The Washington Post ran a follow-up on the story of how US Health and Human Services Secretary Leavitt appeared to be encouraging people to sign living wills in order to save Medicare money. (See our previous post here.)
The follow-up includes comments from several experts, including the National Institutes of Health Bioethics Chair Ezekiel Emanuel, denying that living wills in fact would save much money. Ezekiel said, "I'm a big advocate of living wills because they give people the power to make decisions." However, "I am not a big advocate of living wills because they save money." (We have mentioned Emanuel before, in his role as an advocate for relaxing the proposed NIH conflict of interest rules.)
Leavitt appeared to retreat a bit too. A spokesperson said that he "regrets if the comment was inaccurate. He did not intend to link living wills to the issue of costs."
Fair enough. There may be little evidence that living wills save money.
What is lacking in these responses is any concern that the highest ranking US health official apparently urged the elderly to accept less health care because he thought it would save the US government money. One editorialist did allow that Leavitt's speech sounded "ghoulish." Worse, it seems on the slippery slope towards the government labeling certain citizens as undeserving of health care.
Friday, May 06, 2005
Congressional Hearings on Misleading Marketing of Vioxx
Yet more bad news about Merck, in addition to the issues summarized in our recent post about the resignation of its CEO...
There is an excellent summary, which includes multiple relevant links, from the Kaiser Foundation daily Health Policy Report of the results of a US House of Representatives Committee investigation into how Merck marketed Vioxx. In short, the Committee charged that Merck trained its sales representatives to distract physicians from any concerns they had about Vioxx's adverse effects, and especially from the published results of the VIGOR trial that showed that Vioxx was associated with a higher risk of cardiovascular events then was naproxen. Representatives were instructed not to bring up the trial, and if asked about it, to refuse to discuss it.
The report concluded, "when concerns about Vioxx's safety arose, Merck appeared to use this highly trained force to present a misleading picture to physicians about the drug's cardiovascular risks."
It is tragic how a company once known for good science and good ethics descended to this level.
Undoubtably, this sort of dishonesty has had bad effects on patients, physicians, and the whole health cares system.
I'm still waiting for health care researchers to become interested in how concentration and abuse of power, and the resulting perverse financial incentives; cross-fires and double-binds; deception, disinformation, and propaganda; and coercion and intimidation have hurt patients, physicians, and the health care system.
But it's certainly time for more physicians, at least, to raise their weary heads from the trenches and start protesting these sorts of abuses. If we don't speak up, who will?
There is an excellent summary, which includes multiple relevant links, from the Kaiser Foundation daily Health Policy Report of the results of a US House of Representatives Committee investigation into how Merck marketed Vioxx. In short, the Committee charged that Merck trained its sales representatives to distract physicians from any concerns they had about Vioxx's adverse effects, and especially from the published results of the VIGOR trial that showed that Vioxx was associated with a higher risk of cardiovascular events then was naproxen. Representatives were instructed not to bring up the trial, and if asked about it, to refuse to discuss it.
The report concluded, "when concerns about Vioxx's safety arose, Merck appeared to use this highly trained force to present a misleading picture to physicians about the drug's cardiovascular risks."
It is tragic how a company once known for good science and good ethics descended to this level.
Undoubtably, this sort of dishonesty has had bad effects on patients, physicians, and the whole health cares system.
I'm still waiting for health care researchers to become interested in how concentration and abuse of power, and the resulting perverse financial incentives; cross-fires and double-binds; deception, disinformation, and propaganda; and coercion and intimidation have hurt patients, physicians, and the health care system.
But it's certainly time for more physicians, at least, to raise their weary heads from the trenches and start protesting these sorts of abuses. If we don't speak up, who will?
Thursday, May 05, 2005
How About A Drugmaker for Merck?
In many of my writings and postings I've called for leadership of clinical IT by people who understand both medicine and computing. The same requirement for domain expertise holds true for all areas of healthcare.
It seems Forbes understands the concept of leaders actually knowing what they're leading. In my mind, 1,000 generic people following the finest of process will aways be outperformed by one person who actually knows what they're doing (i.e., has expertise in their domain).
How About A Drugmaker for Merck?
David A. Andelman, 05.05.05, 1:45 PM ET
Then again, another industry observer writes:
-- SS
It seems Forbes understands the concept of leaders actually knowing what they're leading. In my mind, 1,000 generic people following the finest of process will aways be outperformed by one person who actually knows what they're doing (i.e., has expertise in their domain).
How About A Drugmaker for Merck?
David A. Andelman, 05.05.05, 1:45 PM ET
I agree.It's all about the buzz. A flashy resume and some star quality seem to be the most sought-after line on executive résumés these days when it comes to choosing a new leader for a company in trouble. The latest example is Richard Clark, onetime head of Merck pharmacy spinoff Medco. While he has a long tenure at the parent company, most of it was in marketing and manufacturing. He left new drug creation to others. Just like longtime Merck CEO Raymond Gilmartin, an electrical engineer by training, Clark will be leaning heavily on Merck's chief of research, Peter Kim, for the next generation of drugs that may help to put the Vioxx catastrophe behind the drugmaker.
