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.

"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.

How Do We Counter Health Care Disinformation Under a Disinformer-in-Chief?

"Don't worry, things could be worse.  And sure enough, things got worse."

Disinformation in Medicine and Health Care

Stealthy, deceptive systematic marketing, lobbying, and policy advocacy campaigns on behalf of big health care organizations, often pharmaceutical, biotechnology and medical device companies, have long been a subject of Health Care Renewal.  A relatively recently revealed example was the stealth marketing campaign used by GlaxoSmithKline to sell its antidepressant Paxil.  This campaign 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).   Notably, stealth marketing seemed to be one reason 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).

Many of the stealth marketing campaigns we discussed came to light through regulatory and law enforcement action.  For example, the public was made aware of the GSK stealth marketing of Paxil due to Eliot Spitzer's prosecution in 2004 (documented in Side Effects by Alison Bass).  Ultimately, that campaign resulted in a settlement including a multi-billion dollar fine in 2012 (look here).

So we have long advocated better awareness of these insidious disinformation campaigns, and more vigorous regulatory and law-enforcement action against them.   Thus we were aghast in 2017 when a accomplished stealth  health care marketer transited the revolving door to wind up in a top federal position, on the President's Council of Economic Advisors (look here).

That was bad.  Worse, now it appears that the disinformers are in charge of all regulation and law-enforcement.

Disinformation at the Heart of the Current President's Election Campaign

Cambridge Analytica's Appropriated Facebook Data

Less than 10 days ago, the New York Times broke a complex story about the disinformation campaign at the heart of the Trump presidential campaign in 2016.  The campaign used

private information from the Facebook profiles of more than 50 million users without their permission, according to former Cambridge employees, associates and documents, making it one of the largest data leaks in the social network’s history. The breach allowed the company to exploit the private social media activity of a huge swath of the American electorate, developing techniques that underpinned its work on President Trump’s campaign in 2016.

Note that

The data Cambridge collected from profiles, a portion of which was viewed by The Times, included details on users’ identities, friend networks and 'likes.' Only a tiny fraction of the users had agreed to release their information to a third party.

Thus the campaign was based on inappropriately and unethically accessed, that is, hacked data from millions of people.  Such data hacking may prove to be illegal (see below). 

PsyOps

According to a companion article in the Guardian, Cambridge Analytica was linked to and its work based on that of a company called SCL Group,

one of whose subsidiaries, SCL Elections, would go on to create Cambridge Analytica (an incorporated venture between SCL Elections and Robert Mercer, funded by the latter). For all intents and purposes, SCL/Cambridge Analytica are one and the same.

Notably, SCL Group's

expertise was in 'psychological operations' – or psyops – changing people’s minds not through persuasion but through 'informational dominance', a set of techniques that includes rumour, disinformation and fake news.

Per the NY Times, Christopher Wylie, who blew the whistle on Cambridge Analytica et al,

said of its leaders: 'Rules don’t matter for them. For them, this is a war, and it’s all fair.'

'They want to fight a culture war in America,' he added. 'Cambridge Analytica was supposed to be the arsenal of weapons to fight that culture war.'

Per NPR, Wylie later told a UK parliamentary committee

Donald Trump makes it click in your head that this has a much wider impact. I don't think that military-style information operations is conducive for any democratic process.

Furthermore,

They don't care whether or not what they do is legal as long as it gets the job done

Thus it seems pretty clear that Cambridge Analytica/ SCL were in the disinformation business, and were happy to use various tactics, probably unethical and some likely illegal, to accomplish psychological operations to manipulate their subjects.

Overlaps with Trump Campaign

The company leveraged the unauthorized Facebook data:

Under the guidance of Brad Parscale, Mr. Trump’s digital director in 2016 and now the campaign manager for his 2020 re-election effort, Cambridge performed a variety of services, former campaign officials said. That included designing target audiences for digital ads and fund-raising appeals, modeling voter turnout, buying $5 million in television ads and determining where Mr. Trump should travel to best drum up support.

Note that Cambridge Analytica was run by some of Mr Trump's closest associates, including Steve Bannon, a Cambridge Analytica board member, who became Trump's third campaign director, and then a top White House strategic advisor, and Robert Mercer and his daughter Rebekah, investors and board members, who were notable Trump donors and gurus of related political causes. Although the firm first attached itself to the campaign of Ted Cruz, after that lost steam,  according to a Washington Post article

the Mercers switched their allegiance to Trump and pitched their services to Trump’s digital director, Brad Parscale. The company’s hiring was approved by Trump’s son-in-law, Jared Kushner, who was informally helping to manage the campaign with a focus on digital strategy.

Kushner said in an interview with Forbes magazine that the campaign 'found that Facebook and digital targeting were the most effective ways to reach the audiences. . . .We brought in Cambridge Analytica.' Kushner said he 'built;' a data hub for the campaign 'which nobody knew about, until towards the end.'

 Thus the Cambridge Analytica/ SCL disinformation campaign, built on hacked data, was done in the service of the Trump campaign, and with apparent full knowledge, acquiesecence, and sometimes active cooperation of top campaign leaders.  Mr Trump, of course, was ultimately responsible for the actions of his campaign, although none of the reporting so far speaks to his day-to-day participation in the Cambridge Analytica/ SCL disinformation campaign.


A Platform Built on Manipulated Emotion

It appears that the campaign used a variety of disinformation techniques.  It is striking that these techniques were ultimately used to push themes and policies that Cambridge Analytica/ SCL had developed prior to their involvement with Trump, not merely the themes and policies that Trump and his advisers had devised.  Furthermore, these  themes and policy positions later used by the Trump campaign were based not on ideology or policy research, but on the hidden fears and resentments of people assessed by Cambridge Analytica in its "psychographic" analysis campaign. Again, according to the Washington Post article,

The data and analyses that Cambridge Analytica generated in this time provided discoveries that would later form the emotionally charged core of Trump’s presidential platform, said Wylie, whose disclosures in news reports over the past several days have rocked both his onetime employer and Facebook.

