All the President's Trade Negotiators - Revolving Doors, Regulatory Capture, and Health Care Corporate Friendly Trade Agreements

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All the President's Trade Negotiators - Revolving Doors, Regulatory Capture, and Health Care Corporate Friendly Trade Agreements

Unknown 5/14/2015 Komentar

This week's spectacle in Washington, DC was a nearly unanimous Democratic minority in the Senate blocking a proposal for expedited consideration of multinational trade agreements favored by the Republican majority, but also by the Democratic President and his trade negotiators (look here).  Democrats mainly based their actions on perceptions that the trade agreements favored multinational corporations  over people.

While trade agreements may seem to be another, albeit international species of wonkery, these agreements could have major effects on patients' and the public's health.  Since these concerns have been essentially ignored by the US medical and health care literature, (although they have appeared in UK journals, Australian, and New Zealand journals in English), they I will discuss them below. Worthy of further discussion is the possibility that these potential threats to health care and public health may arise not just from ideological disagreements, but also from health care corporations' increasing capture of government, facilitated by the conflicts of interest generated by the revolving door. 

Corporate Friendly Trade Agreements

The US has been negotiating two major multinational trade agreements, the Trans-Pacific Partnership (TPP) and the Transatlantic  Trade and Investment Partnership (TTIP) for years. 

In a March, 2014, commentary, renowned economist Joseph E Stiglitz summarized the objections to the these proposed trade agreements.  His greatest fears were that such agreements

will benefit the wealthiest sliver of the American and global elite at the expense of everyone else.

This seems surprising, since most people think of trade agreements solely in terms of their effects on tariffs, not a big concern for health care and public health professionals.  However, Stiglitz noted

Tariffs around the world are already low. The focus has shifted to 'nontariff barriers,' and the most important of these — for the corporate interests pushing agreements — are regulations. Huge multinational corporations complain that inconsistent regulations make business costly. But most of the regulations, even if they are imperfect, are there for a reason: to protect workers, consumers, the economy and the environment.

What’s more, those regulations were often put in place by governments responding to the democratic demands of their citizens. Trade agreements’ new boosters euphemistically claim that they are simply after regulatory harmonization, a clean-sounding phrase that implies an innocent plan to promote efficiency. One could, of course, get regulatory harmonization by strengthening regulations to the highest standards everywhere. But when corporations call for harmonization, what they really mean is a race to the bottom.

 In the US, and other developed countries, there are lots of regulations that have major effects on health care and public health.  Changes in these regulations, or their implementation, could have major effects again on health care and the public health.  So those interested in health care and public health ought to be concerned about how such trade agreements could affect such regulation.

International Tribunals Could Trump National Law
One of Stiglitz's concerns was  that the trade agreement would allow international tribunals that could override national law, particularly law promoting public health:

What we know of ... particulars [of the TTP] only makes it more unpalatable. One of the worst is that it allows corporations to seek restitution in an international tribunal, not only for unjust expropriation, but also for alleged diminution of their potential profits as a result of regulation. This is not a theoretical problem. Philip Morris has already tried this tactic against Uruguay, claiming that its antismoking regulations, which have won accolades from the World Health Organization, unfairly hurt profits, violating a bilateral trade treaty between Switzerland and Uruguay.

In fact, Philip Morris has also used such tribunals to overturn Australian laws meant to discourage smoking for public health purposes.  The details of the Philip Morris case summarized in May, 2015 in an article by Lauren Carasik in  Foreign Policy, show the major public health implications of such trade tribunals,

In 2011, Australia passed a tobacco-control law to discourage smoking. It required cigarettes to be sold in plain packages with prominent warnings, with brand information relegated to the bottom of the box. Touted as 'one of the most momentous public health measures in Australia’s history' by the country’s health minister, the law was meant to deter a habit that will ultimately kill 1.8 million current Australian smokers, according to a recent study. After the country’s highest court upheld the constitutionality of the anti-smoking law, tobacco giant Philip Morris claimed that it violated the company’s corporate rights and launched a suit using a little-known provision called investor-state dispute settlement (ISDS). The case is pending, as is a similar case against Uruguay. A similar tobacco-control measure in New Zealand is on hold pending the outcome of these cases.

So these examples suggest that national laws meant to promote the public health could be challenged in these trade tribunals by multinational corporations based on these laws' postulated effects on corporate profits, regardless of the laws' public health rationale or legality in their own countries. 


Furthermore, a letter to the Lancet(1) noted,

Investor state dispute settlement (ISDS) provisions allow investors to sue governments if policy changes or even court rulings substantially affect the value of their investment, yet do not allow governments to sue investors for breaching the right to health.   ISDS processes constrain governments' abilities to regulate on the basis of the precautionary principle, or even to implement health policies on the basis of established evidence. These processes can have a chilling effect on efforts to address key health issues, such as alcohol, the obesity epidemic, and climate change. In New Zealand, the fear of costly ISDS litigation is already constraining government regulation on tobacco plain packaging.

Thus, creation of such international tribunals could favor financial concerns of multinational corporations over individual countries' governments' attempts to promote health care or public health. So, while these undemocratic tribunals are touted as a way to reduce non-tariff trade barriers, an editorial in the British Medical Journal(2) asserted,

Yet these barriers are some of our most prized social and environmental standards, including regulations on food safety, pesticide residues, and toxic chemicals....

Not only would these tribunals we able to override national laws, their operation would lack procedural safeguards.  Demonstrating that opposition to these trade agreements is also multinational, an article in the UK Independent in October, 2014, noted,

Critics say the tribunals, held under the so-called Investor-State Dispute Settlement (ISDS) system, subvert democratic justice, giving power over foreign citizens to big companies. Hearings are held in private, in international courts at the World Bank in Washington DC, bypassing the legal system of the country being sued, meaning details are often impossible to uncover. In some cases the very existence of the case is not made public.

In addition, per the article in Foreign Policy,

Critics like Global Trade Watch, a division of Public Citizen, a consumer advocacy organization, say the ISDS system is anti-democratic. Sen. Elizabeth Warren (D-Mass.) called for the ISDS language to be stripped out of the deal, writing in the Washington Post in February, 'If a final TPP agreement includes Investor-State Dispute Settlement, the only winners will be multinational corporations.' The problem is that the ISDS system lacks many procedural safeguards fundamental to the rule of law. The tribunals, run by the World Bank and the United Nations, are three-judge panels composed of highly paid private lawyers picked from a limited pool by states and corporations; individual lawyers can switch between serving as judges and advocates on behalf of corporations in different cases. And there is no comprehensive code of judicial conduct guiding the panelists on matters such as conflicts of interest.

