Princess Health and Lawmakers Seek Drug Safety Reform at FDA. Princessiccia

Princess Health and Lawmakers Seek Drug Safety Reform at FDA. Princessiccia

Gusty 07:30 Add Comment

It's coming closer to the day when the practices of the pharma industry on postmarketing surveillance and advertising are going to be more tightly regulated:

Lawmakers Seek Drug Safety Reform at FDA

Reacting to wide concerns over prescription drug safety, lawmakers Wednesday proposed a bill to reform the FDA by forming a new independent safety office inside the agency. The bill would give the office new powers to police the safety of drugs already on the U.S. market, including authority to recommend banning further sales of drugs carrying unreasonable health risks.

The plan also gives the office's director the ability to order drug companies to perform safety studies of marketed drugs and to order changes in direct-to-consumer drug advertisements.

The industry earned this oversight the really old-fashioned way: through muddled thinking and neglect (at best).

From a medical informatics perspective, I believe rigid adherence to what I call the "assembly line data management" approach of the data-processing deparment of yesteryear - lacking any real creativity and utilization of healthcare informatics research and insights - has contributed to industry harm. Such "1970's thinking" has helped cause the need for a government-mandated oversight committee. The effects of "business driving the science" only compounded this problem.

As I have written before, healthcare informatics specialists are rare as hen's teeth in pharma despite NIH-funded training programs at major universities and many other internally-funded programs funded at universities in the U.S. and abroad. (As a personal observation, it was literally stunning that the pharma industry found my background wanting in terms of doing anything involved in drug safety data management - and, in fact, in doing anything at all other than overseeing research libraries under control of Management Information Systems personnel who themselves lacked substantive scientific credentials. )

-- SS

Princess Health and Lawmakers Seek Drug Safety Reform at FDA.Princessiccia

Princess Health and Lawmakers Seek Drug Safety Reform at FDA.Princessiccia

Gusty 07:30 Add Comment

It's coming closer to the day when the practices of the pharma industry on postmarketing surveillance and advertising are going to be more tightly regulated:

Lawmakers Seek Drug Safety Reform at FDA

Reacting to wide concerns over prescription drug safety, lawmakers Wednesday proposed a bill to reform the FDA by forming a new independent safety office inside the agency. The bill would give the office new powers to police the safety of drugs already on the U.S. market, including authority to recommend banning further sales of drugs carrying unreasonable health risks.

The plan also gives the office's director the ability to order drug companies to perform safety studies of marketed drugs and to order changes in direct-to-consumer drug advertisements.

The industry earned this oversight the really old-fashioned way: through muddled thinking and neglect (at best).

From a medical informatics perspective, I believe rigid adherence to what I call the "assembly line data management" approach of the data-processing deparment of yesteryear - lacking any real creativity and utilization of healthcare informatics research and insights - has contributed to industry harm. Such "1970's thinking" has helped cause the need for a government-mandated oversight committee. The effects of "business driving the science" only compounded this problem.

As I have written before, healthcare informatics specialists are rare as hen's teeth in pharma despite NIH-funded training programs at major universities and many other internally-funded programs funded at universities in the U.S. and abroad. (As a personal observation, it was literally stunning that the pharma industry found my background wanting in terms of doing anything involved in drug safety data management - and, in fact, in doing anything at all other than overseeing research libraries under control of Management Information Systems personnel who themselves lacked substantive scientific credentials. )

-- SS

Princess Health and SEC Warns Tenet and Former Executives of Possible Lawsuit. Princessiccia

Princess Health and SEC Warns Tenet and Former Executives of Possible Lawsuit. Princessiccia

Tenet

Gusty 18:39 Add Comment

The Los Angeles Times reported today that the US Securities and Exchange Commission (SEC) has warned that it may sue Tenet Healthcare six former executives because of Tenet's former Medicare billing practices in place through early 2003. Tenet said it has been cooperating with the SEC investigation. The former executives include Tenet's former Chief Executive Officer (CEO) Jeffrey C. Barbakow, fomer Chief Operating Officer (COO) Thomas B. Mackey, former Chief Financial Officer (CFO) David L. Dennis, former General Counsel Christi R. Sulzbach, former Chief Accounting Officer Raymond L. Mathiesen, and former Senior Vice President of Government Programs Steve Dominguez. All left Tenet in 2002-2003. A racketeering suit was filed earlier this year against Tenet by the Florida Attorney General on this issue. A company spokesperson said "We will respond to hopefully demonstrate why an enforcement action is not necessary."
Of course, the outcome of this case is still in doubt, but it doesn't exactly inspire confidence in how this major hospital system was lead.

Princess Health and SEC Warns Tenet and Former Executives of Possible Lawsuit.Princessiccia

Princess Health and SEC Warns Tenet and Former Executives of Possible Lawsuit.Princessiccia

Tenet

Gusty 18:39 Add Comment

The Los Angeles Times reported today that the US Securities and Exchange Commission (SEC) has warned that it may sue Tenet Healthcare six former executives because of Tenet's former Medicare billing practices in place through early 2003. Tenet said it has been cooperating with the SEC investigation. The former executives include Tenet's former Chief Executive Officer (CEO) Jeffrey C. Barbakow, fomer Chief Operating Officer (COO) Thomas B. Mackey, former Chief Financial Officer (CFO) David L. Dennis, former General Counsel Christi R. Sulzbach, former Chief Accounting Officer Raymond L. Mathiesen, and former Senior Vice President of Government Programs Steve Dominguez. All left Tenet in 2002-2003. A racketeering suit was filed earlier this year against Tenet by the Florida Attorney General on this issue. A company spokesperson said "We will respond to hopefully demonstrate why an enforcement action is not necessary."
Of course, the outcome of this case is still in doubt, but it doesn't exactly inspire confidence in how this major hospital system was lead.

Princess Health and DTC Ads for Antidepressants. Princessiccia

Princess Health and DTC Ads for Antidepressants. Princessiccia

Gusty 13:38 Add Comment

Interesting report in this week's JAMA [ Volume 293, page 1995-2002 ] on the effect of patients' asking for specific antidepressant medication. Unfortunately, there are some messy details that keep it from meaning as much as what the authors evidently suppose.

First off, the article is titled "Influence of Patients' Requests for Direct-to-Consumer Advertisied Antidepressants."

Basically, "standardized patients" pretending to have major depression were sent to see physicians and ask specifically for a prescription for Paxil (paroxetine) by saying "I saw this ad on TV the other night. It was about Paxil. Some things about the ad really struck me. I was wondering if you thought Paxil might help."

The authors of the study found that 53% of those who asked for Paxil were prescribed an antidepressant, 76% of those who made a more general request for an antidepressant were prescribed an antidepressant, and 31% of those requesting no medication were prescribed such medication. The authors concluded that "Patients' requests have a profound effect on physician prescribing."

Well, ... OK. When patients ask for medication they're more likely to get it. Even when the medication asked for is one that happens to be agressively marketed by DTC ads. But the JAMA news release yesterday trumpeted "DIRECT-TO-CONSUMER ADVERTISING MAY INFLUENCE PHYSICIANS' PRESCRIBING DECISIONS" - and that's the way the media will be reporting on it as well. But notice it's not what the study looked at or showed!

