Paging (and Paying) "Dr Coca-Cola"

A few weeks ago, the Los Angeles Times Booster Shots blog announced that "Dr. Coca-Cola will see you now," noting opposition to the recently revealed alliance between the Coca-Cola Company and the American Academy of Family Physicians:

[in] a sharply worded letter sent Wednesday to Dr. Douglas E. Henley, the academy’s chief executive.

'We urge the AAFP to regain its credibility by rejecting the deal with Coca-Cola,' the letter stated. 'If the AAFP declines to do that, we urge your organization to reassert its support for the public health (and its own independence) by supporting a warning label on caloric sugar-sweetened beverages and a federal tax on soft drinks to support health promotion or health insurance programs.'

The letter was signed by 22 doctors, nutritionists and health advocates,

Dr Henley was not moved:

Henley told Food Navigator-USA.com that the academy was aware of the letter. But he stood by the partnership with Coke.

'We will move forward with this commitment together by providing educational materials on sweeteners and how to maintain a healthy, active lifestyle while still enjoying many of the foods and beverages consumers love,' he said in a statement.

Nonetheless, criticism of the deal has continued. A Kansas City Star editorial said:

the Leawood-based American Academy of Family Physicians has set a poor example when it comes to resisting the lure of the soft drink industry.

The academy has accepted a grant from Coca-Cola, reportedly in the neighborhood of $500,000. It will use the money for educational materials about drinks and sweeteners for its consumer Web site, FamilyDoctor.org. Leftover funds will go into the academy’s general budget.

In return, Coca-Cola gets what? Legitimacy, for one thing. Consumers are less likely to consider a product unhealthy if it’s listed as a partner with a leading physicians’ alliance.

In a more shameful scenario, the soft drink manufacturer would succeed in muting the message that the academy puts out to its consumers.

The editorial did not buy Dr Henley's assurances:

Academy leaders say they won’t allow the hefty corporate grant to compromise the organization’s integrity.

'We have total editorial control, as we always have, of FamilyDoctor.org,' said Executive Vice President Douglas Henley.

Henley added, 'I would hope folks won’t rush to judgment but hold us to the content we’re going to put on FamilyDoctor.org.'

But consumers accessing that information will soon be informed that information about soft drinks is being sponsored in part by Coca-Cola, 'a proud partner of FamilyDoctor.org.'

That’s a mixed message, regardless of the content.

Meanwhile, family physician and AAFP member Dr Howard Brody noted on his Hooked: Ethics, Medicine and Pharma blog how AAFP leaders continued to obfuscate:

AAFP President Dr. Lori Heim: obesity is more complex and that 'there's no one evil out there.'

Why does the question of whether it's a good idea for AAFP to take money from Coke so quickly segue into the question of whether Coke is 'evil'? (For our blogger colleague who likes logical fallacies, Roy Poses, this sounds like "straw man." [It sure does - Editor]) Why does it have to be: either they are evil or else it's just fine for us to take their money? What cannot it simply be that they have different interests--they are trying to make a buck selling beverages (some of which I enjoy drinking myself, I am pleased to report, if they don't have calories in them) while AAFP is trying to protect the public interest through credible health education? What part of conflict of interest don't you understand?

Some AAFP members went beyond criticism, as reported by the AP:

Dr. William Walker, public health officer for Contra Costa County near San Francisco, likened the alliance with ads decades ago in which physicians said mild cigarettes are safe,

Walker has been a member of the academy for 25 years but quit last week. He said 20 other doctors who work with his local medical practice also quit because of the Coke deal.

Nonetheless, as Dr Brody later posted,

Sadly, if the responses to this news report from AAFP leadership are accurate, the AAFP still does not get it. '[AAFP CEO Dr. Douglas] Henley said the academy regrets the resignations and hopes other members will not 'rush to judgment' before seeing the new content." News flash: we don't need to see the content to know there's something rotten in Denmark. The deal itself raises concerns about the credibility of anything AAFP posts about diet and obesity from now on.

