Home / All Post

Friday, 27 March 2015

Princess Health and Opinion, CIO Magazine: "The medical profession needs to get over its fear of information technology"- their complaints bogus. Princessiccia

Add Comment
There comes a time when the pundits defending the status quo in the healthcare information technology sector and health IT utopianism simply need to be thoroughly and definitively refuted.

This is such a time.  CIO magazine reaches the country's information technology leadership, including those in heathcare.   Hence, canards and meritless defamation of physicians can (and in my experience does) impact the attitudes and decisions of the leaders of the very technology physicians are increasingly dependent upon to deliver safe care.

Ultimately, such misinformation can and does result in patient harm through bad health IT.

Let's start with the title and subtitle alone of an opinion piece in CIO magazine:

March 26, 2015 
Paddy Padmanabhan - Opinion
http://www.cio.com/article/2886751/healthcare/the-medical-profession-needs-to-get-over-its-fear-of-information-technology.html 

The medical profession needs to get over its fear of information technology
Continued objections to Electronic Health Records ( EHR) by sections of the physician community are bogus. They arise from past entitlements and a lack of accountability.

The term "bogus" has clear meaning:

Merriam-Webster dictionary
http://www.merriam-webster.com/dictionary/bogus
Bogus
:  not genuine :  counterfeit, sham

This is a laughable yet alarming, cavalier defamation and attempted character assassination of the medical profession.

Mr. Padmanabhan is described as a business leader & entrepreneur with over 25 years of experience in Technology and Analytics in the Healthcare sector as well as being a consultant in that domain.  I can openly aver that, with an apparent significant bias as seen below towards the medical profession, I would not want him involved in any way in my own care...

There is nothing "bogus" about, for instance,

The author risibly dismisses them all with the word "bogus."  It might be opined that he was too indolent to conduct research, but I'll just opine he doesn't know what he doesn't know and that the opinion piece was based on simple ignorant arrogance.

I am uncertain what "entitlements" he refers to, but using paper records was not a physician "entitlement" - in fact, they are still used when the lousy hospital IT decides to go on vacation as it recently did, for example, at Children's Hospital Boston ("Boston Children�s emerges from electronic records shutdown", Boston Globe, March 25, 2015,  http://www.bostonglobe.com/metro/2015/03/25/boston-children-emerges-from-day-shutdown-electronic-medical-records/Q6sE7hRM4CxFeMEDYWP8IK/story.html#). 

(Of course, patient safety was not compromised - it never is when the IT goes out - right.  See the many posts at the query link http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised.)

Further, the true "lack of accountability" lies with the healthcare IT industry itself and the hospital leadership who agree to their terms of contractual indemnification (Health care information technology vendors' "hold harmless" clause: implications for patients and clinicians. Koppel & Kreda, JAMA. 2009 Mar 25;301(12):1276-8. doi: 10.1001/jama.2009.398, http://medecon.pbworks.com/f/IT%20Accountability%20JAMA09.pdf. 

Also see my commentary in a JAMA letter to the editor of July 2009 at http://jama.jamanetwork.com/article.aspx?articleid=184302 emphasizing how these arrangements violate Joint Commission safety standards, and my posting my health IT academic site at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

And that was just responding to the title and subtitle.  Now to the body of the piece:

... In a recent article in a national publication, a member of our physician community raked up a debate by declaring the Electronic Health Records (EHR ) mandate to be a debacle and argued that EHR�s actually harm patients.  These are bogus objections.


Congratulations for disrespecting my mother's grave, Mr. Padmanabhan (http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html)  and that of many other people harmed by Information Technology Malpractice as for example in the above links

Also see "The Malpractice Risk of Electronic Health Records", Legal Intelligencer - a Pennsylvania Legal newspaper, March 17, 2015, http://www.thelegalintelligencer.com/most-read-articles/id=1202720405290/The-Malpractice-Risk-of-Electronic-Health-Records.

Thanks for being an expert on the issues you so glibly dismiss, Mr. Padmanabhan.  I guess you forgot to check out the AHRQ hazards taxonomy (http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf) and similar resources on health IT risk:




A "bogus" checklist of known EHR risks from the U.S. government.  Click to enlarge.

