In the US, many important health care organizations are not-for-profit organizations. Many US medical schools, and other health educational institutions, along with their parent universities are not-for-profit. (Essentially all the exceptions are supported by local or state government.) The majority of US hospitals and hospital systems, including academic medical centers, are not-for-profit. Some managed care organizations are not-for-profit. Medical and professional societies, health care advocacy groups, health care charities, and a variety of other groups are not-for-profit.
Not-for-profit health care organizations here have hardly been immune from leadership and governance problems. We have discussed numerous instances of ill-informed, conflicted, and even corrupt leadership of these organizations, and underlying problems with their governance, which may be unrepresentative of key constituencies, unaccountable, secretive and opaque, and not subject to clear ethical rules.
There may be some major changes coming, however, affecting leadership and governance of all US not-f0r-profit organizations, including health care organizations. The US Internal Revenue Service (IRS) has long required that not-for-profits that exceed certain minimums file and make publicly available certain information on a form 990. Relatively recent forms from most US not-for-profits are available online from Guidestar.org. The old forms provided for some minimal transparency. They displayed, for example, a list of the filing not-for-profit organization's trustees, and the salaries and retirement plans given to their five highest-paid employees.
The IRS has revised the forms starting with those to be filed in 2009, which will reflect 2008 data, so as to markedly increase organizational transparency. The actual forms can be found on this IRS web-page, and a discussion of key points can be found here on the GuideStar.org web-site.
For the first time, the forms will include information about certain aspects of leadership and governance.
Leadership Conflicts of Interest
The new form 990 will require each organization to establish the "independence" of the organizations' trustees, directors, officers, and key employees. Independent individuals would be those without any direct or indirect business relationships with the not-for-profit organization; without any relatives with such business relationships; and who were not serving as an officer, director, trustee, key employee, partner, or member of an organization doing business with the not-for-profit organization. The relationships preventing individuals from being independent would have to be documented.
It is likely that perusal of such information on the new form 990 would reveal to some extent the degree the organization's leaders are conflicted. Up to now, it has been very difficult to get information about conflicts affecting the leadership of health care organizations. We have reported numerous cases of seemingly high-level conflicts affecting leaders of not-for-profit health care organizations. It is likely that such conflicts affect the ability and inclination of leaders to uphold their organization's mission, that is, to fulfill their duty of obedience.
Leadership Compensation
The new form 990 will ask for detailed information about the total compensation given to officers, directors, and trustees, key and the five most highly paid employees, and former officers, directors, trustees, key and most highly compensated employees who continued to receive substantial amounts. This will include not only reportable and other compensation, but whether anyone received unusual compensation such as first-class or charter travel, companion travel, tax indemnification for gross-up payments, discretionary spending accounts, housing allowance or residence for personal use, payments for business use of personal residence, health or social club dues or fees, and personal services (e.g., maid, chauffeur, chef). Also, the form inquires about severance packages and supplemental non-qualified retirement plans.
Up to now, little information about the compensation of not-for-profit leaders beyond base salaries, contributions to employee benefit plans and deferred compensation, and expense allowances and the like was available. Clearly, while not reaching the stratospheric levels enjoyed by top leaders of for-profit health care corporations, some leaders of not-for-profit health care organizations have come to be paid enough to make them rich. It is possible that some now regard their positions as first a pathway to wealth, rather than a calling to improve the health of society, or to advance medical education or science. Furthermore, it is possible that some leaders have been receiving additional compensation which has made them even more wealthy, while particular "perks," like staffed houses, chauffeured cars, and first-class travel, has isolated them from the patients, clients, and/or students they are supposed to be serving.
Organizational Policies
The new form 990 will ask whether the organization has a written conflict of interest policy, and if so, how compliance is monitored and enforced, and a written policy to protect whistle blowers.
Summary
In my humble opinion, the IRS' new form 990 could make substantial improvements to the transparency and accountability of not-for-profit health care organizations. Review of form 990's filed starting this year could provide important information about conflicts of interest affecting organizational leaders, whether they have been distracted by new-found wealth, or decoyed by luxurious perks, and whether their organizations have clear policies meant to maintain certain ethical standards.
However, while the IRS will mandate that such information becomes available, it is not clear what it will do about the information so revealed. Additionally, the wealth of information that will be provided could easily bury the few watchdogs, including the Health Care Renewal bloggers, that have been trying to monitor the governance and leadership of health care organizations.
However, the new information provides an important opportunity to other people concerned about these issues. For example, perhaps some health professionals have concerns about how their alma maters are lead and governed. Maybe they will peruse the new information provided, and then try to use it to make their alma maters more accountable. It is at least possible to be optimistic.
What Is to Be Done?
If you are concerned about a particular not-for-profit health care organization, you can prepare for the availability of more information from the revised form 990 in several ways, by searching for already publicly available information. You can peruse older form 990s, which at least provides the names of trustees and officers, and officers' and key employees' salaries.
In addition, the web makes it possible to identify some conflicts of interest affecting current leadership. For example, try first entering each leader's name, surrounded by quotes, into Google, to look for biographical information that could reveal conflicts. Next, try searching on the name plus terms like "board of directors," "board of trustees," "consultant," or "advisory board," which may uncover some additional conflicts. If you find anything of concern, consider making it more public.
Remember, the best way to improve health care leadership is to hold it accountable to an activated public, preferably strongly infused with health care professionals who want to uphold their professionalism.
Monday, May 11, 2009
Friday, May 08, 2009
Attacking "Crusaders" Against Conflicts of Interest with Logical Fallacies
An editorial appeared in the latest edition of Nature Medicine that suggested "crusaders" are making much too much fuss over insignificant "competing financial interests." [Anonymous. A really serious conflict. Nature Medicine 2009; 15: 463-4]
The Editorial's Arguments
Instead of regarding all conflicts of interest as part of a "monolithic scourge," it suggested we should only attack them in two specific situations.
Bad Conflicts of Interest
The first is when it leads to falsification of research data:
The second is when it leads to withholding of data in certain circumstances:
Some Conflicts of Interest are Unavoidable
On the other hand, the editorial asserted that conflicts of interest are unavoidable in certain situations.
Bad Outcomes of the "Crusade" Against Conflicts of Interest
In addition, the editorial argued that because of excess attention paid to minor or unavoidable conflicts of interest, bad things may happen. Clinical trials would be discouraged.
And innovation would be slowed.
Finally, the editorial exhorted:
It is discouraging to see such sloppy thinking and inflammatory rhetoric appear under the masthead of a prominent journal. How was the thinking sloppy? Let me count the ways, and explain the logical fallacies used by the editorial to support its contention.
Arguing that Conflicts are Unavoidable Using False Dilemmas and Appeals to Common Practice
The editorial suggests some conflicts of interest may be unavoidable, even necessary for the advancement of science. To do this, it provided a series of false dilemmas and appeals to common practice. A false dilemma is an argument that x and y are mutually exclusive, when they are not. An appeal to common practice is an argument that because something is common practice, it is necessary, moral, correct, or the only course possible.
The editorial argued that researchers would not work for free, implying that if drug and device companies could not pay researchers to perform clinical trials, no clinical trials would be done. This is a false dilemma, because it is based on the unstated assumption that there is no other possible source of payment for clinical trial researchers other than the companies whose products the trials evaluate. It may be true that it would be hard to get anyone to conduct clinical trials for free, but there is no law of nature that dictates that all clinical trials must be financed directly by companies whose products are the subjects of these trials, or that prevents clinical trials from being funded by government agencies and/or non-governmental organizations disinterested in whether the results favor one treatment or another. Such disinterested sponsors paying researchers would not create conflicts of interest.
The editorial argued that if academic institutions and their employees cannot benefit financially from "the fruits of the advances made in their laboratories," there would be no drug and device development. This is a false dilemma, because it is based on the unstated assumption that the only setting for drug and device development is academic institutions. There is no natural law, however, that restricts drug and device development to academic institutions, or prevents drug development to be done by drug and device companies, or by independent laboratories. The editorial also appended an appeal to common practice. Bayh-Dole may be the current law in the US, but it is hardly natural law.
The editorial argued that without the "deep pockets" of the "pharmaceutical sector" and device companies, no one would pay for clinical research. This was a repetition of the false dilemma noted above. There is no natural law that prevents government and non-governmental organizations from sponsoring clinical trials. The editorial again appended an appeal to common practice. Current laws and social conventions have made drug and device companies extremely profitable, but continuation of their profitability is hardly inevitable.
Red Herrings to Distract from Other Bad Effects of Conflicts
While the editorial identified two particularly bad kinds of conflicts of interest, it ignored other instances that could be equally bad. This was something of a red herring. Although the two examples of bad effects of conflicts of interest were undeniably important, they distracted from other bad effects which the editorial chose to ignore.
The editorial correctly identified falsification of data as bad, but ignored the entire catalog of ways in which clinical research studies can be manipulated to make them more likely to favor a sponsor's product. See our posts (here and here) and the links contained therein for multiple examples of such manipulation.
The editorial noted that concealing data from regulators in order to win drug approval is bad, but ignored all the instances in which data has been suppressed outside of the regulatory process to make drugs or devices seem more efficacious or less dangerous than they really are. See this link for some of our posts containing relevant examples. If it is bad to fool people who must make regulatory decisions, why is it not so bad to fool physicians and patients who must decide whether to use drugs or devices?
The editorial further ignored that conflicts that affect how research is conducted or reported may be linked to conflicts that affect how research is disseminated or used in decision making. The clinical researcher who is paid by a drug or device company to conduct a clinical trial may also be an academic physician paid by the same company as a consultant or through a speakers' bureau to give talks and presentations, and write review articles favorable to the company's product. If it would be bad for the researcher to falsify data to make the product look better, why would it be acceptable for the researcher to act as a huckster for the product while pretending to be a disinterested academic? See this link for posts discussing stealth marketing, and this one for posts discussing the use of key opinion leaders.
Ambiguity and Ad Hominem Attacks Inflating the Bad Effects of Fighting Conflicts
While the editorial minimized the bad outcomes of conflicts of interest, it resorted to ambiguity and inflammatory language to exaggerate what might happen were conflicts to be reduced.
Its most dire prediction of the results of reducing conflicts was that doing so would create a "milieu" in which "pharmaceutical firms have increasingly less breathing space." Literally, this statement was nonsense. Metaphorically, it did not make a clear argument that these highly profitable companies (and even more profitable device companies) could not survive in a "milieu" in which their products were tested by researchers which the companies could not influence. This was not clearly a logical fallacy, but just word-play presented a reasoned argument.
