Aducanumab Approval, Part 2

So how did a drug with such dubious benefit get approved? At best, another clinical trial might be warranted, but certainly not approval. It's a result

1. of a huge campaign by a company (Biogen) that would not accept the failure of its drug
and
2. of pressure from patient organizations like the Alzheimer's Association (which receives major money from pharma, including Biogen and its Japanese partner, Eisai).

The company campaign began in spring 2019, after its Phase 3 trials were stopped for futility after an interim review. A long, detailed, and excellent STATnews article published this week, drawing on insider sources, tells a fascinating but troubling story. The last-ditch effort to get approval was originally called "Operation Phoenix," but was re-titled "Operation Onyx." Biogen managed to get Billy Dunn, Director of the Office of Neuroscience at the FDA, on their side, to the point that he worked closely with them to provide a roadmap for approval, very inappropriately.

After the groundwork was laid for an approval of aducanumab despite the negative advisory committee recommendation, and prior to the announcing of a final decision, the patient organization campaign was carefully timed. In early May, the Alzheimer's Association launched a big campaign seeking to build grassroots support for drug approval. The "More TIme" campaign worked to pull at heartstrings with celebrity endorsements and poignant personal stories. Full-page ads were taken out in the Wall Street Journal and USA Today, and focused on what "more time" would mean to Alzheimer's patients and their families. There were google search ads, Facebook and Twitter and Instagram and LinkedIn posts. The campaign succeeded in getting over a million people to express support in petitions.

After the approval, the Alzheimer's Association spoke of victory:

As the first FDA-approved drug that delays decline due to Alzheimer’s disease, the approval of aducanumab (Aduhelm™) is a victory for people living with Alzheimer’s and their families.

Comments on articles including this one give the flavor of the passion with which some people want to try this unproven therapy.

Denying a medicine which might work is far more worse than approving one that might not work! Do you agree in the case of Alzheimer’s?

The negativity of these old fashion mentality is what has driven new discoveries to a halt. I don’t suffer from Alzheimer’s nor know anyone close to have been dx w it but we need to start somewhere. Prescribing the pharma will only help w research. Get in line MD.

Alzheimer’s is a horrible disease. If the medicine has a chance of success then prescribe it.

And public officials seem to be buffaloed. A Politico article said that not only are public officials mute about the approval, they are hesitant even about making a fuss about the pricing (about which more in another post):

[Politicians are] worried they’ll be seen as dashing desperate patients’ hope for an Alzheimer’s treatment — even one that may provide little or no benefit. The FDA’s controversial approval of Biogen’s drug, known as aducanumab or Aduhelm, has caught both political parties flat-footed ...Everyone is a bit terrified by Alzheimer’s, so the average person hears about the FDA approval of a treatment, and they don’t know about the controversy over whether it works or not,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management who lambasted FDA’s Aduhelm approval. “They hear there’s a new treatment and, that’s great, it’s a sign of hope. Do you want to be the politician who says, ‘I want to take that away from you?’”

Evidently, the public opinion campaign with its drumming up of support for this bogus drug has had its desired effect, creating cowardice to speak about the realities. Subsequent to the publication of the Politico article, two senators did speak out about pricing, but were careful to praise the drug:

Even as they criticize the price, however, Cassidy and Warren still stopped short of directly criticizing Biogen. They offered praise for the drug’s approval, too, calling it a “historic, watershed moment” in the history of the disease.

Public Citizen - who does not have to get elected - did not share this hesitancy. Their long public letter to HHS Secretary Xavier Becerra - which I recommend reading in full - begins as follows:

Public Citizen is writing to express its outrage over the Food and Drug Administration’s (FDA’s) indefensible decision to approve Biogen’s aducanumab (Aduhelm) for treatment of Alzheimer’s disease despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury. The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.

They go on to ask for resignation of key officials in approving aducanumab, including FDA acting head Janet Woodcock and Billy Dunn. They also ask that the Office of the Inspector General for HHS investigate the relationship and "close collaboration" between the FDA and Biogen prior to Aduhelm approval. In addition, they want rescission of the bogus approval:

You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.

Those who pushed for approval seem eager to foreclose any discussions of rescission. In an interview, there was this question and answer with Acting FDA Head Janet Woodcock:

Question: "There’s been some reaction that every time this criticism comes up, the FDA just dismisses it outright and doesn’t really meaningfully engage on it —doesn’t do soul-searching. … Should the FDA do some soul searching? Should you and the FDA be trying to respond more directly to these critics?" Woodcock's reply: "I think we will have some more public soul-searching type of discussions on accelerated approval itself, but the soul-searching when a decision is made goes on before the decision, and once we’ve made the decision, we’ve made the decision."

Similarly, the head of the Alzheimer's Association wants to end discussion of the approval:

Harry Johns is ready to stop talking about whether or not the Food and Drug Administration should have approved Aduhelm, the divisive new Alzheimer’s treatment that got the green light last week. “Dwelling on the approval at this point is not productive for those who can benefit from the treatment,” said Johns, the CEO of the Alzheimer’s Association. The “negative voices” focused on criticizing the decision, he said, are “not pro-patient.”

But, if the aducanamab approval is not rescinded, what will happen and what are the consequences? More on that in another post.

Logical Fallacies in Support of Propaganda and Disinformation

Health Care Renewal's original goal was to open discussion of US health care dysfunction.  We originally focused on issues discussed in my 2003 article (Poses RM.   A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14(2): 123-130. Link here). These included ill-informed, incompetent, self-interested, conflicted or even corrupt leadership; and attacks on the scientific basis of medicine.  We soon found out that bad health leadership and attacks on science were facilitated by deceptive marketing, public relations, propaganda, and disinformation.  Furthermore, we then realized that logical fallacies were important tools used by deceptive marketers, propagandists, and disinformationists.