Back to the opinion piece:

... According to a Rand Corporation study, the three key objections against the implementation of EHR�s:

--It costs too much to implement an EHR system: Yes, it costs money to implement any new software. Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients. What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

"Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients." (?)


Really?

This is an example of a profound anti-physician bias, although one could argue that the term mentioned by Yves Smith on Naked Capitalism, "lunatic triumphalism", comes into play with that statement.

What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

And just what % of the total costs of ownership are covered, Mr. Padmanabhan?   The financial analyses I see show significant clinician unreimbursed expense for the office.

Inpatient settings - that's another matter entirely - we're talking hundreds of millions of dollars or more per organization.

Perhaps my math is wrong, but hundreds of millions of dollars hospitals dish out on corporate health IT can pay for entire new hospitals, or pay for the medical care of countless disadvantaged people.  (e.g., http://hcrenewal.blogspot.com/2014/06/100-million-epic-install-dampens.html, as well as http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html and http://hcrenewal.blogspot.com/2013/06/want-to-help-hospital-go-bankrupt-get.html)

--It takes time away from patient care: Physicians love to talk about how much they care about being with their patients. However, they also routinely overbook their schedules with the sole intention of increasing patient visits and claiming additional reimbursement.

That's a very serious and, to my knowledge, completely unfounded accusation.  Many physicians are burned out from being compelled to see too many patients by administrators, especially if they are employed which is becoming very common. You in my opinion need to be taught how not to hate physicians and other clinicians, Mr. Padmanabhan:

Physician Burnout: It Just Keeps Getting Worse
Medscape, Jan, 26, 2015
http://www.medscape.com/viewarticle/838437

A national survey published in the Archives of Internal Medicine in 2012 reported that US physicians suffer more burnout than other American workers.[1] This year, in the Medscape Physician Lifestyle Report, 46% of all physicians responded that they had burnout, which is a substantial increase since the Medscape 2013 Lifestyle Report, in which burnout was reported in slightly under 40% of respondents. Burnout is commonly defined as loss of enthusiasm for work, feelings of cynicism, and a low sense of personal accomplishment

Back to the opinion piece:

EHR�s can actually aid their productivity by reducing the time it takes to pull up medical history, so that they have more time to spend on actually talking to their patients.

An expert with far more experience than you, Mr. Padmanabhan, says you are flat wrong (not counting me).  His name is Dr. Clement McDonald, and he is an EHR pioneer ("The Tragedy Of Electronic Medical Records", http://hcrenewal.blogspot.com/2014/10/the-tragedy-of-electronic-medical.html):

... McDonald now has a nationally influential post to promote electronic medical records, as the director of the Lister Hill Center for Biomedical Communications, a part of the National Library of Medicine, which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records �steal� 48 minutes per day in free time from primary care physicians.

Back to the opinion of Mr P.:

--EHR systems are hard to use and are not secure: There may be some merit to this. No one is making claims that EHR systems are perfect.


"May be some merit?"

"May?"


There is perhaps merit to saying Mr. Padmanabhan is either ill-informed, or delivering deliberate misinformation  (e.g., "NIST on the EHR Mission Hostile User Experience", http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html, and multiple posts on breach issues retrievable via query link http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy).

However, there are a few key aspects that these physicians prefer to not acknowledge when making these arguments:

--Shared electronic medical records can reduce expenses: Physicians routinely bill for duplicate medical expenses, such as tests, that would be avoided if the test results can simply be pulled up electronically. This should logically reduce healthcare costs at a system level.

Great in theory, but the real world is just not that simple.  Mr. Padmanabhan like many other IT hyper-enthusiasts apparently see IT as a silver bullet.  Just put it in and .... presto!  All complex multi-factorial social problems are solved, with no ill effects. Perhaps he and other hyper-enthusiastic health IT pundits need to read this article:


Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  linkto pdf

And this:

"Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality", http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html

More opinion:

--Quality of treatment can improve significantly: When a complete medical record is available about a patient, including details of visits to multiple healthcare professionals, the quality of diagnosis and hence treatment decisions should improve greatly. This improves patient safety and reduces medical errors, since everyone has access to the same set of data.