Given how prevalent political correctness is, repeatedly characterizing people concerned about conflicts of interest as "crusaders" is inflammatory indeed. Being called "pharmascolds" is one thing, but "crusader" in some circles is regarded as equivalent to racist, a nasty term to label those who promote the separation of clinical research and medical education from commercial interests. Thus, the editorial winds up with a rather nasty version of an ad hominem attack.
We have seen numerous examples of the use of logical fallacies in defense of conflicts of interest, often by authors who were themselves conflicted. It is especially sad to see the editors of a scholarly medical journal employ such logical fallacies in the defense of conflicts of interest.
ADDENDUM (11 May, 2009) - See also the comments by Dr Doug Bremner in the Before You Take That Pill Blog.
ADDENDUM (20 May, 2009) - For an example of how the term "crusader" has become politically incorrect in the US context, see this article in the Boston Globe.
The Editorial's Arguments
Instead of regarding all conflicts of interest as part of a "monolithic scourge," it suggested we should only attack them in two specific situations.
Bad Conflicts of Interest
The first is when it leads to falsification of research data:
If there is one reason we need to worry about CFIs [competing financial interests], it is because they could lead to misconduct whenever a researcher has a financial incentive to fabricate data. So, if a clinical trial goes ahead on the basis of fraudulent preclinical work or if a drug is approved on the basis of false clinical data, the problem is more profound than can be addressed by the declaration of a CFI. Researchers or clinicians who produce sham data to continue receiving funds from a company must be subject to severe disciplinary actions from their institutions and funding bodies.
The second is when it leads to withholding of data in certain circumstances:
Companies that conceal negative data from regulators to receive approval for their drug should face not only fines but also penalties as serious as criminal charges. In any case, the focus should move away from CFI declarations and toward exposing and punishing scientific misconduct.
Some Conflicts of Interest are Unavoidable
On the other hand, the editorial asserted that conflicts of interest are unavoidable in certain situations.
But even though a lot has been written about this subject, it is seldom acknowledged that not all CFIs are equally insidious and that some are even necessary for the success of translational research.
Scientists who share their expertise with a company and clinicians who agree to conduct a clinical trial have to be compensated for their work in the same way that every other professional ought to be rewarded for his or her labor. To suggest that they should make their contributions freely is disingenuous, and to argue that they should not get involved at all can only slow the development of new medicines.
Academic institutions and their employees must be free to benefit financially from the fruits of the advances made in their laboratories, either by independently developing them into products or by selling them to the highest bidder. In the US, the Bayh-Dole Act has protected this right for nearly three decades, and CFIs that result from a university's right to enact this policy should not raise eyebrows.
Bad Outcomes of the "Crusade" Against Conflicts of Interest
In addition, the editorial argued that because of excess attention paid to minor or unavoidable conflicts of interest, bad things may happen. Clinical trials would be discouraged.
However, the fact remains that clinical trials are very expensive, and only the pharmaceutical sector has both the incentive and the deep pockets to pay for them.
And innovation would be slowed.
A third issue that is rarely acknowledged is that the stridency with which the CFI crusaders fight financial interests has created a milieu in which pharmaceutical firms have increasingly less breathing space to conduct their business, leading to a further slowing of drug development.
Finally, the editorial exhorted:
Let us instead accept that most financial interests do not represent a conflict as a matter of course and that the influence of money is negative only if it leads to scientific fraud—the one infidel we need to burn at the crusader's stake.Logical Fallacies and Inflammatory Rhetoric
It is discouraging to see such sloppy thinking and inflammatory rhetoric appear under the masthead of a prominent journal. How was the thinking sloppy? Let me count the ways, and explain the logical fallacies used by the editorial to support its contention.
Arguing that Conflicts are Unavoidable Using False Dilemmas and Appeals to Common Practice
The editorial suggests some conflicts of interest may be unavoidable, even necessary for the advancement of science. To do this, it provided a series of false dilemmas and appeals to common practice. A false dilemma is an argument that x and y are mutually exclusive, when they are not. An appeal to common practice is an argument that because something is common practice, it is necessary, moral, correct, or the only course possible.
The editorial argued that researchers would not work for free, implying that if drug and device companies could not pay researchers to perform clinical trials, no clinical trials would be done. This is a false dilemma, because it is based on the unstated assumption that there is no other possible source of payment for clinical trial researchers other than the companies whose products the trials evaluate. It may be true that it would be hard to get anyone to conduct clinical trials for free, but there is no law of nature that dictates that all clinical trials must be financed directly by companies whose products are the subjects of these trials, or that prevents clinical trials from being funded by government agencies and/or non-governmental organizations disinterested in whether the results favor one treatment or another. Such disinterested sponsors paying researchers would not create conflicts of interest.
The editorial argued that if academic institutions and their employees cannot benefit financially from "the fruits of the advances made in their laboratories," there would be no drug and device development. This is a false dilemma, because it is based on the unstated assumption that the only setting for drug and device development is academic institutions. There is no natural law, however, that restricts drug and device development to academic institutions, or prevents drug development to be done by drug and device companies, or by independent laboratories. The editorial also appended an appeal to common practice. Bayh-Dole may be the current law in the US, but it is hardly natural law.
The editorial argued that without the "deep pockets" of the "pharmaceutical sector" and device companies, no one would pay for clinical research. This was a repetition of the false dilemma noted above. There is no natural law that prevents government and non-governmental organizations from sponsoring clinical trials. The editorial again appended an appeal to common practice. Current laws and social conventions have made drug and device companies extremely profitable, but continuation of their profitability is hardly inevitable.
Red Herrings to Distract from Other Bad Effects of Conflicts
While the editorial identified two particularly bad kinds of conflicts of interest, it ignored other instances that could be equally bad. This was something of a red herring. Although the two examples of bad effects of conflicts of interest were undeniably important, they distracted from other bad effects which the editorial chose to ignore.
The editorial correctly identified falsification of data as bad, but ignored the entire catalog of ways in which clinical research studies can be manipulated to make them more likely to favor a sponsor's product. See our posts (here and here) and the links contained therein for multiple examples of such manipulation.
The editorial noted that concealing data from regulators in order to win drug approval is bad, but ignored all the instances in which data has been suppressed outside of the regulatory process to make drugs or devices seem more efficacious or less dangerous than they really are. See this link for some of our posts containing relevant examples. If it is bad to fool people who must make regulatory decisions, why is it not so bad to fool physicians and patients who must decide whether to use drugs or devices?
The editorial further ignored that conflicts that affect how research is conducted or reported may be linked to conflicts that affect how research is disseminated or used in decision making. The clinical researcher who is paid by a drug or device company to conduct a clinical trial may also be an academic physician paid by the same company as a consultant or through a speakers' bureau to give talks and presentations, and write review articles favorable to the company's product. If it would be bad for the researcher to falsify data to make the product look better, why would it be acceptable for the researcher to act as a huckster for the product while pretending to be a disinterested academic? See this link for posts discussing stealth marketing, and this one for posts discussing the use of key opinion leaders.
Ambiguity and Ad Hominem Attacks Inflating the Bad Effects of Fighting Conflicts
While the editorial minimized the bad outcomes of conflicts of interest, it resorted to ambiguity and inflammatory language to exaggerate what might happen were conflicts to be reduced.
Its most dire prediction of the results of reducing conflicts was that doing so would create a "milieu" in which "pharmaceutical firms have increasingly less breathing space." Literally, this statement was nonsense. Metaphorically, it did not make a clear argument that these highly profitable companies (and even more profitable device companies) could not survive in a "milieu" in which their products were tested by researchers which the companies could not influence. This was not clearly a logical fallacy, but just word-play presented a reasoned argument.
Given how prevalent political correctness is, repeatedly characterizing people concerned about conflicts of interest as "crusaders" is inflammatory indeed. Being called "pharmascolds" is one thing, but "crusader" in some circles is regarded as equivalent to racist, a nasty term to label those who promote the separation of clinical research and medical education from commercial interests. Thus, the editorial winds up with a rather nasty version of an ad hominem attack.
We have seen numerous examples of the use of logical fallacies in defense of conflicts of interest, often by authors who were themselves conflicted. It is especially sad to see the editors of a scholarly medical journal employ such logical fallacies in the defense of conflicts of interest.
ADDENDUM (11 May, 2009) - See also the comments by Dr Doug Bremner in the Before You Take That Pill Blog.
ADDENDUM (20 May, 2009) - For an example of how the term "crusader" has become politically incorrect in the US context, see this article in the Boston Globe.
Thursday, May 07, 2009
Medical Cyber Piracy: Are National Electronic Health Records Plans Premature?
In 1961, President John F. Kennedy stood before a joint session of Congress and declared:
In setting such an ambitious goal, the President was primarily putting at risk a handful of volunteer astronauts, several of whom actually did perish in the effort.
In 2009, President Obama committed the U.S. to full interconnected electronic health records (EHR's) by 2014.
In doing so, the President may be putting at risk millions of non-volunteer, ordinary people if the following is an example of what we can look forward to:
Only the world's dreamiest and most naive optimist could believe that these occurrences of medical cyber piracy - or worse - would not become commonplace, with rapid expansion of a diverse array of commercial electronic health records systems among our nation's thousands of hospitals and hundreds of thousands of practitioners.
This is especially true at our current levels of information technology, but also at "our" (meaning, the existing pool of IT professional's) current levels of competence and intellectual capability to manage this technology.
This story in today's Wall Street Journal is another case in point along those lines:
In Nov. 2008 I wrote in a post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" that 2009 might not be the optimal time for a major national health IT initiative, and that a moratorium on such efforts should be considered. I amplified the point in this followup post and at these posts as well.
The Virginia prescription records debacle adds to my concerns.
There are some national initiatives, such as a lunar landing, that are supported by a likely, relatively small extension of existing technologies, plus a low risk factor or risk factor to a small number of people. There are other national initiatives whose time may not yet have come due to technological limitations, but even more importantly, due to the advanced technology developed by the (brilliant) few outpacing the capabilities of the (average) many to manage it properly.
One needs to ask - without conflict of interest - if the risks of any mass social and technological engineering initiative such as national EHR's are truly outweighed by the benefits at this point in time. This is not an easy decision.
The common refrain that to not proceed with national EHR now would "hold back innovation", however, is one of objectification of the people. It is a "HIT live or let die" philosophy (let people die, or be injured physically or socially, so that IT may live) in my opinion.
I report, you decide.
-- SS
May 8, 2009 addendum:
The "live and let ... die" attitude can be seen in the concluding paragraph in a response by AMIA to Penn researcher Ross Koppel's JAMA article "Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians."
The AMIA response here (PDF) concludes with this paragraph:
I am sympathetic to these concerns, but only to the extent that I can tolerate the commentary's apparent irrationally exuberant and naive character.
