Wednesday, May 27, 2015

Government backs down on some requirements for digital medical records

EHR utopian dreams have taken some pronounced hits in recent years.

In recent months, the hyper-enthusiasts and their government allies have had to eat significant dirt, and scale back their grandiose but risible - to those who actually have the expertise and competence to understand the true challenges of computerization in medicine, and think critically - plans.

(At this point I'll give them the benefit of the doubt and not call the utopians and hyper-enthusiasts corrupt, just stupid.)

USA Today published this article today outlining the retreat:

Government backs down on some requirements for digital medical records

Jayne O'Donnell and Laura Ungar, USAToday  
May 26, 2015

Government regulators are backing down from many of their toughest requirements for doctors' and hospitals' use of digital medical records, just as Congress is stepping up its oversight of issues with the costly technology.

They needed to back down because the technology, vastly over-hyped and over-sold as to capabilities, and vastly undersold as to the expertise required for proper design and implementation, has impaired the practice of medicine significantly - and caused patient harms:

... Now the Department of Health and Human Services is proposing a series of revisions to its rules that would give doctors, hospitals and tech companies more time to meet electronic record requirements and would address a variety of other complaints from health care professionals.
"The problem is we're in the EHR 1.0 stage. They're not good yet," says Terry Fairbanks, a physician who directs MedStar's National Center for Human Factors in Healthcare. The federal government "missed a critical step. They spent billions of dollars to finance the implementation of flawed software."

The "EHR 1.0" stage?  The actual problem is that an industry that's existed regulation-free for decades now was believed, against the advice of the iconoclasts, myself included, when it spoke of this experimental technology as if it were advanced and perfected.

Our leaders all the way up to the last two Presidents were suckered by this industry.  In Feb. 2009 I wrote:

http://www.wsj.com/articles/SB123492035330205101

Dear WSJ:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.
The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.


Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

Nobody was listening.

Back to USA Today:


... William McDade, a Chicago anesthesiologist, checks the medical records of patient Jacob Isham. McDade has moved into electronic medical records but isn't convinced they improve record-keeping, and meanwhile they're expensive and they take time away from patients. 

These digitized records remain the bane of many doctor and patient relationships, as physicians stare at computer screens during consultations.And there's the issue of time. University of Chicago Medicine anesthesiologist William McDade, who has switched from paper to electronic records, says that while EHRs put information at doctors' fingertips, those doctors must take extra time to enter data, and some systems are not intuitive.

The model of physicians as data-entry clerks was experimental from the start, especially in busy inpatient settings and critical care areas.  I opine that particular experiment is a failure.  Paper is far faster, followed by transcription by those without clinical obligations.  That's expensive, of course; but reality is a harsh master.

Praveen Arla of Bullitt County Family Practitioners in Kentucky says even though he's "one of the most tech-savvy people you're ever going to meet," his practice has struggled mightily with its system. It cost hundreds of thousands of dollars to put into place, he says, and it doesn't even connect with other systems in hospitals and elsewhere.

Physicians should not have to be "tech-savvy".  Software, as I've written before, needs to be physician-savvy.  As much of it is written without clinical leadership, we have the results outlined in USA Today.


... The federal government "should've really looked at this more closely when EMRs were implemented. Now, you have a patchwork of EMR systems. There's zero communication between EMR systems," he says. "I am really glad they're trying to look back and slow this down."

I repeatedly called for a slowdown or moratorium of national EHR rollout on this blog.  See 2008 and 2009 posts here and here for example.  My calls were due to the prevalence of bad health IT (BHIT), hopelessly deficient if not deranged talent management practices (especially when compared to clinical medicine) in the health IT industry, and complete lack of regulation, validation and quality control of these potentially harmful medical devices. 

I also called the HITECH stimulus act 'social policy malpractice.'  See my Sept. 2012 post "At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professional".

USA Today then calls out issues of reliability, safety and liability.

Of course, there's always a straddle-the-fence defender of EHRs, with a "EHRs have problems, BUT..." refrain,  even when almost 40 medical societies have complained about safety and usability issues (http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):

... Physician Robert Wachter, author of The Digital Doctor, is a proponent of,EHRs, but sounded several cautionary notes in his book about the problems. At the University of California San Francisco, where he chairs the department of medicine, a teenage patient nearly died of a grand mal seizure after getting 39 times the dose of an antibiotic because of an EHR-related issue. But Wachter says he believes patients are safer with EHRs than they were with paper.

Wachter's book to my belief omitted known cases of EHR fatality - in my view a milquetoast, spineless approach to EHR risk at best.  (I'm trying to be kind and objective, but such spinelessness of others about EHRs put my mother in her grave, http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html.)

Further, the belief that EHRs are safer than paper are not the views in my mind of a critical-thinking scientist, as the true rates of EHR-related harms is unknown, yet the incidences of mass "glitches" affecting potentially thousands of patients at a time and impossible with paper are well-known.

See my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), especially points #1 through 4, and the query link http://hcrenewal.blogspot.com/search/label/glitch.

5/27/2015 addendum:  The author of this USA Today article Jayne O'Donnell informed me that the following appeared in the print edition, but not the electronic version:

But Wachter  and Sally Murphy, former chief nursing officer at HHS' health information technology agency, say they both believe patients are safer with EHRs than they were with paper.

"Is there broad proof that electronic health records have impacted quality? No, " says Murphy, "But you just have to pay attention to the unintended consequences and continue to study them."

First, that response seems the classic salesman's tactic of redirection, to deflect from fully answering to the cruel reality of the evidence.  The second part of the response strikes me as a non-sequitur, in fact.

Second, Murphy and Wachter both seem unable to grasp that the myriad en masse risks to potentially large numbers of patients these systems in their current state cause, impossible with paper (as, for instance, in the many posts at the link above), combined with the lack of evidence about (mass-hyped) "quality improvements", could make patients less safe under electronic enterprise command-and-control systems, which in hospitals is what these systems really are.

Try getting thousands of prescriptions wrong, for instance (see http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or stealing hundreds of thousands of paper records (see for example http://hcrenewal.blogspot.com/2012/06/more-electronic-medical-record-breaches.html).

Compare to well-staffed paper systems led by health information management professionals (not IT geeks), especially those supplemented with document imaging systems.

This type of statement - "EHRs are bad today, BUT they're still better than paper" - strikes me as reflecting, I'm sad to say, limited imagination, limited critical thinking, Pollyanna attitudes, and unfettered faith in computers.

Third, Murphy's somewhat disconnected response "But you just have to pay attention to the unintended consequences and continue to study them" is a bit surprising considering the statement made by the same ONC office just a few years ago:

Contrast to former ONC Chair David Blumenthal, see second quote at my April 27, 2015 essay "Pollyanna Rhetoric, Proximate Futures and Realist's Primer on Health IT Realities in 2015" at http://hcrenewal.blogspot.com/2015/04/pollyanna-statements-proximate-futures.html from an April 30, 2010 article entitled "Blumenthal: Evidence of adverse events with EMRs "anecdotal and fragmented":

... The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety."  (David Blumenthal, former head of ONC at HHS, http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented)

Sadly and tragically, my mother was seriously injured by EHR-related medication reconciliation failure and abrupt cessation of a heart rhythm medication just weeks after Blumenthal said he was unconcerned about risk and that we should go full steam ahead.  That misadventure began on May 19, 2010 to be exact.

