Showing posts with label Purdue Pharma. Show all posts
Showing posts with label Purdue Pharma. Show all posts

Thursday, August 18, 2022

Haunted by the Impunity of Rich Business Leaders - Will One Criminal Conviction make a Difference? The Trump Organization Chief Financial Officer Pleads Guilty

 Impunity: an Introduction

We believe that unaccountable leadership is a major cause of health care dysfunction.  Impunity is an extreme form of unaccountable leadership.

We have noted that despite numerous legal settlements made by health care organizations of allegations like fraud, bribery, and kickbacks, almost never do top leaders who presided over these actions face any negative consequences.  Lack of deterrence caused by such impunity appears to be a major cause of  the epidemic of continuing unethical behavior, crime and corruption on the part of large health care organizations. How executives got to the point of having such impunity has never been clear.

But consider two important cases.  

Columbia/HCA CEO Not Held Responsible for Defrauding the Federal Government in 2003

 In 2010, we described the case of early dominant for-profit hospital system Columbia/HCA, which, after investigations beginning in the late 1990s, settled charges of defrauding the federal government.  The company paid a fine of $1.7 billion, a record amount at that time, but did not admit guilt.  More importantly, the company CEO, Rick Scott, was not charged with anything, suffered no negative consequences even though it was on his watch that the company was involved in apparently fraudulent behavior, and retired with a large golden parachute.  

Mr Scott then went on to be elected Governor of, then Senator from Florida as a Republican.  He is still in the Senate, and has become a big supporter for former President Trump.

In 2010 we wrote:

we have noted a parade of legal settlements involving and guilty pleas and criminal convictions by  health care organizations, (or often just subsidiaries conveniently available to take the rap).  As we have noted, resulting fines may be just be treated as costs of doing business by health care leaders.  Almost never have the people who authorized, directed, or implemented wrong-doing almost never suffer negative consequences.

Instead, they may just continue to haunt health care and society at large
.

and

as I have repeated seemingly infinitum, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Purdue Pharma Executives Convicted in 2007

In 2007, we made quite a lot about criminal convictions for Purdue Pharma, and of three of its executives for the "misbranding" of Oxycontin.  (That was just the beginning of the legal problems for Purdue, and other manufacturers and distributors of "legal" narcotics and their contribution to the epidemic of narcotic abuse.)  At the time, we marveled that

At least in the Purdue Pharma/ Oxycontin case top company leaders were prosecuted, plead guilty, and will personally have to pay substantial financial penalties. Maybe this will convince the leaders of health care organizations that deceptive marketing practices may not be in their long term interests.

Of course, at the time we did not realize that Purdue Pharma was a privately held corporation run largely by the family that owned it, the Sacklers.  While the three executives had some responsibility for company operations, they were not as powerful as the top executives of publicly held health care companies, and so their convictions did not really end the impunity even of the top leaders of even one important health care corporation.

Trump Organization CFO to Plead Guilty of 15 Felonies Involving Tax Cheating in New York Court

Today, as the New York Times reported:

 One of Donald J. Trump’s most trusted executives stood before a judge on Thursday and pleaded guilty to 15 felonies, admitting that he conspired with Mr. Trump’s company to carry out a scheme to avoid paying taxes on lavish perks — even while refusing to implicate the former president himself.

As part of the plea deal with the Manhattan district attorney’s office, the executive, Allen H. Weisselberg, is required to testify at the company’s trial if prosecutors choose to call on him, and to admit his role in conspiring with Mr. Trump’s company to carry out the tax scheme. That testimony could tilt the scales against the company, the Trump Organization, as it prepares for an October trial related to the same accusations. 

This demonstrates that in 2022, it is still big news if an apparently top corporate executive is convicted of a crime involving his management of the corporation.  We have progressed so little.

In particular, we certainly have not yet progressed to the point at which the actual top leaders of big corporations are held accountable for their misbehavior.  The Trump Organization is a closely held private corporation.  Its top leader is generally acknowledged as Donald J Trump, and its other top leaders are likely his children.  None of them so far have been charged in this case.

Donald J Trump as leader of the Trump Organization had a very long record of impunity as leader of the Trump Organization (look here).  It is possible that had he been held to account for his earlier actions, we might never have run for President of the United States.  Trump as President was accused of a long list of conflicts of interest and corrupt acts (look here).  He has denounced the 2020 election, which he lost, as "rigged" despite no evidence in support of that.  He currently is under investigation for leading an insurrection to overturn the election and stage an auto-coup.

Conclusion

We are still haunted, now dangerously haunted, for our failures as a society to hold rich, top business leaders accountable for their actions.

When will we ever learn? Will be learn before it is too late?

 

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.

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.  

Sunday, July 08, 2018

"Hope in a Bottle" - Components of Purdue Pharma Stealth Marketing Campaign for Oxycontin Revealed by Legal Documents from Tennessee

Introduction: Disinformation and Stealth Marketing Campaigns

Back in the distant past the US government made some attempt to hold big health care corporations to account for misleading marketing practices.  We learned a lot about these practices from documents revealed in the resulting litigation, and in particular, about stealthy, deceptive systematic marketing, lobbying, and policy advocacy campaigns on behalf of big health care organizations, often pharmaceutical, biotechnology and medical device companies.  For example, in 2012 we found out about the stealth marketing campaign used by GlaxoSmithKline to sell its antidepressant Paxil.  This included manipulating and suppressing clinical research, bribing physicians to prescribe the drug, use of key opinion leaders as disguised marketers, and manipulation of continuing medical education.  Other notable examples included Johnson and Johnson's campaign to sell Risperdal (look here),  and the infamous Pfizer campaign to sell Neurontin (look here and here).  We also found that stealth marketing seemed to be partially responsible for the growing popularity of narcotics (opioids) starting in the 1990s (look here).

