Will There Ever Be Enough Straws to Break Corporate Health Care Managers' Impunity's Back? - Novartis Settles Yet Again, This Time for Bribing Doctors

boards of directors bribery conflicts of interest deception executive compensation health care corruption impunity marketing Novartis

Will There Ever Be Enough Straws to Break Corporate Health Care Managers' Impunity's Back? - Novartis Settles Yet Again, This Time for Bribing Doctors

Unknown 3/25/2016 Komentar

Umpteenth verse, same as the first...

As just reported by Bloomberg,

Novartis AG said it agreed to pay $25 million to settle a U.S. Securities and Exchange Commission case that claimed the Swiss drugmaker paid bribes to health professionals in China to increase sales from 2009 to 2013.

In particular,

The SEC detailed a number of Foreign Corrupt Practices Act violations where Novartis employees provided items of value to health-care professionals in China, under the supervision of complicit managers. It also cited examples of how the company improperly recorded as legitimate expenses payments employees made for travel and entertainment, conferences, lecture fees, marketing events, educational seminars and medical studies.

For some vivid examples,

In one example cited in the SEC order on Novartis, a sales representative at the drugmaker’s Sandoz China subsidiary submitted a $1,154 receipt to buy holiday gifts for 25 health-care professionals, which was instead used to pay for their spa and sauna sessions. A regional sales manager approved the purchase, the SEC said.

The SEC order also cited how Sandoz China sponsored 20 health-care professionals to attend a 2009 medical conference in Chicago. During the trip, the company paid for the group’s recreational activities such as a Niagara Falls excursions, $150 in 'walking around' money for their spouses, and cover charges to a strip club. The group was accompanied by a Sandoz China senior manager and other staff, according to the SEC.

So, thus far, the allegations were that Novaris bribed Chinese physicians to use their products, and the bribes includes gifts, travel money, and admission to a strip club.  It is likely that these bribes induced the physicians to unnecessarily or excssively prescribe Sandoz drugs to patients, leading to excess expenses, overtreatment, and quite likely adverse effects that should have been prevented.

As per the Wall Street Journal, and as usually happens in such cases, Novartis was allowed to settle without "admitting or denying the findigs." In the Bloomberg article, a Novartis spokesperson gave the usual vague response,

'The issues raised by the SEC, which relate to our subsidiaries in China and go back as far as 2009, largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years,' Novartis spokesman Eric Althoff said in an e-mailed statement Thursday.

The implication was that the company no longer does these bad things, but did not include a promise not to do them. And, of course, just like in many, many other health care cases, and in many, many other cases involving big, powerful, or influential organizations, no one at a top management level went to jail, or even suffered any negative consequences, even for such sleazy allegations as those in this case.  Finally, partially because the amount of this settlement was so small related to the financial bulk of the company involved, this case was relatively anechoic, only reported in the small items in the business press.

Summary

As we are distracted by bloviating billionaires and other spectacles on the US 2016 campaign trail, we continue to accumulate evidence of the corruption of large health care organizations and the impunity of their leaders.  Yet this evidence remains anechoic, even given the apparent recidivism involved.  For example, it was only in last November that we discussed what were then the latest misadventures by Novartis and its leadership.  At that time, our post included these section headings covering 2014-15:

-  Japanese Health, Labor and Welfare Ministry Found that Novartis Concealed Serious Adverse Effects
- Novartis Executive Pleads Guilty to Bribing Polish Official
- Novartis Subsidiary Sandoz Settles Allegations that it Misrepresented Pricing Data to US Medicaid
- Express Scripts Settles Allegations that it Accepted Kickbacks from Novartis
- Novartis Settles US Allegations of Kickbacks to Enhance Sales of Multiple Drugs

Furthermore, in that post we also documented Novartis' previous record.   In March, 2014, we had noted:
- Italian authorities had fined Novartis and Roche for colluding to promote the use of an expensive opthamologic treatment
- the NY Times published interviews with physicians ostensibly showing how Novartis turned them into marketers for the drug Starlix
- Japanese investigators charged Novartis with manipulating clinical research
- Indian regulators canceled a Novartis import license, charging the company with fraud.

Also,  in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look here), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look here)   Other Novartis misadventures from 2010 and earlier appear here.  So Novartis has quite an impressive, if not infamous record of ethical failures.

Yet no Novartis top manager suffered any negative consequences then (although one apparent mid-level company manager at the Polish subsidiary did plead guilty), and all these previous episodes apparently did not suggest a pattern of recidivism to US authorities this time sufficient to attempt to impose any negative consequences on higher level managers.  Meanwhile, Novartis executives continue to be paid handsomely.  The 2015 Novartis executive compensation report listed over 51 million Swiss francs paid

Also, this goes on while large health care companies continue to pay out dizzying amounts to physicians, health care professionals, hospitals and academic institutions, which partially may secure their loyalty.  Novartis, for example, which ProPublica lists as only the 28th biggest payer to physicians, paid out $31.7  million in 2013-14 just to US physicians.    The 2015 Novartis board of directors included Dr Nancy C Andrews, the Dean of the Duke Medical School and Vice-Chancellor for Academic Affairs at Duke University,  Dr Dimitri Azar, Dean of the College of Medicine at the University of Chicago, Illinois, and Dr Charles L Sawyers, a professor and department chair at Weill-Cornell Medical School.   I am unaware that anyone of them have publicly raised any concerns about Novartis' recent misadventures, although I am also unaware whether anyone has publicly asked them such questions. 

