Wednesday, January 30, 2019

Watching the Detectives: Logical Fallacies and Unsubstantiated Claims to Denigrate Investigations of Leaders' Conflicts of Interest and Alleged Corruption

Introduction: Logical Fallacies and Unsubstantiated Claims in Defense of Conflicts of Interest in Health Care

We have long been concerned about deceptive marketing to sell health care products, and deceptive public relations to push policy positions favorable to health care organizations' leaders.  Deceptive marketing and public relations may morph into stealth marketing and stealth advocacy, and then  outright propaganda and disinformation.

At the same time, we have long been concerned about how leaders have become unaccountable for the conflicts of interest generated and outright criminal and corrupt behaviors by their organizations.  They have thus exhibted impunity.

These concerns have sometimes merged.  We have occasionally written posts about how prominent figures in health care, thought leaders, or as health care marketers like to call them, key opinion leaders with impressive credentials, have used questionable data and logical fallacies to defend their and other health care leaders' conflicts of interest.  For example, most recently, in 2015, I discussed a commenary in the prestigious New England Journal of Medicine defending conflicts of interest affecting health care academics.  At the time, I wrote:

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.

The logical fallacies I cited were burden of proof, appeal to authority, ad hominem, appeal to pity, and the straw man fallacy.

I concluded with:

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.

I had written similarly in 2012 on logical fallacies employed in a report by the European Society of Cardiology defending, again, conflicts of interest, and again on logical fallacies employed by the new Chancellor of UCSF in the Wall Street Journal, again to defend conflicts of interest affecting academic medicine.

Now, in 2019, we stil see academics with impressive credentials making arguments in national media based on poor data and logical fallacies, but now to defend the highest leaders of our country from charges of conflicts of interest and corruption.

Victor Davis Hanson's Nationally Syndicated Challenge to the Postulated Over-Investigation of the Trump Administration


Here is one recent, vivid, widely published example.  An op-ed appeared in my local newspaper, the Providence Journal, an abbreviated version of a commentary by Victor Davis Hanson which appeared in the National Review, and was syndicated to numerous other right-wing or conservative publications, such as RealClear Politics, TownHall, and in syndication to multiple news media.  Per the ProJo version, Hanson professes to be "a classicist and historian at the Hoover Institution, at Stanford University."  His official Hoover Institute biograpshy states "Victor Davis Hanson is the Martin and Illie Anderson Senior Fellow at the Hoover Institution; his focus is classics and military history."  It claims he has received multiple awards, and has hundreds of publications.  Thus Hanson claims to be a public intellectual, not a polemicist, and may well fit the definition of a thought leader.

Hanson's main point was that President Donald Trump was being unfairly investigated.  He started with quoting the famous question, "who will watch the watchers," and then goes on to suggest that Trump's watchers (auditors, investigators) need to be reined in, implying that it was unreasonable that the Trump administration " has become the most investigated, the most audited, and the most closely examined presidency in history."

I my humble opinion, in support of his contention, Hanson offered arguments were often illogical, and lacked any substantiating evidence.  Therefore, his piece appeared to be propaganda.   Let me first list some of its illogic.

Hanson's Logical Fallacies


Logical Fallacy: Affirming the Consequent

Hanson's main assertion was:

Given President Trump’s unconventional background, his wheeler-dealer past, and the hatred he incurs from the left, few ever give him the benefit of the doubt.

The paradoxical result is that his tenure in just two years has become the most investigated, the most audited, and the most closely examined presidency in history.

Note that the superlative claims, that is those about the "most investigated," "audited," and "closely examined" presidency, are not substantiated.  These are the essence of  Hanson's argument is that Trump has been scrutinized for (morally) bad reasons, e.g., "hatred from the left."  Hanson is arguing this based on the truth of the result, that his presidency is the most scrutinized.  Yet even if it is, that does not prove the reasons were "hatred from the left," etc.  Thus, this is an example of the logical fallacy of affirming the consequent, presenting an argument in an if p, then q format, but then stating that if q is true, p must have true as well. 


Another example of this fallacy was a little way down the page:

his most frequent accusers — the media — have set themselves up as the country’s moral paragon. Journalists now see themselves as social-justice warriors who are immune from the scrutiny to which they subject others.

The result of such self-righteous moral exemption has led to journalism’s nadir, with an unprecedented lack of public confidence in the media. 'Fake news' now abounds, from CNN to BuzzFeed.

The argument here is a caustive one: if journalists are "immune" "social-justice warriors, then the result is "journalism's nadir," and "fake news."

Again, even if it is true that journalism is at its nadir, that does not mean Hanson's postulated cause, journalists as immune social-justice warriors, is true.  However, Hanson's argument, that the investigations are unreasonable, and the auditors need to be audited, arises from his claim that the original auditors, the journalists, are "immune from scrutiny" and need to be reined in.  Again, he states if p, then q, but then argues that because q, then p.

Logical Fallacy: Hasty Generalization

Trying strengthen his case that journalism as at a "nadir," with "fake news" abounding, Hanson then cited the case of a recent BuzzFeed article:

Recently, BuzzFeed (which first published the unsubstantiated Steele dossier) alleged that there was proof that Trump had ordered his erstwhile lawyer, convicted felon Michael Cohen, to lie.

Furthermore,

the BuzzFeed yarn drew a rare rebuke from Special Counsel Robert Mueller’s team, which disputed the veracity of the story.

That was one case, one anecdote.  Hanson did not cite any other examples of faulty journalism in his commenatry.  So this appears to be a version of the logical fallacy of hasty generalization, also known as an argument from small numbers, or anecdotal reasoning.  Citing an anecdote of a particular pheonomenon means that the phoenomenon is possible, but obviously does not mean that the pheonomenon is common, or important.

Again, Hanson made his argument that the investigations of Trump by law enforcement are alos excessive,


The Department of Justice and the FBI are supposed to be our preeminent guardians of justice. But former director James Comey, former deputy director Andrew McCabe, former general counsel James Baker, and several other top FBI officials have either resigned, retired, or been fired — and some may soon be facing indictments themselves.

Setting aside whether resignations, retirements, or even firingsd under these circumstance indicate excessive zeal or criminal behaviore, and whether Hanson's speculation about indictments are valid, he cited only a few cases to imply that investigation of Trump has been excessive.  So this is another case of reasoning from a small number of anecdotes, thus hasty generalization.

Base Rate Fallacy

Hanson went on to embellish his descriptions of the alleged misbehavior by a few Department of Justice personnel.  In particular, he noted

On 245 occasions in sworn testimony before Congress, Comey answered that he either did not know the answers to questions or could not remember the details of events. Had any private citizen tried such stonewalling in an investigation, he or she would likely end up in jail.

He here was no longer citing one or a few anecdotes.  245 occasions seem to be a lot.  However, Hanson's citation of it omits mentioning the numerator.  Setting aside again the notion that people may go to jail for responding to questions under oath by claiming faulty memory or lack of knowledge, Hanson failed to state either how many questions Comey was asked  Without knowing this, one cannot tell whether the Comey's behavior was frequent or rare.  Thus, Hanson's implication that Comey committed some sort of crime, and that doing so discredits his investigation of Trump, was based on the base rate fallacy.  He focused on the number of times an event occurred, while ignoring how many times it did not.

