Did Toxic Effects of an EHR Kill Rory Staunton?

A stunning story about the death of a young man from sepsis (blood poisoning by infection), missed in an ED, appeared in the New York Times:

An Infection, Unnoticed, Turns Unstoppable

By JIM DWYER
New York Times
Published: July 11, 2012

For a moment, an emergency room doctor stepped away from the scrum of people working on Rory Staunton, 12, and spoke to his parents.

“Your son is seriously ill,” the doctor said.

“How seriously?” Rory’s mother, Orlaith Staunton, asked.

The doctor paused.

“Gravely ill,” he said.

How could that be?

Two days earlier, diving for a basketball at his school gym, Rory had cut his arm. He arrived at his pediatrician’s office the next day, Thursday, March 29, vomiting, feverish and with pain in his leg. He was sent to the emergency room at NYU Langone Medical Center. The doctors agreed: He was suffering from an upset stomach and dehydration. He was given fluids, told to take Tylenol, and sent home.

Partially camouflaged by ordinary childhood woes, Rory’s condition was, in fact, already dire. Bacteria had gotten into his blood, probably through the cut on his arm. He was sliding into a septic crisis, an avalanche of immune responses to infection from which he would not escape. On April 1, three nights after he was sent home from the emergency room, he died in the intensive care unit. The cause was severe septic shock brought on by the infection, hospital records say. 

Rory Staunton, age 12, 5 feet 9 inches tall and 169 pounds, had suffered a cut on his arm.  He presented with a marked fever of 102 F (39 C), pulse markedly elevated at 131, respiratory rate elevated at 22; reported to have hit as high as 36 breaths per minute (in essence, panting).  It was reported by the NYT that before the ED visit his parents said his temperature had reached 104 F (40 C).

That alone should have set off some level of concern.  (It is possible narrative details of his history never made it into the ED chart; ED EHR's are often templated point-and-click affairs that can impair or discourage capture of narrative.)

Per the NYT, the bacteria Streptococcus pyogenes normally dwells in the throat or on the skin, areas where the body is well defended.  Also known as Group A streptococcus, the strain typically causes strep throat or impetigo.  However, if it gets into the blood stream (e.g., via a cut in the skin, as this patient suffered playing ball), the results can be devastating.

The lab results from the first ED visit are particularly stunning:

(From NYT article; click to enlarge)

The white blood cell count is markedly elevated at 14.7, meaning 14,700 cells per microliter of blood (cubic millimeter or 1 mm³).  Further, there is a plain evidence of greatly accelerated new white cell production, in the form of "bands", at 53% of the total (normally 5-15%).  Bands are immature white blood cells that are seen in the blood, being produced as part of the body's response to infection.

Herein is a significant issue.  The NYT noted that:

"Three hours later [i.e., after the ED visit, which reportedly only lasted 2 hours - ed.], Rory’s blood tests came back. High levels of neutrophils and “bands” – immature white blood cells – are evidence of infection. But nobody called the Stauntons, and by the time Rory returned to the hospital the next day, his infection was unstoppable. He died two days later."

Not getting into the issue regarding the patient apparently being discharged before the labs got back (itself an invitation to disaster), and the other abnormalities such as low sodium, low platelets, elevated glucose all pointing to a very sick patient... nobody called the Stantons with white cell results like these?   Nobody entertained the thought of ... antibiotics as a precaution?

It is possible - dare I say likely - that no clinical person in the ED ever saw these results.

EHR's that are poorly designed or implemented can have a toxic effect on care.  For instance, EHR's can cause user confusion if the user interface is complex, data can be lost due to poor relational design.  Data from the wrong patient's data can be presented (misidentification), or data from a lab can come back to the system after a patient has left, and despite being abnormal, just sit there in a silo without being looked at ("out of sight, out of mind"; a "silent silo" syndrome).

It is usually difficult to ascertain exactly which EHR product is being used at a particular hospital.  I note this medical center actively promoted its EPIC EHR in a June 2011 press release "NYU Langone Medical Center Launches Next Phase of Its Electronic Health Record System", although another system "ICIS"  (for Integrated Clinical Information System, "a state-of-the-art healthcare information management system that connects all NYULMC caregivers involved in patient care") is mentioned here.  The ICIS may also contain the Eclipsys Sunrise Clinical Manager, per this link. (I'd noted some clinically relevant problems with the latter in an FDA report here.)

In any case, magical powers are attributed to the technology that are not strongly or uniformly supported by the literature (link), but strongly pushed by industry marketing memes of deterministic health IT benefits and absolute beneficence:

“... Our electronic health record system is an integral part of our ongoing efforts to leverage technology and enhance our ability to provide patient-centered care and enable the highest level of quality care management,” said Bernard A. Birnbaum, MD, senior vice president and vice dean, chief of hospital operations at NYU Langone. “These front-end and back-end services are an important step in assuring our patient’s experience from beginning to end is a seamless one.”