No wonder that ordinary US (and other countries' citizens) feel that they are trapped in a hopeless economic situation by rigged systems designed to benefit from the corrupt insiders.  No wonder that someone of them are seeking the protection of some of those powerful insiders.  But I digress...

In terms of health care, as we have said like a broken record (if anyone remembers what that means), or, if you prefer, where every verse is same as the first...

There seems to be increasing recognition that the continuing rise in US health care costs is unsustainable, and that these costs are not buying us good health care.  There are calls to avoid unnecessary, and sometimes harmful care.  Yet there is a persistent disconnect between how continuing dishonest behavior by health care organizations, impunity of their leaders, and lack of accountability by their board members fuel rising costs, shrinking access, and bad outcomes for patients.

To truly reform health care, we will have to at least recognize the causes of the current dysfunction.  Recognizing how health care dysfunction is created by unaccountable, dishonest leadership should lead to true reform that would promote well-informed, honest, accountable leadership that puts patients' and the public's health ahead of personal gain.

Our musical interlude ("second verse, same as the first,") Herman's Hermits, Henry VIII

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There They Go Again - the New England Medical Journal Publishes another Rant, this Time about Power Morcellation

cancer FDA logical fallacies New England Journal of Medicine Partners Healthcare

There They Go Again - the New England Medical Journal Publishes another Rant, this Time about Power Morcellation

Unknown 3/21/2016 Komentar

In 2015, we noted (here and here) that the New England Journal of Medicine seemed to have been reduced to publishing rants about "pharmascolds" who are paranoid about conflicts of interest. Now there they go again....

Background

The sad story about the risks of power morcellation for the treatment of fibroids has received considerable media attention.  The state of play through July, 2014 was described in a series of articles in the Cancer Letter of July 4, 2014. (Look here.)

Uterine fibroids are a common affliction of women.  Their preferred surgical management had changed from open surgery to minimally invasive surgery, sometimes robotically performed, and often incorporating a device called a power morcellator to pulverize the fibroids, allowing the use of small incision.  However, after a patient at the Brigham and Womens' Hospital (BWH) in Boston, part of the Partners Healthcare system, was found to have disseminated sarcoma post power morcellation, most likely because the machine spread tumor cells throughout her abdomen, the US Food and Drug Administration (FDA) issued an advisory against using the procedure morcellation, and despite some controversy, the procedure is now uncommonly used.

The patient so severely affected was Dr Amy Reed, an anesthesiologist at the BWH.  Her husband, a cardiothoracic surgeon at BWH, launched a campaign to reduce the use of power morcellation.  His pursuit of this campaign underlined an important part of the history, 

The use of power morcellation was effectively allowed by the FDA in the absence of any controlled trials meant to assess its safety or efficacy in this context.  The device was deemed moderate risk and approved through the 510(k) process because it appeared similar to previously allowed devices, even though older devices were not used to remove fibroids.  The Cancer Letter quoted Dr David Challoner, who was on a relevant Institute of Medicine (IOM) committee, saying allowing the device on the market was 

one more example of the clearance of a device for a use, not approval, based on predicates already in the market, that is, prior morcellators for other uses

The New England Journal of Medicine Weighs In - with a Special Pleading

Once again, NEJM national correspondent Dr Lisa Rosenbaum had a contrarian view(1).  As we discussed here and here, last year Dr Rosenbaum wrote three commentaries suggesting the importance of conflicts of interest in health care had been overblown, especially with respect to medical journals.

This time, she argued that the FDA overreacted to the tragic case of  Dr Amy Reed. In particular, she was afraid that the risks of power morcellation were exaggerated, and based on poor quality data,

Several experts argued that these risk estimates were too high and that it was riskier to expose 100,000 or so women per year to open procedures rather than laparoscopic ones. Since the rarity of LMS precludes a randomized trial, however, risk estimates had to be based primarily on retrospective case series of varying rigor. Some studies were poorly stratified for risk factors such as age, and others spanned decades during which diagnostic criteria for LMS had changed.

Dr Rosenbaum failed to mention that the lack of good data about the risks of power morcellation stemmed from the lack of any large, well designed randomized controlled trials done to assess its benefits and harms. Of course, since the device's use was allowed by the FDA 510(k) process without any requirement for trial data, there was no incentive for device companies, at least, to do such trials.

Nonetheless, Dr Rosenbaum also argued the benefits of power morcellation were downplayed. 

the benefits of morcellation are largely invisible and thus 'unavailable.' Who sees the women who undergo a minimally invasive procedure, recover quickly, and avoid losing income? What does a pulmonary embolus, a wound infection, or a hemorrhage that didn’t happen look like? You can’t post pictures of these nonevents on social media. But their nonoccurrence is why we ought to be celebrating.