 Logical Fallacy: Incomplete Comparison

Consider again the two sentences written by Hanson above.  Not only did Hanson not establish the rate Hanson claimed faulty memory or ignorance, he did not address how often "private citizens" make such claims.  Thus, even if we knew the rate of Comey made these claims, we do not know the rate private citizens do so.  This thus appears to be an example of the logical fallacy of incomplete comparison, described as "an incomplete assertion that cannot possibly be refuted. This is popular in advertising."   


Hanson's Unsubstantiated Claims of Fact

I found the following relevant examples of claims about frequency or prevalence without any supporting data.

Half the country apparently believes Trump cannot be trusted.

everything he says and does is the object of pushback, opposition, and audit.

'Fake news' now abounds,

I found the following relevant examples of claims about causation without substantiation.

The sexual-abuse crises within the contemporary Catholic Church arose from the de facto exemptions from the law given to priests.

Too many assumed that men of faith were exempt from prosecution because as holy men they would be the last to violate the trust of minors


I found the following relevant unsubstantiated claims about peoples' intent or state of mind.

They all apparently believed that their loud liberal credentials gave them immunity from being held accountable for their harassment.

They apparently assumed that as supposed victims, they could not be viewed as being sympathetic to victimizers.

Journalists now see themselves as social-justice warriors who are immune from the scrutiny to which they subject others.

Weissmann apparently didn’t mind that the dossier was used by his colleagues to deceive the Foreign Intelligence Surveillance Court into granting a warrant to spy on an American citizen.

Credible Allegations of Trump's and Cronies' Conflicts of Interest and Corruption

While spinning his web of logical fallacies and unsubstantiated claims, Hanson ignored the rationale for the multitude of investigations of President Trump and associates.  In fact, there is voluminous documentation of evidence suggesting he has numerous conflicts of interest and he and his regime are corrupt.  We summarized some of the most recent data here, in October, 2018.  As I said then, up to October, 2018...

In January, 2018, we first raised the question about how health care corruption could be pursued under a corrupt regime.  We noted sources that summarized Trump's. the Trump family's, and the Trump administration's corruption..  These included a website, entitled "Tracking Trump's Conflicts of Interest" published by the Sunlight Foundation, and two articles published in the Washington Monthly in January, 2018. "Commander-in-Thief," categorized Mr Trump's conflicted and corrupt behavior.  A Year in Trump Corruption," was a catalog of the most salient cases in these categories in 2017.

In July, 2018, we addressed the Trump regime's corruption again  By then, more summaries of Trump et al corruption had appeared.   In April, 2018, New York Magazine published "501 Days in Swampland," a time-line of  starting just after the 2016 presidential election. In June, 2018, ProPublica reviewed questionable spending amounting to $16.1 million since the beginning of Trump's candidacy for president at Trump properties by the US government, and by Trump's campaign, and by state and local governments. Meanwhile, Public Citizen released a report on money spent at Trump's hospitality properties.

In October, we summarized the lengthy Tracking Corruption and Conflicts of Interest in the Trump Administration. It broke down Trump and cronies' behavior into the following four categories: 1) US government payments to the Trump Organization; 2) use of the power of the presidency to promote Trump brands; 3)    U.S. government regulatory and policy decisions that benefit the business interests of the Trump family and senior advisors; and 4) private and foreign interests seeking to influence the Trump administration through dealings with Trump businesses.  The lists of specific instances in each category go on for pages, and have grown since October through weekly updates.

Most recently, Citizens for Responsibility and Ethics in Washington (CREW) published a report that listed the following concerning Trump's first two years in office:

CREW has identified 12 foreign governments that have made payments to Trump properties during his first two years in office, each of which is likely a violation of the Constitution’s foreign emoluments clause....

Instead of pushing back on President Trump’s refusal to divest from his business, allies in Congress have embraced the arrangement. 53 U.S. senators and representatives made more than 90 visits to Trump properties during his second year in office, up from 47 visits by 36 members the prior year, and similarly, at least 33 state-level government officials visited Trump properties, likely resulting in taxpayer funds going into Trump’s coffers.

More than 150 political committees, including campaigns and party committees, have spent nearly $5 million at Trump businesses since he became president. In Trump’s second year in office, CREW tracked 33 political events held at Trump properties—13 of which Trump himself attended, meeting and speaking with wealthy donors.

Special interests held at least 20 events at Trump properties during the president’s second year in office. Since Trump took office, at least 13 special interest groups have lobbied the White House, some for the first time, around the same time they patronized a Trump property, suggesting that making large payments to Trump’s businesses is viewed as a way to stay in his administration’s good graces.

Over the past year, President Trump made 118 visits to properties he still profits from in office, bringing his two-year total to 281 visits. CREW also identified 119 federal officials and employees who visited Trump properties over the past year, up from 70 the prior year.
In addition to making frequent visits to his properties, President Trump and other White House staff have promoted Trump businesses on at least 87 occasions. Trump himself mentioned or referred to his company 68 times during his second year in office, more than double the 33 times he did so the prior year.

Paying members at Trump’s resorts and clubs have received benefits beyond getting occasional face time with the President. Four Mar-a-Lago members have been considered for ambassadorships since his election, and three other members—with no federal government experience—acted as unelected, non-Senate-confirmed shadow officials in Trump’s Veterans Administration.
As an aside, in response to Hanson's claim that few have ever given Trump "benefit of a doubt," we discussed here all the credible allegations of misbehavior by Trump prior to his presidency that were investigated minimally, if at all, and which never led to any serious consequences for him.  Trump had been accused of lying to investigators about his Mafia connections; accepting kickbacks; violating fiduciary duties and at least two instances of fraud; failing to disclose he was under grand jury investigation in a casino license application; and perjury.  Also, his casino was found to have committed numerous violations of state regulations, and violating regulations regarding money laundering, but Trump paid no personal penalties.

Hanson ignored all that. 

Discussion

So here is one example, one anecdote, showing, in my humble opinion, an extreme case of illogical, unsupported argumentation in defense of our current president against multiple credible allegations of conflicts of interest and corruption.  These allegations should concern anyone who cares about conflicts of interest and corruption in health care, because the presidency sets the tone for the whole country, and up to now, the executive branch of the US government provided the most and best resources for preventing and challenging conflicts of interest in health care.  Obviously, these allegations should also concern anyone who cares about the state or representative democracy in the US.

This case is notable because of the academic credentials of the person whose argumentation was so illogical and unsubstantiated.  Someone with such a prestigious academic position ought to know better, I think.

The case was also notable for how this widely published article seems to have inspired no criticism to date.  Of course, note that analyzing a short article filled with logical fallacies and unsubantiated claims likely takes much longer than writing said article.  Furthermore, note that the criticism takes much more space than the article itself.  This makes it hard to do criticism that is likely to be noticed much or have much effect.


So in conclusion let me take something I wrote about bad arguments in support of conflicts of interest in medicine in 2015, and edit it for a 2019 audience [additions in brackets]

it is most disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care [and the greater political economy, and all of society].


Then

True ... reform requires such substantive reform of the financial arrangements among corporations  ... and others who make decisions about patients' or the public's health [and about the health of the political economy and the greater society].  To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care [the political economy, and the greater society] ought to be able to participate in this discussion under these conditions.