Indeed, investors seemed underwhelmed by the choice. Merck shares were off a dime at midday Thursday. Whatever happened to the old corporate model--in which the guy who ran the company at least understood the ingredients of what it was making? Steve Jobs and his partner Steve Wozniak are legendary for cobbling together their first Apple in a Silicon Valley garage, not far from the garage where David Packard and William Hewlett had already launched Hewlett-Packard.
Bill Gates got his start writing software code in his dorm room at Harvard before he decided he'd be better off doing that for a living rather than going for a diploma. Jobs managed, by sheer genius and force of personality, or perhaps by transmogrification into a marketer, to avoid having someone hijack his company. Packard and Hewlett weren't quite so lucky. Their idea had to suffer through the hubris of a marketing guru named Carly Fiorina--and we all know what happened to her.
(Other examples cited)
... The moral of this story? It's the medium, not the message. Matching the man or woman with the mission is the essence of success in the corporate suite. In the final analysis, the prescription Merck [and other pharmas] really needs just may be someone who knows how to create drugs.
Then again, another industry observer writes:
Noting that Mr. Clark does not have a medical or research background, Dr. Moskowitz [David Moskowitz, an analyst with Friedman, Billings, Ramsey & Co.] added, “In the past, Merck’s pride came from its research labs; however, the choice for CEO may indicate a different focus.”This would likely mean acquisitions (or being acquired) rather than home-grown research. If this is true, it is a shame considering the historical reputation of the company as world-class research innovator. However, the recent closure of one of the two major internal science research libraries would fit with Moskowitz' analysis. (On the topic of leadership expertise, not long before the 2003 layoffs I had to explain to a computer executive with significant control over research support resources, including the libraries, why the discovery of the thiazide diuretics in the 1950's was so important.)
-- SS
Ghosts of Days Long Past
I have managed to track back the ghost-writing story to at least 1993.
In 1993, an editorial appeared in Lancet entitled "Ghost With a Chance in Publishing Undergrowth." (Anonymous. Ghost with a chance in publishing undergrowth. Lancet 1993; 342: 1498-99.) It clearly describes the ghost-writing phenomenon, "a typical sequence of events beigns with a publisher agreeing to prepare a review article for a drug company to 'raise awareness/profile' of a certain subject that is broadly related to the company's product. " Then, "a staff writer prepares the review to the sponsor's satisfaction, whereuponthe publishing house contacts a doctor with a special interest in the relevant topic to inquire whether he or she would like to be the guest author, subject to approval of the content, for an honorarium." The editorial noted, "negotiations between publishing house and guest author tend to be conducted over the telephone or in person. The final version, when submitted to the journal, may contain no clues about its origin. " Sounds familiar?
In 1994, an editorial in JAMA warned, "there are ghosts lurking in the bylines - shadowy figures who, increasingly, are in fact the actual writers (the authors, some old-fashioned folk would say) of what we editors receive." (Rennie D, Flanigin A. Authorship! authorship! guests, ghosts, grafters and the two-sided coin. JAMA 1994; 271: 469-470.)
A letter in response to the JAMA article briefly described a case very similar to the one Dr. Fugh-Berman described recently in the Journal of General Internal Medicine. (Kasper CK. Authorship! authorship! JAMA 1994; 271: 1904.) In reply, Rennie and Flanigin stated, "it should be obvious that this is both deceptive and disgraceful. The academic whose name appears on the printed paper, and on whose brow no laborious sweat has appeared, must surely know that the exchange of money takes place solely because the deception is seen by some company to be commercially worthwhile."
However, despite these earlier warnings, the practice of ghost-writing seems to have continued, and now involves not only editorials and reviews, but also reports of original research. The practice remains deceptive and disgraceful, and not only the physicians and scientists who serve as "guest authors," but also the shadowy legions of ghost-writers and their even more shadowy sponsors should be ashamed of it.
In 1993, an editorial appeared in Lancet entitled "Ghost With a Chance in Publishing Undergrowth." (Anonymous. Ghost with a chance in publishing undergrowth. Lancet 1993; 342: 1498-99.) It clearly describes the ghost-writing phenomenon, "a typical sequence of events beigns with a publisher agreeing to prepare a review article for a drug company to 'raise awareness/profile' of a certain subject that is broadly related to the company's product. " Then, "a staff writer prepares the review to the sponsor's satisfaction, whereuponthe publishing house contacts a doctor with a special interest in the relevant topic to inquire whether he or she would like to be the guest author, subject to approval of the content, for an honorarium." The editorial noted, "negotiations between publishing house and guest author tend to be conducted over the telephone or in person. The final version, when submitted to the journal, may contain no clues about its origin. " Sounds familiar?