Although the panels adjudicate disputes worth millions or even billions of dollars, they are not accountable to any elected body. Moreover, there is no system of precedent binding judges to an established body of decision-making, making it difficult for the parties to discern the applicable standards and their likelihood of success. And finally, there are no appeals, either within the ISDS system or externally, on the merits of decisions. An annulment is only possible for limited procedural errors, and those proceedings are heard before a different panel drawn from the same pool of professionals.

Under the system, states are deprived of the right to resolve these disputes since corporations can proceed directly to the tribunals without exhausting domestic remedies. But this privilege is not reciprocal: Corporations are not subject to suit in the tribunals by those harmed by their actions. Foreign companies are thus granted expanded rights without corresponding responsibilities.

Finally, in May, 2015, the United Nations special rapporteur on promotion of a democratic and equitable international order suggested that the proposed international tribunals would undermine human rights and violate the UN charter (per this Guardian article).

Further criticism of the tribunals came from the UK Labour party Shadow Health Secretary (as of April, 2014) who felt it would leave British general practitioners "powerless to resist legal challenges from US health giants with huge financial resources in the event of a contractual dispute (per the Independent).

To summarize thus far:  international trade agreements being pushed by the US government could set up trade tribunals that could reverse national laws meant to protect health and safety.  Such tribunals would not follow the procedures used, for example, in US courts, and could not be held accountable by individual governments.  Various aspects of these tribunals, and recent actions involving tribunals already set up by earlier trade agreements suggest the process may be heavily biased in favor of the financial interests of multinational corporation, and against patients' and the public's health.  Thus, health care and public health professionals ought to be alarmed about new agreements that could set up new tribunals, or expand the reach of existing tribunals.


Intellectual Property Rights vs Access to Health Care

Another set of problems affecting patients' and the public's health  are provisions in trade agreements favoring corporate "intellectual property" over access to drugs, devices and health care.  Stiglitz wrote in 2014,

America has been fighting to lower the cost of health care. But the TPP would make the introduction of generic drugs more difficult, and thus raise the price of medicines. In the poorest countries, this is not just about moving money into corporate coffers: thousands would die unnecessarily. Of course, those who do research have to be compensated. That’s why we have a patent system. But the patent system is supposed to carefully balance the benefits of intellectual protection with another worthy goal: making access to knowledge more available. I’ve written before about how the system has been abused by those seeking patents for the genes that predispose women to breast cancer. The Supreme Court ended up rejecting those patents, but not before many women suffered unnecessarily. Trade agreements provide even more opportunities for patent abuse.

To date, most of the details of the proposed trade agreements have been kept secret, but as noted on the PLoS Medicine blog in December, 2013, by Reshma Ramachandran and David Carroll,

Last month, Wikileaks posted the complete Intellectual Property (IP) Chapter of the secretly-negotiated Trans-Pacific Partnership Agreement (TPP) confirming public health advocates’ worst fears of the agreement’s impact on patients worldwide.

In particular,

The Wikileaks posted text revealed that the USTR and Obama Administration have decided to aggressively prioritize the interests of multinational pharmaceutical and medical companies over patients worldwide and at home. In fact, according to emails submitted to Intellectual Property-Watch under the Freedom of Information Act, the USTR has actively solicited the input of industry groups, giving them special access to the negotiating text while consumer and health groups have had to resort to requesting special meetings with negotiators. 

So,

Indeed, the recently leaked TPP chapter reflect these corporate interests as evidenced by the still-included provisions. In the text, the USTR has proposed a number of provisions that will further strengthen patents and data exclusivity for pharmaceuticals. Such provisions will bar the entry of generic competition into the market allowing for brand-name drug companies to retain their monopoly market and set drug prices at exorbitantly high prices. These provisions include:

- Lowering patent standards allowing for “evergreening” or the granting of patents for newer forms of existing medicines including new formulations or minor modifications even in the absence of a therapeutic benefit

- Mandating that surgical, therapeutic, and diagnostic methods must be patented making medical practitioners in TPP member states liable for infringement and restricting their choices for treatment

- Imposing data exclusivity on all pharmaceuticals, including biologics with the minimum period for this class to be set at 12 years (despite the fact that the White House is publicly in favor of a 7 year data exclusivity period and the FTC has stated that there is no need for any data exclusivity period at all) thereby not allowing drug safety regulators from accessing clinical data to grant market approval for generic and biosimilar drugs

-  Adjusting patent term periods to account for “unreasonable delays” including patent prosecution periods ranging from two years to more than four years extra further delaying generic drug entry into the market

- Adjusting patent term periods for regulatory approval periods allowing for patent extensions for both new pharmaceutical products as well as methods for producing or using new pharmaceutical products halting any potential innovation

- Linking patent status and drug marketing approval causing drug regulatory authorities to take on the additional task of early patent enforcement, allowing for bogus patents to be a barrier to generic drug registration Such proposals go beyond current U.S. and international law including the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

Additionally, the TPP has the potential to jeopardize millions of lives in the participating countries by driving up the costs of medicines significantly. Even in the United States, there has been a public outcry from physicians regarding the high cost of medicines. Earlier this year, over 100 oncologists came together to write a perspective piece in the journal Blood calling the prices of brand-name cancer drugs “astronomical, unsustainable, and perhaps even immoral.” The United States health care system has in fact greatly benefited from the entry of generic competition. On May 9, IMS Health released a report entitled Declining Medicine Use and Costs: For Better or Worse?, which found that many Americans had forsaken much needed doctor visits, medicines, and other treatments as they struggled to afford health care. In light of this, it is appalling that U.S. negotiators would continue to push provisions that would further exacerbate the cost burden of healthcare for patients not only abroad, but at home. 

Public Citizen particularly criticized the provision for patenting procedures,

Medical procedure patents raise healthcare costs. Health providers, including surgeons, could be liable for the methods they use to treat patients. Essentially, except for when a surgeon uses her bare hands, surgical methods would be patent eligible subject matter under the U.S. proposal.

Additional concerns about the potential of new trade agreements to increase the price of medicines and health care, and limit access to them, came, per Ramachandran and Carroll, from Doctors Without Borders, the American Association of Retired Person, and the International Federation of Medical Students.  More recently, such concerns were stated by amfAR re access to and costs of HIV medications (reported on Vox), and were restated by Doctors Without Borders (reported by the National Journal).

Perhaps more US health care professionals and public health advocates would be speaking out if they understood the problem.  However, concerns about how new proposed trade agreements could affect health care and public health have been notably anechoic in the US.  I could find absolutely no discussion of them in any moderate or large circulation US health care or medical journal.  There has been discussion in English language medical and and health care journals, but in journals that are relatively obscure, or published outside of the US, for example, see articles by Greenberg and Shiau(3), and Thow et al(4).  Note that the former wrote,

academic public health has failed to appreciate the serious risks of the TPP[A] and has not responded to its threats. 

