Question for the New Year: Why is There Next to No Reaction to the Gilded Age of Health Care?

For the New Year, it is time to ponder- why is there still no organized outrage over the ongoing incompetent, uncaring, self-interested, conflicted, and often outright corrupt leadership of health care organizations we have documented incessantly on Health Care Renewal?

For example, just a few days ago, we documented a series of cases in which large US and multinational health care organizations settled cases alleging they deceptively marketed drugs so as to exaggerate their benefits and conceal their harms, bribed doctors and officials  outside of the US, gave kickbacks to US doctors, defrauded the US government, and monopolized markets for drugs, yet few leaders, and no top leaders of the companies involved suffered any negative consequences for authorizing, directing, or implementing these activities.  We have discussed many previous legal settlements involving similar bad behavior and similar impunity by the leaders of the organizations involved.   Again and again we have discussed how large organizations, often but not always drug, biotechnology and device companies, have manipulated the scientific literature (e.g., see examples of manipulation of clinical research, suppression of clinical research, and specific practices such as ghost-writing of apparently scholarly articles to benefit vested interests.)   We have discussed overblown compensation that made top managers and other organizational insiders rich without any rationale other than their ability to take such money off the top.  Yet in the US, despite ever rising costs presumably provoked by such leadership, without corresponding improvements in quality or access, there is still no organized movement for change.

The problems in US health care, however, seem to parallel problems in the larger society, and the world at large.  We have discussed parallels with bad leadership of financial firms, including the firms that drove us into the global financial collapse/ great recession, and to continuing income stagnation, recession, austerity, and decreasing opportunity for the poor and middle class around the world.

Yet parallel questions are just beginning to be asked about larger related political economic problems.  Recently, historian Brad DeLong attempted to address the question, "why next to no reaction to the second gilded age?"  (See this.).  Unfortunately, while he could demonstrate two powerful political movements that opposed the first Gilded Age, he was completely at a loss to explain why there has been no similar organized outrage about the second Gilded Age in which we exist today.  Despite incompetent, uncaring, self-interested, conflicted, and often outright corrupt leadership of many large corporations, non-profit organizations, and government agencies only a few voices, often bloggers like us, have objected.

Economist Mark Thoma then took up the question, but the best he could do was suggest that outrage has been moderated because of the existing, if frayed, social safety net, and because many people nonetheless saw the last two decades as a time of increasing economic opportunity. (See this. )   He did not address how this view may have been wrong, since the last two decades were a time of obviously worsening income inequality.

Yves Smith of Naked Capitalism finally offered some insight (see this) by noting the importance of "propaganda," corresponding, I think, to the widespread deceptive marketing and public relations, and the use of covertly paid key opinion leaders to further both that we frequently discuss.  Finally she suggested that people feel powerless because they see themselves as "atomized individuals," even though they many are currently being treated as interchangeable parts by the leaders of large organizations who can control the actions of large number of employees to further their self-interest.

There must be more reasons.  There ought to at least be some organized discussion of these reasons.  After that there needs to be some organized action to promote real reform.  I conclude the often miserable 2012 with a plea for those who are interested and concerned to come together to create real solutions.

ADDENDUM (1 January, 2013) - see comments by Dr Howard Brody on the Economism Scam blog.

'Tis the Season for Legal Settlements: GlaxoSmithKline, Eli Lilly, Orthofix, Sanofi all Settle

Reports of legal settlements by big health care organizations tend to dribble out towards the end of the year, maybe in a rush to finalize the year's accounting, maybe because the news will not register as well at times when people are distracted by holidays.  Here is a round-up in alphabetical order of some recent settlements of interest made by drug and device companies.

GlaxoSmithKline

Earlier this year GSK made the largest settlement, in monetary terms, ever by a pharmaceutical company (see this post).  At the end of the year it made two more.  Neither got much media attention.  The first was related to the earlier $3 billion settlement.  As reported by the [Great] Lebanon [Oregon] Express:

Oregon Attorney General Ellen Rosenblum announced in a press release that pharmaceutical giant GlaxoSmithKline has agreed to pay $90 million to Oregon and 37 other states to settle claims that it unlawfully promoted its diabetes drug, Avandia.

As the co-leader of the lawsuit, Oregon will receive $3.9 million of the settlement, according to the release.

The 38 attorneys general claimed in lawsuits filed Nov. 15 that GlaxoSmithKline misrepresented the cardiovascular risks posed by Avandia. A negotiated consent judgment was filed shortly thereafter.

 Avandia was a blockbuster drug for GlaxoSmithKline. First approved by the Food and Drug Administration in 1999, annual sales peaked at more than $2.5 billion in 2006.

Furthermore,

 Oregon and the 37 other states claim GlaxoSmithKline made safety claims about Avandia not supported by the scientific evidence.

The states allege the company failed to disclose negative information about Avendia’s cardiovascular health effects.

In addition to the monetary settlement, the agreement included all sorts of pledges by GSK:

As part of the consent judgment between the parties, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. It agreed to several conditions:
 • To refrain from making false, misleading, or deceptive claims about any diabetes drug;
• To refrain from making comparative safety claims not supported by substantial evidence or substantial clinical experience;
• To refrain from presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;
•   To refrain from misusing statistics or otherwise misrepresenting the nature, applicability, or significance of clinical trials.

The Consent Judgment also has the following terms that are effective for at least eight years:
• GlaxoSmithKline must post summaries of all company sponsored observational studies or meta-analyses conducted by the company that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;
• The company post summaries of company-sponsored clinical trials of diabetes products within eight months of the primary completion date;
• GlaxoSmithKline must register and post all company-sponsored clinical trials as required by federal law.

Even more under the radar was a second, unrelated settlement, only briefly chronicled by Reuters (here via the Chicago Tribune):

 British drugmaker GlaxoSmithKline Plc has reached a $150 million preliminary settlement with U.S. drug wholesalers who claimed the company improperly delayed entry to the market of generic alternatives to its nasal spray Flonase, according to court documents.

The settlement was reached with, among others, AmerisourceBergen Corp, Cardinal Health Inc, and McKesson Corp, who maintained that Glaxo had abused the citizen's petition process to maintain a market monopoly and overcharge for the spray by restricting access to less expensive generic versions.

Note that while the first settlement was clearly about misleading, deceptive marketing of a relatively dangerous drug as safe, a practice that likely lead to suffering and death of some patients, the second settlement which involved an unfair business practice that likely increased the cost of care to some patients, and decreased the profits of some competitors, lead to a monetarily larger settlement.

Again, these latter two settlements seem to just ice the cake of the $3 billion settlement earlier this year.

 Eli Lilly

Eli Lilly pleaded guilty to a misdemeanor charges and settled allegations about questionable marketing practices for its anti-psychotic drug Zyprexa for over $1 billion in 2009 (see post here).  The settlement provided some instructive information about how big pharmaceutical companies employ ghost writing to sell product (see this post).  Now at the end of 2012, Eli Lilly has settled charges that it bribed government officials in countries outside of the US.  The most colorful version of this story appeared in the Wall Street Journal.  In summary,

 Eli Lilly & Co. agreed to pay $29.4 million in a settlement of U.S. government allegations that the drug maker's units made improper payments to foreign government officials to win business.