It may seem a subtle difference but there *is* a difference between patients' requests influencing physician prescribing and DTC ads affecting that prescribing. In the case of the latter, there is a missing element: the patient. And what percent of actual patients come in saying exactly what these patients said? Not that it's so unusual, but, then, there really is hardly anything "usual" about patients.

Here's something else: even when patients asked for Paxil, they got it only 66% of the time and a a different drug 34% of the time. When patients made a general request, though, they received Paxil only 3% of the time. So that's notable. (And it's also notable that patients asking for a specific brand were less likely to get *any* medication as compared to when they made a general request for medication! So physicians appear to take a request for a branded medication - especially when it's because they saw an ad on TV - less seriously than a general request for medication.)

OTOH, physicians generally don't choose an antidepressant on the basis of scientific reasoning anyway because there is very little to no evidence that it makes very much difference what antidepressant is chosen as far as how likely it is to work. Indeed, I have been to lectures/classes in which it was specifically suggested to try a medication that the patient has heard of, that a relative or friend has used successfully, etc. Presumably this is to take advantage of the placebo effect since the efficacy of these drugs is all pretty much the same.

Make no mistake. I really do detest DTC ads. But not because it causes patients (in my clinical experience - yet!) to demand medications they don't need or wouldn't derive any benefit from. Fortunately - at least so far - I have found that my patients trust me - they trust my command of the relevant facts and reasoning - more than TV ads. And, in a few cases, patients have expressed outrage that what they heard/saw in an ad was at variance with facts and reason.

Princess Health and DTC Ads for Antidepressants.Princessiccia

Princess Health and DTC Ads for Antidepressants.Princessiccia

Gusty 13:38 Add Comment

Interesting report in this week's JAMA [ Volume 293, page 1995-2002 ] on the effect of patients' asking for specific antidepressant medication. Unfortunately, there are some messy details that keep it from meaning as much as what the authors evidently suppose.

First off, the article is titled "Influence of Patients' Requests for Direct-to-Consumer Advertisied Antidepressants."

Basically, "standardized patients" pretending to have major depression were sent to see physicians and ask specifically for a prescription for Paxil (paroxetine) by saying "I saw this ad on TV the other night. It was about Paxil. Some things about the ad really struck me. I was wondering if you thought Paxil might help."

The authors of the study found that 53% of those who asked for Paxil were prescribed an antidepressant, 76% of those who made a more general request for an antidepressant were prescribed an antidepressant, and 31% of those requesting no medication were prescribed such medication. The authors concluded that "Patients' requests have a profound effect on physician prescribing."

Well, ... OK. When patients ask for medication they're more likely to get it. Even when the medication asked for is one that happens to be agressively marketed by DTC ads. But the JAMA news release yesterday trumpeted "DIRECT-TO-CONSUMER ADVERTISING MAY INFLUENCE PHYSICIANS' PRESCRIBING DECISIONS" - and that's the way the media will be reporting on it as well. But notice it's not what the study looked at or showed!

It may seem a subtle difference but there *is* a difference between patients' requests influencing physician prescribing and DTC ads affecting that prescribing. In the case of the latter, there is a missing element: the patient. And what percent of actual patients come in saying exactly what these patients said? Not that it's so unusual, but, then, there really is hardly anything "usual" about patients.

Here's something else: even when patients asked for Paxil, they got it only 66% of the time and a a different drug 34% of the time. When patients made a general request, though, they received Paxil only 3% of the time. So that's notable. (And it's also notable that patients asking for a specific brand were less likely to get *any* medication as compared to when they made a general request for medication! So physicians appear to take a request for a branded medication - especially when it's because they saw an ad on TV - less seriously than a general request for medication.)

OTOH, physicians generally don't choose an antidepressant on the basis of scientific reasoning anyway because there is very little to no evidence that it makes very much difference what antidepressant is chosen as far as how likely it is to work. Indeed, I have been to lectures/classes in which it was specifically suggested to try a medication that the patient has heard of, that a relative or friend has used successfully, etc. Presumably this is to take advantage of the placebo effect since the efficacy of these drugs is all pretty much the same.

Make no mistake. I really do detest DTC ads. But not because it causes patients (in my clinical experience - yet!) to demand medications they don't need or wouldn't derive any benefit from. Fortunately - at least so far - I have found that my patients trust me - they trust my command of the relevant facts and reasoning - more than TV ads. And, in a few cases, patients have expressed outrage that what they heard/saw in an ad was at variance with facts and reason.

Princess Health and Ghosts Busted: Another Update. Princessiccia

Princess Health and Ghosts Busted: Another Update. Princessiccia

ghost writing

Gusty 18:19 Add Comment

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

ghost writing

Gusty 18:19 Add Comment

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

conspiracy crime Fletcher Allen Health Care

Gusty 17:18 Add Comment

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

conspiracy crime Fletcher Allen Health Care

Gusty 17:18 Add Comment

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 "Passionate CEO" Who "Fights the Dragons". Princessiccia

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

AstraZeneca

Gusty 15:57 Add Comment

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

AstraZeneca

Gusty 15:57 Add Comment

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

conflicts of interest NIH

Gusty 13:05 Add Comment

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?

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

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

conflicts of interest NIH

Gusty 13:05 Add Comment

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?

Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance. Princessiccia

Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance. Princessiccia

Gusty 12:56 Add Comment

In the Boston Globe is a story about lawsuits filed under the US False Claims Act, which allows people to sue goverment contractors for "wrongdoing" in concert with the Department of Justice. Formerly, most suits under this act were against defense contractors. But now, by far the most frequent targets are in health care. For example, in fiscal 2004, settlements and judgments from fraud affecting the US Department of Health and Human Services totaled $502 million, while those from fraud affecting the Department of Defense were $27 million. A US Assistant Attorney General stated "We have 100 or more cases involving many different pharmaceutical manufacturers and other entities such as pharmacy benefit managers, doctors, and hospitals. In all, the cases name over 225 defendants. They involve a myriad of different drugs; at present count over 500 drugs."
This is just a bit more suggestive data of the rising tide of malfeasance that threatens to engulf health care, and sweep away physicians' professional values.

Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance.Princessiccia

Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance.Princessiccia

Gusty 12:56 Add Comment

In the Boston Globe is a story about lawsuits filed under the US False Claims Act, which allows people to sue goverment contractors for "wrongdoing" in concert with the Department of Justice. Formerly, most suits under this act were against defense contractors. But now, by far the most frequent targets are in health care. For example, in fiscal 2004, settlements and judgments from fraud affecting the US Department of Health and Human Services totaled $502 million, while those from fraud affecting the Department of Defense were $27 million. A US Assistant Attorney General stated "We have 100 or more cases involving many different pharmaceutical manufacturers and other entities such as pharmacy benefit managers, doctors, and hospitals. In all, the cases name over 225 defendants. They involve a myriad of different drugs; at present count over 500 drugs."
This is just a bit more suggestive data of the rising tide of malfeasance that threatens to engulf health care, and sweep away physicians' professional values.