Introduction: Logical Fallacies

To help understand logical fallacies, we used two main sources.  One was the Nizkor project, a Holocaust educational resource, which contained a guide to logical fallacies (available here and here).  The impetus for publishing this guide was to counter the use of logical fallacies to push the agenda of holocaust deniers. Another was Logically Fallacious, a book by Bo Bennett PhD, and its accompanying website. 

Logically Fallacious defines logical fallacies thus:

Criteria for Logical Fallacies: 

It must be an error in reasoning not a factual error.

It must be commonly applied to an argument either in the form of the argument or in the interpretation of the argument. 

It must be deceptive in that it often fools the average adult.

Therefore, we will define a logical fallacy as a concept within argumentation that commonly leads to an error in reasoning due to the deceptive nature of its presentation. Logical fallacies can comprise fallacious arguments that contain one or more non-factual errors in their form or deceptive arguments that often lead to fallacious reasoning in their evaluation.

Our first semi-formal discussion of logical fallacies appeared in 2008. Its focus was how logical fallacies were used to support public relations/ propaganda about health care policy in support of the interests of pharmaceutical corporations. I confess it was rather personal.  The blog and I had come under written attack by a blogger who worked for a non-profit that was funded by and associated with the pharmaceutical industry.  The attacks featured "creative use of multiple logical fallacies."  My post attempted to analyze some examples.

Logical Fallacies in Health Care and Public Health

Since 2008 we published multiple posts about logical fallacies often featuring vivid examples. Logical fallacies were: used to obfuscate the role of an academic medical center in giving apparently preferential treatment to members of Japanese organized crime (Yakuza) (look here);  justify conflicts of interest affecting clinical researchers (look here, ); justify huge compensation given to managers of non-profit hospital systems (look here); justify a federal prosecutor who pursued unethical practices by health care corporations exiting the revolving door to become a defense attorney for such corporations (look here); justify a renowned academic medical center going into the contract research business (look here);  and justify use of a poor clinical research practice, an active run-in period before a randomized controlled trial (look here).

Then things got much wilder during the Trump years.  Early on, Trump and his enablers became known for a steady stream of propaganda and disinformation, often employing logical fallacies, and sometimes to support his health care or health policy ideas.  For example, by 2019, the Washington Post documented Trump's voluminous uses of the appeal to common belief fallacy to justify, among other things, his attacks on the Democrats health care agenda as a "disaster," and his boasts about a reform of the US Veterans Administration, reforms that actually preceded his time in office.

Then we heard about an unusual viral disease in China that quickly morphed into the COVID-19 pandemic.  Logical fallacies became a powerful tool for generating the onslaught of propaganda and disinformation about the pandemic.  The propaganda and disinformation came so fast and the pandemic situation was so unstable that I had trouble keeping up with it, other than documenting it on my Twitter feed.  However, once again logical fallacies were used by the disinformationists, eg, to justify decreases in coronavirus testing (look here); and to justify attacks against pandemic mitigation measures, such as mask wearing (look here).  

So now seems like a good time to catalog some of the logical fallacies that have most frequently or vividly been used in a health care or public health context to support deceptive marketing, propaganda, and disinformation to sell products and services, justify management behavior or misbehavior, or further leaders' self-interest.  The catalog is organized by the usual names of the cognitive fallacy arranged alphabetically.  Examples from the archive of Health Care Renewal of each fallacy will be provided.  Some will be from our early days, when logical fallacies were often used to support aspects of pharmaceutical/ biotechnology/ device company marketing and public relations practices, and to support public relations practices by hospital management and related groups.  Some will be more recent, and reflect the new (ab)normal, their widespread usage to generate propaganda and disinformation about the COVID-19 pandemic

Ad Hominem

There are several sub-types of the ad hominem fallacy. In particular, the circumstantial version is defined:

Suggesting that the person who is making the argument is biased or predisposed to take a particular stance, and therefore, the argument is necessarily invalid.

Example: Richard Epstein, a prominent market fundamentalist law professor, attacked critics of conflicts of interest affecting pharmaceutical marketing as those who "often treat the phrase 'market forces' as though it embodies the worst things in life," that is, as anti-capitalists (look here). 

Example: A physician decrying proposed restrictions on conflicts of interest in medicine called for leaders to "resist the temptation to join the separation witch hunt."  The implication is that people calling for more restrictions are witch hunters, that is embarking on a totally unreasonable and dangerous ideological crusade (look here). 

[Witch from The Lost King of Oz, Ruth Plunky Thompson, 1925]

Note that a person may be biased towards a certain point of view, and that bias could affect that person's arguments, but not necessarily.

The ad hominem tu quoque fallacy is defined:

Claiming the argument is flawed by pointing out that the one making the argument is not acting consistently with the claims of the argument.

Example: Since I worked on a project for and thus was paid as a consultant by Merck in 1997-9, it was implied my criticism of a pharmaceutical company in 2008 was hypocritical and therefore invalid (look here). 

Note that one's actions in one case do not necessarily affect one's arguments in another. 

Appeal to Authority

The appeal to authority is defined:  

Insisting that a claim is true simply because a valid authority or expert on the issue said it was true, without any other supporting evidence offered.

Example: An author tried to dismiss concerns about conflicts of interest affecting medical societies because physicians are so virtuous and responsible that conflicts could not possibly affect them (look here)  

Note that an authority may be more likely to make a valid argument, but there is no guarantee that all arguments made by an authority are valid.

Appeal to Common Belief

The appeal to common belief is defined:

 When the claim that most or many people in general or of a particular group accept a belief as true is presented as evidence for the claim.

Example: President Trump claimed that everyone knew that the Democratic health care policies were a "disaster," and that his reforms of the VA were extremely significant (although they were actually enacted during the previous administration (see the Washington Post in 2019). 

Just because many people believe something does not make it true.

Appeal to Common Practice 

The appeal to common practice has the following structure:

X is a common action.