Indianapolis-based Lilly didn't admit or deny the allegations, but agreed to have an outside consultant review the company's internal controls and its measures to comply with the U.S. Foreign Corrupt Practices Act, or FCPA. 

The colorful details were:

The SEC said in a civil complaint filed in U.S. District Court for the District of Columbia that employees of Lilly's China unit falsified expense reports to provide spa treatments, jewelry and other gifts and cash payments to government-employed doctors between 2006 and 2009.

The SEC also alleged: Lilly hired a drug distributor in 2007 that paid bribes to health officials in a Brazilian state to facilitate about $1.2 million in sales of a Lilly drug to the state; Lilly's Polish unit paid $39,000 between 2000 and 2003 to a charitable foundation run by the head of a regional government health authority and dedicated to restoring a castle in Chudow, Poland; and that its Russian unit paid millions of dollars between 1994 and 2005 to offshore entities that the SEC said 'appear to have been used to funnel money to government officials' to obtain business for the Lilly unit.

The SEC said Lilly didn't curtail the activities of its Russian unit for several years, even after an internal Lilly review raised questions about its use of these offshore arrangements.

As in the previous set of settlements, no individual was charged or had to pay any penalty for authorizing, directing, or implementing any unethical actions.  Note that the alleged bribery went on in multiple different countries, suggesting a systemic problem with the operations of the company.  Note also that the allegations involved bribing doctors as well as bureaucrats.

Orthofix

We discussed three settlements made by medical device company Orthofix only a month ago.  These involved various vivid details including bribes to physicians disguised as consulting and royalty agreements, bribes of foreign government officials disguised as chocolate, and a device sales representative turned stripper.  As best as I can tell, Orthofix just made yet another settlement, maybe not quite so picaresque.  As per Bloomberg,

Orthofix International NV won court approval of a settlement of federal regulators’ claims that the maker of bone-repair products defrauded Medicare through a kickback scheme involving doctors, prosecutors said.

U.S. District Judge William G. Young in Boston yesterday accepted an Orthofix unit’s offer to plead guilty to a felony count of obstructing an audit and pay a $7.6 million criminal fine....

This settlement like some of the previous ones involved allegations of payments to doctors to induce them to use Orthofix devices.

As part of the agreement, Orthofix also will pay $32.3 million plus interest to resolve civil claims first raised in a whistle-blower’s lawsuit that the company defrauded the federal Medicare program through payments to doctors who used its bone-growth stimulators....

This series of cases is unusual because they resulted in a guilty plea to a felony (but by a subsidiary of the company, not the company itself), and in guilty pleas by some company employees (but not apparently any penalties to top management).

Five Orthofix employees have pleaded guilty in connection with the probe, the U.S. Justice Department said. Thomas Guerrieri, a company vice president, pleaded guilty to violating the federal anti-kickback statute by setting up fake consulting agreements for doctors who used the company’s products. 

Sanofi

French multinational pharmaceutical corporation Sanofi-Aventis settled charges of overcharging the US Medicaid system in 2009 for over $90 million  (see post here),  and of overcharging the US Medicare system in 2007 for over $190 million (see post here).  Now it just settled charges that it gave kickbacks to doctors to induce them to prescribe its product.  Per Bloomberg,

 Sanofi,  France’s biggest drugmaker, reached a settlement to pay $109 million over allegations that its U.S. units gave doctors free doses of a medicine to win their business and subvert Medicare’s drug reimbursement system.

Sanofi sales representatives entered into 'illegal sampling arrangements' with physicians, giving them the arthritis drug Hyalgan as kickbacks and 'promising to provide negotiated' amounts of the medication to lower its effective price in violation of the False Claims Act, the U.S. Justice Department said yesterday in a statement.

'Kickback schemes subvert the health-care marketplace and undermine the integrity of public health-care programs,” Stuart Delery,  who heads the department’s civil division, said in the statement. 'We will continue to hold accountable those who we allege are providing illegal incentives to influence the decision-making of health-care providers in federal health-care programs.'

Again, no individual suffered any negative consequences for authorizing, directing or implementing the bad behavior in this case.

Summary

So here we go again, four more settlements by large, rich, well known pharmaceutical and device companies.  Most of the companies involved now have a history of recent settlements for a variety of ethical misadventures.  Most of the new settlements involved allegations of deceiving and bribing physicians.

As we have noted endlessly before, legal settlements like this are useful to provide documentation of how unethical the practices, particularly marketing practices of large health care organizations have become.  However, the increasing number of repeat settlers suggest that the settlements are not deterring bad behavior.  Since the fines involved are usually small compared to the revenues that can be generated by deceptive and unethical marketing of expensive drugs, and the fines are paid out of company coffers, and are thus spread out in their impact over employees and stockholders alike, they usually have no more impact than a lash with a wet noodle, maybe at best a slap on the wrist.  Since the people involved in authorizing, directing and implementing the bad behavior can likely greatly improve their "numbers" and hence generate big salaries and bonuses, but face a minimal risk of any individual negative consequences, they are likely to continue unethical practices.

Given that so many of these cases involve deception and/or bribery of health care professionals, I still hope that some will get upset at the effect on their professional values to take action.

Meanwhile, I repeat until blue in the face....   we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Denying the Inconvenient Truth About Study 329

On 1BoringOldMan, Mickey, the semi-anonymous retired psychiatrist blogger, has updated the saga of Study 329.  The manipulation of Study 329 was a central part of the US government's case against GlaxoSmithKline that was recently settled for $3 billion and resulted in three guilty pleas by the company (look here and here.)

Mickey's previous voluminous series of posts on this subject are listed here.  He and others, most notably Dr Jon Jureidini, have attempted to get the journal that published the now widely ridiculed Study 329 retracted.  His three recent posts on the subject are:
the lesson of Study 329: an unfinished symphony…
 hide-and-go-seek… 
 a response… 

 In the most recent of these, he argued,

In this particular case, there are no facts in question. It was a negative trial, declared negative by the people who did it. The paper was ghost-written and reviewed by the sponsor before any of the twenty two authors ever saw a manuscript. The science was jury-rigged to imply a positive outcome where none was supported using well-documented sleight of hand. None of that is speculative. And the article has been a centerpiece for court settlements worth billions of dollars.

Yet, the  Journal of the American Academy of Child and Adolescent Psychiatry refused to retract the article. Mickey's opinion in the second of the posts listed above,

One can only conclude that they found this article to be an inconvenient truth, and that Dr. Andres Martin and his colleagues in the American Academy of Child and Adolescent Psychiatry believe that acknowledging that truth would do more harm than good [or maybe even found a way not to see the truth at all, though it's hard to imagine how]. Sooner or later, this whole tawdry saga is going to find its way out of the blogs and courtrooms and into the full light of day. And the question that’s going to be asked is why didn’t Medicine itself deal with the problem? Why didn’t the Journal itself retract the misinformation once they knew about it? Why didn’t the industry sponsor itself call for the retraction as part of their settlement with the DOJ? What possible reasonable reason could there be for leaving a paper that is a lie in their journal without even an expression of concern, much less a retraction? And there aren’t going to be any believable answers.