 That may be the only accurate statement in the opinion piece.  Yet, even this is not proven in the real world, and with today's highly experimental health IT.

--EHR�s can enable preventive diagnosis and early intervention that reduces costs and improves patient health: Enter healthcare analytics. Having patient medical records in an electronic system enables this data to be analyzed for preventive and early action, improved disease management, and reduced hospitalizations. The whole notion of population health management rests on this premise and is hard to argue with.

It's actually easy to argue with, as are most grandiose pronouncements about computational alchemy (i.e., in the world of data, turning lead into gold).

Again in theory, yes, but Mr. Padmanabhan is seemingly unaware of issues I raised in my article "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" at http://www.jpands.org/vol14no2/silverstein.pdf.  The uncontrolled nature of aggregated EHR data, and social factors that skew and bias it, never seem to enter into the minds of the computational alchemists.

The truth is:

  • Physicians, nurses and other clinicians are rightfully afraid of having bad health IT forced upon them due to the constraints of their time, their concentration, and their obligations and legal liabilities; 
  • Physicians are rightfully unwilling to be the experimental subjects of IT hyper-enthusiasts who are so hooked on theory, they ignore the actual downsides of an immature, experimental technology in the real world, including patient injury and death; and

I note that I feel dirtied even having to write this post.

-- SS

Addendum 3/27/15:  

A colleague observed:

.. And I suppose all those current med students and residents who grew up with information technology and have known nothing but  EHR�s are �afraid� of information technology?  I�m hearing complaints from the younger generation about the problems with using them. 

-- SS

Thursday, 26 March 2015

Princess Health andFederal dietary guidelines recommend cutting back on red and processed meat, sugar and refined grains.Princessiccia

Princess Health andFederal dietary guidelines recommend cutting back on red and processed meat, sugar and refined grains.Princessiccia

Add Comment
The Department of Agriculture and the Department of Health and Human Services have released proposed 2015 Dietary Guidelines for Americans. The guidelines, released every five years, "provide authoritative advice about consuming fewer calories, making informed food choices, and being physically active to attain and maintain a healthy weight, reduce risk of chronic disease, and promote overall health," says USDA.

It shouldn't come as a surprise that the 2015 guidelines recommend eating healthier foods, while cutting back on less healthy alternatives. "The committee basically recommended Americans take up a diet that is higher in vegetables, fruits, whole grains, low- or non-fat dairy products, seafood, legumes and nuts," Chris Clayton reports for DTN The Progressive Farmer. "We should cut back on red and processed meats and sugar-sweetened foods, drinks and refined grains. And we should be moderate in our alcohol."

Recommended cutbacks of certain foods have not gone over well with those food producers, who met this week to give feedback on the Dietary Guidelines Advisory Committee's recommendations, Clayton writes. The North American Meat Institute argued that "lean meat, poultry, red and processed meats should all be part of a healthy dietary pattern because they are nutrient-dense protein."

Shalene McNeill, a nutritionist for the National Cattlemen's Beef Association, "told the committee that its recommendation to exclude lean meat ignores decades of nutrition science," Clayton writes. McNeill said Americans should be encouraged to eat more lean meat, along with fruits, vegetables and whole grains. Grain, sugar and milk producers also expressed displeasure with the proposed rules.

Most nutritionists have embraced the proposed rules, but say the key is getting people to adopt them, Andrea McDaniels reports for The Baltimore Sun. Among those rules is limiting sugar intake to 200 or less calories, or 10 percent of total calories, per day. Currently, Americans get about 13 percent of their calories, or 268 calories, from added sugar.

"On the flip side, some foods once shunned are now accepted," McDaniels writes. "Research has found that cholesterol-high foods are no longer believed to contribute to high blood cholesterol, so people can now indulge in shrimp, eggs and other foods that were once off limits, the panel said. Rather than focus on cholesterol, people should curb saturated fat to about 8 percent of the diet."