Therefore, X is correct/moral/justified/reasonable etc 

Example: An author tried to dismiss concerns about conflicts of interest affecting physicians, particularly research physicians by saying publication bias "has been reported for more than 2 decades," implying that because it is common, worry is uncalled for (look here). 

Example: The CEO of a renowned academic medical center, formerly a high paid biotechnology executive, defended its venture into the contract research business by saying ""universities need to recognize this is how things are," and "the old way of doing things doesn't really work anymore." (Look here)

Just because some people do something does not mean what they do is justified, or based on truth.

Appeal to Fear

There are many kinds of appeals to emotion, generally defined as.

the general category of many fallacies that use emotion in place of reason in order to attempt to win the argument.  It is a type of manipulation used in place of valid logic.

The appeal to fear is one sub-type.  It is defined:

 When fear, not based on evidence or reason, is being used as the primary motivator to get others to accept an idea, proposition, or conclusion.

Example: A physician decrying proposed restrictions on conflicts of interest in medicine warned that "Those institutions that choose such inquisitional approaches will be blighted and suffer competitive disadvantages." The use of the emotionally charged word "blighted," in the absence of a clear argument that the blight would necessarily occur, made this an appeal to emotion, particularly fear (look here). 

Just because something is feared does not make it more likely.

Appeal to False Authority 

This is related to the appeal to authority, above.  The appeal to false authority is defined:

Using an alleged authority as evidence in your argument when the authority is not really an authority on the facts relevant to the argument.

Example: The CEO of a state hospital association justified the huge compensation given to local hospital system CEOs by quoting "management expert Peter Drucker" who asserted that hospital management is particularly difficult.  Note that she provided no evidence that Mr Drucker has any special expertise about health care (look here).  

Just because someone is said to be an expert in a particular field does not mean that person is an expert.  Just because a person is an expert does not make an argument based on that person's opinions right.

 Appeal to Ignorance

 This is also known as argument from ignorance.  Its definition is:

The assumption of a conclusion or fact based primarily on lack of evidence to the contrary.  Usually best described by, 'absence of evidence is not evidence of absence.'

Newer Example: President Trump called for a decrease in coronavirus testing apparently because he believes that diagnosing fewer cases would mean less actual disease: "Here's the bad part ... when you do testing to that extent, you're going to find more people; you're going to find more cases. So I said to my people, slow the testing down please." (look here and here). 

Newer Example: Governor Kristi Noem of South Dakota also claimed that there were more cases of coronavirus, and hence more hospitalizations for coronavirus in her state than other states because the state was testing at a higher rate (look here).  Thus she and the president seemed to equate diagnosis with disease, and were arguing that if there is less evidence of disease, there must be less actual disease.

Failure to see or detect something does not mean it does not exist.

Slippery Slope

The definition of the slippery slope is:

When a relatively insignificant first event is suggested to lead to a more significant event, which in turn leads to a more significant event, and so on, until some ultimate, significant event is reached, where the connection of each event is not only unwarranted but with each step it becomes more and more improbable.

Example: Richard Epstein, a prominent market fundamentalist law professor, attacked proposals of new restrictions on conflicts of interest affecting pharmaceutical marketing as leading to the prohibition of "the collaborative efforts that have long characterized standard practices [in research]." Yet none of the proposals he mentioned would have directly affected collaboration per se (look here).

Although things may appear to occur in sequence, a chain of causation may not be inevitable.

Special Pleading

The definition of special pleading is:

a fallacy in which a person applies standards, principles, rules, etc. to others while taking herself (or those she has a special interest in) to be exempt, without providing adequate justification for the exemption.

Example: An author attacked the credibility of a published critique of conflicts of interest affecting research sponsored by a particular drug company by saying that critique's authors had failed to completely disclose their alleged conflicts.  They were consultants to attorneys for plaintiffs who had sued the company.  Yet the author did not completely disclose his own conflicts in his article attacking the critiques, suggesting that he believed other people should have to fully disclose conflicts of interest, but he was exempt  (look here).

Straw Man

 [Scarecrow from Dorothy and the Wizard of Oz, L Frank Baum, 1908]

The definition of the straw man fallacy is:

when a person simply ignores a person's actual position and substitutes a distorted, exaggerated or misrepresented version of that position. 

Example: Because I had criticized manipulation and suppression of clinical research about particular drugs (SSRIs, Avandia, Vytorin), my critic implied "I suggested 'people should stop taking SSRIs, Avandia, and Vytorin.' He then added 'now I guess this should also apply to Zocor.'"  However, I had stated no such thing. (Look here)

Newer Example: A state Republican Chairman argued against pandemic mitigation members saying "We can’t live in a world where there’s never again a live, in-person concert or convention or gathering"  No one had credibly argued that pandemic mitigation meant that no such things would ever happen. (look here). 

Other Logical Fallacies Used to Support Propaganda or Disinformation

There are many other logical fallacies.  Some that have been used frequently lately by disinformationists in the political arena include:

- the abusive ad hominem fallacy: "Attacking the person making the argument, rather than the argument itself, when the attack on the person is completely irrelevant to the argument the person is making;" 

- cherry picking: "When only select evidence is presented in order to persuade the audience to accept a position, and evidence that would go against the position is withheld.

-the false dilemma: "When only two choices are presented yet more exist, or a spectrum of possible choices exists between two extremes.  False dilemmas are usually characterized by “either this or that” language"

- the red herring fallacy: "Attempting to redirect the argument to another issue to which the person doing the redirecting can better respond" 

Perusal of Logically Fallacious and the Nizkor project, as well as a number of other good sources, will reveal a catalog of fallacies and errors of reasoning, most of which are being used in contemporary political and sometimes specifically health care and public health related propaganda and disinformation.