In 1994, an editorial in JAMA warned, "there are ghosts lurking in the bylines - shadowy figures who, increasingly, are in fact the actual writers (the authors, some old-fashioned folk would say) of what we editors receive." (Rennie D, Flanigin A. Authorship! authorship! guests, ghosts, grafters and the two-sided coin. JAMA 1994; 271: 469-470.)
A letter in response to the JAMA article briefly described a case very similar to the one Dr. Fugh-Berman described recently in the Journal of General Internal Medicine. (Kasper CK. Authorship! authorship! JAMA 1994; 271: 1904.) In reply, Rennie and Flanigin stated, "it should be obvious that this is both deceptive and disgraceful. The academic whose name appears on the printed paper, and on whose brow no laborious sweat has appeared, must surely know that the exchange of money takes place solely because the deception is seen by some company to be commercially worthwhile."
However, despite these earlier warnings, the practice of ghost-writing seems to have continued, and now involves not only editorials and reviews, but also reports of original research. The practice remains deceptive and disgraceful, and not only the physicians and scientists who serve as "guest authors," but also the shadowy legions of ghost-writers and their even more shadowy sponsors should be ashamed of it.
Merck CEO Quits
Merck CEO Raymond V Gilmartin has just announced his resignation. The new CEO will be Richard Clark. Clark first served as a quality control inspector in 1972, then joined management. He was President of Medco Health from 2000 to 2002, and then CEO until 2003. His most recent job was head of Merck's manufacturing division. (See typical reports in the NY Times and TheStreet.com.)
We have previously posted about Merck's questionable marketing strategies for the promotion of Vioxx (here), how it attempted to discredit reports of Vioxx's adverse effects (here), how it oversold Vioxx as a first-line analgesic, thus exposing more patients to its risks (here), and most recently, how the published report of a key trial of Vioxx was ghost-written (here). Thus, Gilmartin's resignation seems the honorable thing to do.
The question is now whether Clark, who evidently has no clinical or scientific experience, will be able to restore Merck's once pristine ethical reputation. We hope he does.
We have previously posted about Merck's questionable marketing strategies for the promotion of Vioxx (here), how it attempted to discredit reports of Vioxx's adverse effects (here), how it oversold Vioxx as a first-line analgesic, thus exposing more patients to its risks (here), and most recently, how the published report of a key trial of Vioxx was ghost-written (here). Thus, Gilmartin's resignation seems the honorable thing to do.
The question is now whether Clark, who evidently has no clinical or scientific experience, will be able to restore Merck's once pristine ethical reputation. We hope he does.
Minnesota Hospital Systems Agree Not to Charge Some Uninsured Patients More than the Insured
USA Today reports that Minnesota Attorney General Mike Hatch has obtained agreements from four hospital systems not to charge uninsured patients with household incomes less than $125 K more than the discounted rates given large insurers. Hatch had threatened to sue the four systems, Allina, North Memorial, Park Nicollet, and HealthEast Care, and had called their policies of charging uninsured patients higher rates than those given to insured patients "consumer fraud." Hatch had previously gotten a similar agreement from Fairview Health Systems.
This seems to be a hopefully the beginning of a trend. However, it is upsetting that many not-for-profit hospitals and hospital systems still seem to be charging uninsured patients, who are often poor, much more than the rates they negotiate with big managed care organizations.
This seems to be a hopefully the beginning of a trend. However, it is upsetting that many not-for-profit hospitals and hospital systems still seem to be charging uninsured patients, who are often poor, much more than the rates they negotiate with big managed care organizations.
Two 'Perspective' Pieces in NEJM for 05-05-05
With enormous pleasure I have just read the 05-05-05 number of the New England Journal of Medicine. The journal's innovations, including 'front-ending' the so-called 'Perspectives' writings, here clearly pay off.
It is surely no accident that Aneez Esmail's piece, 'Physician as serial killer,' on the UK's good Dr. Shipman--surreptitious killer of well over 200 elderly patients between 1970 and 1998--and Abraham Verghese's piece, 'The calling,' on the physician as reader, appear back to back.
The issue in both cases is our old bugabear of 'professionalism,' refracted through the classic dual prisms of regulation and the self made man. Nurture versus nature.
Verghese wins.
Esmail calls for more regulation--otherwise how to 'equalize the power imbalance'?--but doesn't really say how to make such a thing work. In these blogger pages we have seen just how well the watchdogs perform. Do cattle chutes make better cattle?
On the other hand, Verghese's essay is enormously winning and worth a read by anyone who wants to understand what true professionalism is all about. This, from the pen of a writer brave enough--huzzah!--to call the usual pabulum by what is really is.
'I have marveled,' notes Verghese, 'at the way in which selected fiction discussed in a medical school class effectively conveys the tenets of professionalism and multiculturalism without ever invoking those soporific words.'