Mickey concluded the most recent post,

The loser in this story is the American Academy of Child and Adolescent Psychiatry, and ultimately psychiatry itself…

The longer inconvenient truths are ignored or suppressed, the more inconvenient, and hazardous they will ultimately become. 

ADDENDUM (26 December, 2012) - One more post on 1BoringOldMan: telling the truth as a liability…

Its conclusion

By any criteria, the conclusion to the 2001 Keller et al article is wrong ["Paroxetine is generally well tolerated and effective for major depression in adolescents"]. That’s not the reason that some of us have been so persistent in pushing for retraction. The reason is that it was wrong at the time the article was published, and they knew it was wrong, but published it anyway. We want to make a statement about the integrity of the scientific literature.

ONC's Christmas Confessional on Health IT Safety: "HIT Patient Safety Action & Surveillance Plan for Public Comment"

This time of year is certainly appropriate for a confessional on the health IT industry and hyperenthusiasts' sins.

In the first report I've seen that seems genuinely imbued with a  basic level of recognition of social responsibility incurred by conducting the grand human subjects experiment known as national health IT, ONC has issued a Dec. 21, 2012 report "Health Information Technology Patient Safety Action & Surveillance Plan for Public Comment." It is available at this link in PDF.

Statements are made that have appeared repeatedly since 2004 at this blog, and my health IT difficulties site that went online years before this blog (1998 to be exact); it is possible through my early writing and that of like-minded colleagues that we were the origin of most of these memes.  We wrote them with the result of bringing much scorn upon ourselves. After all, "how could health IT possibly not be a panacea?" was the "you are an apostate" attitude I certainly experienced (e.g., as in my Sept. 2012 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture").

Observations echoed in the new ONC report:

• "Just as health IT can create new opportunities to improve patient care and safety, it can also create new potentials for harm."
• Health IT will only fulfill its enormous potential to improve patient safety if the risks associated with its use are identified, if there is a coordinated effort to mitigate those risks, and if it is used to make care safer.
• Because health IT is so tightly integrated into care delivery today, it is difficult to interpret this initial research [such as the PA Patient Safety Authority study  - ed.], which would seem to suggest that health IT is a modest cause of medical errors. However, it is difficult to say whether a medical error is health IT-related. [Not emphasized, as I wrote here, is the issue of risk when, say, tens of thousands of prescriptions are erroneous due to one software bug, a feat impossible with paper - ed.]
• The proper steps to improve the safety of health IT can only be taken if there is better information regarding health IT’s risks, harms, and impact on patient safety.

Suggested steps to be taken include:

• Make it easier for clinicians to report patient safety events and risks using EHR technology.
• Engage health IT developers to embrace their shared responsibility for patient safety and promote reporting of patient safety events and risks. [I am frankly amazed to see this admission.  In the past, that sector excused itself entirely on the basis of the "learned intermediary" doctrine and "hold harmless" clauses; where the clinician is an all-knowing Deity between computer and patient.  I've been writing for years, however, that the computer is now the intermediary between clinician and patient since all care 'transactions' have to traverse what is now an enterprise clinical resource and clinician control system - ed.]
• Provide support to Patient Safety Organizations (PSOs) to identify, aggregate, and analyze health IT safety event and hazard reports.
• Incorporate health IT safety in post-market surveillance of certified EHR technology
• Align CMS health and safety standards with the safety of health IT, and train surveyors.
• Collect data on health IT safety events through the Quality & Safety Review System (QSRS).
• Monitor health IT adverse event reports to the Manufacturer and User Facility Device Experience (MAUDE) database. [I've been promoting the use of MAUDE for just that purpose, and much more regarding documenting and reporting on mission-hostile health IT; see this post - ed.]

These steps are to be taken in order to "Inspire Confidence and Trust in Health IT and Health Information Exchange."

The title of my keynote address to the Health Informatics Society of Australia this summer was, in fact, "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step".

My thoughts on this report:

• It is at least two decades overdue.
• It was produced largely if not solely due to the pressure of the "HIT apostates", finally overcoming industry memes and control of information flows through great perseverance.
• It is indeed a confessional of the sins committed by the health IT industry over those decades.  Creating, implementing and maintaining mission critical software in a safety-cognizant way is not, and was not, a mystery.  It's been done in numerous industries for decades.
• It is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of risk vs. 'confirmed body counts' as I wrote at my recent post "A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk".
• It is unfortunate that this report did not come from the informatics academic community in the United States, i.e., the American Medical Informatics Association (AMIA).  AMIA's academics have done well in advancing the theoretical aspects of the technologies, and how to create "good health IT" and not "bad health IT."  However, they have largely abrogated their social responsibilities and obligations, including but not limited to those of physicians, in ensuring the theories were followed in practice by an industry all too eager to ignore academic research (which, in order to follow, utilizes money and resources and reduces margins).

(On the latter point, just last week did the American College of Medical Informatics [ACMI] refuse to permit me to be a speaker at their early 2013 annual retreat despite support from some of its members.)

And this:

• If the industry and the academics had been doing their job responsibly, I might be spending this Christmas and New Years's holiday with my mother, rather than visiting her in the cemetery.

All that said, the report is welcome.

Finally, it is hoped - and expected - that public comments will indeed be "public", and that any irregularities in such comments (such as appeared in the public comments period for MU2 due to industry ghostwriting as in my Aug. 2012 post "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" and Sept. 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?") will be reported and acted upon in an aggressive manner.

And finally, from the Healthcare Renewal blog, Merry Christmas.

-- SS

Amgen Settles, Pleads Guilty to Misbranding Aranesp

Now it's Amgen's turn to settle and plead.  Per the New York Times,

The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.

 The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.

Amgen was 'pursuing profits at the risk of patient safety' Marshall L. Miller, acting United States attorney in Brooklyn, said in a telephone news briefing on Tuesday.

David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.

Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation. 

The article noted the key charge against Amgen,

 In court on Tuesday, prosecutors charged that Amgen had promoted the use of Aranesp to treat anemia in cancer patients who were not undergoing chemotherapy, even though the drug’s approval was only for patients receiving chemotherapy.

A subsequent study sponsored by Amgen showed that use of Aranesp by those nonchemotherapy cancer patients had actually increased the risk of death, and the off-label use diminished. 

Also,

 The federal charges also say Amgen promoted using larger but less frequent injection of Aranesp than stated in the label as a way of making the drug more attractive to doctors and patients than Procrit, a rival anemia drug from Johnson & Johnson. 

As is typical of such cases, the prosecutors could not figure out how to charge any individuals who might have authorized, directed, or implemented the bad behavior,

 Mr. Miller said that the evidence in the Amgen case was not sufficient to charge individuals. However, he said, Amgen agreed to sign a corporate integrity agreement that requires executives and board members to personally certify compliance with regulations. That would make it easier to prosecute individuals should violations occur again, he said. 

The Charges in Context

In some reports of the settlement, the issue appeared to be money.  For example, Pharmalot reported that after a whistle-blower filed suit against Amgen, "a subsequent investigation by the Justice Department found that these practices induced physicians to use Amgen medications unnecessarily when lower cost alternatives were available."