It is my belief HHS and ONC still do not take risk seriously and would revert to a Pollyanna stance in a heartbeat without the pressures of the iconoclasts.

Back to the USA Today article:

... Some proponents of EHRs say the government has been thwarting efforts to improve them.

That's laughable.  A review of Australian computer scientist/informtics expert Jon Patrick's analysis of the Cerner ED EHR product, for example, gives insight into just how crappy this industry and its products are, and government was certainly not the cause.   See: Patrick, J. A Study of a Health Enterprise Information System. School of Information Technologies, University of Sydney. Technical Report TR673, 2011 at http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146.


... In addition to extending the deadline for implementing EHR requirements, a series of HHS proposed rules extends the time doctors, hospitals and tech companies have to meet EHR requirements, cuts how much data doctors and hospitals have to collect and reduces how many patients have to access to their own electronic records from 5% of all their patients to just one person.

"That is a slap in the face to patient rights and all the advocates because we worked so hard and for so long to ensure patients could access their data," says patient advocate Regina Holliday.

Holliday became an electronic records advocate after her husband died of kidney cancer in 2009 at age 39. His care was adversely affected because hospitals weren't reading his earlier EHRs and she had trouble getting access to the records.

I met Regina Holliday in Australia during my 2012 keynote presentation to the Health Informatics Society of Australia on health IT trust (http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html).  As I recently mentioned to her, it's even worse that the requirements for a tamper-proof audit trail are also being relaxed.

Without a complete and secure audit trail, electronic records can be altered without detection by hospitals, e.g., after a medical misadventure, to their advantage.   This represents a massive conflict of interest is a violation of patient's rights to a secure and unaltered record in the event of a mishap, in my opinion.

The 2014 Edition EHR CERTIFICATION CRITERIA, 45 CFR 170.314 spells out in great detail specs for such an audit trail (see page 7 at http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf), but compliance has been 'conveniently' relaxed, after hospital and industry lobbying I'm sure.

(The certified electronic health record technology definition proposed by CMS would continue to include the “Base EHR” definition found in the “2015 Edition Health IT Certification Criteria” in addition to CMS’ own objectives and criteria.  This definition does not include mandatory tamper resistant audit trails. The audit trail requirement is not proposed to be included in the 2015 definition of “Base EHR."  Neither is this criterion found in CMS’ own definition of CEHRT; rather it is “strongly recommended” that providers ensure the audit log function is enabled at all times when the CEHRT is in use, since the audit log function helps ensure protection of patient information and mitigate risks in the event of any potential breach.)

"Strongly recommended" in this industry in my opinion equates to "safely ignore" if it impacts margins.


... EHRs "have made our lives harder" without improving safety, says Jean Ross, co-president of National Nurses United. Last year, the nurses' union called on the Food and Drug Administration "to enact much tougher oversight and public protections" on EHR use.

Meanwhile, the medical industry is urging HHS to give them even more time and flexibility to improve their systems.

"The level of federal involvement and prescriptiveness now is unhealthy," says Wachter, who chairs the UCSF department of medicine. "It has skewed the marketplace so vendors are spending too much time meeting federal regulations rather than innovating."

Here's Wachter again, in essence, kissing the industry's ass.  Government EHR regulation is still minimal, and prior to MU was nearly non-existent.  Where was the "innovation" (more properly, quality, usability, efficacy and safety) then, I ask?

... Sen. Lamar Alexander, R-Tenn., chairman of the Senate health committee, and Sen. Patty Murray, D-Wash., announced a bipartisan electronic health records working group late last month to help doctors and hospitals improve quality, safety and privacy and facilitate electronic record exchange among health care providers and different EHR vendors.

 "It's a great idea, it holds promise, but it's not working the way it is supposed to," Alexander said of EHRs at a recent committee hearing

 At a Senate appropriations subcommittee meeting last month, Alexander told HHS Secretary Sylvia Burwell that he wanted EHR issues at the top of his committee and HHS' priority list to be addressed through regulation or legislation.

I have spoken to the Senator's healthcare staff, who are aware of my Drexel website and my writings on this blog.  They were stunned by the reality of health IT, and I hope they have relayed my concerns and writings to the senator and that this contributed to his mandate.


... Minnesota lawmakers became the latest state this week to allow health care providers to opt out of using EHRs. But MedStar's Fairbanks says doctors would welcome well-designed, intuitive EHRs that made their jobs easier instead of more difficult — and that would improve safety for patients, too.

It is my view that under current approaches to health IT, in terms of talent management, leadership, product conception, design, construction, implementation, maintenance (e.g., correction of reported bugs), regulation, and other factors, that dream is simply impossible.

The entire EHR experiment needs serious re-thinking, by people with the appropriate expertise to know what they're doing.

I note that excludes just about the entire business-IT leadership of this country, who, lacking actual clinical experience, are one major source of today's problems.



Today, Pinky, we're going to roll out national health IT ... tomorrow, we TAKE OVER THE WORLD!

-- SS

Tuesday, May 26, 2015

Lahey Health: hospital jobs lost, but computer vendors prosper

At numerous posts on this blog I link to stories of health IT expense putting hospital financial stability at risk, e.g., "Monetary losses and layoffs from EHR expenses and EHR mismanagement" (http://hcrenewal.blogspot.com/2013/06/monetary-losses-and-layoffs-from-ehr.html),  "Financial woes at Maine Medical Center: Reading this blog might have saved them millions of dollars, and prevented massive 'cost saving initiatives'" (http://hcrenewal.blogspot.com/2013/05/financial-woes-at-maine-medical-center.html), "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" (http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html) and others.

Here's another, with human layoffs as a result:

Boston Globe
May 20, 2015
Lahey Health to lay off 130 workers at three hospitals
https://www.bostonglobe.com/business/2015/05/20/lahey-health-lay-off-workers/uXbvA2UcBpBLa8PLfRy5tJ/story.html

Lahey Health, the Burlington-based hospital network, is laying off 130 people at three hospitals and cutting the pay of top executives as it moves to close a budget gap.

Lahey said Wednesday that it lost $21 million during the six months that ended March 31 because it spent more than anticipated on the rollout of a new software system and lost business during the harsh winter as patients canceled appointments. It also blamed what it called low reimbursements from public and private insurers that did not cover the full cost of delivering care to patients.

... The job cuts represent about 1 percent of Lahey’s workforce of about 14,000 and include managers, clinicians, and administrative staff.

They include 95 people at Lahey’s flagship hospital in Burlington, 30 at Winchester Hospital, and five at Beverly Hospital.

In health IT, "spending more than anticipated" is an activity that might be more accurately called "fixing bad software at customer expense."

Perhaps hospitals need to abandon the dream that health IT is going to save money, and consider it a serious money sink for which exceptional due diligence needs to be performed - before purchase.

At least management is taking some of the hits in this case.

-- SS

Thursday, May 21, 2015

Say It Ain't So: Logical Fallacies in Defense of Conflicts of Interest ... in the New England Journal of Medicine?