'Trump wasn’t in our consciousness at that moment; this was well before he became a thing,' Wylie said. 'He wasn’t a client or anything.'

The year before Trump announced his presidential bid, the data firm already had found a high level of alienation among young, white Americans with a conservative bent.

Furthermore, a later Washington Post article stated,

Cambridge Analytica used that information, together with insights gained from focus groups with angry Americans, to identify issues and target voters. Bannon supplied the ideological focus of wanting to remake America and billionaire Robert Mercer provided the money. Neither Bannon nor Mercer has publicly commented since the allegations emerged.

Then,

'One of the things that started to emerge was that we literally heard these sort of narratives about Washington as something that was, like, gross and disgusting, that was dirty,' Wylie said.

So his team tested the phrase 'drain that swamp' to see if people would respond to it on social media. After all, they had access to the data of millions of Facebook users without their knowledge.

And people responded. Through the internet and Trump’s speeches, the slogan became one of the campaign’s most identifiable soundbites.

Perhaps it is the idea of building a wall along the Mexican border that best illustrates Wylie’s work for Cambridge Analytica.

Bannon, Wylie said, was obsessed with the idea of separating the U.S. from the rest of the world so the country can rediscover itself. Trump’s campaign for a wall along the Mexican border is not really about stopping immigrants, Wylie said.

'It’s to embody separation,' he said. 'If you can embody that separation and you can further distance in the minds of Americans us here in America and them elsewhere, even if it is just across a river, or just across a desert, then you have won that culture war.'

So "drain the swamp" was not a catch phrase for fighting corruption, but a hook to deep-seated fears of contamination, and "build the wall" was not a policy position to literally build a physical wall, but a hook to deep-seated fears of otherness.  Yet in office Mr Trump has continued to use these slogans as if they were policy positions, and has remained fixated on building a physical wall.  As we discussed here, there is plenty of evidence that he has fostered, not fought corruption. 


Use of "Proxy Organizations"

Great Britain's Channel 4 interviewed Mr Nix, the CEO of Cambridge Analytica, posing as potential clients. As reported by the Guardian,

Turnbull said the company sometimes used 'proxy organisations', including charities and activist groups, to help disseminate the messages – and keep the company’s involvement in the background.

Use of proxies and third parties are commonly used disinformation tactics.



Questions of Illegality

Claims of Impunity

During the Channel 4 undercover interview, Mr Nix claimed impunity,

When the undercover reporter expressed worries that American authorities might seize on details of a dirty campaign, Nix said the US had no jurisdiction over Cambridge Analytica, even though the company is American and is registered in Delaware.

'I’m absolutely convinced that they have no jurisdiction,' he told the purported client. 'So if US authorities came asking for information, they would simply refuse to collaborate. 'We’ll say: none of your business.''

Maybe his beliefs in impunity facilitated his comfort with the use of some apparently illegal tactics.

Violation of UK Data Privacy Laws


The UK has stringent laws on data privacy.  Its Information Commissioner's Office is apparently actively investigating whether Cambridge Analytica/ SCL violated them.  Late last week, the Guardian reported  

Investigators from Britain’s data watchdog have spent nearly seven hours searching the London offices of Cambridge Analytica.

Eighteen enforcement officers entered the Cambridge Analytica headquarters in London’s West End on Friday night to search the premises after the Information Commissioner’s Office (ICO) was granted a warrant to examine its records.

The officials concluded the search at about 3am on Saturday.

According to CBS News, at least three US states are now investigating whether the company broke US laws by accessing the Facebook data.

Work on a US Campaign by Foreign Nationals

As implied above, Cambridge Analytica and SCL were basically UK operations.  A Guardian article noted the apparent illegality of involvement in US political campaigns by foreign nationals.  The organization's own lawyers warned its leaders that

'Any decision maker must be a US citizen or green card holder,' the memo, seen by the Observer, warned. It also provided a brief legal history of cases involving foreign involvement in election campaigns, drawn up by a lawyer at the firm founded by former New York mayor Rudy Giuliani.

So,

It was clear that as a company largely run and staffed by Britons and Canadians, apart from Bannon and Mercer at the top, Cambridge Analytica – which was to go on to work on Donald’s Trump presidential election campaign – had a looming problem.

The management's response appeared to be subterfuge.

Two employees confirmed that they were still answering ultimately to Nix throughout the mid-term election campaigns that ended in November 2014. In total, more than a dozen foreigners, including Britons and Canadians, filled strategic roles in campaigns across the US.

'We were really speaking directly to the voters in a number of states,' said one former employee, who served on a team with several people who were not US citizens or green card holders.

It is understood that some were working on tourist visas. Another ex-employee claimed that they had been provided with letters to give to US border control officials where needed, stating that they would not be working there.

It seems likely that the Cambridge Analytica/ SCL work for the Trump campaign was mainly accomplished by citizens of countries other than the US.

Coordination with PACs

 Great Britain's Channel 4 interviewed Mr Nix, the CEO of Cambridge Analytica, posing as potential clients. As reported by the Guardian, not only did he boast of his influence in the Trump campaign,

Senior managers then appeared to suggest that in their work for US clients, there was planned division of work between official campaigns and unaffiliated 'political action groups'.

That could be considered coordination – which is not allowed under US election law. The firm has denied any wrongdoing. Also,

In another exchange, Tayler describes an apparently planned division of spending on the campaign trail, with the candidate organising positive' messages, with negative attack ads left to the super Pacs, which may engage in unlimited political spending independently of the campaigns.

'As part of it, sometimes you have to separate it from the political campaign itself ... campaigns are normally subject to limits about how much money they can raise. Whereas outside groups can raise an unlimited amount.'

'So the campaign will use their finite resources for things like persuasion and mobilisation and then they leave the ‘air war’ they call it, like the negative attack ads to other affiliated groups.'

