How Institutional Conflicts of Interest Exacerbate the Anechoic Effect - the Example of ASCO Fearing "Biting the Hand that Feeds You"

As we recently discussed (here, here, here and here), in May, 2015, the New England Journal of Medicine, arguably the world's foremost medical journal, published an editorial and a three-part commentary arguing that current concerns about the effects of financial conflicts of interest (COI) on health care are overblown(1-4).  On June 1, the Wall Street Journal published a report on the 2015 meeting of the American Society of Clinical Oncology (ASCO) that provided a vivid example of why these concerns should not be dismissed.

Questioning Drug Prices at the ASCO Meeting

The main issue in the article was:

In a sign of growing frustration with rising drug prices, a prominent cancer specialist on Sunday sharply criticized the costs of new cancer treatments in a high-profile speech at one of the largest annual medical meetings in the U.S.

'These drugs cost too much,' Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center, said in a speech heard by thousands of doctors here for the annual meeting of the American Society of Clinical Oncology.

The notion that health care prices are high and are rising continuously in the US should hardly be novel for regular Health Care Renewal readers.  We have been writing about it for a while, starting in 2005.

We first posted about high drug prices in July, 2005, with the example of BilDil.  This was a brand-name combination drug that included two compounds that were already cheaply available in generic form, advertised as a uniquely convenient therapy for congestive heart failure.  We were aghast that the price of the combination drug might be $5.40 - $10.80 a day (in 2005 dollars), over three times the cost of the two drugs in generic form.

But only a few days later we noted that three cancer costs had yearly costs in the five figures, and one, Erbitux, cost as much as $100,000.  Most amazingly we noted that Thalidomid was priced at $25,000  a year.  Yet it was just the infamous thalidomide, the drug initially marketed as a tranquilizer that caused severe birth defects after it was initially sold in Europe.  The drug was still available in generic form in South America for about seven cents a pill.

Since then, the ridiculously high prices of many tests and treatments, but most notably new drugs and devices, has been so widely covered our discussion has been limited to special cases.   For example, consider just a few headlines from April to May, 2015.

How Much Would You Pay for an Old Drug? If You Have MS, a Fortune (Bloomberg)

Pharmaceutical Companies Buy Rivals' Drugs, Then Jack Up the Prices (WSJ)

How Marketing Exclusivity Led to Higher Drug Costs and Questionable Benefits (WSJ)

Runaway Drug Prices (NY Times)


Drug Prices as a Taboo Topic

However, despite this wide attention to the problem, the speech at ASCO was notable.  Back to the WSJ...

Dr. Saltz’s speech was unusual because it was made at the meeting’s plenary session, where the field’s most significant scientific research is presented and which all meeting participants are expected to attend. An estimated 25,000 doctors and scientists attended this year’s meeting.

One would think that the high price of drugs, especially cancer drugs, would be a fit subject for discussion at a plenary session of ASCO, however,

It is unprecedented for plenary speeches, which typically address scientific and medical issues, to substantially take on the topic of drug costs, said Alan Venook, a professor of medicine at the University of California San Francisco who planned the meeting’s scientific session and invited Dr. Saltz to speak.

The prominent venue for the speech was also unusual because, like many medical meetings, ASCO is sponsored by pharmaceutical companies and often focuses on highlighting advancements in drug development, said Dr. Venook. He said discussing drug prices there is 'uncomfortable' because it could be seen as 'biting the hand that feeds you.'

Doctors are also reluctant to antagonize the drug industry because they need pharmaceutical firms to invest in developing new medicines for patients, he said.

'It’s a tough balancing act for ASCO where the meeting is largely funded by pharma,' Dr. Venook said in an interview. 'You can’t have a [plenary] talk trashing pharma, but you can have a talk by a respected person questioning it.'

So because pharma gives ASCO a lot of money, at best, only the most distinguished ASCO members can gently question pharma, but cannot criticize, much less "trash" the source of their mammon.


This is thus a succinct example of why financial conflicts of interest in medicine and health care can be bad.  The incredibly high prices of cancer drugs should be a fit topic for discussion at a meeting run by a society of medical oncologists.  But those in charge of the meeting and the society are afraid to initiate such a discussion, and even more afraid of appearing to criticize the companies that charge these prices, because the society has become dependent on money from these very same companies.  So this is further an example of how conflicts of interest can create the anechoic effect - the notion that certain topics in medicine and health care are taboo, because discussing them might trouble the powers that be, and particularly the moneyed interests that now dominate medicine and health care. 

In a succinct response to the NEJM series (1-4) soft pedaling concerns about conflicts of interest, the British Medical Journal ran a commentary by a former NEJM national correspondent, and two former NEJM editors.(5)  It stated,

The NEJM has now sought to reinterpret and downplay the importance of conflicts of interest in medicine by publishing articles that show little understanding of the meaning of the term. The concern is not whether physicians and researchers who receive industry money have been bought by the drug companies, as Drazen writes, or whether members of guideline panels or advisory committees to the US Food and Drug Administration with ties to industry make recommendations that are motivated by a desire for financial gain, as Rosenbaum writes. The essential issue is that it is impossible for editors and readers to know one way or the other.

In this case, we seem not to be talking about the possibility that health care professionals "have been bought by the drug companies,"  but how drug companies essentially "buying" a professional organization has apparently heretofore prevented medical professionals from discussing a vital issue that could have major effects on patients.

Following the Money

In case there is any question about the money involved and its sources, one only needs to go to some publicly available in formation supplied by ASCO (mostly because of reporting requirements imposed on all US non-profit organizations of a certain size).  

The latest (2014) annual report from ASCO reveals that the organization only gets 16.1% of its revenue from member dues.  Thus a ostensible membership organization gets only about a sixth of its funding from members' dues.

Yet the organization has become quite wealthy.  Its most recent (2013) US Internal Revenue Service 990 Form reveals that it owns over $55 million in real estate, and has over $104 million in investments (presumably as an endowment.)  The organizations' leaders are also doing very well. Its CEO, Allen Lichter MD, got $804,775 in total compensation in 2012.  Eleven other managers, of which three are health care professionals (one MD, one RN, one PharmD), got at least $220,000 in total compensation.  Five of them got more than $300,000. 