So here we have the latest variant on institutional conflicts of interest affecting medical associations. We have noted (e.g., here) how professional societies have blithely accepted substantial funding from corporations which sell products physicians may prescribe for or implant in patients. This raises concerns that professional societies have become drug and device marketers. This conflicts with physicians' prime directive, to put the interests of individual patients ahead of their own, and hence to base decisions on which drugs to prescribe, tests to order, and procedures to do on maximizing benefits and minimizing harms for individual patients, not maximizing financial gain for physicians, or their organizations.

Family physicians are a respected source not only of decisions about tests and treatments, but about diet. Having the main family physician organization humming "things go better with Coke" suggests that professional advice could be co-opted by marketing. As Dr Brody noted above, the issue is not whether the product is good or bad, but is whether physicians are giving each patient the best possible advice.

One question implied by the "Dr Coca-Cola" story is why the leadership of the AAFP seems so oblivious to the conflict of interest issues it raises.  As Dr Brody wrote:

What's even more depressing is that with the whole world telling them that they mishandled this affair, the AAFP still seems to think that the problem is someone else's.

I appreciate Dr Brody's depression, but note that this is not the first time that AAFP leadership has seemed tone deaf to the issue of the organization's institutional conflict of interest. In 2005, we posted how the AAFP had banned the "No Free Lunch" organization, which opposes most pharmaceutical marketing to physicians, from appearing in the exhibit hall of its annual meeting. The exhibit hall was otherwise populated by lavish exhibits by pharmaceutical and other health care corporation marketers.

The abstract for a 2006 article in Family Medicine [Standridge JB. Of doctor conventions and drug companies. Fam Med 2006; 38(7):518-20. Link here] began:

Pharmaceutical companies provide the majority of financial support for staging the American Academy of Family Physicians (AAFP) Annual Scientific Assembly. In return they are allowed to dominate the physical and mental environment.

The current web-site for the AAFP Foundation boasts of its corporate partners, which include many of the biggest pharmaceutical and biotechnology companies (at the "Pinnacle" level, Amgen, AstraZeneca, Lilly, Purdue Pharma.

So adding Coca-Cola to the list of corporate sponsors does not seem like such a big step.  In fact, being "Dr Coca-Cola" does not seem intrinsically more questionable than being "Dr Amgen," "Dr AstraZeneca," etc.

Nonetheless, one would think that the latest round of criticism would make the top leaders of this august professional society less comfortable about the organization's financial relationships with pharmaceutical, biotechnology, and now beverage corporations.  I fear, though, that they may live too much in the sort of bubble that now protects top executives of most large health care organizations to really question their corporate ties.  After all, according to the most recent (2007, covering 6/2007-5/2008) US Internal Revenue Service form 990 filed by the AAFP (via Guidestar), its leaders get sufficient compensation to put them into such a bubble.  For example, Dr "Coca-Cola" Hensley received $441,027 regular compensation and $108,930 in benefits and deferred compensation, compared with a median compensation for family physicians in 2008 reported as $159,000 from one survey.  Presumably "voluntary" officers got five- and six-figure "expense accounts and other allowances," maxing out at $195,648 for then President Dr James B King.  It may be hard for leaders who are so comfortably recompensed by the organization to become uncomfortable about the financial relationships that make the largesse they receive seem less of a burden for members who may not be so well-paid.  The leaders' comfort with the current arrangement, however, makes their organization more liable to be viewed as a drug, device, and now beverage marketer rather than a defender of physicians' professionalism.  Maybe the leaders should accept more austere compensation, perhaps similar to what working family doctors get paid, as the price they need to pay to remove questions about their organization's real commitment to professionalism.

Paging (and Paying) "Dr Coca-Cola"

A few weeks ago, the Los Angeles Times Booster Shots blog announced that "Dr. Coca-Cola will see you now," noting opposition to the recently revealed alliance between the Coca-Cola Company and the American Academy of Family Physicians:

[in] a sharply worded letter sent Wednesday to Dr. Douglas E. Henley, the academy’s chief executive.