Note that,

The Campaign Legal Center has accused Cambridge Analytica over allegations of illegal coordination of this nature.

It has filed evidence with the FEC alleging that the super Pac Make America Number 1 made illegal contributions to Trump’s campaign, 'engaging in unlawful coordinated spending by using the common vendor Cambridge Analytica'.

Boasts of Greater Nefariousness

Great Britain's Channel 4 interviewed Mr Nix, the CEO of Cambridge Analytica, posing as potential clients.  As reported by the NY Times, he boasted that the organization had capabilities more nefarious than those above:

We can set up fake IDs and websites, we can be students doing research projects attached to a university, we can be tourists. There’s so many options we can look at.

He also mentioned apparent extortion:

But you know equally effective can be just to go and speak to the incumbents and to offer them a deal that’s too good to be true, and make sure that that’s video-recorded, you know. These sorts of tactics are very effective, instantly having video evidence of corruption, putting it on the internet, these sorts of things.

Finally, he discussed apparent extortion in the form of classic KGB style honey-traps.

Or, Mr. Nix said, they could 'send some girls around to the candidate’s house — we have lots of history of things'

The reporter asked what kind of girls, and Mr. Nix said they could find some Ukrainian women. 'I’m just saying, we could bring some Ukrainians in on holiday with us you know,” Mr. Nix replied. “You know what I’m saying.'

'They are very beautiful,' he said. 'I find that works very well.'

Whether Cambridge Analytica/ SCL actually undertook such activities, particularly on behalf of the Trump campaign, is unknown.  However, their leadership clearly had no qualms about considering them to be options.


Discussion

An international organization, Cambridge Analytica/ SCL based in the UK, led by Trump confidantes including his last campaign leader and former White House strategic adviser Steve Bannon, and major Republican donors and hedge fund magnates Robert and Rebekah Mercer, worked with the Trump 2016 campaign, particularly coordinating with digital coordinator Brad Parscale.  Cambridge Analytica/ SCL leveraged Facebook private data on millions of people, obtained from most without their specific permission, to create a "psyops" political disinformation campaign featuring emotional appeals to voters' internal psychology, coupled with a variety of other tactics.  The campaign used foreign workers within the US, and apparently coordinated with political action committees, possibly violating US law.  The appropriation of private Facebook data possibly violated UK law.  The Cambridge Analytica/ SCL CEO also boasted that the organization was capable of various dirty tricks, including several species of extortion.

It is unclear to what extent, if any, this disinformation campaign helped Mr Trump to win the presidency.  But clearly we now have a president whose campaign was apparently happy to employ disinformation on a grand scale, likely violating US and UK laws in the process, to win election.

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.

A Stealth Marketer Goes Through the Revolving Door to ... the President's Council of Economic Advisors?!

Stealthy, deceptive systematic marketing, lobbying, and policy advocacy campaigns on behalf of big health care organizations, often pharmaceutical, biotechnology and medical device companies, have long been a subject of Health Care Renewal.  A relatively recently revealed example was the stealth marketing campaign used by GlaxoSmithKline to sell its antidepressant Paxil.  This campaign 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 Respirdal (look here),  and the infamous Pfizer campaign to sell Neurontin (look here and here).   Notably, stealth marketing seemed to be one reason for the growing popularity of narcotics (opioids) starting in the 1990s (look here). 

Such campaigns have gotten more exposure in the media and the scholarly literature, so we have not written as much about them in the last few years as previously.  So I confess we did not directly discuss a February, 2017,  investigative report by ProPublica about Precision Health Economics, a company that has orchestrated several such campaigns (although we did allude to it here).

Prof Tomas Philipson Named to President's Council of Economic Advisors

This week this report suddnely appears very salient, since Yahoo News just revealed that a top leader of Precision Health Economics, Prof Tomas Philipson, has been nominated to the President's Council of Economic Advisors by Donald Trump.

Donald Trump’s new senior economic adviser has helped pharmaceutical companies lobby to charge astronomical prices for crucial drugs.

Last Monday, the White House confirmed that Tomas J. Philipson, a health care economist, was joining the President’s Council of Economic Advisors.

That announcement was made just hours after Trump publicly accused Merck CEO Kenneth Frazier of charging patients 'ripoff prices' for drugs after he resigned from the President’s Manufacturing Council in protest at the president’s response to the violence at a white nationalist rally in Charlottesville, Virginia last weekend.

Now that Ken Frazier of Merck Pharma has resigned from President's Manufacturing Council,he will have more time to LOWER RIPOFF DRUG PRICES!

— Donald J. Trump (@realDonaldTrump) August 14, 2017


.@Merck Pharma is a leader in higher & higher drug prices while at the same time taking jobs out of the U.S. Bring jobs back & LOWER PRICES!

— Donald J. Trump (@realDonaldTrump) August 14, 2017

Precision Health Economics

Given the potential influence of Prof Philipson on the Council of Economic Advisors, it is worth summarizing what ProPublic said about his career at Precision Health Economics.

PHE as Orchestrator of Stealth Marketing and Policy Advocacy

First, the business of PHE is to help pharmaceutical and biotechnology companies market their products and influence public policy in their favor.

While collaboration between higher education and industry is hardly unusual, the professors at Precision Health Economics have taken it to the next level, sharpening the conflicts between their scholarly and commercial roles, which they don’t always disclose. Their activities illustrate the growing influence of academics-for-hire in shaping the national debate on issues from climate change to antitrust policy, which ultimately affect the quality of life and the household budgets of ordinary Americans — including what they pay for critical medications.

Furthermore,

'This is just an extension of the way that the drug industry has been involved in every phase of medical education and medical research,' said Harvard Medical School professor Eric G. Campbell, who studies medical conflicts of interest. 'They are using this group of economists it appears to provide data in high-profile journals to have a positive impact on policy.'