I've documented examples of situations where EHR's and other IT components of clinical ERP systems (enterprise resource planning and management systems, a term that more accurately describes what exists in many hospitals now than the misleading, file cabinet-evoking term "EHR") contributed to or caused patient harm, such as at "Babies' deaths spotlight safety risks linked to computerized systems" - a computer error caused a central line placement x-ray to have gone unread, leading to death; "The Sweet death that wasn't very sweet" - a missing "difficult intubation" EHR flag led to a middle-aged man suffocating during an intubation attempt; and others.  An Australian researcher thoroughly studied the potential risks of an EHR meant specifically for ED's ("A Study of an Enterprise Health information System", PDF executive summary at this link).

The following passage in the NYT article also offers another clue:

... Two hours later, though, he had three [signs of sepsis]: his temperature had risen to 102, his pulse was 131 and his respiration rate was 22. But by the time those vital signs were recorded, at 9:26 p.m., they had no bearing on his treatment. In fact, the doctor had already decided that Rory was going home. Rory’s “ExitCare” instructions, signed by his father, were printed 12 minutes before those readings. 

Did those readings escape notice due to delayed charting (data entry), a common problem with EHRs in busy clinical environments?

The Institute of Medicine in its 2011 IOM report on health IT safety admitted harms are reported but the magnitude of harms is unknown due to multiple reporting impediments, as did the FDA in its 2010 internal memo on "H-IT Safety Issues" divulged by the Huffington Post Investigative Fund (see here and here).  The National Institute of Standards and Technology (NIST) admits in its 2011 report on HIT usability that EHR usability is often poor and may lead to "use error" (error caused or promoted by poor design, as distinguished from simple user error, see here), magnitude of problem also unknown.

In a startling medical situation such as Rory Stanton's, where crucial labs seem to have evaporated causing or contributing to delayed treatment of a devastating and obvious illness, I believe EHR-related factors need to be examined and ruled out first.

For, quite simply, if the EHR caused or contributed to this tragic debacle, the public could be at risk.


-- SS

Additional thought:  could this be the "cybernetic Libby Zion case" I've written of?

-- SS

July 18, 2012 Addendum:

The Stauntons, who appeared on the NBC Today Show are seeking to create a “Rory’s Law” in New York to ensure that parents have full access to blood and lab tests done on their children as soon as results are available, and that a doctor will be present to assess the findings. Story here.

-- SS

Quantitating the Corruption of Finance Leadership (Who May Overlap with Health Care Leadership)

The bad leadership in health care that we frequently discuss now appears to exist in a context of an increasingly corrupt society.  In particular, we have discussed how the leadership of major health care organizations, such as teaching hospitals, and the universities within which medical schools operate, now frequently interlocks with the leadership of finance.  The ongoing global financial problems have been blamed on bad leadership in finance.

A Survey of Finance Leaders

Now, a survey by a law firm that supports corporate whistleblowers offers some quantitation of the corruption within finance.  The press release for the survey is here, and a summary of results is here.  The survey respondents were 250 US based, and 250 UK based "senior individuals within the financial services industry."

Key results were:

- 24% of those surveyed believed that the rules may have to be broken in order to be successful.

- 25% of UK respondents believed financial services professionals may need to engage in unethical or illegal activity to get ahead; US respondents were only slightly less inclined to engage in wrongdoing at 22%.

- 12% of total respondents believed that it was likely that staff in their company have engaged in unethical or illegal activity in order to be successful.

Perhaps exhibiting ego bias, the senior professionals thought that there competitors were even worse:

39% of total respondents believed it was likely that their competitors have engaged in illegal or unethical activity in order to be successful.

A substantial number of respondents admitted that they would be willing to engage in illegal activity were the circumstances favorable:

16% of total respondents were at least fairly likely to engage in insider trading if they could get away with it. Perhaps more troubling, only 55% of all respondents could say definitively that they would not engage in insider trading if they could make $10 million with no risk of getting arrested.

An important fraction thought that the worked within organizations that encouraged unethical and illegal behavior:

- 30% of all financial services professionals reported feeling pressure to compromise ethical standards or violate the law as a result of their compensation or bonus plan.

- In assessing other pressures that may lead to unethical or illegal conduct, 23% of all respondents also reported feeling other pressures to compromise ethical standards or violate the law.

Note that due to social desirability bias, the survey likely understates these problems.

Comment

Also note that at least so far, this survey is not much less anechoic than much of the evidence of corruption in health care that we have discussed. Although it has been briefly noted in the financial blogs and press, like Reuters, BusinessWeek, and also in the New York Daily News and Los Angeles Times, no other main-stream media has commented yet.

One post on a Forbes blog by Peter Cohan made the weary observation:

Business corruption follows a well-worn path. The boss tells you to bend the rules, and knowing that ignoring that request will cost you your job, you do what you’re told. At the end of the year you get a big bonus and promotion.

Then a disgruntled customer or employee leaks the shady activity to the press or a regulator and your company pays a fine and gets a few weeks of bad headlines. Time passes and the cycle restarts.