Summary- Propaganda, Disinformation, and Logical Fallacies

As we noted recently, the coronavirus pandemic has been accompanied by a pandemic of disinformation, sometimes called the "infodemic."  In the US, while it would have seemed unthinkable up to 5 years ago, the biggest source of disinformation has been President Donald Trump (look here). Although Trump is now out of office, the barrage of coronavirus disinformation has continued apparently unabated, propagated by Trump's supporters (look here), foreign powers, eg, Russia (look here), and various anonymous internet-based trolls, bots, etc. The infodemic has likely had a major role in amplifying the pandemic by discouraging peoples' cooperation with pandemic control measures, and now generating vaccine hesitancy.  The result has likely been considerable morbidity and death.
If we hope to reduce suffering and death from the pandemic, we will need to confront the propaganda and disinformation that is driving it.

 Propaganda and disinformation operate through multiple mechanisms, including various forms of deception including manipulation and suppression of evidence; generation of specious arguments, including via the use of logical fallacies; and appeals to emotion and manipulation of human psychology.  Better understanding of logical fallacies will help us better counter propaganda and disinformation. 

Why Did the Head of the Center for Medicare and Medicaid Services Outsource Communications Functions to Private Public Relations Firms? - Ethical and Legal Questions

There is now never a dull moment at the Center for Medicare and Medicaid Services (CMS) an agency of the US Department of Health and Human Services (DHHS).  Its current director, Seema Verma, has developed a more efficient way to combine conflicts of interest with self-interest, bad management, and possibly worse.

Outsourcing CMS Communications to Private Public Relations Firms


In summary, Politico reported

The Trump appointee who oversees Medicare, Medicaid and Obamacare [Seema Verma] quietly directed millions of taxpayer dollars in contracts to Republican communications consultants during her tenure atop the agency — including hiring one well-connected GOP media adviser to bolster her public profile.

The communications subcontracts approved by Centers for Medicare and Medicaid Services Administrator Seema Verma — routed through a larger federal contract and described to POLITICO by three individuals with firsthand knowledge of the agreements — represent a sharp break from precedent at the agency. Those deals, managed by Verma’s deputies, came in some cases over the objections of CMS staffers, who raised concerns about her push to use federal funds on GOP consultants and to amplify coverage of Verma’s own work. CMS has its own large communications shop, including about two dozen people who handle the press.

The move to give large contracts to outside public relations (PR) firms seems unprecedented and seems unnecessary.  Per CNN

whether the issue was Medicare, Medicaid or Obamacare, prior heads of the agency were often quoted, profiled and in the news, so current officials said they’re puzzled why so much work is being outsourced.

'The head of Obamacare doesn't need outside consultants to get reporters to talk to her,' said one CMS official, who asked for anonymity. 'The job pitches itself.'

Ethical and Legal Issues

In addition, outsourcing communications to private PR firms raises multiple ethical, and possibly legal questions:

'Outsourcing communications work to private contractors puts the agency's ability to protect ‘potentially market-moving’ information from premature disclosure at considerable risk,' said Andy Schneider, a Medicaid expert who worked at CMS during the Obama administration and is now a researcher at Georgetown University.

Also,

But some career CMS staff have voiced their concerns to political appointees within the agency about routing taxpayer dollars to GOP consultants and helping a federal official like Verma improve her personal brand, said two individuals aware of those conversations. Oversight groups also have raised concerns, saying the behavior, as described to them by POLITICO, would appear to cross ethical lines.

'There are a host of ethical and contractual problems with appointees steering contracts to political allies and subcontractors, and possibly a violation of the ban on personal services contracts if the work is being performed at the direction of the appointee,' Scott Amey, general counsel of the Project on Government Oversight, told POLITICO. 'Contracts are supposed to be above reproach, with complete impartiality, and without preferential treatment, and the HHS Inspector General should review this [Porter Novelli] contract and the activities under it to ensure they are proper.'

The choice of PR firms led to the concerns about steering contracts to "political allies."

The subcontracts are part of a $2.25 million contract administered by Porter Novelli, an international public relations firm that performs a wide variety of government services. CMS’ new top communications official Tom Corry confirmed the arrangement. Two other individuals said CMS also spent at least $1 million on earlier contracts with GOP communications consultants.

One subcontract is with Pam Stevens, a longtime GOP media adviser who specializes in setting up profiles of Republican women. A second subcontract is with Marcus Barlow, whom Verma worked with in Indiana and considered hiring as a top communications official in 2017 before he was blocked by the White House.

And,

A third contract is with Nahigian Strategies, a firm run by a high-profile pair of brothers. Keith Nahigian consulted with several GOP presidential campaigns; Ken Nahigian briefly led President Donald Trump’s presidential transition team in 2017.

In other words, hiring contractors because of their political affiliations for the purposes of burnishing the image of particular government bureaucrats appears to be an abuse of power.


Also, Porter Novelli subcontracted with one Brett O'Donnell, who was involved in the following controversial episode which could be interpreted as a threat to the free press, which is protected by the Bill of Rights:

In a February 2018 incident, contractor Brett O'Donnell barred a Modern Healthcare reporter from a media call for refusing to alter a story that had rankled Verma. CMS officials walked back that threat within days and said a week later that Porter Novelli’s subcontract with O’Donnell, a longtime GOP consultant, would not be renewed. But CMS never provided any explanation of O’Donnell’s role or responsibilities. O’Donnell declined to comment for this article.

We wrote about his incident here. 

Given that federal officials like Verma swear

I will support and defend the Constitution of the United States against all enemies, foreign and domestic; that I will bear true faith and allegiance to the same;

for Ms Verma to have enabled the hiring of a contractor who tried to suppress press freedom could certainly be interpreted as mission-hostile management, or worse. 

Questions About Conflicts of Interest


Although not mentioned in the Politico article, the choice of Porter Novelli as the main contractor may raise concerns about conflicts of interest, it seems to me.