The source of all that money seems mainly to be pharmaceutical and other health care corporations that sell goods and services for cancer care.  US non-profit organizations are not forced by law to reveal the details of their financial support.  However, the ASCO annual report does list 23 pharmaceutical and biotechnology companies, and one for-profit cancer hospital chain as contributing at least $1 million each in total to the non-profit over time.  The report lists 37 pharmaceutical, biotechnology, and medical device companies as current corporate donors, and also 10 other for-profit health care related corporations as current corporate donors.

In addition to these apparently marked institutional conflicts of interest, ASCO leaders may have their own individual conflicts of interest.  I do not have the resources to search all relationships affecting meeting organizers and ASCO officers and trustees, and the organization does not post conflicts of interest affecting its leadership and governance in a prominent place. However, Dr Alan Venook, who confessed to his discomfort about inviting a talk that might be perceived as biting the hand that feeds the finances of ASCO, is or has been on advisory boards for Thershold Pharmaceuticals,  Mirna Therapeutics, and GlobeImmune.  For a 2014 presentation, he gave the following disclosures: "Research support from Genentech/Roche, BMS, Lilly, Novartis; H. Lenz: Consulting, advisory boards and research support from Genentech/Roche, BMS and Merck."  Furthermore, the current chair of the ASCO Board of Directors, Julie M Vose, MD, is also on the Medical Advisory Board of EmergingMed Inc, and the Clinical Advisory Board of Bullet Biotechnology.

Summary

The New England Journal of Medicine recently launched a counter-attack against the "pharmascolds" who are allegedly slowing the pace of medical progress by their excessive and puritanical concerns about financial conflicts of interest.  Yet the arguments that COIs could be bad for health care are logical, and based on at least some reasonably good evidence.  (See the article by Steinbrook et al in the BMJ mentioned above[4], the accompanying BMJ editorial[5] just to start and then the 2009 Institute of Medicine report.)

Moreover, we have encountered a lot of vivid cases suggesting that conflicts of interest can have adverse influences on health care.  In this most recent one, we see at least one prominent if conflicted organizational insider admitting that institutional, and perhaps individual conflicts of interest have made discussion of at least one big health care and health care policy topic taboo.  This seems to corroborate our previous discussion that the anechoic effect - that certain topics in health care are taboo - may be generated by conflicts of interest of the people who ought to discuss them, or of those to whom those people may have to answer.

True health care reform requires full disclosure of conflicts of interest for honesty's sake, and marked reduction of conflicts affecting those who make health care decisions on behalf of individual patients, and health care policy decisions that affect patients' and the public's health.  If we allow conflicts of interest to continue, we will have difficulty even discussing the most severe problems affecting health care, because those generating the topics are benefiting from the circumstances that enable such problems.

ADDENDUM (1 July, 2015) - This post was republished on 28 June, 2015, on the Naked Capitalism blog. 

ADDENDUM (20 July, 2015 ) - This post was republished on July 12, 2015 in OpenHealth News.

References

  1.Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854. Link here.
2. Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015; 372:1860-1864.  Link here.
3. Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here.
4.  Rosenbaum L.  Beyond moral outrage - weighing the trade-offs of COI regulation. N Engl J Med 2015; 372: 2064-2068.  Link here.
5. Steinbrook R, Kassirer JP, Angell M.  Justifying conflicts of interest in medical journals: a very bad idea.  Brit Med J 2015; 350: h2942.  Link here. 
6. Loder E. Revisiting the commercial-academic interface in medical journals.  Brit Med J 2015; 350: h2957.  Link here.

Childish, petty and vindictive: UPMC hospitals ban sale of Post-Gazette from their gift shops

Here's a new angle on how a healthcare organization might react to unfavorable press:

Ban the sale of the newspaper in question from their territory:

UPMC hospitals ban sale of Post-Gazette from their gift shops
June 24, 2015 12:00 AM

http://www.post-gazette.com/business/pittsburgh-company-news/2015/06/24/UPMC-hospitals-ban-sale-of-Post-Gazette-from-their-gift-shops/stories/201506240066

By Steve Twedt / Pittsburgh Post-Gazette

Some UPMC hospitals are banning the Post-Gazette from sale in their gift shops, a move UPMC spokesman Paul Wood said was precipitated by “fairness issues” in the newspaper’s coverage of the health system.

At least three UPMC hospitals -- UPMC Shadyside, UPMC Mercy and Children’s Hospital of Pittsburgh of UPMC -- say they will no longer sell the newspaper.

This seems simply retaliatory and in fact silly, as (at least hopefully) the newspaper will remain on sale in the rest of the city, as well as available online.  That is, assuming UPMC does not go on a vendetta against the newspaper, in its own in-house PR campaigns and mailings, in other media, or in the courts.

Twice in recent years, UPMC executives have canceled the health giant’s advertising in the PG, citing dissatisfaction with the way UPMC was covered in the news pages and how it was portrayed in editorials and editorial cartoons.

One wonders if UPMC has specifically identified false and inaccurate reporting.  Editorial cartoons are also standard fare for newspapers, and if they are not liked, the answer is written response, not banning IMO.

''The Post-Gazette is edited without regard to any special interest, and our news columns are not for sale, at any price,'' said John Robinson Block, publisher of the newspaper. ''We have been here since 1786, and have as our purpose the same goal that UPMC was established for -- to serve the public's interest, not a narrow purpose.''

As pointed out many times at Healthcare Renewal, the purpose of healthcare systems may not entirely be for serving the public's interests anymore.  Rather, they are serving the private interests of a small executive group who reward themselves handsomely for all being such uniformly superb, excellent and deserving managers.

As Roy Poses wrote at http://hcrenewal.blogspot.com/2015/02/outsize-compensation-for-teflon-coated.html, and elsewhere:

... As we have said before, in US health care, the top managers/ administrators/ bureaucrats/ executives - whatever they should be called - continue to prosper ever more mightily as the people who actually take care of patients seem to work harder and harder for less and less. This is the health care version of the rising income inequality that the US public is starting to notice.