Indeed, the whole push to codify, regulate, and legislate 'professionalism' strikes us as just another bloviation in the ongoing Pogo Revolution in healthcare. My recommendation: the astute Dr. Verghese, or someone like him, should be the next Flexner. The prognosis for this happening: well, what day is it today and how do you feel today?
It is surely no accident that Aneez Esmail's piece, 'Physician as serial killer,' on the UK's good Dr. Shipman--surreptitious killer of well over 200 elderly patients between 1970 and 1998--and Abraham Verghese's piece, 'The calling,' on the physician as reader, appear back to back.
The issue in both cases is our old bugabear of 'professionalism,' refracted through the classic dual prisms of regulation and the self made man. Nurture versus nature.
Verghese wins.
Esmail calls for more regulation--otherwise how to 'equalize the power imbalance'?--but doesn't really say how to make such a thing work. In these blogger pages we have seen just how well the watchdogs perform. Do cattle chutes make better cattle?
On the other hand, Verghese's essay is enormously winning and worth a read by anyone who wants to understand what true professionalism is all about. This, from the pen of a writer brave enough--huzzah!--to call the usual pabulum by what is really is.
'I have marveled,' notes Verghese, 'at the way in which selected fiction discussed in a medical school class effectively conveys the tenets of professionalism and multiculturalism without ever invoking those soporific words.'
Indeed, the whole push to codify, regulate, and legislate 'professionalism' strikes us as just another bloviation in the ongoing Pogo Revolution in healthcare. My recommendation: the astute Dr. Verghese, or someone like him, should be the next Flexner. The prognosis for this happening: well, what day is it today and how do you feel today?
Wednesday, May 04, 2005
US HHS Secretary Wants to Use Living Wills to Save Money
A brief story in the Washington Post about a speech given by the US Secretary of Health and Human Services, Mike Leavitt, to some "hospital administrators," about "incorporating living wills into Medicare consultations."
Leavitt said, "It may be that we could build into Medicare a means by which there was a consultation as part of the Medicare physical where the decision [by the patient to sign a living will] could be discussed and potentially made and ... it would not just save families anguish but would likely save the system a remarkable amount of money, allowing that money to be spent in other ways and other places."
The reporter added, "but presumably, if such a proposal is put in place, the government would not spend money keeping alive terminal patients who had filled out living wills rejecting life-prolonging medical care."
This is a despicable example of the slippery slope that having health care run by managers and bureaucrats puts us on. Of course, pressuring people to sign living wills would save money for the government, but at what moral cost?
Leavitt said, "It may be that we could build into Medicare a means by which there was a consultation as part of the Medicare physical where the decision [by the patient to sign a living will] could be discussed and potentially made and ... it would not just save families anguish but would likely save the system a remarkable amount of money, allowing that money to be spent in other ways and other places."
The reporter added, "but presumably, if such a proposal is put in place, the government would not spend money keeping alive terminal patients who had filled out living wills rejecting life-prolonging medical care."
This is a despicable example of the slippery slope that having health care run by managers and bureaucrats puts us on. Of course, pressuring people to sign living wills would save money for the government, but at what moral cost?
"The Catastrophic Collapse in Morale Among Doctors"
In the April 30 Lancet, a scathing editorial about the untoward influence of managers and politicians on British health care.
(Not available without a subscription, the citation is: Anonymous. The unspoken issue that haunts the UK general election. Lancet 2005; 365: 1515.)
Here are some key quotes:
(Not available without a subscription, the citation is: Anonymous. The unspoken issue that haunts the UK general election. Lancet 2005; 365: 1515.)
Here are some key quotes:
- "But sadly, Labour, Conservative, and Liberal Democrat politicians have failed to address the single most important factor hindering the improvement of health services - the catastrohic collapse in morale among doctors. Doctors at all levels within the NHS are utterly demoralised."
- "They are cynical about a new cadre of managers who have little clinical understanding but create a massively overmanaged health service. And they feel let down by their own leaders, who have consistently failed to articulate a positive and assertive vision about the contribution modern medicine makes to society."
- "What UK medicine needs is a new and stronger political voice, one that is more concerned with augmenting professional standards than with protecting professional status."
Another Multi-Million Dollar Managed Care CEO to Retire
It seems that whenever the CEO of a large health care organization is about to step down, the news media opens a tiny, but revealing window into how such organizations work.
The Boston Globe reports on the impending retirement of Blue Cross of Massachusetts CEO William C. Van Faasen. The interesting parts are that Van Faasen's qualifications to be CEO were an MBA degree from Michigan State. His "hand-picked" successor, Cleve L. Killingsworth, at least has a MPH from Yale. It is not clear, however, whether he ever directly worked in health care. His previous position was CEO of the Health Alliance Plan in Detroit.
The article also revealed Van Faasen's current compensation, most recently a cool $2.4 million a year, "making him by far the highest paid chief executive of any of the state's major health insurers." (Recall that the CEO of Harvard Pilgrim only makes a paltry $1 million a year, as we mentioned earlier.)