The organization and complexity of stealth marketing, lobbying and policy advocacy campaigns have often been sufficient to characterize them as disinformation.  For example, we characterized the campaign by commercial health insurance companies to derail the Clinton administration's attempt at health reform in the 1990s, as described by Wendell Potter in his book, Deadly Spin, as just that (look here).  The tactics employed in that campaign included: use of front groups and third parties (useful idiots?); use of spies; distractions to make important issues anechoic; message discipline; and entrapment (double-think).

Nowadays, the current Trump administration does not seem interested in pursuing unethical or corrupt practices by big health care corporations.  A health care corporate fraud strike force was downsized by the Trump administration as we noted in July, 2017.  By May, 2018, legal actions by the US government against apparently corrupt acts by large US health care organizations seemed to be falling off.  Only one significant settlement had made that year.  Bloomberg published a report with the headline, "White-Collar Prosecutions Fall to 20-Year Low Under Trump," on May 25, 2018.  Meanwhile, the administration pulled one former stealth marketer through the revolving door to serve in the White House (look here), and has been  pushing its own disinformation campaigns (look here).
 
However, some state attorneys general and local prosecutors have picked up the baton.  In particular, as the opioid epidemic continues, they have filed many lawsuits against corporations that profited from narcotics sales.

Sleazy Marketing Tactics Used to Sell Oxycontin

And glory be, one such lawsuit has led to the disclosure of the shady marketing tactics used by the now notorious Purdue Pharma to sell Oxycontin.  Several news reports summarized the lawsuit filed by the Tennessee Attorney General against that company.  As described by the Knoxville News Sentinel,

The lawsuit, filed by Tennessee Attorney General Herbert H. Slatery III, uses Purdue’s own company records and its staffers’ own words to show the firm’s founders and executives pushed medical providers to prescribe increasingly high doses of OxyContin for longer periods — even after Purdue promised the state it would stop.

It lays bare a marketing campaign that was highly regimented and highly profitable, built upon a foundation of lies and trickery, and specifically targeted Tennessee’s most vulnerable medical providers and patients, including the elderly and veterans.

'Purdue summarized the marketing for its opioid products with the tagline, ‘We sell hope in a bottle’ in one of the company’s hiring guides for incoming marketing employees,' the lawsuit revealed.



Targeting the Beleaguered

Hope could best be sold through the prescriptions of the most beleaguered prescribers:

Purdue told its sales staffers to target medical providers who were overworked, serving poor communities in Tennessee and had less training, calling them 'high value prescribers' who could be easily persuaded to increase prescriptions and dosages of OxyContin.
To do this, most likely the pharma representatives used psychological manipulation, such as assuring the practitioners that the representatives were their true friends in a hostile health care environment.  Such tactics were well-documented in articles by Ahari and Fugh-Berman, e.g., look here and here

Perverse Incentives for Sales Reps

The company provided perverse incentives to its pharmaceutical representatives (perverse, at least, from the standpoint of the patients' welfare and health professionals' values):

Sales staffers’ bonuses were tied to how well they pushed 'super core' providers — the Tennessee prescribers handing out OxyContin prescriptions at a rate guaranteed to cause fatal overdoses — to keep pushing the drug on their patients.

The firm even had a 'toppers club' for sales staffers who pushed the most OxyContin, awarding them trips and cash, the lawsuit stated.

Deceptions and Third-Party Strategies

Although none of the Tennessee pharma reps were "medical professionals," they

were trained to position themselves as medical experts and then supply providers with carefully scripted lies about the addictive and deadly properties of OxyContin, the internal records show.

'Do (providers) believe (in) me on info?' one sales staffer wrote. 'Buy-in … (Provider) buys me first.'
Again, to do this they likely traded on the misguided trust of the physicians generated by the representatives' psychological manipulations.

Practitioners were supplied with biased, and in today's argot, fake literature to give to the physicians,

literature from fake advocacy groups touting the safety of opioids and labeling the growing opioid epidemic as 'pseudoaddiction' that would level off if providers simply prescribed more OxyContin.

Sales staffers were trained to teach providers that the best way to keep patients from addiction was 'to actually prescribe more and higher doses' until the 'symptoms' of addiction went away, the lawsuit stated.

The suit claimed that Purdue set up a "third party strategy," using "astroturf" organizations to pretend that influential health care professionals and sincere patient advocates supported ever increasing narcotics use:

The firm funded the creation of advocacy groups with names such as the American Pain Society and American Pain Foundation, and pamphlets, videos and social media campaigns to convince Tennesseans that OxyContin was a wonder drug — even as the number of fatal overdoses tied to it began to skyrocket.

The firm specifically targeted veterans with a web campaign titled 'Exit Wounds,' and called OxyContin the 'gold standard' for pain treatment.

'Long experience with opioids shows that people who are not predisposed to addiction are unlikely to become addicted to opioid medications,' veterans were told. 'When used correctly, opioid pain medications increase a person’s level of functioning.'
Third party strategies have been widely used in public relations/ propaganda/ disinformation campaigns. 

Profits Before Patients, and the Law

Purdue Pharma reps were instructed to keep pushing narcotic prescribing by physicians who were in danger of being sanctioned.

The lawsuit reveals Purdue’s sales staffers were instructed to ignore police warnings, indictments and overdose deaths involving Tennessee medical providers and to continue to call on them to hand out high-dose OxyContin — the firm’s most profitable brand — so long as they still had prescription pads.

