Pfizer's Umpteenth Settlement (for $491 Million Plus a Guilty Plea), but No Person Held Responsible

The world's largest research based pharmaceutical company was in court again, as reported by the New York Times,

 The drug maker Pfizer agreed to pay $491 million to settle criminal and civil charges over the illegal marketing of the kidney-transplant drug Rapamune, the Justice Department announced on Tuesday. 

In particular,

 The recent case centers on the practices of Wyeth Pharmaceuticals, which Pfizer acquired in 2009.

Rapamune, which prevents the body’s immune system from rejecting a transplanted organ, was approved by the Food and Drug Administration in 1999 for use in patients receiving a kidney transplant. However, federal officials said Wyeth aggressively promoted the drug for use in patients receiving other organ transplants, even offering financial incentives to its sales force to do so.

Accusations of Wyeth’s practices became public in 2010 after a whistle-blower lawsuit filed by two former employees was unsealed.

After lawmakers announced a Congressional inquiry, the Justice Department opted to join the lawsuit. The settlement announced Tuesday, which also resolves a second, similar whistle-blower suit, includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia. 

The case did not get much media coverage.  So far, the only other somewhat detailed article on it was put out by Bloomberg.   In fact, the lawyer for two of the whistle-blowers who alerted federal authorities to what Wyeth was doing had to say

the spate of pharmaceutical settlements in recent years had blunted reaction to what he said were shameful practices. 'Everybody’s been asking me why this case is different than any other,' he said. 'We used to trust these companies. You can’t trust these companies anymore.'

However, we should not be too blase.  This case was not only about money.  The over-promotion of a potentially dangerous drug likely lead to patients being harmed in the absence of any benefits.  Rapamune suppresses the immune system and increases risks of serious infections and malignancy.  Specific serious adverse events have been reported when it is used in transplants of organs other than the kidney (e.g., lung and liver transplants).  (See full prescribing information here.)  Bloomberg reported that 90% of Wyeth's revenues from Rapamune came from off-label uses, suggesting that quite a few people may have been adversely affected by its excess use. 

As in most other members of the march of legal settlements by big health care organizations, this case involved no negative consequences for anybody who authorized, directed, or implemented the improper marketing practices.  While such people must have existed, they were not even named in the press coverage.  At least this settlement involved a guilty plea to a crime, albeit a misdemeanor (misbranding as reported by Bloomberg), so the company did have to admit some wrongdoing.  

A Pfizer manager, however, tried to disavow responsibility, as noted by Bloomberg,

'Pfizer was not a subject or target of this matter, and cooperated fully with the government from the time it learned of this investigation in October 2009,' Chris Loder, a Pfizer spokesman,...

But Pfizer had purchased Wyeth, and in doing so got not only assets and profits, but responsibility for actions.

Also, neither the settlement nor the criminal plea seemed to take into account Pfizer's amazingly sorry recent track record.  I am losing count of all of Pfizer's settlements and/or guilty plea or convictions since 2000.  (The updated list of previous legal results is in the Appendix.)  

People found guilty of small-time Medicaid or Medicare fraud often forfeit all their assets and go to jail.  Yet actions by large pharmaceutical companies that may harm patients and cost many millions of dollars almost never result in any individual facing any negative consequences, or even being named and shamed.  Meanwhile, the managers of these companies may make gargantuan amounts of money partially rationalized by the revenues produced by such recurrent misbehavior.  In 2012, according to the company's 2013 proxy filing, Pfizer CEO Ian Reed's total compensation was  $25,634,136, and the four next most highly paid executives all made more than $5,000,000. 

So the Kabuki play that is regulation of and law enforcement for large health care organizations goes on.  As our society is being increasingly divided into a huge majority in increasingly difficult economic circumstances and a small and  increasingly rich minority, it also seems to be increasingly divided into little people who may be ruined by lawsuits, and imprisoned for even minor infractions, and big people who have impunity.  

True health care reform would need to start by making leaders of big health care organizations accountable for their organizations' misbehavior. 

APPENDIX - Pfizer's Settlements

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

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

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

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

Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here). 

 Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  

The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).  

Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).   

In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).  

In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post). 

In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).

In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).  

 In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post). 

Patients as lab rats for beta software: have sancrosanct patient's rights been trivialized, while poor software of non-trivial risk been sanctified?

I have noted a class action lawsuit vs. Allscripts and Eclipsys, EHR producers, regarding a merger:

UNITED STATES DISTRICT COURT, NORTHERN DISTRICT OF ILLINOIS, EASTERN DIVISION; BRISTOL COUNTY RETIREMENT SYSTEM, Individually and on Behalf of All Others Similarly Situated, Plaintiff, vs. ALLSCRIPTS HEALTHCARE SOLUTIONS, INC., GLEN E. TULLMAN, WILLIAM J. DAVIS AND LEE SHAPIRO, Defendants.

The Lead Plaintiffs' Amended Complaint is available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf.  It is worth reading, if just to understand the inner workings of an unregulated healthcare device industry on which your well-being and that of your family increasingly depends.

Lead Plaintiffs' Amended Complaint, available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf

The lawsuit is primarily about alleged misrepresentations made to investors by Allscripts and Eclipsys in a merger regarding inability to integrate products, leadership chaos, and materially false and misleading statements and omissions made during the Class period by these companies about their progress.

I note that in a chaotic environment such as alleged, product safety is not likely a big concern.

However, even more ominous are the allegations of deliberate use of beta software on patients without informed consent or any knowledge by patients whatsoever of its use, which apparently did not work out well.  Not indicated is if patient harm occurred.  If the allegations are true, considering the ECRI Deep Dive health IT risk study results of nearly 200 health IT "incidents" in 36 hospitals over 9 weeks voluntarily reported, including 8 harm incidents and 3 possible deaths - see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html it would not be surprising.

From the Complaint, allegations on software beta testing are as follows.  Emphases mine:

41. CW1 [coded person's name - ed.] explained the different interface integration systems as native integration, disparate integration, and High Level 7 “HL7” interface. The goal of native integration was to have the ability to update patient information throughout the Allscripts’ software offerings. This would allow Allscripts’ Sunrise products to seamlessly integrate with Allscripts’ Enterprise, Professional and MyWay products and allow the products to update patient health records without the use of industry standardized codes. Allscripts branded its native software as ADX. [see Complaint footnote 2.] CW1 described disparate integration as allowing Allscripts software to interface with non-Allscripts software which he described as a Health Information Exchange (“HIE”) software that allowed data to be read and
updated from different software vendors.