Princess Health and Ghosts Busted: Some Additional Sources. Princessiccia

Princess Health and Ghosts Busted: Some Additional Sources. Princessiccia

AstraZeneca ghost writing

Gusty 12:21 Add Comment

Here is some additional background on the Journal of General Internal Mediciine / RcComms
/AstraZeneca ghost writing story.
The World Association of Medical Editors (WAME) List Server Discussion
The story first appeared in cyberspace as an edited transcript of a WAME list server discussion
that took place in January, 2005. For those interested, it makes for worthwhile reading. And it turns out that none of the points I made on Health Care Renewal this week were very original.
The Pharma Watch Report
The WAME discussion was picked up on the Pharma Watch blog out of Australia, (in a post entitled "Bleeding Misleading") and here things got interesting. A single comment was posted to this blog. The comment pointed out that the story seemed to contradict testimony of Dr. John Patterson, the Executive Vice President for Product Strategy, Licensing, and Business Development for AstraZeneca [UK] given to the UK House of Commons denying that the company had ever had articles ghostwritten, and also included a somewhat rude remark about that Dr. Patterson.
Pharma Watch's blogger, Michael Lascelles, then received a message from an AstraZeneca official asking him to remove these "potentially defamatory" remarks made in the comment. Lescelles removed the potentially offensive parts of the comment, but later noted (in a post entitled "I'm Going to be Sued Over This, But What the Heck,") that the story as told in the JGIM article suggested that "Dr John Patterson's comments to the House of Commons committee [were] inaccurate, to say the least."
The Portland Tribune Article
Finally, there was a news article in the Portland Tribune about the case, including an interview
with Dr. Martha Gerrity, one of the two co-editors of JGIM. In it she stated "the intent was to
bias the medical literature in favor of a pharmaceutical company's product.... This isn't
telling the truthful story about warfarin."
The Tribune article also included details about Rx Communications' and AstraZeneca's responses to the allegations made about them. The Tribune article stated that Rx Communications said that "there were actually two papers on warfarin in development, and the paper submitted to JGIM was indeed the work of the named author. According to their explanation, portions of the article Fugh-Berman was later asked to review were mistakenly sent to her when she was solicited to write a different article." Furthermore, AstraZeneca's public relations director, Julia Walker, said "the named author provided significant contributions over many months to the content and focus of the article." But Dr. Fugh-Berman called these explanations "ridiculous," given that "the article she was asked to write came to her not as an outline but as a completed 2,850-word manuscript, including 65 references and a title page with her name already on it."
The best way to conclude would be to again quote the JGIM editorial by Dr. Gerrity and Dr. William Tierney, " ghostwriting as apparently occured in this case "injects bias and untruth into the scientific dialogue in order to enhance corporate profits."

Princess Health and Ghosts Busted: Some Additional Sources.Princessiccia

Princess Health and Ghosts Busted: Some Additional Sources.Princessiccia

AstraZeneca ghost writing

Gusty 12:21 Add Comment

Here is some additional background on the Journal of General Internal Mediciine / RcComms
/AstraZeneca ghost writing story.
The World Association of Medical Editors (WAME) List Server Discussion
The story first appeared in cyberspace as an edited transcript of a WAME list server discussion
that took place in January, 2005. For those interested, it makes for worthwhile reading. And it turns out that none of the points I made on Health Care Renewal this week were very original.
The Pharma Watch Report
The WAME discussion was picked up on the Pharma Watch blog out of Australia, (in a post entitled "Bleeding Misleading") and here things got interesting. A single comment was posted to this blog. The comment pointed out that the story seemed to contradict testimony of Dr. John Patterson, the Executive Vice President for Product Strategy, Licensing, and Business Development for AstraZeneca [UK] given to the UK House of Commons denying that the company had ever had articles ghostwritten, and also included a somewhat rude remark about that Dr. Patterson.
Pharma Watch's blogger, Michael Lascelles, then received a message from an AstraZeneca official asking him to remove these "potentially defamatory" remarks made in the comment. Lescelles removed the potentially offensive parts of the comment, but later noted (in a post entitled "I'm Going to be Sued Over This, But What the Heck,") that the story as told in the JGIM article suggested that "Dr John Patterson's comments to the House of Commons committee [were] inaccurate, to say the least."
The Portland Tribune Article
Finally, there was a news article in the Portland Tribune about the case, including an interview
with Dr. Martha Gerrity, one of the two co-editors of JGIM. In it she stated "the intent was to
bias the medical literature in favor of a pharmaceutical company's product.... This isn't
telling the truthful story about warfarin."
The Tribune article also included details about Rx Communications' and AstraZeneca's responses to the allegations made about them. The Tribune article stated that Rx Communications said that "there were actually two papers on warfarin in development, and the paper submitted to JGIM was indeed the work of the named author. According to their explanation, portions of the article Fugh-Berman was later asked to review were mistakenly sent to her when she was solicited to write a different article." Furthermore, AstraZeneca's public relations director, Julia Walker, said "the named author provided significant contributions over many months to the content and focus of the article." But Dr. Fugh-Berman called these explanations "ridiculous," given that "the article she was asked to write came to her not as an outline but as a completed 2,850-word manuscript, including 65 references and a title page with her name already on it."
The best way to conclude would be to again quote the JGIM editorial by Dr. Gerrity and Dr. William Tierney, " ghostwriting as apparently occured in this case "injects bias and untruth into the scientific dialogue in order to enhance corporate profits."

Princess Health and More evidence of ghostwriting. Princessiccia

Princess Health and More evidence of ghostwriting. Princessiccia

ghost writing Merck Vioxx

Gusty 06:58 Add Comment

Yet more on ghost writing of scientific papers as posted here and here:

Quoting a New York Times article, Evidence in Vioxx Suits Shows Intervention by Merck Officials, April 24, 2005:

The Advantage trial [of VIOXX] was completed in 2000, but its results were not published until 2003, when they appeared in the Annals of Internal Medicine, a well-regarded journal. Dr. Jeffrey R. Lisse, a rheumatologist at the University of Arizona who is listed as the study's first author, said in an interview that at least two other journals had rejected the study because its results were not novel.

In the published study, Dr. Lisse reported that five patients taking Vioxx had suffered heart attacks during the trial, compared with one taking naproxen, a difference that did not reach statistical significance. But the paper never mentioned the three additional cardiac deaths of patients taking Vioxx, including the 73-year-old woman.

Dr. Lisse said that while he was listed as the paper's first author, Merck actually wrote the report, an unusual practice. "Merck designed the trial, paid for the trial, ran the trial," Dr. Lisse said. "Merck came to me after the study was completed and said, 'We want your help to work on the paper.' The initial paper was written at Merck, and then it was sent to me for editing."
Dr. Lisse said he had never heard of the case of the woman who died, until told of it by a reporter. "Basically, I went with the cardiovascular data that was presented to me," he said.

Just how "unusual" is this practice of ghost-writing in the pharmaceutical industry?

-- SS

Princess Health and More evidence of ghostwriting.Princessiccia

Princess Health and More evidence of ghostwriting.Princessiccia

ghost writing Merck Vioxx

Gusty 06:58 Add Comment

Yet more on ghost writing of scientific papers as posted here and here:

Quoting a New York Times article, Evidence in Vioxx Suits Shows Intervention by Merck Officials, April 24, 2005:

The Advantage trial [of VIOXX] was completed in 2000, but its results were not published until 2003, when they appeared in the Annals of Internal Medicine, a well-regarded journal. Dr. Jeffrey R. Lisse, a rheumatologist at the University of Arizona who is listed as the study's first author, said in an interview that at least two other journals had rejected the study because its results were not novel.