However, Amgen's practices could have had much worse effects than just removing money from the US Treasury.

Consider the context.  Only a few of the not very numerous articles in the media on this case noted that the key complaint was that Amgen was pushing use of Aranesp for patients with cancer, specifically those not receiving chemotherapy.   (Reuters made this explicit, for example, but not so the Los Angeles Times, or Bloomberg's initial coverage.)

 In fact, there has been concern about the adverse effects of Aranesp for patients with cancer for a while.  In 2007, Khuri noted in a commentary in the New England Journal of Medicine(1) that "concern about a detrimental effect of ESAs [erythropoiesis stimulating agents, a class of drugs of which Aranesp is a prominent member] in patients with cancer arose" after results of a small clinical trial of epoetin beta in patients with oral, pharyngeal or laryngeal cancer receiving radiation therapy showed worse survival in patients receiving that drug.  Subsequently, in 2008, a meta-analysis of multiple randomized clinical trials showed that patients with cancer receiving ESAs, including Aranesp, had an increased risk of venous thromboembolism (drug clots) and death.(2)  In 2009,  another meta-analysis showed that ESAs lead to decreased survival in patients with cancer.(3)

Recall, though, that Aranesp is meant to improve anemia.  It was not meant to cure cancer, or even put the disease into remission.  Its use therefore was mainly adjunctive.  Thus, it appears its benefits for cancer patients (improved anemia, and possibly decrease in such symptoms as fatigue) could not outweigh its harms (including hastening death).

So the issue was not merely that Amgen was promoting a drug in an instance in which its use had not been improved by the US Food and Drug Administration (FDA), or that such use of the drug was unnecessarily costly.  The issue was that Amgen was promoting a drug that had no proven benefits for the patients, but could hasten their death.  It appears that Amgen was pursuing profits at the expense of lives.

Summary

So it is particularly disturbing that no individual apparently will be held responsible for the promotion of Aranesp for patients for whom its use might prove fatal.  The assurance that the proposed corporate integrity agreement will prevent further abuse is notably hollow.  I can recall no recent case in which the government authorities have used such an agreement to pursue charges against individuals.  The likely deterrent effect of the monetary settlement will likely be minimal.  $762 million may look just like a cost of doing business when the drug in question was bringing in over $2 billion a year (per the Los Angeles Times). 

So the legal settlements march on and on.  The government continues to extract fines from health care organizations whose actions endanger not only the federal budget, but patients' well being and lives, without even trying to hold individuals responsible.  The impunity of health care corporate executives thus also continues.

As we have said far too many times, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

References

1.  Khuri FR. Weighing the hazards of erythropoiesis stimulation in patients with cancer.  N Engl J Med 2007; 356: 2445-2447.  Link here.

2.  Bennett CI, Silver SM, Djulbegovic B et al.  Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia.  JAMA 2008; 299: 914-924.  Link here.

3.  Bohlius J, Schmidlin K, Brillant C et al.  Recombinant human eryhtropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials.  Lancet 2009; 373: 1532-1542.  Link here.

A Significant Additional Observation on the PA Patient Safety Authority Report "The Role of the Electronic Health Record in Patient Safety Events" -- Risk

At a Dec. 13, 2012 post "Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events" I alluded to risk in a comment in red italics:

... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) [a risk best avoided to start with, because luck runs out eventually - ed.], and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event. 

The focus of the report is on how the "events" did not cause harm.  Thus the relatively mild caveat:

"Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure."

It occurs that if the title of the paper had been "The Role of the Electronic Health Record in Patient Safety Risk", the results might have been interpreted far differently:

In essence, from from June 2, 2004, through May 18, 2012 (the timeframe of the Pennsylvania Patient Safety Reporting System or PA-PSRS database), from a dataset highly limited in its comprehensiveness as written in the earlier post, there were approximately 3,000 "events" where an error did occur that potentially put patients at risk.

That view - risk - was not the focus of the study.  Should it have been?

These "events" really should be called "risk events."

It is likely the tally of risk events, if the database were more comprehensive (due to better recognition of HIT-related problems, better reporting, etc.) would be much higher.  So would the reports of "harm and death" events as well.

That patient harm did not occur from the majority of "risk events" was through human intervention, which is to say, luck, in large part

Luck runs out, eventually.

I have personally saved a relative several times from computer-related "risk events" that could have caused harm if I were not there personally, and with my own medical knowledge, to have intervened.  My presence was happenstance in several instances; in fact a traffic jam or phone call could have caused me to have not been present.

What's worse, the report notes:

Analysts noted that EHR-related reports are increasing over time, which was to be expected as adoption of EHRs is growing in the United States overall.

In other words, with the current national frenzy to implement healthcare information technology, these "risk events" - and "harm and death events" - counts will increase.  My concern is that they will increase significantly.

I note that health IT is likely the only mission-critical technology that receives special accommodation regarding risk events.  "If the events didn't cause harm, then they're not that important an issue" seems to be the national attitude overall.

Imagine aircraft whose avionics and controls periodically malfunction, freeze, provide wrong results, etc., but most are caught by hyper-vigilant pilots so planes don't go careening out of control and crash.  Imagine nuclear plants where the same occurs, but due to hypervigilance the operators prevent a nuclear meltdown.

Then, imagine reports of these "risk events" - based on fragmentary reporting of pilots and nuclear plant operators reluctant to do so for fear of job retaliation - where the fact of their occurrence takes a back seat to the issue that the planes did not crash, or Three Mile Island or Chernobyl did not reoccur.

That, in fact, seems to be the culture of health IT.

I submit that the major focus that needs addressing in health IT is risk - not just confirmed body counts.

-- SS

The "King of Pain" Recants - Pharmaceutical Paid Key Opinion Leader Admits It Was All "Misinformation"

This may be a first.  A Wall Street Journal story announced that the "key opinion leader" who played a pivotal role in the promotion of  aggressive use of narcotics to treat non-malignant chronic pain has had a change of heart.  

Background - Embracing Narcotics

In the long ago time when I was in medical school, the wisdom was then that narcotics (that is, drugs like morphine or heroin, the latter not legal) should only be used in severe acute pain, like that due to bad trauma or occurring post-operatively, or for the pain of terminal illnesses, like cancer.  The reason their use was so restricted was that the drugs were believed to cause frequent adverse effects, from severe constipation, to addiction, to respiratory depression and death.

However, starting in the 1990s, the conventional wisdom changed.  Suddenly, the focus was on the under-treatment of chronic, but not malignant pain, and it became permissible, or even preferable, to use potent narcotics for this purpose.  Physicians like me who were very conservative in their use of narcotics were chastised for under-treating pain.

The Wall Street Journal article explained how this radical change in approach was apparently engineered by a few key opinion leaders, particularly Dr Russell Portenoy.  It opened,

Two decades ago, the prominent New York pain-care specialist drove a movement to help people with chronic pain. He campaigned to rehabilitate a group of painkillers derived from the opium poppy that were long shunned by physicians because of their addictiveness.