It's funny that with all the concerns about the rising costs of health care, few question whether managed care CEOs with little health care background and million dollar plus salaries are the best qualified people to figure out how to control health care costs without further impacting quality and access.
The Boston Globe reports on the impending retirement of Blue Cross of Massachusetts CEO William C. Van Faasen. The interesting parts are that Van Faasen's qualifications to be CEO were an MBA degree from Michigan State. His "hand-picked" successor, Cleve L. Killingsworth, at least has a MPH from Yale. It is not clear, however, whether he ever directly worked in health care. His previous position was CEO of the Health Alliance Plan in Detroit.
The article also revealed Van Faasen's current compensation, most recently a cool $2.4 million a year, "making him by far the highest paid chief executive of any of the state's major health insurers." (Recall that the CEO of Harvard Pilgrim only makes a paltry $1 million a year, as we mentioned earlier.)
It's funny that with all the concerns about the rising costs of health care, few question whether managed care CEOs with little health care background and million dollar plus salaries are the best qualified people to figure out how to control health care costs without further impacting quality and access.
Celebrity Endorsements for Cancer Screening
After a brief lull, things are getting interesting again....
Just out in the Journal of the National Cancer Institute is an article by the VA Outcomes Group from Vermont about celebrity endorsements of cancer screening. Briefly, the results of the study survey showed that about two-thirds of respondents recalled seeing particular celebrities endorsing cancer screening (e.g., men older than 50 were asked about seeing Norman Schwarzkpopf endorsing PSA screening for prostate cancer). Of those who recalled seeing a particular celebrity, about a quarter said that this exposure made them more likely to get screened.
The problems here are that decisions about cancer screening are sometimes complex, and it isn't always completely obvious that celebrity endorsed screening should be universal. In particular, there is quite a bit of doubt that PSA screening is generally beneficial. Yet celebrity endorsements "typically consist of one-sided messages that either assert that the celebrity's life was saved by a cancer screening test ... or suggest that the life of a loved one was lost due to failure to be screened."
The article concludes, "when it comes to communicating about complex decisions such as cancer screening, the goal should not be to persuade but to inform. Thus, we see no obvious role for celebrity endorsement of cancer screening."
But of course it is the poor primary care physician who will be stuck with the task of informing patients that the simplistic message they saw about screening on TV may not be the whole story. Caught in the cross-fire once again.
Just out in the Journal of the National Cancer Institute is an article by the VA Outcomes Group from Vermont about celebrity endorsements of cancer screening. Briefly, the results of the study survey showed that about two-thirds of respondents recalled seeing particular celebrities endorsing cancer screening (e.g., men older than 50 were asked about seeing Norman Schwarzkpopf endorsing PSA screening for prostate cancer). Of those who recalled seeing a particular celebrity, about a quarter said that this exposure made them more likely to get screened.
The problems here are that decisions about cancer screening are sometimes complex, and it isn't always completely obvious that celebrity endorsed screening should be universal. In particular, there is quite a bit of doubt that PSA screening is generally beneficial. Yet celebrity endorsements "typically consist of one-sided messages that either assert that the celebrity's life was saved by a cancer screening test ... or suggest that the life of a loved one was lost due to failure to be screened."
The article concludes, "when it comes to communicating about complex decisions such as cancer screening, the goal should not be to persuade but to inform. Thus, we see no obvious role for celebrity endorsement of cancer screening."
But of course it is the poor primary care physician who will be stuck with the task of informing patients that the simplistic message they saw about screening on TV may not be the whole story. Caught in the cross-fire once again.
Tuesday, May 03, 2005
Another Ghost Writing Update
Another update on ghost writing...
First, I have put below something by Ted Harding about how to find the report from the UK House of Commons committee that looked into ghost writing.
---------------------
To find the materials from the Health Select Committee, locate the relevant items here.
These are under "Reports":* 5 April 2005 Fourth Report- The Influence of the Pharmaceutical Industry
There are two parts to the Report:
HC 42-I The main Report
HC 42-II Appendices including transcripts of Oral evidence
This Report covers a lot more than the issue of "ghostwriting",which can be located in the section "Use of journals" on pages53(para 195)-55(para 201) of the main report HC 42-I, with references to evidence. It is clear that the Comittee deplores it, but apparently does not recommend specific regulatory action.
In the Introduction to Part II (HC 42-II), section "Promotion of Medicines to Professionals" (paras 4.14-4.22) there is reference to controls on what pharmaceutical companies may do in this area. Mostly this refers to sponsorship of meetings and people, andthe like, and does not explicitly refer to anything related to "ghostwriting". These controls come under Medicines (Advertising) Regulations1994 (regulation 21--inducements and hospitality), breach of which is a criminal offence. There is also reference to The MHRA Guidelines on Promotion and Advertising, which I have not consulted to see what they say about "ghostwriting."