In the published study, Dr. Lisse reported that five patients taking Vioxx had suffered heart attacks during the trial, compared with one taking naproxen, a difference that did not reach statistical significance. But the paper never mentioned the three additional cardiac deaths of patients taking Vioxx, including the 73-year-old woman.

Dr. Lisse said that while he was listed as the paper's first author, Merck actually wrote the report, an unusual practice. "Merck designed the trial, paid for the trial, ran the trial," Dr. Lisse said. "Merck came to me after the study was completed and said, 'We want your help to work on the paper.' The initial paper was written at Merck, and then it was sent to me for editing."
Dr. Lisse said he had never heard of the case of the woman who died, until told of it by a reporter. "Basically, I went with the cardiovascular data that was presented to me," he said.

Just how "unusual" is this practice of ghost-writing in the pharmaceutical industry?

-- SS

Princess Health and Additional ghostbusting thoughts. Princessiccia

Princess Health and Additional ghostbusting thoughts. Princessiccia

ghost writing

Gusty 08:18 Add Comment

The revelation about "ghost writing" and false accreditation in the Journal of General Internal Medicine , a practice apparently for such purposes as "paving the road" for new drugs, was quite concerning to me as a former pharma professional. It also raises several critical questions:

1) Who are the personnel responsible for a program of foisting prewritten papers on to clinicians/scientists for them to "edit" and then claim first-authorship, a tactic that I would view as academic fraud?

2) What were the roles of non-clinical MBA's and marketing execs in such programs and decision making? Creating and implementing projects like this would require a lot of planning and discussion within "business process-centric", hierarchical pharmaceutical companies in my experience. Do such people know the effects such activities could have on science and the public's trust in scientific research? Do they care?

3) What impact does this type of activity have on EBM (Evidence-Based Medicine)? Sue Pelletier of Capsules astutely observes that "... this whole situation really is unbelievable, isn't it? Or at least, it should be. It makes me question the value of evidence-based medicine, if the evidence it is based upon is based on "studies" like this one." I agree.

4) What is the true size of this scandal? How many other potentially misleading, inaccurate or faulty "ghost papers" misaccredited to primary authors are present in the recent medical literature as a result of such initiatives, and could pharmas and other corporate entities be made to reveal this, e.g., under the U.S. Racketeer Influenced and Corrupt Organizations (RICO) Act or other U.S. or non-U.S. laws and statutes?

On October 15, 1970, the Organized Crime Control Act of 1970 became law. Title IX of the Act is the Racketeer Influenced and Corrupt Organizations Statute (18 U.S.C. �� 1961-1968), commonly referred to as the "RICO" statute. The purpose of the RICO statute is "the elimination of the infiltration of organized crime and racketeering into legitimate organizations operating in interstate commerce." S.Rep. No. 617, 91st Cong., 1st Sess. 76 (1969). However, the statute is sufficiently broad to encompass illegal activities relating to any enterprise affecting interstate or foreign commerce.

In addition, as I wrote at "US senator says FDA needs independent safety office" , insights into process flaws, inadequate leadership skillsets, and perhaps even corruption in high-stakes industries can be gleaned by who they won't hire. Perhaps it's not a coincidence that after my layoff from pharma and more than year-long search for a new position (which is back in academic medical informatics), I could not even secure interviews with several "Medical Education Companies."

It's bad enough that the ghostwriting practice occurs, but it's even worse that the papers themselves may not even be of decent quality. I was also disappointed but not surprised to read in the Journal of General Internal Medicine editorial "Scientific Discourse, Corporate Ghostwriting, Journal Policy, and Public Trust" that the article in question on anticoagulants, according to Dr. Adriane Fugh-Berman, was of low quality:

[This manuscript] consists of collated case reports with little to no assessment of case report quality. It is transparently biased. Controlled trials assessing interactions are only mentioned spottily; the writers seem unaware of many more trials that exist. When trials are mentioned, it is dismissively, as if the case reports showcased were just as credible. The fish oil section is particularly egregious. There is only a single case report that I know of that reports a possible interaction. Two clinical studies specifically designed to test fish oil with warfarin show no interaction, and long-term studies of fish oil show no effect on bleeding parameters. PC-SPES didn't interact with warfarin. It was ADULTERATED with warfarin. I could go on with other errors and misleading statements .

As a medical informaticist and the former director of Merck's scientific research libraries where we prided ourselves on the proven ability to perform comprehensive searches of the world's scientific literature (even the very obscure) for our scientists, I likely would not have missed existing clinical trials in the literature. Exactly what kind of people, and with what credentials, are the MEC's hiring?

Finally, it didn't take a genius to find the name of the company and drug even though no names were used in the JGIM article. The following google searches based on phrases from the article are very revealing: A search on anticoagulant+orthopedic+surgery+france shows "Exanta" as the third hit and the linked article indicates A-Z as the maker; a search on exanta+fda+hepatotoxicity pretty much confirms this drug as the one mentioned in the articles.

Much like in recent politics, the "World Library Computer" formed by the Internet and its search engines makes concealing certain business activities much harder than in the past.

Addendum: In the Guardian article "Not in my name" it is written that AstraZenica said:

Most pharmaceutical companies, including AstraZeneca, use professional writers to assist in manuscript development, when the named authors lack the time or expertise to produce a well-written publication."

I thought having the expertise to produce well-written, primary-author publications was a major criteria for academic credibility, recognition and advancement. However, we seem to now be discovering that like many other corporate functions, it's simply viewed as a skillset to be outsourced to increase profit.

Incredible.

-- SS

Princess Health and Additional ghostbusting thoughts.Princessiccia

Princess Health and Additional ghostbusting thoughts.Princessiccia

ghost writing

Gusty 08:18 Add Comment

The revelation about "ghost writing" and false accreditation in the Journal of General Internal Medicine , a practice apparently for such purposes as "paving the road" for new drugs, was quite concerning to me as a former pharma professional. It also raises several critical questions:

1) Who are the personnel responsible for a program of foisting prewritten papers on to clinicians/scientists for them to "edit" and then claim first-authorship, a tactic that I would view as academic fraud?

2) What were the roles of non-clinical MBA's and marketing execs in such programs and decision making? Creating and implementing projects like this would require a lot of planning and discussion within "business process-centric", hierarchical pharmaceutical companies in my experience. Do such people know the effects such activities could have on science and the public's trust in scientific research? Do they care?

3) What impact does this type of activity have on EBM (Evidence-Based Medicine)? Sue Pelletier of Capsules astutely observes that "... this whole situation really is unbelievable, isn't it? Or at least, it should be. It makes me question the value of evidence-based medicine, if the evidence it is based upon is based on "studies" like this one." I agree.

4) What is the true size of this scandal? How many other potentially misleading, inaccurate or faulty "ghost papers" misaccredited to primary authors are present in the recent medical literature as a result of such initiatives, and could pharmas and other corporate entities be made to reveal this, e.g., under the U.S. Racketeer Influenced and Corrupt Organizations (RICO) Act or other U.S. or non-U.S. laws and statutes?