Dr. Portenoy's message was wildly successful. Today, drugs containing opioids like Vicodin, OxyContin and Percocet are among the most widely prescribed pharmaceuticals in America. 

The article provided graphics showing that per capita prescription narcotic use has more than tripled since 1999, 

A Change Driven by Wishful Thinking, not Evidence

Unfortunately, as the article made clear, the radical change that seemed so odd to some of us physicians who were trained before the 1990s was not driven by any good evidence from clinical research.

Per the WSJ,

Because doctors feared they were dangerous and addictive, opioids were long reserved mainly for cancer patients. But Dr. Portenoy argued that they could be also safely be taken for months or years by people suffering from chronic pain. Among the assertions he and his followers made in the 1990s: Less than 1% of opioid users became addicted, the drugs were easy to discontinue and overdoses were extremely rare in pain patients. 

However, Dr Portenoy's contention seemed to be based only on a small case-series of patients, lacking any sort of control group, and too small and likely too selective to generalize, particularly to patients with chronic, non-malignant pain.(Portenoy RK, Foley KM.   Chronic use of opioid analgesics in non-malignant pain: report of 38 cases. Pain 1986; 25:171-86.  This article does not seem to be available online.)

In 1986, at the age of 31, he co-wrote a seminal paper arguing that opioids could also be used in the much larger group of people without cancer who suffered chronic pain. The paper was based on just 38 cases and included several caveats. Nevertheless, it opened the door to much broader prescribing of the drugs for more common complaints such as nerve or back pain. 

 Dr Portenoy also cited

the statistic that less than 1% of opioid users became addicted.

Today, even proponents of opioid use say that figure was wrong. 'It's obviously crazy to think that only 1% of the population is at risk for opioid addiction,' said Lynn Webster, president-elect of the American Academy of Pain Medicine, one of the publishers of the 1996 statement. 'It's just not true.'

The figure came from a single-paragraph report in the New England Journal of Medicine in 1980 describing hospitalized patients briefly given opioids.

The reference here appears to be a letter to the New England Journal of Medicine ( Porter J, Jick H. Addiction rate in patients treated with narcotics. New England Journal of Medicine 1980; 302:123.  Link here.)  This was literally one paragraph long, so the methods of the research it reported cannot be rigorously evaluated.  In any event, the letter appears to have retrospectively documented an observation of hospitalized patients who were given at least a single dose of narcotics, and thus appears not relevant to the effects of long-term narcotics on patients with chronic pain. 

Thus, Dr Portenoy's enthusiasm for aggressive use of narcotics in non-malignant chronic pain was never based on any good evidence from well designed and performed randomized controlled trials with long-term followup that showed that narcotics were safe and effective in this setting.  At best, Dr Portenoy's and colleagues' contentions that narcotics should be liberally utilized for such patient were based on wishful thinking, not good evidence.


A Change Driven by Stealth Marketing

The WSJ article documented how Dr Portenoy was a prime mover in what appeared to be deceptive stealth campaigns to market narcotics for chronic, non-malignant pain.  Dr Portenoy's 1986 case-series

opened the door to much broader prescribing of the drugs for more common complaints such as nerve or back pain.

Charming and articulate, he became a sought-after public speaker. He argued that opioids are a 'gift from nature' that were being forsaken because of 'opiophobia' among doctors. 'We had to destigmatize these drugs,' said Dr. Portenoy.

He rose to chairman of pain medicine and palliative care at Beth Israel Medical Center in New York. His small office is studded with awards and evidence of his offbeat sense of humor. He prominently displays a magazine mock-up that jokingly dubs him 'The King of Pain.'

At medical conferences, his confident, knowing manner helped smooth the way for his message. Before an audience of government regulators, he once joked that he might tell a patient at low risk of abuse: 'Here, [have] six months of drugs. See you later,' he said, according to a Food and Drug Administration transcript. Amid laughter, he added, 'It's just hyperbole. I don't actually do that.'

Steven Passik, a psychologist who once worked closely with Dr. Portenoy and describes him as his mentor, says their message wasn't based on scientific evidence so much as a zeal to improve patients' lives. 'It had all the makings of a religious movement at the time,' he says. 'It had that kind of a spirit to it.'

So Dr Portenoy became a respected opinion leader.  His influence was demonstrated by how he generated disciples

 Dr. Portenoy's ideas about opioids reached into mainstream medicine and attracted outspoken advocates. In a 1998 talk in Houston, Alan Spanos, a South Carolina pain specialist, said patients with chronic noncancer pain could be trusted to decide themselves how many painkillers to take without risk of overdose. According to a recording, Dr. Spanos said he understood that a patient would simply 'go to sleep' before stopping breathing. While asleep, he said, the patient 'can't take a dangerous dose. It sounds scary, but as far as I know, nobody anywhere is getting burned by doing it this way.'

Dr Portenoy was affiliated with organized efforts that facilitated the marketing of narcotics for chronic malignant pain.  The marketing used clinical practice guidelines to push narcotics

Dr. Portenoy helped write a landmark 1996 consensus statement by two professional pain societies that said there was little risk of addiction or overdose among pain patients. 

The campaign enlisted government regulators, and thus seemed to include an element of regulatory capture,

One of Dr. Portenoy's chief complaints was that doctors were reluctant to prescribe opioids because they feared scrutiny by regulators or law enforcement. In the second half of the 1990s, he and his followers campaigned successfully for policies to change that.

In 1998, the Federation of State Medical Boards released a recommended policy reassuring doctors that they wouldn't face regulatory action for prescribing even large amounts of narcotics, as long as it was in the course of medical treatment. In 2004 the group called on state medical boards to make undertreatment of pain punishable for the first time.

This case demonstrated the direct involvement of pharmaceutical companies who sold narcotics,

That policy was drawn up with the help of several people with links to opioid makers, including David Haddox, a senior Purdue Pharma executive then and now. The federation said it received nearly $2 million from opioid makers since 1997. The federation says it derives the majority of its funding from administering medical licensing exams, credential verification, and data services.

A federation-published book outlining the opioid policy was funded by opioid makers including Purdue Pharma, Endo Health Soluttions Inc, and others, with proceeds totaling $280,000 going to the federation. .

 The campaign also involved an important hospital accrediting organization

In 2001, the Joint Commission, [JCAHO] which accredits U.S. hospitals, issued new standards telling hospitals to regularly ask patients about pain and to make treating it a priority. The now-familiar pain scale was introduced in many hospitals, with patients being asked to rate their pain from one to 10 and circle a smiling or frowning face.

The Joint Commission published a guide sponsored by Purdue Pharma. 'Some clinicians have inaccurate and exaggerated concerns" about addiction, tolerance and risk of death, the guide said. "This attitude prevails despite the fact there is no evidence that addiction is a significant issue when persons are given opioids for pain control.'

A Change Leading to Personal Enrichment

Meanwhile, Dr Portenoy was personally profiting from his relationships with pharmaceutical companies

Over his career, Dr. Portenoy has disclosed relationships with more than a dozen companies, most of which produce opioid painkillers. 'My viewpoint is that I can have those relationships, they would benefit my educational mission, they benefit in my research mission, and to some extent, they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation,' he said.