Thus, like hired managers in the larger economy, non-profit hospital managers have become "value extractors."  The opportunity to extract value has become a major driver of managerial decision making.  And this decision making is probably the major reason our health care system is so expensive and inaccessible, and why it provides such mediocre care for so much money. 

Back to the newspaper:

... UPMC officials did not respond Tuesday to questions asking which specific stories they found objectionable.

Perhaps anything that does not read like PR from a large advertising firm painting the organization in the finest light, and editorial cartoons showing executive halos....

''We believe that our coverage of UPMC has been fair-minded in every respect,'' said David M. Shribman, the newspaper's executive editor. ''Every entity in every town feels aggrieved at some point by what a good newspaper writes. It's part of living in a free society where the exchange of news and information is prized, not punished.''

It's sad when newspapers have to state the obvious.

But health system officials have often criticized stories, editorials, and editorial cartoons published in the Post-Gazette in recent years, most frequently in its coverage of the ongoing contract battle with insurer Highmark and, in years past, about the health giant's real-estate holdings and its business practices.

The answer to free speech is more free speech.  Colleges and universities are painfully learning this lesson (e.g., see the website of the Foundation for Individual Rights in Eduction, FIRE, at https://www.thefire.org/).

I actually think a ban on selling the newspaper at UPMC facilities is childish.  UPMC executives seem a bunch of petty, vindictive crybabies for banning sale of the paper from their shops.

-- SS

The US' Multinational Trade Negotiations - Trading Away Its Own and Other Countries' Current and Future Restraints on Drug Prices?

Trade Agreements More about Deregulation than Trade

International trade negotiations, especially their more technical aspects, seem far removed from health care and health policy, and unrelated to health care dysfunction.  However, it seems that such trade negotiations have become a back door route to affect health policy, especially national efforts to regulate health care intended to improve patients' and the public's health.  

We recently discussed how current multinational trade negotiations seem to be more about changing regulation in favor of big corporations than broadly advancing trade.  Some of the effects of the proposed trade pacts could have bad effects on patients' and the public's health, particularly by allowing corporations to challenge particular countries' public health policies outside of these countries' judicial systems, in kangarooish courts seemingly designed to favor corporate interests.  Also, the trade pacts' focus on intellectual property could lead to longer patent protection on drugs, biologics, and devices, raising health care costs.  However, attempts to figure out how proposed trade agreements could affect health care and public health were hindered by the secrecy surrounding the negotiations.

"Procedural Fairness" for Pharmaceutical Companies, not You and Me

Earlier in June, 2015, a part of the current draft of the Trans-Pacific Partnership (TPP) appeared on  Wikileaks, revealing yet another set of concerns about how the agreement could affect health care.  It was entitled "Annex on Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices," and hence was specifically about health care.

The bulk of the annex seemed to be about improving the treatment of drug, device and biotechnology companies by national agencies that make decisions about payments for their products. The annex apparently proposed establishing the companies' rights to rapid reviews, access to applicable procedures and guidelines, access to written decisions, company appeals of the agencies' decisions, and protection of corporate confidential information. On the other hand, there was nothing I could see in the annex about the rights of, say, patients or health care professionals.

We have noted the concern that international trade agreements may make government regulation subject to corporate appeal in "investor-state dispute settlement" (ISDS) processes, essentially international quasi-courts that are not subject to national judicial systems, may not provide for any input by parties other than governments and corporations (that is, by, for example citizens, patients or health professionals), and may not allow appeal.  Thus, by specifically incorporating new protections for corporations seeking favorable payments for their new products from national agencies, the annex could make it possible for the corporations to appeal to ISDS, going around national court systems.  As reported in the Huffington Post,

According to an analysis of the leaked document by Jane Kelsey, a law professor at the University of Auckland in New Zealand, these rules are enough to expose national health authorities to legal challenges under TPP’s investor-state dispute settlement process, or ISDS. ISDS empowers companies to challenge countries’ domestic laws before a tribunal of international judges if they believe the laws unfairly limit investment. The tribunals have the power to impose significant fines on countries if their laws are found responsible for the investment hardship in question. While pharmaceutical companies could not challenge national health programs’ policies through ISDS, their grievances would be eligible for ISDS if the companies claimed the policies hindered investment.

In fact, the Huffington Post article noted suspicions that the US Trade Representative (USTR) has been negotiating on behalf of big US drug, device and biotechnology companies to target price regulations in Australia and New Zealand,

Among the United States’ TPP negotiating partners, pharmaceutical provisions have faced the greatest opposition from Australia and New Zealand, which have national health authorities that provide prescription drugs to their citizens at heavily discounted rates. The U.S. Trade Representative and U.S. pharmaceutical companies have targeted the cost containment measures in those countries’ prescription drug programs for years. Pharmaceutical companies also claim that New Zealand’s drug approval process is opaque and difficult to navigate.

Why Explicitly Include the US Center for Medicare and Medicaid Services (CMS)?

However, anyone in the US who thinks that all the burden from the trade pact is only on other countries, particularly those down under, should think again. The draft trade pact annex also seemed designed to prevent any future attempts by the US government to control drug and device costs, especially for the US Medicare program, even though the current US President has proposed such attempts. 

Note that when the US program was extended to cover drugs, the legislation specifically forbade the government from negotiating prices, a provision that seemed more about protecting corporate revenues than the federal budget.  So, as reported by the New York Times,

The newly leaked annex, dated Dec. 17, 2014, lists Medicare and the Centers for Medicare and Medicaid Services as falling under its strictures.

The USTR pooh poohed any concerns about that,

Officials at the United States trade representative’s office, while declining to comment on a leak they would not acknowledge, said rules in the Pacific accord would have no impact on the United States because Medicare already adhered to them. The trade representative’s office helped develop the proposals.

'Already, transparency and procedural fairness are integral parts of the U.S. legal system and as such are principles reflected in U.S. trade agreements,' the representative’s office said in a statement.