Keeping concerns that the new trade agreements could threaten patients' and the public's health out of public discussion may be just the latest example of what we have called the anechoic effect, because it looks like it may be no accident that these proposed trade agreements favor multinational corporations over patients' and the public's health.  There is evidence that at least the US governmental process for negotiating these agreements was heavily influenced by the interests of these corporations, but not by the interests of patients or citizens. 

Revolving Doors, Regulatory Capture Generate the Momentum

There are thus strong reasons for health care and public health professionals to oppose the rush to approve the new trade agreements (the TTIP and TPP).  Despite these concerns, and the increasingly vocal opposition from many US legislators, the current administration has forged ahead with its proposal to "fast-track" their approval, only to be suddenly blocked, and by its supposed compatriots in the Democratic party.  There are lots of explanations for this, but two that got only a little notice but seem particularly germane to Health Care Renewal are the influences of the revolving door and cultural regulatory capture.

The case for these was best made by a November, 2013 article in the Washington Post by Timothy B Lee,

the U.S. negotiating position also had an unmistakeable bias toward expanding the rights of copyright and patent holders.

Those positions are great for Hollywood and the pharmaceutical industry, but it's not obvious that they are in the interests of the broader U.S. economy. To the contrary, critics contend that the rights of copyright and patent holders have been expanded too much. Those concerns do not seem to have swayed the trade negotiators in the Obama administration.

Two major factors contribute to the USTR's strong pro-rightsholder slant. An obvious one is the revolving door between USTR and private industry. Since the turn of the century, at least a dozen USTR officials have taken jobs with pharmaceutical companies, filmmakers, record labels, and technology companies that favor stronger patent and copyright protection.

A more subtle factor is the structure and culture of USTR itself. In its role as a promoter of global trade, USTR has always worked closely with U.S. exporters. That exporter-focused culture isn't a problem when USTR is merely seeking to remove barriers to selling U.S. goods overseas, but it becomes problematic on issues like copyright and patent law where exporters' interests may run directly counter to those of American consumers.

Lee provided extensive examples of how US trade officials transited the revolving door to and/or from the pharmaceutical industry.

On May 3, 2004, the United States and Australia signed a bilateral trade agreement. The agreement included a section on intellectual property that had numerous provisions favorable to pharmaceutical manufacturers. For example, it barred generic drug makers seeking approval for their drugs from citing safety or efficacy information originally submitted by brand-name drug makers for a period of five years after the information is submitted, making it more difficult for generic drug makers to enter the market.

The lead American negotiator was Ralph Ives, who was promoted to Assistant USTR for Pharmaceutical Policy soon after the negotiations concluded. He was aided by Claude Burcky, Deputy Assistant USTR for Intellectual Property. Less than three months after the Australia agreement was signed, the Sydney Morning Herald reported that both men would take jobs at pharmaceutical or medical device companies. Their new employers stood to benefit from some of the pro-patent-holder provisions of the treaty. Ives took a job at AdvaMed, a trade group representing medical device manufacturers. Burcky moved to the pharmaceutical and medical device company Abbott Labs.

Since then, Abbott has hired two other USTR veterans, Andrea Durkin and Karen Hauda, according to the women's LinkedIn pages. Another USTR official, Kira Alvarez, has gone through the revolving door twice over the last 15 years. Her LinkedIn profile indicates that she served at USTR from 2000 to 2003, spent four years at the pharmaceutical giant Eli Lilly, and then returned to USTR in 2008 as Deputy Assistant USTR for Intellectual Property Enforcement. She was there for five years before she took a job at AbbVie, a pharmaceutical firm that spun off from Abbott earlier this year.

According to his official biography at the site of the Biotechnology Industry Associaiton, Joseph Damond 'was chief negotiator of the historic U.S.-Vietnam Bilateral Trade agreement' during his 12 years at USTR. He then spent five years at the Pharmaceutical Research and Manufacturers of America before moving to BIO. Justin McCarthy went through the revolving door in the other direction. According to a USTR press release, McCarthy was responsible for intellectual property issues at the pharmaceutical company Pfizer from 2003 to 2005 before he was hired at USTR. He now works at a lobbying firm.

Lee also suggested that the US Trade Representative has been culturally captured by industry through its use of advisory panels made up of industry members, but not, for example, clinicians, public health advocates, or interested members of the public.

The agency has established 16 industry trade advisory committees to provide advice about the complex issues USTR deals with in the course of its negotiations. As the name suggests, the ITACs are designed to gather feedback from industry groups. There are no public interest groups, academics, or other non-industry experts on ITAC 15, which focuses on "intellectual property" issues.

And that matters because groups with ITAC seats have access to confidential information about the U.S. negotiating position that isn't available to the public. Sherwin Siy, an attorney at the advocacy organization Public Knowledge, has had multiple meetings with USTR representatives during the course of the TPP negotiations. But he says it was difficult to give USTR meaningful feedback because he didn't know what positions U.S. negotiators were advocating.

'They're willing to sit in a room with us and listen to our objections and our issues and be very polite,' Siy says. But 'whether or not that actually means anything is at best a black box.'

When USTR wants technical advice on transposing U.S. law into international agreements, it naturally turns to the industry representatives on the ITACs. And it stands to reason that the advice the agency receives in response would be a bit one-sided. Where U.S. law is ambiguous, industry groups naturally gravitate toward interpretations of U.S. law that favor their employers' interests. And because public interest groups and independent experts aren't allowed to see proposed language (aside from occasional leaks), the agency may not even realize that it is exporting a warped interpretation of U.S. law.

The pro-industry cultural bias has caused consternation among even well-known libertarians, as Lee noted,

'USTR sees itself as an advocate for U.S. exporter interests,' says Bill Watson, a trade expert at the Cato Institute. 'It's trying to negotiate market access for particular U.S. industries that ask for it. That bias leads USTR to think that because U.S. companies want more IP protection abroad, it's in their interest to negotiate that.'

So it seems quite clear that the US agency that negotiates the new international trade agreements may be staffed by people who came from affected industries, including pharmaceutical, device and biotechnology companies, and privileges advice from such companies.  Thus the agency appears to suffer from conflicts of interest due to the revolving door, and from regulatory capture induced by its bias in favor of advice from industry over that from clinicians, public health advocates, or interested members of the public.  This suggests why it appears that this government agency has actively been promoting trade agreements that favor industry interests over patients' and the public's health.

It may be that top US executive branch officials, all the way up to the President of the US, have been very ill-served by relying on an agency subject to such conflicts of interest and regulatory capture.

Summary

We have frequently written about the revolving door phenomenon, and its effect on government agencies and officials who regulate and control many aspects of health care. Recently, we wrote about how the revolving door risks corruption, and can lead to regulatory, and even state capture.

In 2011, we even wrote about how the revolving door may affect US trade negotiations, and thus important aspects of aspects of global health care.