Introduction

We have been viewing with alarm the web of conflicts of interest draped over medicine and health care since we started Health Care Renewal.  We have been particularly concerned about how conflicts of interest may have led to threats to the integrity of clinical research, especially due to manipulation and suppression of clinical research studies.  We have also been concerned about how COIs have led to threats to the integrity of medical education, especially given how health care corporate marketers have paid influential health care professionals and academics to be "key opinion leaders," mainly to act as salespeople in disguise.  We have discussed individual and institutional conflicts of interest involving all sorts of health care organizations.

When we started writing about these issues, we did not find many who shared our concerns, but the topics have become better known.  The Institute of Medicine wrote an apparently authoritative report in 2009 on conflicts of interest which got some notice, but attracted few adherents.  There have been few changes on the policy front in the US regarding conflicts of interest, with the notable exception of the Sunshine Act incorporated into the Affordable Care Act which required increased disclosure of payments made to health professionals and organizations. 

So it was surprising that the New England Journal of Medicine, probably the most influential and important English language medical journal, recently published an editorial by Drazen (1) and three commentaries by Rosenbaum(2-4) about conflicts of interest, all suggesting that concerns about COIs are overblown, and that excess attention to COIs may be inhibiting medical progress.

It was more surprising, given the reach of this journal, that these articles featured a catalog of logical fallacies in support of their arguments.  We have noted that logical fallacies have been a stock in trade of those who actively defend laissez faire policies about conflicts of interest, and other kinds of interactions among health professionals and industry.  However, I would not have believed that the New England Journal of Medicine would go along with this sort of thing.

However, they did, and so we will endeavor to sort out their catalog, noting the most important uses of logical fallacies, in order of the chronological sequence of the publications....

Burden of Proof Fallacy: That All Physician - Industry Collaborations are Beneficial is Assumed, but Contentions that Financial Conflicts of Interest Affecting Physicians Must be Disclosed, Regulated or Banned Require Rigorous Proof  

"The burden of proof is a fallacy in which the burden of proof is placed on the wrong side," per the Nizkor Project definition.

The Assumption that All Physician-Industry Interactions are Good

The Drazen and Rosenbaum articles assert that the burden of proof rests on those who assert that conflicts of interest ought to be disclosed, regulated or restricted.  However, they take the benefits of all physician-industry interactions as given.  For example,

This partnership between an academic researcher and a drug company went on to alleviate substantial human suffering and should be a model for current behavior. Unfortunately, it is not.(1)

Simply put, in no area of medicine are our diagnostics and therapeutics so good that we can call a halt to improvement, and true improvement can come only through collaboration.(1)

the benefits wrought by interactions between physician-scientists and industry are ... clear.(2)

[Physician-industry] interactions [are] characterized by a shared mission to fight disease.(4)

life-saving therapies ... development requires the combined talents of clinicians and industry scientists.... (4)

The series of articles includes multiple assertions that physician-industry collaboration, which is not further defined, is necessary for the advancement of medicine.  The articles never explicitly exclude various kinds of "collaborations" that others may question, including for example, corporate marketers paying well known, often senior academic physicians to be "key opinion leaders" and thus act as salespeople; or paying physicians to give "drug talks" that are clearly marketing exercises, (e.g., the case of "Dr Drug Rep.")

The NEJM articles only supply anecdotal data at best to support this broad assertion.  Of the two anecdotes used by Drazen(1), one was about collaboration between Selman Waksman and Merck during the 1940s in the development of streptomycin.  The applicability of this anecdote, from long ago, done under the pressures of wartime, and long before the era of "shareholder value" theories of management that put short-term revenue ahead of all else (look here), was unclear.   The other "cogent example has been a vaccine against Ebola virus disease."  However, no such vaccine has been licensed for use or accepted as effective, yet.  In fact, society's failure to develop such a vaccine up to now has been attributed to pharmaceutical industry management's emphasis on the preeminence of revenue.  Until the recent epidemic, Ebola vaccine was not seen as a big money maker (look here).

In short, the series of articles accept the value of physician-industry collaboration, writ broadly, in the absence of clear evidence.

The Contention that the Burden of Proof is on Those Who Argue that COIs Should be Disclosed, Regulated or Restricted


On the other hand, regarding assertion that conflicts of interest ought to be disclosed, regulated, or restricted, Rosenbaum wrote

we still lack an empirical basis to guide effective conflict management.(3)

Equally unclear are the benefits and harms of regulations aimed at exposing or mitigating these conflicts.(3)

It remains unclear whether ... disclosures actually mitigate the risk of bias.(3)

conflict-of-interest policies have evolved not through careful data gathering and analysis.... (4)

In particular, most of Rosenbaum's three articles(2-4) focus on her general doubts about and perceptions of faults in the evidence-base about the harms of conflicts of interest, or the benefits of disclosing, regulating or restricting them. For example,

though considerable social science research suggests that even small gifts may influence physicians, it doesn't necessarily follow that greater financial stakes are more influential.(3)

Suggestive data may be worse than no data at all.(3)

It depends on how you define harm.  Consider pharmaceutical 'gifting,' a practice that smacks of bribery - which may be sufficient reason to prohibit it.  But does it actually harm patients?(4)

Furthermore, while decrying the lack of rigorous data in support of disclosing, regulating or restricting COIs, she raises doubts about such actions based on vague anecdotes and general, but unsubstantiated assertions, including

some of the young, talented physician-investigators I spoke with expressed worry about how any industry relationship would affect their careers.(3)

The proportion of physician-investigators who have such concerns was not stated.

A medical school dean probably won't lose her job if patents aren't produced under her tenure, but she will be taken to task if she appears to lax in regulating faculty-industry interactions.(4)

No further specifics about consequences to such academic leaders appeared. 

For many people, however, the medical-industrial complex elicits deeply negative feelings that make it tough to evaluate fairly any intervention aiming to mitigate industry influence.(4)

The evidence in support of this assertion was not apparent.

I think the desire for retribution against 'bad pharma' informs our management of industry interactions in a way that obscures the possibility that we are obstructing medical advances.(4)

The evidence in support of this thought was not apparent. 

Thus Drazen and Rosenbaum clearly believe that the burden of proof is entirely on those who advocate disclosing, regulating or restricting conflicts of interest.  Yet they never argue this point explicitly.  In my humble opinion, I see no reason that their beliefs should be considered a fundamental law of nature, while the beliefs of those who differ with them should be considered unproven hypotheses. The NEJM series of articles seem to be an extended exercise in the burden of proof fallacy.

Appeal to Authority: Important People and Organizations Agree with Us

The appeal to authority fallacy is that an argument supported by an authority must be true, as per Nizkor.  

Drazen and Rosenbaum corroborate their opinions with those of various authorities, but fail to identify any authorities who disagree with them.  In fact, as noted below, they often cite opinions with which they differ without noting who advanced them.  So, for example, 

The National Center for Advancing Translational Sciences of the National Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration are but a few of the institutions encouraging greater interaction between academics and industry, to provide tangible value for patients.(1)

Shaywitz and Stossel, who have each written on the benefits of academic-industry collaboration and the challenges of bringing new products to market, are rare voices competing with a loud chorus of shaming.(3) 

Richard Epstein, a University of Chicago law professor who writes convincingly about the dangers of overregulating medical conflicts, questions certain limitations on the ties of FDA advisory-panel measures.(3)

Note that the authors of the NEJM articles do not discuss whether these authorities could have their own biases.  For example,while Drazen cited the support of the Gates Foundation above, Rosenbaum later acknowledged the current CEO of the Gates Foundation is a former Vice President of Genentech(4).  Neither noted that Dr Desmond-Hellmann was on record early as an apologist for the huge increases in drug prices that occurred starting in the first decade of this century (look here).  Dr Stossel has been known to deploy his own logical fallacies to defend physician-industry interactions (look here), as has Professor Epstein (look here).  Dr Stossel has been known not to disclose his own relationships with industry (look here).

