Thursday, November 20, 2014

How Many Straws? - After $60 Million Settlement for Poor Manufacturing Quality, Hospira Warned by FDA, Then Assessed Punitive Damages for Firing Whistle-Blower

How many legal cases suggesting failures of leadership of large health care corporations will it take to break the back of health care? 

$60 Million Settlement of Class Action Alleging Cost Cutting Led to Poor Manufacturing of Drugs and Devices

Earlier this year, we posted about the $60 million settlement of a class action lawsuit brought by investors in Hospira Inc,  a drug and device manufacturer.  The plaintiffs had contended that "cost cutting aimed at boosting short-term profitability," and ostensibly "shareholder value" lead to "gutting quality control efforts," and ultimately to quality problems discovered by inspections by the US Food and Drug Administration (FDA).

This case was brought not by law enforcement officials or regulators, but by stock holders who believed that their investments were degraded by management misbehavior. Nonetheless, as is usual in most settlements of civil cases involving big health care organizations, according to Law360, Hospira managers were able to assert,

Defendants deny that they have violated the federal securities laws or any laws and maintain that their conduct was at all times proper and in compliance with all applicable provisions of law.


Note also that company executives, including CEO Michael Ball, were named as defendants, but I could find no record that they had to pay anything themselves.

So this, like many other legal settlements we have discussed, only seemed to serve as a marker of probable, but not definite misbehavior by the leadership of a big health organization that led to problems with the manufacture of drugs or devices. This is concerning since the public and health care professionals trust drug and device manufacturers to proffer products of good quality.  Yet the resolution of the case left lingering uncertainty because the defendants could settle without admitting any wrongdoing.

FDA Warnings, and Punitive Damages for Firing a Whistleblower

Some more evidence that there really were quality problems in Hospira's manufacturing operation appeared in October, 2014, when the FDA warned the company about particles found in drugs manufactured in its Australian factory (per the Chicago Tribune).  

Furthermore, in November, 2014, a story appeared that not only corroborated the existence of important issues with manufacturing quality at Hospira, but suggested that the company had tried to cover up these problems.  As reported by Crain's Chicago Business,


A Lake County jury awarded almost $10 million to a former Hospira employee, finding that the company fired him because he raised concerns that it covered up quality and safety issues with a product

In particular, 


The former employee, Angel Estrada, was a vice president of quality systems and compliance for the Lake Forest-based pharmaceutical company from September 2010 to September 2011, when the company fired him, according to a lawsuit filed in Lake County Circuit Court.

Estrada raised concerns to supervisors that Hospira was not addressing issues in one of its medical pumps that a hospital in Spain reported to the company. The hospital reported that air bubbles had occurred in the device when used on children, which can cause fatalities, according to the complaint.

The lawsuit alleges that Estrada reached out to his superiors, including Hospira CEO Michael Ball, to address the reported issues and notify the FDA and European regulators of the pump's alleged defects.

The lawsuit alleges that on the same day Estrada sent Ball a report, two employees under Estrada were fired 'purportedly for altering a record during the course of an audit.' Hospira fired Estrada 'under the pretext of not properly investigating' one of the employee's conduct during the audit, the lawsuit says.

The real reason he was fired 'was to quash his reporting of the dangers associated' with the pump, the suit alleges.

The jury issued its verdict earlier this month. Of the almost $10 million Estrada was awarded, $7 million was punitive damages.

So in this case, a high ranking corporate executive tried to blow the whistle because of quality problems affecting the manufacture of a medical device.  These problems put patients at risk, and pediatric patients at that. His whistleblowing was vigorous, going as high as the company CEO.  Yet, the jury found that the company responded by firing the whistleblower.  

Still, not surprisingly,

Hospira said it will appeal and that it maintains that the allegations are 'fully without merit.'

That remains management's contention, but the jury found otherwise, and emphasized this finding with punitive damages.

Summary

These cases, added to all our other discussions of legal settlements, crime, and corruption in health care, suggests that bad behavior by leaders of large health care organizations is rampant.  Yet these cases also suggest how hard it is to understand the scope of the problem.  Each of the cases above involving Hospira seemed to proceed in a vacuum, uninformed by previous cases.  None got much media attention.  (For example, the latest jury findings only appeared in two media outlets, as far as I can tell, and both were in Chicago.)  There have been few efforts, beyond those of your humble servant, to try to link various civil, criminal, and regulatory cases involving large health care organizations together in any sense.  Continued lack of awareness of the scope of the problem of management misbehavior in health care mitigates against finding any effective solutions.

Furthermore, the cases above, like most others we have discussed, did not lead to any negative consequences to any individuals for authorizing, directing, or implementing the bad behavior, even though the behavior may have lead to their individual enrichment.  Managers in this era of "shareholder value" are often lavishly awarded for cost cutting that increases short term revenue.  Note that the top executives of Hospira have been lavishly rewarded.  According to the company's 2014 proxy statement, its five top executives each had total compensation exceeding $2,750,000 in 2013.  CEO Michael Ball, who was named as a defendant in the case settled earlier this year, and allegedly ignored the whistleblower's warnings in the most recent case, received $9,892,283.  It is quite possible that all these executives at least indirectly benefited financially from the cost cutting that lead to the quality problems implied by the cases above. Yet as long as there is no accountability for any person who was directly involved in authorizing, directing, or implementing the bad behavior, or who might have benefited from being furnished plausible deniablity about it, future bad behavior will not be deterred.

So how many more cases will it take before we start holding the leaders of large health care organizations accountable?  Will we do so before the back of our health care system is broken?

Tuesday, November 18, 2014

Even Crazy Eddie Knows "Corporations Don't Commit Crimes, People Commit Crimes" - But Biotronik Settles

The deals the government gives are INSANE!!!  Just ask Crazy Eddie's former Chief Financial Officer.

The Former Crazy Eddie CFO on Impunity

Those of a certain age who were in or near the New York area remember Crazy Eddie, a discount appliance and electronics retailer with insane advertisements.




As reported by CNN, Sam F Antar, the former Chief Financial Officer of Crazy Eddie, was a speaker on a conference on financial fraud,

The U.S. government is losing the war against white collar crime.

That's the message from Sam E. Antar, one of the masterminds of the massive Crazy Eddie fraud of the 1980s.

'We are in the golden era of white-collar crime. My biggest regret is I should've been a criminal today rather than 20 years ago,' Antar told CNNMoney on the sidelines of a New Jersey securities fraud summit.

Antar drew a big round of applause when he pointed out that no one from Wall Street went to prison because of crimes that led to the financial crisis.

'We are devoting far less resources to combating crooks like myself today than back in my day,' he said.

Antar knows a thing or two about corporate fraud. He served as Chief Financial Officer of Crazy Eddie, the electronics retailer that became one of the symbols of white-collar crime in the 1980s.

Known for its loud commercials promising "INSAAAANE" prices, Crazy Eddie got into trouble for understating income to avoid taxes and then committing securities fraud once it decided to go public.

'Crazy Eddie was from Day One planned to be a criminal enterprise. We committed our crimes simply because we could,' said Antar, whose cousin Eddie Antar founded the chain.

Because he 'showed the feds where the bodies were buried,' Antar got off with only six months of house arrest, community service and tens of thousands of dollars in civil penalties. Crazy Eddie co-founder Eddie Antar served more than six years in prison.

Today, the convicted felon is advising the government and private companies about white-collar crime. Antar expressed frustration with the government's failure to put Wall Street bankers behind bars.

'We have turned prosecutors into tax collectors,' he said. 'Corporations don't commit crimes, people commit crimes.'