He concluded in part:

The conditions that make business corruption pay off have not changed despite numerous scandals — recent ones include Enron, WorldCom, Madoff, and Lehman Brothers – all of which reflect the same conditions that prompted me to write Value Leadership a decade ago: Let executives write their own report cards, base bonuses on those numbers and you will get corruption every time.

The solution is as clear to me as it is impossible to implement. First, all corporate financial reporting must be conducted by highly paid government auditors –rather than by auditing firms that are paid by the companies they audit. Second, performance-linked bonuses must be set aside in escrow accounts for a decade until it’s clear whether the true benefits of business strategies exceed their costs.

As long as there is no limit to how much money companies can put into politicians’ pockets, this fix will never be implemented. That’s because money puts big business in control of politicians who — if they were responding to the interests of the majority of Americans — would eliminate the conditions that make the benefits of business corruption exceed its costs.

But business corruption pays for those who finance Washington campaigns so the soil in which it flourishes remains fertile.

The same is likely to be true of unethical practices by and corruption of health care leadership. After all, health care leaders now mainly come from business management backgrounds, and so have been trained in the same way as financial professionals, and exposed to the same culture that they have experienced. As we have noted, the leadership of health care and finance often overlap. For example, see ours posts on the finance influence on the board of Dartmouth College; the role of the former CEO of bankrupt Lehman Brothers on the board of New York-Presbyterian hospital; the role of finance leaders who derided the Occupy Wall Street as "imbeciles," among other things on the boards of miscellaneous health care organizations; the role of finance leaders on the board of Pfizer, etc, etc, etc.

True health care reform may require larger reform in the greater society.  In any case, we need to reform the culture of health care organizations so that leaders put patients' and the public's health first, and self-interest last.  Furthermore, health care organizations should not provide positive incentives merely for exceeding financial or volume benchmarks, and should provide strong negative incentives for unethical behavior.

Manipulation of 12,000 Medical Records Made Easy by EHR

This from a hospital in Canberra, Australia using a common ED EHR in that part of the world, iSOFT:

Canberra Hospital embroiled in data scandal
SBI Magazine (Secure Business Intelligence)
Jul 5, 2012 

A Canberra Hospital executive has admitted to manipulating Emergency Department records to make wait times and stays appear shorter than they were.

The executive told the Director-General of the Health Directorate they had made "approximately 20 to 30 changes to hospital records" a day from "late 2010" onwards.

ABC [Australian Broadcasting Corp.] News reported that the matter has been referred to police, while the executive has been suspended without pay.

Though the data manipulation was initially said to be motivated by concerns over job security, changes in 2011 and early 2012 were said to have been made due to "managerial pressure" to improve publicly-reported performance statistics.

This raises the issue that data manipulation might have been performed not just to improve reported statistics, but to cover up medical error, computer related or not, and thus deny injured patients or their heirs the right to legal redress.

"The only thing that worked to achieve benchmark targets was to alter the data," the executive later told investigators at PricewaterhouseCoopers (PwC), which was engaged by Health to perform a forensics analysis. The analysis is detailed in a new Auditor-General report (pdf).

In total, PwC found 11,700 performance records - about six percent of all records stored in the hospital's iSOFT emergency department information solution (EDIS) - had been altered.

It is believed more staff at Canberra Hospital altered records than the executive that has so far admitted responsibility.  "While an executive has admitted to changing EDIS records, it is probable that EDIS records have also been manipulated by other persons with access to the system," the federal auditor-general noted overnight.

This is another area where electronic records make possible tasks that are probably impossible with paper.  Altering 11,000+ records would be hard in paper charts, as the alterations would likely stick out in a pronounced manner.

"The executive’s admission to Audit does not appear to account for all of the changes to EDIS records that have been made to improve timeliness performance."

For example, changes to EDIS records, albeit a much smaller number, appear to have been made on days when the executive was on leave (seven days in total in 2010-11 and early 2011-12). 

I am saddened to note, a proper term for this activity might indeed be "conspiracy":  a conspiracy is an agreement between two or more persons to break the law at some time in the future.

User access control, IT security failures

Poor controls such as generic logins and inadequate user and password security made it easy for insiders to game the data.

While EDIS was on approximately 259 workstations across the hospital and 253 users had permission to run the software, there were only 23 user accounts.

Of these user accounts, only eight were in regular use, including four named administrator accounts (specific to administrative staff) and four generic user accounts: CLERK, NURSE, DOCTOR and BEDMAN.

The generic accounts could be used by personnel across the hospital, not just within the Emergency Department.

Passwords for the four generic user accounts were "very poor" and had "never been changed". Password expiry was set at a default 999 days.

Audit logs were equally poor, not proactively checked and unreliable.

The proper term for these arrangements might be "gross mismanagement" of clinical information technology.

"A feature of the logging record is that it logs the changed field in EDIS and a number of other fields simultaneously, while not identifying which field was changed and what its original value was," auditors noted.

"Audit also notes that the logging record is also ineffective, because every entry in EDIS is logged from “Workstation 14”.  