42. CW1 said ADX 1.0 was designed to pull and update patient electronic health records automatically and was Allscripts’ native integration software. In approximately July 2011, he learned that Allscripts began a complete reworking of ADX 1.0 because customers were complaining about the lack of functionality and integration, and that it did not allow the user to review and approve changes made in other healthcare settings before being accepted by the hospital or physician practice systems. [If the allegations are true, these problems would be creating on its face significant risk of oversights, confusion and medical errors  - ed.] The upgrade was going to be known as ADX 1.5, but the method and interface for data integration changed. In particular, the interface was changed to allow clinicians to approve changes before they were entered into the system. He also learned from other Allscripts employees that ADX 1.0 was being beta tested [see Complaint footnote 3] at Blessing Hospital in Quincy, Illinois and another place he could not recall, but it was suspended in approximately the middle of 2011 because it failed to perform to expectations. [see Complaint footnote 4] [Remarkable - if the allegations are true, experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations" - and what of the unconsenting meatbags a.k.a. patients it was purportedly tested on? - ed.]

Complaint footnotes:

[2] CW1 described the HL7 interface as using industry standardized codes or language to allow users of disparate software systems to update patients electronic health records.

[3] In software development, “beta testing” generally refers to a testing phase in which a subset of the intended user population tries the product out, in order to see how the product works in real-world conditions.  [What sane patient would consent to such testing of medical IT involved in their care, to 'see how it works in real-world conditions'? - ed.]

[4] See also ¶158 (Defendant Davis’ May 8, 2012 statement “our initial release of our integrated capability...was launched in the middle of last year”); ¶189; cf. ¶76 (CW11’s statement that beta testing at Blessing occurred in late 2011 and was halted in Spring 2012);

Again, I find the allegations of great concern - that experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations."  If true, what of the unconsenting meatbags a.k.a. patients?  They would not have counted for much.

More from the Complaint in Count 50:

50. Consistent with CW2, CW3 said the Helios system was never taken to production while he worked at Allscripts. After he left to join Medicity he had heard that Allscripts delivered a Helios type product for beta testing in the fall of 2011 at the New York Presbyterian Hospitals and it did not go well and that the beta testing of the Helios product at the North Shore Long Island Jewish Community Hospital was scratched prior to implementation.

If the allegations are true, New York Presbyterian Hospitals in the fall of 2011 were performing beta testing of software so bad it was deemed unacceptable for LIJ Community Hospital.  Again, if true, what about the risks patients were subjected to, and ... were any harmed?

Still more in Count 76:

76. CW11 said that Blessing Hospital in Quincy, Illinois was beta testing ADX 1.0 sometime in late 2011, but could not recall specifically when it began. CW11 said he was told that the testing was stopped in early 2012 because the product was not working properly and Allscripts deployed a product development team to Blessing Hospital to develop a workflow which lead to ADX 1.5. As far as CW11 knew, no one went live on ADX 1.0. Blessing Hospital began testing ADX 1.5 in late Spring 2012, and was the first to go live using ADX 1.5 in July 2012 which allowed the integration of patient information seamlessly between Sunrise and Enterprise applications. Components of Helios went into ADX 1.5. ADX 1.5 allowed for integration of patient data relating to PAMI (problems, allergies, medications, and immunizations) but some competitor products allow for significantly more types of data to be seamlessly exchanged and Allscripts was working to increase the types of data that could be seamlessly exchanged between acute care and ambulatory applications.

In effect, if the allegations are true, sancrosanct patient's rights have been trivialized, while poor software of non-trivial risk has been sanctified.

This would be, needless to say, deranged.  Software can be debugged in test environments without putting patients at risk - if one is willing to invest the resources to do so.

The Class Action lawsuit Plaintiffs should perhaps seek to discover if there were patient harms or deaths as a result of the alleged software beta testing - assuming that information was not thoroughly "cleansed" by now.

I also note that even small NIH SBIR/STTR grant proposals involving use of new or modified IT on patients, on whose study sections I am an invited reviewer in the domain of Medical Informatics, are subject to human subjects protection evaluation:

http://grants.nih.gov/grants/peer/critiques/sbir-sttr.htm

... Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 [see http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf - ed.], the [grant review] committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

In health IT tests in hospital settings, which is most certainly experimentation, there are simply no human subjects protections whatsoever.  Hospital IT deserves no special accommodation regarding Protections for Human Subjects.  There are no justifiable reasons I can think of. 

-- SS

Addendum:  Perhaps I'm wrong about people's generosity and altruism.  I would like to hear from people who would gladly submit, say, their newborns as test subjects for the beta testing of experimental health IT software.

Guest Post: Incompetent Management Breeds Demoralized Physicians

Health Care Renewal presents a guest post by Dr Howard Brody, John P McGovern Centennial Chair of Family Medicine, Director of the Institute for Medical Humanities at University of Texas - Medical Branch at Galveston, and blogger at Hooked: Ethics, Medicine and Pharma. 

Danielle Ofri, a prominent internist/author at Bellevue in New York, started a recent op-ed piece, “Last week I was ready to quit medicine."

She described an encounter most physicians can relate to—a 15-minute appointment slot, a new patient who spoke only Bengali, a long and complicated problem list, a bag containing 18 different medicines, two forms that had to be filled out by the doctor on this day’s visit, and a computer that froze while she was trying to keep up with the electronic charting. She described how, 45 minutes into the supposedly 15-minute visit, she had a phone in one ear with the Bengali translator and tech support on hold in the other ear.

Ofri’s plaint caught my attention because I had recently put up a guest post on Health Care Renewal about another highly skilled, caring physician who was seriously considering quitting practice. This led me to write a column for some of our local newspapers about demoralized doctors

In the space allowed in an op-ed column, you can’t go into great depth in analyzing a complicated situation. So here’s what I would have wanted to say.

We can list all the management failures that this encounter represents. I won’t even start with the electronic record as that’s such a frequent theme in this blog. Who scheduled such a patient for a 15-minute visit? Where is the pharmacist who could have done a better job of going through all the lady’s medicines? Where is the staffer who could have filled out the forms for Dr. Ofri to sign? This is just to scratch the surface.

There are two things worrisome about this long list of management failures. If the goal of the health care system is actually to take good care of patients, then it seems obvious that Dr. Ofri, who wanted to try to provide high-quality care, had roadblock after roadblock thrown in her way.

Cynics will protest that this system obviously has no interest in quality patient care and seeks only to maximize revenue. If that’s so, is it really true that a board-certified MD is the most efficient labor source for keyboarding data into a computer, filling out paper forms, and doing all the other busy-work tasks that Dr. Ofri had to juggle? Can anyone really believe that this management structure supports either quality care or efficient resource use?

If the management of U.S. hospitals was severely understaffed or underpaid, then we could perhaps forgive such lapses. But we know that while the growth of physicians in the U.S. has been slow, the number of administrators has grown by leaps and bounds [The number of health care managers increased by 726% from 1983-2000 while physician numbers increased by 39%, look here - Ed]  . And we know that at least at the high end, these managers are paid munificent sums, and are lauded for their supposed genius (look here for example). 