While the focus of this conference was corporate fraud and crime in the financial sector, we have frequently discussed corporate crime and corruption in the health care sector.  We have noted, especially in our posts on the march of legal settlements, that most wrongdoing by big health care organizations is punished - if it is punished at all - only by fines assessed against the organization, and perhaps a lightly enforced corporate integrity or deferred prosecution agreement.  Rarely does the organization admit wrongdoing.  Rarely are criminal charges involved (the settlements are usually civil).  Almost never do any individuals who authorized, directed or planned the wrongdoing suffer any negative consequences.

However, in health care, corporations do not do wrong.  People do wrong.

This brings us to our latest example.


Biotronik Settles Kickback Allegations for $4.9 Million

This story barely rippled the media waters, getting its most extensive coverage in the (Portland) Oregonian.

Biotronik, Inc, the Lake Oswego medical device manufacturing firm, will pay $4.9 million to the federal government to resolve allegations that the firm paid kickbacks to doctors in Nevada and Arizona to use its products.

In particular, the Department of Justice charged,

The settlement resolves allegations that Biotronik, through the payment of kickbacks to physicians, caused hospitals and ambulatory surgery centers to submit false claims to Medicare and Medicaid for the implantation of Biotronik pacemakers, defibrillators and cardiac resynchronization therapy devices.

Biotronik allegedly induced electrophysiologists and cardiologists practicing in Nevada and Arizona to continue using Biotronik devices, or to convert to Biotronik devices, by paying the implanting physician in the form of repeated meals at expensive restaurants and inflated payments for membership on a physician advisory board.

So the issue was not only defrauding the government, but giving kickbacks to doctors to induce them to use Biotronik devices, presumably whether or not such devices were the best treatments for their individual patients. Thus, the alleged conduct could have resulted in the unnecessary or inappropriate implantation of devices, leading to patient risks in the absence of benefits.

Nonetheless, as is usual in such cases, Biotronik did not admit any guilt, and in fact refused to talk to the reporter.  Furthermore, no one at Biotronik who authorized, directed or implemented the conduct in question suffered any negative consequence.

The light touch of the law on Biotronik was striking considering the company's track record.

Biotronik's Track Record: 2011 - 2013

Physicians Settle Allegations They Concealed Payments from Biotronik

In fact, the 2014 settlement was actually the second settlement resulting from allegations that Biotronik paid physicians to get them to use its devices.  As the Oregonian reported in 2013,

The state recently concluded a court case against two Salem doctors who put heart implants into patients without telling them that a manufacturer's training program put a sales representative into the operating room. The [Oregon] DOJ accused the doctors in the civil case of having 'misrepresented' their services as 'for the exclusive benefit of the patient' and 'concealing' from patients payments that created a potential "incentive" to use Biotronik implants -- defibrillators and pacemakers. The surgeons received between $400 and $1,250 for implant surgeries when a trainee was present.

This case was unusual in that the prosecutors, from the state of Oregon here, not the US Department of Justice, targeted the physicians who received the money rather than the corporation that provided it. So these individuals actually suffered some negative consequences, albeit rather minor,

cardiologists Matthew Fedor and Kyong Turk admitted no wrongdoing but agreed to pay $25,000 each and inform future patients of any payments from a drug or device maker in connection with their services to that patient and when admitting sales representative trainees to the operating room.

At the time,

At Biotronik's U.S. headquarters in Lake Oswego, president Jake Langer called the state's case unfair and detrimental to good health care.

'We are really clean when it comes to our relationships with physicians,' he said. He blamed the first-of-its-kind case on overzealous prosecutors trying 'to set up a new law' without going to the Legislature.
In 2011, Documents Revealed Biotronik's Marketing Tactics

Furthermore, the relatively meager penalties provided for by the 2014 and 2013 settlements were more incongruous given the colorful evidence provided by a disgruntled Biotronik employee reported in a 2011 New York Times article, about which we posted here.  The article suggested that Biotronik attempted to boost sales through "seeding trials," which are more about recruiting doctors than clinical research, paying "consulting fees" to doctors who wanted their patients implanted with Biotronik products, and  who actually implanted such products, and finally currying physicians' favor by hiring their spouses.

Summary

Those government settlements really are INSAAANE.


The Biotronik settlements followed a familiar pattern.  Now that we have been following organizational misbehavior in health care for some years, we see that organizations that get into trouble once are very likely to get into trouble again.

This may be enabled by how government regulators and law enforcement give large health care organizations such  gentle treatment.  We have talked about the march of legal settlements by such organizations before.  Allegations are usually resolved with legal settlements that involve no admissions of guilt, small monetary penalties (compared with these organizations' total revenues), and sometimes apparently toothless corporate integrity agreements.  Settlements get desultory public notice, rarely informed by previous settlements or other evidence of previous misbehavior.  No individual who may have authorized, encouraged, directed, or implemented the bad behavior is likely to suffer any negative consequences.   It does not help that while nominally public, these settlements get little press, and what coverage there is usually fails to put the whole pattern together.

So we would urge the reporters who cover the next settlements by big health care organizations at least look to see if the organizations had been involved in similar settlements in the past.

Furthermore, as we have said all to often,...   The failure of the current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.  Pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.  So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

Friday, November 14, 2014

The Bigger They Come, the Softer They Fall - the Size of Pharma Companies and How Vigorously they are Prosecuted

After we found lessons to be learned from even  relatively small legal cases involving medical device companies, we reviewed some relatively small cases involving pharmaceutical companies made public in 2014.  Again, we had an index case that linked to larger issues

Merck Settled Fraud Allegations for $31 Million

This case got very little coverage in October, 2014.  A very short story by Reuters included these essentials,


A subsidiary of Merck & Co has agreed to pay U.S. states $31 million to settle claims that it overcharged their Medicaid programs for an antidepressant it had sold at a discount to pharmacy companies, attorney generals from three states said on Wednesday.

The officials from Idaho, New York and Florida said Organon USA Inc offered the drug, Remeron, to nursing home pharmacies at a discount to encourage its use over competitors. At the same time, the company reported the full cost of the drug when seeking reimbursements from state Medicaid programs, the states claimed.

New Jersey-based Organon, which did not admit any wrongdoing, also was accused of improperly promoting use of the drug by children and teens.

The agreement, which includes Washington, D.C., and every state besides Arizona, settled whistleblower lawsuits filed in 2007 in federal courts in Massachusetts and Texas.

That was the main content of the article.

Kickbacks to Promote Use of a Dangerous Drug

However, on the PharmaLot blog, Ed Silverman added important nuance,

Organon also allegedly offered kickbacks to nursing home pharmacies to encourage use of the Remeron antidepressant. The drug maker also allegedly promoted the medicine for uses not approved by the FDA. The marketing included targeting children and teenagers, according to a statement from New York Attorney General Eric Schneiderman.

So this was not merely financial fraud, but involved kickbacks to encourage excess use of a medicine for patients for whom it may have an enhanced risk of severe adverse effects.  In particular, Remeron (mirtazapine) may lead to higher risks of suicide attempts, including successful ones, by adolescents (look here for its official label).  So this case was not only about a company allegedly over-charging the government, but promoting a medicine that might be dangerous for vulnerable patients taking it. 


Merck's Track Record

Merck in some ways is the poster child for health care companies once renowned, but now troubled.  Merck's own voluminous Values and Standards document starts with this famous quote by founder George W Merck,

We try never to forget that medicine is for the people. It is not for the profits. The profits follow ,and if we have remembered that, they have never failed to appear.