"Although EDIS has been disseminated widely throughout the Canberra Hospital each of these users logs into EDIS using the common “Workstation 14”.

"This practice, combined with the use of generic user accounts, makes the EDIS logging information useless for investigations of unauthorised activity."

Furthermore, it was possible to edit EDIS records up to 72 hours after a patient’s treatment, providing a generous window for later unauthorised changes to the records.

These "features" sound like seller misdesign with regard to the metadata (logging records).

Noticing anomalies

It was only in April this year that a full inquiry was commissioned after "anomalies" in performance figures were spotted by the Australian Institute of Health and Welfare (AIHW).

The AIHW found an unusually high number of emergency patients that were reported to have been seen at exactly within the required time for their illness category.

For example, there was an unusually high number of patients who were reported to have been seen at exactly 30 minutes or 60 minutes.

In addition, an unusually high number of people checked out of the Emergency Department precisely 240 minutes after their recorded arrival.

If you're going to engage in this type of activity, at least be competent at it...instead of setting up a red flag bigger than the flag that used to fly over the Kremlin.

The records that were manipulated mean that publicly reported information relating to the timeliness of access to the Emergency Department and overall length of stay in the Emergency Department have been inaccurately reported.

The report could not ascertain the level of over‐estimation due to the lack of a clear audit trail identifying what were legitimate and what were fabricated entries in patients’ records.  

Timelines can be critical to proving medical negligence in court.  Further, if time data could have been manipulated, it seems clinical data could have been manipulated as well.

EHR data manipulation is of unknown magnitude worldwide, but I can imagine if it's easy to do and the benefits potentially substantial, electronic records could possibly be less trustworthy than paper records.

-- SS

Addendum:  while on the topic of clinical IT Down Under, there's also this:

Coast medical records system 'dangerous'
Stephanie Bedo
Goldcoast.com.au

July 6, 2012

SENIOR doctors say Gold Coast Heath's new multimillion dollar electronic medical record system is 'inadequate and dangerous' and could put patients' lives at risk.

Doctors have complained about the system, saying some patient documents are missing, it has log-in problems and 10-minute delays in accessing critical information.

Gold Coast Health was the first region in the state to move to electronic record-keeping, rolled out progressively from October last year.

Queensland Health spent about $200 million on the electronic medical record roll-out last year, which was delayed by 12 months because of problems with the software provider.

... Hospital cardiologist Dr Greg Aroney raised concerns about the system at a Griffith University forum on the future of health on the Gold Coast this week.

"Our system is totally inadequate and dangerous," Dr Aroney said.

Read the whole story at this link:   http://www.goldcoast.com.au/article/2012/07/06/429621_gold-coast-news.html

A similar story from the states where the doctors' complaints were actually ignored is at my Sept. 2011 post "Blake Medical Center (Bradenton, Fla.) Ignores Health IT Warning Letter From 100 Staff Physicians." 

Let's hope the Australian physicians' complaints are taken more seriously.

-- SS

Giant GSK Settlement Provides Reminder of the Pervasiveness of Stealth Marketing

The latest  and biggest legal settlement involving health care to hit the news, that of GlaxoSmithKline (GSK) and the US government, has many familiar elements. As summarized by the New York Times,

In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, federal prosecutors announced Monday. The agreement also includes civil penalties for improper marketing of a half-dozen other drugs.

As was the case for nearly every other legal settlement we have discussed,

No individuals have been charged in any of these cases.

Thus, how well even such a large settlement will deter future wrong-doing is not clear.

Nonetheless, the documents released with it provide good documentation about how pervasive systematic, deceptive stealth marketing campaigns have become in health care. 

In particular, the official "complaint" filed by the US Department of Justice emphasized all these elements in the stealth marketing of paroxetine (Paxil, Seroxat in the UK) to adolescents.

Manipulation of Clinical Research

We have frequently discussed how health care corporations, particularly pharmaceutical, biotechnology and device companies, now sponsor  the majority of clinical research.  Their control of the design, implementation, analysis and dissemination of clinical research allows manipulation that increases the likelihood that the results will be favorable to their vested interests, usually the products and services they sell. 

We have previously discussed the manipulation of Study 329 to promote the marketing of Paxil (look here and here).  However, the US DOJ document makes these concerns more official.  It included:

Manipulation of Study Endpoints

Study 329 was a randomized controlled trial of Paxil vs imipramine vs placebo for depression in adolescents. The two primary endpoints pre-specified to the US Food and Drug Administration were "the degree to which a patient's Hamilton Rating Scale for Depression ('HAM-D') total score changed from baseline"; and "the patient's 'response' to medication, as defined as (a) a 50% or greater reduction in the patient's HAMD-D score, or (b) a HAM-D score of less than or equal to 8." However, initial analysis by GSK failed to show that Paxil improved either of these two end-points. The company concluded "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of [Paxil]."