So we appear to have a system that is slowly (in some cases rapidly) driving the best doctors out of practice, and yet somehow imagines that everything is going all right and there’s no problem—or if there’s a problem, it’s those whining doctors.

All us medical educators know that when we ask the first-year class how may of them have been told by practicing physicians that they’re making a big mistake coming to medical school, the majority will raise their hands. Yet the managers of America’s health systems apparently believe that they can go on demoralizing good practitioners and nothing bad will happen.

This may sound as if I am saying that health care managers are all evil people, but that’s an unfair characterization. These folks are simply trying to do what our society tells them. As I explained some time ago, most of our popular and political discourse has been captured by a belief system that can be variously called neoliberalism, market fundamentalism, or economism. The ideology can be summarized as a quasi-religious faith in the so-called “free market,” steadfast opposition to government regulation of the market, and opposition to just about any form of taxes (for more on the nature of economism, look here.)

Among other things, this ideology teaches us that everything important in our society can be accurately captured in objective measures of “productivity” and “efficiency.”  [This is akin to the "shareholder value" theory of management (look here), or "financialization." - Ed]  Once one has mastered the basic concepts taught in MBA school, there’s no need to learn anything about health care and what makes it a unique activity; there’s no basic difference between providing health care and flipping burgers at McDonalds or making widgets. [We have called this generic management. - Ed.]. And so we get the crazy style of management well documented on this blog, not because of personal nastiness or ill will, but due to the ideological Kool-Aid everyone has been drinking for several decades now.

Today’s physicians seem to be like the proverbial frog being boiled in the pot of water because the heat was turned up so gradually the frog never figured out it needed to jump. [That is, they are suffering from "learned helplessness." - Ed] Dr. Ofri herself seems to represent a typical frog. Why? Perhaps it’s the style of the blog or op-ed writer to start off with a downer and then try to end on an upbeat note. Or perhaps it’s the natural physician’s tendency to stay away from policy questions. I’m not sure.

After starting us off with this hard-hitting description of a dysfunctional system, Dr. Ofri ends by opining that things are going to be better in the future because more women are entering medicine and because today’s medical students are more tech savvy. She gives herself credit for managing to forge a bond with the patient because they sat together and faced this adversity. She cites an upbeat study, “when asked what was the most satisfying aspect of medical practice, the number one answer was relationships with patients. This is what keeps us going on even the most trying of days.”

Dr. Ofri gets full credit for remembering the importance of relationships, and feels that she bonded more firmly with her patient because they went through all this together. How about a word, though, about the people behind the curtain, who are responsible for all that she and her patient had to go through, and who don’t seem to have a clue how bad it is and what it all means? 

Dr Howard Brody

Candid Nurse EHR Opinions at Facebook Page "Friend a Nurse" Are Not So Friendly

At my Jan. 2010 post "An Honest Physician Survey on EHR's" (http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html) I wrote:

I often believe surveys of physicians about EHR's do not present the results candidly, but rather are selective in what is reported - and what is omitted - and generally sugar-coated.

I then presented a candid physician survey on EHR's that was not very complimentary of the technology's value to real-world practicing physicians.

The following candid, informal nurse's survey about EHR's came to my attention the other day via Google.  The thread is on Facebook in the "Friend a Nurse" group pages and can be read at https://www.facebook.com/friendanurse/posts/654085127954821.

Apparently the thread got underway after someone posted the question "What do you think of electronic medical record systems? How was it implemented in your facility? Has it helped or hurt patient care? If so, how?" and a link to the June 25, 2013 Bloomberg News article "Digital Health Records’ Risks Emerge as Deaths Blamed on Systems" (http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html) that mentioned my mother's experience.

The EHR question posed on the "Friend a Nurse" Facebook page at https://www.facebook.com/friendanurse/posts/654085127954821.  Click to enlarge, or click Facebook link, which is public as of this writing.

I note that I had no knowledge of this, nor do I know the responders.  I did add a link to my Drexel website on health IT difficulties at the end of the thread, however, after I discovered it.

Here are the comments from both female and male nurses who belong to this Facebook group.  I redacted the names, however they can be seen at the Facebook page itself at the link above.

------------------------

Big problems when you have unexpected "downtimes".
July 15 at 1:10pm · 4

It is an absolute train wreck, I havent seen one record of mine that is not riddled with mistakes. Especially the allergies, they show me taking meds Im allergic too and not taking meds Im actually on.. A true mess!!And now the records are all intertwined. I dont like it at all!!
July 15 at 1:10pm

It is a nightmare!
July 15 at 1:18pm

I retired just in time so I don,t have to deal with this fiasco
July 15 at 1:19pm via mobile

IT SUCKS
July 15 at 1:19pm

I don't like them; my doctors don't like them; how it will affect patient care is still a 'jury out' matter, but we can guess it will NOT help.
July 15 at 1:30pm

our Rural Community Healthcare system is just now switching over to this..along with our hospital switching over to a totally new computer system..the 2 systems do not talk to each other..In my personal experience I find that the "computer" world takes us away from Direct Patient Care.(to busy playing "ring around the Rosie" on the computer..
July 15 at 1:40pm

I like them, but it is frustrating having "downtime."
July 15 at 1:41pm

I hear patients stating things like "my doctors don't know who I am because they don't look at me they are glued to the computer". It saddens me patients feel less valued. I've worked in places where they've had paper charts and places computerized. Seems the computers are redundant and I personally prefer paper charts. Chart one assessment not one assessment 4 different places.
July 15 at 1:44pm via mobile

It looks to me like physicians are cutting and pasting old histories and physicals, complete with the errors. Doctors in a local ER charted complete physicals on me when they did not get closer that 5 feet away. The records are difficult to read, difficult to find information, and not number in chronological order.
July 15 at 1:47pm

I dislike it . Besides the down time find it very impersonal . I don't feel as if I am giving my full attention to my pt, nor do I feel my PCP is hearing what I ' m saying . They are to busy putting in info on the computer . As for the down time you then have to work late to put in the info gathered while the system is down.
July 15 at 1:47pm via mobile

Electronic charting takes the skilled nurse away from the patient and puts them in front of a computer. Its NOT best for the patient or staff - the people who build the programs have not been at the bedside for eons....so the programs are time consuming, redundant, and inefficient.
July 15 at 1:51pm