Musical Interlude

To lighten things up a bit, here is a 1978 video of Elvis Costello live performing Watching the Detectives




Tuesday, January 29, 2019

Retaliation against physicians reporting EHR flaws that cause use errors? Physicians subpoenaed in Rhode Island, allegedly after reporting EHR risks

It appears that way to my eye.  First, on use errors (as opposed to user errors from carelessness):

“Use error” is a term used very specifically by NIST to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc. From "NISTIR 7804: Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records." It is available at http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf (PDF).

Now this:

Becker's Hospital Review
Physicians subpoenaed in Rhode Island, allegedly after reporting EHR risks
Jessica Kim Cohen
January 25, 2019
https://www.beckershospitalreview.com/legal-regulatory-issues/physicians-subpoenaed-in-rhode-island-allegedly-after-reporting-ehr-risks.html

The Rhode Island Department of Health reportedly has served at least four emergency room physicians at Providence-based Rhode Island Hospital with subpoenas, according to the Politico Morning eHealth newsletter.

The subpoenas allege the physicians participated in behaviors that fall under the umbrella of medical misconduct, on account of mistakes the physicians reported themselves. The mistakes, which didn't injure any patients, reportedly were meant to draw attention to risks associated with the hospital's EHR.

This is outrageous if accurate, especially considering the issues I raised in my Nov. 4, 2011 post "Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands - that, of course, caused no patient harm that they know of - yet" at https://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html.

The RI Dept. of Health owes the public an explanation.

The subpoenas primarily relate to medical scans, such as X-rays, which were mistakenly ordered by the physicians. EHR experts who spoke with Politico said these errors are common because it's easy to click on the wrong icon or patient name in complex system interfaces.

That is classic "use error" and results from poorly-designed, mission-hostile user interfaces of bad health IT as defined by myself and Australian informatics expert Dr. Jon Patrick at at http://cci.drexel.edu/faculty/ssilverstein/cases/:

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

I covered the issue of 'mission-hostile health IT' at a 10-part series in 2009 at http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html

Physicians and EHR safety researchers have raised concerns over the subpoenas, suggesting that the department's response could discourage future clinicians from voluntarily reporting medical errors.

Not "could." 

Will
, and likely by design in my opinion.  The ultimate motive for the subpoenas and those behind them, which may extend outside the DOH, needs to be determined.

"Anyone punishing individual providers for these events is punishing the wrong thing," Jason Adelman, MD, chief patient safety officer at NewYork-Presbyterian Hospital in New York City, told Politico. "These are system issues, not the provider being reckless. The focus should be on things like EHR usability and safety."

I am aware of patient injuries and deaths as a result of mis-clicks due to mission-hostile user interfaces that confuse users and lack appropriate safety alerts and notifications.  This includes ER mistakes.

The corporate response followed the expected boilerplate:

When asked about the subpoenas Jan. 25, Rhode Island Hospital spokesperson David Levesque [Director of Media Relations, Lifespan, https://www.lifespan.org/news-events/news/media-contacts] provided the following statement to Becker's Hospital Review:

"Rhode Island Hospital is deeply committed to the safety of our patients and the continual improvement of our healthcare environment, including the processes our caregivers and staff follow. Furthermore, the hospital's culture of transparency remains a point of pride and is unwavering. Rhode Island Hospital supports our world-class physicians, nurses and other staff and appreciate their tirelessly work in providing world-class healthcare."

As one colleague of mine observed, "the hospital's culture of transparency remains a point of pride" seems to mean that "you can prosecute staff for being transparent, and it is not a contradiction."

I wrote Mr. Levesque regarding this story:

From: S Silverstein
Date: Tue, Jan 29, 2019 at 10:07 AM

Subject: Re: Physicians subpoenaed in Rhode Island, allegedly after reporting EHR risks

"Rhode Island Hospital is deeply committed to the safety of our patients and the continual improvement of our healthcare environment, including the processes our caregivers and staff follow. Furthermore, the hospital's culture of transparency remains a point of pride and is unwavering. Rhode Island Hospital supports our world-class physicians, nurses and other staff and appreciate their tirelessly work in providing world-class healthcare."

Really? 

After the debacle I documented at https://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html , I think this is an outrage.

I am passing this story on to trial lawyers who will likely pass it to the national trial lawyer's listserv.  I believe these actions are retaliation against the physicians.

I am aware of patient injuries and deaths following "wrong clicks" in ER's.

Sincerely,

Scot Silverstein MD

The stated source of the subpoenas, DOH, seems odd.  The hospital should strongly defend its doctors against DOH if the DOH was the sole source of the subpoenas and accusations of medical misconduct, not just provide boilerplate.  If DOH was influenced by some other party to take this action, that needs to be revealed.

I hope I am wrong about the retaliation issue, and that this has all been a misunderstanding.  Perhaps Mr. Levesque will clarify.  Perhaps the subpoenas against the physicians who reported the EHR use error issue were issued by the DOH to gain more information about the alleged EHR problems.  If not, I hope they will be summarily dropped. 

If not, I hope the matter gets wider attention, especially at a time when bad health IT is contributing considerably to clinician burnout per numerous studies and reports (see for instance my Jan. 23, 2019 post at https://hcrenewal.blogspot.com/2019/01/experts-declare-physician-burnout.html).  Burnout increases risk of medical error for everyone.

Supposed accusations of any type of "professional misconduct" are outrageous, and will have a chilling effect on other like-minded, candid clinicians (including nurses) confronting bad health IT.

-- SS

Friday, January 25, 2019

More Than Just Dander

First, a sort of meta-comment in the form of a shout-out to HCRenewal's intrepid editor, Dr. Roy Poses, for his just-published analysis of what we might call "blogging: rise and fall." He sees decline reflected in publications long  devoted to health and health policy, yet now flaking off.

Methinks, however, despite the usefulness of his overview of recent decades, Dr. P need not fret excessively. Water spilling out of the barrel's lip will slow down once folks come along and punch a whole bunch of little mid-section tweet-holes in it. Information still flows. (Sort of.)  In any case, surely there's overlap between blogs' and tweets' readerships. Surely well-researched and -reasoned long form still has its place. Unfortunately, hard to know for sure: it's hard to measure. Nobody's polling these folks and to my knowledge information scientists haven't published much--a quick search inside Google Scholar bears this out--that's of a quantitative nature.

So we're left with admittedly rather unsatisfactory anecdotal reports on people who need blogs like ours and find their way to it. Congressional staffers you know who you are. Rightly or wrongly, I'm hopeful. Maybe we shade this a little by the suspicion that many younger social media users share with me a short attention span. Hence they come to rely more and more on quick hits. In any case, let's hope this is evolution and diversification, not just entropy and a race to the bottom.

Now to my theme of the day. Yet again the dander hath risen for I've lost count how many times around what ails our health delivery systems. And so is my lunch: the gorge, too, hath risen. The miscreants' very relentlessness is nauseating. More, then, on two of them that keep cropping up here like those small burrowing insectivores in this tedious yet oddly riveting game of Whack-A-Mole.

A. Chicanery at the VA: looking back and looking forward.

On balance, and despite its many flaws, VA health's operation in all its enormity is not itself a miscreant. Different story for those folks trying to destroy it from within, on the dubious premise that lest we privatize it it's irredeemable. Search this blog on "VA Cetona" for detail on such matters.