Porter Novelli is a huge public relations firm.  It has substantial business with the government.  However, it is also known for its "health and wellness" practice, per its profile in EverythingPR.  According to SourceWatch, its clients have included multinational pharmaceutical companies: Pfizer, Wyeth, and GlaxoSmithKline.  One of the practice's leaders once was Peter Pitts, who frequently spun stories to advance pharma interests, and who founded the Center for Medicine in the Public Interest (CMPI), which received considerable money from pharma and has often seemed to be an advocate for the industry.  Some examples of Pitts' work were discussed here, and his apologia for opioid manufacturers here.


Discussion

Perhaps there is more to come on this story.  Today, Politico reported that after the publicity of Ms Verma's contract with Porter Novelli et al, those contracts have been suspended. 

 Previously, US News & World Report noted that

House Energy and Commerce Chairman Frank Pallone on Friday called on an inspector general to investigate a report that a top health official appointed by President Donald Trump spent millions of taxpayer dollars on GOP communications consultants.

Also,

Pallone called the contracts a 'highly questionable use of taxpayer dollars' and wants investigators to determine how the contracts got approval and if there was any breach of regulations and ethical guidelines.'

'Given that this agency should be spending tax dollars to ensure Americans can access quality health care, it is particularly egregious that it is using millions to ensure its Administrator has access to outside public relations and image building services,' Pallone said in a statement.

'I intend to ask the HHS OIG [the U.S. Department of Health and Human Services Office of Inspector General] to immediately begin an investigation into how these contracts were approved, whether all regulations and ethical guidelines were followed, and why taxpayers are stuck paying for these unnecessary services. This is not the way to drain the swamp.'

In any case, the Trump administration continues to come up with new and innovative conflicts of interest affecting health care policy and regulation.  We have discussed the rotational velocity of the revolving door that has supplied health care industry stalwarts to become government health care policy-makers and regulators (most recent example is here, and most recent example involving CMS is here).   Now a top DHHS official has decided to commission and big PR firm well known for its pharmaceutical industry clients to promote her attempts to bolster "her tenure running Medicare and Medicaid ... marked by attacks on both programs and their beneficiaries," per a commentary in the National Memo.

This is not the first time we have discussed Ms Verma's conflicts of interest.  Here we noted how she advised the Indiana, Kentucky, and at least seven other states' Medicaid programs while working for Hewlett-Packard, a contractor for those programs.  (Note that Hewlett-Packard was also a big Porter Novelli client, per SourceWatch.)  But she continues to expand her reputation for mingling government functions and commercial interests.

Ms Verma also apparently has used outsourcing to add a propaganda element to government communications (Recall that public relations was just the term Bernays picked because he thought sounded better than "propaganda.")  Furthermore, that propaganda seemed meant not to improve the health of the public, but to enhance Ms Verma's personal image. That seemed to be an abuse of power, in my humble opinion.

Moreover, there was at least one incident in which the propaganda function may have turned into a threat against press freedom (the O'Donnell incident above), and hence was certainly an example of mission-hostile management, and could easily also be viewed as an abuse of power.

We have long written about conflicts of interest, but until 2016, our cases were mostly conflicted academics, health care professionals, or leaders of private health organizations, e.g., hospitals, academic organizations, pharmaceutical companies etc.  Now the most striking cases are coming from the Trump regime.

We have long written about self-interested and mission hostile management, but again, until 2016, our cases were mostly about leaders of private health organizations.  Now the most striking cases are coming from the Trump regime.

How can be talk about true health care reform without talking about true reform of our current government?

"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.

Pontifications About Health Care Reform Written by Insiders Who Benefit from the Status Quo - Worse Than We Think

Perceptions that the US health care system is dysfunctional and needs major reform go way back.  A timeline from the Tampa Bay Times noted President Theodore Roosevelt's proposal for a national health service in 1912.  Nonetheless, as we have discussed endlessly, most attempts at reform failed, and health care dysfunction seems to be getting worse.

One big problem may be that we don't understand how much discussion of health care reform is driven by those who benefit from the status quo. 

A Personal Anecdote

When I began my academic career in 1983, I was often in the audience for talks about how to fix health care by people billed as experts.  Often these talks seemed oddly disconnected from the realities on the ground for a junior assistant professor with a lot of clinical and teaching responsbilities.  Worse, many of the solutions they offered seemed to entail greater burdens for health care professionals, with no obvious compensation other than the warm feeling that we would be benefiting society.  Who else these solutions might benefit was not discussed. 

One talk given a bit later stands out in my memory. On November 29, 2001, one Dr John W Rowe gave the prestigious Levinger Lecture at Brown University entitled "Good Health: Can we Afford It?" (referenced here, see items for 11/14 and 11/16)  As I recall, Dr Rowe spent considerable time scolding us hard working physicians for overuse of medical interventions leading to endless increases in health care costs, and promising more burdensome bureaucratic interventions to rein in our follies.  While promising more burdens on physicians, Dr Rowe did not dwell on how the resulting cost savings might benefit him in his role as CEO and Chairman of Aetna Inc.  Aetna had purchased the notoriously physician-unfriendly US Healthcare, and thus had become a big for-profit health care insurer already known for imposing bureaucratic burdens on physicians in hopes of decreasing their utilization, while increasing the company's revenues (look here).  Were Dr Rowe's pontifications really about improving health care for all Americans, or about justifying his previous management behavior, and perhaps supporting the price of his shares in Aetna? Why was Aetna's public relations given the patina of an academic lecture?

These days, health care professionals continue to be exhorted about health care reform.  Many such pontifications may be not so much about true health care reform as about preserving the fundamental status quo which has benefited and enriched so many insiders. The interests of the pontificators are often less obvious than those of Dr Rowe.  Maybe that is so why there has been so little real reform, and what little reform there has been seems to be under continuous attack.