I ask: how, exactly, are the beliefs "misplaced"? Who actually holds "misplaced" views? Those people who argue for patient and medical professional rights, a cautious approach to HIT, and regulation (as has occurred for decades in other biomedical industries such as pharma and medical devices), or those people who believe vendors can be counted on to disclose defects 100% by themselves on an "honor" system, without regulation?
Ironically, I believe their is much to be learned from another Penn researcher, in an article published in today's Philadelphia Inquirer:
-- SS
"It is time for a great new American enterprise -- time for this nation to take a clearly leading role in space achievement, which in many ways may hold the key to our future on earth ... First, I believe that this nation should commit itself to achieving the goal, before this decade is out, of landing a man on the moon and returning him safely to the earth. No single space project in this period will be more impressive to mankind, or more important for the long-range exploration of space; and none will be so difficult or expensive to accomplish."
In setting such an ambitious goal, the President was primarily putting at risk a handful of volunteer astronauts, several of whom actually did perish in the effort.
In 2009, President Obama committed the U.S. to full interconnected electronic health records (EHR's) by 2014.
In doing so, the President may be putting at risk millions of non-volunteer, ordinary people if the following is an example of what we can look forward to:
Authorities Hunt Hackers in Breach of Va. Health Data
By Brian Krebs and Anita Kumar
Washington Post Staff Writers
Thursday, May 7, 2009 2:06 PM
RICHMOND, May 7 -- The FBI and Virginia State Police are searching for hackers who have demanded the state pay them a $10 million ransom by Thursday for the return of millions of personal pharmaceutical records they stole from the state's prescription drug database.
The hackers claim to have accessed 8 million patient records and 35 million prescriptions collected by the Prescription Monitoring Program.
... State officials learned on April 30 that hackers had replaced the site's homepage with a ransom note demanding the $10 million payment [hence my title of medical cyber piracy - although perhaps I should call it cyber terrorism? -ed.] in order to receive a password needed to retrieve the records, according to a posting on Wikileaks.org, an online clearinghouse for leaked documents.
The program's computer system has been shut down since last week's breach, but all data were backed up and those files have been secured, Whitley Ryals said. Virginians are still able to get prescriptions filled.
"We do have some of systems restored, but we're being very careful in working with experts and authorities to take essential steps as we proceed forward," she said. "Only when the experts tell us that these systems are safe and secure for being live and interactive will that restoration be complete."
State law requires the agency notify individuals whose personal information may have been accessed. Officials are working with state attorneys to figure out how and when they will do that.
The state-run database allows doctors and pharmacies to track powerful narcotics and painkillers to reduce the abuse, theft and illegal sale of the controlled substances sold under labels such as OxyContin and Vicodin. It was set up as a pilot program in southwestern Virginia in 2003 and expanded statewide in 2006.
Emily Wingfield, chief deputy director of the Department of Health Professions, said the database contained 31.3 million prescription records as of Jan. 1. About 1 million records are added every month, she said.
[And now the customary disclaimer - ed.] State officials say they have no evidence that any personal information is at risk, but they recommend that anyone concerned about possible identity theft keep track of personal financial statements and periodically review credit reports.
Only the world's dreamiest and most naive optimist could believe that these occurrences of medical cyber piracy - or worse - would not become commonplace, with rapid expansion of a diverse array of commercial electronic health records systems among our nation's thousands of hospitals and hundreds of thousands of practitioners.
This is especially true at our current levels of information technology, but also at "our" (meaning, the existing pool of IT professional's) current levels of competence and intellectual capability to manage this technology.
This story in today's Wall Street Journal is another case in point along those lines:
FAA's Air-Traffic Networks Breached by Hackers
By SIOBHAN GORMAN
WASHINGTON -- Civilian air-traffic computer networks have been penetrated multiple times in recent years, including an attack that partially shut down air-traffic data systems in Alaska, according to a government report.
The report, which was released by the Transportation Department's inspector general Wednesday, warned that the Federal Aviation Administration's modernization efforts are introducing new vulnerabilities that could increase the risk of cyberattacks on air-traffic control systems. The FAA is slated to spend approximately $20 billion to upgrade its air-traffic control system over the next 15 years.
The increasing reliance of modernized systems on the Internet "is especially worrisome at a time when the nation is facing increased threats from sophisticated nation-state sponsored cyber attacks," wrote Assistant Inspector General Rebecca Leng.
... Security tests identified 763 "high risk" vulnerabilities that could allow hackers access to administrative systems, which could then provide a path to more-sensitive operational systems, the report said.
... Last year, hackers of unspecified origin "took over FAA computers in Alaska" to effectively become agency insiders, and traveled the agency networks to Oklahoma, where they stole the network administrator's password and used it to install malicious codes, the report said. These hackers also gained the ability to obtain 40,000 FAA passwords and other information used to control the administrative network, it said.
In February, another cyber break-in yielded the personal information of 48,000 current and former agency employees.
"The threat of hackers interfering with our air-traffic control systems is not just theoretical; it has already happened," said Republican Rep. Tom Petri of Wisconsin, one of the lawmakers who requested the report. "We must regard the strengthening of our air-traffic control security as an urgent matter."
In Nov. 2008 I wrote in a post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" that 2009 might not be the optimal time for a major national health IT initiative, and that a moratorium on such efforts should be considered. I amplified the point in this followup post and at these posts as well.
The Virginia prescription records debacle adds to my concerns.
There are some national initiatives, such as a lunar landing, that are supported by a likely, relatively small extension of existing technologies, plus a low risk factor or risk factor to a small number of people. There are other national initiatives whose time may not yet have come due to technological limitations, but even more importantly, due to the advanced technology developed by the (brilliant) few outpacing the capabilities of the (average) many to manage it properly.
One needs to ask - without conflict of interest - if the risks of any mass social and technological engineering initiative such as national EHR's are truly outweighed by the benefits at this point in time. This is not an easy decision.
The common refrain that to not proceed with national EHR now would "hold back innovation", however, is one of objectification of the people. It is a "HIT live or let die" philosophy (let people die, or be injured physically or socially, so that IT may live) in my opinion.
I report, you decide.
-- SS
May 8, 2009 addendum:
The "live and let ... die" attitude can be seen in the concluding paragraph in a response by AMIA to Penn researcher Ross Koppel's JAMA article "Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians."
The AMIA response here (PDF) concludes with this paragraph:
While we support increased transparency around error disclosure, the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced. Such an approach would stifle innovation and not achieve the desired goals.
I am sympathetic to these concerns, but only to the extent that I can tolerate the commentary's apparent irrationally exuberant and naive character.
I ask: how, exactly, are the beliefs "misplaced"? Who actually holds "misplaced" views? Those people who argue for patient and medical professional rights, a cautious approach to HIT, and regulation (as has occurred for decades in other biomedical industries such as pharma and medical devices), or those people who believe vendors can be counted on to disclose defects 100% by themselves on an "honor" system, without regulation?
Ironically, I believe their is much to be learned from another Penn researcher, in an article published in today's Philadelphia Inquirer:
Posted on Fri, May. 8, 2009This is one of the strongest cautionary tales regarding the unbridled drive for "innovation" that I've seen in some time.
Looking back, years after Penn gene-therapy death
By Marie McCullough
Inquirer Staff Writer
-- SS
Wednesday, May 06, 2009
Synthes Settles, Agrees to Stop Giving Stock to Physicians Conducting Clinical Trials
Again, 'tis the season for legal settlements. From the Newark Star-Ledger,
What will they think of next? We have seen plenty of cases in which physicians have been given payments that could influence their clinical decision making by companies with products or services to sell. Often, such payments are not disclosed. This is one of the few times I have seen physicians other than those on corporate boards, however, receiving payments in company stock. This would seem to be a new low. It surely would provide a more powerful incentive to make the studies' results favor the company's products than would mere cash payments. At least the settlement will stop this practice, and force disclosure of company payments.
The statements by the state Attorney General were particularly and admirably direct.
However, once again we see some familiar patterns. While human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a fine. In this case, the fine was, in corporate terms, tiny. However, even a large fine, however, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization, even a health care insurance company, will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.
ADDENDUM (6 May, 2009) - See also comments by Merrill Goozner on GoozNews blog.
New Jersey and Pennsylvania-based medical company Synthes reached a settlement today over the company's alleged financial conflicts of interest, which officials are calling a landmark deal, state officials announced today.
The attorney general's office launched an investigation early 2008 into Synthes, which produces devices for treating spinal trauma, to determine whether physicians were financially benefiting from conducting clinical trials on the company's products. Under the agreement, Synthes will no longer pay trial physicians with company stock and must disclose all payments to the physicians and whether the physicians have a financial stake in the outcome of the trial.Attorney General Anne Milgram, who said such provisions were the first of their kind, said conflicts of interest are common within the medical community.
'It is outrageous that doctors who are testing and, in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make the devices,' said Milgram. 'All patients -- but especially those considering high-risk devices such as spinal disc replacements -- deserve honest, objective clinical trial information about the products available.'
She also criticized the Food and Drug Administration, saying the federal agency was not vigilant enough in regulating Synthes, a $3.2 billion global company.
'Medical device makers have a duty to make certain that clinical trial results are accurate and unbiased,' Milgram said. 'In creating these financial incentives for doctors, Synthes and the rest of the industry have done the exact opposite. Going forward, if the industry will not address this problem voluntarily, we most certainly will.'
What will they think of next? We have seen plenty of cases in which physicians have been given payments that could influence their clinical decision making by companies with products or services to sell. Often, such payments are not disclosed. This is one of the few times I have seen physicians other than those on corporate boards, however, receiving payments in company stock. This would seem to be a new low. It surely would provide a more powerful incentive to make the studies' results favor the company's products than would mere cash payments. At least the settlement will stop this practice, and force disclosure of company payments.
The statements by the state Attorney General were particularly and admirably direct.
However, once again we see some familiar patterns. While human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a fine. In this case, the fine was, in corporate terms, tiny. However, even a large fine, however, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization, even a health care insurance company, will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.
ADDENDUM (6 May, 2009) - See also comments by Merrill Goozner on GoozNews blog.
WellCare Settles, Accepts Deferred Prosecution Agreement
'Tis the season for deferred prosecution agreements for health care organizations. As reported by the Wall Street Journal:
This was not the first bit of trouble WellCare got itself into. We posted here about how the state of Connecticut stopped WellCare from running a plan for poor children after the company refused to reveal what it was paying physicians, and why it was failing to pay for particular services.
So, as we have found from blogging on Health Care Renewal for a while, organizations that are found to be committing one sort of mischief often are also found to be committing another sort.
We also see some other familiar patterns. While human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a seemingly large fine. This, however, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization, even a health care insurance company, will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.
Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.