'We urge the AAFP to regain its credibility by rejecting the deal with Coca-Cola,' the letter stated. 'If the AAFP declines to do that, we urge your organization to reassert its support for the public health (and its own independence) by supporting a warning label on caloric sugar-sweetened beverages and a federal tax on soft drinks to support health promotion or health insurance programs.'

The letter was signed by 22 doctors, nutritionists and health advocates,

Dr Henley was not moved:

Henley told Food Navigator-USA.com that the academy was aware of the letter. But he stood by the partnership with Coke.

'We will move forward with this commitment together by providing educational materials on sweeteners and how to maintain a healthy, active lifestyle while still enjoying many of the foods and beverages consumers love,' he said in a statement.

Nonetheless, criticism of the deal has continued. A Kansas City Star editorial said:

the Leawood-based American Academy of Family Physicians has set a poor example when it comes to resisting the lure of the soft drink industry.

The academy has accepted a grant from Coca-Cola, reportedly in the neighborhood of $500,000. It will use the money for educational materials about drinks and sweeteners for its consumer Web site, FamilyDoctor.org. Leftover funds will go into the academy’s general budget.

In return, Coca-Cola gets what? Legitimacy, for one thing. Consumers are less likely to consider a product unhealthy if it’s listed as a partner with a leading physicians’ alliance.

In a more shameful scenario, the soft drink manufacturer would succeed in muting the message that the academy puts out to its consumers.

The editorial did not buy Dr Henley's assurances:

Academy leaders say they won’t allow the hefty corporate grant to compromise the organization’s integrity.

'We have total editorial control, as we always have, of FamilyDoctor.org,' said Executive Vice President Douglas Henley.

Henley added, 'I would hope folks won’t rush to judgment but hold us to the content we’re going to put on FamilyDoctor.org.'

But consumers accessing that information will soon be informed that information about soft drinks is being sponsored in part by Coca-Cola, 'a proud partner of FamilyDoctor.org.'

That’s a mixed message, regardless of the content.

Meanwhile, family physician and AAFP member Dr Howard Brody noted on his Hooked: Ethics, Medicine and Pharma blog how AAFP leaders continued to obfuscate:

AAFP President Dr. Lori Heim: obesity is more complex and that 'there's no one evil out there.'

Why does the question of whether it's a good idea for AAFP to take money from Coke so quickly segue into the question of whether Coke is 'evil'? (For our blogger colleague who likes logical fallacies, Roy Poses, this sounds like "straw man." [It sure does - Editor]) Why does it have to be: either they are evil or else it's just fine for us to take their money? What cannot it simply be that they have different interests--they are trying to make a buck selling beverages (some of which I enjoy drinking myself, I am pleased to report, if they don't have calories in them) while AAFP is trying to protect the public interest through credible health education? What part of conflict of interest don't you understand?

Some AAFP members went beyond criticism, as reported by the AP:

Dr. William Walker, public health officer for Contra Costa County near San Francisco, likened the alliance with ads decades ago in which physicians said mild cigarettes are safe,

Walker has been a member of the academy for 25 years but quit last week. He said 20 other doctors who work with his local medical practice also quit because of the Coke deal.

Nonetheless, as Dr Brody later posted,

Sadly, if the responses to this news report from AAFP leadership are accurate, the AAFP still does not get it. '[AAFP CEO Dr. Douglas] Henley said the academy regrets the resignations and hopes other members will not 'rush to judgment' before seeing the new content." News flash: we don't need to see the content to know there's something rotten in Denmark. The deal itself raises concerns about the credibility of anything AAFP posts about diet and obesity from now on.

So here we have the latest variant on institutional conflicts of interest affecting medical associations. We have noted (e.g., here) how professional societies have blithely accepted substantial funding from corporations which sell products physicians may prescribe for or implant in patients. This raises concerns that professional societies have become drug and device marketers. This conflicts with physicians' prime directive, to put the interests of individual patients ahead of their own, and hence to base decisions on which drugs to prescribe, tests to order, and procedures to do on maximizing benefits and minimizing harms for individual patients, not maximizing financial gain for physicians, or their organizations.