The firm participates in many aspects of a drug’s launch, both advising on 'pricing strategies' and then demonstrating the value of a drug once it comes on the market, according to its brochure. 'Led by professors at elite research universities,' the group boasts of a range of valuable services it has delivered to clients, including generating 'academic publications in the world’s leading research journals' and helping to lead 'formal public debates in prestigious, closely watched forums.'

Again, some people may naively imagine that academic publications are written by unbiased academics, not hired guns for industry, and that formal debates on major issues ought to again by led by people who are disintered and authoritative, not hired guns.  That would be very naive.

So PHE has set itself up as a vehicle to market and advocate on behalf of big corporations while making that work appear to be unbaised academic discourse.  In particular,

Precision Health Economics has counted at least 25 pharmaceutical and biotech companies and trade groups as clients. The roster includes Abbott Nutrition, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Gilead, Intuitive Surgical, Janssen [a subsidiary of Johnson and Johnson], Merck, the National Pharmaceutical Council, Novartis, Otsuka, Pfizer, PhRMA, rEVO Biologics, Shire and Takeda.

Note that many of these companies are known for perpetrating the kinds of marketing shenanigans that we discuss on this blog.  See the links above.

 PHE Has Been Accused of Biased Work for Pharma Prettied by Its Principals' Academic Credentials

To justify the value of expensive drugs, the professors affiliated with Precision Health Economics rely on complicated economic models that purport to quantify the net social benefits that the drugs will create.

However,

Critics have at times questioned the assumptions underlying the consultants’ economic models, such as the choice of patient populations, and suggested that some of their findings tilt toward their industry clients. For example, some have tried and failed to reproduce their results justifying the value of cancer treatments.

Precision Health Economics allows drugmakers to review articles by its academics prior to publication in academic journals, said a former business development manager of the consulting group. Such prior review is controversial in higher education because it can be seen as impinging on academic freedom.

In addition,

About 75 percent of publications by the firm’s employees in the past three years have either been funded by the pharmaceutical industry or have been done in collaboration with drug companies, a ProPublica review found.

Some academics worry that a tight relationship with industry might suggest bias. 'I personally find, when your enterprise relies so substantially on a particular source of funds, you will tend to favor that source,' said Princeton economist Uwe Reinhardt.

Thus several of the firm's campaigns have produced considerable controversy.  For example,

Advocating Increased Pricing for Oncology Drugs

Precision Health Economics raised its profile in 2013 when the president’s annual economic report cited a cancer study by several of the firm’s principals and consultants. To some critics, though, the study showed how industry funding can taint academic research.

Originally published in Health Affairs, where [PHE founder Dana] Goldman also serves on the editorial board, the study found that Americans paid more for cancer care than Europeans but had better survival gains.

As the study acknowledged, it was funded by Bristol-Myers Squibb, a company that at the time was developing a much-anticipated cancer treatment. It was priced at more than $150,000 per year when it eventually came on the market. All three founders of Precision Health Economics were listed as authors of the Health Affairs article, alongside one of their employees, yet none of the founders disclosed their ties to their consulting firm in the published study. In an interview, Goldman said this might have been an 'oversight.'

In addition,

As the cancer study gained national recognition, its methodology and findings came under fire. Researchers from Dartmouth College tried and failed to reproduce the results. Cancer care in the U.S., their research found, may actually provide less value than cancer care in Europe, considering cost.

'We know that [the U.S. health care system] is more disorganized and disorganization is more expensive, so it’s surprising to believe that the U.S. would perform better in a cost-effectiveness sense,' said Samir Soneji, one of the authors of the counter-study and an assistant professor of health policy at Dartmouth. The science in the original study, Soneji says, was 'questionable.'

Soneji was not alone in his criticism. Aaron Carroll, a pediatrics professor at the Indiana University School of Medicine, reviewed the methodology and concluded that the Precision Health Economics researchers had used a measure that can frequently be misinterpreted. Instead of relying on mortality rates, which factor in a patient’s age of death, the study employed survival rates, looking at how long people live after diagnosis. Cancer screening, which can increase survival rates, is more frequent for some cancers in the U.S. than in other countries, Carroll says.

'When they wrote that paper using survival rates, they were clearly cherry picking,' Carroll told ProPublica. 'If the arguments are flawed and people keep using them, I would be concerned that they have some other motive.'

PHE Work on Behalf of PCSK9 Inhibitors

Not long after the controversy over its cancer research, Precision Health Economics became embroiled in another academic spat related to a client’s product. This time, it was over a breakthrough treatment that, injected one to two times per month, could help millions of Americans with high cholesterol. At the $14,000-per-year price set by one of its makers, Amgen, the PCSK9 inhibitor could also hike the nation’s annual prescription drug costs by an unprecedented $125 billion, or 38 percent. Its price in the U.S. is twice as much as in the U.K.

The U.S. price of the drug has come under vigorous attack from the nonprofit Institute for Clinical and Economic Review. ICER, which began as a small research project at Harvard Medical School, studies the cost-effectiveness of drugs, balancing their value to patients against the impact of their cost on society. The Centers for Medicare and Medicaid Services proposed a new rule in March 2016 that includes the use of value-based pricing studies, specifically citing the work of ICER.

The industry has attacked many of the institute’s studies, particularly those that find a treatment is overpriced. 

PHE orchesterated an attack on the ICER conclusions.

ICER concluded in 2015 that the new cholesterol treatment, the PCSK9 inhibitor, should cost about one-fifth what Amgen is charging. A few months later, Philipson, the Precision Health Economics co-founder, and Jena wrote an op-ed in Forbes, citing the institute’s research and deriding its approach to value pricing as 'pseudo-science and voodoo economics.' Only Philipson disclosed his ties to Precision Health Economics, and neither academic disclosed that Amgen was a client of the firm.