Yet Merck was one of the first big multinational pharmaceutical companies to be tripped up by a big scandal in the 21st century.  As we wrote here, 

In summary, Vioxx (rofecoxib, Merck) a Cox-2 inhibitor non-steroidal anti-inflammatory drug used for pain, and touted for its ostensibly low risk of gastrointestinal side-effects, was withdrawn from the market in 2004 because of its cardiac risks.  The Vioxx case is flush with examples of how the company used deception to market a very profitable drug without regard to its risks to patients. 


A longer summary of the Vioxx scandal is in the Appendix below.

Furthermore, Merck also seems to have a chronic problem with honest discussion of another of its products, Zetia (look here).   Merck was also fined by the French government for a "smear campaign" against generic competitors (look here) and this month got a very poor rating for its global corporate transparency from Transparency International (look here). 

So this relatively small case reminds us that when a very large health care company is accused of misbehavior, including deceptive behavior that could have led to patient harms, not only are no individuals who might have authorized, directed or implemented the bad behavior held accountable, but the case is likely resolved in a seeming vacuum, totally uninformed about the company's previous record of similar problems.

Sheffield Pharmaceuticals CEO Pleaded Guilty of Felony for Discharge of Wastewater Without Permit

An interesting contrast is the case of one Mr Thomas Faria, as described by the New London (CT) Day in July, 2014,

Thomas H. Faria, who resigned in March as president and chief executive officer of Sheffield Pharmaceuticals, pleaded guilty in U.S. District Court Tuesday to a felony violation of the Clean Water Act for knowingly discharging untreated industrial wastewater to the New London sewage treatment plant from 1986 to 2011.

His penalty does not yet seem to be public, but could go considerably beyond loss of his job,


Faria pleaded guilty to one count of knowingly violating, or causing to be violated, the Clean Water Act, an offense that carries a maximum penalty of three years of imprisonment and a fine of not less than $5,000 but not more than $50,000 per day of the violation.

Yet the harms produced by the company's actions are not so clear,


The environmental impact of the violation over a 25-year-period is unknown, though Special Assistant U.S. Attorney Peter Kenyon from the Environmental Protection Agency said the EPA is unaware of any fish kills or direct harm suffered by humans.

'The possibility of impact from this type of discharge certainly exists,' Kenyon said during a conference call Tuesday.

So in this case, the offense was environmental, and had nothing directly to do with the over the counter drugs manufactured by the company, or their effects on patients.  The impact of the offense on the environment was unclear.  Nonetheless, the CEO of this small, privately held company lost his job, had a felony on his record, and is liable for large fines or up to three years in jail, pending sentencing.

Jury Found Takeda and Eli Lilly Concealed Cancer Risks of Actos, Company Subject to Punitive Damages of $36.8 Million

The basics of the case were reported by Medscape in April, 2014, and were also covered by Reuters and Bloomberg,

Drugmakers Takeda Pharmaceutical Co. and Eli Lilly and Co. promised to appeal an award of $9 billion in punitive damages — one of the largest in US history — after a federal jury found they had concealed the cancer risks for their type 2 diabetes drug pioglitazone (Actos).

In addition, the jury ordered the payment of $1.475 million in compensatory damages.

Pioglitazone is associated with an increased risk for bladder cancer among persons with type 2 diabetes, according to a 2012 study in BMJ, as reported by Medscape Medical News.  The US Food and Drug Administration in 2011 updated the pioglitazone label to warn against starting the drug in patients with active bladder cancer and to use caution if starting it in patients with a prior history of bladder cancer,...



In addition, the judge ruled that the company destroyed relevant documents to prevent their use in court proceedings,

attorney Mark Lanier said Takeda officials intentionally destroyed documents about the drug.

US District Judge Rebecca Doherty agreed and penalized the company, telling jurors they could infer that the files may have supported Allen's claims that the company wrongfully concealed the medication's health risks. 'The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing,' Doherty wrote in a January ruling.

In late October, 2014, the judge reduced the award for punitive damages, per Reuters,

In her ruling, Doherty said the original $9 billion damages award was 'excessive' and violated the companies' constitutional rights to due process.

She ordered Takeda to pay $27.6 million and Eli Lilly to pay $9.2 million for a total of $36.8 million. Doherty said that, while far smaller than the jury's original award, the reduced punitive damages were still 'large enough to accomplish the jury's clear aim: to send a message to the defendants that their wrongdoing must stop...'>


I should note that apparently the judge found the amount excessive given the size of the compensatory award to the single plaintiff.  However, the judge reiterated her concerns about the companies' deceptive conduct,

The companies also had sought a new trial, arguing that the court had made prejudicial rulings on evidence and jury instructions that tainted the trial's outcome.

Doherty rejected that request Monday, writing that the evidence during the trial showed that the companies 'disregarded, denied, obfuscated and concealed' for more than a decade that Actos could increase patients' risk for bladder cancer.  


Note that in this civil case, a jury found the companies' deceptive conduct reprehensible, and a judge agreed that they "disregarded, denied, obfuscated and concealed" the truth.  No government prosecutors seemed to care to get involved with this particular case.  Because it was a civil case in which the companies were defendants, I am not sure whether any penalties affecting individuals were a possible outcome.  The results seem to suggest, at least in my humble opinion, that both ordinary people, like those sitting on juries, and judges may take greater exception to deceptive conduct that could harm patients than may government law enforcers and regulators.

Teva Pharmaceutical Industries Made $27.6 Million Settlement of Charges that it Induced Physicians' Excessive Prescriptions


This was well summarized by ProPublica in March, 2014,

Teva Pharmaceutical Industries Ltd. has agreed to pay more than $27.6 million to settle state and federal allegations that it induced Chicago psychiatrist Michael Reinstein to overprescribe clozapine, a powerful antipsychotic drug.

Reinstein has twice figured into ProPublica investigations.


Four years ago, ProPublica and the Chicago Tribune spotlighted Reinstein's prescribing pattern, finding that in 2007 he had prescribed more clozapine to patients in Medicaid's Illinois program than all of the doctors in the Medicaid programs of Texas, Florida and North Carolina combined. At least three of Reinstein's patients died of clozapine intoxication. At that time, Reinstein defended his prescription record, arguing that clozapine is effective and underprescribed.

Then, last spring, ProPublica reported that Reinstein prescribed even more of the drug in Medicare's prescription drug program for seniors and the disabled. ProPublica cited Reinstein in an investigation about how Medicare fails to monitor problem prescribers,...

Illinois Attorney General Lisa Madigan and the U.S. Justice Department claimed that IVAX, a Teva Pharmaceuticals subsidiary, paid Reinstein to overprescribe clozapine to Medicare and Medicaid patients. Yesterday Teva agreed to pay almost $15.5 million to the federal government and more than $12.1 million to Illinois to settle those allegations out of court.


Note that the government case seemed to be about how the government had to pay too much, not about harms to patients, despite the patient deaths described above.  Furthermore, the prosecutors, as they usually now do, allowed the case to be settled without any findings of wrongdoing,

Teva spokeswoman Denise Bradley told Reuters that the settlement does not mean that the company has admitted any liability.

It is interesting that the government is apparently pursuing a case against the physician as an individual, but not any cases against corporate managers who might have authorized, directed, or implemented the "inducements" to that physician,


In November 2012, federal prosecutors also filed suit against Reinstein, alleging that IVAX hadpaid him $50,000 a year to work as a consultant, paid his nurse to promote the drug and funded a study at an affiliated research institute. After the payments, Reinstein began overprescribing clozapine. The company also allegedly paid for trips and entertainment for Reinstein and his friends.