Government officials affiliated with all major political parties have been known to transit the revolving door.  The recent cases we have documented have tended to be more about the party that currently controls the executive branch, of course.  But now, we seem to have documented how the revolving door has lead to a supposedly liberal president proposing trade agreements that seemed heavily biased towards corporate rather than popular interests, and thus suffered an embarrassing defeat at the hands of his party compatriots in the legislature.  The president seems to have been particularly ill-served by employees of the executive branch whose previous or potential revolving door transits have made them sing the tunes of industry rather than of the people they are supposed to be serving.  This suggests that in the long run, nobody but the participants in the revolving door ultimately benefits from their rotary transitions.

Instead, as we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?

Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

ADDENDUM (19 May, 2015) - This post was republished in OpEdNews.

ADDENDUM (29 May, 2015) - This post was republished in OpenHealth News.

References

1.  Freeman J, Keating G, Monasterio E at al.  Call for transparency in new generation trade deals. Lancet 2015; 385: 605-605, link here.
2.   Hilary J.  The Transatlantic Trade and Investment Partnership and UK healthcare.  Brit Med J 2014; 349: g6552, link here.
3.  Greenberg H, Shiau S. The vulnerability of being ill-informed: the Trans-Pacific Partnership agreement and global public health.  J Pub Health 2014; 36: 355-357, link here. 
4.  Thow AMT, Gleeson DH, Friel S. What doctors should know about the Trans-Pacific Partnership agreement.  Med J Aust 2015; 202: 165-167, link here.

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DaVita Settles Another Lawsuit Amidst Accusations of "Managing Witnesses to Provide False Testimony," After Justice Department Lost Interest in Participating

DaVita fraud impunity legal settlements

DaVita Settles Another Lawsuit Amidst Accusations of "Managing Witnesses to Provide False Testimony," After Justice Department Lost Interest in Participating

Unknown 5/08/2015 Komentar

The Latest Case

Less than a year since its last big settlement (look here), DaVita HealthCare Partners, the big for-profit dialysis provider, has to settle again.  The basics, according to the Denver Post, were:

DaVita HealthCare Partners said Monday it will pay up to $495 million to settle a whistle-blower lawsuit accusing the Denver company of defrauding the federal Medicare program of millions of dollars. 

The company, which said it does not admit any wrongdoing, has now settled its third whistle-blower lawsuit since 2012, with payouts totaling nearly $1 billion.

The civil suit, filed in Atlanta in 2011, revolves around a claim by Dr. Alon J. Vainer and nurse Daniel D. Barbir, who both worked for DaVita. They noticed that DaVita was throwing out good medicine that it then billed Medicare and Medicaid for, according to the lawsuit.

The details of the allegations about how the government was defrauded were:

The lawsuit cited DaVita's inefficient use and costly waste of the drugs Zemplar, or vitamin D, and Venofer, an iron supplement. If a patient, for example, needed 25 milligrams of Venofer, the physician would use that much and toss the rest of the 100 mg vial. Medicare would be billed for the 100 mg.

In other instances, if a patient needed 8 mg of Zemplar, DaVita doctors were instructed to a use a 10 mg vial, instead of four 2 mg vials.

According to the lawsuit, the National Centers for Disease Control and Prevention recommended against allowing multiple uses of the same vial in 2001, based on infection outbreaks caused by the re-entry of another drug, Epogen. But a year later, CDC changed its policy and allowed re-entry of single-use vials Epogen, Zemplar and Venofer if procedures were followed.

DaVita did not do this but 'should have,' according to the lawsuit, 'but they (DaVita) intentionally did not do so in order to purposefully create and maximize their waste and receive significantly higher reimbursements and revenue for Venofer and Zemplar usage.'

The US Department of Justice did not seem interested.

The case began as a sealed lawsuit filed with the federal government in 2007. But, after two years of investigating, the government decided not to join the lawsuit, according to The New York Times.

As is de rigeur in such cases, a company spokesperson proclaimed that the company only settled to avoid the expense and uncertainty of a trial,

'Although we believe strongly in the merits of our case, we decided it was in our stakeholders' best interests to resolve it,' DaVita's chief legal officer Kim Rivera said in a statement Monday. 'The potential mandatory penalties for being found in the wrong in even a small percentage of instances were simply too large.'

As best as I can tell, the penalties were only monetary, and accrued only to the company as a whole, not to any individuals who authorized, directed, or implemented the alleged misbehavior.

Meanwhile, as reported by Forbes this week,  DaVita CEO Kent Thiry's most recent yearly compensation was $17,099,257, and he continues to feel comfortable pontificating

'They don’t care how much you know,' he tells FORBES, 'until they know how much you care.'

The Forbes piece's timing may have not been coincidental, perhaps designed to put a smiling face on the company after yet more evidence of ethical problems.  If only Mr Thiry would show how much he cares about the ethics of his company's operations.

The company's integrity is particularly an issue since vulnerable patients entrust it with their care.  For example, the company's kidney care division claims it cares for 174,000 dialysis patients.  

However, there is still more to the story.


DaVita's Past Record 

We have often noted that big health care organizations get relatively lenient treatment from law enforcement compared to, say, small time Medicare and Medicaid fraudsters (e.g., look here.)  In this case, law enforcement was not just lenient.  The government law enforcers simply stepped away from the case, leaving it to proceed privately.  

What makes this particularly striking is DaVita's past record.  The Denver Post article included,

Since the case was filed, DaVita has settled on two other lawsuits brought on by whistle-blowers. In 2012, DaVita agreed to pay $55 million to the federal government and others over fraud claims that it medically overused and double-billed the government for Epogen, an anemia drug. The suit was filed by Ivey Woodard, a former employee of Epogen-maker Amgen, in 2002.

In October, the company paid $389 million to settle criminal and civil investigations into whether DaVita offered kickbacks to kidney doctors for patient referrals. David Barbetta, a DaVita senior financial analyst, filed the suit in 2009. The company in January paid an additional $22 million to settle related claims by five states, including Colorado. 

In fact, as we noted in a post last year, Gambro Inc, a company with which DaVita had a joint venture, and which was later acquired by DaVita, made multiple settlements, of alleged kickbacks and health care fraud, from 2000 - 2004.  And the proposed acquisition by DaVita of Gambro provoked charges by the Federal Trade Commission of anti-competitive practices.  

The federal authorities ought to have known about at least the 2000 - 2005 settlements and allegations, and the case filed in 2002 that was settled in 2012, at the time it decided not to pursue the current case.  So their conduct here seemed even more lenient than usual.

Questions of Witness Manipulation

Despite the company's protestations that it settled as a matter of expediency, there is reason to think there might have been other motivation.  A blog post on Reuters by Alison Frankel stated

[Plaintiffs' attorneys] Wood, Wilbanks and their team persuaded the judge overseeing the case, U.S. District Judge Charles Pannell of Atlanta, that DaVita had orchestrated what Judge Pannell called 'a disturbing pattern of alterations in witness testimony.'