The lawsuit and Purdue’s internal records link the firm’s sales staffers to some of Tennessee’s most notorious pill mill doctors, including one of the largest such operations in East Tennessee.

Purdue staffers called one medical provider, who is not identified in the lawsuit, 48 times — after law enforcement told the firm the provider had prescribed fatal doses of OxyContin and was running a cash-for-pills clinic.

A Nashville Public Radio report additionally noted that

According to the lawsuit, Purdue reps also continued to call on doctors after:

Law enforcement identified two particular doctors responsible for significant diversion
Credible reports of patient overdoses
A provider admitting to heroin addiction
Muggings over controlled substances outside a pharmacy linked to a provider
Admission by a provider he was running a pill mill
Observing a patient being coached in a waiting room
Choreographed pill counts and urine screenings
Standing-room-only waiting rooms
Clearly, generating more revenue by selling more drugs trumped respect for ethics or the law. 

Summary

Thus, Purdue Pharma appeared to use the same sort of multi-pronged deceptive marketing approach to ramp up prescriptions of its potent narcotics, even as more and more people became addicted.

While we have been (probably appropriately) distracted by larger scandals, managers of big health care corporations have continued their cynical tactics that put profits ahead of patients, and ahead of professional values. It is likely that deceptive marketing, and full blown stealth marketing is flourishing even more in the shadows created by a government that seems to put the profits of President and family's company ahead of taking "care that the laws be faithfully executed."

At least to some degree state law enforcement is beginning to step into the breach.  As a Tenessee attorney who is also involved in lawsuits against Purdue said (per NPR)  "I think it helps all of us engaged in this fight to better understand what has happened and ultimately to get more quickly and more efficiently to a resolution,..."

So to conclude,

 We have long advocated better awareness of insidious disinformation campaigns in health care, which we previously separated into stealth systematic marketing, lobbying, and policy advocacy campaigns.  Furthermore, we have long advocated more vigorous regulatory and law-enforcement action against them.  Remember that many of the stealth marketing campaigns we discussed came to light through regulatory and law enforcement action.

Yet what sense does that make when the federal regulators and law enforcers operate under a regime that was perfectly happy to use disinformation to secure its election?

It apparently makes no more sense than advocating for better federal law enforcement measures to reduce conflicts of interest and corruption in health care under an extraordinarily conflicted and corrupt regime (look here.)

The fish is rotting from the head. 

So in parallel with what we said then, the only way we can now address health care deception, crime, and corruption is to excise the deception, crime and corruption at the heart of our government.

Tuesday, March 06, 2018

How Corporate Health Care Leaders Maintain Their Impunity: The Case of Purdue Pharma's Funding of the Washington Legal Foundation to Attempt to Weaken the Responsible Corporate Officer Doctrine

The ongoing epidemic of narcotic (opioid) abuse, and the resulting rise in the deaths due to overdoses, has focused attention on pharmaceutical companies' aggressive promotion of these drugs which minimized their substantial risk. A recent article in the Intercept showed how the leadership of one such company tried to insulate itself from responsibility for such actions even while such promotions were continuing.

Background: Impunity of Top Leaders of Big Health Care Organizations

For years, we have railed against the impunity of top leaders of health care organizations.  We have noted that despite numerous legal settlements made by health care organizations of alllegations like fraud, bribery, and kickbacks, almost never do top leaders who presided over these actions face any negative consequences.  Lack of deterrence caused by such impunity appears to be a major cause of  the epidemic of continuing unethical behavior, crime and corruption on the part of large health care organizations. How executives got to the point of having such impunity has never been clear.

Timidity and lenience by regulatory agencies and law enforcement seem to be factors. For example, in 2014, we noted  that Attorney  General Eric Holder had previously been reluctant to go after big organizations because of the economic consequences of their failure:

The attorney general angered many last year when he reiterated those concerns at a congressional hearing, admitting 'that the size of some of these institutions becomes so large that it does become difficult for us to prosecute' because of the potential nasty economic effects of a major company failure.
In general we have seen much tougher enforcement directed against relatively small health care players than against bigger ones.  For example, we noted in 2014 that settlements by  Merck, Eli Lilly, Takeda, and Teva, all large pharmaceutical companies, allowed the companies to pay fines to settle allegations that they pushed dangerous products, while none of the executives who authorized, enabled, or directed these actions faced negative consequences.  In contrast, at that time, the CEO of a relatively tiny Sheffield Pharmaceuticals was convicted of a felonious wastewater discharge (see this post).

However, this rationale does not address the failure to pursue enforcement actions against organizational leaders who who enabled, authorized, directed or implemented misbehavior.  It is not that there are no good legal tools available to do so.  We wrote in 2012,

As we noted here, a Supreme Court case from 1943 empowered the government to seek penalties against responsible corporate officers (the "responsible corporate officer doctrine") who were in a position to stop a fraud that resulted in a guilty plea or conviction, particularly for the selling of misbranded or adulterated drugs into interstate commerce under the US Food and Drug Act.    Despite a threat made in 2010 by the chief counsel of the Inspector General's office of the US Department of Health and Human Services to use such legal authority to "get high level executives out of companies," nothing of the sort has happened.


Later, in 2015, under the previous administration, there was a tiny sign of progress against impunity.  Then, Attorney General Holder authorized the creation of a Corporate Strike Force to take strong actions in response to health care corporate fraud.  However, last year the Trump administration gutted even that small effort  (look here).  The use of the Responsible Corporate Officer doctrine remains at best extremely rare.  Why?  