Dr. Portenoy and Beth Israel declined to provide details of their funding by drug companies. A 2007 fundraising prospectus from Dr. Portenoy's program shows that his program received millions of dollars over the preceding decade in funding from opioid makers including Endo, Abbott Laboratories, Cephalon, Purdue Pharma and  Johnson & Johnson.  

He currently also appears to be on the advisory boards of  Zars Pharma Inc,  Relevare Therapeutics, and Cytogel Pharma.

Thus, it seems that Dr Portenoy fit the usual definition of key opinion leader.  He was regarded as an authority in his area and his opinions were obviously influential.  He was paid by health care corporations with interests in selling their goods or services, in this case, narcotic drugs, and was using his influence to promote individual patient care decisions and policy decisions that facilitated the widespread use of these drugs. 

A Change Leading to Sick and Dead Patients

Since the campaign to "destigmatize" narcotics began, the US has seen what many have called an epidemic of narcotic adverse effects.  The WSJ article provided graphs showing that narcotic related deaths and hospital admissions both increased more than five times since 1999.   As the WSJ put it,

 some specialists now question whether the drugs should be prescribed so freely for months or years to people with chronic pain that isn't related to cancer, as Dr. Portenoy proposed 25 years ago. "People lost sight of the fact that these are dangerous drugs that are highly addictive," said Jane Ballantyne, a pain specialist at the University of Washington. She once agreed with Dr. Portenoy and proponents of broad opioid use but now believes they need to be used more selectively.

Dr Portenoy Recants

What is most remarkable about this case is that it seems to be the first in which a highly influential industry paid key opinion leader has publicly had a change of heart.

Now, Dr. Portenoy and other pain doctors who promoted the drugs say they erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,' Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'

I would note there is some sophistry there.  There was never good evidence for narcotics' effectiveness or safety for patient with chronic, non-malignant pain.

In fact, Dr Portenoy also admitted that, sort of,

'Data about the effectiveness of opioids does not exist,' Dr. Portenoy said in his recent Journal interview. To get a painkiller approved, companies must prove that it is better at reducing pain than a sugar pill during short trials often lasting less than 12 weeks. 'Do they work for five years, 10 years, 20 years?' Dr. Portenoy said in the Journal interview. 'We're at the level of anecdote.'

Again, it is not that the data that supported the use of the drugs has disappeared, or that new data has been developed that contradicts the old data.  There never has been any good data, that is, from well designed and performed randomized controlled trials that demonstrate that the benefits of narcotics outweigh their harms for patients with chronic, non malignant pain.  It does not exist now and it never existed.

Dr Portenoy also admitted,

'I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,' Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished.

In it, Dr. Portenoy said it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording.

So not only did the Wall Street Journal article describe how the overuse of narcotics for chronic, non-malignant pain came from wishful thinking energized by the possibility of corporate and personal profit, it showed how the chief medical cheer leader for these drugs now admits he was wrong.


Summary

In summary, it appears that the huge increase in the use of narcotics to treat chronic, non-malignant pain was never based on clear convincing evidence from well-designed studies.  At best it was based on irrational enthusiasm and wishful thinking by some very vocal and persuasive advocates.  These advocates seemed to become "key opinion leaders," that is, influential people who promoted the use of pharmaceuticals while they were being paid by pharmaceutical companies, and were likely involved in what appears to be systematic stealth marketing campaign by the pharmaceutical companies that make narcotics.  These campaigns included production of clinical practice guidelines promoted as authoritative, and enlistment of accrediting organizations and government regulatory agencies.

One particularly disturbing part of this story was the involvement of numerous people and organizations  entrusted by society to promote good medical care.  It shows how physicians, other health professionals, and the public at large must be very skeptical of vocal advocates of new, aggressive, "innovative" approaches, of clinical practice guidelines even those developed by apparently prestigious professional societies, of accrediting organizations, and of government regulators.  That is discouraging, and could lead to the cynical approach of simply not trusting anyone.

I would note, however, that two ways the headlong rush to over-use of narcotics could have been derailed would have been:
-  employment of extreme skepticism of people paid by narcotics manufacturers advocating increased use of these drugs, no matter how distinguished, scholarly, or influential these people appear to be.  This suggests the need for general skepticism of people with financial relationships with health care corporations pushing the goods or services these corporations provide, or pushing policies that would aid the selling of those goods or services
-  a rigorous evidence-based medicine approach, meaning making clinical and policy decisions based on the best evidence found by systematic search from rigorously evaluated clinical research about the benefits and harms of these decisions, informed by patients' values.  Such an approach would have revealed there was never any good clinical evidence to support long-term use of narcotics for chronic, non-malignant pain, the particular "innovation" being pushed in this case.

So I would argue that the case of the legal narcotics pushers underlines the need for utmost transparency about conflicts of interest affecting people and organizations that advocate for particular approaches to health care, and to the management of individual patients; continuing movement to bar at least the most egregious conflicts, as per the Institute of Medicine report on the topic (look here); and the need for the very skeptical, rigorous application of true evidence-based medicine approaches.  

Finally, I must note that this seems to be the first time that a prominent, highly influential key opinion leader  has recanted.  Maybe he will write an article entitled "Dr Drug Pusher?" - just joking, but at least one former  key opinion leader did write the confessional  "Dr Drug Rep."  Maybe this is the beginning of a movement toward health care based on logic and evidence rather than wishful thinking, irrational enthusiasm, or ideology, or even worse, on deception or personal enrichment.     

Pfizer's 13th Legal Settlement - Will it be Enough to End the Impunity?

It has been almost two months since we lasted noted misbehavior by giant global pharmaceutical firm Pfizer Inc. With little fanfare, however, a few small news items noted the corporation's latest legal settlements.

Deceptive Marketing of Protonix

The first settlement merited only a few paragraphs from Reuters.  The gist was:

Pfizer Inc will pay $55 million plus interest to settle charges that Wyeth promoted its acid reflux drug Protonix for unapproved uses and made unproven claims about the medicine, the U.S. Department of Justice said on Wednesday. 

The infractions took place between February 2000 and June 2001, long before the world's largest drugmaker acquired Wyeth in 2009 for $68 billion.

A report in the examiner explained that Wyeth did not merely go beyond the label in promoting Protonix, it went beyond the evidence.

Wyeth allegedly promoted Protonix as the 'best PPI for nighttime heartburn' even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. 

Furthermore, the charges were that systemic efforts to mislead were sanctioned by top management:

 The allegations in the complaint are that this superiority slogan was formulated at the highest levels of the company. Wyeth retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.

Finally, the government asserted that Wyeth corrupted physicians' continuing medical education in the process:

Finally, the government alleges that Wyeth used continuing medical education (CME) programs to promote Protonix for unapproved uses. CME programs are sponsored by accredited independent providers, such as universities, nonprofit organizations, or specialty societies. Pharmaceutical companies are permitted to provide financial support for CME programs, but they are not permitted to use CME programs as promotional vehicles for off-label indications.