I like EMR very much. The system we use is Allscrips, it is not perfect, but the benefits outweigh the problems. For example, I find most issues are human errors, such as poor spelling, incorrect entry in the proper records, entering incorrect doses. I love the fact that I can actually read and do not spend time deciphering not only the doctors writings, but my coworkers. I like having all the records in one place. There are issues for sure, but some of the issues is from companies who chooses to,purchase low quality EMR packages with poor support. The systems also need to be more standardized and "speak" to each other better. And folks at the end of the day it is your license at risk, do the things you were trained to do in nursing school, the 5 Rs remember those?
July 15 at 1:53pm via mobile

we are starting on it, let you know
July 15 at 1:53pm

In general I dislike it. If it 'goes 'down', you end up being unable to obtain vital information. With the federal system we did have both the computer records and the paper records. This was fine with inpatient informaton. I dislike it when my computer crashes and I can't get anyone to come look at it or fix it. They had a message line which we never had a call back from. I'd have a whole dept be down and non one to repair it. It's very frustrating on a triage line. This made scheduling appts impossible. Lack of vital information could be lethal to critical care patients...Far less pro's than con's. It's just a bad decision all together..
July 15 at 2:01pm

if THE GOVERNMENT CAN GET INTO YOUR RECOREDS SO CAN ANYONE they can hack anywhere now a days and it is scary///
July 15 at 2:05pm

anyone over 25 most likely hates it
July 15 at 2:09pm

I quit 2011...did CPOE no issue but more more is coming seems like q mo. or so keeps adding dig. stuff...hosp. worked with kept changing sys...used to ask myself why fix when not broken also once you got use to it thats when they change...they shld hire more nurses aux. ppl...do not know what to do with their money. Stressout...no more nursing for me . New grads savvy but this boomer did it for 38 yr. Enough is enough!!
July 15 at 2:14pm via mobile

Takes time away from pt care too much:-)
July 15 at 2:34pm

I work in a hospital and I hate it! I feel like I spend more time looking at the computer than at the patient. We have to document the same thing in multiple areas...big waste of time! Also our ER and OR's use a different program and we are not able to access this information when a patient is admitted to the floor. We also use Physician OE and the system we have it is hard to get back to look at an already viewed order. I feel this is dangerous and orders are missed all the time. It is just a ticking time bomb before someone is going to get hurt!
July 15 at 2:35pm

The med was there then disappeared.....software is only as good as the person using it. A PERSON DELETED THE MED! Pharmacies, nurses, and MDs use the computer did it as an excuse. Never understood how I corrected MARs every month and they were worse the next month...the computer did not do it alone. I dislike the MD playing on the computer and half listening to me.
July 15 at 2:38pm

Recently I have had md's not put a patient back on home meds because he/she could put them in correctly. I had to call the doctor on call at night to get these medications in place. The pt was also missing vital medications they needed for their diagnosis. I feel like in some cases emr is not safe. There however some cases where emr is helpful.
July 15 at 2:43pm

it will get better with time...
July 15 at 2:45pm

I worked at a VA until I retired, and I loved it. It is so much easier. Lets face it, anyone that wants your information is going to get it anyway.
July 15 at 2:57pm

I have used EMR in hospitals, home health and hospice for the past 20 yrs. When used within the same corporation w many offices it is very efficient. In that state corrections dept it was very helpful w continuity of care. the medical record follows the inmate to what ever unit they may transfer to. HIPPA is even more important with the EMR systems.
July 15 at 3:14pm

We just changed our system to a new one. It took a large group of staff over 18 months to develop our documentation system. The nursing portion is great. The med ordering part is difficult to use. The docs are all complaining about the system. They want to continue writing their orders.
July 15 at 3:17pm via mobile

We have had epic for over 5 yrs it is a great system.just wish computers worked better always having to shut down and reboot. Has saved us a few times with preventing med errors.covenant healthcare did a great thing when they got this system
July 15 at 3:18pm via mobile

I think it is an injustice to the Patients We are more than a computer file
July 15 at 3:24pm

It helps with a history when a patient is unable to provide
July 15 at 3:29pm via mobile

Plus it may have contacts address patients previous baseline behavior I'm a psych nurse so we utilize this type of system
July 15 at 3:30pm via mobile

Takes time away from patients, goes down too often, difficult when hospitals change systems. There should be a universal system, so info can be shared.
July 15 at 3:40pm via mobile

EPIC is terrible when it comes to outpatient chemotherapy and research. It is cumbersome and takes so much time away from patients. EMR's are here to stay and I think it's a great thing, for the most part, but sheesh make it easy on the provider, will ya?
July 15 at 4:07pm

we fear medication errors because some doctors start up home meds that are no longer correct. getting used to it is the hardest. the younger nurses are much more efficient and comfortable with it.
July 15 at 4:16pm via mobile

I agree with Noelle, it took focus away from the patient because it was cumbersome and repetitious, and because of the environment we had to keep the people moving through recovery....so it was dreadful. I was happy to retire and leave it to others to deal with.
July 15 at 4:30pm

I've worked with electronic T-system, Promed blue, Meditech, etc and all have their advantages and disadvantages, but the major disadvantage is that we don't do patient care anymore...we do computer care...I could also go on and talk about the fact we also don't get to spend as much time with our patients because of patient ratios and patient loads and the computer charting we have to get back to...
July 15 at 4:32pm via mobile

you are right on target here.....I retired because of this, there is very little patient care, it is indeed computer care !
July 15 at 5:00pm · 1

Nursing Informatics Institute How has nursing been involved in the planning and implementation of these systems? Feel free to share your experiences, it is very interesting to hear about your practice.
July 15 at 5:15pm

I love the electronic records. I do not love all the different styles ect programs out there. So many glitches. Patient's need to be proactive and as involved in their healthcare and that of their loved ones as possible. That means bringing ALL of your med bottles with you to each and every doc visit you go to. I don't care how many times or how many diff docs you see in a week, ALWAYS take ALL of your meds in the ORIGINAL bottles. Where I work there is 100+ doc's in this group, each doc office has access to same record I see when the patient comes to us. Each doc office can ad or make changes to the chart accordingly, so if you don't bring your meds with you to each visit and doc A changed a med and made the notation in the chart we see it but can't verify it. ALWAYS keep an updated list of meds in your wallet/purse for those emergencies when you don't have your meds. Include on this list, your surgical history, your medical history(Diabetes, hypertension ect ect ect), who your PCP is and a #, allergies, blood type, your wishes as far as DNR ...... It will save your loved ones precious time and allow them to focus on you, and not that new pill doc so & so started you on for her diabetes, I think. Anyway, with so many spoons in our medical records here, I catch mistakes all the time where a med has been deleted/added ... By another office. Usually because the patient did not bring the meds, or the patient is a poor historian of their own medical history and the family has no clue. Be proactive people, don't trust us to do it all. Get the dam electronic records fixed so they make sense, and stops all this confusion ..... Why so many different types and formats are needed is beyond me.
July 15 at 6:01pm 

not the systems that cause the problems, staffers that program only what they think is important when making diagnosis.
July 15 at 6:37pm