Furthermore, while Rosenbaum attributed a stance in favor of disclosing, regulating or restricting COIs  to former NEJM editor Dr Arnold Relman, it was in the context of doubting his approach, rather than supporting his authority.(3)  Most of the views she cited as opposing hers were not attributed.


Ad Hominem Fallacy: People who Advocate Increased Disclosure, Regulation, or Restriction of COIs are "Pharmascolds"

The ad hominem fallacy is that a posited defect in the character, abilities, competence etc of a person making an argument means the argument is false, see Nizkor.  Rosenbaum wrote,


Physicians know that 'pharmascolds,' as physician-scientist David Saywitz and Tom Stossel have dubbed them, will 'vilify the medical products industry and portray academics working with them as traitors and sellouts.'(3)

The wording thus gives credence to the idea that anyone who advocates for disclosure, regulation or restriction of conflicts of interest is such a "pharmascold."  The articles by Rosenbaum never seeks to balance that assertion with any epithets that might be applied to people who advocate for unrestricted physician-industry interaction.  The implication is that "pharmascolds" are at best excessively sensitive, or worse, engaged in witch hunts. Thus this appears to be at least a back-handed use of the ad hominem fallacy.

Appeal to Pity Fallacy: People Who Advocate a Lenient Approach to Conflicts of Interest are Besieged by a Monolithic Force of "Pharmascolds"

The appeal to pity is an attempt to make an argument more convincing by making the person making it worthy of pity, see Nizkor.  

Rosenbaum started her second article(3) thus,

In 1980, the Journal’s editor Arnold Relman wrote an editorial entitled, 'The New Medical-Industrial Complex' Although it’s hard to pinpoint the moment when a culture forever changed, the editorial represented a seminal event.

She further stated, "In the ensuing decades, endless attention has been paid."  Her examples of this endless attention were two books, the report by the Institute of Medicine, "new rules," and the "recent passage of the Physician Payment Sunshine Act."

Rosenbaum opened her third article(4) thus,

Although I probably couldn’t have explained its rationale, I never questioned the anti-pharma animus that pervaded my medical education. The message I received from certain outspoken classmates and fellow trainees was that interacting with pharmaceutical reps was simply wrong.

She noted that

I suspect my experience was not unique. Indeed, the American Medical School Student Association (AMSA) now grades medical schools on their creation of a 'pharma-free' environment, issuing annual report cards on conflict-of-interest policies and curricula.

As mentioned above, she cited with dismay her interpretation of a single medical student's opinion that a biased lecture caused "violation."  She later cited a Wall Street Journal article and a British Medical Journal article which she thought were too critical of industry.

Near the end of the article was this personal anecdote,

Recently, for the first time, I was asked to consult for a medical products company. My first thought was, 'This would be fascinating.' My second was, 'There’s no way.' I would have to disclose the relationship, my credibility would suffer, and I would be defenseless. That I immediately succumbed to this fear reflects our failure to manage industry relationships effectively.

So the evidence for a huge, powerful, monolithic movement of "pharmascolds" presented was minimal.  Rosenbaum cited a 1980 article and asserted it changed the world, without any real documentation of that.  Otherwise, she cited a few books, a society of medical students, and some personal anecdotes about medical students.  The most telling anecdote was about the author's person perception that her credibility would suffer - presumably unfairly in her eyes - were she to consult on a "fascinating" project, never mind what she would have been paid to do that.  So at the very end, this ostensibly scholarly article concludes with an apparent appeal to pity its poor author for having to give up this wonderful opportunity.  That seems like the essence of an appeal to pity fallacy.

Furthermore, while the evidence of a powerful army of pharmascolds was lacking, the author did not address the evidence that the majority of academic physicians have conflicts of interest, as do the majority of department chairs(5,6).  While she speculated how a medical school dean might be oppressed by the pharmascolds, she did not address how many medical school deans, leaders of academic medical centers, and other top leaders of academic medicine have conflicts (look here).  Finally, she neglected to mention that conflicts of interest mainly come out of corporate marketing and public relations budgets that total billions in US dollars yearly nationally.

So the image of the poor pitiful defenders of the laissez faire approach to industry relationships seems a bit overdrawn.  


Straw Man Fallacies Industry Critics Claim to be Free of Bias, Equate COIs with Rape and Child Abuse, Use Flawed Reasoning, Believe All Physician-Industry Interactions Constitute Fraud

Per Nizkor, "the Straw Man fallacy is committed when a person simply ignores a person's actual position and substitutes a distorted, exaggerated or misrepresented version of that position."  Rosenbaum attributes to all or most supporters of disclosing, regulating, or restricting conflicts of interest all sorts of statements or beliefs without evidence that anyone, or more than a few people actually hold such beliefs, viz...


But couldn't industry critics blind spots leave them unjustifiably confident that despite their industry aversion, they are bias free?(3)

There was no documentation that industry critics claim they are free of all biases.

The application of language associated with rape and child abuse to the circumstances of education about effective drugs reveals a feature of the conflict-of-interest movement that has fed its contagion and rendered it virtually unassailable....(4)

Note that this was based on a single Harvard Medical student saying a single lecture lead him or her to feel "violated."  There was no documentation that anyone actually made a comparison to rape or child abuse, much less that such ideas are widely held.

Such flawed syllogistic reasoning has become the norm.(4)

Note that this refers to a "narrative" that someone who works with industry must have a favorable view of industry and therefore must make decisions based not on "clinical and research expertise but a desire for financial gain."  That in turn was derived from a single article in the news media.

'If post-Hart political journalism has a motto,' writes [journalist Matt] Bai, 'it would be: 'we know you're a fraud somehow.  Our job is to prove it.'  A similar motto could apply to much reporting on physician-industry interactions.'(4)

Furthermore,

the climate is so permeated with assumptions of fraudulence that treatments ... that have revolutionized our ability to prevent and treat disease become pawns in the hunt for wrongdoing.(4)

The few examples Rosenbaum supplied of supposedly faulty journalism did not seem to discuss fraud at all.

Summary

The series of articles about conflicts of interest that just appeared in the New England Journal, while ostensibly scholarly, published by the journal's "national correspondent" in the Medicine and Society section, appear to be polemical.  They deployed a substantial number of logical fallacies to make the point that medicine and society have gotten too tough on conflicts of interest.  They are notably short on logical, dispassionate discussion of the evidence.  Thus, they seem more like posts on a very opinionated blog site rather than commentaries in a scholarly medical journal.

By publishing this series of high visibility articles, the New England Journal of Medicine seems to have deliberately muddied the waters of discussion about conflicts of interest.  This is sad, because the journal was once considered the foremost English language scholarly medical journal, but it now seems to be publishing polemics.