Further evidence, some not printed in the Report, can be found here. Of these items, the "Supplementary memorandum by AstraZeneca(PI 33A)" (a follow-on to the PI 33 in the Report Pt II) has a section "Role of Professional Medical Writers" which sets out their asserted atttitude to "ghostwriting".
Under "Uncorrected Oral Evidence" see:
* 25 November 2004 The Influence of the Pharmaceutical Industry
* 2 December 2004 The Influence of the Pharmaceutical Industry
* 16 December 2004 The Influence of the Pharmaceutical Industry
* 13 January 2005 The Influence of the Pharmaceutical Industry
* 20 January 2005 The Influence of the Pharmaceutical Industry
* 7 February 2005 The Influence of the Pharmaceutical Industry
As can be seen from HC 42-I and HC 42-II, oral Evidence was infact taken from Thu 9 Sept 2004 onwards, but only the "raw" evidence from the 2004-5 session (7 Feb 2005 on) is available; there seems to be none on the 2003-4 website.
---------------------
Second, I found a 1997 report of an attempt to get a ghost written review article published, quite similar to that described by Dr. Fugh-Berman in the Journal of General Internal Medicine. The 1997 incident was documented in the journal Anesthesiology (Cullen DJ. Ghostwriting in scientific anesthesia journals. Anesthesiology 1997; 87: 195-196.) It can be found on the web by starting here.
In fact, the 1997 article includes earlier references (which I am trying to track down) which include yet another incident similar to the 1997 and current cases, but this time from 1993.
So, in summary, it seems that ghost writing is not a new problem, just one that has lurked below the radar for quite a while. This makes it all the more important to address it. Until we do, it will have a corrosive effect on our trust in the medical scientific literature.
First, I have put below something by Ted Harding about how to find the report from the UK House of Commons committee that looked into ghost writing.
---------------------
To find the materials from the Health Select Committee, locate the relevant items here.
These are under "Reports":* 5 April 2005 Fourth Report- The Influence of the Pharmaceutical Industry
There are two parts to the Report:
HC 42-I The main Report
HC 42-II Appendices including transcripts of Oral evidence
This Report covers a lot more than the issue of "ghostwriting",which can be located in the section "Use of journals" on pages53(para 195)-55(para 201) of the main report HC 42-I, with references to evidence. It is clear that the Comittee deplores it, but apparently does not recommend specific regulatory action.
In the Introduction to Part II (HC 42-II), section "Promotion of Medicines to Professionals" (paras 4.14-4.22) there is reference to controls on what pharmaceutical companies may do in this area. Mostly this refers to sponsorship of meetings and people, andthe like, and does not explicitly refer to anything related to "ghostwriting". These controls come under Medicines (Advertising) Regulations1994 (regulation 21--inducements and hospitality), breach of which is a criminal offence. There is also reference to The MHRA Guidelines on Promotion and Advertising, which I have not consulted to see what they say about "ghostwriting."
Further evidence, some not printed in the Report, can be found here. Of these items, the "Supplementary memorandum by AstraZeneca(PI 33A)" (a follow-on to the PI 33 in the Report Pt II) has a section "Role of Professional Medical Writers" which sets out their asserted atttitude to "ghostwriting".
Under "Uncorrected Oral Evidence" see:
* 25 November 2004 The Influence of the Pharmaceutical Industry
* 2 December 2004 The Influence of the Pharmaceutical Industry
* 16 December 2004 The Influence of the Pharmaceutical Industry
* 13 January 2005 The Influence of the Pharmaceutical Industry
* 20 January 2005 The Influence of the Pharmaceutical Industry
* 7 February 2005 The Influence of the Pharmaceutical Industry
As can be seen from HC 42-I and HC 42-II, oral Evidence was infact taken from Thu 9 Sept 2004 onwards, but only the "raw" evidence from the 2004-5 session (7 Feb 2005 on) is available; there seems to be none on the 2003-4 website.
---------------------
Second, I found a 1997 report of an attempt to get a ghost written review article published, quite similar to that described by Dr. Fugh-Berman in the Journal of General Internal Medicine. The 1997 incident was documented in the journal Anesthesiology (Cullen DJ. Ghostwriting in scientific anesthesia journals. Anesthesiology 1997; 87: 195-196.) It can be found on the web by starting here.
In fact, the 1997 article includes earlier references (which I am trying to track down) which include yet another incident similar to the 1997 and current cases, but this time from 1993.
So, in summary, it seems that ghost writing is not a new problem, just one that has lurked below the radar for quite a while. This makes it all the more important to address it. Until we do, it will have a corrosive effect on our trust in the medical scientific literature.
Friday, April 29, 2005
Lawmakers Seek Drug Safety Reform at FDA
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
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
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
Thursday, April 28, 2005
SEC Warns Tenet and Former Executives of Possible Lawsuit
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.
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.
Wednesday, April 27, 2005
DTC Ads for Antidepressants
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.
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.
Tuesday, April 26, 2005
Ghosts Busted: Another Update
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:
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."
