Wednesday, April 30, 2014

The Pervasiveness of Health Care Corruption as Shown by Another Roundup of Legal Settlements

Legal settlements are one way to document unethical and even corrupt behavior by large health care organizations, even if they may not deter bad behavior in the future.  It is time for another roundup of settlements by large pharmaceutical and device companies, presented in alphabetical order

Abbott Laboratories

This one goes back to late December, 2013.  As described in the Chattanoogan (from Tennessee):

Abbott Laboratories, a global healthcare company, has agreed to pay $5.475 million to settle alleged violations of the False Claims Act, and other federal laws and regulations in connection with the operation of its medical device business which manufactures, markets and supplies carotid, biliary, and peripheral vascular products.

The US Justice Department accused Abbott of kickbacks to physicians,

 As alleged in the settlement agreement, between 2005 and 2010, through its employees and a third party continuing medical education providers, Abbott offered physicians paid teaching and training assignments, consulting arrangements, speaking engagements, and/or sponsorship grants for physician conferences, for the purpose of inducing physicians to arrange for or recommend that the hospitals with which they were affiliated purchase or order Abbott’s carotid, biliary and peripheral vascular products.

Note in particular that the kickbacks were disguised as payments for consulting or speaking. 

As is usual in such cases, no individual seems to have paid any penalty or been subject to any punishment.  Because this was a legal settlement, the company did not admit wrongdoing.

Abbott's previous issues are discussed here, including a $1.6 billion settlement in 2012

Baxter International

This was reported in April, 2014 by Modern Healthcare,

 Baxter International agreed to pay $64 million to settle a class-action lawsuit that alleged the Deerfield, Ill.-based company and some of its competitors colluded to raise prices of plasma-based therapies.

Unlike the other cases above and below, this seemed to be a purely financial misadventure, although one that clearly increased health care costs,

Hospitals and drug distributors, saying they bought the plasma products at inflated prices, sued in 2009 Baxter; Victoria, Australia-based CSL; and the Plasma Protein Therapeutics Association, an Annapolis, Md.-based trade group.

Once more, the company admitted no wrongdoing, and no individuals seemed to be subject to any negative consequences.  

Baxter International's previous misadventures are here, including the striking case of its marketing of contaminated and sometimes deadly heparin made from Chinese pigs. 

Endo Health Solutions

This one is from February, 2014, as reported by Bloomberg

Endo Health Solutions entered a deferred-prosecution agreement and will pay $193 million to settle whistle-blower claims that it marketed the shingles drug Lidoderm for unapproved purposes, the U.S. said.
Endo will pay $20.8 million in forfeitures and $171.9 million in civil false claims settlements with the states and the U.S. government, the Justice Department said today in a statement. 

This one was all about marketing for uses not approved by the US Food an Drug Administration,

Between 2002 and 2006, Endo sales managers instructed some representatives on how to expand 'sales conversations' with doctors beyond the treatment of shingles-related pain, the U.S. said. Under the deferred-prosecution agreement, Endo admitted that it intended Lidoderm to be used for uses not approved by the U.S. Food and Drug Administration, the Justice Department said. 

Note that this case involves false claims, that is, fraud, because it is illegal to bill government programs for unapproved uses.

Again, no individual suffered any consequences, and the company offered the usual kind of statement that admitted neither responsibility nor guilt,

'We are pleased to resolve this matter and are confident that we have robust programs in place to assist us in satisfying our legal and regulatory agreements,' Endo Chief Executive Officer Rajiv De Silva said in a statement.  

One wonders, as usual, why a company would pay so much merely to avoid the legal expenses of a trial, unless of course the lawyers suspected the trail would not go well?

Hospira

This one was about hiding quality problems due to cost-cutting from investors, as reported by Reuters in March, 2014.  

Hospira Inc has agreed to pay $60 million to resolve a class action lawsuit accusing the drug maker of misleading investors about quality control problems that undermined an initiative to improve the company's margins and operations.

The details included,

As Hospira was promising to address issues raised by the U.S. Food and Drug Administration following inspections, the plaintiffs said the company was 'making the problems worse by gutting quality control efforts through cost cutting aimed at boosting short-term profitability.'

The lawsuit said those cost-cutting moves stemmed from a March 2009 initiative called 'Project Fuel' intended to increase shareholder value by eliminating underperforming and duplicative units and reducing its global workforce.

Plaintiffs contended the cuts in the budget and workforce hurt Hospira's quality control efforts, particularly at Rocky Mount, the company's largest facility.

An FDA inspection in January 2010 of the Rocky Mount facility found a number of problems with the company's quality control and drug validation processes, the lawsuit said, and the agency issued a warning letter that April.


Note that this involved quality control problems presumably in drug or device production, possibly leading to safety risks for patients.  Yet it was investors who brought the lawsuit.

Note also that this seemed to be a clear case in which cost-cutting measures meant to improve short-term corporate revenue lead to problems that could have caused such risks.  

One interesting feature of this case was that company executives were named as defendant (presumably again because it was investors, not patients or law-enforcement officials who initiated the suit.)


The lawsuit ... also named executives including Chief Executive Officer Michael Ball as defendants,...


I cannot find any information about whether these executives were personally liable for any payments, however.   

Pfizer

This is yet another settlement involving the marketing of Neurontin, as reported by Bloomberg in April, 2014,


Pfizer Inc the world’s biggest drugmaker, agreed to pay $190 million to end a lawsuit claiming it violated federal antitrust laws by delaying generic versions of its Neurontin epilepsy drug. 
Pfizer agreed to settle the class-action litigation pending in federal court in Newark, New Jersey, according to a filing today. U.S. District Judge Faith Hochberg must approve the accord, which would cover purchasers of Neurontin from December 2002 to August 2008. 

Note that this settlement, like many others, is of matter from a long time ago.  When it comes to bad behavior by big health care corporations, any form of justice is not swift.

Note also that this is only the latest chapter in the long saga of Neurontin, for whose mis-marketing Pfizer has already shelled out a lot of money (see this post to start, and here for the collection).  Pfizer has an amazing record of bad behavior on view here.  In fact, it has had a conviction as a Racketeering Influenced Corrupt Organization (RICO) on the basis of its previous marketing of Neurontin (look here).

This particular bad behavior involved included,

 improperly listing certain patents with the U.S. Food and Drug Administration, engaging in illegal promotion and sales of Neurontin for unapproved uses, filing and maintaining sham litigations with respect to certain patents, and making misrepresentations to the patent courts,

Note that while much of this was legalistic, illegal marketing was in there too.

Once more, I found nothing about any negative consequences for individuals who authorized, directed, or implemented questionable actions.

Summary

So it is all drearily familiar.  Big health care organizations seem to repeatedly engage in deceptive marketing, providing kickbacks to health professionals, fraudulent billing, anti-competitive practices, etc, etc.  These practices increase health care costs, and may risk patients' health and safety.  Many of these practices are corrupt, at least according to the Transparency International definition of corruption, "abuse of entrusted power for private gain."  Drug and device companies, for example, are entrusted to provide safe and effective products.  Deceptive marketing, kickbacks to health professionals to encourage overuse, and cutting quality control to cut costs all seem to be examples of abuse of this entrusted power.  The private gain obviously goes to any managers and executives who score bigger bonuses due to the increases in revenue that result. 

Yet there are very few examples of any individuals who gained ever being subject to any negative consequences.  Given that lack, and the lack of any requirement for corporate leaders to admit responsibility, much less guilt, is it any surprise that these practices go on and on.  The failure of current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.   (Note that in fact, as noted above, one of the pharmaceutical companies above actually was convicted of being a RICO, racketeering influenced corrupt organization, yet that conviction seemed to have no real negative consequences for the organization or any of the people involved.)