Maybe preventing any government negotiation about, much less control of drug and device prices may be part of what the USTR called "procedural fairness."  In any case, if the US, and specifically CMS are doing so well, why bother giving this trade pact jurisdiction over them, unless to prevent any uppity future US government from daring to negotiate with the pharmaceutical industry?

The Huffington Post noted that

In an earlier statement, [Director of Public Citizen's Global Access to Medicine Project Peter]  Maybarduk expressed concern that the rules would 'limit Congress’ ability to enact policy reforms that would reduce prescription drug costs for Americans –- and might even open to challenge aspects of our health care system today.'

He expanded on that in a commentary for The Hill,

Earlier this week, WikiLeaks published the draft TPP 'Annex' on healthcare technologies. In the five-page document, the U.S. government commits Medicare to rules and procedures that would make it difficult — if not impossible — to implement a national formulary that would provide leverage for proposed negotiations with drugmakers under Medicare Part D.

Medicare costs are expected to more than double from $77 billion in 2015 to about $174 billion in the next decade. In February, the president called for giving Medicare the power to negotiate prices with drug manufacturers to ameliorate this cost burden. Americans support giving Medicare negotiating power by wide margins and across party lines.

Negotiations are most effective if the U.S. government has leverage. Experts suggest that key leverage in Medicare negotiations should come from developing a national drug formulary — a list of drugs that Medicare would cover. A formulary would stimulate competition, reduce prices and lead to healthier outcomes for patients and the healthcare system.

But the leaked TPP 'Annex' shows that the pact would impose procedural requirements on formulary decisions, exact significant administrative costs and open up the drug review process to increased corporate influence. Medicare would have to live by these rules. The result could be a toothless negotiator, and a formulary filled with expensive drugs that have questionable public health benefits, if any.

Summary

So why did the US Trade Representative acquiesce to, if not actively promote, a trade pact that would limit the ability of the US government, specifically, CMS to try to put a damper on the ever rising health care prices that threaten to bankrupt individuals and maybe eventually the Medicare program itself? And why, incidentally did it do so when this appeared to contradict the current US President's own stated goal to have Medicare negotiate the prices it pays for drugs?  (And why, incidentally, did it promote a pact that would give international tribunals jurisdiction over US government actions when that may be unconstitutional according to an increasing number of experts?) 

The best speculation we offered before was that the USTR has been "captured" by industry, in part through the conflicts of interest generated by multiple passages through the revolving door by current and former USTR personnel. 

At the moment, the TPP has stalled again in the US Congress.  However, do not underestimate the ability of its proponents to get it moving again.  The now intermittent drip of secrets from the ongoing trade negotiations showing how little they have to do with trade, and how much they have to do with advancing corporate interests suggest the need for much more vigilance in defense of patients' and the public's health.

Meanwhile, I repeat again that we need to do a lot more to undo regulatory capture that affects health care, and stop the incessantly spinning revolving door.    Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

Challenging the meme that [yes, there are all these drastic flaws and problems - BUT] ... EHRs improve patient safety

One of the most persistent memes in healthcare IT is that, for all their deficits, bugs, flaws, interferences in care, and so forth, these systems "improve patient safety."

I find the meme remarkable.

37 medical societies can issue a complaint letter about how EHR systems interfere in care and pose patient risk (http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html).  The Joint Commission can issue a detailed Sentinel Event Alert outlining the myriad ways that these systems "introduce new kinds of risks into an already complex health care environment where both technical and social factors must be considered" (http://www.jointcommission.org/assets/1/18/SEA_54.pdf).

ECRI Institute can, year-after-year, report health IT as among the top ten technology risks in healthcare (2015 list at https://www.ecri.org/press/Pages/ECRI-Institute-Announces-Top-10-Health-Technology-Hazards-for-2015.aspx).

This writer can casually aggregate quite a few examples of EHR flaws, risks and harms without really trying very hard (http://hcrenewal.blogspot.com/search/label/glitch).  Some of these include incidents where EHR flaws could have or did affect thousands, a feat nearly impossible with paper (http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html).

Outages that make all records unavailable can occur with regularity (e.g., http://hcrenewal.blogspot.com/2015/05/another-day-another-ehr-outage-medstar.html).

The ECRI Institute in its "Deep Dive" analysis can gather voluntary reports of 171 IT mishaps in just 9 weeks from 36 hospitals capable of causing harm, with 8 injuries and 3 possible deaths resulting (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

Medical malpractice insurers can reveal an increasing number of medical malpractice cases (and injury) involve EHRs (e.g., http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html, also http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal, also http://www.msms.org/AboutMSMS/News/tabid/178/ID/2595/System-Dangers-How-EHRs-Can-Contribute-to-Medical-Malpractice-Claims.aspx).

Yet, the "BUT" phrase seems to reliably appear in articles about these flaws:

"BUT" EHRs improve safety.

Of course the comparator in such statements is the paper record.

For instance, in the June 11, 2015 Politico report "Why Health Care IT Is Still on Life Support" (http://www.politico.com/magazine/story/2015/06/electronic-medical-records-doctors-118881.html), Arthur Allen sums up the problems very well such as:

• In surveys, doctors describe the EHR as the biggest cause of job burnout—worse than long hours, billing and other nuisances.  [Burnout is not exactly contributory to patient safety - ed.]
• One frequent complaint is mental strain.
• The doctors can’t tell one patient from another in the absence of idiosyncratic impressions. The memorable rash or symptom a patient reported is buried in screen after screen of seemingly trivial data [what I've called "legible gibberish" on this blog - ed.] In an ER or ICU, with time of the essence, this can become a critical safety problem.
• EHRs are inevitably listed among the 10 top safety concerns for doctors because they introduce new kinds of errors.
• “All the clicking saps intellectual power and concentration and blocks normal conversation."
•  “The computerization of medicine will surely be that long-awaited ‘disruptive innovation,’” but “today it’s often just plain disruptive: of the doctor-patient relationship, of clinicians’ professional interactions and work flow, and of the way we measure and try to improve things.”