The panel also said "up to five cups of coffee a day are fine, so long they are not flavored with lots of milk and sugar," McDaniels writes. "The panel also singled out the Mediterranean diet�rich in fish and chicken, fruits and vegetables, nuts, whole grains, olive oil and legumes�for its nutritional value."
Princess Health and Is Meat Unhealthy? Consolidated links. Princessiccia

Princess Health and Is Meat Unhealthy? Consolidated links. Princessiccia

Add Comment
Several people have asked for a consolidated list of links to my series on meat and health.  Here it is!  This should make it easier to share.  

Is Meat Unhealthy?  Part I.  Introduction and ethical/environmental considerations.
Is Meat Unhealthy?  Part II.  Our evolutionary history with meat.
Is Meat Unhealthy?  Part III.  Meat and cardiovascular disease.
Is Meat Unhealthy?  Part IV.  Meat and obesity risk.
Is Meat Unhealthy?  Part V.  Meat and type 2 diabetes risk.
Is Meat Unhealthy?  Part VI.  Meat and cancer risk.
Is Meat Unhealthy?  Part VII.  Meat and total mortality.
Is Meat Unhealthy?  Part VIII.  Health vs. the absence of disease.

Wednesday, 25 March 2015

Princess Health andHeroin bill finally passes and is signed into law; Naloxone program put into motion; dating-violence bill sent to Beshear.Princessiccia

Princess Health andHeroin bill finally passes and is signed into law; Naloxone program put into motion; dating-violence bill sent to Beshear.Princessiccia

Add Comment
By Melissa Patrick
Kentucky Health News

The long-negotiated bill to tackle Kentucky's heroin-overdose epidemic passed in the final hours of the 2015 legislative session.

Almost immediately after the heroin bill passed the Senate, a bill to offer immediate civil protections to dating partners who are victims of dating violence was passed after being held in the chamber since February 13 -- likely because Democratic Rep. John Tilley of Hopkinsville, chair of the House Judiciary Committee, was the original sponsor of both bills.

Tilley told reporters that the passage of the two bills meant it had been a successful session.

Gov. Steve Beshear signed the heroin legislation, Senate Bill 192, into law Wednesday, March 25, less than 12 hours after it passed, so that its emergency clause could put it into effect immediately. The dating violence bill, House Bill 8, has been delivered for his signature.

"Senate Bill 192 is tough on traffickers who bring these deadly drugs into our communities, but compassionate toward those who report overdoses or who admit they need help for their addiction," Beshear said in a release. "I applaud our legislators for putting aside partisan interests for the greater good of all Kentuckians who have been affected by this devastating drug."

The bill passed the Democrat-controlled House 100-0 and the Republican-controlled Senate 34-4. Republican senators John Schickel of Union, Joe Bowen of Owensboro, Chris Girdler of Somerset and Paul Hornback of Shelbyville voted against it.

The stickiest issues were a needle-exchange program, which many senators opposed, and tough new penalties for drug traffickers, which Tilley and many House members said would not be effective. The new law allows needle-exchange programs of approved by local governments, and the tough penalties, but allows the judge to be lenient in sentencing if the defendant is an addict.

The bill also allocates money for drug treatment programs; includes a "good Samaritan" provision that allows a person to seek medical help for an overdose victim and stay with them without fear of being charged; access for addicts and their families to the drug Naloxone, a drug that reverses the effects of an overdose; and allows the Department of Corrections to provide an approved medication to inmates to prevent a relapse in their addiction.

"The bill includes provisions that are important to law enforcement and me: increasing penalties for large volume traffickers, expanding access to treatment, and getting heroin overdose reversal kits into the hands of our first responders. I know this legislation will save lives," Attorney General Jack Conway said in a news release.

Hornback argued that "forced rehab doesn't usually work," providing addicts with Naloxone and free needles simply enables them and the bill does not allow addicts any "consequences for their actions."

He said that while he knows there are people dying from heroin overdoses,"I didn't make that decision for them and I for one, and a lot of my constituents are tired of paying for people's bad decisions and that is what this (bill) does."

Tilley said in an interview after the vote that needle exchange programs are proven to work, will save taxpayers money and are absolutely necessary to "stem the tide of two tidal-waves that are headed Kentucky's way: HIV and Hepatitis C and Hepatitis B."