PHE Principals Have Failed to Disclose Their Conflicts of Interest

The professors’ disclosure of their ties to the firm and to the pharmaceutical industry in scholarly articles is inconsistent: sometimes extensive, sometimes scanty. Members of Precision Health tend to reveal less about their paid work in blogs, public forums like conferences, and legislative testimony. At the Capitol Hill briefing last May on hepatitis C drugs, Lakdawalla didn’t mention his affiliation with Precision Health Economics, though it was listed in the journal issue, which was provided to attendees.

One can argue that failing to disclose relevant conflicts of interest is deceptive.

Prof Philipson's Role in PHE has Increased in Scope

PHE was sold in 2015 to a "privately held biotech company, Precision for Value."  Since the sale, "Philipson is listed as chief economist and the chair of the strategy and innovation board."

A Problem Beyond the Revolving Door

We have frequently railed about the revolving door affecting health care.  Prof Philipson clearly will be transiting the revolving door, in that he will be going directly from a responsible corporate position into a government role in which we will be able to influence policy that affects the corporation in question (as well as other corporate interests, of course).  Nowadays, people frequently transit the revolving door from or to US government positions.  We most recently posted about the revolving door affecting health care in the current US administration here.

We previously opined about the revolving door....

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 ongoing parade of people transiting the revolving door from industry to the Trump administration 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. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

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.

However, the case of Prof Philipson raises issues beyond the revolving door.  Prof Philipson is not a mere corporate executive.  He is a master of stealth marketing/ lobbying advocacy.  Stealth marketing, in particular, has been one of the scourges of US health care.

Back in a 2006 blog post about the stealth marketing of Neurontin, I wrote:

Physicians must be increasingly skeptical about educational and scholarly activities that may be disguised efforts at drug marketing.

Shame on the companies that have implemented such stealth marketing programs. Shame on the academic physicians who have taken money to help them out without revealing their financial interests to their physicians colleagues.

In a 2008 blog post about the same case, I wrote:

 This unfortunately is another blow to the current paradigm of evidence-based medicine. The EBM paradigm calls for physicians to make optimal decisions for individual patients based on their knowledge of the clinical context, the patients' values and wishes, and a critical review of the best relevant evidence from clinical research. For the paradigm to work, the assumptions are that all relevant research can be found, and that the research studies, while imperfect, were not intentionally designed or reported to deceive the reader. Yet the case of gabapentin adds to fears that relevant evidence that is unfavorable to the interests of the drug, device, or biotechnology company which sponsored the work is likely to be suppressed by that sponsor, and that commercially sponsored research is often deliberately manipulated to make its results appear more favorable.

Also, as Professor Dickersin noted (reported by the WSJ), "in exchange for being experimented upon in trials, patients are told they are contributing to human knowledge. To withhold negative results from the public breaks that ethical obligation to such patients...."

I began to think in the years after 2008 that the increasing exposure of stealth marketing (and related stealth lobbying and policy advocacy) campaigns would lead to their eventual decrease.  Never in my wildest dreams in 2008 did I foresee a stealth marketing master transiting the revolving door to be appointed to the President's Council of Economic Advisors.  (But then again, back then I would have laughed out loud at the notion of Donald Trump as President).  I seem to be really bad at prophecy.

We are slipping farther and farther from my ideal of true health care reform.  

Promoting Amphetamines for Over-Eating - What Could Possibly Go Wrong?

Every day seems to bring the latest breathlessly touted innovation in modern health care.  The endless hawking of new health care wonders is beginning to inspire some skepticism, but maybe not enough.

The Promotion of Vyvanse for Binge Eating Disorder


For example, at the end of January, 2015, reports of the first ever drug therapy for binge eating disorder appeared.  For example, see Jonathan Rockoff writing in the Wall Street Journal

Shire PLC’s drug Vyvanse became the first drug approved for sale in the U.S. to treat some of the estimated 2.8 million adults who have a binge-eating disorder.

Rather ominously, the article described this disorder thus,

Patients regularly eat more food than they need, often when they aren’t hungry and until they feel uncomfortably full, the FDA said. The condition can lead to weight gain, obesity and related health problems.

Furthermore, it appears to be common,

An estimated 2.8 million adults in the U.S. are binge eaters, two times more than those who have the eating disorders anorexia and bulimia combined, according to Shire.

However, now there is a pharmaceutical solution!

In two pivotal studies, binge eating episodes declined to an average of one day a week among patients taking Vyvanse capsules for 12 weeks, down from an average of five days a week, Phil Vickers, Shire’s head of research and development, said in an interview.

'The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating,' Mitchell Mathis, director of the FDA’s division of psychiatry drug products, said in a statement.

Because the disease is common, that may mean a lot of money for Shire

For Shire, the approval could eventually add 'several hundred million' dollars in sales, and help the company reach its goal of $10 billion in yearly sales by 2020, said Flemming Ornskov, the company’s chief executive. Vyvanse is the company’s top-selling drug, notching $1.1 billion of the company’s $4.3 billion in total sales during the first nine months of last year.

The only hitch is that all those long suffering victims of binge eating disorder have to be found, and presented with this wonderful new alternative:

One challenge: increasing the numbers of patients diagnosed as binge eaters. Shire estimates that just 3% of Americans with the disease have been diagnosed under the mental-disorder criteria, Dr. Ornskov said.

Brief coverage of the initial approval of Vyvanse appeared in the NY Times. Bloomberg also weighed in, adding to the urgency by underlining how seriously the FDA had handled this:

'Binge eating can cause serious health problems and difficulties with work, home and social life,' Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA gave Vyvanse priority review, a designation for drugs with promise to 'provide a significant improvement over available therapies,' the agency said.

Among the major media covering the rollout, only Reuters noted a potential fly in the ointment in this  article,

Vyvanse is an amphetamine which, like other amphetamines, carries the potential for abuse and addiction. They also have been associated with increase blood press sure and heart rate, sudden death, stroke, heart attack, insomnia and psychiatric side effects such as hallucinations and mania.

What Really is the Clinical Evidence Supporting Vyvanse for Binge Eating Disorder?