Why does this even happen? We've described the VA's Shadow Rulers (search here on that as well) in these pages. The SR's fall in the 0.1%. Why do they need or want the headache of trying, in what's fated to be a futile effort, to upend and hollow out the health lifeline extended for nearly a century to patriots returning from the military?

When the left gets power it tries to expand and improve government. (Of course the efforts can unfortunately go awry, viz. Hillarycare in the 1990s, and cast shade on future attempts.) When the right gets power, at least in the two generations since an actor became president in 1980, government is seen as "not the solution but the problem." The response may be to try to rejigger and downsize. "Drown the baby in the bath." Or, perhaps far more likely, something else now happening in the VA and throughout the Trump kakistocracy.

Namely, don't seize power to return it to the people. Seize it in order to use it in a third-dimensional play to drain resources. As for the first two dimensions, don't even try to improve--David Shulkin's mistake (see below)--or eliminate (despite Mick Mulvaney's baby drowning proclivities, hugely unpopular) care provided by the VA. Not when there's a third way: divert those resources. In fact, from the earliest instances of frontier exploitation to the newest frontier we have--our heretofore private personal information--despoliation has been the watchword, the core motive, the secret sauce: don't ameliorate. Don't eliminate. (Honestly: viz., Shrub's expansion of guvmint.) Despoliate.

It is, as Shrub used to say (maybe), one of our country's most basic pieces of strategery.

Such a strategy was discussed (and surely it's as old as the hills) by Times tech reporter Steve Lohr in a recent piece on, of all things, artificial intelligence. ("Elixir of prosperity [or] job killer"?) Lohr makes clear that what's old is new again, linking the asset of private data to all the other assets that've been strip-mined. "In the American model," notes Lohr, "coming from Silicon Valley in California, a handful of Internet companies become big winners and society is treated as a data-generating resource to be strip mined."

As Buffy the Vampire Slayer once said, "can you spell 'duh'?"

Strip mining started with the earliest settlers, and now ... data, the final frontier. Same deal, though. The American model, and economic maldistribution, and so much of our plight is bound up with this baked-in trait, which seems to've seeped into society's DNA. Or else originated there. Find a mine. Strip it. Let others pick up the pieces.

But let's go back to that last credible VA Secretary. How do we know that Shulkin pissed off the strip-miners? Why, just read what he himself wrote in a scholarly publication just a few months ago in the prestigious New England Journal. In a piece entitled "why the VA needs more competition," he and closely-associated Michigan colleague Kyle Sheetz first declared, unequivocally and repetitiously, competition: good!!! Emphasis in the original through repetition. Clever. After reassuring their audience how much they liked competition they let the cat out of the bag in the final paragraph of a long-ish article: "Privatizing the VA by offering unregulated access to private-sector providers is probably not feasible, necessary, or the best way to care for veterans."

That's exactly what the quietly-undermining, unelected Trumpsters pushing for strip-mining veterans' health care didn't want to hear. We know (see below) how that came out.

Similar in emphasis is a piece just out (January 2019) in the equally prestigious Annals of Internal Medicine, by (no pun intended) veteran federal health official Carolyn Clancy and her own VA/AHRQ colleagues. I'm perplexed at the way Clancy herself has hung in there (and yet she persisted) at the federal agencies to which she's contributed greatly over recent decades. I'm perplexed about how, within these agencies,she's been bounced around, most recently landing as the VA's "Deputy Under Secretary for Discovery, Education and Affiliate Networks." (That top's spinning so fast what I just wrote may already be superannuated news.)

In any case Clancy et al. put their shoulders to Shulkin's wheel extolling the May 2018 federal MISSION legislation streamlining VA and non-VA care, and the ostensible role their new Center for Innovation might play in such an effort. They pointed out all the right innovation-cum-research caveats about the need for adequate data: "paying for value could backfire without accurate measurement of costs and outcomes." In this case they were certainly correct: privatizers in this particular world aren't interested in evidence-based anything. They're profiteers. (See: "Department of Education." See: "Department of the Interior." See: Environmental Protection Agency.)

Shulkin's words saw the light of day about a month after the MISSION legislation, in the final days of June, 2018. But here's why I put Shulkin having "liked competition" in the past tense. By the time his NEJM piece appeared Shulkin, also accused of what I still deem to've been truly flimsy ethics violations, was already gone from his organization. By the end of March the Orange Man had already fired him. As a personal fiasco this was unseemly, since the VA secretary was a rare bird who both consented to be a hold-over from early administrations, yet managed early on to be a current POTUS favorite. Surprising? In this White House?

In none of these events was there ever put forward any really compelling justification either for privatizing VA care or for starting with the assumptions that outside "leaders" and outside doctors could do a better job than--what with all their flaws--VA medical staff. Suzanne Gordon, a distinguished journalist and author, admittedly parti pris as a fellow of the Oakland-based 501(c)3 Veterans Healthcare Policy Institute, has just published an American Prospect piece on "Trump’s under-the-radar push to dismantle veterans' health care." Her central thesis is worth quoting in extenso.
[The Republican] strategy will not only erase what has been the most successful American experiment in government-delivered health care, but will also send veterans out into a private system that is more expensive, less accountable, and unable to meet their particular needs. The key notion underpinning the Mission Act, that the private sector can offer comparable care to the VHA, is deeply flawed. Study after study (after study) has found that the VHA generally outperforms the private sector on key quality metrics, and that private providers are woefully unprepared to treat the often unique and difficult veteran patient population. The most recent evidence came in a Dartmouth College study published in December, which compared performance between VHA and private hospitals in 121 regions across the country. The results: In 14 out of 15 measures, government care fared “significantly better” than private hospitals.

Gordon also has a new book out on this subject, as most supporters of the traditional VA system already know. Worth a look. Meanwhile the Senate and White House and those advising them clearly never really cared about quaint ideas such as "studies," "evidence," or "data." They cherry-pick a few quotes about the brusqueness of some VA care, which often is admittedly more bureaucratic than today's "consumer-facing" and endlessly-polling private-care organizations. You can find those quotes as well as I can--any search engine known to man will do the trick.

Recent events on the larger political canvas make it abundantly clear, in the meantime. It's not about quality. It never was. It's about callously starting with a dismissive attitude toward government workers, then back-solving from there. Having worked for years at the VA, I can vouch for its quality as well as its struggle to assist the really needy patients who depend upon it. In fact, this new study shows quite rigorously that the VA was already dramatically reducing wait-times within multiple VA installations, right down to private-sector levels. So this branch of government has listened and successfully striven to achieve a performance level that's not just high-science but also high-touch, as medicine's "customers" (yechhh) have come to expect.

The present furlough of federal employees proves the point. If you can dismiss someone as human collateral-damage, you don't start first by examining the good things they've done for you. You're an elephant poacher. Take the spoils and leave the carcass to rot.


B. More on the Opiate Eaters Who Eat Very Well.

Speaking of despoliators, Dr. Poses and I both wrote here recently on how, in the world of dangerous narcotics, this single family of mostly physicians, the Sacklers, garnered a much more grand market share than they like to let on. Time to add to that and earlier reporting with a few updates.

When, in a different venue than the VA I was providing front line medical care to privately-insured patients, I noticed an arresting change. I saw more and more folks arrive in my office in shop-till-you-drop mode seeing opiate renewals. Always OxyContin, Percocet or Vicodin. If I didn't provide the "fill" they'd go next door. The demand built and built. The drug makers kept assuring they were safe and effective. At free dinners they paid an army of fellow physicians to regale us with the same message.