"The cost of treating someone with HIV is $350,000. The cost of treating someone with Hepatitis C is $85,000. The budget now had a $55 million hit just with the explosion of Hepatitis C last year. We can't afford that in Kentucky," he said. Advocates say the programs can be a gateway to treatment and rehabilitation.

Meanwhile, Conway and first lady Jane Beshear announced that funding for Naloxone kits would be made available to the hospitals in Kentucky with the highest rates of heroin overdose deaths. The kits will be provided free to every treated and discharged overdose victim at the pilot-project hospitals.

They made the announcement at the University of Louisville, which treated 588 people in 2013 for heroin overdoses, a news release said. In 2013, the latest data available, 230 of the 722 autopsied overdose deaths, or 32 percent, were caused by heroin, according to the Kentucky Office of Drug Control Policy.

Tilley and Republican Sen. Whitney Westerfield, also of Hopkinsville, "forged a friendship that allowed the two men to work out differences on a pair of high profile bills fraught with political pitfalls," Adam Beam reports for The Associated Press. "Westerfield, a former prosecutor, is running for attorney general against the son of Democratic Gov. Steve Beshear, giving Democrats all the reason in the world not to work with him."

The AP notes that Republican Sen. Chris McDaniel wrote the first draft of the heroin bill that passed the Senate in January, but it omits McDaniel's other role: candidate for lieutenant governor on a slate headed by Agriculture Commissioner James Comer. As the Senate prepared to give the final bill final passage, Republican Floor Leader Damon Thayer accused the House of not passing McDaniel's bill because of his candidacy.
Read more here: http://www.kentucky.com/2015/03/25/3767938_political-compromises-brokered.html?rh=1#storylink=cpy

Princess Health andCounty Health Rankings look familiar, but show that some counties overcame bad factors to have encouraging outcomes.Princessiccia

Add Comment
The 2015 County Health Rankings for Kentucky, compiled by the University of Wisconsin Population Health Institute in collaboration with the Robert Wood Johnson Foundation, have been released. For the fourth year in a row, Oldham County ranked highest in Kentucky for health outcomes. Statistical differences among closely ranked counties are very small, so rankings are arranged in quartiles (quarters) in the maps below.

The rankings fall into two categories: factors and outcomes. Health factors, left, include the health behaviors (with factors such as adult smoking), clinical care (with factors such as the ratio of population to primary-care physicians), social and economic factors (such as the percentage of children under 18 in poverty) and physical environment (with factors such as the percentage of workforce that drives alone to work). Oldham County was followed by Boone, Woodford, Scott and Anderson counties. Clay County ranked last, preceded by Martin, Leslie, Wolfe and Knott. Generally, health factors and outcomes reflect income and education levels.

Health outcomes, right, include premature death, poor or fair health, poor physical health days, poor mental health days and low birthweight. Boone County ranked first, followed by Oldham, Shelby, Fayette and Jessamine. Owsley County ranked last, preceded by Floyd, Leslie, Clay and Perry.

Some counties, such as Morgan and Wayne, overcame their poor health factors to have better-than-average outcomes. To see the full, specific list of county rankings, click here.
Princess Health and Two New Independent Reports on the Death of Dan Markingson, But Now What Will Happen? . Princessiccia

Princess Health and Two New Independent Reports on the Death of Dan Markingson, But Now What Will Happen? . Princessiccia

Add Comment
Years after his death, there is now a little more clarity about the clinical trial in which Dan Markingson was enrolled when he died.  Whether this clarity will have any impact remains to be seen.

We most recently posted about the aftermath of Mr Markingson's death here, (and see posts in 2013 here, and in 2011 here.)  Very briefly, Mr Markingson was an acutely psychotic patient enrolled in a drug trial sponsored by Astra Zeneca at the University of Minnesota.  His enrollment was said to be voluntary although at the time he enrolled he had been under a stayed order that could have involuntarily committed him to care.  Despite his mother's ongoing and vocal concerns that he was not doing well on the study drug and under the care of trial investigators, he continued in the trial until he died violently by his own hand.  After his death, his mother Mary Weiss, friend Mike Howard, and University of Minnesota bioethics professor Carl Elliott campaigned for a fair review of what actually happened.  University managers not only rebuffed their concerns, but harshly criticized Professor Elliott, and ended up reprimanding him for "unprofessional conduct."