So Vyvanse is actually lisdexamfetamine, and having been a child when the slogan "speed kills" referred to methamphetamine, not driving automobiles fast,  I thought it might be worth looking into the evidence that this somewhat new amphetamine, a relative of that infamous "speed," was now deemed a wondrous treatment for eating too much.

In particular, a recent article in JAMA Psychiatry reported results of one of the two trials Shire did of Vyvanse for binge eating disorder.(1)  The study by McElroy et al randomized patients with binge eating disorder to one of four groups, to receive the drug at dosages of 30, 50, or 70 mg/ day or placebo.  The investigators followed patients for 11 weeks.  The main outcome variable was the number of binge eating days per week reported by the patients.

Patients in all groups were binge eating during approximately 4.5 days/ week at the beginning of the study.  At 11 weeks, the average number of binge eating days/ week declined in all groups, dropping 3.3 days/ week for the placebo group, 3.5 for the 30 mg group, 4.1 for the 50 mg group, and 4.1 for the 70 mg group.  Thus, by this measure, the difference between patients given placebo versus patients given maximum dosage of the drug was an average decrease of 0.8 binge eating days a week.  That does not seem like a very big effect size, or in other words, it seems that the drug had only a small effect on binge eating compared to placebo.

That impression was reinforced by looking at some other study outcomes.  The average numbers of binge eating episodes per week at 11 weeks were 1.1 for placebo, 1.2 for the 30 mg group, 0.5 for the 50 mg group, and 0.5 for the 70 mg group.  Again, patients given the maximum dose of the drug had only a slightly smaller number of binge eating episodes than those given placebo, reinforcing the impression that the drug is not very effective.

A graph of binge eating days/ week measured over time makes things clearer.  It showed that all groups, including patients given placebo, markedly reduced their reported binge eating over the 11 week period.  Since the study did not allow any patients to get any other treatment for binge eating other than placebo or the study drug, this again suggests that the drug was not much better than placebo.  Further, the apparent reduction in binge eating by patients given placebo suggests a number of possibilities:
-  Just paying more attention to patients by putting them in a trial could lead to marked decreases in binge eating, or
-  People in binge eating trials could tend to report they are improving, whatever treatment they get, or
-  Binge eating may not be a stable phenomenon, and its intensity could vary over time, or
-  It may be difficult to make a reliable diagnosis of binge eating disorder.

In summary, at best, the trial showed that Vyvanse only caused small reductions in binge eating, and that binge eating may decrease spontaneously, or at least when patients are given more attention or scrutiny.  Thus, even putting the best face on the evidence from a trial done by the maker of Vyvanse does not greatly support the benefits of this drug.

In addition, according to evidence-based medicine advocates, the benefits of a treatment must be balanced with its potential harms.  In this study, about 5% of patients given any dosage of Vyvanse had to discontinue its use because of adverse effects.  3/196 patients initially randomized to Vyvanse had serious adverse effects, and one patient died, apparently of an amphetamine overdose.  Oddly, the article declared that the one death, due to methamphetamine overdose, was thought by a study investigator not to be related to treatment with another amphetamine, lisdexamfetamine.  That makes little sense, given that in a randomized controlled trial, the presumption is that differences in groups given different treatments were caused by these treatments.

In addition, patients given Vyvanse (lisdexamfetamine) had higher rates of various symptoms that are commonly associated with amphetamines, including insomnia, nausea, constipation or diarrhea, anxiety, feeling jittery, palpitations, and sleep disorder.

This suggests that the relatively small apparent benefits of the drug must be weighed against rates of adverse events that are not negligible, especially given the short amounts of time patients were followed. So this study did not show that the benefits of Vyvanse clearly outweigh its harms.

Finally, there were many problems with this trial that further cloud its validity, or applicability to patients (generalizability):
-  Patients were diagnosed using DSM-4 criteria, rather than the new DSM-5 criteria
-  Patients with any other psychiatric illness were excluded, limiting the applicability of its results.
-  Patients with an ostensibly chronic disease were only followed for 11 weeks, so the effects of this drug given for the treatment duration that might be needed to treat a chronic problem are unknown
-  The loss to follow-up rate, about 5% for treated patients decreases precision of the results given the relatively small effect size
-  The study was done at a large number of sites, initially 32, given the size of the patient population (starting at 260), and one site was dropped because of an "investigation," raising questions about the quality of the study implementation and data collection

So, in my humble opinion, even this Shire sponsored study, which was responsible for half the evidence used to support the approval of Vyvanse for binge eating disorder, provided only weak and questionable evidence that the benefits of the drug outweigh its harms in the short term, and no evidence about long-term use of the drug.  

However, no media coverage so far has addressed the weakness of the clinical evidence supporting the use of Vyvanse.  I have yet to see any other attempts at a rigorous, skeptical review of the clinical trial evidence supporting Vyvanse in this application.  Instead, the media reporting so far seems to have accepted the word of the manufacturer's executives, who obviously have an interest in promoting the drug.  (See the WSJ article above which just repeats assertions by a Shire executive.

Why So Much Enthusiasm about a Type of Drug with Such a Bleak Past?

This lack of skepticism was particularly baffling given the nature of the drug that was being promoted, and its long and unfortunate history.  As I noted, the amphetamines have proved to be dangerous drugs when abused, and they are abused frequently.

The beginnings of widespread amphetamine abuse grew out of previous efforts to promote these drugs for obesity (which can be, of course, a consequence of eating too much).  As documented by Cohen and colleagues(2),

The discovery of amphetamine energized the weight loss industry. Introduced as the Benzedrine inhaler in 1932 by venerable Philadelphia firm Smith, Kline, and French, the American Medical Association (AMA) soon recognized Benzedrine as a  treatment of narcolepsy, postencephaletic Parkinsonism, and certain depressive psychopathic conditions. Several clinical studies first published in the late 1930s demonstrated amphetamine’s anorectic effect. The Clark & Clark Company of Camden, NJ, established in 1941, was one of the earliest manufacturers of diet pills combining amphetamine sulfate and thyroid along with phenobarbital, aloin, and atropine sulfate to counteract untoward effects.