A March 18, 2016 article asked my opinion about Dr Rosenbaum's use of the clinical evidence.

'She talks about the data concerning the possible harms of power morcellation and argues that that data comes from relatively low-quality studies, not randomized, controlled trials, and that it is hard to tell the actual rate of harms, in particular, the dissemination of cancer. On the other hand, Dr. Rosenbaum implies that the benefits of power morcellation are well known.'

'She writes initially that power morcellation allows the treatment of fibroids to be ‘done more efficiently and effectively,’ she later implies that power morcellation is less invasive, leads to quicker recovery, avoids income loss, and furthermore, reduces the likelihood of pulmonary embolus, wound infection, or hemorrhage.'

'However, she doesn’t provide any data about these ostensible benefits. A quick search suggested that there are no good randomized, controlled trials that assessed benefits. Her argument that we have abandoned a beneficial treatment based on poor quality and perhaps exaggerated the data about its harms—that does not seem to be supported by any clear data about its benefits.'

I rendered that opinion on March 18 before I read a Cochrane Collaboration review of minimally invasive surgery versus open surgery for fibroids(2).  However, that review does not seem to contradict my statements above.  The review included some patients who were treated using power morcellation, but apparently did not find any studies that assessed patients treated only with power morcellation with those treated only with an alternative.  Even so, it only included nine studies that enrolled a total of 808 patients.  Thus, I think it is reasonable to say that there have not been any large, well-done randomized controlled trials of power morcellation versus other treatments of fibroids.  Even so, while the review found some advantages for minimally invasive surgery versus open surgery in terms of short-term post-operative pain and length of hospital stay, it did not address pulmonary embolus, wound infection, or hemorrhage directly.  So while Dr Rosenbaum was right to say that the evidence from clinical research about the magnitude and nature of harms of power morcellation was relatively weak, the evidence about its benefits is also weak. Thus, Dr Rosenbaum's argument that the harms have been exaggerated while the benefits were overlooked was based on a logical fallacy, special pleading. 

This special pleading seemed the basis for her claim that

women may suffer more from its [power morcellation's] disuse.

So, as I was quoted by the Cancer Letter,

'The NEJM is perhaps the most prestigious, most highly regarded English-language medical journal in the world,' Poses said. 'It is, in many cases, viewed as the standard for scholarly medical journals. I am a bit surprised that it published a commentary by its own national correspondent that appears to make an argument—about benefits and harms of treatment and policymaking about treatment—that does not have a clear discussion of the data that support or fail to support either the benefits or the harms of the treatment.'

More Arguments, Less Justification

Dr Rosenbaum insisted that her concerns were about the question,

How do you use data to clarify tough trade-offs when the most compelling narratives paint evidence-based reasoning itself as an anathema?

However, she did not demonstrate an approach to policy making on power morcellation that was more evidence-based than what has transpired so far.

In addition, Dr Rosenbaum decried challenges to health care innovation from "the power of tragic stories," and the title of her commentary ("N-of-1 policymaking") suggested that the the FDA approach to power morcellation was based on a single tragic story.  Yet an FDA spokesperson insisted in the March 18, 2016 Cancer Letter article,

The FDA evaluated the available data at the time and determined that it was of sufficient quality and reliability to support our November 14, 2014 decision.

Furthermore, Dr Rosenbaum expressed concerns that power morcellation met its "demise" because of unwarranted concerns about the "greedy corporation," "medicine's corruption," and "industry greed."   Yet she ignored arguments that these concerns were not unreasonable.    

First, the commentary ignored claims that power morcellation procedures were very lucrative, e.g., those in the 2014 Cancer Letter article

'This is a very lucrative procedure.'  [Dr] Noorchashm, [Dr Reed's husband] said.  'The procedure itself bills $30,000 to $50,000, depending on the center.'

Nor did she argue against the assertion in the same article that device companies used political influence to promote their very expensive product,

There is a very strong pressure from the device industry to get into the market quickly.

The device companies have been able to make [the 510(k) process that allowed power morcellation] survive politically over the ensuing 40 years.

Also, Dr Rosenbaum's NEJM commentary failed to counter the assertion by Dr Noorchashm that the device manufacturers concealed the risks of power morcellation.

Device manufacturers clearly knew of the cancer risk.  You can see warnings about malignant tumors in the Ethicon and Karl Storz user manuals.  Clearly, their lawyers had warned them to put them there to avoid liability.  The bottom line is that these manufacturers knew of this hazard, but neither reported it back to the FDA, as would have been the safe and responsible thing to do.(3) 

Finally, according to the March 18, 2016 Cancer Letter article, while Dr Reed has apparently sued the BWH, and Dr Rosenbaum admitted she is on "faculty" at the BWH, neither she, the NEJM, nor the BWH will say whether she is currently being paid by the BWH.  Particularly,

the hospital declined to provide information on Rosenbaum's title and whether she is a full-time faculty member, citing personnel policies.

My response (in the Cancer Letter article) was

'I can see that the hospital would not want to reveal her salary, if in fact she has one, and that has privacy implications,' Poses said. 'But I don’t understand why the hospital would not be able to simply tell you whether or not she is employed there and in what capacity.'