Former Fletcher Allen Health Care CEO Sentenced for Conspiracy
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:
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.'"
- "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. "
- "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."
- "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."
Sunday, April 24, 2005
"Passionate CEO" Who "Fights the Dragons"
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."
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?
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.
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...."
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....
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.
NIH Dissidents Keep Fighting Conflict of Interest Rules
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?
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?
Some Evidence of the Rising Tide of Health Care Malfeasance
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.
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.
Ghosts Busted: Some Additional Sources
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."
/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."
More evidence of ghostwriting
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:
Just how "unusual" is this practice of ghost-writing in the pharmaceutical industry?
-- SS
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.
-- SS
Friday, April 22, 2005
Additional ghostbusting thoughts
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?
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:
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:
Incredible.
-- SS
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
Thursday, April 21, 2005
Ghosts Busted
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:
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.
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."
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.'"
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.
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."
Wednesday, April 20, 2005
State Senator Indicted for "Influence Peddling" to Health Care Organizations
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?
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?
"Crackdowns Can't Keep Pace as Scams Grow More Cunning"
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.
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.
26-digit patient ID codes and other dumb ideas
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:
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
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:
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."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."
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
Tuesday, April 19, 2005
"This Pricing is a Joke:" The $1275 Physical Therapy Session
A bizarre story about health care costs from the Miami Herald: A patient required hand physical therapy after a motor vehicle accident. She went to Palmetto General Hospital, owned by Tenet.
Because she was on a UnitedHealthCare policy which included a deductible and a 10% co-pay, she asked the hospital about how much a course of therapy would cost. After talking to at least one uncooperative functionary in the hospital's finance department, another told her the physical therapy would cost about $35 to $55 a session.
She first went for an evaluation and then had 11 additional sessions, the latter lasting around 45 minutes, sometimes one on one with a therapist, sometimes as part of a small group of patients with a therapist. So far, so good.
Then she started getting bills. For her first session, Palmetto General charged a whopping
$2713. With United's discount, this was reduced to a still whopping $1275. For her additional
sessions, charges ranged from $228 to $2454.
Palmetto General refused to respond to the Herald regarding the specifics of the case, but said "We support providing patients with meaningful information about the cost of health care."
UnitedHealthcare spokesman Roger Rollman also refused to respond directly about the case because of "privacy laws," (even though the patient had provided the Herald with her side of the story.) But Rollman did say "UnitedHealthcare strongly believes in transparency of hospital costs to the public."
Teri Bielefeld, the President of the Hand Rehabilitation Section of the American Physical Therapy Association responded to the story by saying, "my heart dropped. That's way out of range. That's incredible." She thought an evaluation session ought to cost around $200 and individual sessions around $50 per half an hour. Thus she thought "This pricing is a joke. Somebody needs to do something about it."
I'm not sure which is more amazing: that the hospital would charge thousands of dollars per
therapy session, or that UnitedHealthcare would be willing to pay these charges after a 50%
discount.
It is arguable that the major rationale for the rise of for-profit managed care organizations
like United was controlling costs. Such managed care organizations often have reputations for
being extremely tough on physician reimbursement, at least for cognitive and especially primary care services. This may be one reason that primary care physicians have an increasingly hard time just staying in businees, and why primary care is having an increasingly hard time attracting new trainees.
So why would a managed care organization with a reputation for fiscal toughness be willing to pay over a thousand dollars for a physical therapy session?
Because she was on a UnitedHealthCare policy which included a deductible and a 10% co-pay, she asked the hospital about how much a course of therapy would cost. After talking to at least one uncooperative functionary in the hospital's finance department, another told her the physical therapy would cost about $35 to $55 a session.
She first went for an evaluation and then had 11 additional sessions, the latter lasting around 45 minutes, sometimes one on one with a therapist, sometimes as part of a small group of patients with a therapist. So far, so good.
Then she started getting bills. For her first session, Palmetto General charged a whopping
$2713. With United's discount, this was reduced to a still whopping $1275. For her additional
sessions, charges ranged from $228 to $2454.
Palmetto General refused to respond to the Herald regarding the specifics of the case, but said "We support providing patients with meaningful information about the cost of health care."
UnitedHealthcare spokesman Roger Rollman also refused to respond directly about the case because of "privacy laws," (even though the patient had provided the Herald with her side of the story.) But Rollman did say "UnitedHealthcare strongly believes in transparency of hospital costs to the public."
Teri Bielefeld, the President of the Hand Rehabilitation Section of the American Physical Therapy Association responded to the story by saying, "my heart dropped. That's way out of range. That's incredible." She thought an evaluation session ought to cost around $200 and individual sessions around $50 per half an hour. Thus she thought "This pricing is a joke. Somebody needs to do something about it."
I'm not sure which is more amazing: that the hospital would charge thousands of dollars per
therapy session, or that UnitedHealthcare would be willing to pay these charges after a 50%
discount.