Family physicians are a respected source not only of decisions about tests and treatments, but about diet. Having the main family physician organization humming "things go better with Coke" suggests that professional advice could be co-opted by marketing. As Dr Brody noted above, the issue is not whether the product is good or bad, but is whether physicians are giving each patient the best possible advice.

One question implied by the "Dr Coca-Cola" story is why the leadership of the AAFP seems so oblivious to the conflict of interest issues it raises.  As Dr Brody wrote:

What's even more depressing is that with the whole world telling them that they mishandled this affair, the AAFP still seems to think that the problem is someone else's.

I appreciate Dr Brody's depression, but note that this is not the first time that AAFP leadership has seemed tone deaf to the issue of the organization's institutional conflict of interest. In 2005, we posted how the AAFP had banned the "No Free Lunch" organization, which opposes most pharmaceutical marketing to physicians, from appearing in the exhibit hall of its annual meeting. The exhibit hall was otherwise populated by lavish exhibits by pharmaceutical and other health care corporation marketers.

The abstract for a 2006 article in Family Medicine [Standridge JB. Of doctor conventions and drug companies. Fam Med 2006; 38(7):518-20. Link here] began:

Pharmaceutical companies provide the majority of financial support for staging the American Academy of Family Physicians (AAFP) Annual Scientific Assembly. In return they are allowed to dominate the physical and mental environment.

The current web-site for the AAFP Foundation boasts of its corporate partners, which include many of the biggest pharmaceutical and biotechnology companies (at the "Pinnacle" level, Amgen, AstraZeneca, Lilly, Purdue Pharma.

So adding Coca-Cola to the list of corporate sponsors does not seem like such a big step.  In fact, being "Dr Coca-Cola" does not seem intrinsically more questionable than being "Dr Amgen," "Dr AstraZeneca," etc.

Nonetheless, one would think that the latest round of criticism would make the top leaders of this august professional society less comfortable about the organization's financial relationships with pharmaceutical, biotechnology, and now beverage corporations.  I fear, though, that they may live too much in the sort of bubble that now protects top executives of most large health care organizations to really question their corporate ties.  After all, according to the most recent (2007, covering 6/2007-5/2008) US Internal Revenue Service form 990 filed by the AAFP (via Guidestar), its leaders get sufficient compensation to put them into such a bubble.  For example, Dr "Coca-Cola" Hensley received $441,027 regular compensation and $108,930 in benefits and deferred compensation, compared with a median compensation for family physicians in 2008 reported as $159,000 from one survey.  Presumably "voluntary" officers got five- and six-figure "expense accounts and other allowances," maxing out at $195,648 for then President Dr James B King.  It may be hard for leaders who are so comfortably recompensed by the organization to become uncomfortable about the financial relationships that make the largesse they receive seem less of a burden for members who may not be so well-paid.  The leaders' comfort with the current arrangement, however, makes their organization more liable to be viewed as a drug, device, and now beverage marketer rather than a defender of physicians' professionalism.  Maybe the leaders should accept more austere compensation, perhaps similar to what working family doctors get paid, as the price they need to pay to remove questions about their organization's real commitment to professionalism.

Academic Freedom and ED EHR's Down Under: An Update

At the post "Academic Freedom Curtailed?" I wrote:

The essay on Emergency Department electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney, that I referenced in my posts "The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" and "NSW Nightmare and Overuse of Computers" appears to have been censored. This apparently occurred at the level of the the government.

Professor Patrick has updated his web page that formerly contained a link to his essay on problems with EHR's in that state's EDs.

He advises:

... This document has been temporarily withdrawn by the university following a complaint from NSWHealth. I think the University has acted appropriately by investigating the complaint and I do not yet consider it an act of censorship. I am working through the issues with the University and expect that the essay will be re-published.

I would like to thank all the people who have written to me to offer support and I would encourage you to write to me if you are interested in the matter so that i can demonstrate to the university the importance of this issue to both the Australian and international communities. I do not wish for people to write to anyone else but me. I have no wish to run a public campaign and I am not available for statements to the press about this particular matter. This matter has brought to light many interesting and illuminating things that i will be happy to share in the next version of the Critical Essay.