Then those patients started to die on me. OD courtesy of "safe" Purdue (and others') product.

Then in the past very few years, and I honestly should've seen it coming but didn't, the crisis spilled over from doctors' exam rooms into the political arena. It's actually something, unlike the VA, that's garnering a certain timid degree of nonpartisan interest in finding practical solutions, call it consensus even, starting with decriminalizing measures. But I find it gorge-raising to see the usual suspects continuously fighting the notion that as a society, we blew it with opiates. We blew it. With their help.

I've spent a fair amount of time looking at similar medico-legal crises, including the far-reaching tobacco and environmental lead poisoning matters, as well as narrower ones such as evolving surgical and pharmacological approaches to certain diseases. In every case our tort system, combined with the deep pockets of those who are (allegedly) truly guilty, conspire to perpetuate Bleak House-style court battles over culpability. Strip miners seem to believe--or want us to swallow whole the absurdist notion--that they leave the world a better place. In the case of Purdue, this false consciousness is undoubtedly propped up by the Sacklers' prowess as culturati: one can hardly turn around, as I recently did at the Met in New York, without finding their name plastered on this gallery or that institution of higher learning. But the motive, be it within the strip miners' organization or that of a cultural organization, comes down to the same thing: "we need the money." Allegedly.

Recent disclosures from "sources," including internal Purdue emails, clarify all this. Fortunately for us it turns out the founder's (Raymond's) son Richard was an early adopter--relatively so--of email. Both were physicians, but Richard was of the first generation to be granted an American MD. Email was barely used at all in 1995 when Microsoft first added a TCP/IP stack to its operating system, with the introduction of Windows 95. Then email really took off, by 2001 having a fair amount of penetration in the business world. So maybe we shouldn't be so surprised that Purdue Pharma was squirreling away some of Richard's pronouncements in an archival time capsule for our delectation nearly a generation later.

According to a new court filing recently revealed in the NY Times, Richard Sackler said some, um, fairly incriminating things to say in these internal emails. Still earning his spurs as head of daddy's (and Uncle Mortimer's) company after a couple of years or so in the saddle, and undoubtedly aware of the dramatic uptick in addiction issues that I saw in my own clinic in those turn-of-the-century years, he allegedly blasted everyone else in sight--except, of course, his own ever-so-cultured family.

"[T]he launch of OxyContin tablets will be followed by a blizzard of prescriptions that will bury the competition. The prescription blizzard will be so deep, dense, and white...." said Sackler fils. Based on no evidence reps were told to claim a “less than one percent" risk of addiction. As for that small subset of patients who did find themselves hopelessly addicted, the claim was to be made that “We have to hammer on abusers in every way possible.... They are the culprits and the problem. They are reckless criminals.”

Now, hot off the press in 2019, the Guardian reports how this overall attitude has been replicated within the lobbyist-influenced government of Messrs. Trump and Azar. Since 2015 (pre-Trump! pre-Azar!) chair of the FDA's own Anesthetic and Analgesic Drug Products Advisory Committee, Kentucky anesthesiology professor Raeford Brown has bravely characterized the rift that now mires down the FDA in tackling this crisis seriously. Admittedly with cover from many in Congress, Brown said this to interviewers.
I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.
Scott Gottlieb, who's tying your hands? Is it this guy? The FDA seems to be replete with such interlocking-directorate staff, all trying to assure  the "level playing field." And what is that playing field? Who are the players? We can answer this. Talk to the drug reps (I have). Except of course those who wake up and see what they're really doing, burn out and bail out. Talk to the lobbyists and the investors (I have). The watchword is not "safe and effective." It's blame-the-victim and lucrative. Let's get our motives straight here. You can do that just fine without listening to us at Health Care Renewal. Just listen to Richard Sackler in a time capsule from 2001.

Ever wonder why the strip-miners need so much of our patients' loot? Well, take a little trip to Davos, Switzerland, where the rich and rich go to rub shoulders and tell each other how smart they are: YouTube offers a hint here.

B'bye--too much dander, got to go take a bath.

Wednesday, January 23, 2019

Experts declare physician burnout ‘a public health crisis’ - and health IT a significant pathogen

I'm certain when the information technology hyperenthusiasts and non-clinical management information systems "experts" and pundits get the technology all figured out, this burnout crisis will end.


It will be about the same time as Zefram Cochrane invents the warp drive in Bozeman, Montana just prior to first contact by the Vulcans. That is in 2063 or so.


Experts declare physician burnout ‘a public health crisis’
January 22, 2019
https://www.healio.com/psychiatry/practice-management/news/online/%7B7f2124e2-d72e-4e3e-be53-6fbe41986186%7D/experts-declare-physician-burnout-a-public-health-crisis

Experts from leading U.S. health organizations deemed physician burnout “a public health crisis” in a recent report.

Physician burnout has received some attention in recent years, but not enough. As a result, it is both poorly understood and getting worse,” Andrew R. Iliff, MA, JD, lead writer and program manager at Harvard Global Health Institute, told Healio Psychiatry.

“Like the blind man describing an elephant, people have described the challenges in front of them, including unhelpful electronic health records and a looming physician shortage,” he continued. “We believe it is important to frame this as a systems problem, requiring systemic solutions in order to avoid further adding to ballooning health care costs and undermining the provision of care.”

In their paper, experts from Harvard T.H. Chan School of Public Health, the Harvard Global Health Institute, the Massachusetts Medical Society and the Massachusetts Health and Hospital Association recommended ways to address the prevalence of burnout among physicians and other health care providers. Recommendations included:
  • appointing an executive-level chief wellness officer (CWO) at every major health care organization;
  • providing support for those experiencing burnout; and
  • improving the efficiency of EHRs.

More on that third Pavlovian, formulaic, hackneyed, health IT amateur-proffered bullet point in a moment.

... The usability of EHRs must be addressed through reform of certification standards by the federal government; improved interoperability; use of application programming interfaces by vendors; and increased physician engagement in the records’ design, implementation and customization, according to the report.

"Certification" standards are useless towards the stated ends.  Interoperability via API's is not the major issue, either; fundamental operability and, ultimately, clinician burden is.

It is also far too late in the game for "physician engagement" to make any difference.   People in my specialty, myself included dating back to the 1990's - and me on this blog starting ca. 2004 - had been calling for clinician (and especially Medical Informatics) leadership (not merely "engagement") of health IT. 

I note that the original title for my health IT academic site, still residing here, was "Preventing Medical Errors: Medical Informatics and Leadership of Clinical Computing."  The original ca. 1999 site is partially archived at http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/index_org.htm.

Little has changed, and the worst predictions I'd been making about the healthcare IT bubble/experiment (see query search https://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment) seem to be reaching unfortunate fruition.

Regarding the "efficiency" bullet point above:  quite seriously, from the perspective of this trained-by-the-pioneers Medical Informatics specialist, the "efficiency of EHRs" can only marginally be "improved."  This is due to both technical and political reasons.  The systems are far too complex, with far too many templates, widgets, options, "tricks", "gotchas" etc.  (with user manuals hundreds of pages long for each, that cause even my eyes to glaze over), too embedded, too protected by the industry, especially those involving legacy code, and too entrenched by politics - to name just some of the issues making major reform of the systems themselves impractical.