As I have said again and again, 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.

Sunday, April 27, 2014

From a physician and former USAF air traffic controller/pilot on the state of healthcare IT

From a colleague, a physician and blogger and fellow AMIA member with an eclectic background, on the state of healthcare information technology.  Reposted with his permission.

Emphases in bold are mine:

To restate the old joke, the nice things about medical informatics standards, are their are so many of them too chose from… don’t think we necessarily need to invest even more time and energy on ever more sophisticated data models or ever more exhaustive standards (which are then largely ignored). 

The fact of the matter is that the EMR remains in the United States a tool for maximization of reimbursement and as such is not a  technological destination but rather a technological dead end. The driver for proliferation of this ‘dead end’ is the government being willing to fund its expansion with their fervent hope that it will be their magic bullet for finding the cheats and cheaters of Medicare. 

When I was in the USAF, I was trained to be a software and systems engineer at their great expense and at my great pleasure. Additionally, I was for several years prior to my medical school career a USAF Air Traffic Controller and so I was intimately familiar with perhaps the most perfect of all known systems engineering efforts the Worldwide Air Traffic Control System, and most remarkably (from the wellsprings of my fading memories) I have 50 hours of stick time in the F-16. 

The flying environment of the F-16 which is ‘eyes outside the cockpit’ was made possible by advanced human engineering efforts that resulted in Heads Up Displays of both intense rational and aesthetic beauty that made the machine a joy to fly. 

Fast forward 20 years and what am I given as a clinician to work with…. to keep my head out of the cockpit…… spreadsheets…… designed by engineers who like spreadsheets and think in spread sheets…..  and who don’t even take the 30 minutes it takes to articulate the logic of presentation of clinical data, i.e., present the serum salts together with the BUN/Creatinine, present the RDW with the RBC indices and the hematocrit and hemoglobin … present the last 3 d’s worth of data together aggregated by type rather than alphabetized and homogenized and distributed in clinically illogical boxes. 

The F-16 was designed by engineers, but pilots oversaw its development and the display of its information systems were always the results of intense end user interaction with the design teams. This type of intense physician interaction and veto power of poor information design efforts does not exist in [the health IT] industry. Their goal is feature proliferation and uniqueness (not commonality) of function as a market differentiation tool and to avoid suits for ‘look and feel’ viz a viz the Apple vs Microsoft suits of the 80’s. 

The reality is the train has left, those of us addicted to patient care watch in dismayed horror as our productivity plunges and we struggle to restructure not our workflows but our clinical thought processes to badly designed, logically flawed, and obscenely overpriced documentation tools that distract the expert clinician from a high quality clinical encounter. 

Quite honestly gentleman and gentlewomen of the jury, I don’t give a ‘rats a**’ about superior documentation, I am obsessed with superior outcomes, and as somebody who actually has to work with this junk, it all sucks………. and will continue to suck until such time as real world clinicians have veto power over the efforts of systems design teams with respect to their information design efforts…. What information design efforts?  My point precisely……. 

As always Acerbically Yours, 


frnk m (Frank Meissner)

“I am not a pessimist, I am an optimist who has not arrived’ 
                                                                      Mark Twain

My reply back was:

Frank, on a related note, I was at a fleamarket yesterday looking for radio & electronics stuff (my hobby) and came across a man selling copies of "Aviation Week" from 1960.  He had the entire year's set.

I looked through them and was STUNNED.

The engineering prowess described in not just the articles but in the advertisements as well - bearings, servos, instrumentation, etc. for aircraft and spacecraft was stunning.  There was even an ad for a desktop computer, a Packard Bell PB-250 with "microsecond add time, 350 transistors and 46 (or so) instructions" for a mere $30,000.

What you are describing - and what I have been trying to describe for over a decade and a half - is an intellectually impoverished industry that ignores our specialty [Medical Informatics] and good engineering practices in general.

That AMIA has made itself appear comfortable with that status quo has been a disappointment to say the least.  What you just wrote should have come from the leadership, and years ago, not from the grass roots.

If physicians could refuse use of clinical IT without sanction, I believe in 2014 that most would walk away.

The fact that this technology is now forced on clinicians is not what the pioneers in informatics intended, I am confident; our medical leadership, furthermore, should be ashamed of this set of affairs. As a former medical manager for the Southeastern PA Transportation Authority, even bus drivers and porters in public transit had more rights to determine what equipment they would or would not use in their work, and its configuration, than physicians have in theirs.

-- SS

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (https://www.ecri.org/About/Pages/default.aspx) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports.

Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf.

Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

From the new report:

CONCERN #1: Data integrity failures with health information technology systems

At page 7:


With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.

For example, the integrity of data in health IT systems can be compromised from any of the following: data entry errors, missing data or delayed data delivery, inappropriate use of default values, copying and pasting older information into a new report, use of both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the following:


Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff 
Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended
Providing sufficient user training and support
Establishing a mechanism for users to report problems as they are discovered


In the Bizarro world in which we find ourselves in 2014, however:

  • FDA has decided that healthcare information technology systems "for health information and data management" (I quote) are of "sufficiently low risk", even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html). 
(Got that?)

While:
The E-cigarette focus is For The Children, no doubt.


Bizarro World (http://en.wikipedia.org/wiki/Bizarro_World).


Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems.

CONCERN #2: Poor Care Coordination with Patient’s Next Level of Care (page 8):

... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? EHRs could become a barrier “if physicians are second-guessing one another,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.

CONCERN #3: Test Results Reporting Errors (page 10):

... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results typically reported to the practice.

As more healthcare organizations adopt EHR systems, Callahan warns against being lulled into thinking the systems are a panacea and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”

I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results.

-- SS

Saturday, April 26, 2014

Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" (http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html) I noted that the American Association of Physicians and Surgeons (AAPS) had received a reply from CMS to a FOIA request that:

"We [CMS] do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."

Put another way, the country is embarking on a $1 trillion healthcare experiment, and blindly.

I mentioned I'd post the letter when received from AAPS.  That just occurred.

The letter is below (click to enlarge):


CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

I've added it as an addendum to the original post, but thought it worthwhile to call out the letter in a post of its own to those who might not revisit the original.

An additional thought:

While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they do have (or should have made it their business to have) information that EHRs cause harm and take lives (e.g., via FDA at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html , ECRI at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html and others).

-- SS

Friday, April 25, 2014

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (http://cci.drexel.edu/faculty/ssilverstein/cases/) as follows:

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

Health IT is unregulated, and Bad Health IT results in patient injuries and deaths.   This is unarguable from the data cited in this post and related posts I've linked to.  The levels of harm are unknown.

At my April 9, 2014 post "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) I observed how the FDA bent over backwards to avoid regulating Electronic Medical Records systems and other healthcare IT systems:

To recap that post:

Out of one side of their mouth FDA wrote this:

... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, [even] if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.

While out of the side of their mouth that was not intended for public viewing, discovered by investigative reporter Fred Schulte, they wrote this:

...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications.
 
FDA is thus claiming "we know what we non-publicly concluded it is not possible to know, and Health IT is not worth regulating ... even in face of dangers we do know" (e.g., see the alarming ECRI Institute data at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

Note that everyone who needs medical care (which is. essentially, everyone) is increasingly exposed to these electronic products with health management heath IT functions, against their will and without any informed consent processes.  The only people exposed to E-cigarettes are those who willingly buy and consume them.