Jon Patrick 27th October 2009 0930 Eastern Australian Summer time

He then follows up with this:

Update on the withdrawal of "Essay No.6"

It is now two weeks since the original essay was withdrawn. In that time I have been able to establish confidently that NSWHealth phoned my Head of Department and asked him to remove the article without giving a specific complaint. He refused. Subsequently a person from another faculty took up the cause and succeeded in persuading an appropriate person to order withdrawal of the essay. To this time i have not received a specific complaint let alone a written complaint. The Univeristy's Office of General Counsel has studied the essay at my request through my Dean, and found that it is "consistent with the University's Public Comment Policy". I am awaiting further investigations by the University.

Subsequently I have received many messages of support from around the world, and importantly much more information to be included in the essay. I am preparing a much enhanced version.

5th November 2009 1150 Eastern Australian Summer time

I sincerely hope this matter will be resolved in favor of dissemination of the enhanced and updated piece. I think it contains information that is quite valuable to a worldwide audience of clinicians, IT vendors and patients.

I also note that those who aim to suppress a document such as this in the age of informational computing, one product of which is the Internet, should be confined to using only the Commodore PET due to their technological and sociological ineptitude:

State-of-the-art computing for the would-be Health IT article police

-- SS

Addendum

Nov. 10, 2009, evening EST:

The essay in version 5 is once again available as Item 6 at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 .

-- SS

Academic Freedom and ED EHR's Down Under: An Update

At the post "Academic Freedom Curtailed?" I wrote:

The essay on Emergency Department electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney, that I referenced in my posts "The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" and "NSW Nightmare and Overuse of Computers" appears to have been censored. This apparently occurred at the level of the the government.

Professor Patrick has updated his web page that formerly contained a link to his essay on problems with EHR's in that state's EDs.

He advises:

... This document has been temporarily withdrawn by the university following a complaint from NSWHealth. I think the University has acted appropriately by investigating the complaint and I do not yet consider it an act of censorship. I am working through the issues with the University and expect that the essay will be re-published.

I would like to thank all the people who have written to me to offer support and I would encourage you to write to me if you are interested in the matter so that i can demonstrate to the university the importance of this issue to both the Australian and international communities. I do not wish for people to write to anyone else but me. I have no wish to run a public campaign and I am not available for statements to the press about this particular matter. This matter has brought to light many interesting and illuminating things that i will be happy to share in the next version of the Critical Essay.

Jon Patrick 27th October 2009 0930 Eastern Australian Summer time

He then follows up with this:

Update on the withdrawal of "Essay No.6"

It is now two weeks since the original essay was withdrawn. In that time I have been able to establish confidently that NSWHealth phoned my Head of Department and asked him to remove the article without giving a specific complaint. He refused. Subsequently a person from another faculty took up the cause and succeeded in persuading an appropriate person to order withdrawal of the essay. To this time i have not received a specific complaint let alone a written complaint. The Univeristy's Office of General Counsel has studied the essay at my request through my Dean, and found that it is "consistent with the University's Public Comment Policy". I am awaiting further investigations by the University.

Subsequently I have received many messages of support from around the world, and importantly much more information to be included in the essay. I am preparing a much enhanced version.

5th November 2009 1150 Eastern Australian Summer time

I sincerely hope this matter will be resolved in favor of dissemination of the enhanced and updated piece. I think it contains information that is quite valuable to a worldwide audience of clinicians, IT vendors and patients.

I also note that those who aim to suppress a document such as this in the age of informational computing, one product of which is the Internet, should be confined to using only the Commodore PET due to their technological and sociological ineptitude:

State-of-the-art computing for the would-be Health IT article police

-- SS

Addendum

Nov. 10, 2009, evening EST:

The essay in version 5 is once again available as Item 6 at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 .

-- SS

Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:

Switch to electronic records alarms Jefferson Regional physicians

By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Friday, October 30, 2009

Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety.

In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians."

Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed.

"It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."

Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying.

I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns.

Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions:

• How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?

• Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?

I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations.

HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason.

On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer.

This is especially true when conflicts of interest exist.

According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.