At the time the case settled, the judge was contemplating a motion by the whistleblowers to lift attorney-client privilege under the crime-fraud exception. Even DaVita, in a post-hearing brief filed on March 31, conceded that 'regrettable mistakes have been made in this case.'

Those mistakes began to emerge in November 2013, when Wood and the other whistleblower lawyers filed a motion for sanctions against DaVita. They claimed, among many other things, that the witness DaVita designated as its expert on a computerized dosage system gave false testimony at his deposition in October 2012 and only admitted his mistakes when plaintiffs’ lawyers confronted him with contradictions a year later. According to the sanctions motion, DaVita’s lawyers also improperly coached witnesses to change their deposition testimony about the dosage system. DaVita responded that its expert witness had corrected his testimony as soon as he realized his mistake, long before plaintiffs threatened sanctions. The company called the plaintiffs’ coaching and conspiracy theories 'facially incredible and a complete fiction.'

Nevertheless, after discovery that Judge Pannell called 'a series of protracted fights resulting in furious rounds of briefing, hearings, and accusations' and a three-day hearing before the judge in July 2014, Pannell concluded the evidence of forgetfulness and changed testimony from several witnesses was 'highly suspect.' At best, he said, DaVita tacitly led the whistleblower lawyers astray by letting erroneous testimony from its computer expert stand for a year.

At worst, Pannell wrote, 'the defendants purposely manipulated the evidence and witnesses to hide the truth from the (plaintiffs) and the court.' He ordered discovery to be reopened and instructed DaVita to pay plaintiffs’ lawyers their fees and costs for the sanctions litigation and the newly ordered discovery.

DaVita’s troubles still weren’t over, however. According to a November 2014 motion by the whistleblowers’ lawyers, a former DaVita clinical services specialist admitted in a post-sanctions deposition that she lied under oath at one of her previous depositions. She said she couldn’t say why without revealing privileged communications, which prompted plaintiffs’ lawyers to ask Judge Pannell to lift the privilege. 'DaVita’s scheme of managing witnesses to provide false testimony,' they wrote, 'will now collapse like a house of cards.'

The judge was sufficiently concerned to order an in camera review of communications between DaVita lawyers and three DaVita witnesses who changed their deposition testimony about the computer dosage system through errata filings or cited privilege in refusing to answer questions about it. He also held four days of hearings on the whistleblowers’ crime-fraud motion, including in camera testimony from those three witnesses and from two DaVita defense lawyers.

So the judge in this case thought there were serious suspicions that DaVita lawyers manipulated witnesses.  If true, this would be a whole other order of unethical behavior. Yet again this case was not considered big enough to become a "federal case."

Summary

So yet again we see a large health care company settling a lawsuit that alleged unethical acts, and in this case, generated further allegations of unethical acts during the litigation itself.  The settlement was for what seemed a lot of money, but actually little money compared to the corporation's revenues.  The settlement did not take into account previous legal and ethical allegations against the company.  The settlement did not involve any negative consequences for any individual who might have authorized, directed or implemented any of the apparent bad behavior.

We have seen such settlements again and again in the US health care sphere, and indeed in other spheres, such as finance.  They appear, as I have said before, to be part of a larger, mannered Kabuki play, in which rituals are performed to show some symbolic acceptance of ethics and morality, but without any true deterrent effect on bad behavior.

Perhaps the origin of the script was in some neoliberal fantasy that big corporations and their leaders ought to be exempt from even slightly harsh justice because of their economic importance, e.g., that they are Too Big to Jail.  A recent review of the book "Too Big to Jail" in the Washington Monthly noted that Mr Eric Holder, the current US Attorney General has urged leniency for big, and hence economically powerful corporations,

a memo written by Holder in 1999, during his stint as deputy U.S. attorney general. The document, 'Bringing Criminal Charges Against Corporations,' urged prosecutors to take into account 'collateral consequences' when pursuing cases against companies, lest they topple and take the economy down with them. Holder also raised the possibility of deferring prosecution against corporations in an effort to spur greater cooperation and reforms—a policy, unsurprisingly, later supported by the Bush administration.

The attorney general angered many last year when he reiterated those concerns at a congressional hearing, admitting 'that the size of some of these institutions becomes so large that it does become difficult for us to prosecute' because of the potential nasty economic effects of a major company failure.

Relieving large corporations and their leaders from the need to follow the law is a recipe for impunity, if not oligarch, and goes against the fundamental spirit of the US Constitution.  But, hey, who's counting?

The impunity of large corporations and their leaders has become so routine as not to even be news anymore.  I cannot find any coverage of the current DaVita settlement so far beyond a few regional news outlets, and one business wire service.  The national media and as been as blase as was the Justice Department.  A short version of the story, similar to that in the Denver Post, did appear in a nephrology news service, but I saw nothing in the national medical news media.  Legal settlements like this remain relatively anechoic. 

So yet another marcher in the parade of legal settlements could inspire boredom.  However, the cumulative procession of demonstrations that neither the US government, the news media, the medical and health care literature, nor any medical societies, patient advocacy groups, accrediting organizations, health care foundations and the like seem to care about continuing, repeated unethical behavior by large health care organizations should chill the hearts of patients and health care professionals.  If we do not stand up for ethical, honest health care, what kind of swamp will health care become?

As I have said again, again, again,...  Leadership that cares not for honesty, transparency, or accountability, and that puts short term revenue, and usually personal enrichment ahead of patients' and the public's health may be the single most important reason that US health care is so dysfunctional.  Yet hardly anyone even dares discuss the damning facts about health care leadership, much less propose solutions.  If we do not reform our health care leadership so that it is transparent, honest, accountable, unconflicted, and it puts patients' and the public's health over personal enrichment, our health care system will continue to founder.  

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Health IT - How Did Things Get So Bad? Look to Late 20th Century Recruiters and "The School of Hard Knocks" Leaders They Preferred

Flexner Report Goodman Group healthcare IT dissatisfaction Hersher Associates talent management

Health IT - How Did Things Get So Bad? Look to Late 20th Century Recruiters and "The School of Hard Knocks" Leaders They Preferred

Unknown 5/07/2015 Komentar

I have a long memory, unfortunately for health IT opportunists and hyper-enthusiasts.

