finds the Lorenz oeuvre "fascinating" would be a splendid starting point for all sorts of interesting ongoing discussions. Lorenz's analysis of social organization and ritual behaviors would be a useful context for understanding why organizations risk shooting themselves in the foot.
Worth pondering and discussing a lot more, methinks. Here is a gentleman who actually appears to want out from Big Pharma, but not until he's shored up his one company's pipeline and its market fortunes. He's right to be fascinated by the work of other students of aggression.
Princess Health and  "Passionate CEO" Who "Fights the Dragons".Princessiccia

Princess Health and "Passionate CEO" Who "Fights the Dragons".Princessiccia

The Philadelphia Inquirer for Sunday 04-24-2005, features an interesting piece by Thomas Ginsberg on the CEO, Sir Tom McKillop, at AstraZeneca, which has its US HQ near me, in the Delaware Valley. The article will probably be available here for a week or so after the above date, then I expect may disappear into the giant maw of pay-per-view and sundry search engine caches.

Recall that AZ is one of the recent drug companies--Merck is another--alleged to have participated in "ghost authoring," a practice the ethics of which many have questioned both in this blog and elsewhere. Hence, before returning to Sir Tom and the Inquirer, I suppose I'd like to ask the remedial question: should there be a "bright line" between scientific authorship, interpreted in plain old old-school fashion as "something I worked up, researched it myself, and then wrote it up," on the one hand, and some investigator lightly buffing a Medical Education Company's prose and proclaiming him/herself "first author"?

(The MEC in the AZ case advertises itself here. They were founded on "a vision of excellence.")

If there's a bright line, how is crossing it to be prevented? What sanctions can or should be imposed? (The Journal of General Internal Medicine may have recently come up with one, at least one that will give pause to this particular putative author.) And what can the old-school "gentlemen's clubs" journals, many of them run by collegiate societies, do to make that bright line as, well, bright as it clearly needs to be?

In the case of AstraZeneca, I doubt its approach was any different than many other pharmas. (Not sure which is more chilling: this is anomalous, or this is business-as-usual.) And I doubt, though cannot truly know yea or nay, whether Sir Tom knew about the "attempted plant" in JGIM, on which Dr. Adriane Fugh-Berman recently blew the whistle.

Yet some of the Inquirer reporter's notes and observations, in an article that sports the headline "Aggressive Stance," bear repeating here, since the last time I checked with Jack Welch, CEOs of large companies set the tone for the organizational behavior under them.

Here are some of the "dragons" that this gentleman, in a recent interview, sought to "lance."
  • "Drug safety advocates are sputtering 'nonsense.'"
  • "Regulators are creating 'imbalance' in risk-vs.-benefit decisions."
  • "Americans are catching 'the European disease' of excess caution...."
And so on. I have many good friends who work, or have worked, in pharma. It is completely understandable how pharma top management comes to think unflatteringly about FDA hold-outs, Sid Wolfe, and even this blog. Fish gotta swim, birds gotta fly. We're all just doing our jobs.
But a couple big questions linger.
One, where do authors, in academia or the private sector either one, get the idea that it's de rigueur to slap their name on a MEC-authored paper? Put another way, do they have no idea what might happen to them if someone like Dr. Fugh-Berman blows the whistle?
And two, what are we to make of the last quotable quote from the Inquirer piece on Sir Tom?
  • A favorite book is Konrad Lorenz's classic tome, On Aggression....
Let's not stop quite there, though. In point of fact, that AZ's Sir Tom, chemist-turned-CEO, finds the Lorenz oeuvre "fascinating" would be a splendid starting point for all sorts of interesting ongoing discussions. Lorenz's analysis of social organization and ritual behaviors would be a useful context for understanding why organizations risk shooting themselves in the foot.
Worth pondering and discussing a lot more, methinks. Here is a gentleman who actually appears to want out from Big Pharma, but not until he's shored up his one company's pipeline and its market fortunes. He's right to be fascinated by the work of other students of aggression.
Princess Health and NIH Dissidents Keep Fighting Conflict of Interest Rules. Princessiccia

Princess Health and NIH Dissidents Keep Fighting Conflict of Interest Rules. Princessiccia

The LA Times reported that over at the National Institutes of Health (NIH), the dissident Assembly of Scientists is ramping up its fight to preserve the ability of NIH physicians, scientists, and leaders to personally hold pharmaceutical and biotechnology stocks, and to take fees in addition to their salaries to consult for pharmaceutical and biotechnology companies.
The Assembly has hired the firm of Arent Fox PLLC as its representative. The LA Times article alleged that Arent Fox also has represented makers of pharmaceuticals, medical devices, and dietary supplements, and one of its clients is the Biotechnology Industry Organization. Apparently, the Assembly of Scientists is getting these services at a discount, for reasons that are unclear. Furthermore, it turns out that Rep. Chris Van Hollen (D-MD), who asked NIH Director Zerhouni to delay implementation of more stringent conflict of interest rules, is a former partner in Arent Fox.
My comment is that the more that top NIH scientists and leaders seem focused on keeping their lucrative outside consulting work for biotechnology and pharmaceutical corporations, the more doubts will be raised about where their true loyalties lie. Are they first loyal public servants, or industry consultants? If the latter, are their writings and actions primarily meant to advance science, or advance the commercial interests of their consulting clients?