By the way, one member of the WellCare board of directors is Regina Herzlinger, a well known and prolific health policy expert, and holds the Nancy R. McPherson Professor of Business Administration Chair of the Harvard Business School. As far as I know, Prof Herzlinger is one of the many health policy experts who avoids discussing the sorts of problems with the accountability, integrity, and transparency of health care leadership which is grist for the mill here at Health Care Renewal. Yet under the stewardship of such an august expert, WellCare had to "accept and acknowledge full responsibility for ... conduct" that included fraud. Perhaps, Prof Herzlinger, like many other main stream health policy experts, should learn to acknowledge that health care leadership may be unaccountable, opaque, dishonest, and sometimes flagrantly corrupt. Furthermore, Prof Herzlinger, like many other well-paid board members of health care organization, should pay a bit more attention to the mischief being committed by those who answer to her.
WellCare Health Plans Inc. agreed to pay $80 million to settle a Florida Medicaid fraud investigation that has embroiled the company since the fall of 2007, previously prompting a management shake-up and restatement of more than three years of the company's earnings.
The settlement resolves federal and state criminal probes into allegations that WellCare defrauded Florida benefits programs for low-income adults and children of about $40 million by improperly inflating what it spent on care.
WellCare, based in Tampa, Fla., administers medical benefits for about 2.5 million enrollees in government-sponsored plans in several states.
Under a deferred prosecution agreement, the U.S. Attorney's Office for the Middle District of Florida in Tampa filed a fraud conspiracy charge against the company but said it wouldn't prosecute the case if WellCare meets all of the deal's terms.
U.S. Attorney A. Brian Albritton said in a news conference Tuesday that his office could have pursued a conviction but that it likely would have put the insurer out of business, hurting customers, innocent employees and shareholders. In penalizing the company, 'we have, at the same time, tried to avoid crushing it,' he said.
Under the terms, WellCare must forfeit $40 million and pay another $40 million in restitution to Florida's Medicaid and 'Healthy Kids' plans. WellCare also has agreed 'to accept and acknowledge full responsibility for the conduct that led to the government's investigations,' according to the deferred prosecution agreement. The company declined to elaborate.
In addition, the company also must retain an independent monitor to review its business operations, cooperate with the government's ongoing investigations and implement new procedures within 60 days to prevent future abuse or faulty reports to state health care programs.
This was not the first bit of trouble WellCare got itself into. We posted here about how the state of Connecticut stopped WellCare from running a plan for poor children after the company refused to reveal what it was paying physicians, and why it was failing to pay for particular services.
So, as we have found from blogging on Health Care Renewal for a while, organizations that are found to be committing one sort of mischief often are also found to be committing another sort.
We also see some other familiar patterns. While human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a seemingly large fine. This, however, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization, even a health care insurance company, will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.
Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.
By the way, one member of the WellCare board of directors is Regina Herzlinger, a well known and prolific health policy expert, and holds the Nancy R. McPherson Professor of Business Administration Chair of the Harvard Business School. As far as I know, Prof Herzlinger is one of the many health policy experts who avoids discussing the sorts of problems with the accountability, integrity, and transparency of health care leadership which is grist for the mill here at Health Care Renewal. Yet under the stewardship of such an august expert, WellCare had to "accept and acknowledge full responsibility for ... conduct" that included fraud. Perhaps, Prof Herzlinger, like many other main stream health policy experts, should learn to acknowledge that health care leadership may be unaccountable, opaque, dishonest, and sometimes flagrantly corrupt. Furthermore, Prof Herzlinger, like many other well-paid board members of health care organization, should pay a bit more attention to the mischief being committed by those who answer to her.
Tuesday, May 05, 2009
EHR's and Scarcity of Public Reviews of the User Experience
I recently downloaded the public beta (incomplete trial version) of Apple's new web browser Safari 4.
I like its user experience and features, presenting a main page "posterboard" of most visited or user-selected sites, a searchable, flip-panel history of visited pages (using the Macintosh OS X Spotlight and Cover Flow paradigms), top located tabs, and other useful features. (Note: I use both Macs and PC's, and hold no financial stakes in Apple whatsoever.)
What struck me was the vociferous online discussions and debates about every facet of the new browser version, down to the level of minutiae. The following review particularly struck me for its level of detail - Observations, Complaints, Quibbles, and Suggestions Regarding the Safari 4 Public Beta Released One Week Ago, Roughly in Order of Importance by John Gruber. It includes minutiae such as this:
Etcetera and so forth, on and on, as in other reviews easily found online.
In Electronic Health Records and other clinical IT, by way of contrast, reviews at this level of detail are ... nearly nonexistent (I use the term "nearly" because I authored such a review, in general terms, starting here). One reason EHR and other clinical IT user experience and performance debates are so rare is because customers are contractually forbidden to engage in them publicly. Koppel's and Kreda's JAMA paper makes that clear:
Vendors claim they are protecting their "intellectual property." I'm not exactly sure what IP they are holding as closely as the crown jewels.
Is it their:
In other words, what, exactly, is being protected by shielding commercial EHR's from external scrutiny and debate?
Is this the Secret Sauce the commercial EHR vendors seek to conceal?
The loss engendered by such policies is the reduced feedback from, and reduced interaction among endusers. This interaction occurs commonly on the Internet in 2009 on a great number of topics, but EHR user experiences are not one of them.
Companies like Apple and Microsoft, strongly user centric, encourage such debates through release of their beta's, both of enduser tools and of operating systems e.g., Windows 7 Beta. I should note that with these pieces of software, lives are not at stake, unlike with electronic health records systems.
The Veterans Health Administration makes a full working copy of VistA Computerized Patient Record System (CPRS) available as a free public download to anyone in the world here. I use it in my teaching (and am forced to do so, as commercial EHR demos are as available as, say, demos of the National Security Agency's spy and decryption software).
What, exactly, is the commercial EHR vendors' real excuse for the levels of product secrecy they maintain?
Could it be embarrassment and fear of exposure of defects, ill conceived design features and a mission hostile user experience?
-- SS
I like its user experience and features, presenting a main page "posterboard" of most visited or user-selected sites, a searchable, flip-panel history of visited pages (using the Macintosh OS X Spotlight and Cover Flow paradigms), top located tabs, and other useful features. (Note: I use both Macs and PC's, and hold no financial stakes in Apple whatsoever.)
What struck me was the vociferous online discussions and debates about every facet of the new browser version, down to the level of minutiae. The following review particularly struck me for its level of detail - Observations, Complaints, Quibbles, and Suggestions Regarding the Safari 4 Public Beta Released One Week Ago, Roughly in Order of Importance by John Gruber. It includes minutiae such as this:
... THE TABS
Safari’s new tab layout, placing the tabs directly in the window title bar, is a radical change. There’s no use addressing the specific details — good and bad — of this new arrangement, without first trying to figure out why Apple did this. Again, the designers are behind Apple’s wall of silence, so we’re left to speculate.
Rule out the notion that Safari’s designers undertook this change lightly. This is a major change to an important feature that many users feel strongly about. My guess is that this is an attempt to bring tabbed browsing to the masses. The biggest and most important change is that the interface for the tabs is now far more prominent. In fact, previously, the entire interface for tabbed browsing was not visible in Safari by default — in a window with just one tab, Safari’s default settings were such that the tab bar was not shown.
In Safari 4, there’s a prominent and unique “+” button that is always visible in the top right corner of every window, where the standard tic-tac button for toggling the display of the toolbar usually resides.1 Because the interface to create new tabs is now obvious, I can only assume that the point of this redesign is to encourage more people to use, or at least try, tabbed browsing.
But the problems with this new tab layout are significant.
Conceptually, the basic idea is sound. Browser tabs are, effectively, a collection of separate browser windows grouped together in a single parent window. Safari’s new tab layout makes this a tab is like a sub-window metaphor more explicit. The anchor, the conceptual root, of a standard Mac OS window is the title bar, and in Safari 4, the tabs aren’t just in the title bar, they are the title bar ...
Etcetera and so forth, on and on, as in other reviews easily found online.
In Electronic Health Records and other clinical IT, by way of contrast, reviews at this level of detail are ... nearly nonexistent (I use the term "nearly" because I authored such a review, in general terms, starting here). One reason EHR and other clinical IT user experience and performance debates are so rare is because customers are contractually forbidden to engage in them publicly. Koppel's and Kreda's JAMA paper makes that clear:
Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278
Vendors claim they are protecting their "intellectual property." I'm not exactly sure what IP they are holding as closely as the crown jewels.
Is it their:
- Earth shaking, 22nd century user interfaces?
- Secretive and ingenious widgets that revolutionize user selection from choice lists?
- Hyper-efficient, never before seen data structures and algorithms?
- Artificial intelligence routines that would make Captain Picard and his android sidekick Mr. Data envious?
In other words, what, exactly, is being protected by shielding commercial EHR's from external scrutiny and debate?
Is this the Secret Sauce the commercial EHR vendors seek to conceal?The loss engendered by such policies is the reduced feedback from, and reduced interaction among endusers. This interaction occurs commonly on the Internet in 2009 on a great number of topics, but EHR user experiences are not one of them.
Companies like Apple and Microsoft, strongly user centric, encourage such debates through release of their beta's, both of enduser tools and of operating systems e.g., Windows 7 Beta. I should note that with these pieces of software, lives are not at stake, unlike with electronic health records systems.
The Veterans Health Administration makes a full working copy of VistA Computerized Patient Record System (CPRS) available as a free public download to anyone in the world here. I use it in my teaching (and am forced to do so, as commercial EHR demos are as available as, say, demos of the National Security Agency's spy and decryption software).
What, exactly, is the commercial EHR vendors' real excuse for the levels of product secrecy they maintain?
Could it be embarrassment and fear of exposure of defects, ill conceived design features and a mission hostile user experience?
-- SS
Monday, May 04, 2009
Bio-Tech U
The San Francisco Chronicle just reported that a new Chancellor has been nominated for the University of California - San Francisco (UCSF). UCSF is functionally a health sciences university, and its Chancellor functions as its president. The UCSF medical school is generally considered one of the elite US academic medical institutions.
Dr Desmond-Hellmann is, in my humble opinion, a very unusual candidate to be Chancellor of one of the country's premier academic medical institutions. According to her official Genentech bio (taken off the Genentech server, but transiently available in the Google cache here), and a biography in Nature Drug Discovery, Dr Desmond-Hellmann, after getting both an MD and an MPH, spent two years doing AIDS research in Uganda as a UCSF junior faculty member, and then spent a few years in private practice hematology-oncology. She published few articles (5, according to Medline, last in 1995), and by 1993 went to work in industry, first for Bristol-Myers-Squibb. She started at Genentech in 1995, and worked her way up to her current position, "president, Product Development. In this role, Hellmann is responsible for Genentech's Development, Process Research & Development, Business Development, Product Portfolio Management, Alliance Management and Pipeline Planning Support functions. Hellmann is a member of Genentech's executive committee." Before her nomination to be Chancellor, Dr Desmond-Hellmann was "affiliated" faculty of the Department of Epidemiology and Biostatistics at UCSF, apparently with the rank of adjunct associate professor. In that capacity, she apparently gave a single seminar in 2007, and lectured in the Designing Clinical Research course in 2003.