Thus, the latest commentary in the New England Journal of Medicine by National Correspondent Dr Lisa Rosenbaum used special pleading to argue for an expensive medical device with dubious benefits but which no more dubious evidence suggests may cause cancer.  The commentary also decried the device's critics as unreasonably concerned about "greed" and "corruption," even though the device is clearly expensive, there are at least creditable allegations that the device makers used political influence to promote it and concealed its risks, and ironically the commentary itself obfuscated whether Dr Rosenbaum has a major financial relationship to the hospital that is being sued in connection with use of that device there.

Thus, this latest New England Journal of Medicinearticle, like those by the same author in the same journal which we have discussed before (here and here), seems more like a rant in a political blog than a scholarly article in the US' and perhaps the world's most prestigious scholarly medical journal.  What is going on at the NEJM? What has happened to its editorial standards?  Why should it continue to inspire such trust?    

ADDENDUM (22 March, 2016) - See also comments in the 1BoringOldMan blog. 


References

1.  Rosenbaum L.  N-of-1 policymaking - tragedy, trade-offs, and the demise of morcellation.  N Engl J Med 2016; 374: 986-990.  Link here.
2.  Chittawar PB, Franik S, Pouwer AW et al.  Minimally invasive surgical techniques versus open myomectomy for uterine fibroids. Cochrane Library 2014. Link here.
3.  Dyer O. US surgeon who campaigned against potentially dangerous device receives legal threat.  Brit Med J 2014; 349: g5577.  

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Criminal matter for the Attorney General of NY? Hail the gods of medical computing, and the need for human sacrifice. NYC’s $764M medical records system will lead to ‘patient death’: insiders

Dr. Charles Perry Elmhurst Hospital Center EPIC healthcare IT risk Michael Gartland Mismanagement NY Post NYC Health and Hospitals politics Ramanathan Raju

Criminal matter for the Attorney General of NY? Hail the gods of medical computing, and the need for human sacrifice. NYC’s $764M medical records system will lead to ‘patient death’: insiders

Unknown 3/17/2016 Komentar

I believe the suffering and death of my mother in 2010-2011 due to EHR flaws - including but not limited to lack of essential confirmation dialogs on medication deletion at triage, lack of notification messages informing down-line staff of such action by unqualified personnel (inadequate support of teamwork), and other issues - lends me some moral standing to comment on the following as a horrifying and potentially criminal matter.  (See http://khn.org/news/scot-silverstein-health-information-technology/).


Two back-to-back articles appeared in the New York Post:

NYC’s $764M medical records system will lead to ‘patient death’: insiders
By Michael Gartland
March 15, 2016
http://nypost.com/2016/03/15/nycs-764m-medical-records-system-will-lead-to-patient-death-insiders/

and

Hospital exec [CMIO] quits, compares $764M upgrade to Challenger disaster
By Michael Gartland
March 16, 2016
http://nypost.com/2016/03/16/hospital-exec-quits-compares-764m-upgrade-to-challenger-disaster/ 

It is well-known and indisputable that this technology can and does injure and kill, especially when poorly designed, defective, poorly implemented, or all of the above.  See for instance the ECRI EHR risk Deep Dive study results at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

Any official in leadership of health IT who denies this - or sidesteps it - or makes excuses for compromises on health IT safety, especially in view of dire warnings from clinician experts - in 2016 is guilty of conduct of the type below:

http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.

Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.

The two articles reflect a good possibility that the politics of what I'd once termed "cybernetics über alles" has trumped patient safety concerns in NYC.

Here's details from the first article:

A new $764 million medical records system is launching at the municipal hospital system on April 2 — even though insiders warn it isn’t ready and patients will suffer.

The soft launch of the electronic system Epic is scheduled at Elmhurst and Queens hospitals.

“Sooner or later, it will crash,” said one source involved in the project. “There will be patient harm — patient harm and patient death.”

That sounds like insiders warning of far more problems than mere crashes causing patient harm and death, a brave act considering possible retaliation.

I wonder if the users of this EPIC system are having imposed on them the speech and though controls imposed on users at University of Arizona (see my Oct. 3, 2013 post "Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As 'Advised' At The University Of Arizona Health Network" at http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html).

Sources say Dr. Ramanathan Raju, who runs the municipal network, NYC Health + Hospitals, is under the gun from City Hall to meet the deadline and fears he’ll be fired if he doesn’t.

“Raju has said too many times to count that the Mayor’s Office has told him if April 1st doesn’t happen, then Ram will lose his job,” one source said.

The source added that Raju has threatened to fire top executives if the project doesn’t launch on time.

If this is true, than the "gun" from City Hall is aimed straight at patients, and if patients indeed are mortally affected, the responsible officials might be deemed accessories to murder.

I add that this type of situation represents fundamental and severe mismanagement, as I'd been writing about since the late 1990's at my academic site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/.

The hospital system is already on City Hall’s watch list, having required a $337 million bailout in January to stay afloat. 

Money for EHR's grows on trees.