Otherwise, this case is typical of many US government and state prosecutors have pursued against big health care corporations.  There was a monetary settlement that might appear big to the public, but was tiny given the size of the company.  (According to Yahoo Finance, Teva's annual revenue is about $20 billion.)  The settlement did not involve any admission of wrongful behavior.  No one in the company who may have been involved with the wrongdoing that was not admitted suffered any negative consequences.  But, as is not usual, the government is pursuing a case against one individual, the physician who allegedly was paid as a "consultant," by maybe actually just to prescribe the company's product.

Summary

These cases add to the march of legal settlements about which we have often written.  These settlements and other legal cases suggest how frequently big health care organizations are involved in practices that may be unethical, illegal, and/or harmful to the patients they proclaim to serve.  Yet almost never do cases that involve US state and particularly federal law enforcement ever impose monetary penalties that are more than costs of doing business for the companies involved.  Almost never do they impose any negative consequences on any individuals within the companies who might have authorized, directed or implemented unethical, illegal, or harmful behavior.  

However, as we saw before, when the government asserts its law enforcement power against small organizations, small companies, or individuals, people may lose their livelihoods or go to jail.

The leniency of the government towards big health care corporations is very similar to the leniency shown towards big financial corporations.  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.

Furthermore, the book provided some essentially epidemiological evidence that the government in fact has been more lenient towards bigger corporations, at least in the finance sphere,

There’s some compelling evidence that the largest, most established companies are more likely to win leniency with a delayed or canceled prosecution: 58 percent of the companies awarded such deals are public firms listed on a U.S. stock exchange, while publicly traded firms make up just 6 percent of those against whom the Department of Justice obtained convictions.

Yet there seems to be no evidence that this policy produces social good.  In particular, there seems to be no evidence that corporations treated leniently behave any better.

Finally, there is a question of essential fairness, and equal treatment under the laws.  It appears that executives of large finance, and likely health care corporations have virtual impunity.  Yet little people in health care, or finance, who do something wrong may go to jail.

True health care reform would establish a level playing field.  True health care reform would deter unethical behavior, especially when it harms patients.  True health care reform would make leaders of health care organizations accountable for putting patients' and the peoples' health first.   


Appendix- Vioxx Case

There is evidence is that the company knew about the cardiac risks of Vioxx since 2000, but suppressed the clinical research evidence until 2003.(1)  In particular, in 2005, the editors of the New England Journal of Medicine raised concerns that an article published in that journal in 2000 about the results of the VIGOR study of rofecoxib sponsored by Merck failed to report data that would have suggested that the drug caused excess cardiovascular risks.(2) In 2007, the company paid more than $4.9 billion to settle patient lawsuits alleging harm due to Vioxx.(3)  Also in 2008, the company made a $58 million settlement of claims its advertising of Vioxx deceptively minimized its risks.(4) In 2008, it became clear that at least one apparently clinical trial of Vioxx, the ADVANTAGE trial, was merely a "seeding trial,' that is, a marketing exercise.(5)

On Health Care Renewal, we starting writing about Vioxx in 2005, including,
- here about ghost-writing of a Vioxx research publication;
- here, and here about allegations that Merck executives tried to intimidate Vioxx critics;
- here about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case;
- here about the ADVANTAGE "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and
- here about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs.
here about how in settling a shareholder lawsuit Merck vowed to improve its scientific and academic integrity, and refrain from manipulating and suppressing clinical research.

In 2010, we summarized the Vioxx case thus, " the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case)." 

In case there are any doubts about the harms patients suffered as a result of using Vioxx as a pain reliever, in 2004, a cumulative meta-analysis of published trials of Vioxx known by then estimated the risk of myocardial infarction (heart attack) due to Vioxx compared with placebo or other non-steroidal anti-inflammatory drugs was 2.3 times the baseline rate.(6)  That analysis suggested that there was data by 2000 that Vioxx increased the risk of bad cardiovascular events.  A cumulative meta-analysis from 2009 suggested that the risk of death due to Vioxx was 1.7 times the baseline rate.(7)   That analysis suggested there was data by 2001 that Vioxx increased the risk of bad cardiovascular events.  Graham and colleagues' nested case-control study of Vioxx use in a large managed care organization lead them to estimate that "88 000 - 140 000 excess cases of serious coronary heart disease probably occurred in the USA over the market-life of rofecoxib."(8).

References

1. Topol EJ. Failing the public health - rofecoxib, Merck and the FDA. N Engl J Med 2004; 351: 1707-1709.  Link here.
2. Curfman GD, Morrisey S, Drazen JM et al.  Expression of concern reaffirmed. N Engl J Med 2006; 354:1193. Link here.
3. Charatan F. Merck to pay $5bn in rofecoxib claims. Brit Med J 2007; 335: 1011. Link here.
4. Charatan F. Merck to pay $58m in settlements over rofecoxib advertising. Brit Med J 2008; 336: 1208-1209. Link here.
5. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Int Med 2008; 149: 251-258. Link here.
6.  Juni P, Nartey L, Reichenbach S et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis.  Lancet 2004; 364: 2021-2029.  Link here.
7.  Ross JS, Madigan D, Hill KP et al.  Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.  Arch Intern Med 2009; 169: 1976-1984.  Link here.
8.  Graham DM, Campen D, Hui R et al.  Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study.  Lancet 2005; 365: 475-481.  Link here.

Wednesday, November 12, 2014

What in God's Name is Going on With Healthcare IT at Cambridge University Hospitals?

This story about a  UK hospital that recently "went live"with an American electronic health record/enterprise command-and-control system (EPIC) was not only predictable, but expected considering the sorry state of the health IT industry in terms of clinical leadership and regulation.

(It appears this was a "big bang" rollout, see http://www.ehi.co.uk/news/EHI/8845/cambridge-goes-for-epic-big-bang, an implementation method better suited for warehouses and widget suppliers than major hospitals.)

Addenbrooke’s staff blame blood shortage on new eHospital
By CambridgeNews  |  Posted: November 05, 2014
http://www.cambridge-news.co.uk/Addenbrooke-8217-s-staff-blame-blood-shortage-new/story-24513716-detail/story.html

By Freya Leng

Members of staff at Addenbrooke's [hospital, http://www.cuh.org.uk/addenbrookes-hospital] have voiced their concerns about the new IT system which has been blamed for a blood shortage.

Cambridge University Hospitals' eHospital went live on October 26 and is designed to improve the quality of care for patients by allowing clinicians and frontline staff to access patient information wherever they are, at the click of a button.

I must put to rest this lie once again.  The unregulated, generally terrible software being sold by the so-called EHR vendors is NOT simply software to allow clinicians to  "access patient information wherever they are."  

This is enterprise clinician and clinical resource command-and-control software, through which increasingly each transaction related to care must pass.  In other words, ERP packages to manage patient care, as one might manage inventory and shipping in a merchant enterprise:

http://en.wikipedia.org/wiki/Enterprise_resource_planning

Enterprise resource planning (ERP) is a business management software—usually a suite of integrated applications—that a company can use to collect, store, manage and interpret data from many business activities

Unfortunately, the reductionist assumptions behind the conception, design, authoring and implementation of such ERP software - that hospitals and healthcare are linear, predictable processes - are both deadly wrong, and the beliefs of fools and the recklessly cavalier.

To wit:

But since the launch, the News has been contacted by a senior member of staff at Addenbrooke's who said the new IT system was having "serious consequences" on the "operational running of the service".