So, on one hand, Dr Desmond-Hellmann, to be charitable, does not have much of an academic track record, at best approximating that of a very junior medical faculty member. She also certainly has no experience in academic administration. In general, people who lead academic medicine often have substantial track records in academics and in academic administration. So, in some sense, Dr Desmond-Hellmann's appointment seems to based on the theory of the generic manager. That is, the popular notion in the business world managers can manage anything, any organization, with any mission, in any context. Managing in the complex health care context, especially managing large, complex academic medical institutions, may not be easy for those used to managing elsewhere, even in the health care corporate world.
Furthermore, the complex mission of academic medicine, which includes providing excellent care of individual patients, while discovering and disseminating the truth in a spirit of free enquiry, is very different from the mission of a for-profit biotechnology company. How well someone used to the bottom-line mentality of the corporate world would uphold the academic mission is not clear.
Dr Desmond-Hellmann came from a company known for charging very high prices for the drugs it marketed, and Dr Desmond-Hellmann was on record personally defending this practice. Quoting from a news article in the Journal of the National Cancer Institute [McNeil C. Sticker shock sharpens focus on biologics. JNCI 2007; 99: 910-914.]
But, while Dr Desmond-Hellmann was defending pricing drugs that at more than $55,000 a year, and complaining about low industry profits, she was pocketing lavish rewards. According to Genentech's 2008 proxy statement, (the last available, since the company has been bought out by Roche), her total compensation was $8,361,348 in 2007 and $7,820,142 in 2006. In 2007, her total compensation was equal to 0.3% of the firm's total net income, and the top five company executives' total compensation was equal to about 1.5% of the firm's total revenues. In 2007, the firm's stock price declined from 91.30 on 6 January 2007 to 66.38 on 4 January, 2008, or 27%, according to Google Finance. In 2007, she held 1,616,383 shares of stock, or stock options exercisable within 60 days of January 31, 2008. In 2007 she exercised 170,000 stock options, realizing $11,556,663. So perhaps those high drug prices were needed not only to pay for research, but to make top executives, including Dr Desmond-Hellmann, very rich.
This raises further questions about her inclination to uphold the university's mission in the future.
In any case, hiring a lavishly compensated top executive from a biotech firm known for its high drug prices to run a public health sciences university does considerably blur the line between academic medicine and the health care industry. In the Chronicle article, Dr Desmond-Hellmann declared, "I began my career at UCSF and my heart has never left it." If she does become Chancellor, let us hope that her heart will speak louder than all those millions she used to make by, among other means, charging more than $55,000 a year for bevacizumab.
Genentech executive Susan Desmond-Hellmann has been nominated to be the next chancellor of UCSF, making her the first woman or biotech leader ever asked to run the research campus and hospital system that is San Francisco's second-largest employer.
Desmond-Hellmann has served most recently as president of drug development at Genentech, the South San Francisco biotech firm that was recently acquired by Swiss drugmaker Roche. She was trained as a physician, did her internship at UCSF and has taught there recently as an adjunct associate professor while working at Genentech.
Although prior UCSF chancellors have come from more academic or scientific backgrounds, [Dr Holly] Smith said Desmond-Hellmann's biotech connections would be an advantage as the university tries to translate scientific discoveries into medical treatments.
Dr Desmond-Hellmann is, in my humble opinion, a very unusual candidate to be Chancellor of one of the country's premier academic medical institutions. According to her official Genentech bio (taken off the Genentech server, but transiently available in the Google cache here), and a biography in Nature Drug Discovery, Dr Desmond-Hellmann, after getting both an MD and an MPH, spent two years doing AIDS research in Uganda as a UCSF junior faculty member, and then spent a few years in private practice hematology-oncology. She published few articles (5, according to Medline, last in 1995), and by 1993 went to work in industry, first for Bristol-Myers-Squibb. She started at Genentech in 1995, and worked her way up to her current position, "president, Product Development. In this role, Hellmann is responsible for Genentech's Development, Process Research & Development, Business Development, Product Portfolio Management, Alliance Management and Pipeline Planning Support functions. Hellmann is a member of Genentech's executive committee." Before her nomination to be Chancellor, Dr Desmond-Hellmann was "affiliated" faculty of the Department of Epidemiology and Biostatistics at UCSF, apparently with the rank of adjunct associate professor. In that capacity, she apparently gave a single seminar in 2007, and lectured in the Designing Clinical Research course in 2003.
So, on one hand, Dr Desmond-Hellmann, to be charitable, does not have much of an academic track record, at best approximating that of a very junior medical faculty member. She also certainly has no experience in academic administration. In general, people who lead academic medicine often have substantial track records in academics and in academic administration. So, in some sense, Dr Desmond-Hellmann's appointment seems to based on the theory of the generic manager. That is, the popular notion in the business world managers can manage anything, any organization, with any mission, in any context. Managing in the complex health care context, especially managing large, complex academic medical institutions, may not be easy for those used to managing elsewhere, even in the health care corporate world.
Furthermore, the complex mission of academic medicine, which includes providing excellent care of individual patients, while discovering and disseminating the truth in a spirit of free enquiry, is very different from the mission of a for-profit biotechnology company. How well someone used to the bottom-line mentality of the corporate world would uphold the academic mission is not clear.
Dr Desmond-Hellmann came from a company known for charging very high prices for the drugs it marketed, and Dr Desmond-Hellmann was on record personally defending this practice. Quoting from a news article in the Journal of the National Cancer Institute [McNeil C. Sticker shock sharpens focus on biologics. JNCI 2007; 99: 910-914.]
Never mind their novel targets and mechanisms. It's the cost of new biologic agents that's creating a buzz these days. At thousands of dollars a month, which can mean many tens of thousands for some regimens, sticker shock has generated recent, prominent articles in both the national and trade press.
On one level, the argument is about macroeconomics. Neal Meropol, M.D., of Fox Chase Cancer Center in Philadelphia, pointed out that cancer drugs account for 40% of all Medicare drug expenditures. That makes them a major contributor to the country's high health care costs, now about 17% of our gross domestic product (GDP) and growing. That percentage is much higher than in other developed countries with higher life expectancies, he said at a forum on cancer care costs at the American Association of Cancer Research annual meeting.
On the other side of the macroeconomic debate, experts point out that the U.S. has a high GDP to begin with and so can afford to spend more on health. And cancer biologics, though among the most costly drugs, are still only a tiny fraction of total GDP, said Genentech's Susan Desmond-Hellmann, president for product development, at AACR.
Hellmann and others argue that with these drugs’ potential to alleviate the huge societal burden of cancer, biologics are worth the cost.
The industry has responded to concerns about costs by putting more resources into patient assistance programs. When Genentech received U.S. Food and Drug Administration approval for bevacizumab in lung cancer last October, it also announced a cap on expenditures for the drug for patients with family incomes less than $100,000 a year. In 2005, the median household income was $46,326.
Originally announced as $55,000, the cap actually doesn't kick in until after a patient has received 10,000 mg. At the wholesale acquisition cost, 10,000 mg is about $55,000, said Genentech spokesperson Edward Lang.
What the companies have not done so far is reduce prices. The reason, industry representatives say, is the need to recoup massive research and development costs, including high manufacturing costs for biologics. These costs have long kept biotech companies from making much of a profit overall, Hellmann said. She noted that profit levels of publicly held biotech firms have "hovered close to zero" throughout the life of the industry.
But, while Dr Desmond-Hellmann was defending pricing drugs that at more than $55,000 a year, and complaining about low industry profits, she was pocketing lavish rewards. According to Genentech's 2008 proxy statement, (the last available, since the company has been bought out by Roche), her total compensation was $8,361,348 in 2007 and $7,820,142 in 2006. In 2007, her total compensation was equal to 0.3% of the firm's total net income, and the top five company executives' total compensation was equal to about 1.5% of the firm's total revenues. In 2007, the firm's stock price declined from 91.30 on 6 January 2007 to 66.38 on 4 January, 2008, or 27%, according to Google Finance. In 2007, she held 1,616,383 shares of stock, or stock options exercisable within 60 days of January 31, 2008. In 2007 she exercised 170,000 stock options, realizing $11,556,663. So perhaps those high drug prices were needed not only to pay for research, but to make top executives, including Dr Desmond-Hellmann, very rich.
This raises further questions about her inclination to uphold the university's mission in the future.
University of California, San Francisco is a leading university dedicated to defining health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
In any case, hiring a lavishly compensated top executive from a biotech firm known for its high drug prices to run a public health sciences university does considerably blur the line between academic medicine and the health care industry. In the Chronicle article, Dr Desmond-Hellmann declared, "I began my career at UCSF and my heart has never left it." If she does become Chancellor, let us hope that her heart will speak louder than all those millions she used to make by, among other means, charging more than $55,000 a year for bevacizumab.
BLOGSCAN - At UMDNJ, Lose Your Job, Keep Your Cell Phone
We have frequently discussed the plight of the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest health care university in the US. Facing indictment for federal crimes, the university operated under a deferred prosecution agreement and the supervision of a federal monitor from 2005 to 2007. We most recently blogged about UMDNJ here, and see links backward to previous posts from here. On the University Diaries blog, Prof Margaret Soltan discussed the latest aspect of mismanagement at UMDNJ to be uncovered.
BLOGSCAN - Merck Hired Elsevier to Create Fake Peer-Reviewed Medical Journal
You just can't make this stuff up. On the Respectful Insolence blog, Orac recounted how pharmaceutical giant Merck hired medical publishing giant Elsevier to create what appeared to be a peer-reviewed journal, but theAustralasian Journal of Bone and Joint Medicine really was just a marketing outlet. The goal was to market Fosamax and Vioxx. This is another bizarre variant on the stealth marketing theme, taken to quite an extreme. And the pharmaceutical companies wonder why people don't trust them?
ADDENDUM (4 May, 2009) - Dr Aubrey Blumsohn is back online on his Scientific Misconduct Blog, and noted the academic luminaries who were willing to serve on the editorial board of this fake peer-reviewed journal.
ADDENDUM (11 May, 2009) - See also comments on Laika's MedLibBlog.
ADDENDUM (4 May, 2009) - Dr Aubrey Blumsohn is back online on his Scientific Misconduct Blog, and noted the academic luminaries who were willing to serve on the editorial board of this fake peer-reviewed journal.