How Leaders of Purdue Pharma Tried to Undercut the Responsible Corporate Officer Doctrine

A recent article in the Intercept provided one explanation.  It provided a telling example of top health care corporate leaders who took active, but stealthy measures to preserve their own impunity by attempting to undermine the Responsible Corporate Officer Doctrine,

Executives at Purdue [Pharma]were once charged using the corporate office doctrine in 2007, in a case that found that the company had 'misbranded' its drugs as less likely to be abused than other narcotics. The company agreed to pay a settlement of $634.5 million.

As reported then by the New York Times, three corporate executives pleaded guilty of misdemeanor charges of misbranding Oxycontin.  It appeared that corporate leadership wanted to try to prevent further efforts to hold them accountable.

Purdue didn’t attach its name to the recent effort to weaken the responsible corporate officer doctrine. Instead, the company provided funding to the Washington Legal Foundation, a legal nonprofit that litigates in support of business interests, to petition the Supreme Court last year to accept a case that would give it the opportunity to weaken the RCO doctrine. The foundation closely protects the names of its donors and the drugmakers’ ties to the group were unclear until recently.

The legal strategy was confirmed by former staffers at the Washington Legal Foundation who spoke to The Intercept on the condition of anonymity. The foundation did not respond to a request for comment.

The effort revolved around a case known as DeCoster v. United States, one of the most significant challenges to the responsible corporate officer doctrine in four decades.

The lawsuit challenged the conviction of executives at Quality Egg LCC, an Iowa-based company, who were found guilty for shipping salmonella-tainted eggs that sickened 56,000 people. The federal prosecution shocked the business community because it represented a rare case of corporate executives held criminally responsible for actions committed by subordinates. The Department of Justice prosecutors relied on the RCO doctrine, which has historically been used for food- and drug-related offenses in cases in which companies have caused widespread health problems, to sentence executives at Quality Egg to three months in jail.

Business interest groups watched the case with interest, and the foundation filed a brief to overturn the decision after the case was upheld by an appellate court.

In its petition to the Supreme Court to take up the Quality Egg case, the Washington Legal Foundation called the responsible corporate officer doctrine 'a peculiar anomaly in criminal law' that allows imprisonment of corporate executives 'based on little more than his supervisory role in the company.' The foundation urged the Supreme Court to take up the case as an “opportunity to revisit the very notion of Park doctrine liability.”

"Little more than his supervisory role?"  Corporate executives command huge compensation specifically justified by their "supervisory" role.

The Intercept provided more detail about the role of Purdue Pharma leadership in this challenge,

According to a former Washington Legal Foundation official, an attorney with Purdue Pharma reached out to thank them for the work being done on the RCO doctrine. Another former foundation employee noted that the Washington Legal Foundation has long worked to weaken the doctrine, and that Purdue Pharma was one of several donors that had supported the effort.

While the foundation says all of its funding comes in the form of unrestricted grants, former employees told The Intercept that donors had effectively influenced briefs and others filings made by the Washington Legal Foundation. Connie Larcher, president of the foundation, has long coordinated the nonprofit’s legal strategy in close coordination with donors, the sources said. Some of the Purdue Pharma money was intended to promote the legal strategy around the RCO doctrine.

Asked for comment, Purdue Pharma did not speak directly to the relationship with the Washington Legal Foundation.

The Intercept also provided more details about the ongoing relationship between Purdue Pharma leadership and the Washington Legal Foundation,

Ties between Washington Legal Foundation and Purdue Pharma were reported by The Intercept in 2015 in a story detailing how the foundation had helped Purdue Pharma attempt to block the Centers for Disease Control and Prevention from issuing voluntary guidelines to discourage the overprescription of opioid narcotics.

Last week, Sen. Claire McCaskill, D-Mo., confirmed the prior relationship and released a report revealing that Purdue Pharma had donated $500,000 to the Washington Legal Foundation. The report noted that the foundation had taken the unusual step of lashing out at the CDC opioid guidelines.

Finally, the Intercept suggested that the Washington Legal Foundation

has long faced accusations in the past that the nonprofit operates as a legal front for corporations to undercut public health and safety standards.

The group figured prominently in the tobacco wars that raged throughout the ’90s. The group routinely filed briefs supporting the tobacco industry’s lawsuits challenging government regulations on tobacco products. A 1994 memo by Philip Morris executive Roy Marden noted that he was '[w]orking with the Washington Legal Foundation (WLF) in the development of a strategy to counteract and attack the efforts of the antis,' a reference to public health advocates. The group also sponsored advertisements criticizing 'anti-smoking zealots in government' without disclosing that the group was being funded by several major tobacco firms.

So this suggests that leaders of large health care corporations have actively attempted to preserve their impunity.  Furthermore, their methods have been aimed not just at increasing their personal impunity, but the impunity of all corporate leaders, which has implications beyond health care. In that they resemble efforts of leaders of other big corporations, like tobacco companies, to combat specific regulations by campaigning against regulation in general.  Finally, they have deliberately obscured their efforts to dodge responsbility by using third parties paid with concealed funds.

Summary

The Intercept noted that the strategy employed by Purdue Pharma and the Washington Legal Foundation to change the results of DeCoster vs United States failed.  However, this case raises the possibility that health care and other corporate leaders are using other deceptive strategies to preserve their own impunity in other contexts.  Furthermore, these strategies could have the effect of increasing impunity widely for other corporate and top organizational leaders, thus reducing deterrence of corruption.   If we ever want to have really responsible corporate leaders, we will have to uncover the schemes current leaders use to avoid responsibility and maintain impunity.