In a letter, the staff member who does not want to be named [due to potential for retaliation - ed.], said: "The hospital has very little blood available due to transfusion lab technical failures. Truth - the new IT system is responsible."

The letter also states the impact the shortage of blood has had on the hospital including the cancellation of all elective surgery until November 8 as well as impacting on any procedure that holds a risk of blood transfusion and organ transplantation.

"I believe sufficient risk has been placed upon all patients under care of Addenbrooke's," the staff member said. "Someone needs to be responsible for the implementation of the new IT system."

In my experience, the non-clinical executives who often select this technology, and the IT personnel who then implement the technology (often ignoring clinicians), do need to be held responsible for bad outcomes - in the courtroom.

The News also understands the whole system went down for six hours at the weekend with staff reverting back to paper and all major trauma cases diverted elsewhere.

There are numerous cases on this blog of disruptive and patient-endangering EHR system outages.  These are simply inexcusable regarding life-critical computing. The unexpected transitions back and forth between paper endanger patients.

A doctor, who also did not want to be named, said the wifi system which supports all the ward rounds is "unfit for purpose" and is leading to gross inefficiency.

If this is true, it once again represents the cavalier nature of those technologists rarely held accountable for mistakes that, of they occurred in other critical industries (e.g., aviation, nuclear energy) might leave smoldering ruins and radioactive clouds that would result in the end of their careers...at the very least.  Unfortunately, individual injured and dead patients are not quite as visible to the public.

"The general feeling on the ground is that they could not have implemented the system any worse than they have done and without any doubt it has already significantly affected patient care." they said.

This is consistent with my own personal experience with hospital IT departments in the U.S., where mistakes that I could not even have conceived of making, were regularly made - leaving me to have to point out and clean up the mess, at risk to my own career due to the reactions of the non-clinical IT leaders and staff to being shown their own inadequacy regarding clinical affairs.  (This was, of course, an odd reaction by people who'd never gone to medical school, let alone had doctoral or postdoctoral study, research and development experience in Medical Informatics.)

A CUH spokesman said: "eHospital gives our staff more time with patients at the bedside, many of whom are frail, elderly and have complex conditions.

Right, just those patients who are most vulnerable to IT debacles and the cascading errors that can result.

"However, unlike banks, shops or travel agents, we cannot close our doors or stop our services to the hundreds of thousands of people we treat every year. So it was always going to be a challenge to implement such a massive change.

That is a very poor excuse for IT malpractice.  It makes the reader believe everything possible in due diligence was done, that others' experience was completely paid attention to, etc.  The results give me great doubt about that...

"Pathology was affected early last week, which led to a brief reduction in the number of tests, but we are increasingly operating as normal. We did carry out a successful 're-boot' of the system early on Sunday morning.

There we go once again  the typical bureaucratic spin that "the malfunctions were minor, nothing to see here, move along, patient safety was not compromised"  (a recurrent refrain with its own index term on this blog, see the 25+ posts at http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised) - while at the same time these systems are represented as revolutionizing medicine - except when they malfunction, at which time they have no meaningful effects on care.

"The much bigger challenge we face is that the Trust is incredibly busy and we have limited numbers of beds available, and which need to be kept free for emergency cases. Operations will continue to be rescheduled until the community care for those who no longer need a hospital bed is in place. We do sympathise with the frustration that people feel and apologise for the delay they are experiencing."

In my opinion, patients put at risk, and injured and dead patients need and deserve more than apologies for information technology malpractice.

Especially at Cambridge University, where in my opinion, this whole affair is truly a world-class embarrassment.

-- SS

Tuesday, November 11, 2014

Promises, Promises - Dendreon Bankrupt, Steward Healthcare Closes Quincy Hospital

Physicians and other health professionals are trained to attempt to make realistic, unbiased predictions, most frequently of the prognoses of individual patients.  Thus physicians may not question apparently authoritative predictions, claims, and promises made in the health care context.  They may not question, for example, predictions about the efficacy and safety of drugs and devices, even by people working for drug and device companies; predictions of the benefits of health care services, even by people working for the hospitals that provide them; and predictions of the benefits of health policies, even by politicians or organizations that stand to benefit if they are adapted.  Yet such predictions may influence health care policies and decisions.

However, in the business culture, confidence is often conflated with competence.  Generic managers, trained in business schools, and steeped in business culture, now run most health care organizations.  Managers are responsible for most of the sorts of predictions listed above, perhaps mediated through their marketing and public relations staffs.


Thus it should come as no surprise that a lot of the predictions, claims, and promises we now hear in health care eventually come to naught, but long after they have already influenced decisions and policy. 

Dendreon Bankruptcy

In 2007, we first wrote about biotechnology company Dendreon, and its single product, a vaccine meant to treat prostate cancer with the trade name Provenge ( generic name, sipuleucel-T).  Provenge has aroused unusual passions.  When the US Food and Drug Administration delayed its approval after a single small trial showed equivocal results, much hoopla produced by Dendreon partisans occurred.  Investors and patient advocates protested, at times picketing the FDA.  Someone threatened physicians who were publicly skeptical of the vaccine.  It did appear that Dendreon funded a patient advocacy group which was one of the vaccine's vocal supporters.

In 2009, Matthew Herper, writing in Forbes, reported that the company had released preliminary data from a new trial before the results were presented at any conference or published, apparently after breaking the treatment blinding, causing one biostatistics expert to say, "I'm shocked."  At that point, company CEO Mitch Gold

has been using the [controversial, unpublished] data to talk up Provenge. 'We’re clearly within shooting range,' Gold told analysts at a JP Morgan investor conference in January. 'Sometimes I use a football analogy where we are on the 10-yard line and we are in the red zone, and we need to punch it in the end zone right now.'

A TheStreet.com article noted that

Dendreon threw a celebratory cocktail party Tuesday night at a Chicago hotel just off the Miracle Mile. CEO Mitch Gold was beaming as he slapped backs, shook hands and hugged employees, investors and supporters.

In 2010, the FDA approved the vaccine based on the eventually published study that showed that Provenge prolonged survival for an average of about four months.  The company then priced a course of therapy at $93,000, starting one of the early big controversies about extremely expensive new drugs with apparently small benefits  (see this Washington Post article) .  

According to a 2011 article by Jim Edwards for CBS, through 2010 and into 2011, CEO Gold and Chief Operating Officer Hans Bishop continued to make optimistic forecasts about sales of Provenge.  But during the same time period, Gold and other insiders sold $87 million in stock.  Then in 2011, the company announced that its revenue projections had been far too optimistic.

Things continued downhill from there.  Dendreon settled for $40 million an investor class action lawsuit that asserted corporate executives made "false or misleading statements about the company," according to one very brief story in the Seattle Times.  

Then, on November 10, 2014, per the Seattle Times, the company announced it would file for bankruptcy,

Dendreon said it has filed for bankruptcy protection as part of a plan to restructure $620 million in debt, a move likely to effectively wipe out the value of its common stock.

The biotechnology company, once Seattle’s largest, filed a voluntary Chapter 11 bankruptcy petition Monday in Delaware.

"Within shooting range" - no more.  Yet from 2007 to 2011, the company CEO (and COO), aided by corporate marketers and public relations, created a huge brouhaha over the company's one product, making management insiders rich meanwhile.  The high price the company charged for the vaccine may have driven up the stock price early, facilitating the amassing of wealth by top management insiders.  While this pricing decision may have helped other health care corporations pursue gigantic revenues from new products, it may have ultimately damped demand and lead to bankruptcy.  How much money the managers who created the hoopla will keep remains to be seen.  Why skepticism about the executives fabulous predictions was not initially higher is unclear. 