With E-cigarettes, however: 

CBS/AP  April 24, 2014 
FDA: Ban sales of electronic cigarettes to minors 

http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/

WASHINGTON -- The federal government wants to ban sales of electronic cigarettes to minors and require health warning labels and approval for new products under regulations being proposed by the Food and Drug Administration.

Wonderful.  How thoughtful.  (E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.)

While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.

The agency said the proposal sets a foundation for regulating the products but the rules don't immediately ban the wide array of flavors of e-cigarettes, curb marketing in places like TV or set product standards.

Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said.

(Perhaps the E-cigarette industry hasn't figured out who to pay off yet?)

... "By being able to regulate e-cigarettes, we'll get a lot more information about what's in them, how they're made and we're already studying e-cigarettes in terms of how they're being used and what are their implications for health," Hamburg told CBS News.

"At the present time, when we can't regulate cigarettes, it's like they wild, wild West" she said. "Companies can do anything they want. They can market in ways that they want. ... Unless they make a therapeutic claim that it is a product for actual cessation of nicotine use, we can't regulate them. If they make a therapeutic claim, we can regulate them as a medical product."

The "Wild, wild west" is a perfect descriptor of the health IT market.  And claims of benefits?  How about some 'Words that Work?'  (http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html)

Hamburg stressed to CBS News that, "Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products. ... We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc. So we see this as really a crucial first step."

The health IT industry has special accommodations in that regard that the E-cigarette company lawyers need to closely examine.
Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn't contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.

It's undeniably unclear how safe clinical IT devices are, either.  The ECRI Institute, for instance, found 171 mishaps in 9 weeks at 36 hospitals voluntarily reported, leaving 8 patients harmed and possibly three of them dead.   (A likely far more than serous problem than GM cars with defective ignitions that killed ~13 in a decade...)   The FDA found many injuries and several deaths in their own self-admitted limited dataset as well.  (See FDA Internal Memo on HIT risk at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html).

... Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.

There is no premarket review of clinical IT of the types categorized by FDA as "with health management heath IT functions" as above, even if those devices meet the statutory requirements as a medical device that falls under the Food, Drug & Cosmetic Act.  These systems increasingly mediate and regulate every transaction of healthcare.

E-cigarettes, however, are a major concern that are being reviewed in earnest?

Unbelievable.

-- SS

DISCLAIMER:  I neither use tobacco products in any form nor E-cigarettes, never did, and have no conflicts of interest of any kind with either the tobacco or E-cigarette industries.

Innumeracy at the Centers for Medicare & Medicaid Services (CMS)

A physician participant in an American Medical Informatics Association listserv I subscribe to had some time ago commented that the CMS, in their requirement that physicians meet certain percentages on measures regarding adherence to the "Meaningful Use" incentive program for EHRs, were calculating those percentages incorrectly.

He followed up with an actual response from CMS, and has given me permission to repost.  I am redacting his name:

... I have posted previously that the CMS calculator found at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Stage_2.html appears to calculate improperly.  Last night I received a response from CMS regarding my concern:

“Dear Mr. (sic) [name redacted],

Thank you for your recent inquiry. Below is the information you requested about the attestation calculator.

As adopted by CMS, measures generally require that providers achieve "more than" a specific percentage. The language in these measures is clear; "more than 50 percent" would equate to 51 percent or more. This has consistently been the policy from the beginning of the program.

The attestation calculator now rounds fractions of a percent to the closest whole number. This correctly identifies when the required performance level is reached.

The tracking number for this inquiry is 2014-XXXXX. . . . “


My examples included a numerator of 549 with a denominator of 10,000 for a metric that required “greater than 5%”.  These are screen shots of the submission:




Note that the calculator appears to use 3 significant figures, but in fact rejects the calculation by rounding to only 1 significant figure.  

Years ago at a CMS conference I remember the speaker remarking that physicians and hospitals only had to enter the numbers “and we could agree on the arithmetic.”  I learned in fourth grade how to round numbers, and how to count significant digits.  I do not agree with their arithmetic, nor do I accept their determination that “more than 50 percent" would equate to 51 percent or more”.  Granted, one hopes that those attempting to attest will not have numbers that skim so closely to the metric limit, but it could happen.

I note in the reply from CMS this statement:

"The language in these measures is clear; 'more than 50 percent' would equate to 51 percent or more."

I emphasize:   

THE - LANGUAGE - IN - THESE - MEASURES - IS - CLEAR.

Here are  actual instructions for, say, CPOE measurement on medication ordering (http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/Stage2_EPCore_1_CPOE_MedicationOrders.pdf):

Attestation Requirements
DENOMINATOR/NUMERATOR/THRESHOLD/EXCLUSION

Measure 1: Medication

DENOMINATOR: Number of medication orders created by the EP during the EHR reporting period.

NUMERATOR: The number of orders in the denominator recorded using CPOE.

THRESHOLD: The resulting percentage must be more than 60 percent in order for an EP to meet this measure.

EXCLUSION: Any EP who writes fewer than 100 medication orders during the HER (sic) reporting period.

Now, I had a perfect "800" in math on my SAT test in 1974, so (while probably excluding me from some employment in today's culture of stupid due to having "too much experience"), I do believe I am perfectly well qualified to determine that "more than 60 percent" would mean, anything more than 60.0, such as, say, 60.1%.

Let's consider possible explanations.

Possibility (1)
Perhaps CMS is performing their calculations with an old Pentium-1 computer whose CPU has the FDIV bug causing math errors (http://en.wikipedia.org/wiki/Pentium_FDIV_bug)?

On second thought:

I don't think that is a good explanation.

Possibility (2)
Perhaps I have become demented from too much exposure to the numeracy-challenged since 1974?

An experiment is in order:

In 1969, we landed men on the Moon.  It took a lot of math to perform that feat, and miscalculation would have led to disaster, for example on the 25,000-MPH re-entry into Earth's atmosphere at precisely the correct angle required to avoid burn up, or skipping off the atmosphere like a stone off a pond, back out into space to be lost forever.

I learned computing about that time on a Digital Equipment Corporation PDP-8/S, a computer from that era (http://cci.drexel.edu/faculty/ssilverstein/medinformatic1/gw-pdp8s.htm).

I wrote and ran a small program on a PDP-8 emulator WinEight (available free at http://www.sparetimegizmos.com/Software/WinEight.htm) that perfectly emulates the old PDP-8.  Here is the program in the programming language FOCAL, 1969 version:

CONGRATULATIONS!!
YOU HAVE SUCCESSFULLY LOADED 'FOCAL,1969' ON A PDP-8 COMPUTER.

SHALL I RETAIN LOG, EXP, ATN ?:YES

PROCEED.

*1.1 SET P=(601/1000)*100
*1.2 IF (P-60) 1.3, 1.4, 1.5
*1.3 TYPE "P IS LESS THAN 60%";G 1.6
*1.4 TYPE "P EQUALS 60%";G 1.6
*1.5 TYPE "P IS MORE THAN 60%"
*1.6 TYPE !;QUIT

The program sets variable "P" to 601/1000, then multiplies by 100 to derive a percent.  It then compares the result stored in "P" to 60, and branches to the correct statement regarding the relation of P to 60%.  Let's run the program:

*
*GO
P IS MORE THAN 60%
*

Good news.

I guess I am not demented after all.

Possibility (3)
Someone (or a group of people) at CMS doesn't or don't realize that in large datasets, percentages are often not integer whole numbers.

Possibility #3 can be illustrated best by a cartoon:


Click to enlarge.  1+3 = 13, right?


Or perhaps this:

Math for Underachievers.  Click to enlarge.

I leave it to the reader to determine which of the three possibilities is the explanation for the assertion by CMS that "The language in these measures is clear; 'more than 50 percent' would equate to 51 percent or more."