Two Examples of How Hard It Is to Discover the Interests of Health Care Policy Pontificators

In the last few weeks I posted about two recent ostensibly authoritative pontifications.  One was about ways to address the worsening problem of physician burn-out (see this post). It was written by the CEOs of large, non-profit hospital systems, joined by the CEO of the American Medical Association.  The other was about a health care reform proposal from the prestigious National Academy of Medicine (see this post).  A rather uncritical article in the Washington Post hailed it as a "radical idea" because it was written by "doctors." In both cases, I was skeptical, mainly because many of the proponents had conflicts of interest, mostly undisclosed, that suggested they were already benefiting mightily from the current system.

However, it gets worse.  While I thought my posts were based on reasonable efforts to find undisclosed conflicts of interest affecting the authors of these exhortations, within a few weeks I realized I had missed one important item affecting each.  The lesson is that the web of conflicts of interest that ensnares the insiders who run most of US health care is even more complex and adherent than any of us realizes.

Dr John Noseworthy, Author of the Health Affairs Post on Reducing Physician Burnout: CEO of the Mayo Clinic, But Also Now Nominated to be a Director of Merck

Dr Noseworthy, CEO of the Mayo Clinic, was the lead author of a post in HealthAffairs about reducing physician burnout.  (Oddly enough, none of the proposed action items seemed to involve increasing physician autonomy by reducing the power of managers over health care professionals.)

Two weeks after Noseworthy and colleagues' post appeared, an article on the Minnesota Public Radio website reported that Dr Noseworthy has just been nominated to a seat on the Merck board of directors.  Presumably the possibility of this nomination had been known at the time the post was published.

I had previously written that two of the authors of the Health Affairs post were on corporate boards.  One, Dr Paul Rothman, was already on the board of Merck.  As corporate directors, they have fiduciary responsibilties to promote the revenues of their corporations.  Now it turns out there were at least three such board members among the health system CEOs who had pontificated to physicians about how to reduce their burn-out.

Yet the power of such health care systems, whose management is often mission-hostile, and who often put revenue ahead of physicians' professional values (per the shareholder value theory), is arguably a major cause of physician burnout.  Furthermore, Merck, in particular, has had its share of management misbehavior as demonstrated by a recent $830 million settlement for deceiving shareholders, a mere $5.9 million 2015 settlement for deceptive marketing, and multiple setttlements, cumulatively totaling more than $1 billion, plus one guilty plea for the historic deceptive marketing of Vioxx (see this post).

So to what extent are the authors of this pontification about reducing physician burnout (without really giving physicians much new autonomy) insiders benefiting from the status quo in health care?  It may be more than what we think, even now.

Mr Leonard Schaeffer, Author of National Academy of Medicine Article on Health Care Reform: Member of the Boards of Wahlgreen Boots, Quintiles, scPharmaceuticals, but Also Long-Term Director of Amgen

Mr Schaeffer was an author of the National Academy of Medicine article, now published online in JAMA, about health care reform.  (Oddly enough, none of the "vital directions issue areas" mentioned in the article involved real challenges to the power of large health care organizations, particularly for-profit corporations, or increased autonomy for health care professionals.)

The version of the article published online by the NAM did not include any explicit disclosures of conflicts of interest.  It did note that two authors were full-time employees of health care corporations, one was a consultant to health care corporations, one was a lobbyist for health care corporations, and one was on the boards of health care corporations.  The online JAMA version added more disclosures, but these were incomplete.  In my post, I noted that fully 13 of the 19 authors had major ties to large health care corporations, as employees, lobbyists, consultants or  board members.

In particular, Mr Leonard D Schaeffer was listed in the NAM version as simply affiliated with the University of Southern California, but I found was actually on the boards of Wahlgreens Boots Alliance, Quintiles Transnational, and scPharmaceuticals Inc.  That was still an incomplete picture of his conflicts of interest.

A ProPublica article from February, 2017 recounted how big pharmaceutical companies engaged Precision Health Economics to wage public relations campaigns to try to justify high pharmaceutical prices.  The article noted the following about Mr Schaeffer.  

Amgen has ties to all three founders of Precision Health Economics. Working for other firms, Philipson has twice testified as an expert witness for Amgen, defending the company’s rights to drug patents, according to his curriculum vitae. The other two founders, Goldman and Lakdawalla, are principals at the Leonard D. Schaeffer Center for Health Policy and Economics at USC, which received $500,000 in late 2016 from Amgen for an 'innovation initiative,' according to public disclosures. Goldman said the funds were unrestricted and could be used at the center’s discretion. Robert Bradway, the CEO and chair of Amgen, is on the advisory board of the university center, and Leonard Schaeffer, a professor at USC and the namesake of the center, sat on Amgen’s board of directors for nearly a decade.

With funding from Amgen, the Schaeffer Center hosted a forum in Washington, D.C., in October 2015 on the affordability of specialty drugs. Before a panel focused on the new cholesterol treatment, Goldman cautioned against lowering drug prices.

So Mr Schaeffer, in addition to his current board positions, turns out to have had a long relationship with Amgen.  Given that according to the 2013 Amgen proxy statement, Mr Schaeffer retired from the board with at least 28,277 shares of Amgen stock and options for 15,000 more, he may have current financial ties to the company. 

So once again, to what extent were the authors of the 2017 NAM report on health care reform (which did not challenge the influence of large health care corporations over the health of US citizens) insiders benefiting from the status quo in health care?  It may be more than what we think, even now.

Summary

Health care professionals, policy makers, and the public are constantly harangued by apparently unbaised experts about health care reform.  Yet many of these authorities are insiders who benefit from the status quo.  Many of their financial connections to the corporations that make the most money from the US commercialized health care system are not disclosed.  It may take considerable investigation to determine their involvement in a web of conflicts of interest that drapes over the US health care system.

Meanwhile, audiences should demand that those who lecture us about health care reform disclose all their financial conflicts of interest.  Any whiff of deception about their personal interests should suggest intense skepticism. 

True health care reform requires honest discussion of the issues.  Honesty in this case entails complete and detailed disclosure of the discussants' conflicts of interest. Until such honesty is the rule, be very, very careful about taking sanctimonious spiels at face value. 