Note other hospitals where EHR implementations led to financial disaster (e.g., http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html, http://hcrenewal.blogspot.com/2013/05/clouded-visionary-leadership-wake.html, http://hcrenewal.blogspot.com/2013/06/want-to-help-hospital-go-bankrupt-get.html, http://hcrenewal.blogspot.com/2014/06/100-million-epic-install-dampens.html as examples).

Insiders contend that the only safe way to roll out Epic is to take more time — about three months — to address several key issues.

One is planning for a crash, which some consider almost inevitable because the new setup hasn’t been configured to work with systems at other hospitals or with some of its own internal billing and tracking software.

Existing patient data also has to be transferred from the old system — a process that would normally take six months, but which was shoehorned into less than one.

Going "live" with a half-baked EHR under such circumstances for political reasons, if these facts are true, would be, in my professional opinion, an act worthy of prison time if harm results.

“There are supposed to be all these dry runs,” a source said. “They haven’t been done.”

Again, if true, this reflects expediency at the expense of patient well-being, by rows of political hacks, fools and incompetents calling the shots in an area in which they have no business being involved.

City officials contend Epic remains “on-time and within budget.”

I have a feeling this will be revisited at some time in the future - in court.

A mayoral spokeswoman said there would be a round-the-clock effort to ensure there are no glitches. 

"No glitches?" 

That is a hollow promise that cannot be kept even under the best of circumstances.  Under the hellish circumstances described, such a statement is outright frightening. The Mayor truly has no clue about EHR "glitches", but I offer the many posts at query link http://hcrenewal.blogspot.com/search/label/glitch for his education.

Mr. Mayor, here's an example of EPIC and other EHR implementations under the best of circumstances.  These systems are so immensely complex, trying to be pressure-fit into a vastly complex, varying and changing environment, that to not heed CMIO and other expert warnings is the height of recklessness:

• Nov. 2013:  "We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System, at http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html

•  June 2014:  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

• Oct. 2010:  "Medical center has more than 6000 'issues' with Cerner CPOE system in four months - has patient harm resulted?", http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html)

Of course, we are reassured that the crack team assigned the implementation duties will produce stellar results:

“NYC Health + Hospitals and its Epic implementation experts are prepared to implement the new system in Queens facilities beginning April 2, and have assembled a team of about 900 technicians and Epic experts who will work around-the-clock that week both in Queens and at remote data centers to ensure the transition to the new system goes as smoothly as possible,” said spokeswoman Ishanee Parikh.

EPIC experts like these?  From this link at the "Histalk" site on staffing of health IT projects, Aug. 16, 2010. Emphases mine:

Epic Staffing Guide 

A reader sent over a copy of the staffing guide that Epic provides to its customers. I thought it was interesting, first and foremost in that Epic is so specific in its implementation plan that it sends customers an 18-page document on how staff their part of the project. 

Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say. 

The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores. 

I bet many readers were taught by their HR departments to do behavioral interviewing, i.e. “Tell me about a time when you …” Epic says that’s crap, suggesting instead that candidates be given scenarios and asked how they would respond. They also say that interviews are not predictive of work quality since some people just interview well. 

Don’t just hire the agreeable candidate, the guide says, since it may take someone annoying to push a project along or to ask the hard but important questions that all the suck-ups will avoid. 

Epic likes giving candidates tests, particularly those of the logic variety.

The part about "not worrying about relevant experience" and about "hiring recent college graduates as HIT project analysts" is bizarre if true, and downright frightening.

Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be. These practices as described, in my view, represent faulty and dangerous advice on first principles.  The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

The second NY Post article cited above is even more dire:

A senior official was so worried a new $764 million medical records system for the municipal hospital system was launching too early that he resigned, comparing it to the disastrous space shuttle Challenger launch in 1986.

In a “resignation and thank-you” email last week, Dr. Charles Perry urged colleagues at NYC Health + Hospitals — formerly the Health and Hospitals Corp. — to sound the alarm and press for an “external review” to stop the system from going live next month.

Perry was chief medical information officer of Queens and Elmhurst Hospital Centers, the first scheduled to get the new electronic medical data system.

When a CMIO - a role I held in the mid 1990s -  resigns under such circumstances, a project should be halted in its tracks and external examination begun.  Instead, it appears we have spin control.

In his email, Perry offered a comparison to the launch of the Challenger — aboard which seven crew members died when it exploded 73 seconds after liftoff on Jan. 28, 1986 — and cited a presidential panel’s report examining how the disaster occurred.

That is as dire and direct a warning as they come.  Unqualified individuals who second guess such a warning should be held legally accountable for adverse outcomes.

(Such a warning letter about EHRs now sits as "Exhibit A" in the lawsuit complaint regarding my dead mother.  It had not been heeded.)

“For a successful technology, ­reality must take precedence over public relations, for nature cannot be fooled,” Perry wrote in his ­email, quoting from the report.

But fools in leadership roles in health IT think they can fool Mother Nature.

Perry went on to urge a short delay despite “vehement entreaties to make the April 1st date by officials and consultants with jobs and paydays on the line.”

This is exactly how patients end up maimed and dead.

Agency president Dr. Ramanathan Raju has repeatedly told colleagues his job is on the line if the deadline isn’t met, sources said.