Two New Reports

In the last few weeks, two new independent reports on the case appeared.  Both vindicated the concerns and questions raised by Mary Weiss, Mike Howard, and Prof Elliott.

Association for Accreditation of Human Research Protection

One, called for by the University of Minnesota faculty senate, was by the Association for Accreditation of Human Research Protection,  and said that the university left research subjects "susceptible to risks that otherwise would be avoidable" (see this Minneapolis Star-Tribune article.)  Furthermore, according to a post in the Science Insider blog from the American Association for the Advancement of Science, it said,

[T]he external review team believes the University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust,

Also, it said the university has been

assuming a defensive posture. In other words, in the context of nearly continuous negative attention, the University has not persuaded its critics (from within and outside the University) that it is interested in more than protecting its reputation and that it is instead open to feedback, able to acknowledge its errors, and will take responsibility for deficiencies and their consequences.

Finally, it noted a "climate of fear" in the Department of Psychiatry.

Office of the Legislative Auditor for the State of Minnesota

The second report, available in full here,was from the Office of the Legislative Auditor for Minnesota.  If anything, it was more damning. Its summary included,

the Markingson case raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge. They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration of the Markingson case by making misleading statements about past reviews. This insular and inaccurate response has seriously harmed the University of Minnesota�s credibility and reputation.

It seemed to affirm in detail nearly all of Weiss', Howard's and Elliott's concerns.  It recommended that the University should suspend new psychiatric drug trials until the problems it identified were remedied (see Star-Tribune article here.)

Vindication, but Will It Lead to Progress?  

Taken together, these reports vindicate the work of Mr Markingson's mother, friend, and academic watchdog Professor Elliott and their supporters.  As the Star-Tribune reported,

'Over the past eleven years the University of Minnesota has made us feel as if we have no voice, no rights and absolutely nothing remotely called justice,' wrote Mike Howard, a close friend to Markingson�s mother, in a letter in the audit. 'This report is the first step toward accountability.'

The Minnesota Post added the response of Professor Elliott and a colleague,

'It�s nice to have an independent confirmation of what we�ve been telling the university for five years, but which they have refused to listen to,' he told MinnPost on Thursday.

Elliott said he is not convinced, however, that Kaler and other university leaders are going to take responsibility for what happened in the Markingson case � or take the necessary steps to fix the problem going forward.

'One of the most worrying findings in the report was the widespread belief on campus that the university leadership doesn�t care about human study subjects,' he said.

Leigh Turner, another U bioethicist who has also been outspoken about the issues raised by the Markingson case, expressed similar concerns. 'Can we expect reform from the very people who have done nothing for the past several years?' he said in a phone interview.

'I hope there�s some change,' he added. 'But the fact that [Markingson died in 2004] and it�s now 2015, I think hope has to be tempered with a dose of realism. There are some very powerful forces interested in minimizing the findings and suggesting that there are only minor things that need to be done.'

It appears there a several major remaining questions.

What Were the Underlying Causes?

Although both reports went into some detail about what happened to Mr Markingson, they seemed not to dwell on why it happened.  They did not seem to address relevant contextual factors, policies, and decisions.  For example, the report by the Office of the Legislative Auditor included,

We understand that the University of Minnesota has been and should continue to be an institution that delivers not only high quality medical care but also engages in cutting edge medical research� research that does pose risks to human subjects. In addition, we do not question the appropriateness of the University obtaining money from pharmaceutical and other medical companies to support that research. However, in every medical research study�whether supported with public or private money�the University must always make the protection of human subjects its paramount responsibility.