Meanwhile, there is justified public anger about the narcotic (opioid) epidemic, and in the works are multiple legal cases against the drug companies that sold and aggressively marketed these drugs.  Will any hold responsible the drug company executives who presided over these companies?  As the man said, we will see....

To conclude with the usual exhortation,

True health care reform requires well-informed leaders who uphold health care professionals' values, put patient's and the public's health ahead of all other considerations, avoid self-interest and conflicts of interest, are honest and ethical, and surely are not corrupt.  They need to work in the context of a government that is of, by and for the people, not of, by and for a demagogic leader.


Thursday, February 15, 2018

Welcome to the DOG Patch: first in a series?

Lately my dander is up so often and so copiously, over what's happening in health care and the world at large, I'm exhausted. Covered with nasty dander. Cowering under the sheets. Others seem to share this dysphoria. But I found if not a cure, at least a palliative. There's so much dander I can scrape it off with a great big shovel and toss as much as I can your way. Here's my first Dander Omnium Gatherum, or DOG, from the Cetona DOG Patch. Remember, these stories are all DOGs.

  • Litmus Test for New HHS Secretary. The new sheriff at Health & Human Services, Alex Azar, has barely had a chance to wipe his feet in front of the now ironically-named Hubert Humphrey Building in DC. And already the attorney and former Eli Lilly big shot gets his big shot at letting us know whether he'll go up against his fellow plutocrats when it comes to the Affordable Care Act. WaPo has a good story on how, in Idaho, Azar's fellow rich white guy, multi-million dollar livestock owner and red state governor Butch Otter, is considering a truly insidious gem of a way to gut sick folks' access to health care in the Gem State. Allow insurors to sell ACA-noncompliant policies, which, if the sheriff doesn't come to town and say not on my watch, allows risk pools to be invidiously divided. Which of course drives up sick folks' premiums to untenable levels. What's it going to be, Alex?
  • Opioid Addiction Industry: the Gift that Keeps On Giving. Hard to be snarky when so many people are dying including my own patients. But I'll try anyway. Actually, this is a slightly more hopeful comment than my recent ones on the depredations inflicted by this industry, especially Purdue Pharma and its founders from the Sackler family. Can you guess the cost to society of this crisis? Oh, about a trillion dollars in the past decade and a half. I'd not seen it quantified heretofore, but Altarum has given it a go here. In any case, pressured by who knows who--for sure not HCRenewal, but maybe some inordinately publicity-shy latter generation Sackler family members--Purdue just announced they'd no longer promote OxyContin to providers. Oh, wait. Could it have anything to do with the fact that doctors are sick of them? Or, even more likely, that earlier this week Senator Claire McCaskill (D-MO) released a report on the back-door support this industry's been slipping to advocacy groups. A telling quote: "'The question was: Do we make these people suffer, or do we work with this company that has a terrible name?' said U.S. Pain founder Paul Gileno, explaining why his organization sought the money." Read McCaskill's report here.
  • The Soul of the Texas GOP. What's it got to do with health policy and HCRenewal? Antivax, folks, antivax. In Houston--not exactly the most rabidly extreme, left or right, among Texas cities--a PAC and Facebook (surprise surprise) offshoot called "Texans for Vaccine Choice" is mounting a challenge to Republican Sarah Davis, re-election candidate for the state legislature. (This is in the heart of Texas medicine: Baylor, M. D. Anderson, etc. Seems an awful lot of ultraconservatives go to Harvard Law then come back to Texas. This challenger edited an in-house law review featuring Ted Cruz and Neil Gorsuch.) Seems Davis committed the mortal sin of opposing a proposal to prevent physicians from vaccinating foster children. I guess this is normalized. In Texas we already knew there's a rift between business moderates and ideologues. And anti-vaccination is rampant nationwide, backed by celebrities. Rugged individualism, and resistance to empathic concern for one's neighbors, has brought us antivax, the gun death epidemic, and so so much more. It's all about choice, folks. Texas GOP seems to be divided on this matter, actually, so again, Watch This Space.
  • California Probes Aetna Medical Director. Funnily enough, I can easily see how and why this happens. But it don't make it right. The insurance commissioner in the Golden State is investigating Aetna after one of its medical directors (who's now moved on) admitted to CNN that he never looked at any of the patient files he was adjudicating for health care approvals. (Aetna, of course, denies.) How could this happen, you ask? Guy (under direction from non-physician bosses) sits there and judges patients' futures without a glance at their records? If you ever sat on hold for an hour waiting for one of this guy's lieutenants, typically nurses or even lower-rung than that, you wouldn't ask. Then you argue for an hour with the nurse. Sometimes (s)he sees the light and coaches you in how to game the system--which didn't really need to be gamed in the first place--but you end up outraged at the arbitrariness. Then this guy, in the present instance family physician Jay Ken Iinuma MD, pushes out the denial letter to your patient. You appeal. Eventually, if you had your act together in the first place, on behalf of your patient, you win. The inefficiency of it of course is just the point. I appeal. Many don't. Aetna makes out. And our system costs double anyone else's.
  • Tech Industry: the Impossible Dream. It's fun to tilt at windmills a la Don Quixote. Tech entrepreneurs--I know a lot of them--come up with a lot of great ideas. Most are DOGs. But a few are pretty neat. Here's one just maybe in the latter group. Year before last, in the Research Triangle of North Carolina, some IBMers came up with a patient-centered navigation tool whereby sick folks could look up symptoms and see their options. The company is already defunct. “'The short answer is nobody really used [it],' according to Ateev Mehrotra from Harvard. 'For a variety of reasons, they just forgot about it. This is what I would say in my defense: I still think it’s a good idea.'” But this one's a little bit complicated. Mehrotra, who spends a fair amount of time investigating such tools, had previously authored a BMJ article showing that a whole bunch of these tools, net net, are right about half the time at best. A Kaiser article on the matter noted that "[h]alf the sites had the right diagnosis among their top three results, and 58 percent listed it in their top 20 suggestions." Jury's out on this one. On top of which, the only tech applications, thanks to ACA and HITECH, that've really made it in the health care marketplace are EHRs (see InformaticsMD's many great pieces in this blog) and--actually a little better--patient portals. For now, they may just be crowding everything else out.
  • When are Ted Cruz and Diane Feinstein on the Same Team? Rarely. But WaPo now reports an instance of "real change to drug pricing being ignored by Congress." The so-called CREATES act is procompetitive in the generic space. It's supported by the ultraconservative FreedomWorks caucus, AHIP, and AHA. So why not pass it? It got left out of the recent deficit-swelling spendthrift legislation that broke the back of the threatened Can you spell Big Pharma? What's there to be said. The drug lobby and the gun lobby together practically run this country. Is it a democratic country? Do patients, who're also voters, count? Or do lobbyists' contributions to the characters writing the legislation? Oh, wait.... Why do I even pose that as a question?
  • Postmodernism Yet Again. Dr. Poses, your editor, has written eloquently and often in this blog about the baleful effect of pomo thinking on modern science and medicine, especially in the scientific and medical education spaces. This writer has stayed away from the topic, mostly because they believe the postmodern "turn" since the 1970s has been confined largely to the realms of architecture and the academy. (Lots of the academy.) But the topic is suddenly very much in the news again of late, mainly because of the truthiness--or lack thereof--on the part of so many political actors. A recent NY Times piece by Thomas Edsall, entitled "Is President Trump a Stealth Postmodernist or Just a Liar?", is especially juicy. Edsall has a truly admirable Rolodex of people to whom he can reach out and ask the question embodied in his title. If "truth is not found but made," than who among us can be righter than the next guy--say our president? Some on Edsall's Rolodex made the point that pomo just made it a lot harder to rely glibly on western "grand narratives." That much we can concede, for sure. But the truth (whoops) is: we're left in a state of ambiguity. A decade or so ago historian Charles Rosenberg, in a superb essay based on his book Our Present Complaint, said this of the "inconveniently subjective object, the patient [creating] the characteristic split screen that faces today’s clinician": we're left with "a feeling of paradox, the juxtaposition of a powerful faith in scientific medicine with a widespread discontent at the circumstances in which it is made available. It is a set of attitudes and expectations postmodern as well as quintessentially modern." But maybe the last word should go to New Republic columnist Jeet Heer, who quotes Fredric Jameson in characterizing pomo as the "transformation of the ‘real’ into so many pseudoevents." In other words, the fractionation of our political and cultural understandings of policy and society. As Roger Cohen recently wrote, the fact that politicians and lobbyists have so successfully divided us into warring tribes, where everything and everyone is self-serving and convinced of its own reality, there's the real danger. And many traditional institutions, outside of those still harboring Received Truth, have abdicated their former bridging roles along with in loco parentis.
Cetona looks forward to hearing your responses to any of these emanations from the DOG Patch.