Yet with all of the above, the following familiar claim is made about these systems:

• Overall, EHRs are probably improving patient safety—they have replaced illegible medical scrawl with typing, for instance.

At least the word "probably" was used.  Not to single out this article, as the refrain seems commonplace.

I opine in any case that the advantages of occasional handwriting illegibility problem resolved by EHRs are quite thoroughly nullified by critical data being "buried in screen after screen of seemingly trivial data" and other information-clouding issues related to EHR outputs.  See for instance "Two weeks, two reams" at http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html.

(Missing in this report, like most others on EHR problems such as the May 2015 American College of Physicians report "Frustrations with EHRs rampant as development slows" (http://www.acpinternist.org/archives/2015/05/EHRs.htm) are mentions of patient harm and deaths.  That topic seems verboten.)

In view of all the above, let me state this clearly:

With the increasing amount of knowledge about the flaws of these systems, coupled with the reports of harms in an environment where our top medical organizations and officials admit that the true rate of harms cannot be known due to inadequate reporting infrastructure, policies, and procedures (see http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), my belief is that these systems in their present form do not improve patient safety.

My belief is that these systems as they are today decrease patient safety, perhaps markedly, over a reasonably-staffed clinician paper records system. 

To take the enthusiast view is to ignore all of the above.  

For instance, extrapolating the ECRI Deep Dive figures alone is alarming, and to date I have not seen any arguments whatsoever as to why those figures should not be extrapolated.

The situation is only to become worse as more and more hospitals without strong internal expertise increase the complexity of the in-house clinical information systems.

The line that "EHRs increase patient safety" in view of all the problems that are now apparent even to the most hyper-enthusiastic EHR pundit is, I believe, wishful thinking run amok.

Such statements defy common sense.

The need for a very robust reporting mandate on EHR-related close calls and actual harms sorely needed.

It is the only way to know for sure whether we've moved from the occasional paper record-related mishap to a more pervasive EHR-confusion related medical misadventure circus.

Unfortunately, I don't see such mandatory reporting taking place any time soon.  A "health IT safety center" without regulatory authority and receiving HIT mishap reports on a 'voluntary' basis is favored by the industry and its government sponsors (see http://hcrenewal.blogspot.com/2014/07/new-onc-director-karen-de-salvo-no.html).  A safety center will quite likely be "safely" ignored by the sellers and users of the systems, when it suits their financial interests (which is nearly always).  It is a band-aid solution to a very serious problem.

It seems apparent to me, considering all these problems, that health IT incentives should stop.  Further, new EHR rollouts need to be put on hold until this technology is more thoroughly vetted.  Until then, harms and deaths of patients are in part the fault of those who knew, should have known, or should have made it their business to know of the risks of bad health IT.

-- SS

The 2015 PharmedOut Meeting

The 2015 PharmedOut.org meeting is now in the history books.  It featured many presentations and considerable formal and informal discussion about issues relevant to Health Care Renewal, including adverse effects of drugs, manipulation and suppression of research, deceptive marketing, disease mongering, etc.  The schedule is here.  The abstracts are here.  The new PharmedOut.org video makes some of the main points with some irony and humor.  It is available on their main page, and below



The new PharmedOut.org promotional video,

Who Benefits? - Despite Data Breaches, Staff Cuts, Vulnerable Patients' Coverage Cuts, Transplant Program Probation, Multi-Million Dollar Executive Compensation Persists at UPMC

There are so many things wrong with US and global health care that it is easy to get lost in the details, and despair of finding solutions.  Keep in mind, however, that the intractability of many of the problems may be quite man made.  Many problems may persist because the status quo is so beneficial to some people.

The Current Troubles at UPMC

Consider, for example, the troubles that have recently plagued UPMC, the giant health care system in western Pennsylvania.  In the last month, the following reports have appeared.

Electronic Data Breach Affected 2200 Patients

On May 15, the Pittsburgh Tribune-Review reported,

Personal data may have been stolen from more than 2,000 UPMC patients by an employee of an outside company the hospital giant used to handle emergency room billing, the latest in a string of data thefts to hit Pittsburgh health companies.

Note that this was only the most recent data breach at UPMC,

 UPMC was the victim of a data breach last year in which Social Security numbers and other sensitive data from all 62,000 UPMC employees were stolen when thieves hacked into an employee database at the health system.

The confidentiality of patient records is a  major responsibility of health care professionals and hospitals.  Yet UPMC does not seem to be doing a good job in protecting such confidentiality.

UPMC Move to Cut 182,000 "Vulnerable" Elderly Patients from it Medicare Advantage Plan Challenged in Court

The Pittsburgh Business Times reported on May 21,

Health system UPMC will defend its decision to cut 182,000 seniors from its provider network at a Commonwealth Court hearing May 27 in Harrisburg.

The hearing will determine whether UPMC complied with a consent decree that was reached last year and intended to protect 'vulnerable' populations from fallout of the messy Highmark-UPMC divorce. The seniors have Medicare Advantage coverage through UPMC rival Highmark Inc., and most commercial contract relations between the two health care titans ended Dec. 31.

This doesn't sound like the "patient-centered" care UPMC boasts about on its website.

UPMC to Cut 3,500 Staff Via Buyouts

Modern Healthcare reported on May 26,

In Pittsburgh's fiercely competitive healthcare market, UPMC announced voluntary buyouts to reduce its labor costs.

The system—which has also cut its hospital capacity in recent months—offered 3,500 workers voluntary buyouts to 'achieve cost-savings for UPMC by adjusting our workforce to meet the demands of the healthcare marketplace,' said spokeswoman Gloria Kreps.

Not mentioned by UPMC spokespeople were the possible effects on patient care of cutting about 5% of the most experienced members of the UPMC workforce.

UPMC Attorneys Disqualified from Defense of Wrongful Death Case

The Pittsburgh Post-Gazette reported on May 30,

The law firm that represents UPMC in many civil matter was disqualified from a medical malpractice cast this week after a judge found that an attorney from Dickie, McCarney & Chilcote improperly spoke with and advised a witness.

This does not say a lot for how UPMC managers pick legal counsel and manage their seemingly many legal defenses.