ADDENDUM (11 May, 2009) - See also comments on Laika's MedLibBlog.
Friday, May 01, 2009
Was Google lobbying Washington for HIPAA exclusion of their PHR effort?
At "Should Google Seek the Resignations of Those Responsible for This Healthcare IT Debacle?" I expressed great concern about what I term the cross occupational intrusion of the IT industry into healthcare.
My major concern in that post was how the information technologists at Google, even with nearly unlimited access to capital (and therefore to the world's informatics expertise) badly mismanaged a Personal Health Records (PHR) project through commission of a most fundamental biomedical information science blunder (quite distinct from IT; most IT technologists and MIS personnel really stink at biomedical information science). They tried to map relatively ungranular, imprecise, and often misused billing codes back to enduser-viewable diagnoses, resulting in easily predictable patient panic and mayhem.
As usual in HIT: it's possibly even worse.
I am quite concerned about a letter from the consumer education and advocacy organization Consumer Watchdog.org and their allegations that Google has been lobbying Congress to be excluded from HIPAA provisions on privacy and forbidding sales of medical records. The letter, dated April 22, is here (http://www.consumerwatchdog.org/resources/LtrSchmidt042209.pdf).
Considering that Google is heavily into the PHR space, and even worse, considering they made an Informatics 101 error in attempting to map billing codes into user-viewable diagnostic data, I would (and I'm sure others would as well) view such attempts if they indeed occurred as ominous, a true heavy handed intrusion of the IT industry not only into the affairs of medicine but into what really is another human rights issue. (I'd pointed out another potential HIT-related human rights issue at the post "UPMC as Proving Ground for IT Tests On Children".)
I would be interested in additional information on the Google lobbying issue, especially from those at Harvard and other academic centers who have been involved in the Google PHR initiative.
I have shared these concerns with the American Medical Informatics Association (AMIA) clinical information systems workgroup (cis-wg) and the people & organizational issues workgroup (poi-wg) as well.
I hope the Consumer Watchdog allegations are not accurate, because if they are valid, the implications of national EHR grow increasingly unsettling.
My major concern in that post was how the information technologists at Google, even with nearly unlimited access to capital (and therefore to the world's informatics expertise) badly mismanaged a Personal Health Records (PHR) project through commission of a most fundamental biomedical information science blunder (quite distinct from IT; most IT technologists and MIS personnel really stink at biomedical information science). They tried to map relatively ungranular, imprecise, and often misused billing codes back to enduser-viewable diagnoses, resulting in easily predictable patient panic and mayhem.
As usual in HIT: it's possibly even worse.
I am quite concerned about a letter from the consumer education and advocacy organization Consumer Watchdog.org and their allegations that Google has been lobbying Congress to be excluded from HIPAA provisions on privacy and forbidding sales of medical records. The letter, dated April 22, is here (http://www.consumerwatchdog.org/resources/LtrSchmidt042209.pdf).
Considering that Google is heavily into the PHR space, and even worse, considering they made an Informatics 101 error in attempting to map billing codes into user-viewable diagnostic data, I would (and I'm sure others would as well) view such attempts if they indeed occurred as ominous, a true heavy handed intrusion of the IT industry not only into the affairs of medicine but into what really is another human rights issue. (I'd pointed out another potential HIT-related human rights issue at the post "UPMC as Proving Ground for IT Tests On Children".)
I would be interested in additional information on the Google lobbying issue, especially from those at Harvard and other academic centers who have been involved in the Google PHR initiative.
I have shared these concerns with the American Medical Informatics Association (AMIA) clinical information systems workgroup (cis-wg) and the people & organizational issues workgroup (poi-wg) as well.
I hope the Consumer Watchdog allegations are not accurate, because if they are valid, the implications of national EHR grow increasingly unsettling.
Thursday, April 30, 2009
BLOGSCAN - Accountable Academic Governance Under Threat
On The Torch blog, hosted by FIRE (Foundation for Individual Rights in Education), this post by Kyle Smeallie summarized the travails of "petition candidates" for the boards of trustees of two elite American universities (Dartmouth and Harvard). As we have noted, at most universities, the boards of trustees, the bodies ultimately responsible for upholding the universities' missions, are closed shops. At most universities, the boards appoint new members to replace departing ones, without input from alumni, parents, students, faculty or anyone else who might be considered constituents. Thus, at most universities, even though the boards are ultimately responsible for the stewardship of the institutions, and upholding the institutions' missions, practically, they are accountable to no one. At very few universities, there may be contested elections for a few board seats, and an opportunity for those outside the board, usually alumni, to place candidates on the ballot. However, even at those somewhat more enlightened universities, those candidates face an uphill battle. Thus, while Dartmouth and Harvard have somewhat more transparent, accountable, and representative governance than do most academic institutions, even that is under threat.
Wednesday, April 29, 2009
Another Key Opinion Leader Confesses
The Milwaukee Journal-Sentinel published another story in their series on physicians' entanglements with health care corporations. This one tells the story of a single university faculty member who was seduced by pharmaceutical companies, then eventually became disillusioned.
It is nice that a few commercially paid "key opinion leaders" have realized what they were really doing. Maybe, Dr Stein will follow in the footsteps of Dr Daniel Carlat, and try to atone for his previous role in drug marketing disguised as education. (See Dr Carlat's excellent blog here, and his now classic article, "Dr Drug Rep.")
This compelling narrative reinforces some points about relationships among physicians and health care corporations.
Health care corporations do not pay for nothing, and are not charitable organizations. If a company pays a physician to give talks, it is almost certainly because those talks will help market company products or services.
Pharmaceutical and device companies have argued that they only pay the best and the brightest physicians as speakers and consultants. But this story (and others, e.g. here) suggest that they recruit young physicians who seem to be malleable and likely to go along with the company line, and groom them to do marketing in the guise of education.
The company's money thus helps mold "key opinion leaders." Worse, at many medical schools, being a commercially supported speaker or consult was a badge of honor. Thus, faculty chosen by commercial firms as most tractable and sympathetic to the companies' viewpoints, came to be regarded as the best and the brightest.
Why getting money from commercial firms was regarded as indicative of honor and intelligence, rather than gullibility, naivete, or worse, is not clear. I wonder whether it correlated with increasing alignment of the leadership of medical schools with commercial interests, and domination of the very top leadership, that is, the universities' board of directors, by those formerly regarded as Masters of the Universe (but now often seen as stupid, arrogant, greedy, or even corrupt. See posts about how the boards of Dartmouth, Harvard, and Yeshiva were disproportionately populated by leaders of [faux] finance).
At any rate, this is truly a cautionary tale of seduction of academia into hucksterism.
Hat tip to Margaret Soltan at University Diaries.
ADDENDUM (30 April, 2009) - See also the comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.
[Dr James] Stein, now a professor at the University of Wisconsin School of Medicine and Public Health, was a 29-year-old cardiology fellow in Chicago in 1994 when his faculty mentor asked him to fill in for him at a drug company-funded lecture to a large group of doctors.
It would be his first taste of life as a drug company speaker and consultant.
Stein got first-class airfare to Dallas. A limousine took him to a luxury hotel for the talk.
He walked off the stage, and a doctor from the conference handed him an envelope containing a $500 check.
'I got a pat on the back and he said, 'There's more where that came from, son.' I had no idea what that meant, but I went home and paid off part of my student loans,' Stein said in a presentation at UW this month.
Stein's first drug company talk led to more than a decade of work for drug companies before he gave it up for ethical reasons. Now he is speaking out.
Over the years, many of the big names in the drug industry would hire Stein to give speeches or serve as a consultant, eventually leading to fees of $2,000 to $3,000 per talk.
About a month after his first talk in 1994, Stein was asked by another drug company to give a lecture on cholesterol at a small hospital in Chicago, just as blockbuster statin drugs were coming on the market.
'I was really flattered because over and over again I was told that I was a future thought leader,' he said. 'I did my talk. I got a $750 honorarium and I was hooked.'
Stein said he now realizes that the speech at the hospital was just an audition.
'They wanted to know what I would say and how I would deliver,' he said. 'And I think they also wanted to know what I would say about their product.'
He joined speakers bureaus for several drug companies. It was a kind of badge of honor, he said. The more companies a doctor spoke for, the more highly he or she was regarded.
Stein, now 44, came to UW in 1996. Over the years, he would give talks and do other work for many of the top names in the pharmaceutical industry.
For instance, in 2005 Stein did work for six drug makers, according to a disclosure form filed with UW. That year, Pfizer paid him between $10,000 and $20,000 for four days of work as a speaker and advisory board member.
LipoScience, a firm that markets a cholesterol test, paid him $10,000 to $20,000 for four days of similar work.
Another firm, Schering-Plough, paid him about $12,000 for two days as a lecturer.
Although he said he had concerns about the propriety of his work, Stein said he was assured by his superiors there was nothing wrong with it as long as he did it on his own time. Indeed, they said it enhanced the reputation of the university.
And, he said, he considered himself an educator, not a salesman.
He said he tried to manage any conflicts of interest by disclosing who paid him, controlling the content of what he said and doing the work on personal time.
Things started to change rapidly beginning several years ago.
Drug companies began referring to the talks as promotional. They wanted him to use their slides; he refused. Then, medical journals and the lay press began printing articles questioning the ethics of the relationships.
A 2006 article in a Madison newspaper listed Stein as being among the UW doctors who reported the most money from the drug industry. Stein said he was embarrassed.
But, he said, he continued to try to manage his relationships with drug companies. He sent letters to patients disclosing his ties to industry. As of December 2006, he donated all the money from his talks to charity.
Why didn't he just stop doing the work?
He said he believed he could save more lives lecturing than by working in the emergency room. Stein said he saw no harm in being paid. But he admitted that giving the talks also made him feel important.
At the same time, new scientific articles suggested that it is impossible for doctors to be unbiased when they receive gifts or payments from drug companies.
'I have learned that human beings, physicians included, are incapable of recognizing bias in themselves, and even when you try not to be biased it is impossible to avoid it, especially when money is involved,' he said.
He said he came to realize that drug and medical device firms were no longer trustworthy partners in medical education.
He also said it has become obvious that patients have the least power and drug companies have the most power.
'I was wrong,' he said.
Stein said he stands by what he taught.
But, he added, 'I was naïve to think I was not influenced by the money and power of the drug and device companies.'
As of last December, he said, he stopped all drug company speaking and consulting other than bona fide research.
It is nice that a few commercially paid "key opinion leaders" have realized what they were really doing. Maybe, Dr Stein will follow in the footsteps of Dr Daniel Carlat, and try to atone for his previous role in drug marketing disguised as education. (See Dr Carlat's excellent blog here, and his now classic article, "Dr Drug Rep.")