Perry, a medical doctor with an MBA, declined to comment.

Maybe Raju should quit, too.  He should know that Discovery over such matters would not be very pleasant, especially if I am assisting attorneys in such matters - which could very well occur.

“He [Perry] took a stand,” said one insider. “He wasn’t going to take part in something that was going to compromise patient safety.”

It's good to know someone in Medical Informatics still has balls.

The idea that we’d jeopardize patients to meet a deadline is simply wrong,” said Karen Hinton, Mayor Bill de Blasio’s spokeswoman.

“If a patient safety issue is identified, the project will stop until it is addressed.

“NYC Health + Hospitals and its Epic implementation experts have assembled a team of about 900 technicians and Epic experts who will work around the clock through the week surrounding the transition in both Queens and at remote data centers to ensure we shift to the new system as smoothly as possible.”

It's been said that one expert who truly know what they're doing will always outperform 1,000 (or 900) generalists following the finest of "process" who are in over their heads (to wit, 900 generic musicians could never exceed the work of Beethoven or Brahms).

In this matter, I take the CMIO's word over the 900 techies and "experts", once having voiced such concerns myself.

-- SS

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

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"How Employed Physicians' Contracts May Threaten Their Patients and Professionalism" Authored by Health Care Renewal Bloggers Published in Annals of Internal Medicine

Annals of Internal Medicine contracts corporate physician generic managers hospital systems hospitals

"How Employed Physicians' Contracts May Threaten Their Patients and Professionalism" Authored by Health Care Renewal Bloggers Published in Annals of Internal Medicine

Unknown 3/10/2016 Komentar

We have noted that increasing numbers of physicians provide patient care as employees of large organizations, often hospital systems, sometimes for-profit.  Since in these settings physicians must answer to generic management which may be more concerned with short-term revenues than patient care, these new arrangements are frought with hazards for physicians and patients.

One set of hazards may be found in the contracts employed physicians must sign.  

My fellow blogger, Dr Wally Smith, and I authored an article just published online "How Employed Physicians' Contracts May Threaten Their Patients and Professionalism." Here is the link.

In it we listed multiple contractual provisions that may be found in employed physicians contracts  that may threaten professionalism and good patient care:

 Confidentiality clauses - which may hide quality and safety problems, medical errors, unethical conduct, other problematic contract clauses, and malfeasance
Productivity clauses - which may provide incentives for actions that primarily increase employers' revenues, and thus may encourage overtreatment
"Leakage control" clauses - which may discourage referrals outside of the employers' systems and thus discourage appropriate referrals for particular patients, potentially threatening quality
Clauses that allow termination without cause - which may reduce access for the terminated physicians' patients, and may discourage complaints by physicians about quality, safety, unethical behavior, or malfeasance
Noncompete clauses - which may reduce access and physicians' ability to leave unsatisfactory positions
Clauses that restrict outside activites - which may restrict teaching or research, or academic freedom or free speech

We also noted clauses in contracts that employers may sign with third parties that may also threaten professionalism and good patient care:

"Gag" clauses affecting employees - which may hide quality and safety problems, medical errors, unethical conduct and malfeasance
"Anti-poaching" clauses - which may reduce patients' access to care, and physicians' ability to leave unsatisfactory positions.

We were able to find cases illustrating all the clauses published in the news media, or publications such as Medscape or Medical Economics.  However, they have largely anechoic in the scholarly medical and health services literature, and largely unaddressed by the medical societies that ostensbibly protect physicians' professionalism and patients' and the public's health.   

We suggested that such contractual problems may be becoming more frequent in a health care system in which physicians more often are corporate. We suggested that all physicians confronted with new employment contracts should seek competent legal connsel and try to negotiate egregious provisions.  However, such actions may now be futile given the increasing market dominance of the hospital systems that are employing increasing numbers of physicians.

We urged medical societies to inform physicians about such employment issues, and better support physicians who struggle with them.  However, these contract problems may merely be a reflection of an increasingly commercialized, deregulated health care system run by generic managers who may put revenue generation ahead of supporting physicians' professionalism.  So, better enforcement of existing laws, and new laws including bans on the commercial practice of medicine may be the only solutions to this newly recognized plight of corporate physicians and their patients.   

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Trumped Up "Nutritional" Products - A Cautionary Tale of Immediate Relevance

complementary/ alternative medicine deception Donald Trump marketing

Trumped Up "Nutritional" Products - A Cautionary Tale of Immediate Relevance

Unknown 3/04/2016 Komentar

On Health Care Renewal, we frequently discuss deceptive marketing schemes designed to sell tests and treatments whose benefits for patients do not clearly outweigh their harms, and sometimes which are useless or dangerous.  In fact, we have to be selective about discussing such cases, because they are all too common.  Therefore, we tend to focus on cases involving the biggest and most powerful health care organizations, and/or the worst risks to patients.

We have generally not discussed the myriad promotions of dubious "nutritional" tests and therapies, because there are just so many of them, the players involved are generally small, and these products were effectively deregulated in the US by the 1994 Dietary Supplement Health and Education Act.  However, last year we discussed how the marketing of a "nutritional supplement" containing an amphetamine like substance was seemingly facilitated by the revolving door at the US Food and Drug Administration (FDA).