Pharmaceutical Company Leaders Pretend to Advocate for the Public Interest - But Maybe it's All "For the Love of Money"

In this political season, the US public is confronted with a blizzard of protestations from candidates who claim to want to serve their interests.  We ought to be used to this, because leaders of big health care organizations have been protesting for years about how they are always in it for the public and the patients' health.  Yet as we have repeatedly discuss, such leaders often manage in ways that subvert their own mission.

Recently, there were two striking examples of pharmaceutical leadership saying they were all about the public interest, despite evidence to the contrary.

It's All About the Children Says Insys Therapeutics, or Perhaps the Market Share

In the Intercept, Lee Fang reported the touching concern of the executives at Insys Therapeutics for America's children.

On August 31, Insys Therapeutics Inc. donated $500,000 to Arizonans for Responsible Drug Policy, becoming the single largest donor to the group leading the charge to defeat a ballot measure in Arizona to legalize marijuana.

The drug company, which currently markets a fast-acting version of the deadly painkiller fentanyl, assured local news reporters that they had the public interest in mind when making the hefty donation. A spokesperson told the Arizona Republic that Insys opposes the legalization measure, Prop. 205, 'because it fails to protect the safety of Arizona’s citizens, and particularly its children.'

However, it turns out the company admitted it had other compelling reasons to want to fight the legalization of marijuana.

Investor filings examined by The Intercept confirm the obvious.

Insys is currently developing a product called the Dronabinol Oral Solution, a drug that uses a synthetic version of tetrahydrocannabinol (THC) to alleviate chemotherapy-caused nausea and vomiting. In an early filing related to the dronabinol drug, assessing market concerns and competition, Insys filed a disclosure statement with the Securities and Exchange Commission stating plainly that legal marijuana is a direct threat to their product line:

Legalization of marijuana or non-synthetic cannabinoids in the United States could significantly limit the commercial success of any dronabinol product candidate. … If marijuana or non-synthetic cannabinoids were legalized in the United States, the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected.

Insys explains in the filing that dronabinol is 'one of a limited number of FDA-approved synthetic cannabinoids in the United States' and 'therefore in the United States, dronabinol products do not have to compete with natural cannabis or non-synthetic cannabinoids.'

The company concedes that scientific literature has argued the benefits of marijuana over synthetic dronabinol, and that support for marijuana legalization is growing. In the company’s latest 10-K filing with the SEC, in a section outlining competitive threats, Insys warns that several states 'have already enacted laws legalizing medicinal and recreational marijuana.'

Insys insists on its web-site

We are an innovative organization with a focus on providing therapeutic solutions helping to improve the lives of patients. 

Also,

Our commitment to better patient care is measured not only by our focus on bringing innovative technologies to patients and physicians, but also by the importance we place on making an impact within the communities where we work and live.

But it really more seems to be all about market share, which drives the revenue, which drives the executive compensation (which was $3,862,000 for outgoing CEO Michael L Babich in 2015, per the 2016 proxy statement). 

Pfizer CEO Advocates for the Public Who Do Not Support National Health Insurance, or Maybe They Do

Bloomberg reported that Ian Read, the CEO of Pfizer, "America's biggest drugmaker," said

that Democratic presidential nominee Hillary Clinton’s proposals to contain the price of pharmaceuticals would be 'very negative' for the industry and are a step toward single-payer health care.

Pfizer CEO Ian Read criticized Clinton’s plan, which she released earlier this month, at an investor conference hosted by Wells Fargo in Boston. Clinton’s prescription drug policy would give the government a broad role in overseeing drug prices, including a board to monitor sharp cost increases, and would specifically target price hikes on older medicines.

It is pretty obvious why the CEO of Pfizer would not like any policy that might reduce the prices of his products.   However, Mr Read in addition stated that

'The Clinton approach to health care drives you to a one-payer system, and drives you to rationing, drives you to a place where most consumers don’t want to be,' Read said. “In its totality it would be very negative for innovation.”

One might be suprised that Mr Read, who received $17,987,962 in total compensation in 2015 (per the 2016 proxy statement), would be in touch with what most consumers want.  But maye he was just following the strategic imperative described in the 2016 proxy statement:

Earn greater respect

Earn society’s respect by generating breakthrough therapies, improving access, expanding the dialogue on healthcare and acting as a responsible corporate citizen.

However, it appears that Mr Read did not know what the public really wants.

There is at least some systematic evidence to the contrary, that the US public generally supports single-payer government health insurance, aka national health insurance.  A Gallup poll this year found 58% support for a federally funded health system (look here).  A 2013 survey of people visiting emergency departments in safety-net hospitals in in Massachusets, which has had a longer experience with an "Obamacare" like system than most of the US, showed that 72% would prefer national health insurance. (Saluja S et al. Support for National Health Insurance Seven Years Into Massachusetts Healthcare Reform: Views of Populations Targeted by the Reform. Int J Health Serv 2016; 46: 185-200. Link here.)  For more discussion, see this.

So was Mr Read's insistence that he did not like the Clinton policy on the pharmaceutical industry because he was advocating for the public who did not want national health insurance?  Or was it all about the Benjamins?

Comment

Unfortunately, the US, and perhaps other western countries are beset by rising distrust of increasingly powerful elites.  It seems that this may be in response to those elites grabbing an ever increasing share of the nations' wealth.  More unfortunately, this distrust may lead to support of outsider politicians who claim to be on the side of the people, and who may have quick, but often very dirty solutions.  Before grabbing at such easy fixes, or applauding figurative men on white horses, perhaps we need to focus more attention on the leaders who should have inspired mistrust in the first place.

Health care leaders often inspire trust, since they frequently claim to be in it for patients' and the public's health.  We have frequently shown, however, that they may instead do what is best for their personal interests, even if that is hostile to their ostensible health care mission.