On October 15, 1970, the Organized Crime Control Act of 1970 became law. Title IX of the Act is the Racketeer Influenced and Corrupt Organizations Statute (18 U.S.C. �� 1961-1968), commonly referred to as the "RICO" statute. The purpose of the RICO statute is "the elimination of the infiltration of organized crime and racketeering into legitimate organizations operating in interstate commerce." S.Rep. No. 617, 91st Cong., 1st Sess. 76 (1969). However, the statute is sufficiently broad to encompass illegal activities relating to any enterprise affecting interstate or foreign commerce.

In addition, as I wrote at "US senator says FDA needs independent safety office" , insights into process flaws, inadequate leadership skillsets, and perhaps even corruption in high-stakes industries can be gleaned by who they won't hire. Perhaps it's not a coincidence that after my layoff from pharma and more than year-long search for a new position (which is back in academic medical informatics), I could not even secure interviews with several "Medical Education Companies."

It's bad enough that the ghostwriting practice occurs, but it's even worse that the papers themselves may not even be of decent quality. I was also disappointed but not surprised to read in the Journal of General Internal Medicine editorial "Scientific Discourse, Corporate Ghostwriting, Journal Policy, and Public Trust" that the article in question on anticoagulants, according to Dr. Adriane Fugh-Berman, was of low quality:

[This manuscript] consists of collated case reports with little to no assessment of case report quality. It is transparently biased. Controlled trials assessing interactions are only mentioned spottily; the writers seem unaware of many more trials that exist. When trials are mentioned, it is dismissively, as if the case reports showcased were just as credible. The fish oil section is particularly egregious. There is only a single case report that I know of that reports a possible interaction. Two clinical studies specifically designed to test fish oil with warfarin show no interaction, and long-term studies of fish oil show no effect on bleeding parameters. PC-SPES didn't interact with warfarin. It was ADULTERATED with warfarin. I could go on with other errors and misleading statements .

As a medical informaticist and the former director of Merck's scientific research libraries where we prided ourselves on the proven ability to perform comprehensive searches of the world's scientific literature (even the very obscure) for our scientists, I likely would not have missed existing clinical trials in the literature. Exactly what kind of people, and with what credentials, are the MEC's hiring?

Finally, it didn't take a genius to find the name of the company and drug even though no names were used in the JGIM article. The following google searches based on phrases from the article are very revealing: A search on anticoagulant+orthopedic+surgery+france shows "Exanta" as the third hit and the linked article indicates A-Z as the maker; a search on exanta+fda+hepatotoxicity pretty much confirms this drug as the one mentioned in the articles.

Much like in recent politics, the "World Library Computer" formed by the Internet and its search engines makes concealing certain business activities much harder than in the past.

Addendum: In the Guardian article "Not in my name" it is written that AstraZenica said:

Most pharmaceutical companies, including AstraZeneca, use professional writers to assist in manuscript development, when the named authors lack the time or expertise to produce a well-written publication."

I thought having the expertise to produce well-written, primary-author publications was a major criteria for academic credibility, recognition and advancement. However, we seem to now be discovering that like many other corporate functions, it's simply viewed as a skillset to be outsourced to increase profit.

Incredible.

-- SS

Princess Health and Ghosts Busted. Princessiccia

Princess Health and Ghosts Busted. Princessiccia

ghost writing

Gusty 08:43 Add Comment

The Journal of General Internal Medicine (JGIM) has released early a very important article about how pharmaceutical companies infiltrate the peer-reviewed medical literature and use it as a marketing tool.
The whistle-blowing article by Dr. Adriane Fugh-Berman recounts how the author was approached to serve as the front author on a manuscript already written by a "medical education company" on behalf of a pharmaceutical company. The manuscript purported to be a review of interactions between warfarin and herbal remedies. The manuscript was provided to Dr. Fugh-Berman in essentially complete form, with her name on the first page as first author. The pharmaceutical company that sponsored the writing of this manuscript had developed a new oral anti-coagulant, already approved for use in France, and with a New Drug Application pending before the US Food and Drug Administration (FDA). Presumably, the company expected that the new drug would compete with warfarin. Thus, the apparent goal of the manuscript was to disparage warfarin, the drug with which the pharmaceutical company's new product would compete.
Dr. Fugh-Berman rejected the offer from the medical education company. As luck would have it, however, the company recruited another front author, who submitted the manuscript to the Journal of General Internal Medicine, who in turn forwarded the article to Dr. Fugh-Berman as a peer-reviewer. When she recognized the manuscript for what it was, she notified the journal editors.
Prompted by this incident, Dr. Fugh-Berman began investigating the relationships among pharmaceutical and biotechnology companies and medical education companies. Based on this investigation, she made the following points:

• "Pharmaceutical companies routinely seed medical literature with revews or commentaries that advantageously frame a marketed drug, but some sponsored articles never mention the targeted drug."
• "Companies regularly fund articles and talks that never mention the targeted drug, but are meant to disadvantage the competition."
• "Articles are usually written by a medical education company (MEC) that receives funding from the pharmaceutical company."
• " Academic physicians are recruited to sign these articles. The division of labor for such acorporate-sponsored article is rarely equal: although the signed author is invited to make changes, the primary obligation of the academic coauthor is to claim authorship."
• "The primary author from the MEC remains anonymous, and any instructions given to the primary author regarding tone or emphasis are not shared with the named author."
• "True incidence of corporate ghost authorship is unknown: anecdotally, many of my colleagues who speak at national meetings have been approached with such offers."
• "The placement of articles in peer-reviewed journals is a valued marketing technique. For example, an industry conference, titled "Publication Planning 2003: Utilizing ScientificallyAccurate, Commercially Relevant Strategies for Optimal Drug Exposure" had a conference brochure that stated, "'For a manufacturer, having research published in a highly regarded peer review [sic] medical journal or presented at a leading conference is desirable.'" One workshop described changes in how pharmaceutical companies handle publishing so that "'These changes have seen publications shift from being an academic, data-driven pursuit to adopting a message-driven model that is part of a broader communication strategy and integral to pharmaceutical life-cycle management.'"

So, to summarize up to this point: Corporations, including but not necessarily only pharmaceutical corporations, may use the peer-reviewed medical literature as a marketing tool. To disguise their intent, they work through medical education companies, who ghost write articles in a "message-driven model," and then recruit academics to serve as front authors for them. The articles may be published without acknowledging who really wrote them, nor what their intent really was.
Dr. Fugh-Berman has done us the important service of describing a previously undisclosed kind of attack on the scientific basis of medical practice.
An accompanying editorial in JGIM called the events described by Dr. Fugh-Berman "an egregious case of unethical behavior by an author, a pharmaceutical manufacturer, and a medical education company." Furthermore, it charged "Publishing biased literature is not simply 'getting the message out' for the pharmaceutical client of the medical education company. It injects bias and untruth into the scientific dialogue in order to enhance corporate profits." "How much is sullying the medical literature worth in market share?"
The editorial noted that JGIM has changed its policy to require all real authors of articles to be acknowledged, and all financial arrangements among authors and other interested parties to be revealed. Apparently, the World Association of Medical Editors (WAME) will also be similarly changing their policy.
Dr. Fugh-Berman went further, suggesting developing a "publicly available, regularly updated database of conflicts of interest and ethical transgressions." "And we need a mechanism foracademicians to expose the more subtle strategies used by drug companies to affect prescribing."
In my humble opinion, the issues are even more global, and the strategies needed to combat thisegregious assault on the scientific basis of medical practice need to be broader as well.