The Trump Network -Background

But a story recently republished by Stat is now suddenly relevant because one of the players involved is now so influential.  It recounted the rise and fall of The Trump Network, a network marketing scheme to sell nutritional products.

Actually, the most colorful version of the background of this story comes from a 2011 article in New York Magazine.  Here is how the network marketing worked, using an example centered around a Trump Network marketer-to-be named Izzo:

He would order the vitamins from a company called Ideal Health. She would earn a commission on the sale and he, in turn, would become a part of her team and encourage other people to buy the vitamins. For those sales, Izzo would earn a commission, as would she (his 'upline'), and then the people he sold the vitamins to would become part of his sales team and would go on to create their own sales teams, who would go on to create their own sales teams, etc., ad infinitum, all of them funneling commissions from their sales up to Izzo and the woman on the phone. As he listened, 'something clicked,' Izzo says. 'I saw the beauty of the business model. And I said, ‘How can I do this, and do this big?’ '

The idea was so big it was picked up by no other than "The Donald" Trump.

'The name is hot!” Donald Trump booms over the speakerphone from his office at 725 Fifth Avenue, where, ever since The Apprentice breathed new life into his brand, he has presided over an ever-diversifying array of businesses. He is, of course, speaking of his own name. “It’s on fire!”

In March 2009, Trump purchased Ideal Health, rebranding it the Trump Network. Though the packaging has now been imprinted with the Trump family crest, the product line is still much the same. There are the two multivitamins: Prime Essentials and the more expensive Custom Essentials, the ingredients of which are determined by the Trump Network–branded PrivaTest, a urine test that claims to determine which vitamins the user needs. There’s also a line of healthy snacks for kids called Snazzle Snaxxs, QuikStik energy drinks, and a Silhouette Solutions diet program. With the Trump investment, the company has added a skin-care line that goes by the seductively foreign name BioCé Cosmeceuticals.

Back then, Mr Trump thought the sky would be the limit.

Next year, the Trump Network plans to add more products and extend its reach to Europe and Asia. The goal, Trump says, is to eventually become bigger than Amway, now an $8.4 billion company and the giant in the field. Whether or not the people of Laos will spring for a skin-care line from a man famous for his perma-tan, some Long Islanders seem convinced.

“People have said, ‘This is Donald Trump’s network-marketing company? I want in,’ ” says Alex, Izzo’s pretty 29-year-old daughter, who quit her job and moved back in with her parents last year in order to become a marketer, as the people in the network call themselves. “I was talking to a woman the other day and she said, ‘If I can’t trust Donald Trump, who can I trust?’ And I said, ‘You’re totally right.’ ”

As Stat noted, Trump helped market the network with great enthusiasm back then.


Donald Trump was ready to make some money on vitamins.

On a Friday night in November 2009, Trump stood before a crowd of thousands at the Hyatt Regency in Miami to launch a new enterprise, The Trump Network. Behind him was a gigantic image of his family crest and an enormous photograph of himself.

'We’re gonna come out with new and different products,' Trump told the crowd. 'They’re gonna be wonderful products.'

Marketing videos that include Mr Trump are still readily available online,



In the video, Mr Trump said"Americans need a new plan. They need a new dream. The Trump Network means to give millions of people a new hope."

The Problems with the Trump Network

Well, how did that work out?

The Stat article described the Network's big product:

The Trump Network asserted that it could use a urine test to recommend customized nutritional supplements, its signature products. It also offered products that purportedly tested for allergies and bone health.

In particular,

The Trump Network sold many health and wellness products, and its main one was a customized nutritional supplement whose composition was determined by a urine test, called the PrivaTest.

A former marketer provided STAT with a kit for Ideal Health’s PrivaTest. It contained a urine collection cup, five test tubes, a cold pack, a biohazard bag, a prepaid FedEx mailing label, and detailed instructions. Customers collected their urine and shipped it to a lab for analysis. That lab analyzed the urine with three tests and produced a report, which was sent to The Trump Network.

The Trump Network bundled the report with a package of pills and shipped it all back to the customer. The pills were marketed as 'Custom Essentials,' formulations based on the results of the test and manufactured by another lab. In all, there were 48 formulations.

According to an archived version of The Trump Network’s website that can still be found online, the PrivaTest, along with a month’s worth of the Custom Essentials, cost $139.95. Retesting was available for $99.95, plus shipping and handling. The company recommended retesting every nine to 12 months.

Other products purportedly tested for food allergies, stress, and digestive health. One claimed to measure 'the balance between your ‘good’ estrogen and your ‘bad’ estrogen.'

The problem is that there is no evidence that these products, particularly PrivaTest, worked in any sense. First, there appeared to be no publicly available data on how the tests worked, what they actually tested, or how accurate they were.  Then there was no data about how the test results could rationally be used to suggest particular mixes of vitamin supplements.  Also, there was apparently no public data about what vitamins were in the potions sent to consumers, their purity, their strength, etc.