Love it - but when they go down.....
July 15 at 6:39pm

Mostly like it. Rather type than write. Does take more time than paper note, but overall I like it. I agree when I see patients & when I or my family is the patient, MD hardly looks at you; too busy inputting data.
July 15 at 6:52pm via mobile

No Comment.
July 15 at 6:52pm 

it is a huge improvement! and a potential life saver - no more figuring out what that handwriting is saying.
July 15 at 7:13pm

I generally like EMRs but some programs are so damned redundant (charting the same IV start every time you admin an IV med?) and/or lacking in -- how do I put it? -- intuitiveness. Sometimes I really wonder if anyone actually working with patients was involved in the design or implementation of some of the programs we use.
July 15 at 7:31pm 

Has it's good points and bad points. But I spend more time on the computer, then at the bedside.
July 15 at 7:55pm

I think computer charting has went way overboard and takes the nurse away from the bedside. How does family view nurses that are at the desk on the computer all the time?
July 15 at 8:27pm

it is disconcerting to the patient and or family if the health care provider starts firing questions and then spends the entire visit looking through the chart instead of listening to the patient's effort to provide a history of symptoms. No eye contact diminishes the interaction significantly!
July 15 at 9:15pm

for some things they are O.K. but everything no. Maybe scanned for some things. Now I have not thought out a plan for which, maybe someone with more time than I have could do a better job.
July 15 at 11:36pm

Haven't seen it work too well.
July 16 at 1:04am

It takes a lot of patience to get it implemented into a facility. The inservices that we
have had are few and basically it is a learn as you go. When everyone is finally sure of how to do it, it will be OK but is taking a long time for all of it to be taught to us
July 16 at 7:31am

mountains of paper, I mean mountains...
July 16 at 10:22am

as nurses, we are buried in paperwork... so are the docs... looking for a way out, we all THINK the digital answer with EMR is THE way... BUT nobody has proved it is superior, or really saves time or workload... and now the GOVERNMENT is pushing us into a costly and complex system
July 16 at 11:14am

------------------------

I think the comments (largely negative with several "positive but with significant concerns") more accurately reflect EHR reality "in the trenches" than the marketing propaganda emanating from government, the health IT manufacturers, the academic pundits, and other "see no evil, hear no evil, speak no evil" triple-simian hyper-enthusiasts.

On EHRs:  see no evil, hear no evil, speak no evil

Of course, the hyper-enthusiasts will call these opinions "anecdotal", but as one investigative reporter who does work in the EHR sector opined when sent the Facebook page:  

"That's a lot of anecdotes."

-- SS

Why Do People Think US Health Care is Corrupt? - The Examples of Amgen, Mallinckrodt Settling Charges of Giving Kickbacks to Doctors to Induce them to Prescribe Their Products, While No Individual Suffers Negative Consequences

We recently posted a discussion of the results of Transparency International's 2013 corruption barometer, focusing on the US results.  43% of survey respondents thought US health care is corrupt.  Our coverage, apparently the only substantial discussion of the US results published in the US, got star ranking for a while on Reddit.  But many anonymous commentators dismissed the survey results as coming from a naive public who does not understand health care economics.

I submit that one can recognize corruption without a degree in economics.  In fact, as we discussed in the initial post, there is a lot of evidence for the prevalence of health care corruption in the US, other developed countries, and globally.  It is just that such evidence rarely gets discussed in public (the anechoic effect, as we say on this blog), probably because doing so might make those who are profiting from the corruption uncomfortable.

So today let me summarize just the latest evidence about US health care corruption, as defined by Transparency International as the abuse of entrusted power for private gain.  (Note that the Transparency International definition of corruption, which is an ethical, not necessarily a legal definition, at least in most jurisdictions.)

Amgen

An article in the Thousand Oaks [CA] Acorn described the legal settlement,

Amgen Inc. paid the United States more than $15 million this month as part of a settlement agreement to resolve allegations that the biopharmaceutical company used financial kickbacks to persuade doctors to prescribe the cancer drug Xgeva to their patients.

The settlement resolves a qui tam, or 'whistleblower,' lawsuit filed Jan. 20, 2012, in federal court by William Davis and Spencer Miller—two Amgen employees who work at the company’s Thousand Oaks headquarters.

Davis, sales planning director for Amgen’s oncology business unit, and Miller, a senior marketing manager at the company, alleged their employer violated both the Medicare Anti- Kickback Statute and False Claims Act—two laws that aim to prevent Medicare fraud and abuse.

The allegations were that Amgen used a somewhat complex and deceptive strategy to pay doctors who prescribed its drug, using a survey about practice patterns as a cover story,

According to the U.S. attorney’s office, Amgen used what the company called 'Deep Dive' contracts—or data purchase agreements—in an effort to boost sales of Xgeva, which was approved by the FDA in late 2010 for use by certain cancer patients undergoing chemotherapy.

The drug is most commonly prescribed to prevent bone fractures in patients who have been diagnosed with a certain type of tumor after it has spread to the bones.

Under Amgen’s original Deep Dive program, the company paid doctors to fill out an Internet-based survey, which asked how they were treating patients with bone cancer and which drugs they used.

'That’s not illegal to do,' said Abraham Meltzer, assistant U.S. attorney in the Los Angeles civil fraud section. 'A lot of pharmaceutical companies purchase data legitimately on how various conditions are treated.'

But Amgen altered its Deep Dive program, Meltzer said, by increasing the amount of money it offered to pay the doctors who specifically prescribed Xgeva to their patients.

Also,

 The U.S. attorney’s office also alleged that Amgen paid oncologists and urologists to participate in market research surveys, audience response sessions and advisory programs that publicized the benefits of Xgeva.

As is typical in such cases, the settlement did not require any contrition on Amgen's part.  Instead,

In a prepared statement emailed to the Thousand Oaks Acorn on Tuesday, Amgen denied all allegations of wrongful conduct.

'Amgen settled this matter to avoid the delay, uncertainty, inconvenience and expense of protracted litigation,' the statement read.

As is also typical, there seemed to be no negative consequences for the human beings who must have engineered the "Deep Dive" contracts and the payments to the oncologists and urologists.  Nor was there any overt consideration of Amgen's sketchy recent ethical record, as described by the Acorn,

This month’s settlement is not the first time the biopharmaceutical giant has been held to answer for kickback allegations or false claims charges.

In December 2012, Amgen pleaded guilty to illegally selling the drug Aranesp, an anti-anemia drug, for uses or doses not approved by the FDA, according to the U.S. Department of Justice.

As part of the false claims case, which was also brought on by a whistleblower lawsuit, Amgen agreed to pay a $612-million civil settlement to the U.S. and individual states, as well as $150 million in criminal penalties.