So the analysis emphasized secondary outcomes, the "Study 329 investigators later added several additional efficacy measures not specified in the protocol. Paxil separate statistically from placebo on certain of these measures." Adding numerous post-hoc measures increased the likelihood of finding a difference on at least one due to chance alone.

Manipulation of Data

Initial analysis of the data suggested that patients given Paxil experienced 11 serious adverse events, including five that appeared related to suicidal ideation or action. When the FDA later reexamined the data, "upon closer examination the number of possible suicide-related events among the Study 329 Paxil patients increased beyond the five patients GSK described in the JACAAP article as having 'emotional lability.' While collecting saftey information for the FDA, GSK admitted that there were four more possible suicide-related events among Paxil patients in Study 329. In addition the FDA later identified yet another possible suicide-related event in the Study 329 Paxil patients, which was also not among the 11 serious advents listed in the JAACAP article. Thus, altogether, 10 of the 93 Paxil patients in Study 329 experienced a possible suicidal event, compared to one in 87 patients on placebo. This is a fundamentally different picture of Paxil's pediatric safety profile than the one painted by the JAACAP article...." 

Manipulation of Dissemination

The report describing the results of Study 329 (Keller MB, Ryan ND, Strober M et al.  Efficacy of paroxetine in the treatment of adolescent major depression: a randomized controlled trial.  J Am Acad Child Adolescent Psychiatry 2001; 40: 762-772.  Link here. ) was written under the control of GSK. "In April 1998, GSK hired Scientific Therapeutics Information, Inc (STI) to prepare a journal article about Study 329. GSK worked closely with STI on the article by providing a draft clinical report to 'serve as a template for the proposed publication.'"

The published report of Study 329 "mischaracterized the results." "Although the ... article identified the study's two primary endpoints in the abstract, the article did not explicitly state that Paxil failed to show superiority to placebo on either of the primary efficacy measures." Also, "the article did not explicitly identify the two protocol-specified primary outcome measures - or that Paxil failed to show superiority to placebo on these two measures. Instead the article claimed that there were eight efficacy measures and that Paxil was statistically superior to placebo on four of them." In addition, "while the article listed the five protocol-defined secondary endpoints, the text of the article omitted any discussion regarding three of the secondary measures on which Paxil failed to statistically demonstrate its superiority to placebo and instead focused on the five secondary measures that GSK added belatedly and never incorporated into the Study 329 protocol. The article claimed that these finve secondary measures had been identified 'a priori,' therefore incorrectly suggesting that all secondary endpoints had been part of the original study protocol." In other words, the final published articles contained multiple outright falsehoods about the drug's efficacy that exaggerated that efficacy.

Furthermore, initial analysis showed that patients given Paxil had more serious adverse events than others. An initial draft of the study article stated, "serious adverse events occurred in 11 patients in the paroxetine group, 5 in the imipramine group, and 2 in the placebo group." These included "headache during down-titration(1 patient), and various psychiatric events (10 patients): worsening depression (2); emotional lability (e.g., suicidal ideation/ gestures, overdoses), (5); conduct problems or hostility (e.g., aggressiveness, behavioral disturbance in school) (2); and mania (1)." As noted above, the number of suicide related events was actually double that noted in this draft as "emotional lability."  However, the published version of the report "falsely state[d] that only one of the 11 serious adverse events in Paxil patients was considered related to treatment...."  Nor did it mention the true number of events related to suicidal ideation or action.

The article only "listed at most five possibly suicidal events among Paxil patients, brushed those off as unrelated to Paxil, and conclude that treating children with Paxil was safe."

Later, GSK marketing materials described the results of the study thus,

This 'cutting-edge,' landmark study is the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression."

Thus the conrol exerted by GSK over the published article, despite its apparent academic authorship, enabled it to promote a drug that was not efficacious and had major adverse events as remarkably safe and effective, a totally deceptive result that would mislead any health care professional who used the article to guide clinical practice. 

Suppression of Clinical Research

GSK sponsored two other studies of Paxil in pediatric populations, Studies 377 and 701. As stated in the Department of Justice's Criminal Complaint against GSK,

GSK Did Not Publicize the Results of Studies 377 and 701
43. GSK learned the results of Study 377 in 1998 and the results of Study 701 in 2001. Paxil failed to demonstrate efficacy on any of the endpoints of either study.
44. GSK did not hire a contractor to help write medical articles about the results of Studies 377 and 701, as it had with Study 329.
45. GSK did not inform its sales representatives about the results of Studies 377 and 701.

Thus, GSK managed to conceal the fact that the majority of the studies it sponsored about Paxil used for adolescent patients showed no evidence that the drug worked, again seriously distorting the evidence-base on which clinicians made decisions, and doubtless leading to the use of a dangerous, ineffective drug by numerous vulnerable patients.

Bribing Physicians to Prescribe

GSK's sales representative reflected in their call notes their use of money, gifts, entertainment and other kickbacks to induct doctors to prescribe GSK drugs....