These rainbow pills were used with great enthusiasm, however,

adverse events, including deaths, began to be reported to the FDA as early as the 1940s. In the early 1950s, additional adverse reactions including deaths prompted a detailed investigation by the agency.

By the 1960s, the problem was acute,

Efforts had been in place at least since the 1965 Drug Abuse Control Amendments to increase accountability of the use of amphetamine in medical practice. Diversion of the drug for recreational use and the concomitant public health concerns had been recognized as a serious problem by the 1950s, but prescribing amphetamine— whether alone, as part of the rainbow regime, or for indications other than weight loss—continued to rise in the 1960s.  Under the Comprehensive Drug Abuse Prevention and Control Act of 1970, which established different schedules for certain drugs based on their medical value vis-á-vis their abuse potential, amphetamine was relegated to Schedule II. This status mandated even greater hurdles for the prescribing and dispensing of the drug as well as production ceilings. In the 1970s, FDA also reconsidered obesity as a safe and effective use of amphetamine and its congeners, ruling that amphetamines were effective but only safe for short-term use, which essentially 'marginalized the anorectics and contributed to the eventual decline in their use.'

That is, until they were resurrected as a treatment for attention deficit disorder in children, and then their use was extended to adult patients with so-called adult ADHD, and now to patients with binge eating disorder.


Given this history, the rapid approval of Vyvanse by the FDA, without the benefit of an expert panel, especially given that it was for a supposedly common disorder of adults, is very curious, and worrisome.  As Dr Daniel Carlat said (quoted on the WBUR CommonHealth blog),

 

'I’m concerned that the FDA’s approval of Vyvanse for binge eating disorder is going to worsen our problems with stimulant abuse,' Carlat says.

'Vyvanse is a derivative of Dexedrine. We’ve seen epidemics of Dexedrine abuse in the past when it was used to help people diet. I predict that the FDA has just opened the gates to another similar epidemic – after all, binge eating disorder is a subjective diagnosis that could be potentially expanded to cover many millions of people.'

Why So Much Enthusiasm about Treating Such a Doubtful Diagnosis?

As Dr Carlat noted above, it is not so obvious that binge eating disorder should be considered to be a disease.  Starting with first principles, its definition is very vague and subjective.  According to the Alliance for Eating Disorders, the DSM-5 criteria for it are:

• Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
  • eating, in a discrete period of time (for example, within any 2-hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances
  • a sense of lack of control over eating during the episode (for example, a feeling that one cannot stop eating or control what or how much one is eating)
• The binge-eating episodes are associated with three (or more) of the following:
  • eating much more rapidly than normal
  • eating until feeling uncomfortably full 
  • eating large amounts of food when not feeling physically hungry 
  • eating alone because of feeling embarrassed by how much one is eating
  • feeling disgusted with oneself, depressed, or very guilty afterwards
• Marked distress regarding binge eating is present.
• The binge eating occurs, on average, at least once a week for three months.
• The binge eating is not associated with the recurrent use of inappropriate compensatory behavior (for example, purging) and does not occur exclusively during the course Anorexia Nervosa, Bulimia Nervosa, or Avoidant/Restrictive Food Intake Disorder.

"An amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances?"  In this case, how are "larger," "most people," and "similar circumstances" defined, and by whom?  If I go out to eat with friends, and am the only one who has desert, or soup, for that matter, does that qualify?  Similarly subjective are "a sense of lack of control," and "eating more rapidly than normal."

In fact, the DSM-5 which ordained the new binge eating disorder diagnosis has been roundly criticized for embodying "diagnostic hyperinflation," turning aspects of the human condition, symptoms, and behavioral variants into disease.  Dr Allen Frances, who has been one of its prime critics, described "binge eating disorder" thus,

 Excessive eating 12 times in 3 months is no longer just a manifestation of gluttony and the easy availability of really great tasting food. DSM-5 has instead turned it into a psychiatric illness called Binge Eating Disorder.

Perhaps the enthusiasm to make binge eating disorder a disease had to do more with the financial relationships among the authors of DSM-5 and pharmaceutical companies that wanted to market drugs for the problem.  An article by Cosgrove and colleagues(3) noted that members of the DSM-5 work group that approved binge eating disorder as a disease included three people with financial relationships with Eli Lilly, maker of Cymbalta, three people with relationships with GlaxoSmithKline, maker of Lamictal, and one person with a relationship to Shire, maker of Vyvanse.  

Yet the discussion of Vyvanse in the big media outlets did not address these past questions about the validity of the binge eating diagnosis for which it is now being promoted. 

The Over-Marketing of Binge Eating Disorder to Promote Vyvanse

This week, however, at least some skepticism about other aspects of Vyvanse's promotion appeared in a major media outlet.  Just a few weeks after that initial coverage, the NY Times published a somewhat more skeptical take on the promotion of Vyvanse.  It noted that Shire was underwriting celebrity endorsements without disclosing its financial backing of them,

The retired tennis player Monica Seles spent this month making the rounds of television talk shows, appearing on everything from 'Good Morning America' to 'The Dr. Oz Show' to share her personal struggle with binge eating.

'It took a while until I felt comfortable talking about it,' she said in a People magazine interview, explaining that she secretly devoured food for years while she was a professional athlete. 'That’s one of the reasons I decided to do this campaign: to raise awareness that binge eating is a real medical condition.'

But that is not the only reason. Ms. Seles is a paid spokeswoman for Shire, which late last month won approval to market its top-selling drug, Vyvanse, to treat binge-eating disorder,...

Shire also was funding patient groups as part of its promotional efforts,

And patient advocacy groups — freshly infused with donations from Shire — began driving social media traffic to a company website that provides advice on how to raise the issue of binge eating with a doctor.