ADDENDUM (20 November, 2014) - Added paragraph re 2013 investor class action settlement.

Steward Healthcare Closes Quincy Hospital

Starting in 2010, we wrote about the takeover of the Massachusetts non-profit Catholic hospital system Caritas Christi by private equity firm Cerberus Capital Management (named for the mythological three-headed dog that guards the gates of the underworld, look here.)  Despite some controversy, and the apparent contrast between Catholicism and the three-headed dog guarding the gates of hell, the takeover was approved, yielding the now privately held, for-profit Steward Healthcare.

Over the time period, proponents of the sale gave some big assurances.  In 2010, the Boston Globe reported,

Brett Ingersoll, co-head of private equity at Cerberus, called the Caritas acquisition 'a big win for the hard-working communities of Greater Boston.'’ Ingersoll said the new owners 'plan to create jobs, expand local tax bases, and provide world-class health care facilities.'

Similarly, from a Boston Herald article,

'Cerberus is pleased to be making a long-term investment that will help ensure the viability and future success of the Caritas Christi health care system,' said W. Brett Ingersoll, co-director of private equity at Cerberus in a statement.  'Caritas is the region's largest community hospital network, and our investment will give physicians, nurses, and other health professionals the additional tools they need to deliver world-class care to patients in the communities they serve.'

Later in October, Dr Ralph De La Torre, Caritas Christi CEO, a former cardiovascular surgeon who apparently no longer held an active medical license (look here), intoned per the Globe,

'The business plan, the strategy, or whatever you want to call it, is all about keeping care locally,' he said. 'If we improve the facilities, improve the infrastructure, make it so that our very own patients want to stay in our hospitals, that’s the business plan.'

Furthermore, at the same meeting,

The new holding company 'will continue to promote the public interest after this transaction,' Lisa Gray, Cerberus general counsel executive and a Steward board member, told the council.

A few days later, again per the Globe, Caritas Christi spokesman Chris Murphy said,

Once finalized, the sale will ensure the future of our system, the jobs of our employees, and the pensions of our retirees.


The takeover was eventually completed, and the new Steward Healthcare commenced acquisitions of other hospitals.  CEO De La Torre had become the most highly paid hospital system CEO in the Boston area, and was widely anticipated to be on the way to even higher compensation under Steward (look here). 

In 2011, Steward set its sights on Quincy Medical Center.  Once again, promises were made, per the Boston Herald,

In a statement today, interim CEO John Kastanis said the hospital's announcement is 'the culmination of an exhaustive process to find a capital partner who is committed to our mission, our employees and physicians, and the communities we serve.'

'We have found the partner in Steward,' Katsanis said.  'Steward is a community-based hospital system with tremendous resources that will enable us to grow and continue to provide world-class health care for generations to come.'

The Massachusetts Attorney General approved the sale of Quincy Medical Center to Steward, but with some conditions, as a September 8, 2011, Boston Globe article noted,

[Attorney General Martha]  Coakley imposed multiple conditions on the deal that are meant to safeguard patients and employees of the financially struggling hospitals. They included a guarantee that Boston-based Steward will not sell either one for at least five years, that it will keep making capital improvements after five years,...

Also, Steward

agreed to a 10-year “no close’’ period for both hospitals, though the deals included clauses that would allow Steward to close the hospitals under certain conditions in the last three years if financial targets aren’t met.


It all sounded so good.  However, on November 6, 2014, slightly more than three years after the sale of Quincy Medical Center was approved with the conditions above, per the Globe,

Steward Health Care System said Thursday that it would close Quincy Medical Center and displace nearly 700 workers after the long-struggling hospital finally succumbed to the intense competition for patients south of Boston.

 The shutdown, scheduled to be completed by the end the year, marks the biggest hospital closing in the state in at least a decade and the first failure for Steward, the for-profit company that promised to reinvent community health care when it entered the Massachusetts market four years ago.


So what happened to "world class health care for generations to come," or being "committed to our employees?"  The commitment lasted a little over three years, the employees will need to find new jobs, and the patients will need to go elsewhere for health care, whether world class or not.  At least Attorney General Coakley is looking into options given that Steward Health Care seemed to have violated that 2011 agreement, per the Herald,

The Attorney General’s Office is investigating whether Steward Health Care System violated the terms of a 2011 agreement when it announced yesterday that Quincy Medical Center will shut down operations by the end of the year, a spokesman said.

'We have just been notified about this decision and are currently reviewing it in the context of Steward’s legal obligations,' said Brad Puffer, a spokesman for Attorney General Martha Coakley.
When Steward bought the 196-bed Quincy hospital in a bankruptcy auction in 2011, it signed an agreement with Coakley that included a 10-year 'No Close Period' requiring that it 'maintain an acute care hospital in Quincy providing at least the same scope of services as Quincy Medical Center currently provides.'

Steward could close Quincy Medical in the last three-and-a-half years of that 10-year period if it could show the hospital 'experienced two consecutive fiscal years of negative operating margins' and provide the state’s Department of Public Health with 'at least 18 months prior written notice of its intent to close,' according to the agreement.

A Steward spokeswoman declined to comment when asked about the no-close clause last night.

 In any case, while there was plenty of skepticism about the acquisition of Caritas Christi by Cerberus Capital Management, and the ambitious expansion plans of the resulting Steward Healthcare, it was insufficient to slow down these aggressive plans.  I could speculate that had more skepticism come from physicians and health care policy experts, maybe things would have been different.  It is likely that Steward Healthcare/ Cerberus Capital Management insiders made plenty of money from the deals, although now that the hospital system is privately held, little about individual compensation has been disclosed.  The takeover of a once religious based, non-profit health care system by private equity, and the aggressive initial expansion of the new for-profit system, were in part enabled by extravagant promises and claims.  While this expansion is now clearly seen as not an unalloyed good, those making the claims likely have already personally profited from it. 

Summary

There have been lots of other expansive predictions in our era of commercialized health care that have come to naught.  In general, lots of physicians seemed convinced by predictions that:
- commercial managed care would improve access and quality, and cut costs
- large, vertically integrated hospital systems would improve access and quality, and cut costs
- commercial electronic health records would - guest what - improve access and quality, and cut costs.

How did those turn out?

There were lots of more specific and local predictions that proved equally inoperative.  Remember the former CEO of the Allegheny Health Education and Research Foundation (AHERF), one of the first really large vertically integrated health care systems, promising to create a more flexible, adoptable, and agile organization.  That organization was soon bankrupt, and he was soon in jail.  (Look here).

So now we have two new reminders that even apparently authoritative health care claims, predictions, and promises, particularly when made by executives or managers, when enabled through public relations or marketing, or appear likely to be self-serving, ought to be regarded with extreme skepticism, if not outright ridicule.  Many doctors now realize that they should not trust advertising of health care products and services.  Nor should they trust flowery pronouncements of business people about health care products, services, and policies when the predictors are in a position to benefit from short term actions adherent to these predictions.

True health care reform would restore leadership of health care that is knowledgeable about health care, committed to its values, and held accountable for patients' and the public's health.  Meanwhile, we ought to be extremely skeptical of claims, predictions, and promises made by health care organizations' management. 

Friday, November 07, 2014

Bug in MetaVision ICU system potentially catastrophic - American bad health IT goes Down Under

I have often written in this blog about healthcare IT defects and the lack of quality control regulation and safety testing.   I have indicated that patients have become guinea pigs for software development and testing, and healthcare facilities a software beta testing "proving ground" and defects remediation site.