According to the complaint, Wyeth spent millions of dollars providing 'unrestricted educational grants' to CME providers, and these grants invariably included promises that Wyeth would not attempt to influence the content of the program in any way. Nevertheless, the government alleges that one of Wyeth’s core marketing tactics for Protonix was to use CME programs to drive off-label use of the drug. According to the complaint, the Protonix 'brand team' influenced virtually every aspect of these CME programs: program topics, speaker selection, organization, and content. In addition, the government alleges that Wyeth even insisted that the CME program materials use the same color and appearance as Protonix promotional materials–a tactic that Wyeth and the vendor called 'branducation.'

So it seemed that the company put on quite an effort to promote what we have called elsewhere pseudo-evidence based medicine, yet, like many other legal settlements involving large health care organizations, this one involved no penalties of any type against the people within the organization who authorized, directed, or implemented the bad behavior. 

 Misleading Marketing of Zyvox, Lyrica 

Another settlement, for a few dollars less, got even less attention.  Fox Business news did report this:

 Pfizer Inc. (PFE) agreed to pay a combined $42.9 million to North Carolina and 32 other states in a settlement of allegations that the drug maker used unfair and deceptive practices in the marketing of antibiotic Zyvox and nerve-pain medicine Lyrica.

I could find no detail about the sorts of deception allegedly involved in the news media.  What little more Fox provided did suggest that this case also involved pitching drugs in instances in which their use was unsupported by good evidence:

The states had alleged that Pfizer had marketed Zyvox as superior to another antibiotic in fighting certain types of infections, though there allegedly wasn't substantial evidence to support superior results for some uses that Pfizer claimed.

The states also alleged that Pfizer marketed Lyrica for some off-label, or unapproved, uses.

There was no hint that again any individual would suffer any negative consequences for this particular set of deceits either.

Avoiding Impunity as a Topic of Polite Discussion

We have discussed a seemingly endless parade of legal settlements by large health care organizations.  In almost none was there any consequence beyond a fine paid by the company, and sometimes a pledge that the company would thereafter behave better.  While these relatively small costs were diffused throughout the organizations, almost never did the people who authorized, directed, or implemented the bad behavior pay any price or suffer any penalty.  Thus we have opined again and again (e.g., most recently here) that these settlements have become just another cost of doing business, and have no power to deter future bad behavior.

In addition, we have noted not only have multiple organizations made such settlements, some organizations have settled again and again.  Yet even in the cases of these multiple organizational offenders, the individuals involved maintain their immunity from any negative consequences.  Thus these are examples of impunity.  

Transparency International declared 23 November, 2012, as the International Day to End Impunity, explained as follows:

At Transparency International we view impunity as getting away with bending the law, beating the system or escaping punishment. Impunity is anathema to the fight against corruption.

However, impunity is one of those concepts which never seems to be a subject of polite conversation in health care, or, as we say, it has become anechoic.  

Therefore, it is fascinating that while these two Pfizer settlements were announced almost simultaneously, each was discussed, such as it was, as if it occurred in a vacuum.  Moreover, it also seems that each settlement was crafted by law enforcers without any attention to the record of the company making the settlement.  Thus, any implications about impunity were avoided.

Pfizer's Multiple Ethical Opfenses

In fact, during the time we have been posting on Health Care Renewal, Pfizer has become one of the great repeat ethical offenders in the health care arena.  Its track record since the beginning of the 21st century, (with yello colored background below, compiled from this post), is remarkable.

In the beginning of the 21st century, according to the Philadelphia Inquirer, Pfizer made three major settlements,

October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.

May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.

April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).  Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).  In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post). Finally, in August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post). 

By my count, the two current settlements would be numbers twelve and thirteen.  Of course, while I believe this list is accurate, it may be incomplete.

Since none of these posts involved any negative consequences for any individuals who authorized, directed, or implemented the bad behavior, or who profited from it, and none involved any changed in the leadership or organization of the company, this becomes an amazing record of the impunity of Pfizer leadership over time and space. 

Will Impunity Finally Lead to Outrage?

Impunity, though, is a concept that is beginning to command some attention.

The Brasilia Declaration which was published at the conclusion of the 15th International Anti-Corruption Conference (hosted by Transparency International) included:

it is clear we all face a common challenge in our work: impunity for those who abuse positions of power. 

If impunity is not stopped, we risk the dissolution of the very fabric of society and the rule of law, our trust in our politics and our hope for social justice.

Activists, businesspeople, politicians, public officials, journalists, academics, youth and citizens who gathered in Brasilia to discuss the threat of corruption made it clear that impunity undermines integrity everywhere.

Whether we are investing collective efforts and resources in fighting poverty, human rights violations, climate change or bailing out indebted economies, we need to give the people a reason to believe that impunity will be stopped.

While the two latest Pfizer settlements barely got media coverage, maybe a $1.9 billion dollar settlement in the US by international banking giant will get more attention.  The charges in this case were not merely deceiving some doctors and patients about drug efficacy and safety.  The company was accused of aiding money laundering by drug cartels, and facilitating rogue regimes get around international sanctions.  As the New York Times reported,

State and federal authorities decided against indicting HSBC in a money-laundering case over concerns that criminal charges could jeopardize one of the world’s largest banks and ultimately destabilize the global financial system.

Instead, HSBC announced on Tuesday that it had agreed to a record $1.92 billion settlement with authorities. The bank, which is based in Britain, faces accusations that it transferred billions of dollars for nations like Iran and enabled Mexican drug cartels to move money illegally through its American subsidiaries.

Unlike Pfizer's slow-motion impunity, this example got attention.  The Los Angeles Times noted,

The massive penalty still was not enough to appease some critics. No bank executives were charged as part of the investigation, leading some analysts to question the government's willingness to hold powerful Wall Street firms accountable.

'It's mind-boggling how they think you can have a financial system and allow this kind of impunity,' said William Black, a former banking regulator who aided federal prosecutors during the savings and loan crisis of the 1980s and 1990s. HSBC 'put the world at enormous risk.'

A NY Times editorial opened,

It is a dark day for the rule of law.   Federal and state authorities have not to indict HSBC, the London-based bank, on charges of vast and prolonged money laundering, for fear that criminal prosecution would topple the bank and, in the process, endanger the financial system.  They have also not charged any top HSBC banker in the case, though it boggles the mind that a bank could launder money as HSBC did without anyone in a position of authority making culpable decisions.

Clearly, the government has bought into the notion that too big to fail is too big to jail.  When prosecutors choose not to prosecute to the full extent of the law in a case as egregious as this, the law itself is diminished.  The deterrence that comes from the threat of criminal prosecution is weakened, if not lost.

So maybe this huge financial case will prove to be the straw that breaks impunity's back.  So I will close by quoting the end of the Brasilia Declaration, in the hope that a few people will take it to heart in the context of health care, as well as in finance.

To take this important struggle forward the international anti-corruption community should promote greater people engagement and find ways to provide greater security for anti-corruption activists.

Reducing impunity also requires independent and well-resourced judiciaries that are accountable to the people they serve.

We call on leaders everywhere to embrace not only transparency in public life but a culture of transparency leading to a participatory society in which leaders are accountable.

We call on the anti-corruption movement to support and protect the activists, whistleblowers and journalists who speak out against corruption, often at great risk.