UPMC Lung Transplant Program on Probation, Again

On June 2, the Tribune-Review reported,

A national organ-sharing group has put UPMC's lung transplant program on probation for a year, listing concerns about how the program handled donated organs. 

The United Network for Organ Sharing cited 14 cases in 2013 and 2014 when the hospital system accepted lungs that UPMC doctors later found could not be transplanted in intended recipients, said Dr. Jonathan D'Cunha, UPMC's lung transplantation surgical director.

UPMC kept the organs for other patients in UPMC Presbyterian in Oakland, an approach approved by regional organ procurement groups that supplied the lungs, D'Cunha said. But UNOS, a nonprofit that manages the American organ transplant system, objected to what it called 'an unusually high number of instances' of the practice.

Probation ordered by the board of UNOS and the Organ Procurement and Transplantation Network took effect Monday, according to UNOS.

D'Cunha said the transplant program remains fully operational but will be operating under a corrective-action plan.

This was not the first trouble that a UPMC transplant program has encountered.  As the Pittsburgh Post-Gazette reported,

This is  the second time UPMC has been placed on probation for a transplant problem.

In 2011, it was placed on probation ... after disease was transferred from a living kidney donor to a recipient.

Note that while the first instance of probation seemed to suggest competency issues, the latest one seems to be about ethical issues.  By transplanting kidneys into immediately available UPMC patients who may have lower priorities than other patients on the list, UPMC may be disfavoring patients from "outside," whose transplants, incidentally, would not generate much revenue for UPMC.

An editorial in the Post-Gazette suggested while UPMC "pleads ignorance" about these rules, "Western Pennsylvania's largest hospital network should have known better."

Just Another Bad Month?

Thus it was just another bad month at the office for UPMC management.  But UPMC management has had lots of bad months.  For example, since 2011, we have previously discussed
-  Fantastical musing by the UPMC CEO about health care run by computers, not doctors (look here)
-  Fantastical claims by UPMC in response to a lawsuit that is has no employees (look here)
-  Numerous malpractice cases filed against UPMC related to problems with its electronic medical records (look here, here, here, here)
-  Layoffs at UPMC due to problems with its electronic medical records (look here)
-  A lawsuit by the Mayor of Pittsburgh claiming UPMC should be stripped of its non-profit status (look here).  

The $6.4 Million CEO, and the Other Million Dollar Managers

One would think that these series of events, all in a short time, coupled with all these previous stories, might raise questions about who is running the institution, and what they are being paid.


Instead, however, the Pittsburgh Tribune-Review published a story on May 15, 2015, about just how well paid top UPMC managers continue to be.

UPMC's Jeffrey Romoff banked total compensation of $6.4 million two years ago, ranking the chief executive's pay among the nation's highest for nonprofit health leaders.

The 69-year-old Romoff was one of 31 employees of Western Pennsylvania's largest integrated health system to be paid more than $1 million in 2013,...

Romoff's 2013 pay, which included a base salary of nearly $1 million plus $5 million in incentives and deferred income, was down 3 percent from the previous year but well above the median compensation for a nonprofit hospital CEO.

The defense of Mr Romoff's compensation followed the same pattern we have discussed repeatedly. Justifications for exceedingly generous compensation for health care managers, particularly of non-profit hospital, often are superficial, limited to talking points we have repeatedly discussed, (first  here, with additional examples of their use here, here here, here, here, here, here, and here.)  These are:
- We have to pay competitive rates
  We have to pay enough to retain at least competent executives, given how hard it is to be an executive
- Our executives are not merely competitive, but brilliant (and have to be to do such a difficult job).

So,

UPMC spokeswoman Susan Manko wrote in an email that compensation for the company's executives is tied to performance that is based on 'clearly defined goals, including quality of care, community benefit, financial measures and other key factors.'  Pay takes into consideration what other industry executives are making, she noted.

Thus,, by inference, she implied Mr Romoff's brilliance in meeting the "clearly defined goals," and overtly stressed the competitive rates talking point.

However, the clearly defined goals including putting the transplant on probation twice, having several electronic data breaches, trying to discharge the most experienced employees, being sued for being a non-profit in name only, being subject to numerous malpractice suits, and having one law firm used to defend one of these suits disqualified,  and dumping hundreds of thousands of elderly, "vulnerable" patients?  Really?

A fair comparison was to other overpaid managers, not to the dedicated health care professionals who make the system work?  Really?

Also, as the Pittsburgh-Tribune Review reported on February, 2015, the Chairman of the Board of UPMC, Nicholas Beckwith, thinks Mr Romoff is a

brilliant leader and stood by the board's decision to pay Romoff $6.6 million a year, among the highest CEO salaries for nonprofits in the region.

Furthermore,

'When people ask me about his pay, I say, ‘What would you pay him?'' Beckwith said. 'If they're going to understand the brilliance of Jeffrey Romoff, they have to acknowledge there's no more effective leader in the nation than Jeff Romoff.'

So here was the "brilliance" talking point really writ large.  The most effective leader in the entire US?  Really?

At best, Mr Beckwith seemed to be only thinking about the financial performance of UPMC, rather than its clinical performance, its ethical performance or its effects on patients and their outcomes. But then again, Mr Beckwith might not know much about that,

Beckwith worked as a salesman for Murrysville-based Beckwith Machinery and eventually became its CEO.

But one letter to the Pittsburgh Tribune-Review did suggest

Perhaps UPMC should consider offering buyouts to that group of egotists who inhabit the upper reaches of the U.S. Steel Tower. Then they could move to the next phase of life — old and wealthy.

Summary

So we have presented the recent unpleasantness at UPMC as emblematic of some of the types of unpleasantness that afflict US (and global) health care, including threats to patients' confidentiality and access, problems with quality of health care, possible ethical misconduct, ill treatment of experienced health care staff, etc.  Yet consider that despite these multiple failings, and a history of similar failings going back years, the top hired managers of the non-profit hospital health care system are being made millionaires many times over.  They clearly are benefiting greatly from the current system, regardless of whether the system benefits others.  In fact, one begins to wonder if they are paid well despite the current problems, or because of them?