The situation should never have gotten this far, predicted as far back as 1969 by EHR pioneer Dr. Donald A.B. Lindberg (http://www.nlm.nih.gov/od/roster/lindberg.html), who wrote that an effect of the "over sell" even occurring then has been "the feeling that logic compels us to build total hospital information systems like military command-and-control systems ... and other grotesque concepts too numerous to mention."
  

Lindberg in 1969.  From Collen, "A History of Medical Informatics in the United States: 1950 to 1990"

What is needed is a significant downgrading of required clinician (physician/nurse) interaction with these "command-and-control systems", including data entry, and the use of clericals to perform those functions.  See my August 2016 essay "More on uncoupling clinicians from EHR clerical oppression" at https://hcrenewal.blogspot.com/2016/08/more-on-uncoupling-clinicians-from-ehr_91.html

More generally, see my numerous posts on this issue at https://hcrenewal.blogspot.com/search?q=oppression

One last quote from the Healio article:
... Burnout not only causes physicians suffering, it also can adversely impact patients. Prior research has shown that burnout may does increase the risk for medical errors.  [Fixed the academic equivocation - ed.]

Put more simply, physician and nurse burnout can kill you.

If a healthcare organization cannot afford the appropriate clerical help to avoid clinician burnout, then they cannot afford an EHR.

Finally:

Can I now say "I told you so?" without the health IT industry sockpuppets coming out of the woodwork? (http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html)

-- SS

Friday, January 18, 2019

Return of the Anechoic Effect - Rest in Peace, Health Wonk Review

Introduction: Blogging About Taboo Topics in Health Care

We started Health Care Renewal in 2004 to discuss the causes of health care dysfunction that rarely were mentioned in polite conversation at the time.  When we started Health Care Renewal, such issues as suppression and manipulation of research, and health care professionals' conflicts of interests rarely appeared in the media or in medical and health care scholarly literature.  While these issues are now more often publicly discussed, many other topics, such as  deceptive marketing of health care products and services; distortion of health care regulation and policy making through propaganda and disinformation,  regulatory capture, and the revolving door; ill-informed. mission-hostile, conflicted  corrupt or criminal leadership; etc, etc, etc; still rarely appear in the media or scholarly literature, and certainly seem to appear much less frequently than their importance would warrant (see this post).  For example, a survey by Transparency International showed that 43% of US resondents thought that American health care is corrupt.  It was covered by this blog, but not by any major US media outlet or medical or health care journal.  We have termed the failure of such issues to create any echoes of public discussion the anechoic effect.

Public discussion of the issues above might discomfit those who personally profit from the status quo in health care.  As we noted above, the people who profit the most, those involved in the leadership and governance of health care organizations and their cronies, also have considerable power to damp down any public discussion that might cause them displeasure. In particular, we have seen how those who attempt to blow the whistle on what really causes health care dysfunction may be persecuted.  But, if we cannot even discuss what is really wrong with health care, how are we going to fix it?

In the early 2000s, new internet based platforms appeared that allowed us and others to publish facts and opinions about health care dysfunction that otherwise were taboo.

The Darkness Gathers

Unfortunately, now the world of incisive medical and health care policy discussion is contracting again. Health Wonk Review, a compendium of the best blogging in health care policy, is closing down.  The email from its founders and blog-meisters read:

After a baker’s dozen years  and more than 280 issues, we’ve decided to call it a day.

It’s become a bit more of a heavy lift to get varied hosts.

We moved to a monthly issue to address that, but it’s still been slow going.

Submissions are down too as more people abandon blogs in favor of social channels like Twitter and LinkedIn.

Readership and cross posting appears to have waned, too. 

Going forward, we may host an ad hoc issue occasionally under the HWR banner and invite your participation when health policy issues rise to the surface, but the regular issues will cease.

So it joins the many medical and health care blogs I used to follow to help learn about what was really going on in health care, including items that it was considered impolite to discuss too loudly, lest they offend the powers that be. Some worthy blogs now gone are,  in alphabetical order:

1BoringOldMan - since 2017, after the death of its revered blogger, Dr Mickey Nardo

Carlat Psychiatry Blog - 2017, by Dr Daniel Carlat

HealthBeat - 2015, by journalist Maggie Mahar

HealthNewsReview - 2018, by journalist Gary Schwitzer

Hooked: Ethics, Medicine and Pharma - 2014, by Dr Howard Brody

Not Running a Hospital - 2016, by former hospital CEO Paul Levy

PharmaGossip - 2016, by an anonymous blogger

Scientific Misconduct Blog - 2010, by Dr Aubrey Blumsohn

Side Effects- by journalist Alison Bass

Note that the content of blogs with links above is still available, but the bloggers are not posting any more.

What Next?

Blogs, which were seen as a big innovation in the early 2000s, now of course seem a bit old fashioned and stuffy only a few years later.  However, blogs then served an important purpose.  They provided publication platforms which were immediate, and not subject to external editing, publication delays, or the worries of publishers' attorneys or corporate leaders.

Many of us went to blogging to discuss anechoic issues because it was so difficult to inject these discussions into the media, or medical or health care scholarly publications, at least without long delays, and editing that was not always helpful, and at times took not only the edge off, but much of the content as well. 

However, as the leaders of Health Wonk Review indicated above, social media is now all the rage. But social media has weaknesses, and social media platforms may not replace blogs.

Blogs can be as immediate as Twitter, for example (and I confess I do have a Twitter feed.)  But they allow longer form posts that can include nuance, complex arguments, analytic approaches, etc.  Anyone can read most blogs.  They do not push people to identify as followers.  They do not necessarily come with advertisements, with atttempts to profile readers for marketing purposes. They do not only supply thoughts selected for similarity with what one has read before, and hence can take a reader out of his or her algorithmically developed bubble.

However, I fear that in losing blogs such as these, we lose important voices that have helped challenge our pre-existing beliefs, illuminated what has gone wrong with health care, and showed us the way forward.

So rest in peace, Health Wonk Review.  I hope that there will be some way to continue the vigor of discussion that characterized it, and other health care blogs which are now defunct.
 



Tuesday, January 08, 2019

The Mysteries Surrounding Rhodes Pharmaceuticals, the Sackler Family's Second Opioid Company



 Mysteries still abound in the not so wonderful world of health care dysfunction, so, quick, the game's afoot...

Today's mysteries involve beneficial ownership.  Beneficial ownership questions are important to anti-corruption campaigners.  Beneficial ownership simply refers to "anyone who enjoys the benefits of ownership of a security or property, without being on the record as being the owner." (per Wikipedia). Concealing who really owns a company enables concealing sources of funds (as in money laundering), market power (when the owner also owns competitors), and sources of political influence, and enables those benefiting from the actions of the company to escape responsibility for their consequences.

A few months ago, a big question about the beneficial ownership of a local (to me) company suggested important local and national health care implications, and yet the case has remained anechoic.  The case has some mysterious aspects.

The  Mystery of the Ownership of Rhodes Technologies and Hence Rhodes Pharmaceuticals Solved

In September, the UK based Financial Times reported,

The billionaire Sackler family, which has been blamed for fuelling the US opioid addiction epidemic, owns a second drugmaker that churns out millions of addictive painkiller pills every year, the Financial Times can reveal.