Friday, November 18, 2016

Trumping En Masse Through the Revolving Door - the Trump Advisory and Transition Teams

We have frequently posted on the revolving door as a type of severe conflict of interest, if not corruption, affecting health care.  Our posts have covered various cases of people going from influential positions in or related to health care and some anti-health corporations, and government positions that make health care policy or regulate health care. 

Donald J Trump, the president elect, has pledged to "drain the swamp," that is, to generally reduce crony capitalism, conflicts of interest, the revolving door, and government corruption (e.g., look here.)  However, it appears that his campaign advisory/ transition team has been full of people who had just traversed the revolving door.  Examples I have found so far follow, in alphabetical order.

Rich Bagger

Back in July, 2016, per BioCentury Extra

EVP of Consumer Affairs and Market Access Rich Bagger has taken a leave of absence from Celgene Corp to work on the transition team for presidential candidate Donald Trump....

Mr Bagger recently left the transition team, apparently as part of the purge of Chris Christie associates.  Celgene is a pharmaceutical company that was one of the leaders in pushing the envelope in drug pricing (upward that is, e.g., see this post). 


Stephen Feinberg

the co-founder of Cerberus Capital Management LP ... was relieved by Mr. Trump’s victory, a person familiar with the matter said. Mr. Feinberg came on board as an economic adviser [per the Wall Street Journal, November 10, 2016]

As we have discussed here, Cerberus Capital Management bought the former Caritas Christi Health system in Massachusetts, which it renamed Steward Health Care, and subsequently managed, or some would say mismanaged so that Cerberus could extract as much money as possible from Steward.

Mike Ferguson

Reported by Stat News, November 15, 2016,

Not long after Trump’s victory, the law firm where he works, BakerHostetler, circulated an email touting former Representative Mike Ferguson’s 'genuine connection' to Trump, Vice President-elect Mike Pence, and others on the transition team.

The message noted the firm’s 'in-depth relationships' with 'many people who are positioned for senior roles in the incoming administration' at the Department of Health and Human Services, Food and Drug Administration, and the Centers for Medicare and Medicaid Services.