So one lesson is: every time some new version of health care dysfunction appears in public, think not only about its bad effects on patients, professional values, the public, etc.  Think about who is gaining from the current bad status quo.

 For a slightly more specific lesson....  In a 2014 interview, corporate governance experts Robert Monks and Nell Minow, Monks said,

Chief executive officers' pay is both the symptom and the disease.

Also,

CEO pay is the thermometer. If you have a situation in which, essentially, people pay themselves without reference to history or the value added or to any objective criteria, you have corroboration of... We haven't fundamentally made progress about management being accountable.

The symptom and the disease have metastasized to health care, from huge for-profit corporations now also to even small non-profit hospitals.   Thus, like hired managers in the larger economy, health care managers have become "value extractors."  The opportunity to extract value has become a major driver of managerial decision making.  And this decision making is probably the major reason our health care system is so expensive and inaccessible, and why it provides such mediocre care for so much money. 

One wonders how long the people who actually do the work in health care will suffer the value extraction to continue?
As we have said far too many times - without much impact so far, unfortunately - true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.

As Robert Monks also said in the 2014 interview,

People with power are very reluctant to give it up. While all of us recognize the problem, those with the power to change it like things the way they are.

So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes. 

ADDENDUM (16 June, 2015) - This post was re-posted on OpEdNews.com. 

Health Care Professional Societies Whose Leadership Betrays Their Own Members - the APA Alleged to Have Supported Torture, and Deceived its Members to Collect Money

Health care professionals usually view their professional societies as allies, supporting their values and acting in their professional and their patients' interests.  Increasingly, however, these societies appear to be run more to support the interests of their top leaders. 

Allegations that the American Psychological Association (APA) Supported Torture

The latest example is the American Psychological Association.  As noted by a Washington Post article from May, 2015, "the APA ... represents more than 122,000 doctoral-level psychologists around the world...."  Of these, about 60,000 are licensed clinical psychologists, and the remainder are mainly research psychologists.

The most serious allegations that the APA had betrayed its members values were described in a New York Times article from late April, 2015. 

The American Psychological Association secretly collaborated with the administration of President George W. Bush to bolster a legal and ethical justification for the torture of prisoners swept up in the post-Sept. 11 war on terror, according to a new report by a group of dissident health professionals and human rights activists.

Furthermore,

The involvement of health professionals in the Bush-era interrogation program was significant because it enabled the Justice Department to argue in secret opinions that the program was legal and did not constitute torture, since the interrogations were being monitored by health professionals to make sure they were safe.

The interrogation program has since been shut down, and last year the Senate Intelligence Committee issued a detailed report that described the program as both ineffective and abusive.

In particular,

In early June 2004, a senior official with the association, the nation’s largest professional organization for psychologists, issued an invitation to a carefully selected group of psychologists and behavioral scientists inside the government to a private meeting to discuss the crisis and the role of psychologists in the interrogation program.

Psychologists from the C.I.A. and other agencies met with association officials in July, and by the next year the association issued guidelines that reaffirmed that it was acceptable for its members to be involved in the interrogation program.

To emphasize their argument that the association grew too close to the interrogation program, the critics’ new report cites a 2003 email from a senior psychologist at the C.I.A. to a senior official at the psychological association. In the email, the C.I.A. psychologist appears to be confiding in the association official about the work of James Mitchell and Bruce Jessen, the private contractors who developed and helped run the enhanced interrogation program at the C.I.A.’s secret prisons around the world.

In the email, written years before the involvement of the two contractors in the interrogation program was made public, the C.I.A. psychologist explains to the association official that the contractors 'are doing special things to special people in special places.'

These are very serious allegations.  In a Forbes blog post, Todd Essig wrote,

Starting after 9/11, and continuing to the present day, APA leadership has made a series of bad decisions, ones with appalling and destructive consequence. Significant numbers of people have been harmed. Opportunities to apply psychological knowledge to benefit society and improve people’s lives have been lost. The public trust in the profession of psychology has been undermined. Things are so bad that the only way forward now is for the involved leadership to resign.

Essig emphasized that the actions of APA leadership appeared to directly conflict with the organization's mission,

Every day without decisive action to redress the breach of the public trust further undermines the APA’s ability to fulfill its mission to 'advance the creation, communication and application of psychological knowledge to benefit society and improve people’s lives.'

Nonetheless, the APA leadership has made no move to resign, and appear to be waiting for the supposedly independent review they have commissioned of the society's actions regarding torture.

Legal Settlement that the APA Deceived its Members to Collect More Money

While less dramatic, another story appeared last month that further suggested that the APA has seemed to have gone rogue from the interests of its members and their patients.  The Washington Post reported,

The American Psychological Association (APA) has settled a class-action lawsuit that accused the organization of deceptively requiring many of its members to pay a large annual fee to fund the group's lobbying arm. The fee was actually optional.

Under the settlement, the APA, which represents more than 122,000 doctoral-level psychologists around the world, has agreed to refund a total of $9.02 million to members who paid the fee between 2000 and early 2015. The assessment, which changed from year to year, was about $140 annually and was charged only to licensed clinicians, not research scientists and others. It generated about $6 million a year, according to the lawsuit.

Note that...

The lawsuit claimed that in a variety of ways over the years, the APA 'deceptively created the impression that the fee was actually required as part of annual APA dues.' For example, an annual dues assessment said that members who provide health-related services “must pay" the fee that supports the lobbying arm, a separate group known as the APA Practice Organization (APAPO). It was established separately because tax laws restrict nonprofits like the APA from political work and other forms of advocacy.

In 2002, the APA’s Web site stated that members 'must pay the Special Assessment,' and in 2004, the APA announced that starting in 2005 'all APA members who are licensed psychologists will be billed the assessment,' the lawsuit claimed.

This was a legal settlement, so APA leadership did not have to

concede that its communications were misleading and acknowledged no wrongdoing in the settlement. In a news release sent out in January, when the settlement was announced, the organization said that 'APA/APAPO and the plaintiffs disagreed about whether the APA dues statement could mislead practice members concerning the annual practice assessment.'