This compelling narrative reinforces some points about relationships among physicians and health care corporations.
Health care corporations do not pay for nothing, and are not charitable organizations. If a company pays a physician to give talks, it is almost certainly because those talks will help market company products or services.
Pharmaceutical and device companies have argued that they only pay the best and the brightest physicians as speakers and consultants. But this story (and others, e.g. here) suggest that they recruit young physicians who seem to be malleable and likely to go along with the company line, and groom them to do marketing in the guise of education.
The company's money thus helps mold "key opinion leaders." Worse, at many medical schools, being a commercially supported speaker or consult was a badge of honor. Thus, faculty chosen by commercial firms as most tractable and sympathetic to the companies' viewpoints, came to be regarded as the best and the brightest.
Why getting money from commercial firms was regarded as indicative of honor and intelligence, rather than gullibility, naivete, or worse, is not clear. I wonder whether it correlated with increasing alignment of the leadership of medical schools with commercial interests, and domination of the very top leadership, that is, the universities' board of directors, by those formerly regarded as Masters of the Universe (but now often seen as stupid, arrogant, greedy, or even corrupt. See posts about how the boards of Dartmouth, Harvard, and Yeshiva were disproportionately populated by leaders of [faux] finance).
At any rate, this is truly a cautionary tale of seduction of academia into hucksterism.
Hat tip to Margaret Soltan at University Diaries.
ADDENDUM (30 April, 2009) - See also the comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.
Tuesday, April 28, 2009
UPMC as "Proving Ground" for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?
Hospitals as a "Proving Ground" for tests of unproven health IT - upon children?
At my post "BusinessWeek on Health IT: The Dubious Promise of Digital Medicine" I began to discuss the responses made by health IT vendors and organizations regarding HIT problems and defects, raised in a very serious April 23, 2009 BusinessWeek article on these issues.
In this post I address the following claims regarding UMPC and a controversial Dec. 2005 article by a UPMC physician in the journal Pediatrics ("Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System", Yong Y. Han et al. -- my comments on this paper at that time were at this link).
BusinessWeek wrote:
Again, I emphasize we are considering the healthcare of children in this matter.
Here are my observations and questions:
Pioneers?
Pioneers in what, exactly?
As a former NIH informatics fellow and then former CMIO myself more than a decade ago, it seems more likely UPHS (as well as the children and their parents, and the pediatricians who held the ultimate responsibility per Koppel and Kreda's Hold Harmless paper in JAMA) learned the "hard way" because the organization ignored the work of the pioneers.
There is literature going back fifty years on the challenges of health IT as mentioned in my many posts at HC Renewal, such as here.
I began my informatics postdoc in 1992-4 working on CPOE implementation at Yale-New Haven Hospital. I'd learned lessons from the writings of others who'd experienced CPOE difficulties years before that, such as (emphases mine):
The entire thirty year old field of Social Informatics spells out the dangers of unintended consequences, and books such as Lorenzi and Riley's "Managing Technological Change: Organizational Aspects of Health Informatics", which contains enough information to have allowed avoidance of the issues in the 2005 paper, was first published in 1994.
My website on HIT difficulties would have helped avoid these issues as well, and it has been online and nearly unique (and the top hit on queries on 'healthcare IT failure' - click here - and similar) for a decade. Did anyone in this CPOE project do such a search, read it, and perhaps query its author about the material [of course not - ed.] before spending tens of millions of dollars and putting patients at risk?
In other words, was true due diligence performed? Considering this was a Children's Hospital, one would have expected extraordinary levels of due diligence.
Pioneers learning the hard way? No. It seems this medical center was a pioneer in ignoring the lessons of the past. I believe a simpler explanation of the difficulties in this CPOE project might be that, like many HIT projects, the project was mismanaged.
Perhaps Dr. Martich meant UPMC were pioneers in this particular new CPOE system. As in this article in the Pittsburgh Tribune:
I cannot believe I am reading such a claim. A hospital and patients, as I have written before, are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk.
Were patients or their parents asked to give consent to the use of HIT (such as here)? Were they even aware they were serving as subjects of a "proving ground?" Likewise for clinicians?
It should be kept in mind that in this "proving ground" (i.e., experimental) situation we are dealing with children. Using a hospital as a "proving ground" for unproven HIT on unconsented or coerced subjects (e.g., children, their parents, and the doctors themselves) probably amounts to battery at the very least, is consistent with violations of fiduciary and Joint Commission safety standards, and I am concerned about it representing human rights violations as well.
In view of the recent Koppel and Kreda paper in JAMA on "hold HIT vendors harmless" and "defects gag" clauses, this entire arrangement seems incredibly disturbing at the very least.
I also believe the conflict of interest represented by a healthcare organization partnering with a vendor to "commercialize new medical technology" on unconsented subjects while sharing profits is a horrendous development, for as I stated, the appropriate settings for such practices are properly conducted, impartial clinical trials. The potential for abuses in the current arrangement seems uncomfortably high.
My sentiments seem aligned with IOM's recommendation 4.1 and others on Conflict of Interest as pointed out by fellow HC Renewal blogger Bernard Carroll at this post:
One wonders if the individuals involved in the CPOE project had unreported conflicts of interest with the HIT industry. Perhaps, as in pharma, this needs to be explored.
Han's 2005 article in Pediatrics suggesting children died as a result of the "experiment" should probably be further explored on the basis of the issues I raise above. I also note Han is no longer at UPMC; perhaps his treatment after publication of this article should also be investigated.
In Dec. 2005 on this blog I wrote:
I stand by that assessment.
Finally, putting the camera to my statement that medicine is suffering a cross occupational invasion by the IT industry, in Business Week the picture below appeared of a handsome and proud physician in his office:
Cerner CEO Neal Patterson
Oh, wait...
That person is not a physician nor does he have any medical experience of which I am aware. He is the CEO of the Cerner HIT company.
This picture is the future face of medicine, and it will not be the brightest of futures if this cross occupational invasion continues unopposed by those of a scientific and biomedical mindset much longer.
I really do believe it is the time for a Congressional investigation of these issues, and strong consideration of FDA regulation of health IT, a precedent set long ago in the pharmaceutical industry.
-- SS
Addendum: I note in Dr. Martich's bio an impressive list of medical credentials; however I find formal Biomedical Informatics and/or computer science training lacking. This is not to attack the person, but the culture of HIT, as this scenario is common in HIT and represents what I refer to as "amateurs" running health IT.
I use the term "amateur" not derisively, but in the same sense that I am a radio amateur (albeit licensed after examination at the Extra class and in the "old days", when 20 WPM morse code proficiency was also required). I am not a telecommunications professional. While I have excellent skills in telecommunications theory, hardware, antennas, and operations, I would not consider myself even remotely qualified to, say, run a strategic telecommunications project for a large organization.
In medicine, I always believed education was critical. I may have been mistaken.
At my post "BusinessWeek on Health IT: The Dubious Promise of Digital Medicine" I began to discuss the responses made by health IT vendors and organizations regarding HIT problems and defects, raised in a very serious April 23, 2009 BusinessWeek article on these issues.
In this post I address the following claims regarding UMPC and a controversial Dec. 2005 article by a UPMC physician in the journal Pediatrics ("Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System", Yong Y. Han et al. -- my comments on this paper at that time were at this link).
BusinessWeek wrote:
... [HIT vendor Cerner] faced more questions over its technology at the University of Pittsburgh Medical Center (UPMC). In 2005 researchers there [i.e., Han et al. - ed.] found that at the university's Children's Hospital [note that this is a Children's Hospital - ed.], patient deaths more than doubled, to 6.6% of intensive-care admissions, in the five months following the installation of a computerized order-entry system. The research on child patient deaths at the University of Pittsburgh found a "direct association between [computerized records] and increased mortality," according to an article published in December 2005 in the medical journal Pediatrics. Digital technology slowed treatment in several ways, the researchers concluded. One example: Doctors and nurses in the intensive-care unit were accustomed to ordering medications and tests while a sick child was en route to the hospital.
The Cerner system required that orders be submitted only when the patient arrived, costing crucial time. The authors of the Pediatrics article acknowledged that their work clashed with other studies showing that digitization decreases errors and shortens hospital stays [but also is consistent with another body of literature (examples here) that Health IT vendors and others with conflicts of interest simply ignore, as per my numerous HC Renewal posts on the issue. Pharma should only have it as good - ed.]
G. Daniel Martich, chief medical information officer at UPMC, says the Pediatrics study was flawed. Factors other than the installation of computers, such as the centralization of pharmacy services, also disrupted care, he emphasizes. The problems identified in the 2005 paper have all been resolved, Martich adds. "There were workflow issues," he says. "We learned the hard way because we were pioneers." Over the long run, he says, technology has helped decrease mortality rates and cut medication errors in half at Children's Hospital since 2003 .
Again, I emphasize we are considering the healthcare of children in this matter.
Here are my observations and questions:
- Why is the 2005 paper simply being dismissed? This is not a scientific approach to the peer reviewed literature, especially where the deaths of children are concerned. I believed in 2005 and believe now that the red flags raised by this paper may have been "brushed under the carpet" too rapidly. See my 2005 post on the matter.
- The implication that the Cerner CPOE was uninvolved in the increased mortality would itself require a very careful observational study to ferret out the exact contributions of its deficits and that of the "centralization" of pharmacy services and other factors. Has such a study been performed and peer reviewed, and has a rebuttal been posted by the original study's authors? Can such a prospective study even be performed after the fact?
- While CMIO G. Daniel Martich claims "the problems in the 2005 paper have all been resolved" [wait - I thought the paper was flawed, yet it illustrated problems now resolved? - ed.], how can patients be assured of this? Where are the studies that show the issues have all been resolved?
- Does the damning commentary by the UK's former NHS HIT Director Richard Granger, stories such as patients going untreated for months at a time related to Cerner Millennium Care Records Service ("If NPfiT were a jumbo jet heaven help 747 flyers"), an equally damning report in Jan. 2009 on Cerner's EHR products (i.e., "Millenium") as reported by the UK House of Commons Public Accounts Committee, and the impact on the UK's £12.7 billion national Health IT project suggest a systemic problem needing investigation?
Pioneers?
Pioneers in what, exactly?
As a former NIH informatics fellow and then former CMIO myself more than a decade ago, it seems more likely UPHS (as well as the children and their parents, and the pediatricians who held the ultimate responsibility per Koppel and Kreda's Hold Harmless paper in JAMA) learned the "hard way" because the organization ignored the work of the pioneers.
There is literature going back fifty years on the challenges of health IT as mentioned in my many posts at HC Renewal, such as here.