After reading letters and reports such as:

• The Jan. 15, 2015 Complaint Letter about EHRs to ONC from this country's major medical societies (http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html), 
• The 2015 Joint Commission Sentinel Events Alert on Health IT risk (http://www.jointcommission.org/assets/1/18/SEA_54.pdf), 
• The stunning mishap and injury figures in the ECRI Institute Deep Dive study of EHR risk and the ECRI annual "Top Ten Technology Risks in Healthcare" reports (http://www.healthit.gov/facas/sites/faca/files/STF_Deep_Dive_Health_Information_Technology_2014-06-13.pdf), 
• The FDA Internal Memo on HIT risk (http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html) 
• and others (e.g., http://hcrenewal.blogspot.com/search/label/glitch):

One might ask the question:

"How did things get so bad?"

I believe one needs to look to the culture of medicine and to the culture of IT, specifically, the culture of IT recruiting in medicine by exclusive retained recruiters hired by hospitals to secure IT leadership (the predominant model used, with the contractual agreement that jobs will only be filled through the recruiter). 

The culture of medicine is one of demanding education and proof through repeated testing and licensure that some fundamental level of competence exists.  This cultire arose, in part, as a result of the Flexner Report of 1910 (http://www.medicinenet.com/script/main/art.asp?articlekey=8795) that called out abuses in medical education and practice where anyone from the "school of hard knocks" could call themself a physician and hang a shingle, with disastrous results:

... The Flexner Report triggered much-needed reforms in the standards, organization, and curriculum of North American medical schools. At the time of the Report, many medical schools were proprietary schools operated more for profit than for education. Flexner criticized these schools as a loose and lax apprenticeship system that lacked defined standards or goals beyond the generation of financial gain. In their stead Flexner proposed medical schools in the German tradition of strong biomedical sciences together with hands-on clinical training. The Flexner Report caused many medical schools to close down and most of the remaining schools were reformed to conform to the Flexnerian model.

The culture of health IT recruiting?  Perverse.

Having posted many times on the issue of "expertise not needed" relative to HIT, the mother of all statements on health IT talent management has to be this from the major HIT recruiters of the late 20th century.

From the article "Who's Growing CIOs?" in the journal “Healthcare Informatics", November 1, 1998, see http://www.healthcare-informatics.com/article/who-s-growing-cios?page=3:

... In seeking out CIO talent, recruiter Lion Goodman doesn’t think clinical experience yields IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs, according to Goodman. "They don’t think of the business issues at hand because they’re consumed with patient care issues." ... Instead of healthcare organizations looking just outside their IT divisions to recruit IT management, Goodman advises, "Look for someone who has experience outside healthcare as well as inside healthcare," in particular people with IT experience from industries such as banking and manufacturing, which use more advanced information system technology.

When I first saw this in 1998, I was stunned by its abject stupidity and feared for the future implications.  My fears in 2015 are now realized, in spades.

Lion Goodman was an idiot, and a dangerous idiot at that in my opinion.  "Patient care issues" ARE the business of hospitals.

Experience in banking and manufacturing IT is not helpful because medicine is not a mercantile or banking activity.  Also, "advanced technology" was not the issue as today's usability, interoperability, crashes and other failures demonstrate.  Banking and manufacturing IT personnel understood the more critical issues of human factors engineering supporting healthcare provision like a fish understood nuclear physics.

More importantly, medicine is far different and in fact the IT culture in those environments is anathema to the flexibility and understanding of the poorly bounded, high tempo, high risk practice of medicine (see "Hiding in Plain Sight", Nemeth & Cook, http://www.researchgate.net/publication/7738740_Hiding_in_plain_sight_what_Koppel_et_al._tell_us_about_healthcare_IT, click on "full text" image on right).

That health IT is now nearly universally reviled by physicians and nurses and is harming and killing people and even bankrupting healthcare systems trying to fix 10,000 bugs (e.g., "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red", http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html) is a predictable outcome of hiring patterns for today's health IT leaders that resulted from such a perverse and ignorant talent management ideology.

Even worse, in the same article from Goodman and another major IT recruiter of the day with whom I was very familiar is this gem:

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks."

Ms. Goodman and Ms. Hersher must have been transported to the late 20th century from the Dark Ages.

Oh wait ... even Medieval monks in monasteries believed in the value of scholarship.

These attitudes are completely alien to medicine, and for good reason.  The damage done to health IT by the hiring practices of the past is incalculable, but likely considerable.  I was shocked even then by the qualifications and abilities of the health IT leaders I encountered, most of whom I had to clean up after, one way or another in order to protect patients from their abject medical recklessness and ignorance (e.g., http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU , and http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story as just two examples).

One wonders just how many "from the school of hard knocks" HIT leaders were pushed by these recruiters onto healthcare organizations, and the harm such leadership may have done to healthcare, healthcare IT, and to patients in the intervening years.

Such an ideology widened the pool of candidates and likely increased the recruiter's profits ... the ultimate in parasitism considering, in 2015, the waste of hundreds of billions of dollars on terrible technology, reviled by most users and causing harm, in part due to being designed and implemented by leaders from "the school of hard knocks."

-- SS

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Politico: Electronic record errors growing issue in lawsuits

Arthur Allen healthcare IT litigation healthcare IT risk Politico

Politico: Electronic record errors growing issue in lawsuits

Unknown 5/07/2015 Komentar

The indefatigable Arthur Allen of Politico.com has authored a nice piece on the issue of EHRs being a cause of medical malpractice, with resultant litigation.  I was a contributor:

Electronic record errors growing issue in lawsuits
By Arthur Allen
5/4/15 6:40 AM EDT
http://www.politico.com/story/2015/05/electronic-record-errors-growing-issue-in-lawsuits-117591.html

Medical errors that can be traced to the automation of the U.S. health care system are increasingly an issue in medical malpractice lawsuits.

Some of the doctors, attorneys and health IT experts involved in the litigation fear that safety and data integrity problems could undercut the benefits of electronic health records unless HHS and Congress address them aggressively.

I already believe the benefits of EHR technology have been severely undercut - if not destroyed - by the unbelievably poor quality, user experience and incompetent implementations presented by most commercial health IT software today.

I even have a dead mother to offer as evidence, due to an ED EHR's lack of fundamental and crucial confirmation dialogs and notification messages to team members.  These computer science-101 level deficiencies permitted a triage nurse's failure to successfully click a heart medication for continuation to propagate through several days of ICU/floor hospitalization unnoticed.  Gross overconfidence in computer output and cavalier attitudes in the ICU about med reconciliation sealed the deal, where, recognizing something seemed amiss with the meds list vs. the history of arrhythmia, the ICU doctor did nothing except leave a question in the chart about it, resulting in catastrophe.

“This is kind of like the car industry in Detroit in 1965,” says physician Michael Victoroff, a liability expert and a critic of the federal program encouraging providers to adopt EHRs. “We’re making gigantic, horrendous, unsafe machines with no seat belts, and they are selling like hot cakes. But there’s no Ralph Nader saying, ‘Really?’”

There are, actually, but an "Unsafe at any MHz" has not yet been written and taken seriously by the public about EHRs.  The industry has been too in control of the narrative for that to happen.