One really creative way to pay physicians to be exposed to marketing:

For example, in or about 2000 or 2001, GSK used 'Reprint Mastery Training Programs' or 'RMTS' to further promote drugs by purporting to pay physicians to train sales representative to review reprints of studies. Although the training was purportedly for the representatives, in fact, the sales force was already familiar with the materials. GSK typically paid physicians $250 to $500 to review the reprints.

Thus GSK simply paid physicians to use its drug, a practice characterized as kickbacks in the official complaint.  An article in the Guardian noted that the US Attorney involved in the case put it even more bluntly,

The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts.

Use of Key Opinion Leaders as Disguised Marketers

GSK also created a group of national 'key opinion leaders' ('KOLs') who were paid generous consulting fees. GSK selected many of these physicians based on their prescribing habits and influence within the community and used the speaker fees paid to these physicians to induce and reward prescribing of GSK's products. GSK used these individual to communicate marketing messages focused on the drug's marketing campaigns at the time, including off-label uses. Some physicians on GSK's speaker's board have been paid more than a million dollars for speaking on behalf of the company and recommending its drugs.

Thus key opinion leaders were paid specifically to market drugs, and as a reward, a bribe for prescribing drugs.

Consulting Fees as Kickbacks

In general,

In order to induce physicians to prescribe and recommend its drugs, GSK paid kickbacks to health professionals in various forms, including speaking or consulting fees, travel, entertainment, gifts, grants, and sham advisory boards, training,....

In particular,

During 2000 and 2001 at least, GSK also utilized events termed 'advisory boards' or consultant meetings and forums to disseminate its promotional message. Although these boards were purportedly composed of 'thought leaders' for the purpose of obtaining advice from the physicians, in fact, the 'advisory boards' were little more than promotional events coupled with financial inducement to prescribing and influential physicians.

Also,

GSK typically paid the physician between $250 and $750 to attend each local 'advisory' meeting. The payments did not reflect the value of services. The physician was not required to do anything but show up. GSK had no legitimate business reason to hire thousands of 'advisors' to 'consult' with the company about a single drug.

Manipulation of Continuing Medical Education

GSK also used so-called CME and CME Express programs and other sham training for marketing purposes, and to promote off-labe uses for the GSK prescription drugs.

Furthermore,

These CME programs purported to be independent eduaction free of company influence, but in fact functioned as GSK promotional programs disguised as medical education. GSK maintained control and influence over the purportedly independent CME programs through speaker selection, and influence over content and audience, among other things. Although third party vendors were usually also involved, they served only as artificial 'firewalls' that did not insulate the program from GSK's influence.

Summary

The legal documentation of the GSK settlement demonstrated how one drug company used an integrated, systematic campaign incorporating deception and bribery to sell drugs. Its elements included manipulation and suppression of the clinical research it sponsored, paying key opinion leaders to be disguised drug marketers, outright payments to physicians to prescribe drugs, and manipulation, again using payments to physicians, of supposedly independent continuing medical education. 

Note that while I summarized the elements of the stealth marketing campaign to sell Paxil, particularly for use in pediatric patients, the US government complaint also documents similar activities used to sell other drugs.  Furthermore, other stealth marketing campaigns have come to light through legal action, and many other instances of manipulation and suppression of clinical research, use of KOLs as disguised marketers, kickbacks and bribes, and manipulation of CME have been documented.

This means that any claims that:
- commercially sponsored clinical research provides clear, unbiased data that should drive clinical decisions
- health care professionals and academics paid as consultants by commercial health care firms are not influenced by these payments, and can provide clear, unbiased opinions
- commercially sponsored medical education provides clear, unbiased teaching
unfortunately must be viewed with extreme skepticism. This is particularly unfortunate given that most clinical research is now supported by commercial sponsors, and the majority of influential academics in medicine get some form of payments from the health care industry (look here).

Of course, there are some physicians who consult for commercial firms who actually provide clinical or scientific advice or assistance, and some commercially sponsored activities are honest. But we must wonder what garden path all those advocates for increasing industry "collaboration" to promote "innovation," and who regard conflicts of interest as "inevitable" and "manageable" are taking us down (e.g., look here and here).

Although the current settlement will require a huge payment, as I have said many times before (as early as 2008, here), do not expect such settlements to deter future bad behavior like that listed above.  The cost of the settlement will actually be spread among all company shareholders, all company employees, and likely patients and taxpayers.  However, the settlement will entail no specific negative consequences to the people who authorized, directed, or implemented the bad behavior.  In particular, executives whose remuneration was swollen by proceeds from the sales of affected drugs, and the health care professionals who willingly accepted what the US Attorney called bribes will not pay any sort of penalty.  The bad behavior listed above was doubtless personally very profitable for some people.  Unless people who indulge in such behavior face the possibility of penalties worse than their expected gains, expect such bad behavior to continue.

In fact, as the New York Times reported,

critics argue that even large fines are not enough to deter drug companies from unlawful behavior. Only when prosecutors single out individual executives for punishment, they say, will practices begin to change.