Worse, there was no evidence that any of this provided any benefits to the people who ended up taking the vitamins.

To support the necessity of supplements, The Trump Network’s website cited a 2002 article from the Journal of the American Medical Association. The article, it said, 'stated that every adult needs to supplement their nutrition to remain healthy.'

But the article also specifically cautioned against the types of products that The Trump Network sold.  'The Internet and health food stores are filled with promotions for these special-purpose multivitamins, which are often costly,” the article said. “The only evidence-based arguments for taking more than a common multivitamin once a day pertain to the elderly and women who might become pregnant.'

The JAMA article warned against tests that claimed they can help consumers determine which vitamins they should take.

Worse,

While the FDA may not have evaluated the tests or supplements, independent scientists have — and raised many questions.

Cohen, one of several scientists who reviewed materials from Ideal Health and The Trump Network, said that the tests were marketed too broadly and seemed to be 'pathologizing normal human life.'

The website, for example, recommended its “AllerTest” to anyone who had dark circles under their eyes, occasional digestive problems, fluctuating blood sugar, sinus and respiratory problems, or tiredness after eating.

'Does your blood sugar fluctuate?' Cohen said, laughing. 'If your blood sugar does not fluctuate, you are extremely ill. You will not be long on this planet.'

What’s more, the AllerTest did not measure food allergies, as the network’s website claimed it would, according to outside analysis of materials from the testing lab and Ideal Health publications.

The test measured information about an antibody known as immunoglobulin G, or IgG, according to company publications. The antibody is normally produced in the body and not indicative of a food allergy, said Dr. Robert Wood, director of pediatric allergy and immunology at Johns Hopkins School of Medicine.

'There’s no disease condition for which the IgG antibodies have any relevance at all,' Wood said.

So while Mr Trump, his company, and some of his marketers might have made money from the Trump Network, there is no evidence that its products actually provided any health benefits.

Also, in the long run, Mr Trump's grandiose claims about how the riches his new marketers would receive also proved wanting.  Despite Trump's initial enthusiasm, the Trump Network hardly went global,

Regardless of the science, Trump’s name did wonders for Ideal Health in the short term. Former marketers said the company grew significantly in the months following the name change.

Then, the network began experiencing financial difficulties.

'The Trump Network had gotten in trouble financially,' said Bonnie Futrell, a former marketer and 'diamond director' — one of the top-tier marketers in the company. 'They weren’t being able to pay [the lab]. They weren’t paying vendors. They weren’t paying us.'

Futrell said she was involved in discussions with company higher-ups about how to salvage the organization.

On Dec. 31, 2011, the license agreement expired, said Garten, the general counsel for The Trump Organization. It was not renewed.

Note that this story was also summarized in an AP article available via CBS.   The Network's products were also reviewed, not favorably, on QuackWatch.

Summary

The Trump Network sold nutritional testing and products any clear evidence that they provided any benefits to patients, or that they worked at all in any sense.  Some of the products, like the allergy test discussed above, did not appear to be what they were advertised to be.  Since the Network's products and the outcomes of people using them apparently never were the subject of any clinical research, whether the products did any harm is unknown.  Thus, the Network was like many other dodgy efforts to sell totally unproven "nutritional" products.  Its main results seem to have been transferring money from the pockets of the gullible to the marketers, and to Mr Trump himself.  While Mr Trump recruited marketers with boastful assertions of giving people "new hope," that hope was false.

The increasing commercialization of health care, enabled by deregulation justified by market fundamentalism,  now means that health care has become increasingly a means of transferring money from the little people to big corporations, in this example, those corporations owned by Mr Trump, without providing any net health benefit to those whose pockets have been invaded.  This is bad enough.

But at the moment, Mr Trump is considered the front runner for the Republican presidential nomination, although he is attracting more enmity, much of it from the Republican party. It is ironic that Mr Trump seems to be winning support from a lot of "little people" whom he has promised to defend.  Yet it was the little people who marketed the Trump Network and bought its products who were eventually left hanging. 

The Stat article mentioned that some minor candidates for the Republican nomination this year were also tarred with stories about their involvement in questionable health marketing schemes.  And previous major party candidates have certainly had some health care conflicts of interest.  In fact, we discussed that the current First Lady once was a top executive of a big hospital chain, and the last Republican presidential candidate was a leader of a private equity firm that owned numerous health companies.   It may be unprecedented, at least in recent history, for someone who had been directly involved in the shady marketing of dubious health remedies to be a genuine contender for the US presidency.

There are many bigger issues in the current election than health care.  But now we are faced with Mr Trump, who once hawked unsubstantiated health benefits of dodgy nutritional products, and recruited marketers for these products with false promises of wealth to come.  And Mr Trump has some real possibility of  becoming the President of the US, to whom the Department of Health and Human Services, and the Department of Veterans Affairs report.  What damage could such a leader do to health care?  And what other damage could a man who so cavalierly fleeced the little people with his dubious nutritional product marketing scheme  do, especially to the little people who now so unconditionally support him?

Is there a better example showing why we as a society need to completely rethink who gets to become our leaders?  My only hope is we can do that rethinking in time to prevent a disaster. 

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