This latest publishing phenomenon, or debacle, should be a reminder why conflicts of interest, if unhindered, become so prevalent.  They are relationships that benefit both parties involved.  For example, a pharmaceutical company marketing department presumably benefits from the increased revenue generated by increased sales generated by prominent key opinion leaders touting its products in the guise of professional and/or academic experts.  The KOLs, on the other hand, benefit from their generous payment.  Who loses?  - physicians who are increasingly regarded as pharma shills; physicians, whose decision making on behalf of patients may be hindered by constant exposure to marketing and public relations drowning out logical, evidence based discussion;  patients, who need to worry whether the tests and treatments they get were ultimately too influenced by conflict of interest fueled marketing and public relations, and not enough by evidence and logic.

As we said many times before, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first. 

ADDENDUM (21 May, 2015) - See also detailed comments by Larry Husten on Forbes.and by Dr Susan Molchan on the HealthNewsReview blog.  Both delve into the details of some of the cases and data that Dr Rosenbaum does cite, and thus raise questions about the facts she chose to use, and how she chose to interpret them. Also, corrected citation for "pharmascolds."

ADDENDUM (26 May, 2015) - See additional posts here, here, here and here by Micky on the 1BoringOldMan blog.

ADDENDUM (29 May, 2015) - See posts in the Lown Institute blog by Shannon Brownlee, Dr Vinay Prasad, and Dr Vikas Saini


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.  Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
6.  Campbell EG, Weissman JS, Ehringhaus S et al.  Institutional academic-industry relationships.  JAMA 2007;298(15):1779-1786. doi:10.1001/jama.298.15.1779.  Link here.

Monday, May 18, 2015

Why is the New England Journal of Medicine Scolding "Pharmascolds"?


I, a normally quiet blogger on this site, was disquieted by what may be a backlash aimed at quashing the anti-conflict-of-interest movement.

Lisa Rosenbaum just published her second of three treatises in the highly prestigious New England Journal of Medine, scolding "pharmascolds" (see Conflicts of Interest: Understanding Bias — The Case for Careful Study). "Pharmascolds" is the term Rosenbaum and others use for those of us at Health Care Renewal, the Institute of Medicine, and countless medical journals and institutions.  Why?  Because we dare assert there is great danger when providers practice though saddled by (potential) conflicts of interests in medicine.  Such conflicts are created when physicians (up to 94% of us, according to Rosenbaum's research), other health care providers in practice, and health care organizations accept, not only gifts and trinkets, but also large, sometimes clandestine consulting fees and other arrangements from pharma and device companies, all the while providing direct patient care using the companies' products.

Rosenbaum and others say we pharmascolds are essentially self-righteous and obstructionist, holding back the progress of medical science.  In this article, she seems to claim that not proving direct patient harm from a specific questionable financial arrangement with a company whose product we may therefore more likely prescribe, speak well of, or publish (pseudo)evidence supporting the use of, is enough of a reason to justify the arrangement. 

Wouldn't that be the same as saying, "Until you actually crash into another car while texting, it's ok to text while driving, even if it's distracting."?

Rosenbaum uses mainly anecdote to prove her point, and appeals to a little-quoted, but still important, heuristic/bias called "moral liscensing."  Rosenbaum describes the phenomenon correctly: "once disclosure [of a conflict of interest] gets the weight [of guilt] off your chest, you feel liberated and may feel licensed to behave immorally."  True.  But then Rosenbaum seems to support non-disclosure of acts that create conflicts of interest, because disclosure doesn't decrease the acts themselves.

Rosenbaum goes further. At the same time as she supports non-disclosure of conflicts, she attempts to paint those who accept conflict-generating arrangements and keep them clandestine as victims--afraid to "come out of the closet" because doing so is socially taboo, though the activity is not wrong. 

I beg to differ.  For certain acts, potential conflicts, and actual conflicts, it seems to me that mere disclosure of the act or conflict shouldn't relieve one of the guilt associated with the act or conflict.  It also seems disclosure of a conflict should not make a speaker seem more credible to his/her audience because of its disclosure, though some research Rosenbaum quotes seems to show that disclosure improves credibility. 

Perhaps the stronger argument for disclosure is to disqualify people from activities that should be prohibited for people in conflict, as well as to warn people away from engaging in questionable activities that would result in conflicts. 

In an unbelievable twist of logic, Rosenbaum seems to be arguing in this article for more, not less of these questionable activities, in the interest of advancing science, until we prove patients are directly hurt by them, i.e., we have a "wreck."  Heck, let's get rid of traffic lights too, while we're at it.  People have eyes. We should trust them. They should be able to avoid accidents voluntarily, on their own.

In short, how could Dr. Rosenbaum not see that the best solution for the "problem" of conflicts of interests is avoidance when possible?  One can't help but wonder if she and the Journal aren't blinded by the shimmer and pull of powerful, influential organizations, ones so shiny, so strong, and so ubiquitous that resistance is just too hard for her, the Journal, and for 94% of us.

Conflicts of interest should be avoided.  Society has accepted that improved health will result not just from secondary prevention (e.g., not texting while driving after one has had an accident from the activity), but also from primary prevention (not texting while driving, even before an accident occurs). 

Wally R. Smith, MD

Sunday, May 17, 2015

BLOGSCAN - New England Journal of Medicine Scoffs at "Pharmascolds"

The venerable New England Journal of Medicine has now published an editorial,(1) and two commentaries(2-3), with one more promised, hailing physician industry "partnership," as per NEJM editor Jeffrey Drazen,(1) and deploring the "pharmascolds,"(3) who might question the glorious innovations that could arise when industry pays academic and practicing physicians.   

In a tweet, Dr Harlan Krumholz said he was "shocked" that a NEJM commentary would "give credence to the 'pharmascold' narrative.  

So far, the only more detailed questions about this new direction for the Journal came in a guest blog by Dr Susan Molchan in the HealthNewsReview blog, which responded only to the editorial(1) and the first commentary(2).  Dr Molchan wrote, 


Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs. She asks, “Have stories about industry greed so permeated our collective consciousness that we have forgotten that industry and physicians often share a mission — to fight disease?” Is Dr. Rosenbaum’s consciousness so clouded as to think that pharmaceutical companies don’t exist first and foremost to make money? That their primary responsibility is not to their shareholders?  It’s true that a means to this end is fighting disease, (including new “diseases,” tailored to one’s drug), but this should not be confused or conflated with the primary mission of (hopefully most) physicians.

I and many others suggest that the 'stories about industry greed' have not permeated enough, and that this problem has polluted much of medical research and medical practice, to the point where trust of the medical research enterprise has been eroded....

The airtime the NEJM is giving this issue, including publishing three - count them - strongly opinionated but hardly journalistic commentaries by their ostensible"national correspondent," suggest a major push against the "pharmascolds."  Again, note this this inflammatory and ad hominem term was used in a supposedly serious article on "Medicine and Society."  I strongly doubt we have heard the last of this.  Stay tuned. 

ADDENDUM (20 May, 2015) - See also comments by Mickey on the 1BoringOldMan blog.  

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



Friday, May 15, 2015

Apologies to All - Sitemeter Forced Redirect Problem Now Fixed

My apologies.  Starting yesterday I discovered that anyone attempting to view this blog was involuntarily transferred to a non-working URL, gogardenclub.com.  The problem seemed to result from the Site Meter widget, which was originally meant to keep track of our blog hits.  I have removed Site Meter, and I believe the problem is solved.   