This should all be occurring in the lab, not on live patients who've never given their consent to the use of these experimental cybernetic "command and control" systems that, in fact, regulate and govern their care in many ways.

Now there's this from Down Under in the journal Pulse*IT:

http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=2127:bug-in-metavision-icu-system-potentially-catastrophic 

Bug in MetaVision ICU system potentially catastrophic
Written by Kate McDonald on 27 October 2014.

A bug in the MetaVision intensive care software package being rolled out in several Brisbane hospitals has been identified as having the potential to seriously harm or even kill patients, several media outlets are reporting.

Fairfax's The Brisbane Times reported that a risk assessment by the Metro North Hospital and Health Service - which covers Brisbane's Prince Charles and Royal Brisbane and Women's (RBWH) hospitals - had found potentially catastrophic problems with prescription errors caused by the system that had a 60 to 90 per cent likelihood of causing a patient death.

MetaVision, from US vendor iMDsoft, is one of the few specialist critical care software packages on the market. It is able to capture information from medical devices and contains a full medical record specific to ICU patients.

This is U.S. software being foisted onto the very sick ICU patients of another country, Australia.

I should note that the author of the article, Kate McDonald, did an article about me in July 2012 and about my - at the time - upcoming presentation to the Health Informatics Society of Australia in health IT trust (article at http://issuu.com/pulseitmagazine/docs/pulseit_july2012/56, writeup of my presentation and link to slides at http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html).

A 60 to 90 percent likelihood of causing a patient death is of great concern, especially in an ICU.  The likelihood of injury is probably in the same ballpark.

Who detected the problems?  The true experts - those with clinical expertise:

... It also contains medications management and decision support, and is able to interface with the complex IV infusion pumps used to administer medications to patients in intensive care.

The ABC [Australian Broadcasting Company] reported that according to the risk assessment report, “monitoring of patient records by pharmacists has revealed several potentially serious prescription errors specifically caused by the system”.

"Large volume prescriptions and high acuity of patients overlayed [sic] with functional risks of the system increases the likelihood of a SAC 1 (serious harm or death) event.

(Where have I seen computer-caused prescription errors with harm potential caused by bad health IT before?  Here, for one:   "Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands", http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html.)

According to the ABC, the testing of this software was about par for the course in this unregulated health IT industry:

"There is no record of robust regression or functional testing at vendor, Queensland Health corporate or facility level."

Yet the software has been, and is, being rolled out by eager beavers seemingly just jolly at subjecting non-consenting ICU patients to an American experiment:

MetaVision has been rolled out in the ICUs at the Canberra and Calvary hospitals in the ACT, and at the Gold Coast, Prince Charles, Townsville, Rockhampton, Cairns and Logan hospitals in Queensland, where it has been installed for over a year.

It went live at Brisbane's Royal Children's in June, RBWH in September and at Princess Alexandra Hospital (PAH) just last week.

It is live at the Sydney Adventist Hospital and has also been chosen for a statewide roll-out in all ICUs in NSW.

The software company responds:

MDsoft issued a statement late on Monday saying that the problem was unique to the version implemented at Queensland Heath and does not affect any other installations in Australia.

"Late last week, certain clinicians from Queensland Heath highlighted potential risks as a result of prescribing with the MetaVision clinical information system," iMDsoft's director of marketing, Anne Belkin, said.

"iMDsoft is aware of this issue, and has already provided a solution to Queensland Heath. The software fix has been in testing at the site for several weeks and will be implemented in the near future.

First, one wonders why software being rolled out at hospitals in the Australian state of Queensland would be uniquely affected by such a severe bug, while at other sites it has not.  I question if some "new" features are being alpha- or beta-tested there - using Queensland Health ICU patients as unwitting laboratory rats.

Unless that "fix in testing" is being tested completely offline, this suggests patients are being used as literal software debugging test subjects regarding a flaw that could kill them.  The very best interpretation is that clinicians are asked to work around a potentially fatal "bug" in an ICU setting with the very sickest patients while the "fix" for a bug that should not exist in the first place is being remediated.   

"The risks highlighted by the report were originally identified during testing and, with close cooperation between iMDsoft and the clinicians at the Hospital and Health Service sites, a mitigation plan was immediately put into effect.  ... [The Brisbane Times] said the system has been manually over-ridden with medical charts [presumably the electronic charts - ed.] being reviewed daily by ICU specialists.

This suggests workarounds, which can be dangerous themselves ("one should not have to work around that which is not in their way", as I've written.)

A better and more ethical solution, in my opinion, to a potentially fatal bug's "mitigation plan" would be to turn the system off in the interim and revert to paper - as if the system had crashed - until the "bug" is fixed.

The company is then quoted as making this statement:

"The underlying risk is unique to the version implemented at Queensland Heath, and does not exist in any prior or subsequent releases for Australia. MetaVision is used at more than three hundred sites worldwide and is regulated by stringent international standards to ensure patient safety."

"Three hundred sites worldwide" is a very small number.  This suggests this is a very recent - or perhaps unpopular - offering.

The company site offers this:

iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements.
iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements. - See more at: http://www.imd-soft.us/about-us#sthash.RZMu32FN.dpuf
iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements. - See more at: http://www.imd-soft.us/about-us#sthash.RZMu32FN.dpuf

It would be interesting to know what "stringent international standards" are being followed to "ensure patient safety" (ISO 13485, http://www.iso.org/iso/catalogue_detail?csnumber=36786 for medical devices is likely the one being cited), and what testing the FDA performed specifically.

I don't know of such standards for ICU health IT in the U.S., the country of origin of this software, where regulation of health IT is in the discussion stages by the government and FDA, and very unsatisfactorily I might add (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).

Nor do I know of rigorous ICU clinical EHR software evaluation and testing regulations and procedures anywhere else, for that matter, although would be glad to be informed of some that could be adopted in the U.S.

The expected excuses also appear:

Brent Richards, director of intensive care at the Gold Coast Hospital and then chairman of Queensland's Statewide Intensive Care Clinical Network, told Pulse+IT last year that the system delivered improvements in workflow and safety.

“ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said. “You want to capture all of that data including the data from the equipment interfaces, which is transferred minutely in MetaVision.

Giving drugs is a lot more complex because ICU patients frequently have numerous infusions, and there is frequent real-time management of infusions – titrating medication infusions is normal in ICU – and the system has got to be able to capture it.”

In response, I penned this letter to Kate McDonald.  It speaks for itself:

From: Silverstein,Scot
Sent: Friday, November 07, 2014 9:58 AM
To: Kate McDonald
Subject: Re: Bug in MetaVision ICU system potentially catastrophic
Re:  http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=2127:bug-in-metavision-icu-system-potentially-catastrophic

Dear Kate,

I hope you are well.  My Australian colleagues alerted me to your article on the Metavision ICU flaws.

The excuse that:

... “ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said.

rings incredibly hollow.

If an ICU is so complex, the most stringent IT testing is indicated BEFORE go-live on actual patients.  If this were an aircraft or nuclear energy facility, one might now have a smoldering ruin or a Chernobyl (or Three Mile Island in the U.S., http://en.wikipedia.org/wiki/Three_Mile_Island_accident) radiation cloud.

Live patient environments, especially with the sickest in an ICU, are not proper software beta testing and debugging environments.

This is why in the U.S. I call for mandatory and strict quality and safety regulation of healthcare IT that will be employed on patients, much as software is regulated in other mission-critical and life-critical industries.