Then in April, the Thousand Oaks-based company paid the U.S. another $24.9 million to settle whistleblower allegations that it gave financial kickbacks to long-term care pharmacy providers in exchange for switching Medicare and Medicaid benefi- ciaries from a competing drug to Aranesp, a DOJ press release states.

We discussed the guilty plea in the cases of Aranesp misbranding and alleged kickbacks to pharmacists.  Also, in 2013, we noted that Amgen settled allegations that it overpriced its products sold to government health programs in 36 states.  We also noted that despite, or perhaps because of all this misbehavior, the current CEO of Amgen received over $13 million in compensation in 2012, while his predecessor walked away with over $9 million that year.

Mallinckrodt

A small news item from the Associated Press, via the Nanaimo (MO) Daily News, outlined this legal settlement,

A St. Louis-based drug maker will pay $3.5 million to settle allegations that it paid doctors to prescribe 'outdated, third rate' antidepressants and sleep aids, the U.S. attorney's office in San Francisco announced.

In particular,

The lawsuit alleged the company targeted doctors who prescribed the type of antidepressants and sleep pills Mallinkrodt manufactured.

Again, the company was allowed to settle without admitting anything.

'While we deny the allegations in this matter, we are glad they are resolved,' company spokeswoman Erica Abbett said in a statement.

Again, although human beings would have had to engineer any payments to the doctors to induce them to prescribe, no human beings suffered any consequences as a result of this settlement.

Mallinckrodt, a storied corporate name, had been acquired by Covidien, and then was spun off again as a separate company in June, 2013 (look here).  It had been acquired in 2000 by Tyco International, which later spun off its health care operations as Covidien.   According to its 2013 proxy statement, Covidien's CEO received over $10 million in total compensation in 2012.


[Note that Tyco was the subject of one of the major scandal stories of the early 21st century.  In 2005, at a time when law enforcement authorities were still pursuing actions against elite corporate executives,  its former CEO and CFO were convicted of stealing millions from it (see USAToday summary)].

Summary - Why do People Think US Health Care is Corrupt?  

Again, the Transparency International definition of corruption is abuse of entrusted power for private gain.  I would argue that pharmaceutical companies are entrusted with the power to honestly sell drugs whose benefits to patients outweigh their harms.  I would further argue that paying physicians, who are entrusted with providing the best possible care to each individual patient, to prescribe drugs which may not be the best treatment for individual patients is an abuse of both the company's and the physicians' entrusted power.  Further, such payments provide private gain to the physicians.  They also may increase revenues for the company who makes these payments, and very likely these increased revenues lead to better compensation for those in the company who authorized, directed or directly provided the payments, that is to private gain for these corporate insiders.  Thus it seems that kickbacks to physicians to prescribe drugs is a form of corruption.

While both cases above were settled without admissions of guilt, such settlements do not refute the contentions that kickbacks were given.  Why would the law enforcement officials have brought the cases in the absence of evidence, and why would the companies have settled if the cases were completely baseless?  So I would argue that these settlements provide evidence, although not legal proof, that kickbacks were given.  People with far more legal knowledge than I possess have remarked on the absurdity of settling cases of alleged wrongdoing without any acknowledgement or statement of the facts (see posts here and here).

We have posted lots of instances of conflicts of interest affecting health care, many of which likely involved payments providing private gain that raised the risk of abuse of entrusted power.  We have also discussed many instances of crime, kickbacks, bribery, fraud other kinds of health care corruption.

So were the people who answered the Transparency International survey naive and foolish about health care corruption?  Or did they have reasonable beliefs about a topic that the powers that be really do not want to discuss?

EHR importance vastly oversold? Community health center battles for electronic patients' records - but patient care goes on anyway

There are two lessons from the Milwaukee Journal Sentinel story below.

1) Beware outsourcing the ownership of your hospital or clinic's medical records.

2) The value of EHRs has been massively and repeatedly exaggerated.  Milwaukee Health Services have been operating without access to electronic patient charts for almost a month, yet there are no reports of massive casualties.  There are numerous reports on this blog of EHR system downtimes lasting weeks, loss and sabotage of electronic records, and other mishaps, yet patient care is claimed to have not been compromised.  Perhaps those who make such claims need to be taken at face value.

It follows that expenditures of hundreds of billions of dollars for EHR systems is simply unnecessary and the technology's importance vastly oversold.

Excerpts are below; read the full story at the hyperlink.

-- SS

Community health center battles for patients' records

By Guy Boulton of the Journal Sentinel
July 20, 2013

Doctors at Milwaukee Health Services have not had access to the medical records of 40,000 patients since June 30, when an Atlanta company cut off the community health center's access to its electronic medical records after their contract ended.

Milwaukee Health Services sued Business Computer Applications Inc., the Atlanta company, last week in federal court and is seeking a court order to restore access to patients' medical records.

The records include patients' medications, problem lists, allergies, immunization records, treatment plans and other clinical information.

The doctors and other health care providers at the community health center can get key information, such as medication lists and lab results, from pharmacies and other sources, said Tito Izard, a physician and chief executive of Milwaukee Health Services.

But access to patients' medical records is "obviously important," Izard said.

Milwaukee Health Services sought a court order last week to require Business Computer Applications, known as BCA, to restore access to the medical records, contending that the safety of patients was at serious risk.

The court denied the request for a temporary restraining order.

... Milwaukee Health Services, which provides care to about 30,000 people a year and has medical records for about 40,000 people, entered into a five-year agreement with BCA on July 1, 2008.

The community health center contends that BCA's system was not fully functional after paying the company $3.1 million over the past five years.

"There was a never-ending request for more money to fix the system," Izard said.

... In its complaint, Milwaukee Health Services alleges BCA violated the Wisconsin law that requires health care records to be released upon the request of a health care provider in the care of patients.

The community health center plans to seek a court order in the next several weeks that requires BCA to provide access to the medical records of its patients.

More here:  http://www.courthousenews.com/2013/07/17/59431.htm.  Looks like the patients affected are predominantly poor and/or minorities:

... A computer firm is "jeopardizing the health and safety of about 40,000 people" - many of them uninsured or underinsured - by freezing a hospital out of access to its own medical records because of a billing dispute, the hospital claims in court ...  Milwaukee Health Services Inc. "specializ(es) in the care of underserved populations," the hospital says in its complaint. It says it "serves everyone regardless of income or third party coverage."

-- SS

Electronic siloing: An unintended consequence of the electronic health record - Cleveland Clinic Journal of Medicine

EHR systems have largely been designed by those of a manufacturing, mercantile, and management computing background, largely due to abdication of responsibility and acquiescence by medical professionals, and political impotence of organized medicine and medical informatics organizations.

The results were predictable - a toxic effect on healthcare.  One such toxic effect is an impairment of essential communications between caregiving personnel - exactly the opposite effect the hundreds of billions of dollars spent on today's health IT was intended to improve.