Note: this post was meant as satire and humor and irony, but innumeracy in our healthcare regulators is anything but funny.

-- SS

Thursday, April 24, 2014

American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently discussed the American Board of Internal Medicine's exceedingly weak conflict of interest policy.  This came to light after the board's previous president was revealed to have simultaneously served for years on the board of directors of a privately held for-profit hospital purchasing organization.

The susceptibility of ABIM leadership to conflicts of interest is particularly important because the board, in its role as the de facto sole source of credentialing for all US internists and internal medicine sub-specialists, sets what these physicians need to know to pass the certifying examinations. Conflicts of interest raise doubts about whether the examinations may be used to further commercial agendas and similar vested interests.

Furthermore, the ABIM has been willfully expanding its scope into "maintenance of certification," that is, into requiring physicians to engage in ABIM educational and evaluation activities to maintain their previously obtained certification.  They have been criticized in particular (e.g., here and here) for pursuing maintenance of certification in the absence of clear evidence that it improves physician performance or patients' outcomes.  Conflicts of interest affecting MOC raise further doubts that this "innovation" may also be about furthering commercial interests.

ABIM Begins Conflict of Interest Disclosure

Now it appears that the ABIM is beginning to disclose more about its leadership's conflicts of interest.  One of our scouts notified me that the ABIM web-site now provides disclosures for the members of its board of directors and officer, council, and executives.

There seem to be limits to these disclosures.  As far as I can tell,They do not reflect a change in the preexisting ABIM conflict of interest policy, which still calls for conflicts to be disclosed, but only to ABIM leadership, while they are otherwise kept confidential.  Nor were these disclosures accompanied by any further explanation that I can find.  The disclosures include multiple categories, consulting relationships, peer educational activities, promotional activities, grants, intellectual property, stock/option, gift/ donations, expert witness, leadership in professional organizations, and other, which are not otherwise defined.  It was not clear, however, whether the disclosures covered services on corporate advisory boards or boards of directors, or service as executives or founders of companies.  The time course of the disclosed relationships were not clear.  Finally, ttere are no disclosures about members of exam writing committees of sub-specialty board members

Nonetheless, the disclosures do give an idea of the scope of conflicts of interest affecting ABIM leadership.  Because the disclosures have not otherwise been publicized, I thought it would be worthwhile to summarize them here.

Prevalence of Conflicts

Of the 12 officers and directors, 8 disclosed relationships with for-profit health care corporations

Of the 15 council members (one of whom is also a director), 9 revealed conflicts.

Of the 12 executives, 5 revealed conflicts.

Thus, a majority of ABIM physician leadership, and nearly a majority of  ABIM executives disclosed conflicts of interest.

Nature of Conflicts

The conflicts were predominantly consulting relationships, grants, holdings of patents, or of stocks or options.  The conflicts of the officers, directors and council members primarily involved pharmaceutical, biotechnology and device companies.  Several officers, directors and council members had two kinds of relationships with the same company, for example, consulting relationships and grant funding.




It was striking that 15 companies had multiple relationships with officers, directors and council members.  All were large pharmaceutical, biotechnology, and device companies.  They were

AbbVie (1 consulting relationship 2 grants)
Amgen (1 consulting, 1 grant, 2 stock holdings)
AstraZeneca (3 consulting, 1 grant)
Bristol-Myers-Squibb (2 consutling, 2 grants, 1 stocks)
Celgene (2 consulting, 1 grant)
Gilead (1 consulting, 2 grants, 1 stocks)
Johnson and Johnson (1 consulting, 2 grants [one through Janssen], 2 stocks)
Eli Lilly (1 consulting, 1 grant)
Medtronic (2 consulting, 1 grant)
Merck (2 consulting, 2 stocks)
Novartis (2 grants, 1 stocks)
Pfizer (1 consulting, 1 grant, 2 stocks)
Roche (1 consulting, 2 stocks)
Teva (1 consulting, 1 stocks)
Millennium (1 consulting, 1 grant)

The officers, directors, and council members additionally had relationships with a vast number of companies, including in attempted alphabetical order: Abbott Laboratories, Agios, Allos, AllScripts, Arrowhead, Biocontrol Medical, Cephalon, Cephied, CorAssist, Cornovus, CVRx, Covidien, Dr Redy's Labs, Emergent Biosolutions, Express Scripts, Genentech, Gen-Probe, Hologic, Human Genome Sciences, Incyte,  ION(?), miRNA Therapeutics, Peluton Therapeutics, Pharmacyclics, Regeneron, Repros Therapeutics, Research to Practice (owned by AmerisourceBergen) Prime Healthcare, Rigel, Seattle Genetics, Sunesis, TG Therapeutics, UnitedHealthcare, Value Capture, Viamet, Ventrigen, Vertex, XCenda,  and ZS Pharma.

Thus, the conflicts of interest were extensive, and involved major health care corporations.

Summary

The American Board of Internal Medicine is to be congratulated for taking steps towards more transparency and honesty about conflicts of interest affecting its leadership.  However, the steps were baby steps.  Lacking still are definitions and time courses of the relationships disclosed, assurances of the completeness of disclosure of all relevant relationships, assurances that disclosure is now the policy going forward, and disclosures for members of committees and sub-specialty boards who are also very influential in constructing examinations and maintenance of certification activities.  These ought to be addressed.

The disclosures reveal that the conflicts of ABIM leadership were extensive.  While disclosure is good, disclosure does not assure physicians and the public that certification and now maintenance of certification are not influenced by marketing needs and other commercial interests.  In my humble opinion, the ABIM now ought to phase out, as quickly as possible conflicts of interest affecting those who make its policy, write its exams, and conduct its other activities that can influence physician behavior, decisions made for patients, and health policy.  Also, in my humble opinion, the ABIM ought to suspend its efforts to promote maintenance of certification until it has greatly reduced the conflicts of interest that may affect this effort.

Tuesday, April 22, 2014

A Tangled Web of Perversity by a Healthcare Company Owner - Subpoenaing Emails of Law Student Critics at NYU Law School, Where He is a Trustee

At Healthcare Renewal, we are largely calling for removal from healthcare of perverse managers and perverse management practices. 

One of those practices is the attempted silencing of critics.

I have first hand experience with a perverse but unsuccessful attempt myself, where the apparently (and IMO, and as protected by the 1st Amendent) megalomaniacal management of a once-reasonable hospital (I did my residency there 1985-7) sought to abridge my 1st Amendment rights regarding care of my late mother.  See my August 11, 2013 post "Who Would Have Thought, Comrades, That The Most Severe Form of Attempted Internet Censorship Could Originate in a Community Hospital, Abington Memorial, That Alleges Itself A Non-Profit Public Servant?" at http://hcrenewal.blogspot.com/2013/08/who-would-have-thought-comrades-that.html.

This recent story, however, is simply stunning in the audacity of its principal regarding "shutting up" critics, this time two law students at a law school of which he is a Trustee:

Law School Trustee's Company Chills Critical Speech With Subpoena For Students' Personal Emails

A New York University trustee has found a way to chill speech critical of him and the [healthcare] companies he owns: subpoena the personal emails of two particularly outspoken opponents.
A New York University Law trustee's company wants two students to hand over their personal emails after they circulated a letter criticizing him, according to a subpoena.