• The scope of this practice, as Dr. Fugh-Berman noted, is unclear. We cannot assume that its use is restricted only to pharmaceutical companies. We have seen that mismanagement and unethical behavior occurs in a variety of health care organizations. It is therefore quite possible that organizations other than pharmaceutical companies use stealth techniques to inject marketing and propaganda into the scientific literature.
• Although revising journal policies is a worthwhile first step, it is doubtful that asking authors who have already agreed to front for ghost authors to tell the truth will have much effect.
• Dr. Fugh-Berman's call for a database of conflicts of interest and ethical transgressions and to facilitate whistle-blowing about them are excellent ideas. One could view Health Care Renewal as a crude first attempt to develop such a database and such a mechanism.
• We need to develop watch-dog organizations within health care to cope with what now seems an epidemic of mismanagement, conflicts of interests, dishonesty, unethical behavior, and outright crime and corruption. Main-line medical organizations have so far been reluctant to step into this fray, but maybe they can be persuaded. If not, we need to develop new organizations to fight external attacks on medical professsionalism.

Note: thanks to Revere for first publicizing the JGIM article on Effect Measure. His comments are here.
Addendum: Dr. Fugh-Berman today also published a commentary in the Manchester Guardian on this case. In it, she names names, which she did not do in her JGIM article. The medical education was the British RxComms. On its web-site is the statement that RxComms writes "everything from abstracts to full manuscripts; from clinical trial reports to sales aids and slide kits." The pharmaceutical company was AstraZeneca, and the drug they hoped would compete with warfarin was ximelagatran. Dr. Fugh-Berman noted that RxComms claimed that the manuscript sent to her was actually written by the person named as first author in the version sent to JGIM. AstraZeneca claimed that it follows strict guidelines that require authors to take responsbility of the content of the articles they write. Nonetheless, "Most pharmaceutical companies, including AstraZeneca, use professional writers to assist in manuscript development, when the named authors lack the time or expertise to produce a well-written publication."

Princess Health and Ghosts Busted.Princessiccia

Princess Health and Ghosts Busted.Princessiccia

ghost writing

Gusty 08:43 Add Comment

The Journal of General Internal Medicine (JGIM) has released early a very important article about how pharmaceutical companies infiltrate the peer-reviewed medical literature and use it as a marketing tool.
The whistle-blowing article by Dr. Adriane Fugh-Berman recounts how the author was approached to serve as the front author on a manuscript already written by a "medical education company" on behalf of a pharmaceutical company. The manuscript purported to be a review of interactions between warfarin and herbal remedies. The manuscript was provided to Dr. Fugh-Berman in essentially complete form, with her name on the first page as first author. The pharmaceutical company that sponsored the writing of this manuscript had developed a new oral anti-coagulant, already approved for use in France, and with a New Drug Application pending before the US Food and Drug Administration (FDA). Presumably, the company expected that the new drug would compete with warfarin. Thus, the apparent goal of the manuscript was to disparage warfarin, the drug with which the pharmaceutical company's new product would compete.
Dr. Fugh-Berman rejected the offer from the medical education company. As luck would have it, however, the company recruited another front author, who submitted the manuscript to the Journal of General Internal Medicine, who in turn forwarded the article to Dr. Fugh-Berman as a peer-reviewer. When she recognized the manuscript for what it was, she notified the journal editors.
Prompted by this incident, Dr. Fugh-Berman began investigating the relationships among pharmaceutical and biotechnology companies and medical education companies. Based on this investigation, she made the following points:

• "Pharmaceutical companies routinely seed medical literature with revews or commentaries that advantageously frame a marketed drug, but some sponsored articles never mention the targeted drug."
• "Companies regularly fund articles and talks that never mention the targeted drug, but are meant to disadvantage the competition."
• "Articles are usually written by a medical education company (MEC) that receives funding from the pharmaceutical company."
• " Academic physicians are recruited to sign these articles. The division of labor for such acorporate-sponsored article is rarely equal: although the signed author is invited to make changes, the primary obligation of the academic coauthor is to claim authorship."
• "The primary author from the MEC remains anonymous, and any instructions given to the primary author regarding tone or emphasis are not shared with the named author."
• "True incidence of corporate ghost authorship is unknown: anecdotally, many of my colleagues who speak at national meetings have been approached with such offers."
• "The placement of articles in peer-reviewed journals is a valued marketing technique. For example, an industry conference, titled "Publication Planning 2003: Utilizing ScientificallyAccurate, Commercially Relevant Strategies for Optimal Drug Exposure" had a conference brochure that stated, "'For a manufacturer, having research published in a highly regarded peer review [sic] medical journal or presented at a leading conference is desirable.'" One workshop described changes in how pharmaceutical companies handle publishing so that "'These changes have seen publications shift from being an academic, data-driven pursuit to adopting a message-driven model that is part of a broader communication strategy and integral to pharmaceutical life-cycle management.'"

So, to summarize up to this point: Corporations, including but not necessarily only pharmaceutical corporations, may use the peer-reviewed medical literature as a marketing tool. To disguise their intent, they work through medical education companies, who ghost write articles in a "message-driven model," and then recruit academics to serve as front authors for them. The articles may be published without acknowledging who really wrote them, nor what their intent really was.
Dr. Fugh-Berman has done us the important service of describing a previously undisclosed kind of attack on the scientific basis of medical practice.
An accompanying editorial in JGIM called the events described by Dr. Fugh-Berman "an egregious case of unethical behavior by an author, a pharmaceutical manufacturer, and a medical education company." Furthermore, it charged "Publishing biased literature is not simply 'getting the message out' for the pharmaceutical client of the medical education company. It injects bias and untruth into the scientific dialogue in order to enhance corporate profits." "How much is sullying the medical literature worth in market share?"
The editorial noted that JGIM has changed its policy to require all real authors of articles to be acknowledged, and all financial arrangements among authors and other interested parties to be revealed. Apparently, the World Association of Medical Editors (WAME) will also be similarly changing their policy.
Dr. Fugh-Berman went further, suggesting developing a "publicly available, regularly updated database of conflicts of interest and ethical transgressions." "And we need a mechanism foracademicians to expose the more subtle strategies used by drug companies to affect prescribing."
In my humble opinion, the issues are even more global, and the strategies needed to combat thisegregious assault on the scientific basis of medical practice need to be broader as well.

• The scope of this practice, as Dr. Fugh-Berman noted, is unclear. We cannot assume that its use is restricted only to pharmaceutical companies. We have seen that mismanagement and unethical behavior occurs in a variety of health care organizations. It is therefore quite possible that organizations other than pharmaceutical companies use stealth techniques to inject marketing and propaganda into the scientific literature.
• Although revising journal policies is a worthwhile first step, it is doubtful that asking authors who have already agreed to front for ghost authors to tell the truth will have much effect.
• Dr. Fugh-Berman's call for a database of conflicts of interest and ethical transgressions and to facilitate whistle-blowing about them are excellent ideas. One could view Health Care Renewal as a crude first attempt to develop such a database and such a mechanism.
• We need to develop watch-dog organizations within health care to cope with what now seems an epidemic of mismanagement, conflicts of interests, dishonesty, unethical behavior, and outright crime and corruption. Main-line medical organizations have so far been reluctant to step into this fray, but maybe they can be persuaded. If not, we need to develop new organizations to fight external attacks on medical professsionalism.