It is up to all of us in government, business and society to embrace transparency so that it ensures full participation of all people, bringing us together to send a clear message: We are watching those who act with impunity and we will not let them get away with it.

Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events

The Pennsylvania Patient Safety Authority has released a report "The Role of the Electronic Health Record in Patient Safety Events."  A press release is at this link, and the full report in PDF is at this link.  In the report, the Pennsylvania Patient Safety Authority analyzed reports of EHR-related events from a state database of reported medical errors and identified several major themes.

The report was prepared with the assistance of Erin Sparnon, Senior Patient Safety Analyst the ECRI Institute near Philadelphia.  The ECRI Institute is an independent organization renowned for its safety testing of medical technologies and reporting on same, and that "researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care."  I've mentioned it and its bylaws in this blog in the past as a model for independent, unbiased testing and reporting of healthcare techonlogies.

Regarding the Patient Safety Authority:

The Pennsylvania Patient Safety Authority was established under Act 13 of 2002, the Medical Care Availability and Reduction of Error ("Mcare") Act, as an independent state agency. It operates under an 11-member Board of Directors, six appointed by the Governor and four appointed by the Senate and House leadership. The eleventh member is a physician appointed by the Governor as Board Chair.  Current membership includes three physicians, three attorneys, three nurses, a pharmacist and a non-healthcare worker.

The Authority is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety in hospitals, ambulatory surgical facilities, birthing centers and certain abortion facilities. Under Act 13 of 2002, these facilities  must report what the Act defines as "Serious Events" and "Incidents" to the Authority.

The Authority maintains a database of serious events and incidents:

Consistent with Act 13 of 2002, the Authority developed the Pennsylvania Patient Safety Reporting System (PA-PSRS, pronounced "PAY-sirs"), a confidential web-based system that both receives and analyzes reports of what the Act calls Serious Events (actual occurrences) and Incidents (so-called "near-misses").

Cutting right to the chase, the paper's summary:

As adoption of health information technology solutions like electronic health records (EHRs) has increased across the United States, increasing attention is being paid to the safety and risk profile of these technologies. However, several groups have called out a lack of available safety data as a major challenge to assessing EHR safety, and this study was performed to inform the field about the types of EHR-related errors and problems reported to the Pennsylvania Patient Safety Authority and to serve as a basis for further study. Authority analysts queried the Pennsylvania Patient Safety Reporting System for reports related to EHR technologies and performed an exploratory analysis of 3,099 reports using a previously published classification structure specific to health information technology. The majority of EHR-related reports involved errors in human data entry, such as entry of “wrong” data or the failure to enter data, and a few reports indicated technical failures on the part of the EHR system. This may reflect the clinical mindset of frontline caregivers who report events to the Authority.

Results:

... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) [a risk best avoided to start with, because luck runs out eventually - ed.], and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event. Fifteen reports involved temporary harm to the patient due to the following: entering wrong medication data (n = 6), administering the wrong medication (n = 3), ignoring a documented allergy (n = 2), failure to enter lab tests (n = 2), and failure to document (n = 2). Only one event report, related to a failure to properly document an allergy, involved significant harm.

A significant "study limitations" section was included that addressed: 

• Issues regarding reporting statutes of the PA-PSRS errors database; 

• lack of awareness of EHRs as a potential contributing factor to an error;

• limitations of narrative reporting affecting both the types of reports queried and the tags applied (the study used textual data mining methodolgies);

• query design of the study; and

• the need for further refinement of the machine learning tool used in creating the working dataset, which may have missed relevant cases.

Some of these impediments to knowing the magnitude of extant HIT issues are also present in the 2008 Joint Commission Sentinel Events Alert on HIT, the 2010 FDA internal memorandum on HIT Safety, and the 2011 IOM report on the same topic.

(The IOM report specifically observed that the "barriers to generating evidence pose unacceptable risks to safety.") 

The major obstacle to this study in my view, though, was the nature of the dataset.  The database is for general reporting of medical errors, and it contains no specific fields or reminders about EHRs or the known ways in which they can contribute to, or cause, medical mistakes.  

The attempt was made, as acknowledged in the study, to glean information about EHR-related events from, in large part, textual analysis of narrative in the hopes that the reporter recognized the role of IT, and reported it using terms that could be detected by the search algorithms.  In other words, the data was not "purposed" for this type of study.  

It is axiomatic that one cannot find data that is simply not present, no matter how fancy the search algorithm.  Further, passive analysis of clinical IT risk/harms data in an industry where lack of knowledge of causation and misconceptions abound will produce only partial results that suggest further study is needed, and not give an indicator of just how incomplete the results are.

Thus, this cautionary statement was made in the new PA Patient Safety Authority report:

"Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure." 

My comments:

The report is welcome.

The most important part of the paper, I point out, is the “Limitations” section. FDA, IOM and others have made similar observations – we don’t know the true magnitude of the problem due to systematic limitations of the available data. 

Therefore, at best what is available must be deemed as risk management-relevant case reports, a “red flag” that could represent (using the words of FDA CDRH director Jeffrey Shuren regarding HIT safety), the tip of the iceberg.

It is imperative far more work be done in post-market surveillance as this technology is deployed nationally and internationally.  This is to ensure that good health IT (GHIT) prevails and bad health IT (BHIT) is either remediated or removed from the marketplace.  I had defined those in other writings as follows:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. 

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

An additional major factor that also contributes to lack of knowledge of EHR-related adverse events is hospital reporting non-compliance. For instance, I know of cases from my own legal consulting work and personal experience that I would have expected to appear in the database, but apparently do not.

But don’t take it from me alone. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on this.

From “Hospitals Are Not Reporting Errors as Required by Law, Phila. Inquirer”, pg. 4, http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety:
  

... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board.

He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. [Thus reducing risk of litigation, and, incidentally, potentially infringing on patients' rights to legal recourse - ed.]

Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years.

Fixing this “is not a priority,” he added.

This coincides with my own personal experience precisely.  In a case where my relative was permanently injured as a result of EHR-related medication error, and then died of the injuries, I never received the required report in writing from the hospital.  I also do not believe the case was reported to the Safety Authority, at least not as IT-related.

I suspect the true rates of EHR-related close calls, reversible injuries, permanent injuries and deaths is significantly higher than the limited data available suggests. That data is merely a red flag that much more education, stringent reporting requirements,  templates of known causes of error, and enforcement are needed.  (An April 2010  "thought experiment" on this issue I wrote about at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" certainly suggested as much.)

Slides where I made those types of recommendations to the Patient Safety Authority, at a presentation I gave in July 2012 at their invitation, are at http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt

A major concern I have is that the HIT industry will use this new report in a manner that ignores its limitations.

(Disclosure: I was an invited reviewer of this new PPSA report.)

-- SS 

Addendum Dec. 13:   

Also worth review is "Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration", Magrabi, Ong, Runciman, and Coiera, AMIA Annu Symp Proc. 2011.  

Data here came from FDA's voluntary (i.e., also tip of the iceberg) Manufacturer and User Facility Device Experience (MAUDE) database.  Ironically, the study was done in Australia using Australian grant funds.

-- SS