I find this an interesting finding. After a short Google search, the following appeared:

Western Pennsylvania Hospital News

20 Years of Hospital Information Technology
by John Fries
(December 2005)

... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System.

At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades.

The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy.

This raises a number of questions:

• Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?
• Who did/does the Site Executive report to?
• Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?
• What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?

These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest.

I have noted that a Congressional investigation of the health IT industry is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys.

Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."

He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns.

This is typical of the Wild West environment of Health IT.

-- SS

Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:

Switch to electronic records alarms Jefferson Regional physicians

By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Friday, October 30, 2009

Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety.

In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians."
Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed.
"It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."

Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying.

I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns.

Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions:

• How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?

• Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?

I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations.

HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason.

On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer.

This is especially true when conflicts of interest exist.

According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.

I find this an interesting finding. After a short Google search, the following appeared:

Western Pennsylvania Hospital News
20 Years of Hospital Information Technology
by John Fries
(December 2005)


... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System.
At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades.

The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy.

This raises a number of questions:

• Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?
• Who did/does the Site Executive report to?
• Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?
• What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?

These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest.

I have noted that a Congressional investigation of the health IT industry is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys.

Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."

He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns.

This is typical of the Wild West environment of Health IT.

-- SS

2009 a Pivotal Year in Healthcare IT

2009 is proving to be a pivotal year in healthcare IT. Recent authoritative articles and reports on health IT problems largely validate the issues presented at this blog and others focusing on health IT issues, and at my academic website on HIT difficulties started over a decade ago, in 1998, freely available to the industry.

These articles and reports have ultimately led to a U.S. Senate investigation of the healthcare IT industry initiated in Oct. 2009 (link below).

2009 may be the year that healthcare IT vendors will finally begin to understand that not lending credence to decades of teachings from Medical Informatics professionals on healthcare IT design, implementation, lifecycle support, involvement of end users, and sales and marketing has been harmful to their businesses and to their investors. Instead, the commercial health IT companies took a simplistic management information systems-based approach to building medical devices in an incomparably complex environment they did not -- or did not care to – understand.

These devices are, in fact, virtual medical devices that happen to reside on a computer, not business computing systems that happen to be used by clinicians. These medical devices are soon to undergo regulation as such in the EU (pdf report from the Swedish Medical Products Agency here), Canada, the U.S. and other countries as well.

The teachings of Medical Informatics about such devices have been documented in the extensive literature of Medical Informatics. For example, the book “A History of Medical Informatics in the United States, 1950 to 1990” by informatics pioneer Morris F. Collen (published in 1995) explicitly demonstrates the progression of the field and the wisdom of the pioneers dating back to the 1950’s, as in the bons mots here.

The 2009 articles and reports below demonstrate numerous undesirable outcomes of the management information systems approach to development and implementation of virtual clinical devices:

• The Joint Commission’s “Sentinel Event Alert on Healthcare IT” is here.

• The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient" and link to a full report on an investigation of healthcare IT lack of progress is here.

• The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

• The Washington Post’s article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is here.

• Hoffman and Podgurski’s paper from Case Western entitled “e-Health Hazards: Provider Liability and Electronic Health Record Systems” on EHR medical and legal risks is here.

• My commentary on the May 2009 AMIA workshop report on healthcare IT failure with free PDF is available here.

• My commentary on a sentinel Mar. 2009 JAMA article by University of Pennsylvania researchers Ross Koppel and David Kreda “Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians” on unsafe contract terms demanded by healthcare IT, and the violations of Joint Commission safety standards and fiduciary responsibilities committed by hospital governance personnel who agree to such terms, is here.

• A link to the Oct. 25, 2009 Washington Post article “Electronic medical records not seen as a cure-all” and my commentary are here.

Finally, and perhaps most importantly, the Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices is here (PDF).

I have used this medieval illustration in a prior post on these pages, but sadly in this case it is probably even more highly appropriate:

"Margaritas ante Porcos" - click to enlarge

Not to be gratuitously impolite, but hard truths are often an unpleasant medicine, especially when ignoring those truths results in adverse consequences to patients and their caregivers.

-- SS