Thursday, May 14, 2015

All the President's Trade Negotiators - Revolving Doors, Regulatory Capture, and Health Care Corporate Friendly Trade Agreements

This week's spectacle in Washington, DC was a nearly unanimous Democratic minority in the Senate blocking a proposal for expedited consideration of multinational trade agreements favored by the Republican majority, but also by the Democratic President and his trade negotiators (look here).  Democrats mainly based their actions on perceptions that the trade agreements favored multinational corporations  over people.

While trade agreements may seem to be another, albeit international species of wonkery, these agreements could have major effects on patients' and the public's health.  Since these concerns have been essentially ignored by the US medical and health care literature, (although they have appeared in UK journals, Australian, and New Zealand journals in English), they I will discuss them below. Worthy of further discussion is the possibility that these potential threats to health care and public health may arise not just from ideological disagreements, but also from health care corporations' increasing capture of government, facilitated by the conflicts of interest generated by the revolving door. 

Corporate Friendly Trade Agreements

The US has been negotiating two major multinational trade agreements, the Trans-Pacific Partnership (TPP) and the Transatlantic  Trade and Investment Partnership (TTIP) for years. 

In a March, 2014, commentary, renowned economist Joseph E Stiglitz summarized the objections to the these proposed trade agreements.  His greatest fears were that such agreements

will benefit the wealthiest sliver of the American and global elite at the expense of everyone else.


This seems surprising, since most people think of trade agreements solely in terms of their effects on tariffs, not a big concern for health care and public health professionals.  However, Stiglitz noted

Tariffs around the world are already low. The focus has shifted to 'nontariff barriers,' and the most important of these — for the corporate interests pushing agreements — are regulations. Huge multinational corporations complain that inconsistent regulations make business costly. But most of the regulations, even if they are imperfect, are there for a reason: to protect workers, consumers, the economy and the environment.

What’s more, those regulations were often put in place by governments responding to the democratic demands of their citizens. Trade agreements’ new boosters euphemistically claim that they are simply after regulatory harmonization, a clean-sounding phrase that implies an innocent plan to promote efficiency. One could, of course, get regulatory harmonization by strengthening regulations to the highest standards everywhere. But when corporations call for harmonization, what they really mean is a race to the bottom.

 In the US, and other developed countries, there are lots of regulations that have major effects on health care and public health.  Changes in these regulations, or their implementation, could have major effects again on health care and the public health.  So those interested in health care and public health ought to be concerned about how such trade agreements could affect such regulation.

International Tribunals Could Trump National Law
One of Stiglitz's concerns was  that the trade agreement would allow international tribunals that could override national law, particularly law promoting public health:

What we know of ... particulars [of the TTP] only makes it more unpalatable. One of the worst is that it allows corporations to seek restitution in an international tribunal, not only for unjust expropriation, but also for alleged diminution of their potential profits as a result of regulation. This is not a theoretical problem. Philip Morris has already tried this tactic against Uruguay, claiming that its antismoking regulations, which have won accolades from the World Health Organization, unfairly hurt profits, violating a bilateral trade treaty between Switzerland and Uruguay.

In fact, Philip Morris has also used such tribunals to overturn Australian laws meant to discourage smoking for public health purposes.  The details of the Philip Morris case summarized in May, 2015 in an article by Lauren Carasik in  Foreign Policy, show the major public health implications of such trade tribunals,

In 2011, Australia passed a tobacco-control law to discourage smoking. It required cigarettes to be sold in plain packages with prominent warnings, with brand information relegated to the bottom of the box. Touted as 'one of the most momentous public health measures in Australia’s history' by the country’s health minister, the law was meant to deter a habit that will ultimately kill 1.8 million current Australian smokers, according to a recent study. After the country’s highest court upheld the constitutionality of the anti-smoking law, tobacco giant Philip Morris claimed that it violated the company’s corporate rights and launched a suit using a little-known provision called investor-state dispute settlement (ISDS). The case is pending, as is a similar case against Uruguay. A similar tobacco-control measure in New Zealand is on hold pending the outcome of these cases.

So these examples suggest that national laws meant to promote the public health could be challenged in these trade tribunals by multinational corporations based on these laws' postulated effects on corporate profits, regardless of the laws' public health rationale or legality in their own countries. 


Furthermore, a letter to the Lancet(1) noted,

Investor state dispute settlement (ISDS) provisions allow investors to sue governments if policy changes or even court rulings substantially affect the value of their investment, yet do not allow governments to sue investors for breaching the right to health.   ISDS processes constrain governments' abilities to regulate on the basis of the precautionary principle, or even to implement health policies on the basis of established evidence. These processes can have a chilling effect on efforts to address key health issues, such as alcohol, the obesity epidemic, and climate change. In New Zealand, the fear of costly ISDS litigation is already constraining government regulation on tobacco plain packaging.

Thus, creation of such international tribunals could favor financial concerns of multinational corporations over individual countries' governments' attempts to promote health care or public health. So, while these undemocratic tribunals are touted as a way to reduce non-tariff trade barriers, an editorial in the British Medical Journal(2) asserted,

Yet these barriers are some of our most prized social and environmental standards, including regulations on food safety, pesticide residues, and toxic chemicals....

Not only would these tribunals we able to override national laws, their operation would lack procedural safeguards.  Demonstrating that opposition to these trade agreements is also multinational, an article in the UK Independent in October, 2014, noted,

Critics say the tribunals, held under the so-called Investor-State Dispute Settlement (ISDS) system, subvert democratic justice, giving power over foreign citizens to big companies. Hearings are held in private, in international courts at the World Bank in Washington DC, bypassing the legal system of the country being sued, meaning details are often impossible to uncover. In some cases the very existence of the case is not made public.

In addition, per the article in Foreign Policy,

Critics like Global Trade Watch, a division of Public Citizen, a consumer advocacy organization, say the ISDS system is anti-democratic. Sen. Elizabeth Warren (D-Mass.) called for the ISDS language to be stripped out of the deal, writing in the Washington Post in February, 'If a final TPP agreement includes Investor-State Dispute Settlement, the only winners will be multinational corporations.' The problem is that the ISDS system lacks many procedural safeguards fundamental to the rule of law. The tribunals, run by the World Bank and the United Nations, are three-judge panels composed of highly paid private lawyers picked from a limited pool by states and corporations; individual lawyers can switch between serving as judges and advocates on behalf of corporations in different cases. And there is no comprehensive code of judicial conduct guiding the panelists on matters such as conflicts of interest.

Although the panels adjudicate disputes worth millions or even billions of dollars, they are not accountable to any elected body. Moreover, there is no system of precedent binding judges to an established body of decision-making, making it difficult for the parties to discern the applicable standards and their likelihood of success. And finally, there are no appeals, either within the ISDS system or externally, on the merits of decisions. An annulment is only possible for limited procedural errors, and those proceedings are heard before a different panel drawn from the same pool of professionals.

Under the system, states are deprived of the right to resolve these disputes since corporations can proceed directly to the tribunals without exhausting domestic remedies. But this privilege is not reciprocal: Corporations are not subject to suit in the tribunals by those harmed by their actions. Foreign companies are thus granted expanded rights without corresponding responsibilities.