The law students, second-year Luke Herrine and first-year Leo Gertner, were targeted after they helped circulate a letter denouncing NYU Law School trustee Daniel Straus, who owns Care One Management, a home health aide and nursing home company embroiled in a labor dispute.
The two students started a petition asking for the removal of Straus from the Board of Trustees, pointing out that a law school should probably be associated with someone who respects the law, something Straus' companies seem to have trouble doing. His two companies, CareOne (http://care-one.com/) and HealthBridge Management (http://www.healthbridgemanagement.com/), have been cited at least 38 times by the National Labor Relations Board for violating federal labor laws. In addition, HealthBridge was held in contempt of court for refusing to allow 600 workers to return to their jobs at their pre-strike pay levels.

"A law school should probably be associated with someone who respects the law" seems an oxymoron, not to mention protected speech under the First Amendment of the U.S. Constitution: http://en.wikipedia.org/wiki/First_Amendment_to_the_United_States_Constitution.

CareOne's current legal battle with a local labor union, Service Employees International Union (SEIU), something that has dragged on for years at this point, has seemingly turned into a convenient way for Straus to get back at his critics. Of course, CareOne claims otherwise.
CareOne spokesperson Deborah Maxson said the deadline for the requested information is April 25.

Straus is not a party to the lawsuit and is not managing the litigation,” Maxson said.
Straus may not be a party to this lawsuit, but these are his companies, and there can be very little doubt that Straus would prefer the ongoing criticism of his business efforts be halted. If CareOne wants to use the excuse that Straus isn't a "party" to this lawsuit, then it needs to extend that same courtesy to the two students, who also aren't a "party" to the ongoing legal fight.

But they're defenseless students, and in healthcare matters, dissing a high-ranking healthcare management  person seems to be a crime that such persons cannot seem to tolerate.  (I won't get into the psychopathological issues that may come into play).

Then there's the content sought by the subpoenas. This, too, mentions Straus directly, even as CareOne claims this has nothing to do with him. According to a letter sent by the Board of Trustees to NYU administration, this is what CareOne is hoping to obtain:
The subpoenas requested information regarding any contact the students may have had with SEIU and any activity they may have engaged in, such as protests or meetings, relating to Mr. Straus or CareOne...”
If Straus isn't "party" to this lawsuit, why does CareOne need information relating to Straus? Beyond that, the information requested bears all the hallmarks of trying to use the power of the court to silence free speech. Protests and meetings, both activities covered by the First Amendment, are mentioned specifically by the subpoena.


Perhaps some members of the generation after the "Greatest generation" have such low self-esteem that they have to bully mere students into submission.

For what it's worth, NYU has stepped up and has provided the students with the pro bono help of one of the school's lawyers. It also issued a very carefully-worded defense of the students, no doubt mindful of Straus' $1.25 million annual endowment.
The Law School is not a party to the litigation between Care One and SEIU, and will remain uninvolved in it," the school wrote in a statement to DNAinfo New York sent Thursday. "We vigorously support the right of our students to express their views and to organize and participate in lawful demonstrations and other protest activity, at the same time that we acknowledge that parties to litigation are permitted, subject to applicable rules and judicial oversight, to gather evidence in support of their case."
Further statements reiterated NYU's support for its students' rights but also noted it considered Straus to be an "upright and honorable person."

That said, it seems that there is a clear -- and somewhat massive -- conflict of interest for Straus to remain on the board of trustees at NYU Law at the same time he's using the legal process to demand the email contents from two of its students.

Conflicts of interest are nothing new to healthcare.

As is noted by the students' new petition demanding the withdrawal of the subpoenas, this sort of activity, undertaken by a "victim" of criticism, will discourage others from approaching anything remotely controversial.
Forcing students to turn over emails and other private communications in litigation that does not concern them can chill free speech on campus and make students think twice about raising their voice about controversial issues. This is antithetical to NYU's mission of open academic inquiry and commitment to the public interest.

That's assuming the mission of NYU and other universities still remains "open academic inquiry."  Many have begun to doubt that, and with good reason; e.g., see http://www.bloombergview.com/articles/2014-04-22/free-speech-zones-and-other-college-lies as just one example.

Rather than address these concerns, Straus is allowing (or directing) his company to shut down his critics by seeking personal communications from non-party NYU students. Straus also has additional leverage with the university should this fail to keep future criticism at bay. Of course, there's always a chance NYU will side with the students and decide that Straus' companies don't really reflect the culture it's trying to instill in its students. But until this all plays out, we're just witnessing the sort of tactics deployed by entities who would rather shut people up than address their concerns.

I note the following statement on the web page of Care One Management:

"With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.

With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities."

With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.
With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.
- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf


With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.
With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.
- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf


With a focus on the highest standards, clinical best practices and strong management principles, CareOne has developed a reputation as a premier health care company in New Jersey.
With services that include post-hospital care, rehabilitation, assisted living, long-term care and a variety of clinical specialty programs, CareOne offers compassionate care in gracious, professionally managed centers and communities.
- See more at: http://care-one.com/#sthash.mAHNhXEp.dpuf P { margin-bottom: 0.08in; }A:link { }
In healthcare, I remind, the "shut people up" mentality results in patient injury and death.  It seems to me that this Trustee is not just setting a bad example for the legal profession, but it also throws the management of his healthcare organizations into question.

-- SS

Wednesday, April 16, 2014

Knee Deep in the Hoopla - "A Triumph of Medical Technology" Sans Evidence of Superiority from Published Randomized Double Blind Controlled Trials

With the publication of several new articles in the prestigious New England Journal of Medicine, the buzz about Sovaldi (sofosbuvir - Gilead), a new oral treatment of hepatitis C, has become feverish.  The drug had been hailed as near miraculous, and the only debate has been about its near stratospheric cost (look here). 

This week, of all weeks, however we should be extremely skeptical about expensive drugs promoted as the cures of our most feared ills.  This week a series of articles appeared in the British Medical Journal showing that there was no evidence to support the clinical value of the  antiviral drugs stockpiled for governments as proof against dreaded influenza epidemics (look here to start).  

The Latest Buzz

As we posted earlier, the discussions contrast the ostensibly near miraculous aspects of the drug's performance with its extremely high price.  For example, a few days ago the Los Angeles Times reported,

In a series of clinical trial results, a new generation of antiviral medications was able to clear the liver-ravaging virus from virtually all patients' bloodstreams in as little as eight weeks. Even in patients with the most stubborn infections, the new drugs were capable of suppressing the virus completely at rates well over 90%. The treatments, however, come with a steep price tag.

So,

The new medications are 'a triumph of modern medical technology,' said Dr. Jeffrey Tice, a UC San Francisco physician who was not involved in any of the clinical trials.

Accompanying the research reports in the New England Journal was a commentary by Dr Raymond T Chung and Dr Thomas F Baumert.  Its title proclaimed Sovaldi and similar drugs also to be part of "The Arc of Medical Triumph."(1)  Buried in the commentary's supplementary material was a link to disclosure forms that showed that:

Dr Chung reports grant support from Gilead Sciences [the manufacturer of Sovaldi], Mass Biologics, Vertex and Merck, and personal fees from Abbvie, Enanta and Idenix.

Note that Abbvie and Merck are also at work on antiviral treatments for hepatitis C.

and

Dr Baumert reports several patents ... and pending patents [apparently that could be conflicts of interest]

It is clear that there have been major scientific advances in the characterization of the hepatitis C virus, and development of multiple new antiviral agents which promise to treat that infection.  Furthermore, clearly there is reason for hope for treatment of hepatitis C that prevents its long-term complications and averts premature death. (Of course, that hope could be a bit stronger in the hearts of those who have financial relationships with the corporations that stand to profit from sales of these drugs.)

But it is not obvious that there is sufficient clear evidence from clinical research, particularly from double-blind randomized controlled trials (RCTs), that shows the newest treatments will provide triumphal benefits to patients that outweigh their possible harms.