From the Cleveland Clinic Journal of Medicine:

Electronic siloing: An unintended consequence of the electronic health record
July 2013

JAMES K. STOLLER, MD, MS
Chair, Education Institute; Staff, Department of Pulmonary, Allergy, and Critical Care Medicine, Cleveland Clinic; Jean Wall Bennett Professor of Medicine, Cleveland Clinic Lerner College of Medicine, Cleveland, OH

For all the purported benefits of the electronic health record (EHR), an unintended adverse effect is “electronic siloing.”

I define electronic siloing as the isolating effect of the EHR on clinical workflow that drives caregivers to work in silos, ie, alone at their workstations, thereby discouraging spontaneous interaction. To the extent that increasing evidence supports the importance of interaction among clinical colleagues and of teamwork to optimize clinical outcomes, electronic siloing threatens optimal practice and quality.

Not only does it "threaten" optimal quality, it causes that quality to deteriorate to the point where a recent volunteer study at 36 hospitals by the renowned ECRI Institute (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html) found more than 170 health IT-related mishaps in a mere 9 weeks, 8 of those incidents resulting in patient harm and 3 possibly contributory towards patient death.

... THE EHR BRINGS CHANGES, GOOD AND BAD [the latter especially from bad health IT - ed.]

The EHR represents a major change in health care, with reported benefits that include standardized ordering, reduced medical errors, embedded protocols for guideline-based care, data access to analyze clinical practice patterns and outcomes, and enhanced communication among colleagues who are geographically separated (eg, virtual consults). On the basis of these benefits and the federal Medicare and Medicaid financial incentives associated with “meaningful use,” the EHR is being increasingly adopted.

The literature supporting those benefits is scarce, of poor quality, and refuted by other literature by credible authors - not the optimal environment to justify spending hundreds of billions of dollars (e.g., see http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html).

Yet for all these benefits and the promise that technology can enhance interaction among health care providers, unintended risks of the EHR paradoxically threaten optimal clinical care.6Recognized risks include the threat to care should the EHR fail, the time and inefficiency costs of typing and multiple log-ons, and the perpetuation of errors in the medical record caused by the cutting and pasting of clinical notes.

To name just a few, all covered on this blog in various posts.

... Niazkhani et al noted that computerized ordering can change communication channels and collaboration mechanisms. More specifically, they point out that these systems can “replace interpersonal contacts that may result in fewer opportunities for team-wide negotiations."

This is, in fact, obvious to any practicing physician or nurse and requires no academic "proof."

Similarly, Ash et al cited the unintended consequences of patient care information systems, especially increased overreliance on the system to communicate, which can undermine direct communication between healthcare providers ... Taken together, these observations suggest that the EHR and computerized order entry in particular can disrupt interaction between physicians and other health care providers, such as nurses and pharmacists.

Similarly, that this needs to be stated in 2013 is akin to stating that it's a good idea to use sterile technique in surgery.

...  the EHR can inadvertently lessen spontaneous interaction between physicians as they care for outpatients. I have proposed the term electronic siloing to reflect the isolating impact of the EHR on clinical workflow that drives caregivers to work alone at their workstations, thereby discouraging spontaneous interaction between colleagues (eg, between primary care physicians and subspecialists, and between subspecialists in different disciplines). Because spontaneous face-to-face encounters and conversations among clinicians can encourage clinical insights that benefit patient care, electronic siloing can undermine optimal care. My thesis here is that the EHR predisposes to electronic siloing and that the solution is to first recognize and then to design care to prevent this effect.

The solution is first to force the industry and its pundits to admit the problem is poor design and hyper-enthusiasm that resulted in a premature national program for health IT diffusion, and abandon claims that clinicians are "Luddites" (see "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).

Defenders of the EHR will point out that the EHR does not preclude such face-to-face encounters.

"Defenders of the EHR" will frequently default to fictitious and often ad hominem "blame the user" canards, since their scientific rationale for the proliferation of today's very poor systems is very weak.

While technically this is correct, it is also equally true that such encounters are less likely because they no longer flow naturally from the workflow of writing a note side-by-side with colleagues with the films displayed nearby. Pressured for time, clinicians learn efficiency of motion and are simply less likely to leave their workstations to seek another colleague who, in turn, may be tethered to a workstation and absorbed in keyboarding and monitor-watching. The net effect is that such spontaneous face-to-face encounters are clearly less common in the EHR era.

Again, this thinking will be countered by the hyper-enthusiasts by blaming users.  My response is that good health IT never depends on users to compensate for poor design or implementation, and there's nothing else to debate on that point.

... So, given the many clear benefits of the EHR and its current wave of adoption in health care, how can we maximize the benefits of the EHR while minimizing the adverse effects of electronic siloing?

Reasonable suggestions follow; see the article at the link above. 

The problem is that the reasonable suggestions are being proffered in an unreasonable, industry-dominated environment.

The first step is political action and activism by clinicians to take charge of the clinical information technology playing field.  Until and unless that occurs, even thoughtful articles from Cleveland Clinic, Harvard, Yale etc. will simply be shelved.

-- SS

Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity

I had guessed that this sort of thing was going on all the time, but being kept very well hidden.  Now we have some more evidence.

An article in yesterdays Guardian showed how the pharmaceutical industry is using pet patient advocacy groups in a public relations campaign to defeat calls for for measures against suppression and manipulation of clinical research. In summary,

The pharmaceutical industry has 'mobilised' an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.

More specifically,

The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.  The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee.

The email describes a four-pronged campaign that starts with 'mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.

The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database.

The argument for continuing to allow clinical trials to be suppressed was to be,

The patient groups focus on the concern that if companies release all of their clinical trials data, the information might be misconstrued, or intentionally cherry-picked, and spark damaging health scares around certain drugs or vaccines.

The Guardian story did not disclose which patient groups were cooperating with this effort.

By the way, the other parts of this strategy involved using scientific associations and academics to push the pharmaceutical companies' agenda,

 Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. The final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. 

Several of the large multinational drug companies contacted by the Guardian issued the usual non-denial denials

In response to queries from the Guardian, GSK said: 'This is not something we are doing. One of the reasons we're involved in this is we want more companies to move towards greater transparency. I don't think it's for us to be mobilising patient groups to campaign on a negative level.'

A Roche spokesperson said the company consulted patient groups to understand their concerns about clinical trials, but 'to our knowledge Roche has not been involved in any EFPIA's potential activity in mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'.

A Lilly spokesman said: 'Lilly is committed to working with Europe-based patient advocacy organisations for the benefit of patients in a way that is true to the EFPIA code of practice and Lilly's integrity in business policy.'