Finally, in May, 2015, the United Nations special rapporteur on promotion of a democratic and equitable international order suggested that the proposed international tribunals would undermine human rights and violate the UN charter (per this Guardian article).

Further criticism of the tribunals came from the UK Labour party Shadow Health Secretary (as of April, 2014) who felt it would leave British general practitioners "powerless to resist legal challenges from US health giants with huge financial resources in the event of a contractual dispute (per the Independent).

To summarize thus far:  international trade agreements being pushed by the US government could set up trade tribunals that could reverse national laws meant to protect health and safety.  Such tribunals would not follow the procedures used, for example, in US courts, and could not be held accountable by individual governments.  Various aspects of these tribunals, and recent actions involving tribunals already set up by earlier trade agreements suggest the process may be heavily biased in favor of the financial interests of multinational corporation, and against patients' and the public's health.  Thus, health care and public health professionals ought to be alarmed about new agreements that could set up new tribunals, or expand the reach of existing tribunals.


Intellectual Property Rights vs Access to Health Care

Another set of problems affecting patients' and the public's health  are provisions in trade agreements favoring corporate "intellectual property" over access to drugs, devices and health care.  Stiglitz wrote in 2014,

America has been fighting to lower the cost of health care. But the TPP would make the introduction of generic drugs more difficult, and thus raise the price of medicines. In the poorest countries, this is not just about moving money into corporate coffers: thousands would die unnecessarily. Of course, those who do research have to be compensated. That’s why we have a patent system. But the patent system is supposed to carefully balance the benefits of intellectual protection with another worthy goal: making access to knowledge more available. I’ve written before about how the system has been abused by those seeking patents for the genes that predispose women to breast cancer. The Supreme Court ended up rejecting those patents, but not before many women suffered unnecessarily. Trade agreements provide even more opportunities for patent abuse.

To date, most of the details of the proposed trade agreements have been kept secret, but as noted on the PLoS Medicine blog in December, 2013, by Reshma Ramachandran and David Carroll,

Last month, Wikileaks posted the complete Intellectual Property (IP) Chapter of the secretly-negotiated Trans-Pacific Partnership Agreement (TPP) confirming public health advocates’ worst fears of the agreement’s impact on patients worldwide.

In particular,

The Wikileaks posted text revealed that the USTR and Obama Administration have decided to aggressively prioritize the interests of multinational pharmaceutical and medical companies over patients worldwide and at home. In fact, according to emails submitted to Intellectual Property-Watch under the Freedom of Information Act, the USTR has actively solicited the input of industry groups, giving them special access to the negotiating text while consumer and health groups have had to resort to requesting special meetings with negotiators. 

So,

Indeed, the recently leaked TPP chapter reflect these corporate interests as evidenced by the still-included provisions. In the text, the USTR has proposed a number of provisions that will further strengthen patents and data exclusivity for pharmaceuticals. Such provisions will bar the entry of generic competition into the market allowing for brand-name drug companies to retain their monopoly market and set drug prices at exorbitantly high prices. These provisions include:

- Lowering patent standards allowing for “evergreening” or the granting of patents for newer forms of existing medicines including new formulations or minor modifications even in the absence of a therapeutic benefit

- Mandating that surgical, therapeutic, and diagnostic methods must be patented making medical practitioners in TPP member states liable for infringement and restricting their choices for treatment

- Imposing data exclusivity on all pharmaceuticals, including biologics with the minimum period for this class to be set at 12 years (despite the fact that the White House is publicly in favor of a 7 year data exclusivity period and the FTC has stated that there is no need for any data exclusivity period at all) thereby not allowing drug safety regulators from accessing clinical data to grant market approval for generic and biosimilar drugs

-  Adjusting patent term periods to account for “unreasonable delays” including patent prosecution periods ranging from two years to more than four years extra further delaying generic drug entry into the market

- Adjusting patent term periods for regulatory approval periods allowing for patent extensions for both new pharmaceutical products as well as methods for producing or using new pharmaceutical products halting any potential innovation

- Linking patent status and drug marketing approval causing drug regulatory authorities to take on the additional task of early patent enforcement, allowing for bogus patents to be a barrier to generic drug registration Such proposals go beyond current U.S. and international law including the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

Additionally, the TPP has the potential to jeopardize millions of lives in the participating countries by driving up the costs of medicines significantly. Even in the United States, there has been a public outcry from physicians regarding the high cost of medicines. Earlier this year, over 100 oncologists came together to write a perspective piece in the journal Blood calling the prices of brand-name cancer drugs “astronomical, unsustainable, and perhaps even immoral.” The United States health care system has in fact greatly benefited from the entry of generic competition. On May 9, IMS Health released a report entitled Declining Medicine Use and Costs: For Better or Worse?, which found that many Americans had forsaken much needed doctor visits, medicines, and other treatments as they struggled to afford health care. In light of this, it is appalling that U.S. negotiators would continue to push provisions that would further exacerbate the cost burden of healthcare for patients not only abroad, but at home. 

Public Citizen particularly criticized the provision for patenting procedures,

Medical procedure patents raise healthcare costs. Health providers, including surgeons, could be liable for the methods they use to treat patients. Essentially, except for when a surgeon uses her bare hands, surgical methods would be patent eligible subject matter under the U.S. proposal.
Additional concerns about the potential of new trade agreements to increase the price of medicines and health care, and limit access to them, came, per Ramachandran and Carroll, from Doctors Without Borders, the American Association of Retired Person, and the International Federation of Medical Students.  More recently, such concerns were stated by amfAR re access to and costs of HIV medications (reported on Vox), and were restated by Doctors Without Borders (reported by the National Journal).

Perhaps more US health care professionals and public health advocates would be speaking out if they understood the problem.  However, concerns about how new proposed trade agreements could affect health care and public health have been notably anechoic in the US.  I could find absolutely no discussion of them in any moderate or large circulation US health care or medical journal.  There has been discussion in English language medical and and health care journals, but in journals that are relatively obscure, or published outside of the US, for example, see articles by Greenberg and Shiau(3), and Thow et al(4).  Note that the former wrote,

academic public health has failed to appreciate the serious risks of the TPP[A] and has not responded to its threats. 

Keeping concerns that the new trade agreements could threaten patients' and the public's health out of public discussion may be just the latest example of what we have called the anechoic effect, because it looks like it may be no accident that these proposed trade agreements favor multinational corporations over patients' and the public's health.  There is evidence that at least the US governmental process for negotiating these agreements was heavily influenced by the interests of these corporations, but not by the interests of patients or citizens. 

Revolving Doors, Regulatory Capture Generate the Momentum

There are thus strong reasons for health care and public health professionals to oppose the rush to approve the new trade agreements (the TTIP and TPP).  Despite these concerns, and the increasingly vocal opposition from many US legislators, the current administration has forged ahead with its proposal to "fast-track" their approval, only to be suddenly blocked, and by its supposed compatriots in the Democratic party.  There are lots of explanations for this, but two that got only a little notice but seem particularly germane to Health Care Renewal are the influences of the revolving door and cultural regulatory capture.

The case for these was best made by a November, 2013 article in the Washington Post by Timothy B Lee,

the U.S. negotiating position also had an unmistakeable bias toward expanding the rights of copyright and patent holders.