One Published Unblinded RCT Compared Sovaldi to Peg-Interferon


In our previous post, written after the immense price of the new drug in the US became apparent, we questioned whether the evidence from controlled trials then available would justify the hype, and the high price.

We looked at what appeared to be the then single best available study. The most prominent randomized controlled trial of Sovaldi for patients who had not had previous therapy for hepatitis C that had been published by March, 2014, appeared in the New England Journal of Medicine in May, 2013.(2)   While it provided some reason for hope, it did not provide clear evidence that Sovaldi was a miracle drug.

The study showed that Sovaldi plus ribavirin produced the same rate of sustained virologic response (SVR), 67%, as did the previously accepted standard treatment, peg-interferon plus ribavirin, again 67%.  (SVR means that the hepatitis C virus has become undetectable in the patient's blood, and is believed, but not proven to represent a cure.)

While Sovaldi had lower rates of unpleasant side effects than did peg-interferon, these rates were not negligible. For example, the rate of nausea after peg-interferon was reported to be 29%, but after Sovaldi it was still 18%.  Given that the trial was unblinded, and that some of these side effects have a subjective element, these figures could have been biased due to patient expectations that the new drug would have fewer side effects.

Furthermore, Sovaldi appeared to produce higher rates of severe adverse effects (3%) than peg-interferon (1%).  However, the article did not mention any deaths in either treatment group.  When I later reviewed the  supplemental data available on the web from the May, 2013 article, I found that buried within this information were the facts that two people died during treatment with Sovaldi, and one after treatment with peg-interferon.  So, the rate of  severe adverse effects or death after Sovaldi treatment was more than double (9/256 ) than that after peg-interferon (4/243).  It is very curious and concerning that the authors chose not to mention deaths of study subjects in the paper that reported their trial results.   

Finally, the trial, like just about all previous trials of treatment of hepatitis C, did not follow patients long-term, and hence could not show whether treatment actually resulted in better clinical outcomes, for example, longer survival, decreased rates of severe liver disease, etc.  We thus concluded that there really was no clear evidence that Sovaldi was really a miracle drug, which could cure more people, in fact, nearly everyone, compared to standard therapy, yet with fewer side effects and more safety.

Any Evidence from Other Controlled Trials?

We looked through the newly published articles, the articles they cited, and the official US label for sofosbuvir to see if there is any other evidence from controlled trials to support the triumphant claims about sofosbuvir.  To simplify this casual, not systematic review, we only looked at articles about patients who had not been previously treated for hepatitis C.

The drug label mentioned a controlled trial that compared sofosbuvir to placebo.  The POSITRON study (study 107) was a trail that compared Sovaldi and ribavirin to placebo in patients who are "interferon intolerant, ineligible or unwilling."  The overall SVR in the treated group was 78%.  The label did not mention adverse effects rates in this trial, and as far as I can tell, it was not published.  Again, while the SVR was good, it was NOT over 90%.  As far as I could tell, the results of this study have not otherwise been published. 

The new studies in the New England Journal, and the studies cited by one of them were NOT double-blind randomized controlled trials of sofosbuvir versus some other treatment, or versus placebo for that matter.

For example, the study by Afdhal et al in the New England Journal considered sofosbuvir in combination with another new drug from Gilead, ledipasvir.  However, this was an open label (unblinded) study that compared patients given different durations of treatment with both sofosbuvir and ledipasvir with or without ribavirin.  It did NOT directly compare sofosbuvir (or ledipasvir) to any other treatment, or to placebo.(3) Another study by Sulkowski et al in the NEJM focused on previously treated patients.

Cited by Afdhal et al were studies by Osinusi et al (an unblinded study that compared different doses of ribavirin given to patients also who all received sofosbuvir)(4); Lawitz et al (an unblinded study that compared different durations of treatment for both sofosbuvir and ledipavir with or without ribavirin)(5); and Gane et al (a study that compared various drugs again all added to sofosbuvir)(6).  Again, NO study compared sofosbuvir to any other treatment, or to placebo.

Thus so far I have been unable to find any additional studies that compared Sovaldi (sofosbuvir) to any other potential treatments for hepatitis C.  Without a comparison to another treatment, it is not possible to tell whether the high rates of patients whose blood tests show no detectable hepatitis C virus in the short-term after treatment were due to the excellence of the treatment, or due to selection of patients with particularly good prognoses.   Recall that there is evidence that some patients with hepatitis C spontaneously clear their blood of hepatitis C, and become spontaneously cured (see our previous discussion, and particularly the study by Seeff et al[7]). 

There is evidence that the studies above may have been designed to only include patients with the best prognoses.  They generally were designed with very complicated, restrictive and subjective inclusion and exclusion criteria that could have eliminated all but the healthiest patients.  For example, according to the study protocol found in the supplementary material for the study by Afdhal et al, patients with "clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol" would have been excluded, as would have "subjects currently under evaluation for a potentially clinically-significant illness (other than HCV)...."

So, while many articles about sofosbuvir (Sovaldi) have appeared recently, in my humble opinion they do not provide strong clear evidence that this drug is extremely effective and remarkably safe, i.e., that the drug is a "triumph" that will cure nearly everyone without risk or harm to them, and therefore warrants a princely price.

Summary

While the buzz about Sovaldi intensifies, there still seems to be little clear evidence to justify extravagant claims made for it, or the extravagant price demanded for it.  Yet there seems to be a bandwagon building to somehow pay whatever it takes to provide the "triumph" of medical science to every patient who needs it.  At the current price, that should make the CEO of Gilead even richer (increases in the stock price after the $84,000/ course drug price was announced already turned him into a billionaire on paper, look here.)  As noted above, it is not clear what benefits such a costly policy would bring to patients, and at what risks.

We have discussed how our current policy of letting corporations sponsor and run the clinical research meant to assess their own products has lead to widespread manipulation of research to make their products look better, and sometimes suppression of research that cannot be manipulated into making their products look good.  This should make health care professionals, policy makers, and the public extremely skeptical of every over-hyped new "innovation."  So far, there seems to be no public skepticism about this latest, and seemingly most expensive pharmaceutical "triumph."

The US health care system, and to some extent the health care systems in most developed countries are experiencing ever higher prices.  Much of these prices' effects seem to drive up remuneration of health care executives and managers, but whether they buy better care or outcomes for most people is not so clear.  The ever rising prices seem to be buoyed by endless enthusiasm for new tests, treatments, programs, and unbridled faith in the benefits of all new technology.  It is not clear how much of that is due to evidence, how much is based on ideology and unquestioning faith in technological progress, and how much is driven by marketing and public relations, which not always may be entirely honest and free from deception.

Evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients.  The skepticism EBM should engender could lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. If only such skepticism were easier to find.


References
1.  Chung RT, Baumert TF.  Curing chronic hepatitis C - the arc of medical triumph.  N Engl J Med 2014:  Link here.
2.   Lawitz E, Mangia A, Wyles D et al.  Sofosbuvir for previously untreated chronic hepatitis C infection.  N Engl J Med 2013; 368: 1878-1887.  Link here.
3.  Afdhal N et al.  Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.  N Engl J Med 2014: Link here.
4.  Orinusi A Meissner EG, Lee YJ et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.  JAMA 2013; 310: 804.  Link here.
5.  Lawitz E, Poordad FF, Hyland RH et al.  Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised phase 2 trial.  Lancet 2013; 383: 515.  Link here.
6.  Gane EJ, Stedman CA, Hyland RH et al.  Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection.  Gastroenterology 2013.  Link here.
7.  Seeff LB, Hollilnger B, Alter HJ et al.  Long-term mortality and morbidity of transfusion- associated non-A, non-B, and type C hepatitis: a National Heart Lung and Blood Institute Collaborative Study.  Hepatology 2001; 33: 455-463.  Link here.