However, as we and many others more erudite have discussed frequently, clinical research that evaluates products or services made by the commercial sponsors of the research has proven to be highly susceptible to manipulation by these sponsors to increase the likelihood that the results will serve marketing purposes, and suppression if the manipulation fails to produce the wanted results.  Commercial sponsors often strongly influence the design, implementation, analysis and dissemination of clinical research.  Often their influence is mediated by financial relationships with individual researchers and with academic institutions who seem more and more beholden to outside sponsors, that is, by conflicts of interest.  The report by the Auditor noted pressures, including financial pressures on the physician who ran the study in which Mr Markingson was a subject to enroll more patients and keep them enrolled.  To protect patients better in the future, in my humble opinion the relationships among commercial sponsors, academic medical institutions, and individual researchers need further consideration.  Is the easy money supporting research coming from commercial firms with vested interests in the outcome of that research really worth the risks of biased results, hidden results, and to research subjects?   

Will Anything Change and Will Anyone be Held Accountable?

Once these two reports were delivered, it now seems to be up to university managers to make needed changes.  In general, these are the same managers who are described above as so "defensive," who not only ignored complaints, but appeared to try to silence those who complained.  If they are left in charge, why should we expect them to make any meaningful changes?  Instead, should they  not be held accountable for their actions?  

Will the University Cease Hostilities Against Dr Elliott?

Again, as noted above, university managers did not merely disagree with Professor Elliott.  They disparaged him, appeared to try to intimidate him, and reprimanded him.  It seems at the very least he is owed an apology.  So far, nothing in the news coverage suggests he has or will receive one.

Will Anyone Notice? 

So far, this case has gotten good coverage in Minnesota media.  However, it has largely been ignored in the national media.  Beyond Minnesota, I could only find mention in some blogs, e.g., in PharmaLot by Ed Silverman, and in Forbes by Judy Stone.  I have seen nothing in any US medical or health care journal, although the British Medical Journal did cover it in a news feature.  This case clearly has global implications, and ought to be considered one of the most important cases illustrating the perils of commercially sponsored human research, but it remains proportionately anechoic.

Summary

The latest reports seem only to confirm that clinical research at major academic institutions has gone way off track.  It now seems that in their haste to bring in external funding, university administrators and the academic researchers who are beholden to them have sadly neglected the protection of their own patients.  As we have said ad infinitum, true health care reform would turn leadership of health care organizations over the people who understand and are willing to uphold the mission of health care, and particularly willing to put patients' and the public's health, and the integrity of medical education and research when applicable, ahead of the leaders' personal interests and financial gain.

ADDENDUM (25 March, 2015) - See also numerous posts by Professor Elliott on the Fear and Loathing in Bioethics blog,  by Bill Gleason in the Periodic Table blog,  and by Mickey Nardo on the 1BoringOldMan blog. 

ADDENDUM (30 March, 2015) - Note that after receiving offline comments, I changed the first paragraph to emphasize the clarity is about the trial, rather than the patient's death, and second paragraph to clarify that the order to commit was stayed.

Tuesday, 24 March 2015

Princess Health andHealth reform law has been good for hospital finances, health-care costs, Obama administration says.Princessiccia

Princess Health andHealth reform law has been good for hospital finances, health-care costs, Obama administration says.Princessiccia

Add Comment
U.S. hospitals have saved billions of dollars because the federal health-reform law has provided coverage for patients who were once charity cases, the Obama administration announced Monday, the fifth anniversary of the Patient Protection and Affordable Care Act.

"Hospitals also saw fewer emergency room visits, which rack up far higher costs and often leave hospitals with the tab," Sarah Ferris writes for The Hill, which covers Congress. "The government�s report, which focuses on the benefits of Medicaid expansion, is an effort to entice states that have been politically resistant to expanding the program."

Kentucky hospitals have acknowledged that the law has reduced their losses from "uncompensated care," but say other aspects of the law have created a mixed effect, depending partly on hospitals' ability to adapt. The increase in coverage has brought hospitals much more money, but they say continued problems with managed-care Medicaid have cause them financial difficulty.

From paying patients' point of view, the law appears to have reduced inflation in health-care costs, but has not achieved advocates' goal of reducing costs. A White House report said, "Since the Affordable Care Act was enacted, health care prices have risen at the slowest rate in nearly 50 years. Thanks to exceptionally slow growth in per-person costs throughout our health care system, national health expenditures grew at the slowest rate on record from 2010 through 2013."

For the White House's Kentucky-specific list of benefits of the law, click here.
Subscribe to: Posts (Atom)