The Sacklers are best known as the owners of Purdue Pharma, the privately held drugmaker that makes the now infamous opioid painkiller OxyContin, which has been described as 'heroin in a pill'.

However, an FT analysis of company registration documents has established that the family also owns Rhodes Pharma, a little-known Rhode Island-based drugmaker that is among the largest producers of off-patent generic opioids in the US.

Furthermore,

Rhodes Pharmaceuticals was set up in 2007, four months after Purdue pleaded guilty to federal criminal charges that it had mis-marketed OxyContin over the previous decade.

The little-known company now makes several opioid-based products containing highly-addictive drugs such as oxycodone, morphine and hydrocodone, according to a US Food and Drug Administration database. Many of its drugs are made in factories owned by Purdue.

The Mystery of the Mysteriousness of the Rhodes Companies and Facility

The FT report was noted by our local on-line news site, GoLocalProv, which tried to find out more about the company. It reported,

And tucked away in Coventry, Rhode Island, along a country road, is Rhodes Technology — surrounded by massive security. The company’s website has been under -reconstruction for the past few years -- all an effort to keep a low profile.

A 2005 version of the Rhodes Technologies’ website GoLocal uncovered said, 'We have very broad capabilities in developing sophisticated chemicals and offer confidential production of high purity APIs and finished dosage forms of innovative pharmaceuticals, as well as marketing and sales services. A multi-million dollar investment in a new cGMP facility completed in 2002 added controlled substances to our manufacturing capabilities. Rhodes is a diversified, dependable firm well positioned for partnerships.'

The marketing arm of the Rhodes Technologies is Rhodes Pharmaceuticals and it self-describes itself as 'a privately held company headquartered in picturesque Rhode Island....developing and distributing quality pharmaceutical products since 2008.'

Emails and requests for an interview were not responded to by Rhodes Pharmaceuticals.

GoLocalProv article included a blurry picture of a large factory building apparently copied from an old website.  I could find no pictures or descriptions of the Rhodes facility on the web other than the picture below from Google Satellite:




The satellite picture does suggest that the Rhodes facility is apparently massive.  However, I could find nothing, at least via web searching, to otherwise describe it.  Despite its size, I could find no coverage of the company, the facility, the buidling of the facility (which likely was quite a project), or anything else relevant in local media, or on the web.

The reasons to keep the ownership of this company mysterious are not hard to fathom.  But the reasons for the company itself to maintain such a "low profile," and for its facilities to be so well hidden, and to have such "massive security" (not otherwise described by GoLocalProv), are ongoing mysteries.

The Mystery of the Sackler Family's Opioid Market Power Partly Solved


It appears that the Sackler's previously secret ownership of Rhodes enabled them to conceal their market power. Per the FT,

Purdue Pharma has always insisted that its drug OxyContin cannot be considered a prime culprit in the crisis because it accounts for only 1.7 per cent of overall opioid prescriptions in the US.

However, Rhodes and Purdue combined accounted for 14.4m opioid prescriptions in 2016, according to figures seen by the FT, giving them a total share of 6 per cent of the US opioid market.

That puts the combined Rhodes-Purdue in seventh place among opioid makers by market share, behind Teva, the generic drugmaking giant, and well ahead of other pharma groups that have been named in lawsuits, such as Johnson & Johnson and Endo.

'This further debunks the Sackler family’s whole claim that they are not responsible for the crisis,' said Andrew Kolodny, a professor at Brandeis University who is one of the foremost experts on the US addiction epidemic.

He added: 'They have always said, ‘Why is everyone picking on us, we’re only 2 per cent of prescriptions?' A spokesperson for the family declined to comment.

A second GoLocalProv article also revealed that

The billionaire family whose company is being sued by states and cities across the country for their role in creating the opioid crisis is now launching a new recently patented antidote for the drug known as ‘heroine in a pill.’

Both oxycodone and the new drug will be produced side-by-side at the Rhodes Technologies plant -- an affiliate company of Purdue Pharma -- in Coventry, Rhode Island.

To corroborate that,

The U.S. Patent and Trademakr [sic] Office information shows the Rhodes Technologies’ plant in Coventry, RI is assigned the patent for the new drug. Rhodes Technologies is the subsidiary of Purdue Pharma owned by the Sackler family.

Calls and emails to Rhodes Technologies and its affiliated marketing company Rhodes Pharma have not been responded to.

Note that the "new drug" that is considered an "antidote" to oxycodone is simply a minor modification of an old drug, buprenorphine, already used to treat opioid addiction.  Per Stat News,

The patent concerns a new formulation of buprenorphine, one of the medications shown to help people with opioid addiction. It is already approved by the Food and Drug Administration in tablet and film form, but the patent describes a wafer that could dissolve even faster than existing forms when put under the tongue.

The patent says that the faster the treatment dissolves, the less risk there is for diversion.

So now we know more about the power of the Sackler family in the opioid market.

The Mystery of Accountability for Deceptive Marketing of Opioids Partly Solved

Purdue Pharma has a long and sorry history of deceptive marketing of its narcotics, and has been accused of being a major driver of the ongoing opioid (narcotic) epidemic.  The case has recently been very well covered in the media.  (Our latest discussion is here, our discussion of Purdue Pharma's first legal troubles, which were fairly anechoic at the time, is here, and all our Purdue Pharma related posts are here.)

It appears that the Sackler's concealed ownership of Rhodes Technologies/ Pharma also put them in a position to generate more financial conflicts of interest among physicians which could be used to enable more deceptive marketing.  A search of the ProPublica "Dollars for Docs" data base revealed that Rhodes paid $1.43M to physicians from August, 2013, to December, 2016.  They paid the most, $121K, to a single physician in Saint Charles, MO.

Admittedly, their contribution to physicians' conflicts of interest was modest compared to that of the Sackler's better known Purdue Pharma, $27.9M over the same time period, but it should not be overlooked.

So we now know a bit more about the extent Sackler family owned opioid manufacturers enlisted physicians to market their products, at times deceptively. 

The Mystery of the Sackler Family's Political Influence

This is admittedly speculation, but it is possible that Rhodes Technologies/ Pharma was also used as a vehicle for political influence to affect policy making relevant to the Sackler's interests.  Purdue Pharma certainly has a track record of such influence.

For example, we noted here that Purdue Pharma donated money to the Washington Legal Foundation in support of its efforts to weaken enforcement of laws that could have penalized the company's misbehavior.   In particular, the Washington Legal Foundation challenged the responsible corporate officer doctrine that allowed legal action against corporate executives for company wrong-doing that occurred on their watches.  Perhaps corporate leaders were worried that its executives could again face penalties, given the Purdue Pharma executives had previously pled guilty to misbranding Oxycontin (look here).  Purdue Pharma had also worked with the Washington Legal Foundation to push against guidelines from the Centers for Disease Control that would have potentially reduced opioid prescribing.

Furthermore, we noted here that Rudolf Giuliani, now President Donald Trump's lawyer, and previously and probably currently highly influential in the Trump regime, formerly represented Purdue Pharma and had helped mitigate the company's punishment for past mischief, an interesting example of the revolving door from the pharmaceutical industry to government.

So I think it is reasonable to say that whether Sackler-owned Rhodes Technologies/ Pharma was also used as a tool to conceal political influence remains a mystery.