Furthermore, Shire has been trying to raise awareness of the new binge eating disorder diagnosis in ways that obfuscate its promotional interests,

Shire appeared to be following a familiar drug industry playbook by promoting awareness of a disorder, in this case binge eating, before more directly marketing its treatment. A company website, BingeEatingDisorder.com, makes no mention of Vyvanse but provides detailed information about how to talk about the disorder with a doctor, including a printable symptom checklist and sample opening lines to start the conversation. The site also tells patients 'don’t give up' if a doctor initially resists.

Some experts in prescription-drug abuse said the content was troubling because it appeared to coach patients about how to receive a diagnosis for a relatively uncommon condition, or shop for a new doctor if they were not successful.

Note Shire's use of undisclosed payments to celebrity spokespeople and patient advocacy groups and a disease awareness website whose connection to the company's drug was obscured suggests the operation of a stealth marketing campaign.  Furthermore, the article noted that Shire has been accused of deceptive marketing in the past, and specifically for its marketing of Vyvanse and another stimulant.

In 2011, the F.D.A. cited Shire, which is based in Dublin, for misleading advertising, and last fall the company paid $56.5 million to settle federal charges that it improperly promoted Vyvanse, Adderall and other drugs. Among the allegations, which Shire denied, was that the company played down Vyvanse’s addiction potential and said it would prevent car accidents, divorce, arrests and unemployment.

 We posted about that settlement here. 

The article also emphasized concerns about this new pushing of amphetamines,

 With the approval of Vyvanse for binge eating, 'now we have another reason for the public to learn about the glories of amphetamine — it’s very worrisome,' said Dr. Lawrence H. Diller, a behavioral pediatrician in Walnut Creek, Calif., who has written about A.D.H.D. drugs. 'My hat’s off to Shire. They’ve done it again.'

Also,

Several drug safety and addiction experts said the approval was of particular concern because of amphetamines’ troubled history as a treatment for weight loss. Vyvanse is converted by the body into an amphetamine when it is swallowed. 

From the 1940s through the 1970s, the drugs were commonly prescribed to overweight people who then became addicted. After public outcry and tighter government controls, companies stopped selling amphetamines as obesity treatments and their use is now tightly restricted. In 2012, the F.D.A. approved Qsymia, a drug combination that treats obesity and contains the amphetamine phentermine, although unlike Vyvanse, it is classified by the federal government as having a low potential for abuse.

The F.D.A. expressly forbade Shire from promoting Vyvanse as an obesity drug, but some drug safety experts said they worried its weight-loss attributes could be attractive to people who habitually overeat. The company says about 80 percent of people with the disorder are overweight or obese. Weight loss and appetite suppression are a common side effect of amphetamines.

'There’s so many reasons to be concerned about this,' said Dr. Andrew Kolodny, the chief medical officer of Phoenix House, a drug treatment organization.

He questioned why the F.D.A. approved the new use of Vyvanse so swiftly and said that given amphetamines’ troubled past, more caution was necessary.  'We had a horrible experience with amphetamines in this country, so the fact that this would just get rushed through without even bringing it before an advisory committee is especially concerning,'  he said.

However, the NY Times article still did not address the lack of good evidence that the drug provided a substantial benefit even in terms of just reducing binge eating, and questions raised whether binge eating disorder is a valid diagnosis. 

Summary

Once again we see the overenthusiastic promotion of the latest wonder drug, starting with uncritical media reports that parroted drug company executives.  At least this time some skepticism appeared about how an apparent stealth marketing campaign was organized, and about how the drug's riskiness was soft-pedaled. 

However, so far there has been little skepticism about the efficacy of the drug.  In fact, close reading of the report of one major trial showed that at best it has minimal efficacy, and even the evidence for that is weak and sketchy.  Furthermore, major news media have been hesitant to cite the real questions that have been raised about the nature of the disease for which the drug was advocated.

Most concerning is that this promotion was of an amphetamine, a type of drug with a very dark past, a type of "hard drug" responsible for major abuse problems, and known to cause particularly bad side effects, a type of drug whose illicit use has been previously sparked by over-enthusiastic marketing for dubious indications.

So once again I get to say that physicians need to be much more skeptical about the new "innovations," often promoted as miracle cures, that seem to appear weekly.  Attempts to educate physicians about clinical epidemiology, the principles of evidence based medicine, and just simply how to read a clinical research article with an appropriately skeptical and critical eye seem to have fallen by the wayside.  Furthermore, the diminishing number of health care journalists with diminishing resources may not be able to sufficiently skeptical of the marketing and public relations hype surrounding new drugs and devices.  Physicians and journalists need to have the courage to be more skeptical, and the public, who may trust journalists and physicians to cut through the bloviation, need to advocate for better training of physicians and journalists.

Finally, health care professionals and the public at large have been told to trust government regulators to only approve medicines that are safe and effective.  Yet the US Food and Drug Administration increasingly seems too cowed to challenge the pharmaceutical industry, and did not seem to exert much critical thinking before approving an amphetamine for over-eating.  The public and health care professionals ought to be advocating intensely for regulators that are less captured by the industry they are supposed to oversee.

As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.

For our closing musical inspiration, or warning, note the chorus in "Amphetamine Annie" by Canned Heat...




"Speed Kills"

References

1.  McElroy SL, Hudson JI, Mitchell JE et al.  Efficacy and safety of lisdesamfetamine for treatment of adults with moderate to severe binge eating disoder: a randomized clinical trial.  JAMA Psychiatry 2015;   Link here.
2.  Cohen PA, Goday A, Swann JP. The return of rainbow diet pills.  Am J Pub Health 2012; 102: 1676-1686. Link here.

3.  Cosgrove L, Krimsky S, Wheeler EE et al.  Tripartite conflicts of interest and high stakes patent extensions in the DSM-5.  Psychother Psychosom 2014; 83: 106-113.   Link here.