ADDENDUM (21 April, 2014) - Also see the post on "breakthrough cures?" by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog

CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives?

If this is true, the EHR hyper-enthusiasm problem is even worse than I believed.

From the April 2014 newsletter of the American Association for Physicians and Surgeons (http://www.aapsonline.org/index.php/about_us/), an organization that is dedicated "to preserving the sanctity of the patient-physician relationship and the practice of private medicine":

CMS Claims to Have No Information on EHRs

On Mar. 14, 2014, the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare and Medicaid Services replied to a Freedom of Information Act (FOIA) request sent Apr. 4, 2012:  The American Recovery and Reinvestment Act of 2009 (ARRA) created the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.  While our Office of E-Health Standards and Services works to implement the provisions of the ARRA, we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."

However, that doesn't stop our government from spending billions of taxpayer dollars on them, when, in fact, we do know of harms they cause.  One can reasonably assume their primary interest is in bookkeeping.

With FDA, it's even worse.  Rather than stopping at admitting they simply don't know due to admitted impediments to knowing, they simply leap to a conclusion that the technology is of 'sufficiently low risk' not to warrant their regulatory attention, even if such systems meet the statutory requirements to be a medical device and thus fall under the Food, Drug & Cosmetic Act.

See my Apr. 9, 2014 post "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" and its ten-point (and non-comprehensive) summary of risks: http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.  Another FOIA request is surely needed...

More generally, I know from personal development and implementation experience that when "done well", that is, when good health IT and good implementation practices are offered and with patient safety as a priority, health IT can save lives and improve care.  It's just that the commercial for-profit health IT sector does not meet those expectations, due largely to its leadership model from the merchant-computing culture.  Instead, bad health IT is the norm.  From my academic site at http://cci.drexel.edu/faculty/ssilverstein/cases/:

Good Health IT is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

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

 I am seeking source material from the AAPS and will post it.

-- SS

April 26, 2014 Addendum:

Below is the letter to AAPS from CMS.  Click to enlarge.


CMS:  "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

An additional thought:

While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they do have (or should have made it their business to have) information that EHRs cause harm and take lives (e.g., via FDA at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html , ECRI at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html and others).

-- SS

Monday, April 14, 2014

Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another article in its series on the high cost of US health care.  This one, focused on the care of type 1 diabetes mellitus and other chronic diseases, shines some light on the business management practices that now determine how our health care system functions, or not, and implies who benefits the most from them.

Planned Obsolescence Disguised as Innovation

The article first discussed the brave new world of type 1 diabetes treatment.  The introductory theme was:

Today, the routine care costs of many chronic illnesses eclipse that of acute care because new treatments that keep patients well have become a multibillion-dollar business opportunity for device and drug makers and medical providers.

Much of modern diabetes treatment seems to depend on medical devices and disposable medical supplies:

That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments, borrowing business models from technology companies like Apple: Each pump and monitor requires the separate purchase of an array of items that are often brand and model specific.

A steady stream of new models and updates often offer dubious improvement: colored pumps; talking, bilingual meters; sensors reporting minute-by-minute sugar readouts. [Diabetes patient] Ms. Hayley’s new pump will cost $7,350 (she will pay $2,500 under the terms of her insurance). But she will also need to pay her part for supplies, including $100 monitor probes that must be replaced every week, disposable tubing that she must change every three days and 10 or so test strips every day.

Of course, the device and supply manufacturers claim that the high prices reflect the value of the wondrous new innovations:

Companies that produce the treatments say the higher costs reflect medical advances and the need to recoup money spent on research.

Yet now the Times reporter was able to find physicians who claim the "innovations" are really just the latest version of planned obsolescence:

Diabetes experts say a good part of what companies label as innovation amounts to planned obsolescence. Just as Apple customers can no longer buy an iPhone 3 even if they were content with it, diabetics are nudged to keep up with the latest model.
For example,

Those companies spend millions of dollars recruiting patients at health fairs, through physicians’ offices and with aggressive advertising — often urging them to get devices and treatments that are not necessary, doctors say. 'They may be better in some abstract sense, but the clinical relevance is minor,' said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center.

'People don’t need a meter that talks to them,' he added. 'There’s an incredible waste of money.'


Pharmaceutical companies have also discovered this model.

insulin ... has been produced with genetic engineering and protected by patents, so that a medicine that cost a few dollars when Ms. Hayley was a child now often sells for more than $200 a vial, meaning some patients must pay more than $4,000 a year.

In particular,

Synthetic human insulin is safer for patients, who sometimes developed reactions to animal insulin. But it is made by only three companies: Eli Lilly, Sanofi and Novo Nordisk. Manufactured in microbes, each one’s product has minor dissimilarities that reflect the type of cell in which it was made. Since the companies owned the cell lines, it is nearly impossible for other companies to make exact copies or even similar versions that would be cheaper, even once the patents expire. And the pharmaceutical companies defend the patents ferociously.

What’s more, the three companies continued to refine their product, adding chemical groups that made the insulin absorb somewhat more quickly or evenly, for example. They are called insulin analogues, and their benefits are promoted tirelessly to doctors and patients.


Of course, the pharmaceutical companies also claim that it's all about innnovation,

Dr. Todd Hobbs, chief medical officer of Novo Nordisk, defended the rising prices of insulin, linking them to medical benefits. 'The cost to develop these new insulin products has been enormous, and the cost of the insulin to the consumer in developed countries has risen to enable these and future advancements to occur,' he wrote in an email.
 Not everyone is convinced,

'The insulins are tweaked for minor benefits that may help a small number of patients with difficult-to-control diabetes, and result in major price increases for all,' [Kings College, London, UK Professor] Dr. Pickup said. Because of analogues, he added, Britain’s National Health Service has had to spend 130 percent more on insulin in the past five years.

In the United States, said Dr. Zonszein at Montefiore, the price of Humalog, Lilly’s analogue insulin, was typically two to four times that of its older human insulin line, called Humulin. 'There is not a lot of difference between Humulin and analogues,' he said, but he noted that Humulin was getting 'hard to find.' Sanofi Aventis has stopped selling its older product in the United States, and Mr. Kliff, the financial analyst, said other companies were likely to follow suit, effectively forcing patients to use the costlier versions.


The arguments about valuable innovation also do not explain why the prognosis of diabetes in the US does not seem to reflect all the money we spend on the disease,

Complication rates from diabetes in the United States are generally higher than in other developed countries. That is true even though the United States spends more per patient and per capita treating diabetes than elsewhere, said Ping Zhang, an economist at the Centers for Disease Control and Prevention.

The high costs are taking their toll on public coffers, since 62 percent of that treatment money comes from government insurers. The cumulative outlays for treating Type 1 and Type 2 diabetes reached nearly $200 billion in 2012, or about 7 percent of America’s health care bill.

So to summarize, there is considerable evidence that companies that make drugs and devices to manage type 1 diabetes constantly provide "innovations," yet most are minor changes that encourage obsolescence of previous products, but do not provide important increases in benefits or reductions in harm for patients. 


Oligopoly Disguised as a Free Market

Many in the US sing the praises of our supposed free-market health care system.  As noted above however, the insulin market is an oligopoly, dominated by three companies.  The diabetes device market is also dominated by a few companies, and in particular, the insulin pump market is dominated by a single company,

Medtronic is the dominant insulin pump manufacturer, serving 65 percent of American patients and the majority of those worldwide. Though smaller companies sell cheaper pumps, it is hard to make inroads: Once familiar with the Medtronic system and its extensive support network for troubleshooting problems, patients are reluctant to switch. Doctors are leery of prescribing equipment from a new company that may be out of business in a year; their office computer may not sync with the new software anyway.