'What we’re learning is that money doesn’t deter corporate malfeasance,' said Eliot Spitzer, who, as New York’s attorney general, sued GlaxoSmithKline in 2004 over similar accusations involving Paxil. 'The only thing that will work in my view is C.E.O.’s and officials being forced to resign and individual culpability being enforced.'

True health care reform would strive to eliminate important conflicts of interest affecting clinical research and medical education.  Specifically, it would prevent corporations that sell health care products or services from controlling clinical research meant to evaluate these products or services.  It would seek to eliminate serious conflicts of interest affecting health care professionals.  Finally, it would prevent vested interests from controlling medical education.  Not that I expect any such reform in the near future, it would be too threatening to those who have personally benefited from the current system.

Hat tip to Dr Howard Brody whose Hooked: Ethics, Medicine and Pharma blog scooped me on the details of the settlement relevant to study 329.

ADDENDUM (11 July, 2012) - see also this post on the 1BoringOldMan blog.

Fool Us Once, Shame on You, Fool Us Twice, Shame on Us - The Untrustworthy Pronouncements of Aetna's Former CEOs

A small tempest in the larger US health care reform teapot was produced a few weeks ago when Ron Williams, former CEO of Aetna, declared in a Wall Street Journal op-ed that he no longer supported the health insurance mandate.  The "mandate" for all US citizens to buy health insurance, actually a relatively small tax that would be imposed on people without health insurance, was the central point of contention in the lawsuit before the US Supreme Court challenging the Affordable Care Act (ACA). 

Immediate Past-CEO of Aetna Ron Williams' Abrupt Change of Mind on the Individual Mandate

Williams wrote,

Soon the U.S. Supreme Court will rule on the constitutionality of the Affordable Care Act. I am not a lawyer, or an expert on the Constitution. But as the chairman and CEO of a major health plan, I had a ringside seat to the entire health-care reform process. After much reflection, I have concluded that the federal individual mandate, which requires all Americans to purchase health insurance starting in 2014, will not be upheld.

On this, Williams was soon proven wrong. The Supreme Court upheld the law. However, the tempest was not due just to Williams' reversal of his former opinion, but the role he actually played in pushing his former opinion into the passage of the law, which was really far more than being a "ringside" spectator.

In an August 24, 2009 article, "Aetna's Ron Williams on Health Reform," Forbes' Dan Whelan noted,

Williams, 59, is taking a surprisingly visible role in arguing for change in the health care system. He has met with Obama a half-dozen times (he shrugs off the surname gaffe), has testified four times in front of Senate committees this year and participates in shindigs set up by the many trade groups for which he's a director.

Williams' position echoes that of the HMO industry generally: He's against a government-run plan but favors universal coverage and forcing insurers to take all comers.

As Wendell Potter, the former head of public relations for large health for-profit health insurance company Cigna, who is now a strong industry critic, put it on his blog,

Ron Williams who possibly more than anyone else had persuaded the President to reconsider his campaign pledge to enact reform without making people buy coverage from a private insurer. Candidate Obama’s reform platform differed from those of Hillary Clinton’s and John Edwards’ in only one significant way: both Clinton and Edwards embraced the mandate, which Williams was championing, first behind the scenes and then publicly, on behalf of the insurance industry. Candidate Obama said he didn’t believe it was right for people to be forced to buy something they couldn’t afford.

Williams was the industry’s most visible CEO on Capitol Hill during the debate on reform. He testified at numerous congressional hearings about how essential it was to move the millions of uninsured Americans into private health insurance plans and how an individual mandate was necessary to make that happen. He also never missed an opportunity to trash the idea of a 'public option' to compete with private insurance companies, which candidate Obama had said was essential 'to keep private insurers honest.'

Capitol Hill was not the only place Williams was frequenting during the reform debate. In an August 2009 article in Forbes, Williams was quoted as saying that he already had met with the President six times. When I called the White House to confirm that, a top aide told me it was true Williams had been there many times, adding, 'We’ve found him to be one of the more reasonable ones.'

Williams' recent seeming disavowal of the individual mandate raises the question of why anyone, much less President Obama, trusted him in the first place. After all, he was CEO of Aetna.

2001 Aetna CEO John Rowe Blamed Everyone Else for Health Care Problems

In fact, perusal of my memory, and a few file folders suggested several previous cases in which Aetna CEOs issued pronouncements that should not have been trusted.

First I recalled a meeting in 2001 at Brown during which the then Aetna CEO was honored by giving the Paul Levinger Lecture on "Good Health: Can We Afford It?" (See original Brown news release here.) My memory is that of Dr Rowe blaming just about everybody other than the for-profit health care insurance companies for health care's ills. A Brown Daily Herald article (not currently on line, Baskin B. Health care getting harder to afford, Aetna chief tells Brown U. Brown Daily Herald, November 30, 2001) recounted him blaming "cost inflation," (presumably due to doctors and hospitals), and employers, for whom "quality doesn't matter." He only allowed that insurers were to blame for not giving "better service," but not either rising costs or poor quality. I also recall Dr Rowe being treated with great respect by the audience. After all, this was a prestigious lecture.