Ferguson, a Republican who represented New Jersey for eight years, 'is in close contact with members of the Trump transition team during this critical time,' said the note. The law firm lobbies for Celgene (see above), Advaxis, and the Children’s Hospital Association — and is ready for more customers. 
 Newt Gingrich

Former House Speaker Gingrich early on was chosen as a Trump insider. Not so well known are his previous health care activities, including financial ties to big health care corporations. As we posted in 2011, Mr Gingrich set up a for-profit consulting group, the Center for Health Transformation, which

brought in dues of as much as $200,000 per year from insurers and other health-care firms, offering some of them 'access to Newt Gingrich' and 'direct Newt interaction,' according to promotional materials. [per the Washington Post]

As we noted then,  The Center for Health Transformation was largely funded by big health care corporations. The Post first noted,

The biggest funders, ... [included] firms such as AstraZeneca, Blue Cross Blue Shield and Novo Nordisk,...

Also,
The center has listed scores of firms and industry groups as members over the years, amounting to a Who’s Who of the medical field, from GE Healthcare to the American Hospital Association to Wellpoint, [now Anthem] the nation’s largest health insurer.

Other clients were listed in a Bloomberg article,
Among the member companies were drugmaker Johnson & Johnson (JNJ) and health insurer Blue Cross and Blue Shield Association....

Also,
Pfizer Inc. (PFE), the world’s largest drugmaker, had consulting contracts with Gingrich, according to two people familiar with the arrangements. Pfizer spokesman Ray Kerins didn’t respond to requests for comment.

The Pharmaceutical Research and Manufacturers of America, the industry’s trade group, was also a client. His firm 'was retained by the PhRMA general counsel’s office at one time to provide advice on a positioning project,' the group said.
In addition, clients included important firms in the health care information technology (IT) sector, including GE, IBM, Microsoft, Allscripts, and Siemens.


We also then wrote about several cases in which Mr Gingrich apparently intervened on behalf of his clients to promote their business interests in the guise of promoting his views on health policy solutions.  In some cases, the views he promoted did not fit with what is generally regarded as his political philosophy, suggesting that the interests of his paying clients overrode his political views.[again, see this post]

Note that we have discussed the managerial, ethical and sometimes criminal misadventures of many of the companies listed above (see the links above for specific firms).  

Rudolph Giuliani

Mr Giuliani, like Mr Gingrich, early on became a close Trump adviser. Per the New York Times, November 15, 2016, Mr Giuliani's consulting firm's clients included Purdue Pharma,

Under contract with Purdue Pharma, the maker of the often-abused painkiller OxyContin, Mr. Giuliani used his clout with the Justice Department to press the federal authorities to offer a less onerous punishment to the company after allegations that security problems at its warehouses might have contributed to black market sales.
We have discussed, and others have discussed more extensively, the saga of Purdue Pharma, which aggressively and deceptively marketed the narcotic OxyContin, doubtless contributing to the deadly epidemic of prescription opioid abuse.


J Steven Hart

Hart, an attorney and accountant who perennially appears on lists of top D.C. lobbyists, is chairman of the law and lobbying firm Williams & Jensen [per the National Law Journal, November 10, 2016]

Hart joined Williams & Jensen in 1984 and became chairman in 1999. At the firm, he has lobbied for many Fortune 500 companies. In 2016 alone, according to filings from the U.S. Senate Lobbying Disclosure Act database, Hart’s clients have included General Electric Co., Coca-Cola Co., Pfizer Inc. and Visa Inc.

More clients of his firm include giant health insurance/ managed care company Anthem, and PhRMA, the association of pharmaceutical manufacturers, per Politico, November 11, 2016


Cindy Hayden

Trump's Homeland Security team ... is being led by Cindy Hayden, a director at the US tobacco giant Altria [per the Business Insider, November 11, 2016]

Given the well known health risks of smoking, Altria could just as well be called an anti-health care company.  As a member of its board of directors, Ms Hayden has a fiduciary responsibility to increase the company's revenue. 

Howard Lorber

Back in August, per the Washington Post, Mr Trump announced a list of core economic advisers that included Mr Lorber, "chief executive of the Vector Group." Per the company website, the Vector Group Ltd is a holding company that holds primarily tobacco companies:

Through our subsidiaries, Liggett Group LLC and Vector Tobacco Inc., we manufacture and market high quality cigarette products to adult smokers in the United States. Vector Group also owns New Valley LLC.

Vector Group’s tobacco subsidiaries have a proud history of charting an independent course in the tobacco industry, dating from Liggett’s founding in 1873.

Also,

We have also developed our e-cigarette brand, Zoom, which we believe is a superior disposable e-cigarette product.

As noted above, tobacco companies could easily be called anti-health care companies.  The more use of tobacco, the more the public health risk.  Yet Mr Lorber's job is to increase the company's revenue, and hence, presumably the use of tobacco. 


Betsy McCaughey

As reported by NPR in August, Mr Trump added a group of women to his economic advisory team. They included,

New York Lt. Gov. Betsy McCaughey, who wrote several influential but highly controversial articles criticizing Hillary Clinton's health care proposals in the 1990s, is also on the list. More recently, she has written books taking on the Affordable Care Act.

As we noted in a post in 2009, in an op-ed column for Bloomberg News that got wide attention, Betsy McCaughey, who is described as, "former lieutenant governor of New York and is an adjunct senior fellow at the Hudson Institute," attacked as "dangerous" provisions in the new Affordable Care Act (ACA, "Obamacare") which supported comparative effectiveness research.  However, not noted in Betsy McCaughey's op-ed article was that she ... [was] on the board of directors of Cantel Medical, a device company, and formerly on the board of Genta, a biotechnology company.