Of course, Medtronic public relations will justify it all again based on innovation,

Medtronic declined to talk about specific prices, but said a core tenet was to make only 'a fair profit.' Amanda Sheldon, a spokeswoman, added: 'We are committed to reinvesting in research and development of new technologies to improve the lives of people with diabetes, and our current pricing structure ensures that we can bring new products to market.'

The article also discussed the prices of treating chronic diseases other than diabetes.  For example, see how a nominally non-profit hospital priced treatments for chronic diseases,

Dr. Kivi was on high doses of steroids for debilitating joint pain that left him unable to walk at times.

But when his last three-hour infusion at NYU Langone Medical Center’s outpatient clinic generated a bill of $133,000 — and his insurer paid $99,593 — Dr. Kivi was so outraged that he decided to risk switching to another drug that he could inject by himself at home. 

However,  this pricing appears to have been facilitated by the hospital's increasing market domination generated by its purchase of physician practices,

He had moved his care to NYU Langone to follow his longtime doctor, who had moved her practice from a nearby hospital where the same infusion had been billed at $19,000. The average price that hospitals paid for Dr. Kivi’s dose of Remicade late last year was about $1,200, according to Medicare data.

So in summary, a few companies now dominate the production of drugs and devices for the management of diabetes, and a few large hospitals may increasingly dominate the treatment of particular chronic diseases.  Such oligopolists are able to increase prices without improving treatment to or outcomes of patients.

Enrichment of the Oligarchs

This example shows how the current US health care system is dominated by huge organizations, mostly for-profit corporations but including some nominally non-profit corporations that act similarly.  They loudly proclaim innovation, but much of that innovation seems to provide few benefits to patients, and actually appears to be planned obsolescence.  The result is high and ever-rising prices. So if patients do not benefit from this, who does?

It does not appear to be the health care professionals,

Meanwhile, as the price of supplies rises, endocrinologists remain among the lowest-paid specialists in American medicine, meaning severe physician shortages in many areas and long waits to see a doctor.

We  have seen other examples of how leaders of the big health care organizations have become as rich as royalty.  Therefore, let us consider the pay of the leaders of the organizations mentioned above.  I will focus on the two US based corporations, Eli Lilly and Medtronic, and the New York hospital, NYU Langone Medical Center.

Eli Lilly

According to the company's 2014 proxy statement, the 2013 total compensation of its five highest paid hired executives was

- John C Lechleiter PhD, CEO                                      $11,217,000

- Derica W Rice, CFO                                                   $5,176,822

- Jan M Lundberg, PhD, EVP, Science and Technology   $4,774,535

- Michael J Harrington, General Counsel                          $3,174,222

- Erico A Conterno, President Lilly Diabetes                    $3,009,041

Note that all of these executives save Mr Harrington have also amassed more than 100,000 shares of company stock, and Dr Lechleiter has amassed more than 1,000,000.

It should be no surprise, given our recent discussion (e.g., here) of the currently symbiotic relationship among top health care corporations and academic medicine, that several of the members of the Lilly board of directors that has exercised stewardship over the company, and is thus responsible for these gargantuan compensation packages and the business practices discussed above are top academic leaders.  These include,

- Alfred G Gilman, MD, PhD, Regental Professor Emeritus, recent (until 2009) executive vice presdient, provost, and dean of medicine, University of Texas Southwestern 

- William G Kaelin Jr, MD, Professor of Medicine, Associate Director of Basic Science, Dana-Farber Cancer Center, Harvard University

- Marschall S Runge MD, Executive Dean and Chair of the Department of Medicine, University of North Carolina Medical School

- Katherine Baicker PhD, Professor of Health Economics, Harvard University School of Public Health  (I must note that Prof Baicker is also - amazingly - on the Medicare Payment Advisory Committee, MEDPAC).

- Ellen R Marram, Trustee, New York-Presbyterian Hospital

- Ralph Alvarez, President's Council, University of Miami

- R David Hooper, Trustee, Children's Hospital of Colorado

- Franklyn G Pendergast MD PhD, Professor, Mayo Medical School

All but the newest directors were paid at least $250,000 a year by the company (and thus by the executives the directors are supposed to supervise), and all but the newest directors had accumulated tens of thousands of shares of stock or the equivalent as pay for their services.


Medtronic

Similarly, according to the company's 2013 proxy (the latest now available), CEO Omar Ishrak made $8,975,866 in 2013, and the next four highest paid executives all made over $2,500,000 each.   Mr Ishrak owned or could acquire the equivalent of more than 500,000 shares of stock, and the other top paid executives owned of could acquire from over 100,000 to over 1,000,000 shares of stock.

Again, the executives were nominally supervised by a board of directors that included an academic and non-profit leader, Dr Victor J Dzau, MD former chancellor for health affairs at Duke University, and president-elect of the Institute of Medicine (note that we discussed Dr Dzau's conflicts of interest most recently here).  It also included a former government leader, Michael O Leavitt, former US Secretary of Health and Human Services; and a hospital leader, Preetha Reddy, Managing Director of Apollo Hospitals Enterprise Limited (India). 

NYU Langone Medical Center

The Medical Center's 2011 US form 990 is old, but the latest available, and is remarkably obscure, omitting, for example, mentioning the titles of any of the people listed as highest paid officers and employees.  The current CEO, was listed as receiving total compensation of just over $2.000,000.  Four individuals then received over $1,000,000.  The 990 form also mentioned that the Medical Center provided some individuals with first class travel, tax gross-up payments, housing allowances, and reimbursement for personal services.  Neither the 990, nor the center's web-site makes all the possible conflicts of interest of its trustees obvious.   

So in summary, the large organizations, for-profit and non-profit, that are able to greatly increase their prices through planned obsolescence disguised as innovation, and oligopoly disguised as free markets, are able to make their top executives very rich, and also enrich those who are supposed to exercise stewardship over them. 


Summary

An extensive journalistic investigation revealed how certain aspects of chronic care in the US health care system are dominated by a few large organizations.  These organizations are able to charge very high prices, mainly through market domination, and with the aid of marketing and public relations that tout planned obsolescence as valuable innovation.  The leaders of these organizations have become wealthy, often fabulously so.  This state of affairs has not been challenged by those who are supposed to provide stewardship, including many prominent academics.

The US health care system is the most expensive, on a per capita basis, in the world, and far more expensive than that in any other developed country.  Yet there is no evidence that its results are superior to those of other countries.  What evidence there is suggests in fact that our results are mediocre at best.

The current example suggests how the US system differs from those of other countries.  It has an ostensible free market focus.  Yet the system appears more to be an oligopoly, with most of its market components dominated by a few large organizations, run as an oligarchy, by a small, overlapping in-group of managers, executives and their cronies, with elements of corporatism, that is with the cooperation of, rather than regulation by government entities and leaders

A real free market health care system would include a level playing field.  This could only be achieved by the government acting as a fair umpire, not a crony.  Anti-competitive practices would have to end.  Oligopolies would have to be broken.  Deceptive marketing and public relations would have to be exposed.  Leaders would have to be made accountable, especially for putting patients' and the public's health ahead of their own enrichment.  All this would be horribly difficult, as the oligarchs have amassed much money and control, and would oppose, possibly violently, any effort to challenge them.  If we do not challenge them in the US, however, not only will our health care continue to become ever more expensive, less accessible, and less beneficial to patients, but we will all cease to be citizens of one of the first real democracies, and end up serfs instead.