Note: thanks to Revere for first publicizing the JGIM article on Effect Measure. His comments are here.
Addendum: Dr. Fugh-Berman today also published a commentary in the Manchester Guardian on this case. In it, she names names, which she did not do in her JGIM article. The medical education was the British RxComms. On its web-site is the statement that RxComms writes "everything from abstracts to full manuscripts; from clinical trial reports to sales aids and slide kits." The pharmaceutical company was AstraZeneca, and the drug they hoped would compete with warfarin was ximelagatran. Dr. Fugh-Berman noted that RxComms claimed that the manuscript sent to her was actually written by the person named as first author in the version sent to JGIM. AstraZeneca claimed that it follows strict guidelines that require authors to take responsbility of the content of the articles they write. Nonetheless, "Most pharmaceutical companies, including AstraZeneca, use professional writers to assist in manuscript development, when the named authors lack the time or expertise to produce a well-written publication."

Princess Health and State Senator Indicted for "Influence Peddling" to Health Care Organizations. Princessiccia

Princess Health and State Senator Indicted for "Influence Peddling" to Health Care Organizations. Princessiccia

bribery CVS Rhode Island Blue Cross Roger Williams Medical Center

Gusty 11:37 Add Comment

A follow-up of a complex local story in the Providence Journal: John Celona, a former Rhode Island State Senator, was just indicted by a state grand jury for using his public office for private gain (or, as the headline said, "influence peddling.")
He was charged with having three financial relationships with one for-profit and two not-for-profit corporations "while he was in a position to influence legislation of interest to these companies."
Relevant to this blog is that all three organizations are in health care. They are the CVS pharmacy chain, Rhode Island Blue Cross and Blue Shield, a not-for-profit health insurance and managed care organization (and by far the dominant such organization in the state), and Roger Williams Medical Center, a not-for-profit university affiliated medical center. Two counts of the indictment "alleged that Celona violated the state's Code of Ethics by accepting employment with Roger Williams Medical Center and CVS ... which 'did impair his independence of judgment'...." One count alleged that he "uses his public office 'to obtain financial gain' for himself and a TV production company... from Blue Cross."
Kim Keough, a Blue Cross spokesperson, said "obviously, the indictment surrounding Mr. Celona's actions are not allegations against Blue Cross whatsoever." CVS' written statement simply stated that the company "will continue to cooperate with any and all inquiries into this matter." Roger Williams declined comment.
The investigation is not yet over, and some matters may well be referred to a federal grand jury.
H. Philip West Jr, Executive Director of Common Cause of Rhode Island, said "Hopefully, this indictment and the trial will demonstrate to the public some of the ways that some lobbying groups have sought to compromise public officials. Until now, CVS and others who paid Celona have come through unscathed."
A brief Providence Journal editorial added, "Mr. Celona's trial might illuminate how special-interest groups use legislators to promote their interest. Meanwhile, people wonder what will happen to those who 'hired' Messrs. Celona and Irons [another State Senator who resigned under fire for accepting "broker commissions from Blue Cross]."
Providence Journal columnist M. Charles Bakst opined, "What about CVS, Blue Cross, and the Roger Williams Medical Center? These are the entities with which Celona is charged with striking private financial deals. If something smelly happened, isn't it reasonable to think they were as much a part of it as this prominent Democrate who chaired a top Senate committee? The public will find it hard to take if Celona lands in the slammer, but the folks he served, or who allowed themselves to be exploited, skate."
As we have noted before, Blue Cross in Rhode Island was known for its rapid premium increases, stingy payments to doctors, and recent lack of interest in maintaining a dialogue with health care professionals. Last year, its CEO resigned after his huge financial compensation package was revealed by the Providence Journal. It is gratifying that the civil authorities are now starting to address dubious relationships between large health care organizations and politicians. But where are the watchdogs within health care who could address how concentration and abuse of power damages patients and health care professionals?

Princess Health and State Senator Indicted for "Influence Peddling" to Health Care Organizations.Princessiccia

Princess Health and State Senator Indicted for "Influence Peddling" to Health Care Organizations.Princessiccia

bribery CVS Rhode Island Blue Cross Roger Williams Medical Center

Gusty 11:37 Add Comment

A follow-up of a complex local story in the Providence Journal: John Celona, a former Rhode Island State Senator, was just indicted by a state grand jury for using his public office for private gain (or, as the headline said, "influence peddling.")
He was charged with having three financial relationships with one for-profit and two not-for-profit corporations "while he was in a position to influence legislation of interest to these companies."
Relevant to this blog is that all three organizations are in health care. They are the CVS pharmacy chain, Rhode Island Blue Cross and Blue Shield, a not-for-profit health insurance and managed care organization (and by far the dominant such organization in the state), and Roger Williams Medical Center, a not-for-profit university affiliated medical center. Two counts of the indictment "alleged that Celona violated the state's Code of Ethics by accepting employment with Roger Williams Medical Center and CVS ... which 'did impair his independence of judgment'...." One count alleged that he "uses his public office 'to obtain financial gain' for himself and a TV production company... from Blue Cross."
Kim Keough, a Blue Cross spokesperson, said "obviously, the indictment surrounding Mr. Celona's actions are not allegations against Blue Cross whatsoever." CVS' written statement simply stated that the company "will continue to cooperate with any and all inquiries into this matter." Roger Williams declined comment.
The investigation is not yet over, and some matters may well be referred to a federal grand jury.
H. Philip West Jr, Executive Director of Common Cause of Rhode Island, said "Hopefully, this indictment and the trial will demonstrate to the public some of the ways that some lobbying groups have sought to compromise public officials. Until now, CVS and others who paid Celona have come through unscathed."
A brief Providence Journal editorial added, "Mr. Celona's trial might illuminate how special-interest groups use legislators to promote their interest. Meanwhile, people wonder what will happen to those who 'hired' Messrs. Celona and Irons [another State Senator who resigned under fire for accepting "broker commissions from Blue Cross]."
Providence Journal columnist M. Charles Bakst opined, "What about CVS, Blue Cross, and the Roger Williams Medical Center? These are the entities with which Celona is charged with striking private financial deals. If something smelly happened, isn't it reasonable to think they were as much a part of it as this prominent Democrate who chaired a top Senate committee? The public will find it hard to take if Celona lands in the slammer, but the folks he served, or who allowed themselves to be exploited, skate."
As we have noted before, Blue Cross in Rhode Island was known for its rapid premium increases, stingy payments to doctors, and recent lack of interest in maintaining a dialogue with health care professionals. Last year, its CEO resigned after his huge financial compensation package was revealed by the Providence Journal. It is gratifying that the civil authorities are now starting to address dubious relationships between large health care organizations and politicians. But where are the watchdogs within health care who could address how concentration and abuse of power damages patients and health care professionals?