It is arguable that the major rationale for the rise of for-profit managed care organizations
like United was controlling costs. Such managed care organizations often have reputations for
being extremely tough on physician reimbursement, at least for cognitive and especially primary care services. This may be one reason that primary care physicians have an increasingly hard time just staying in businees, and why primary care is having an increasingly hard time attracting new trainees.
So why would a managed care organization with a reputation for fiscal toughness be willing to pay over a thousand dollars for a physical therapy session?
The Collapse of Reciprocal of America
From the New York Times: the story of the decline and fall of Reciprocal of America, a
malpractice insurer based in Richmond, VA, which sold a substantial number of policies in the
South and the Mid-West USA. The story documents the effects of the collapse on physicians,
hospitals, and patients. Some physicians were unable to effectively defend against malpractice
law-suits after their insurer went bankrupt. A few found themselves personally liable for
malpractice judgments, and risk personal bankruptcy. Many physicians lost malpractice coverage, and found that they had to pay more than they expected for new policies. Some hospitals also lost malpractice coverage and also found that new policies cost much more than they had budgeted. Some patients have yet to receive promised compensation.
The failure of Reciprocal was not due to simply bad luck, or even less than brilliant management. Its former CEO, Kenneth R. Patterson, and former Executive Vice President Carolyn B. Hudgins have pled guilty to federal fraud charges. The US Department of Justice is pursuing investigations of other individuals involved with the company.
The Times documents what may now sound like familiar stories of a "dizzying matric of offshore accounts, secret transactions and financial sleight of hand" with "deals in luxurious surroundings, even as Reciprocal itself was falling apart." In fact, the fall of Reciprocal is now linked to larger problems affectin companies such as General Re and American International Group.
Here is yet another story of shady managers of a large health care organization whose mismanagement was to the detriment of patients, doctors, and hospitals.
malpractice insurer based in Richmond, VA, which sold a substantial number of policies in the
South and the Mid-West USA. The story documents the effects of the collapse on physicians,
hospitals, and patients. Some physicians were unable to effectively defend against malpractice
law-suits after their insurer went bankrupt. A few found themselves personally liable for
malpractice judgments, and risk personal bankruptcy. Many physicians lost malpractice coverage, and found that they had to pay more than they expected for new policies. Some hospitals also lost malpractice coverage and also found that new policies cost much more than they had budgeted. Some patients have yet to receive promised compensation.
The failure of Reciprocal was not due to simply bad luck, or even less than brilliant management. Its former CEO, Kenneth R. Patterson, and former Executive Vice President Carolyn B. Hudgins have pled guilty to federal fraud charges. The US Department of Justice is pursuing investigations of other individuals involved with the company.
The Times documents what may now sound like familiar stories of a "dizzying matric of offshore accounts, secret transactions and financial sleight of hand" with "deals in luxurious surroundings, even as Reciprocal itself was falling apart." In fact, the fall of Reciprocal is now linked to larger problems affectin companies such as General Re and American International Group.
Here is yet another story of shady managers of a large health care organization whose mismanagement was to the detriment of patients, doctors, and hospitals.
Saturday, April 16, 2005
FDA Orders "My Man" Off the Air
See the Washington Post for the story that the US Food and Drug Administration (FDA) has ordered Bayer and GlaxoSmithKline to stop broadcasting their 15 second television advertisement for Levitra, apparently entitled "My Man." This is the ad in which an attractive actress purrs "in the mood for something different?" and then touts Levitra "is the best way to experience the difference."
As a "reminder," this ad should have only called attention to the drug, but not say how well the drug works or how to use it. The FDA contended instead that the ad violated this principle by claiming that Levitra would improve the female partner's sexual experience.
I will be perfectly happy not to have to watch that ad any more.
But Bayer and GlaxoSmithKline probably already got their money's worth from it.
Rather than depending on the FDA's ponderous bureaucracy, wouldn't a more effective way to counter such expansive advertising be to run counter-advertising based on the clinical research evidence? (For example, "Here is what we know Levitra does.... Here are its side-effects.... And here is what the ad claims that is not supported by any evidence....") Maybe managed care would find this a more effective way to decrease costs than twisting physicians' arms not to prescribe such expensive drugs.
As a "reminder," this ad should have only called attention to the drug, but not say how well the drug works or how to use it. The FDA contended instead that the ad violated this principle by claiming that Levitra would improve the female partner's sexual experience.
I will be perfectly happy not to have to watch that ad any more.
But Bayer and GlaxoSmithKline probably already got their money's worth from it.
Rather than depending on the FDA's ponderous bureaucracy, wouldn't a more effective way to counter such expansive advertising be to run counter-advertising based on the clinical research evidence? (For example, "Here is what we know Levitra does.... Here are its side-effects.... And here is what the ad claims that is not supported by any evidence....") Maybe managed care would find this a more effective way to decrease costs than twisting physicians' arms not to prescribe such expensive drugs.
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