I began my informatics postdoc in 1992-4 working on CPOE implementation at Yale-New Haven Hospital. I'd learned lessons from the writings of others who'd experienced CPOE difficulties years before that, such as (emphases mine):
Massaro TA. Introducing physician order entry at a major academic medical center. I: Impact on organizational culture and behavior. Acad Med 1993;68:20–5. [PubMed]
Summary: In 1988 the University of Virginia Medical Center began implementation of a medical information system based on mandatory physician order entry. The implementation process was much more difficult than expected. The program experienced considerable delays, and cost much more than was originally estimated. Although there were some legitimate questions concerning the user-friendliness of the new technology, these were less significant than the cultural and behavioral problems encountered. The new system challenged basic institutional assumptions; it disturbed traditional patterns of conduct and forced people to modify established practice routines ... The author describes the problems that occurred and the organizational behaviors on which they were based, analyzes the lessons learned, documents the progress that has been achieved, and outlines the challenges that remain. The center's experience provides insight into the issue of technology-driven organizational transformation in academic medical centers. Recommendations for successful introduction of similar agents of institutional change are presented.
and
Massaro TA. Introducing physician order entry at a major academic medical center: II. Impact on medical education. Acad Med 1993;68:25–30. [PubMed]:
Summary: The introduction [in 1988] of an information technology (IT) system that mandates order entry by physicians had significant and often unexpected effects on medical education at the University of Virginia Medical Center. The system was deactivated briefly after the introduction of laboratory ordering, and frustration with the pharmacy ordering pathways provoked a major confrontation between the residents and medical center management. Changes in responsibilities, patterns, and priorities of work introduced by the system also contributed significantly to the general dissatisfaction. These issues had not been thoroughly considered in the planning stage, but it was only after accommodation was made to these changes that integration of the technology into routine practice could proceed. The author emphasizes the importance of extensive involvement and leadership of attending physicians in the planning and implementation of such a system. He presents a set of recommendations to those considering similar IT initiatives and wishing to reduce the disruptions that may accompany their introduction. With time and experience, however, the housestaff have adjusted to the system and developed facility in using it. Much of the dissatisfaction was derived from the perception that "doctors spend too much time on the computer." In fact, less than 10% of the physicians spent more than an hour each day. However, a small group of residents on call for the busier services were sometimes at the computer for more than four hours each day.
The entire thirty year old field of Social Informatics spells out the dangers of unintended consequences, and books such as Lorenzi and Riley's "Managing Technological Change: Organizational Aspects of Health Informatics", which contains enough information to have allowed avoidance of the issues in the 2005 paper, was first published in 1994.
My website on HIT difficulties would have helped avoid these issues as well, and it has been online and nearly unique (and the top hit on queries on 'healthcare IT failure' - click here - and similar) for a decade. Did anyone in this CPOE project do such a search, read it, and perhaps query its author about the material [of course not - ed.] before spending tens of millions of dollars and putting patients at risk?
In other words, was true due diligence performed? Considering this was a Children's Hospital, one would have expected extraordinary levels of due diligence.
Pioneers learning the hard way? No. It seems this medical center was a pioneer in ignoring the lessons of the past. I believe a simpler explanation of the difficulties in this CPOE project might be that, like many HIT projects, the project was mismanaged.
Perhaps Dr. Martich meant UPMC were pioneers in this particular new CPOE system. As in this article in the Pittsburgh Tribune:
The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology."Proving ground?"
UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort.
The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM.
As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits.
I cannot believe I am reading such a claim. A hospital and patients, as I have written before, are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk.
Were patients or their parents asked to give consent to the use of HIT (such as here)? Were they even aware they were serving as subjects of a "proving ground?" Likewise for clinicians?
It should be kept in mind that in this "proving ground" (i.e., experimental) situation we are dealing with children. Using a hospital as a "proving ground" for unproven HIT on unconsented or coerced subjects (e.g., children, their parents, and the doctors themselves) probably amounts to battery at the very least, is consistent with violations of fiduciary and Joint Commission safety standards, and I am concerned about it representing human rights violations as well.
In view of the recent Koppel and Kreda paper in JAMA on "hold HIT vendors harmless" and "defects gag" clauses, this entire arrangement seems incredibly disturbing at the very least.
I also believe the conflict of interest represented by a healthcare organization partnering with a vendor to "commercialize new medical technology" on unconsented subjects while sharing profits is a horrendous development, for as I stated, the appropriate settings for such practices are properly conducted, impartial clinical trials. The potential for abuses in the current arrangement seems uncomfortably high.
My sentiments seem aligned with IOM's recommendation 4.1 and others on Conflict of Interest as pointed out by fellow HC Renewal blogger Bernard Carroll at this post:
Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).
One wonders if the individuals involved in the CPOE project had unreported conflicts of interest with the HIT industry. Perhaps, as in pharma, this needs to be explored.
Han's 2005 article in Pediatrics suggesting children died as a result of the "experiment" should probably be further explored on the basis of the issues I raise above. I also note Han is no longer at UPMC; perhaps his treatment after publication of this article should also be investigated.
In Dec. 2005 on this blog I wrote:
... This study is dealing with children, of course, and is perhaps a flag that much more detailed study of these systems, especially in socially-sensitive environments such as pediatrics, need to be performed.
For if this study's findings are not just due to serendipity and do reflect some underlying causation, the medical, ethical and legal issues could be enormous.
I stand by that assessment.
Finally, putting the camera to my statement that medicine is suffering a cross occupational invasion by the IT industry, in Business Week the picture below appeared of a handsome and proud physician in his office:
Cerner CEO Neal PattersonOh, wait...
That person is not a physician nor does he have any medical experience of which I am aware. He is the CEO of the Cerner HIT company.
This picture is the future face of medicine, and it will not be the brightest of futures if this cross occupational invasion continues unopposed by those of a scientific and biomedical mindset much longer.
I really do believe it is the time for a Congressional investigation of these issues, and strong consideration of FDA regulation of health IT, a precedent set long ago in the pharmaceutical industry.
-- SS
Addendum: I note in Dr. Martich's bio an impressive list of medical credentials; however I find formal Biomedical Informatics and/or computer science training lacking. This is not to attack the person, but the culture of HIT, as this scenario is common in HIT and represents what I refer to as "amateurs" running health IT.
I use the term "amateur" not derisively, but in the same sense that I am a radio amateur (albeit licensed after examination at the Extra class and in the "old days", when 20 WPM morse code proficiency was also required). I am not a telecommunications professional. While I have excellent skills in telecommunications theory, hardware, antennas, and operations, I would not consider myself even remotely qualified to, say, run a strategic telecommunications project for a large organization.
In medicine, I always believed education was critical. I may have been mistaken.
INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST
INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST
Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences issued a report of its Committee on Conflict of Interest in Medical Research, Education and Practice. The report is comprehensive, even exhaustive, running to 353 pages. Gardner Harris in the New York Times today calls it “scolding,” “stinging,” and “damning.” The recommendations go well beyond any proposed in the recent past by medical schools or by other professional organizations. The NYT quoted David Rothman, president of the Institute on Medicine as a Profession at Columbia University: “With the I.O.M.’s endorsement, issues that were once controversial now are indisputable. Conflicts of interest in medicine are no longer acceptable.”
It will take some time for the field to digest the scope of the IOM recommendations. It will take even longer for the new standards to be implemented. For now, I offer just a few observations.
First, if the IOM hopes for maximum credibility then it might ought want to do some housecleaning. A few years ago I fired a shot across the bow of the IOM concerning COI. [Can the Institute of Medicine Review the FDA? Nature Medicine 11, 369 (1 April 2005) doi:10.1038/nm0405-369] Nothing much changed, and in the following years, national scandals erupted involving several of the issues I had highlighted. Prominent IOM members, who were well known to be poster boys for COI, were exposed by Senator Charles Grassley (R-Iowa). Their embarrassing behaviors included incomplete financial disclosures and noncompliance with NIH policy on financial conflict of interest. The exposés included Emory’s Charles Nemeroff and Stanford’s Alan Schatzberg. In both cases, administrative rearrangements have now been implemented. The case of Dr. Nemeroff has been referred by Senator Grassley to the Inspector General of the Department of Health and Human Services. It is perhaps no accident that Dean Claudia Adkison of Emory and Dean Philip Pizzo of Stanford were included as external reviewers of the draft IOM report. Their insights would have been invaluable.
Another ongoing embarrassment for the IOM is Lester Crawford. He was the FDA Commissioner who resigned abruptly in 2005 and later pleaded guilty to criminal conflict of interest. He had been charged with falsely reporting information about his stock holdings in companies he was in charge of regulating. He received a sentence of three years of supervised probation and a fine of about $90,000. He is now senior counsel with a health care lobbying firm in Washington, DC. The Institute of Medicine does not help its image by continuing the membership of such a compromised individual.
As the Emory-Nemeroff and Stanford-Schatzberg cases unfolded it appeared that the respective institutions had themselves contributed to the problems, either through inaction or through studiously nontransparent procedures on disclosure. Stanford, for instance, apparently did not require faculty members to report the proceeds of stock sales, and when challenged the university invoked on-line financial reporting services and SEC filings as a sufficient substitute. Not surprisingly, because Stanford didn’t know about Dr. Schatzberg’s realized gain of some $109,000 from sale of founder’s stock in his biotech start-up company, Corcept Therapeutics, this information was not reported to NIH.
Recommendation 4.1 One of the IOM’s recommendations applies particularly to the Stanford-Schatzberg case. Recommendation 4.1 addresses the boundary between academia and commerce in the case of research involving human subjects. Here is the specific language:
“Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).
Last year I posted several times about this issue in the Stanford-Schatzberg case. It is gratifying now to see the IOM affirm the importance of the boundary. The activities declared off-limits by the IOM include not only “recruiting subjects; obtaining informed consent; assessing the clinical end points;” but also “analyzing data; or writing the results, conclusions, and abstracts for publications reporting the findings of the study.” (page 4-17). In Stanford’s earlier plan for managing the conflict and protecting the integrity of the research, Dr. Schatzberg was free to engage in the latter group of activities. Indeed, his hands were all over the project when it came to responding to scientific critiques, managing the climate of professional opinion, attacking and threatening critics, promoting his company’s interest through review articles and press releases, slipping unpublished and non-peer-reviewed commercial data into academic reviews, and generally conducting commercially slanted public relations through academic outlets.
When Stanford adopts the IOM recommendations, such activities will be blocked. As I stated last year, “Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be.”
We should congratulate the IOM committee members for their work, and we hope to see the field embrace their recommendations.
Bernard Carroll.
UPDATE 04-30-2009: The link provided earlier for the IOM report document is no longer operative. Here is where to go now for a copy of the report. This time it will cost you.
Subscribe to:
Posts (Atom)