Summary

We have long discussed and decried how vested interests, chiefly health care corporations with services and products to sell, have manipulated clinical research to make their wares look better, and suppressed research whose results, even if manipulated, could not be made sufficiently favorable. This has resulted in making drugs and devices look more efficacious and/or less hazardous than they really are.  See this post for our latest discussion, and information on the latest effort to counter suppression and manipulation of clinical research.

It is not surprising that pharmaceutical companies do not want to have to publish every clinical trial they sponsor, or expose their manipulations of these trials.  Instead, the Guardian article suggests that companies and their trade associations, including the US based pharmaceutical trade association, and several large US companies, and well as large companies based elsewhere, are using a third-party public relations strategy.  Wendell Potter's muckraking book on the US commercial health care insurance industry, Deadly Spin, revealed how similar strategies were used by US based health insurance companies to defeat the Clinton administration's attempt at health care reform, and other measures targeted to make the US commercial health care insurance system more equitable and ethical  (see post here).  Third party strategies are fundamentally deceptive.   

The current alleged use of the third party strategies by pharmaceutical companies to support ongoing suppression and manipulation of clinical research is more than just deceptive.  It is corrupt.

Patient advocacy groups are usually believed to represent patients' interests.  For such groups to support a public relations campaign that could allow ongoing harm of patients (by suppressing and manipulating evidence to prevent it from being used to forestall excess use of ineffective, dangerous drugs) is abuse of their entrusted power.  To do it for money, money used to support these groups, or help underwrite generous compensation for their executives, fits the definition of corruption used by Transparency International - abuse of entrusted power for private gain.

Note that the Guardian provided this viewpoint,

Tim Reed, of Health Action International, a group that has previously exposed the pharmaceutical industry's financial links with patient groups, said: 'It's incredibly ironic that this is a transparency initiative and we've now got clear indications that the pharmaceutical industry is ready to use patient organisations to fight their corner.

'It underlines the fact that patient groups who are in the pay of the pharmaceutical industry will go into battle for them. There's a hidden agenda here. The patient groups will say they think it's a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry.

'Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we're not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials,' he added.

We have previously noted isolated examples of evidence that particular US based patient advocacy groups were being supported by commercial firms presumably to aid their marketing.  We have also found examples of conflicts of interest affecting medical societies, and many affecting non-profit hospitals and academic medical institutions, and their staff and faculty.  I begin to wonder if most health care non-profit organizations in the US, and now it appears maybe in UK and in Europe, have been paid off to support marketing and/or public relations interests of health care corporations.

This latest example suggests that health care worldwide has become deeply corrupt, even more corrupt than Transparency International's Global Report on health care corruption in 2006, or the those responding to Transparency International's global corruption survey in 2013, could envision.

I only hope that the pile up of new examples - each seemingly worse than the one before - of health care corruption, will be sufficient to overcome the anechoic effect, and create enough global outrage to give us a chance to clean up our corrupt health care before it destroys our health.

ADDENDUM (25 July, 2013) - See also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. 

ADDENDUM (29 July, 2013 - See the comment on the 1BoringOldMan blog. 

Johnson and Johnson Settles Suit Alleging Management Incompetence and Deception, Managers Continue to Prosper

Very quietly, pharmaceutical/ biotechnology/ medical device corporate giant Johnson & Johnson just settled another lawsuit. The most pithy version is by Ed Silverman on Pharmalot, although Reuters and Bloomberg published short accounts.

The New Settlement

Per Mr Silverman, the gist is:

The health care giant agreed to resolve the dispute brought over allegations that J&J management shirked their responsibilities and allowed a chain of events that resulted in congressional probes; lost market share, consumer confidence and revenue, and a consent decree with the FDA. In the lawsuit, a shareholder charged that J&J bungled the integration of the Pfizer consumer health acquisition, placed inexperienced execs in charges of its OTC unit and cut costs so drastically that quality control suffered.

The lawsuit, which was brought by Ronald Monk, alleged that the health care giant made misleading statements about its products before disclosing problems with the Fort Washington plant and another in Puerto Rico. He also maintained that J&J withheld material information before its decision three years ago to shut down the Fort Washington plant, where contamination led to the unpublicized recall of defective Motrin tablets in 2009.

In agreeing to the settlement, J&J refused to admit any wrongdoing

So let me review. The allegations in this case were all about problems with the management of Johnson and Johnson.  They included allegations that management was incompetent and deceptive.  The incompetence was in handling the core functions of the company, assuring that its drug products were pure and unadulterated.  The deception was of patients, the public, and the nominal owners of the company to whom management is supposed to report, and allegedly included an attempt to cover up concerns about the purity of its drug products.

The proposed settlement follows the current practice of allowing the defendant not to admit the allegations, leaving their truth unproven.  However, one wonders, given that the allegations are about the core responsibilities of management and were leveled by the company owners, why the management would not defend their honor more forthrightly.

The Company's Sorry Legal Record

Furthermore, this settlement also follows the current practice of being made without reference to any other seemingly relevant legal proceedings.  In fact, it is just the latest of a long string of settlements and other resolutions of legal actions, including guilty pleas, by Johnson and Johnson management.  As we summarized most recently here, these included:

- Convictions in two different states in 2010 for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax in 2010
- Guilty pleas to bribery in Europe in 2011 by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see this link for all of the above)

- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
- In 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Also in 2012,  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Also in 2012, Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).

Even though the record includes a number of settlement in which management did not have to admit guilt, the company has made a surprising number of guilty pleas in just the last few years.  Despite all this evidence of poor, that is incompetent or unethical management, Johnson and Johnson managers have been getting very rich.

As we mentioned here, Mr William Weldon, the outgoing CEO on whose watch most of the misbehavior resulting in the legal actions above occurred, retired with a huge retirement package, after receiving extremely generous compensation prior to that.  The new CEO as of April, 2012,  Mr  Alex Gorsky, per the company's 2013 proxy statement, already owns more than 190,000 Johnson and Johnson shares,  and received $10,977,109  total compensation in 2012.  Mr Weldon received over $29 million in total compensation just for 2012, the year in which he retired.  Other top executives received from over $3.5 million to over $8 million. 

Summary

So why do the stockholders, the owners of Johnson and Johnson continue to pay so much to an executive team on whose watch so many bad things have happened?  Why did law enforcement authorities allow the company to continue to plead guilty or settle cases without imposing any negative consequences on these executives?  Maybe only the Shadow knows. Of course, the lack of any discussion beyond that on Health Care Renewal, that puts each new settlement or guilty plea in the context of the ones before, and juxtaposes them to the rewards of given to management, may not help. 

As we said the last time we addressed the contrast between Johnson and Johnson's sorry legal record and its voluminous payments to executives, we have noted again and again and again that many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved.

These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look here). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "grow a backbone" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care.

As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.