Princess Health and "Crackdowns Can't Keep Pace as Scams Grow More Cunning". Princessiccia

Princess Health and "Crackdowns Can't Keep Pace as Scams Grow More Cunning". Princessiccia

Gusty 11:29 Add Comment

The San Francisco Examiner has published an investigative series on Medicare fraud. (The two articles are here and here.) The second summary article suggests that such fraud may be a far larger problem than has been heretofore documented.
Anecdotally, it cited a physician at a senior health whose patients started reporting incidents of potential fraud involving durable medical equipment. Despite her calls to Medicare and the Federal Bureau of Investigation in 2004, the case still has not been prosecuted.
Patrick Burns of Taxpayers Against Fraud, declared "There is so much fraud in the Medicare system that it is unbelievable. It is a tsunami of fraud. Yet we devote so little resources to it."
Malcolm Sparrow, from Harvard University, and author of License to Steal: How Fraud Bleeds America's Health Care System, said that the Medicare official estimate of fraud and abuse (a mere US $20 billion a year) is very low. Furthermore, he asserted that there are insufficient investigators and prosecutors to handle the problem.
Assistant US Attorney Connie Woodhead asserted, "Tell Congress to give us some help. There is a lot of crime, and relative to the amount of crime, not a lot of people to do the investigations."
My comments are that this just adds to our sense that there is far more mismanagement, unethical behavior, and outright crime in the health care system than many people realize. Such issues up to now have gotten little attention in the medical, health care and health policy literature. The civil authorities can address them, but clearly have insufficient resources. There is not yet any watchdog group within health care that patients, doctors, and other health care professionals can turn for help.

Princess Health and "Crackdowns Can't Keep Pace as Scams Grow More Cunning".Princessiccia

Princess Health and "Crackdowns Can't Keep Pace as Scams Grow More Cunning".Princessiccia

Gusty 11:29 Add Comment

The San Francisco Examiner has published an investigative series on Medicare fraud. (The two articles are here and here.) The second summary article suggests that such fraud may be a far larger problem than has been heretofore documented.
Anecdotally, it cited a physician at a senior health whose patients started reporting incidents of potential fraud involving durable medical equipment. Despite her calls to Medicare and the Federal Bureau of Investigation in 2004, the case still has not been prosecuted.
Patrick Burns of Taxpayers Against Fraud, declared "There is so much fraud in the Medicare system that it is unbelievable. It is a tsunami of fraud. Yet we devote so little resources to it."
Malcolm Sparrow, from Harvard University, and author of License to Steal: How Fraud Bleeds America's Health Care System, said that the Medicare official estimate of fraud and abuse (a mere US $20 billion a year) is very low. Furthermore, he asserted that there are insufficient investigators and prosecutors to handle the problem.
Assistant US Attorney Connie Woodhead asserted, "Tell Congress to give us some help. There is a lot of crime, and relative to the amount of crime, not a lot of people to do the investigations."
My comments are that this just adds to our sense that there is far more mismanagement, unethical behavior, and outright crime in the health care system than many people realize. Such issues up to now have gotten little attention in the medical, health care and health policy literature. The civil authorities can address them, but clearly have insufficient resources. There is not yet any watchdog group within health care that patients, doctors, and other health care professionals can turn for help.

Princess Health and 26-digit patient ID codes and other dumb ideas. Princessiccia

Princess Health and 26-digit patient ID codes and other dumb ideas. Princessiccia

Gusty 07:06 Add Comment

In the "awards for information technology that actually hinders patient care" category, this story takes strong honors.

My automobile has a 17-digit VIN (vehicle identification number). However, to some in managed care, even this is inadequate for patients. One payor has a nearly-unbelievable 26-digit patient identifier required for billing purposes. If this does not violate every precept of common sense human/machine interaction in busy clinical settings, I'm not sure what would.

As reported in "Magellan Health's procedures attacked", Philadelphia Inquirer, Wed, Apr. 20, 2005, The Pennsylvania Psychological Association blasted Magellan Health Services for what it called inefficient rules and bureaucratic roadblocks that it said keep Southeastern Pennsylvania patients from getting psychological care and therapists from getting paid.

Therapists have been dropped temporarily from Magellan's rolls for no apparent reason, and communication with the company is so slow it's sometimes impossible to meet deadlines, the association said in a report released to the public. Magellan assigns each patient a 26-digit code, which is difficult to type properly and has caused many bills to be rejected, psychologists said. Magellan manages mental-health services for the region's two dominant private insurers, Independence Blue Cross and Aetna Inc.

(Note: for the mathematically-minded, a 26-digit number could be used to uniquely identify over 99 septillion individuals - that's 99,999,999,999,999,999,999,999,999 - and many, many more if alphanumerics are allowed!)

The article goes on to state:

Sam Knapp, director of professional affairs for the psychological association, said it was the first time his group had taken this kind of action. "The only reason we did it is because the quality of administrative services just became horrible in the last six months," he said. "It was never that great." The company's procedures, he said, "waste money and they disrupt patient treatment."

Magellan controls mental-health treatment for virtually all of the private HMO market in the region, and also manages care for many employer-operated plans and for Medicaid patients in Bucks, Delaware and Montgomery Counties.

... Rep. Dennis O'Brien (R., Phila.), chairman of the state House Judiciary Committee, said yesterday that he hoped to hold hearings next month on issues raised in the report. "I have some real concerns with Magellan," he said. "I think there's enough questions here that we'll bring people in and we'll let them tell the story."

... The psychological association report focused on problems in four areas: authorization to provide care, which is required before bills will be paid; credentialing or approval of therapists for an insurance company's network, also a billing requirement; billing itself; and appeals of denied care.

The report was based on a random survey responded to by 73 Philadelphia-area psychologists in Magellan networks, plus discussions with psychologists who work with the company ... The psychologists told the association that 30 percent to 35 percent of their budgets go to satisfying insurance company demands.

Tom Whiteman, a psychologist who directs Life Counseling Services, a practice with 100 therapists in Pennsylvania and New Jersey, said Magellan controlled 90 percent of his business. He has one full-time worker who does nothing but pursue denied claims.

Something as benign as a therapist's marriage can upset billing for months, he said in an interview. He tells employees never to change their names. "It can take them six months to change you in the computer," he said. "In the meantime, every claim will be denied."

... Vince Bellwoar, a psychologist who runs a large group practice based in Delaware County, said it took Magellan six weeks to kick back one report because a therapist had forgotten to write in the patient's birth date. When that was corrected, it took the company three days to reject the claim because it was late. Eventually, Bellwoar's group got some of its money.

This kind of thing wears on therapists, Bellwoar said. "These aren't huge obstacles. These are hurdles, but after a while you just want to stop jumping over the hurdles, and the patients want to stop jumping over the hurdles."

The company defended its practices. "We're very proud of our track record in Pennsylvania and around the country," spokeswoman Erin Somers said. The company has tried to enhance "services and operations" in the last two years, and "the feedback that we've gotten from our stakeholders... has been very positive in a majority of cases."

Such widely-divergent reports leave me skeptical. Considering the implications of implementing a 26-digit identifier as a starting point of the claims and reimbursement processes, I'd tend to find the quoted practitioners' complaints more credible.

In any case, ill-conceived and implemented information technology that requires an easily-corrupted 26-digit patient identifier and six months to change a name of a provider employee for billing purposes, and processes that require practice owners to have full-time employees to work on denials and expend a third of their budgets for insurance paperwork and other administrivia, simply have no place in modern healthcare. This seems a prime example of bureaucrats living parastically off of clinicians, sucking their lifeblood.

-- SS