Furthermore, per an August article in the Huffington Post,

Betsy McCaughey built a career out of saying bombastic, completely false things about health care reform. She is reviled by actual health care policy analysts from the left, right and center for spreading frightening, but demonstrably false, misinformation while adopting the tone and posture of a serious expert.

In 1994, she claimed that Hillary Clinton’s health care reform plan would bar people from purchasing care outside the new Clinton system, which would cruelly ration treatments to curb costs. It wasn’t true. The magazine that published the article would later disavow it.

Here’s what she said about Obamacare in 2009:

'One of the most shocking things I found in this bill, and there were many, is on page 425, where the Congress would make it mandatory ― absolutely require ― that every five years, people in Medicare have a required counseling session that will tell them how to end their life sooner ... all to do what’s in society’s best interest or your family’s best interest and cut your life short. These are such sacred issues of life and death. Government should have nothing to do with this.'

Pretty scary! And totally untrue. Completely, 100 percent false. Zero correspondence with reality. But McCaughey’s nonsense took off. She made the same claim in op-eds for The Wall Street Journal and the New York Post. When Sarah Palin picked up the idea, the mandatory meetings morphed into “Obama’s death panel.” Conservative media and Republican politicians went wild.

Paula Stannard

According to Stat News, November 15, 2016, Ms Stannard served

in the last Republican administration as deputy general counsel to the Department of Health and Human Services.

She was responsible for food and drug issues and other matters, including federal health insurance and public health preparedness. On the Trump transition, she will be working under Bremberg.

However, her firm

has earned more than $4.4 million lobbying so far this year for health care companies and trade groups including Novartis AG, Verax Biomedical, the American Hospital Association, St. Jude Children’s Research Hospital, and Aetna — plus an untold amount doing legal and regulatory work, which does not have to be reported. 

Re her position in the transition team, Stat News quoted Dr Michael Carome, who runs the Health Research Group for Public Citizen,

I think this reflects the fact that Trump’s pledge to drain the swamp is not going to take place. Individuals who have close ties to regulated industries such as pharmaceuticals is worrisome, because such individuals are likely to pursue an agenda that is very industry friendly and not consumer and patient friendly.... 

Tommy Thompson

Also according to Stat News, November 15, 2016, Mr Thompson, a former Secretary of Health and Human Services under President George W Bush, served

as a founding member of the Bush Alumni Coalition Supporting Trump, which launched in late September. (Very late.)

Thompson, who ran the group, served as governor of Wisconsin from 1987 to 2001. He was also a partner at Akin Gump Strauss Hauer & Feld, which lobbies for the American Medical Association, PharmAthene, and the Alliance for a Stronger FDA, among other health care concerns.

Thompson’s participation could also be good news for the health care companies whose boards he serves on: Centene, United Therapeutics, and TherapeuticsMD. He is a former director of Cytori Therapeutics.
Note again that we have previously discussed managerial, ethical, and sometimes criminal misadventures of some of the companies with which Mr Hart, Ms McCaughey, Ms Stannard, and Mr Thompson were affiliated (see the links to the companies noted in the discussions above.)

Summary

Donald Trump's candidacy seemingly was welcomed by many people who really thought he would be an economic reformer.  They thought he would address the plight of poor, working and middle class people, who saw their incomes stagnant or falling, had trouble finding decently paying jobs, may have lost their jobs and/or their housing, saw their communities hollowed out, and generally felt the system was rigged against them. Even some health care professionals saw Mr Trump as a reformer of a rigged health system. For example, in July, 2016, Stat News published an editorial by Dr Charles D Rosen:

As a physician, I believe that Trump is absolutely right about allowing cheaper pharmaceutical drugs manufactured abroad to be sold in the United States. He is right that the pharmaceutical companies essentially sell their products to the federal government via Medicare and Medicaid without competitive bidding. In other areas of the budget, such as defense, federal laws require competitive bidding. It is outrageous this doesn’t occur with drugs and devices, especially since the health care budget is right behind defense in terms of expense.

Trump is right when he says that drug companies control the landscape. He appears to be willing to call it as it is and not worry about repercussions from the powerful drug interests, and has moved in the right direction in saying he would let Medicare negotiate with pharmaceutical companies if he becomes president.

However, by November 15, 2016, as reported by the Los Angeles Times,

the president-elect appears to have downgraded plans to act aggressively to control rising drug prices, handing the pharmaceutical industry an early victory and providing another illustration of the influence of lobbyists on the new Trump administration, despite Trump’s promise to 'drain the swamp' of special interests in Washington.

Trump, who once made the cost of pharmaceuticals a central part of his campaign healthcare pitch and included the issue on his campaign website, hasn’t mentioned the subject since the election, even though the issue is consistently cited as the top healthcare problem Americans want to see fixed.

And Trump’s transition healthcare agenda makes no mention of drug prices, though it lists six other healthcare priorities, including restricting abortion, speeding federal approval of new drugs and restructuring Medicare and Medicaid.

So like Dr Phil used to say, how is it working for you now, Dr Rosen?

Mr Trump seemed to promise economic reform, and to "drain the swamp" or Washington crony capitalism, insider dealing, conflicts of interest, and corruption.  But at least in the health care sphere, many of his cronies on his advisory and transition teams seem to be rotators through the revolving door, having gone from being corporate insiders to being political advisers.  

And as we noted previously, the revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,
The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
The case of the Trump transition once again suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works, and that the country is still increasingly being run by a cozy group of insiders with ties to both government and industry.

So, as we have said before.... The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.

But did we really think the self-proclaimed billionaire and former star of The Apprentice was going to be a reformer?  After all, its theme song was "For the Love of Money"