However, his talk seemed just the least bit self-serving. If the audience had been aware of his record at the time, maybe we would have been more skeptical.

Mount Sinai CEO Dr John Rowe Extolled Merger with New York University, Jumped to Become Aetna CEO as Merger Began to Fail

By 1993, Dr Rowe was CEO of Mount Sinai Medical Center, and was seemingly at the vanguard of the movement for health care CEOs to be paid a lot. The New York Times reported that the 1993 Chronicle of Philanthropy survey showed him to be the country's best paid non-profit CEO, bringing in total compensation of over $800,000 in 1993 dollars. By 1998, Dr Rowe's big project was pushing concentration of power in health care in the form of a proposed merger between New York University Medical Center and Mount Sinai. According to the New York Times, the plan would be for Dr Rowe to become CEO of the combined entity. At the time, he said,

The advantages of merging hospitals are so great, they far outweigh any hypothetical potential negative impact.

The bond issue needed to finance the merger, however, ran into trouble by early 2000.  Soon after that, Dr Rowe seemingly demonstrated his lack of faith in it by jumping to the leadership of Aetna. It turned out, according to the Hartford Courant, Aetna's offer was just to rich to turn down.

Rowe got a $2 million sign-on bonus to leave Mount Sinai NYU Health and become chief executive of Aetna's health business, the document says. He will also get a $1.4 million retention bonus on July 3, 2001.

Both bonuses are designed to replace money that Rowe forfeited by leaving the giant New York hospital system, Aetna spokeswoman Joyce Oberdorf said.

In addition, Rowe will get an annual salary of at least $1 million and an annual bonus of $1 million to $3 million, depending on how well goals are met, under a three-year employment agreement with two possible one-year extensions.

Rowe, who already received 25,000 shares of restricted Aetna stock and options on 500,000 shares, will get another 100,000 options. The new options will be granted when Aetna spins off its health business to shareholders, or on Jan. 1, 2001 -- whichever comes first. The exercise price will be about $72.73, or whatever price Aetna stock is trading at the time if it's higher than that.

By 2001, the New York Times referred to the merger as existing "in name only." That year, the campuses resumed separate administration. The merger was officially terminated in 2008. Its failure was documented in an Academic Medicine article. (Kastor JA. Failure of the merger of the Mount Sinai and New York University hospitals and medical schools: part 2. Acad Med 2010; 85: 1828-32. Link here.)

If the Brown audience had known that the merger Dr Rowe extolled with such confidence was already failing, but that he was able to leverage his role in its development to go from the country's best paid non-profit CEO to a multi-million dollar a year insurance CEO, maybe we would have felt less guilt about our responsibility for health care's high cost, low access and poor quality.

Aetna CEO Richard Huber's Failure to "Walk the Walk"

In fact, searching through the files showed an even earlier example of an Aetna CEO talking out of two sides of his mouth.

By 1998, an American Medical News article documented the "rocky relations" between Aetna and physicians. By early 2000, Aetna CEO Richard Huber was known as "the managed care executive physicians love to hate," per the American Medical News. His departure was characterized by then American Medical News Street Smarts columnist Dr Scott Gottlieb, as partly due to how

Huber talked out of one side of his mouth about his company's obsessive quest for 'quality' health care -- while out of the other he was screaming at doctors, hospitals and drug firms about controlling costs. Yet Aetna's medical costs were still creeping up. As Richard Huber learned, you can't talk the talk if you don't walk the walk.

Summary

So the unreliability of recent Aetna CEO Ron Williams' advocacy of the "patient mandate," was presaged by similarly untrustworthy pronouncement by two former Aetna CEOs. In each case, the remarks of the particular CEO seemed more designed to promote his immediate self-interest than to provide trustworthy opinion or policy advice.

By the way, this summary should not be viewed as particularly an indictment of Aetna. I am sure I could find equally untrustworthy but self-serving pronouncements from the leaders of many other health care organizations. (Recall the visionary pronouncements of the failed and ultimately jailed CEO of the now vanished Allegheny Health Education and Research Foundation, see post here.)

The recent Ron Williams reversal should serve, however, as a stark reminder that we, meaning physicians, other health care professionals, those who study health care and health policy, policy makers, and the public at large, should be very, very skeptical about any pronouncements about health policy by top executives of health care organizations. They as a group have shown themselves to be remarkably good at doing whatever it takes to buttress their immediate self-interest, including making apparently oracular but ultimately foolish policy pronouncements.

The real question is why these pronouncements continue to be treated with reverence, if not as "visionaries,"  by health care professionals, health care and policy researchers, the news media, health care and medical journals, policy makers, politicians, and the public at large? Why has hardly anyone, besides yours truly, gone back to check the accuracy of their previous pontifications before swooning over their latest ones? Why has hardly anyone examined the accuracy of their predecessors' opinions, given that most executives these days seem to be subject to the same incentives to make things look good in the short term, and never mind the consequences?