Summary

So we now know that the Sackler Family, owner of Purdue Pharma, also owns a generic pharmaceutical company that manufacturers an important portion of the narcotics sold in the US.  Thus the share of the opioid market held by the Sackler family is likely four times larger than was previously apparent .  The Sackler's generic drug company is now known to have paid physicians a small but important amount to assist in its marketing of opioids.  It is also possible that the generic company also has been used to increase the family's influence over politics and policy that increased opioid sales and hence its responsibility for the opioid epidemic.  Thus, it is likely that the Sackler family's responsibility for the ongoing opioid epidemic is larger than was previously appreciated.

Why the Sackler's may have concealed their ownership of the company seems obvious.  Why the company and its physical plant were so secretive is not so clear.  

It is unknown whether the family owns similar companies that have not been discovered.  It is unknown whether big pharmaceutical and other big health care corporations similarly have concealed beneficial ownership of other companies that could be used to conceal all manners of mischief.

Anti-corruption campaigner have pushed to reveal the beneficial ownership of all corporate entities.  (Look here for the relevant report from Transparency International.) They have made little headway, so far.  The case of the mysteries surrounding Rhodes Technologies/ Pharma should be another impetus to support this campaign. 

True health care reform requires all sorts of transparency, now particularly including transparency about corporate beneficial ownership.  

Wednesday, January 02, 2019

For the Years of Investigation to Come: a Guide to Resources for Challenging Health Care Corruption

The Enduring Problem of Health Care Corruption

Now arrives the years of investigation.  Here in the US, a new majority in the US House of Representatives promises multi-pronged investigations of, among other topics, the corruption that now seems pervasive at the highest reaches of the US government, corruption that has badly affected efforts to truly reform US health care (look here).  Meanwhile, similar investigations are likely to get underway in various US states.  We can only hope that this flurry of activity will end up with some positive steps to reduce US health care corruption, an enduring problem about which we often write.


As we wrote in August, 2017, Transparency International (TI) defines corruption as


Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.
the scale of corruption is vast in both rich and poor countries.

Also,
Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,
However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Presumably the leaders of other kinds of corrupt organizations can do the same. 

When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects some other places, mainly  presumably benighted less developed countries.  At best, the corruption in developed countries that gets discussed is at low levels.  In the US, frequent examples are the "pill mills"  and various cheating of government and private insurance programs by practitioners and patients.  Lately these have gotten even more attention as they are decried as a cause of the narcotics (opioids) crisis (e.g., look here).  In contrast, the US government has been less inclined to address the activities of the leaders of the pharmaceutical companies who have pushed legal narcotics (e.g., see this post). 

However, Health Care Renewal has stressed "grand corruption," or the corruption of health care leaders.  We have noted the continuing impunity of top health care corporate managers.  Health care corporations have allegedly used kickbacks and fraud to enhance their revenue, but at best such corporations have been able to make legal settlements that result in fines that small relative to their  multi-billion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

We have been posting about this for years at Health Care Renewal, while seeing little progress on this issue.

Things only seem to be getting worse given the increasing evidence that the Trump administration is corrupt at the highest levels.   In January, 2018, we first raised the question about how health care corruption could be pursued under a corrupt regime.  We noted sources that summarized Trump's. the Trump family's, and the Trump administration's corruption..  These included a website, entitled "Tracking Trump's Conflicts of Interest" published by the Sunlight Foundation, and two articles published in the Washington Monthly in January, 2018. "Commander-in-Thief," categorized Mr Trump's conflicted and corrupt behavior.  A Year in Trump Corruption," was a catalog of the most salient cases in these categories in 2017.

In July, 2018, we addressed the Trump regime's corruption again  By then, more summaries of Trump et al corruption had appeared.   In April, 2018, New York Magazine published "501 Days in Swampland," a time-line of  starting just after the 2016 presidential election. In June, 2018, ProPublica reviewed questionable spending amounting to $16.1 million since the beginning of Trump's candidacy for president at Trump properties by the US government, and by Trump's campaign, and by state and local governments. Meanwhile, Public Citizen released a report on money spent at Trump's hospitality properties.  Meanwhile, the voluminous Tracking Corruption and Conflicts of Interest in the Trump Administration summary appearing in the Global Anti-Corruption Blog has grown and grown. 

 So the driver of US health care corruption may now be the executive branch of government and its relationship with the Trump family and cronies, trumping even the influence of health care corporate corruption.  

However, in our work we have been heartened to find some useful resources (although unfortunately none specifically targeted at health care corruption in the US).  To inspire others to join the fight against health care corruption and related ills, I take this opportunity to post an idiosyncratic list of some of the most helpful resources I have found (including one very new one).  In alphabetical order:



Basel Institute on Governance

Located in Basel, Switzerland,

an independent not-for-profit competence centre working around the world with the public and private sectors to counter corruption and other financial crimes and to improve the quality of governance.

The Institute does not have a specific health care focus, but focuses on broad issues with applicability to health care: asset recovery, public governance, corporate governance and compliance, collective action, and public finance management.

Curbing Corruption

This is a new website staffed by anti-corruption experts mainly based in the UK, meant

to appeal widely to people who want to take action to reduce corruption within their sector of society, and/or within their organisation. This includes Members of Parliament, the private sector, civil society organisations, professional associations, the media and the judiciary.

However, their main focus now are politicians and public officials.

The website includes sector specific resources, including a very extensive review document on the health sector.

Global Anti-Corruption Blog

A multi-author US based blog

devoted to promoting analysis and discussion of the problem of corruption around the world. This blog is intended to provide a forum for exchanging information and ideas across disciplinary and professional boundaries, and to foster rigorous, vigorous, and constructive debate about corruption’s causes, consequences, and potential remedies.

It includes an extensive list of international anti-corruption resources (much bigger than this idiosyncratic list), but which tellingly has no organization specifically focused on health care, and no organization specifically focused on US corruption.

Transparency International

Perhaps the best known international anti-corruption NGO (non-governmental organization), based in Berlin, Germany.  It proclaims 
 
From villages in rural India to the corridors of power in Brussels, Transparency International gives voice to the victims and witnesses of corruption. We work together with governments, businesses and citizens to stop the abuse of power, bribery and secret deals.

As a global movement with one vision, we want a world free of corruption. Through chapters in more than 100 countries and an international secretariat in Berlin, we are leading the fight against corruption to turn this vision into reality.

Its website is extensive.  It hosts more or less biannual International Anti-Corruption Conferences.  It provides many resources, including a well known annual international survey of corruption perceptions.  It has chapters in multiple countries (although, tellingly, its US chapter was dis-accredited in 2017, look here).

The TI UK chapter has a specific health care initiative focusing on the pharmaceutical industry.

U4 Anti-Corruption Resource Centre

Located in Bergen, Norway,

 U4 is a permanent centre at the Chr. Michelsen Institute (CMI) in Norway. CMI is a non-profit, multi-disciplinary research institute with social scientists specialising in development studies.

Its introductory statement

At U4, we work to reduce the harmful impact of corruption on society. We share research and evidence to help international development actors get sustainable results.

U4 provides publications and resources for various sectors, including health care.

Summary

Corruption in health care is a daunting problem, but 2018 showed us in the US that when people get upset enough about problems, things happen (albeit, not always great things).  So we urge all concerned about health care corruption to make things happen.  The resources above may help them do so.