How Did a Society's Leadership Become So Disconnected from its Members and their Values?

These allegations do raise the question of how the leadership of a health care professional society could become so profoundly disconnected from its members.  I briefly would suggest the hypothesis that many health care professional societies have functionally become more like publishing houses or marketing and public relations firms. 

Consider the most recent financial statement (US IRS form 990) available from the APA (for 2013, link here).    The APA had total revenue of over $127 million.  Of that, less than 10% came from membership dues ($10,802,967) and convention and conference fees ($2,742,353).  So the major sources of revenue of this supposed membership organization were not the members, but "licensing, royalties, and rights," "journal subscriptions," "publication sales," and "other program service."  Thus, the organization's finances were more that of a publishing house/ marketing and public relations firm than that of a membership organization. Presumably, leadership may have been more concerned about continuing to generate revenue from such activities than about their membership's wishes, or interests.


The revenue from these activities allowed the organization to accrue real estate valued at over $78 million, and investments valued at over $90 million.  Also, it allowed generous payments to the members who served as officers.  Twelve members who served as officers, on the board of directors, or otherwise in leadership got more than $10,000 a year.  The president got more than $38,000.  Traditionally, officers and board members of true membership organizations are unpaid.  In addition, the APA paid its hired managers very handsomely.  Sixteen received more than $225,000.  Of those, twelve received more than $300,000.  The executive vice president/ CEO received over $750,000. 

So the transformation of the APA from a membership organization to a publishing house/ marketing and public relations firm that allegedly ended up supporting torture, and deceiving its supposed members created a very cozy and remunerative environment for its leaders and those who ostensibly exercised stewardship over them.

Again, this is particularly egregious since this was supposed to be a membership organization that would support research and education in psychology, and psychological care of patients. 

Summary

In the bigger story from last month, very serious allegations surfaced about the American Psychological Association.  These included accusations that top society leaders collaborated with torture, which would seem to be a huge contradiction of the organization's supposed mission to help patients with psychological problems.  At the same time, the organization settled a lawsuit that had alleged organizational leaders had deceived their own members in order to collect money to support their lobbying efforts. 

We have frequently discussed how leaders of large nominally non-profit health care organizations, mainly hospitals and hospital systems, often seem to put revenue, and their own financial advancement, ahead of the organizations' missions.  Sometimes, their actions have been actively mission-hostile.  The takeover of hospitals and hospital systems by people with little concern for, or even hostility to those organizations' once noble missions appears to be a singularly bad problem that may be responsible for much health care dysfunction, rising costs, declining access, and ultimately bad patient outcomes. 

Now we see another example of a large health care organization, this time a health care professional society,  whose leadership seems to have trampled their members' values, supported mistreatment of human beings, and just incidentally deceived their members' to make more money.  An important difference in this case is that the organization's leadership is nominally supposed to represent its members.  So maybe its members can rise up to ensure leadership that would actually uphold their professional values and their and most importantly their patients' interests.


Maybe the members will still rise up and force the resignations of the officers and managers who profited so much from this mess.  At least, if they were to leave the organization, it could no longer pretend to be a membership organization.

As we have said until blue in the face, true health care reform requires leadership of health care organizations that understand health care, cares about its mission, and is willing to be held accountable.  A good place to start such reform would be the organizations that are supposed to represent health care professionals. 

Say It Ain't So, Again - a "Push Poll" to Minimize the Hazards of Conflicts of Interest ...in the New England Journal of Medicine?

The New England Journal of Medicine recently published a remarkable series of apologiae for conflicts of interest,(1-4) about which we have published three posts, here, here, and here.  Just to ice the cake, the NEJM also set up a reader poll on the subject. Its introduction stated,

we invite you to put yourself in the role of editor and help us decide about the suitability of three hypothetical potential authors of review articles for the Journal.

However, as noted first in a post on the HealthNewsReview.org blog, the poll had a curious design. 

Each of the three hypothetical experts has some type of financial arrangement with the pharmaceutical industry – either royalty payments, speaking fees, or commercially supported research at a university that covers everything except the researcher’s salary.

Noticeably absent was a 'Case #4' describing a potential author with no conflict of interest. 

IMHO, this seems like a biased survey design.  By failing to incorporate a questions about an unconflicted author, the numeric results of the poll could not show whether those answering it would actually favor authors without conflicts of interest.  Of course, the whole thrust of the three commentary(2-4) plus one editorial(1) NEJM series was that concerns about such conflicts are overblown.

Nonetheless, the poll allowed for comments, and as the blog post showed, this bias did not escape notice.  One commentator, Dr David Newman, wrote

The only reason to choose any of the individuals in these cases would be if there were no available alternatives.

This survey bias did not escape Dr Josh Farkas, who wrote this in a PulmCrit blog post,

Perhaps the most interesting component of the media campaign is the reader poll about the adequacy of various hypothetical authors for a review article.  Three potential authors are described, all of whom have significant COIs.  The design of this poll itself is biased, by presenting no authors without COIs.  A more transparent approach might be to simply ask readers 'do you think review article authors should be allowed to have COIs?'

Thus, the NEJM conflict of interest poll appears to be not an attempt at unbiased data collection, but a "push poll."  A "push poll," per Wikipedia, is:

an interactive marketing technique, most commonly employed during political campaigning, in which an individual or organization attempts to influence or alter the view of voters under the guise of conducting a poll.

By prominently publishing a poll with such a biased design, the NEJM has further supported my argument that its current editors are engaging in polemics rather than scholarly debate about the very important issue of conflicts of interest in medicine and health care.  Perhaps the current NEJM editors should consider joining the blogsphere in which polemics abound, while leaving the serious business of scholarly journal editing to those who are more dispassionate.   

References
1.Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854. Link here.
2. Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015; 372:1860-1864.  Link here.
3. Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here.
4.  Rosenbaum L.  Beyond moral outrage - weighing the trade-offs of COI regulation. N Engl J Med 2015; 372: 2064-2068.  Link here.