According to a review by The Doctors Company, the largest physician-owned U.S. medical malpractice insurer, EHR issues were involved in only 1 percent of a sample of lawsuits concluded from 2007 through 2013. But that finding could be deceptive since it takes five or six years to close a suit, and during that period the numbers of such cases grew rapidly as electronic health records become more pervasive in hospitals and physician offices. The pace of these cases doubled from 2013 to early 2014.

At the linked report at http://www.thedoctors.com/KnowledgeCenter/Publications/TheDoctorsAdvocate/CON_ID_006908 the med mal insurer "The Doctor's Company" noted:

... Shortly after electronic health records (EHRs) began to be widely adopted, The Doctors Company and other medical professional liability insurers became aware of their potential liability risks. We anticipated that EHRs would become a contributing factor in medical liability claims. Due to the three- to four-year lag time between an adverse event and a claim being filed, however, EHR-related claims have only recently begun to appear. In 2013, we began coding closed claims using 15 EHR contributing factor codes (eight for system factors and seven for user factors) developed by CRICO Strategies for its Comprehensive Risk Intelligence Tool (CRIT).

In 2013, The Doctors Company closed 28 claims in which the EHR was a contributing factor, and we closed another 26 claims in the first two quarters of 2014. During a pilot study to evaluate CRICO’s EHR codes, 43 additional claims closed by The Doctors Company were identified (22 from 2012, 19 from 2011, and 2 from 2007–2010).

What is not stated is the fact that many EHR-related harms are not recognized as such; many injured patients do not sue, and many who want to cannot do so due to the expense and time involved for plaintiff's attorneys (I have heard the figure that perhaps 5% do make it to suit).  Along with the time lag noted, these figures are another Red Flag, as are the ECRI Deep Dive harm figures, representing what is likely just the "tip of the iceberg."

(See "Peering Underneath the Iceberg's Water Level" at  http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html and "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html).

Back to Politico:

The lawsuits allege a broad range of mistakes and information gaps — typos that lead to medication errors; voice-recognition software that drops key words; doctors’ reliance on old or incorrect records; and nurses’ misinterpretation of drop-down menus, with errors inserted as a result in reports on patient status.

In addition, discrepancies between what doctors and nurses see on their computer screens and the printouts of electronic records that plaintiffs bring to court are leading some judges and juries to discredit provider testimony and hand out big awards. In one case, a patient in septic shock had suffered gangrene and a severe skin rash, but computer records read “skin normal.” They also showed repeated physician interviews with the patient — when she was comatose.

I can verify both of these issues personally, from my legal work - not to mention outright electronic record tampering.

... While the percentage of EHR-related cases is still low, “this is going to become a bigger and bigger issue,” said David Troxel, medical director of The Doctors Company. “I get more calls from frustrated, angry doctors about their EHRs than any other subject.”

Doctors may be following my advice (see end of my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html) where I wrote:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

• ... Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

Back to Politico:

The industry “takes very seriously the need to enhance the well-documented ability of EHRs to increase patient safety,” an association spokesperson said. “It also recognizes the importance of looking for opportunities to identify and reduce any potential risks associated with development and use of EHRs. All these efforts are essential to the goal of learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways.”

This is pure B.S. and spin.  There is no "well-documented ability of EHRs to increase patient safety", just a number of methodologically flawed/biased studies (like this one, http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html), a lot of pro-HIT rhetoric, and a lot of harms data that the industry ignored for many years.

The statement also ignores what the domain expert end users - physicians and nurses - themselves are saying, see "Accenture - Fewer U.S. Doctors Believe IT Improves Health Outcomes (April 2015)" at http://www.businesswire.com/news/home/20150413005148/en/Increased-Electronic-Medical-Records-U.S.-Doctors-Improves#.VT5bmpOTqUk.

Why, one should ask as well, should an industry that's been around for decades only now be "learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways?"  

I see that statement as an industry self-condemnation of years of cavalier IT practice. 

... But providers and health care systems are eventually going to start suing vendors, analysts said, in part because software companies are viewed as having deep pockets. “It’s only a matter of time before a company like athenahealth or Allscripts or Epic or Cerner gets sued,” said Klein.

Plaintiffs’ attorneys are already eyeing such cases, according to Scot Silverstein, a Drexel University health IT expert and internist who is suing a hospital over a lapse in care of his mother that Silverstein claims was caused by poor EHR implementation. Silverstein and two plaintiff’s attorneys met with Rep. Matthew Cartwright (D-Pa.) and other lawmakers in November to plead for more government regulation of EHRs.

I was actually more direct with the author of the article, Mr. Allen.  I said that the sellers of these systems deserved to be sued - that they had earned it through slovenly practices in thought and application enabled by the extraordinary regulatory accommodations afforded to and protected by the industry since its inception (i.e., no regulation) - when system flaws result in patient harm. 

... Some recent studies show that EHRs do make hospitals safer. But the data isn’t conclusive, said William Marella, executive director of the ECRI Institute Patient Safety Organization. Last year, ECRI convened a partnership of EHR vendors, safety experts, academics and medical groups to share and analyze health IT problems ... EHR safety issues are frequently misdiagnosed — and thus under-diagnosed — by providers, according to ECRI’s Marella. “They say, ‘wrong site surgery,’ or ‘drug error,’ which can make it hard to ferret out the cases where IT is responsible.”

It is absurd and disingenuous to speak of 'safety improvements' when the true harms rates are admittedly unknown (see "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html) for more on that issue.

... In about 200 EHR-related legal cases that the liability firm CRICO analyzed, the glitches rarely led directly to patient harm, said Dana Siegal, the company’s director of patient safety services. But she added, “We’re seeing failures to communicate or providers acting on inaccurate information that was driven in part by an EHR issue.”

This brings up another issue.  Computers don't pull triggers and the mayhem they cause doesn't usually immediately kill people.  My mother, for example, survived the initial EHR-led assault on her life, though her survival required emergency reversal of anticoagulation in the face of critical carotid stenosis that had already caused a TIA, emergency craniotomy (brain surgery), and other risky interventions.  She died a year later of complications of her injuries.  Her case would not be likely to be counted as an "EHR-related death" in any statistics (if it was reported at all).  This "time delay" would likely cause any statistics on EHR-related deaths to be understated on their face.

... While the effect of EHRs on malpractice suits is still modest, many analysts worry about the overall uncertainty concerning information in such systems. Confusing or inaccurate records, if they proliferate, not only cast doubt on a doctor in court but could taint clinical research that draws on these large pools of data.