Those positions are great for Hollywood and the pharmaceutical industry, but it's not obvious that they are in the interests of the broader U.S. economy. To the contrary, critics contend that the rights of copyright and patent holders have been expanded too much. Those concerns do not seem to have swayed the trade negotiators in the Obama administration.

Two major factors contribute to the USTR's strong pro-rightsholder slant. An obvious one is the revolving door between USTR and private industry. Since the turn of the century, at least a dozen USTR officials have taken jobs with pharmaceutical companies, filmmakers, record labels, and technology companies that favor stronger patent and copyright protection.

A more subtle factor is the structure and culture of USTR itself. In its role as a promoter of global trade, USTR has always worked closely with U.S. exporters. That exporter-focused culture isn't a problem when USTR is merely seeking to remove barriers to selling U.S. goods overseas, but it becomes problematic on issues like copyright and patent law where exporters' interests may run directly counter to those of American consumers.

Lee provided extensive examples of how US trade officials transited the revolving door to and/or from the pharmaceutical industry.

On May 3, 2004, the United States and Australia signed a bilateral trade agreement. The agreement included a section on intellectual property that had numerous provisions favorable to pharmaceutical manufacturers. For example, it barred generic drug makers seeking approval for their drugs from citing safety or efficacy information originally submitted by brand-name drug makers for a period of five years after the information is submitted, making it more difficult for generic drug makers to enter the market.

The lead American negotiator was Ralph Ives, who was promoted to Assistant USTR for Pharmaceutical Policy soon after the negotiations concluded. He was aided by Claude Burcky, Deputy Assistant USTR for Intellectual Property. Less than three months after the Australia agreement was signed, the Sydney Morning Herald reported that both men would take jobs at pharmaceutical or medical device companies. Their new employers stood to benefit from some of the pro-patent-holder provisions of the treaty. Ives took a job at AdvaMed, a trade group representing medical device manufacturers. Burcky moved to the pharmaceutical and medical device company Abbott Labs.

Since then, Abbott has hired two other USTR veterans, Andrea Durkin and Karen Hauda, according to the women's LinkedIn pages. Another USTR official, Kira Alvarez, has gone through the revolving door twice over the last 15 years. Her LinkedIn profile indicates that she served at USTR from 2000 to 2003, spent four years at the pharmaceutical giant Eli Lilly, and then returned to USTR in 2008 as Deputy Assistant USTR for Intellectual Property Enforcement. She was there for five years before she took a job at AbbVie, a pharmaceutical firm that spun off from Abbott earlier this year.

According to his official biography at the site of the Biotechnology Industry Associaiton, Joseph Damond 'was chief negotiator of the historic U.S.-Vietnam Bilateral Trade agreement' during his 12 years at USTR. He then spent five years at the Pharmaceutical Research and Manufacturers of America before moving to BIO. Justin McCarthy went through the revolving door in the other direction. According to a USTR press release, McCarthy was responsible for intellectual property issues at the pharmaceutical company Pfizer from 2003 to 2005 before he was hired at USTR. He now works at a lobbying firm.

Lee also suggested that the US Trade Representative has been culturally captured by industry through its use of advisory panels made up of industry members, but not, for example, clinicians, public health advocates, or interested members of the public.

The agency has established 16 industry trade advisory committees to provide advice about the complex issues USTR deals with in the course of its negotiations. As the name suggests, the ITACs are designed to gather feedback from industry groups. There are no public interest groups, academics, or other non-industry experts on ITAC 15, which focuses on "intellectual property" issues.

And that matters because groups with ITAC seats have access to confidential information about the U.S. negotiating position that isn't available to the public. Sherwin Siy, an attorney at the advocacy organization Public Knowledge, has had multiple meetings with USTR representatives during the course of the TPP negotiations. But he says it was difficult to give USTR meaningful feedback because he didn't know what positions U.S. negotiators were advocating.

'They're willing to sit in a room with us and listen to our objections and our issues and be very polite,' Siy says. But 'whether or not that actually means anything is at best a black box.'

When USTR wants technical advice on transposing U.S. law into international agreements, it naturally turns to the industry representatives on the ITACs. And it stands to reason that the advice the agency receives in response would be a bit one-sided. Where U.S. law is ambiguous, industry groups naturally gravitate toward interpretations of U.S. law that favor their employers' interests. And because public interest groups and independent experts aren't allowed to see proposed language (aside from occasional leaks), the agency may not even realize that it is exporting a warped interpretation of U.S. law.


The pro-industry cultural bias has caused consternation among even well-known libertarians, as Lee noted,

'USTR sees itself as an advocate for U.S. exporter interests,' says Bill Watson, a trade expert at the Cato Institute. 'It's trying to negotiate market access for particular U.S. industries that ask for it. That bias leads USTR to think that because U.S. companies want more IP protection abroad, it's in their interest to negotiate that.'

So it seems quite clear that the US agency that negotiates the new international trade agreements may be staffed by people who came from affected industries, including pharmaceutical, device and biotechnology companies, and privileges advice from such companies.  Thus the agency appears to suffer from conflicts of interest due to the revolving door, and from regulatory capture induced by its bias in favor of advice from industry over that from clinicians, public health advocates, or interested members of the public.  This suggests why it appears that this government agency has actively been promoting trade agreements that favor industry interests over patients' and the public's health.

It may be that top US executive branch officials, all the way up to the President of the US, have been very ill-served by relying on an agency subject to such conflicts of interest and regulatory capture.

Summary

We have frequently written about the revolving door phenomenon, and its effect on government agencies and officials who regulate and control many aspects of health care. Recently, we wrote about how the revolving door risks corruption, and can lead to regulatory, and even state capture.

In 2011, we even wrote about how the revolving door may affect US trade negotiations, and thus important aspects of aspects of global health care.

Government officials affiliated with all major political parties have been known to transit the revolving door.  The recent cases we have documented have tended to be more about the party that currently controls the executive branch, of course.  But now, we seem to have documented how the revolving door has lead to a supposedly liberal president proposing trade agreements that seemed heavily biased towards corporate rather than popular interests, and thus suffered an embarrassing defeat at the hands of his party compatriots in the legislature.  The president seems to have been particularly ill-served by employees of the executive branch whose previous or potential revolving door transits have made them sing the tunes of industry rather than of the people they are supposed to be serving.  This suggests that in the long run, nobody but the participants in the revolving door ultimately benefits from their rotary transitions.

Instead, as we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?


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.

ADDENDUM (19 May, 2015) - This post was republished in OpEdNews.

ADDENDUM (29 May, 2015) - This post was republished in OpenHealth News.

References

1.  Freeman J, Keating G, Monasterio E at al.  Call for transparency in new generation trade deals. Lancet 2015; 385: 605-605, link here.
2.   Hilary J.  The Transatlantic Trade and Investment Partnership and UK healthcare.  Brit Med J 2014; 349: g6552, link here.
3.  Greenberg H, Shiau S. The vulnerability of being ill-informed: the Trans-Pacific Partnership agreement and global public health.  J Pub Health 2014; 36: 355-357, link here
4.  Thow AMT, Gleeson DH, Friel S. What doctors should know about the Trans-Pacific Partnership agreement.  Med J Aust 2015; 202: 165-167, link here.