The health IT industry has for decades been given an extraordinary regulatory accommodation - that is, little to no regulation - and this can, and has, harmed and killed patients.

Please consider this letter suitable for publication.  I addressed some of these issues in my keynote at HISA 2012 in Sydney.

Sincerely,

Scot Silverstein

I, for one, certainly do not want buggy software deployed in ICU's anywhere near my residence.  Hospitals have a legal and ethical obligation to maintain safe environments for care.

Australian as well as American hospital management seem to have been cavalier about that when it comes to healthcare information technology.

-- SS

Thursday, November 06, 2014

What Big Drug and Biotechnology Companies Will Not Tell Us - Transparency International on Corporate Reporting

Drug companies are entrusted to provide pure, unadulterated medicines.  Increasingly drug companies are now entrusted with doing research, including experimental studies, on human beings, and providing education to doctors and patients.  Ordinarily, trust requires confidence in transparency. However, a new report suggests that large multinational drug and biotechnology companies are not very transparent.

Transparency International just released a report on the transparency, or lack thereof, of the 124 biggest multinational corporations.  The report detailed how well these companies disclosed their internal anti-corruption programs, their subsidiaries, affiliates, and joint ventures, and their financial data broken down by the countries in which they operate.  In summary, the overall results for disclosing anti-corruption programs were mediocre, and for disclosing organizational structure and country-by-country financial data, they were dismal.

The report is highly relevant to health care.  It included the biggest multinational health care corporations, all drug and/or biotechnology companies: Abbott Laboratories, (based in the US), Amgen (US), AstraZeneca (UK), Gilead Sciences (US), GlaxoSmithKline (UK), Johnson and Johnson (US), Merck and Co (US), Novartis (Switzerland), Novo Nordisk (Denmark), Pfizer (US), Roche Holding (Switzerland), Sanofi (France), Teva Pharmaceutical Industries (Israel).

The report has so far received little media coverage.  In the US, several news services provided brief  summaries.  Somewhat more substantial articles came from Reuters, the Wall Street Journal's Risk and Compliance Journal, and CNBC.  None gave specifics about health care.  Coverage from other countries, e.g., Germany by Deutsche Welle, and the UK by the Guardian, was more detailed but also did not specifically mention health care.

Therefore, I will summarize the rationale and assessment methods used by Transparency International for its three dimensions of transparency, and then show results from the 13 health care corporations.

Disclosure of Anti-Corruption Programs

The rationale for addressing this area was:

Global companies have legal and ethical obligations to conduct their business honestly. This requires
commitment, resources and the ongoing management of a range of risks – legal, political and reputational – including those associated with corruption. The implementation of a comprehensive range of anticorruption policies and management systems is fundamental to efforts to prevent and remediate corruption within organisations.

Transparency International believes that public reporting by companies on their anti-corruption programmes allows for increased monitoring by stakeholders and the public at large, thereby making companies more accountable

Evaluation of disclosure of anti-corruption programs was

based on 13 questions, which are derived from the UN Global Compact and Transparency International Reporting Guidance on the 10th Principle against Corruption. This tool, based on the Business Principles for Countering Bribery, which were developed by Transparency International in collaboration with a multi-stakeholder group, includes recommendations for companies on how to publicly report on their anticorruption programmes.

Note that the project addressed only reporting of anti-corruption programs, not their implementation or effectiveness.

For this and the other two dimensions of transparency, responses were converted into a 0% to 100% scale, with 100% being the best possible result.

Organizational Transparency

The rationale was:

As many of the recent corporate scandals have shown, acts of corruption are very often aided by the use of opaque company structures and secrecy jurisdictions.  But the use of offshore companies and their lack of transparency are posing increasing risks for global companies as well as for their shareholders, employees and local communities.

So,

Companies can mitigate the risks posed by lack of transparency and ownership arrangements by shedding more light on their corporate structures and by making basic financial information public on a country-by-country basis. This allows stakeholders to have a clearer understanding of the extent of a company’s operations and makes the company more accountable for its activities in a given country, including assessing whether it contributes financially in a manner appropriate to its level of activity.

The measurement strategy was,

Transparency International researchers consulted publicly available documents such as annual reports and stock exchange filings for information about company subsidiaries, affiliates, joint ventures and other holdings. The information sought included corporate names, percentages of ownership by the parent company, countries of incorporation and the countries in which the companies operate.

Country-by-Country Reporting

The rationale included:

The importance of country-by-country reporting was first recognised in the extractive sector as a way to ensure that revenues from natural resources are used to foster economic and social development rather than line the pockets of kleptocratic elites.

So,

country-by-country reporting ... [is] a recognised building block for corporate transparency and as a tool for countering tax avoidance.

In addition, country-by-country reporting provides investors with more comprehensive financial information about companies and helps them address investment risk more effectively.

The items measured were disclosure of revenue/sales, capital expenditures, pre-tax income, income tax, and community contribution in each country in which the company operated.

Results for Health Care Corporations

Company                      Total  Anti-Corruption P  Org Structure  by-Country

Abbott Laboratories    40             81                           38                3
Amgen                          37             85                           25                0
AstraZeneca                37             88                           19                3
Gilead Sciences           26             54                           25                0
GlaxoSmithKline          52            96                           50               11
Johnson and Johnson  26           65                           13                0
Merck and Co               42           77                            50                0
Novartis                        38            77                           38                1
Novo Nordisk               39            81                           38                0
Pfizer                             35            92                           13                0
Roche Holding              33            62                           38                1
Sanofi                            38            77                           38                0
Teva Pharmaceutical  35            85                            19                0

Again, only one company, GlaxoSmithKline, achieved an overall score of barely better than 50%.  All the others had lower scores.  Only two companies achieved a 50% score on disclosure of organizational structure, and only one achieved a score of better than 10% for disclosing country-by-country results.  The Transparency International report noted that the health care companies got particularly bad scores for disclosing organizational structure, averaging 31%, the third worst performance by economic sector.


Summary

 The drug and biotechnology companies generally did a fairly good job disclosing what their anti-corruption programs were supposed to do.  However, note that the Transparency International report did not assess how well these programs were implemented or enforced.  That this concern is not academic is underscored by some of these companies disreputable track records.  Some have long histories of legal actions, including billion dollar plus legal settlements, some of which were of allegations of fraud or kickbacks, and some have been convicted of crimes.  See the records of, for example: Abbott Laboratories (look here and here), Amgen (here), AstraZeneca (here), GlaxoSmithKline (here), Johnson and Johnson (here), Merck (here), Novartis (here), Novo Nordisk (here), Pfizer (here), Roche (here), Sanofi (here), and Teva (here).

Moreover, the companies did not do a good job disclosing their organizational structures, and hardly any bothered to report any financial results broken down by country.

We have frequently discussed health care corporations' deceptive marketing, induction of conflicts of interest, including those of supposed "key opinion leaders" who often are marketers in academic or professional clothing, and manipulation and suppression of clinical research.  There has been an ongoing procession of legal settlements involving health care corporations, often involving allegations of, and sometimes convictions for fraud, kickbacks, bribery, or other crimes.  There have even been some cases in which drug companies have failed to assure that their products are pure and unadulterated, their most basic mission.  Thus many are distrustful of drug and biotechnology companies, and large health care organizations in general.

So, as Transparency International's report noted, to rebuild trust,

integrity must be central to these efforts. Those efforts, in turn, can only become fully credible if they are undertaken with a sustained commitment to ethical behaviour and transparency across companies’ operations.

In my humble opinion, a basic premise of true health care reform would be that health care organizations become sufficiently transparent to restore basic trust in them.