Bravo to Arthur Allen for pointing out that clinical research that draws on garbage, uncontrolled data will turn out garbage.  See my paper "The Syndrome of Inappropriate Overconfidence in Computing" at http://www.jpands.org/vol14no2/silverstein.pdf for more on that issue where I observed:

... This increasing confidence in EHR data to perform far more complex tasks than postmarketing surveillance of a single drug is of great concern. Prompt detection of adverse drug events (ADEs) from single drugs, using aggregated EHR data, is within the realm of possibility. Detection of relatively more nebulous (i.e., compared to major ADE) “outcomes differences” between two or more drugs or treatments via EHR data—such as, did treatment A lower blood pressure more than drug B, or did drug C lessen depression more than drug D—rises to the level of “grand overconfidence in computing” and perhaps “grand folly.”

To accomplish this task with reasonable scientific certainty from aggregated EHR data originating from different vendor systems, input by myriad people of different backgrounds, with differing interpretations of terminologies (students/residents/attending
MDs/RNs etc), under different pressures and motivators (time limits, cognitive overload from poor HIT user interfaces, reimbursement maximization, and so forth), seems improbable.

What levels of statistical validity could arise from such studies? Could they even approach the level deemed “acceptable” in good science?We do not know, although I suspect a “garbage in, garbage out” (GIGO) phenomenon, leading to studies whose results are more likely related to chance than to solid reality.

Back to Politico:

A recent report by the HHS Office of Inspector General said the department has failed to assure that EHR data are secure and accurate. Many hospitals have unsecured audit trails—meaning that information in the record could be altered without detection, it said.

This ability - to alter records - has been admitted under oath by EHR systems administrators in cases in which I have been an advisor to the Plaintiffs' attorney - and had the questions asked.  Hospitals have possession and control of easily-alterable information (far easier than paper) that is the only evidence of potential misadventures - a major conflict of interest.

... “There’s really no one with a vested interest in the integrity of the record besides you, the patient,” said Reed Gelzer, a physician and health IT expert.

Yes, but getting it can cost thousands of dollars.  I paid about one thousand dollars for a few reams of printed EHRs, and this is not uncommon.

... Concerns led the Institute of Medicine in 2011 to propose the creation of a dedicated IT safety center with the power to investigate EHR risks. ONC has since settled on a center that would have no investigatory power but would provide a safe environment in which real-life problems could be analyzed and solutions developed.

In other words, ONC has settled on a joke, on tension management.

The safety center is a “critical priority right now for ensuring the transformation from a world of paper to a world of electronics and connectedness,” said Patricia McGaffigan, COO and a senior vice president at the National Patient Safety Foundation.

Yes, a powerless, industry-friendly "safety center" is a priority for good reason.  Not to sound mean-spirited, but if the wife, child, parent of one of the proponents of a milquetoast "Safety Center" suffers EHR-related injury and dies a painful and lingering death as a result, as did my mother, the proponent will get little sympathy from me.   They've certainly tempted the Gods.

I will leave the final word to physician Michael Victoroff:

“The vendors are very right that if they had true product liability they wouldn’t make these things,” he said.

To which I say to the Information Technology vendors, if you can't take the heat (of accountability in medicine), then get the hell out of our medical kitchen.

-- SS

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Another day, another EHR outage: MEDSTAR EHR goes dark for days

healthcare IT crash healthcare IT outage MedStar Health Patient care has not been compromised Politico

Another day, another EHR outage: MEDSTAR EHR goes dark for days

Unknown 5/06/2015 Komentar

At my March 2, 2015 post "Rideout Hospital, California: CEO Pinocchio on quality of patient care during hospital computer crash" (http://hcrenewal.blogspot.com/2015/03/rideout-hospital-california-ceo.html) I highlighted a stunning example of when the light shone through the corporate B.S. about health IT outages, thanks to a letter to the editor by a family member of an affected patient:

Letter: Re: Rideout Hospital computer problems

http://www.appeal-democrat.com/opinion/letter-re-rideout-computer-problems/article_4a408cc0-be47-11e4-9b7b-93c22da930d4.html 

Friday, February 27, 2015 

I am writing in regard to comments made by the CEO of Rideout Hospital regarding its recent computer crash. 

He said quality of care for patients had not been compromised during this incident. He is lying.

My spouse went to Rideout almost two weeks ago and had a Lexiscan of her heart when the computer system went down. The hospital doctor released her and assured her that if anything were wrong, the radiology department would spot it and she would inform us.

Here it is two weeks later and now they are saying because of the computer problem the entire test didn't get to her cardiologist until today. They think she may have had a minor heart attack and needs further cardiac intervention.

 Is this the new "open and improved" truths we are getting from this hospital? Rideout CEO Robert Chason misinformed us all. 

I am sure my spouse, who has fallen through the cracks during this inexcusable lapse in Rideout's technical policies, is not the only patient suffering similar situations. 

Shame on Chason for minimizing the effects of this catastrophe at our local hospital. 

Edward Ferreira 
Yuba City

I am aware of another major EHR outage via Politico.com:

4/9/15
http://www.politico.com/morningehealth/0415/morningehealth17818.html

MEDSTAR EHR GOES DARK FOR DAYS: MedStar’s outpatient clinics in the D.C. and Baltimore area lost access to their EHRs Monday and Tuesday when the GE Centricity EHR system crashed. The system went offline for scheduled maintenance on Friday and had come back on Monday when it suffered a “severe” malfunction, according to an email from Medstar management that was shared with Morning eHealth.

“All of a sudden the screens lit up with a giant text warning telling us to log off immediately,” a doctor said. “They kept saying it would be back up in an hour, but when I left work Tuesday night it was still down.”

This doctor told us that the outage was “disruptive and liberating at the same time. I wrote prescriptions on a pad for two days instead of clicking 13 times to send an e-script. And I got to talk to my patients much more than I usually do.

But of course we didn’t have access to any notes or medication history, and that was problematic.” MedStar notified clinicians in the email that any information entered in the EHR after Friday was lost.

I do not know if corporate issued the standard "patient safety was not compromised" line, but can almost predict it was uttered somewhere along the line.

MedStar is a big healthcare system.  An outage for several days at its outpatient clinics is disruptive and will lead to harms in the short term, but also in the long term, that cannot be effectively tallied, due to lost information. 

That includes information put on backup paper that fails to get entered when an EHR goes back up, as well as outright computer data loss as occurred here.

Note the doctor's comments about the "liberating" aspect of being freed from health IT.  He/she could actually practice medicine, not computer babysitting.

How many harms will come of this "major malfunction?"  There is no way to know.  However, hospitals cannot have it both ways.  If these systems are touted as improving safety, then safety is affected when they are down and emergency measures are put into place, resulting in chaos; and certainly when information simply goes to the "bit bucket."

The answer?  Either far more redundancy, or far less reliance on "paperless" systems.

There also needs to be mandatory reporting of EHR outages and root cause analysis so the incidence and the reasons can be studied, at the very least.

-- SS

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