Now we have just two more quick, and also dirty examples of leaders, this time of pharmaceutical companies, pledging their support of the public while managing to so what is best for their corporate bottom lines (and presumably thus their personal compensation).

As we have said far too many times - without much impact so far, unfortunately - true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

For our musical interlude, here is "For the Love of Money," by the O'Jays, as used in the introductory sequence for the "reality show," The Celebrity Apprentice, hosted by, well, you know...

Stealth Public Relations and Health Advocacy, Special Pleadings and the Opposition to Guidelines Discouraging Overuse of Narcotics

As I have written before as a physician who saw too many dire results of intravenous drug abuse, I was amazed how narcotics were pushed as the treatment of choice for chronic pain in the 1990s, with the result that the US was once again engulfed in an epidemic of narcotic abuse and its effects.  In mid-December, 2015, as reported in the Washington Post,

The nation continues to suffer through a widespread epidemic to prescription opioids and their illegal cousin, heroin. The CDC estimated that 20 percent of patients who complain about acute or chronic pain that is not from cancer are prescribed opioids. Health-care providers wrote 259 million prescriptions for the medications in 2012, 'enough for every adult in the United States to have a bottle of pills,' the CDC wrote.

Last week, the National Center for Health Statistics reported that the number of overdose deaths from legal opioid drugs surged by 16.3 percent in 2014, to 18,893, while overdose fatalities from heroin climbed by 28 percent, to 10,574. Authorities have said that previous efforts to restrict prescription drug abuse have forced some people with addictions to the medications onto heroin, which is cheaper and widely available.

This rising tide of death and morbidity seems to have been fueled by reckless, sometimes deceptive, sometimes illegal marketing by the pharmaceutical companies that produced narcotics other than heroin.

Background - Legal Drug Pushing

As I wrote in 2013,

the realization began to dawn that patients, doctors and society were being victimized by a new type of pusher man, this time dressed in a suit and working for an 'ethical' drug company.  In the earlier days of Health Care Renewal, we first posted (in 2006) about allegations of deceptive and unethical promotion of fentanyl by Cephalon that lead to its overuse by patients beyond those with cancer who were its ostensible target population.  Then in 2007 came the spectacular case of guilty pleas by a subsidiary of Purdue Pharma and several of its executives for 'misbranding' Oxycontin,  that is, promoting it far beyond any medically legitimate use in severe chronic pain.  Following that various investigations, well chronicled in the Milwaukee Journal Sentinel, showed how pharmaceutical companies employed deceptive marketing techniques, subverting medical education and research, and creating conflicted key opinion leaders and institutionally conflicted disease advocacy groups, to push more 'legal' narcotics  For example, see the Journal Sentinel reports the subversion of :  medical schools and their faculty; .medical societies, disease advocacy groups, and foundations; and guideline writing panels.  In 2012, we posted about how a drug company paid key opinion leader admitted to second thoughts about his role promoting narcotics.

As I described in that 2012 post, the new narcotic pushers relied on only the most sketchy evidence about the safety of prescription narcotics.  In the 1990s, they taught that the rate of addiction caused by prescribing legal narcotics was only 1%, but this was based on a tiny flawed case series of a mere 38 patients.  In 1996, a consensus statement from the American Academy of Pain Medicine and the American Pain Society, entitled "The Use of Opioids for the Treatment of Chronic Pain," included the following statements,

Pain is often managed inadequately, despite the ready availability of safe and effective treatments.

Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low.

Yet one of the primary proponents of profligate use of narcotics to treat chronic pain later admitted he

erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,' Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'

Also,

'I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,' Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished.

In it, Dr. Portenoy said it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording.

The CDC Attempts to Moderate the Use of Opioids for Chronic Pain

So to me it seems quite reasonable the US Center for Disease Control and Prevention (CDC), being cognizant of the rising toll of narcotic addiction, would attempt to do something about it.  As reported by the Washington Post,

The government on Monday urged primary-care physicians who prescribe opioids for pain relief to rein in their use of the drugs, proposing new guidelines that call for a more conservative approach than the one that has led to a crippling epidemic of addiction to the powerful narcotics.

Just a few days after a new report showed a surge of drug-related overdoses in 2014, the Centers for Disease Control and Prevention suggested in draft recommendations that physicians tackle chronic pain with other methods, such as physical therapy and non-opioid analgesics, before turning to the powerful medications. If opioids, such as OxyContin and Percocet, are necessary, the agency recommended short-acting versions over extended release formulations, the lowest possible dose and short-term prescriptions.

It also suggested that doctors ask patients to take urine tests before prescribing opioids and additional urine tests at least once a year if they continue on the drugs, to ensure that they aren't secretly taking other opioids or illegal drugs.

'What we want to just make sure is that doctors understand that starting a patient on an opiate is a momentous decision,' said CDC director Tom Frieden. 'The risks are addiction and death, and the benefits are unproven.'

Based on the events since they 1990s, the lack of clear data from well performed randomized controlled trials of the effectiveness of opioids in chronic pain, and their obvious, known risks, that seems like common sense to me.

The Strong but Obscure Opposition to the CDC Guidelines

However,others disagreed.  The guidelines attracted immediate opposition, for reasons that were not immediately obvious.  Four days after the Post article, the Associated Press reported that the guidelines were in big trouble,

A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.

Also,

Critics complained the CDC guidelines went too far and had mostly been written behind closed doors. One group threatened to sue. Then earlier this month, officials from the FDA and other health agencies at a meeting of pain experts bashed the guidelines as 'shortsighted,' relying on 'low-quality evidence.' They said they planned to file a formal complaint.

The CDC a week later abandoned its January target date, instead opening the guidelines to public comment for 30 days and additional changes.

Anti-addiction activists worry the delay could scuttle the guidelines entirely.

This, however, did not make much sense.  I repeat, the evidence that narcotics are effective for chronic pain other than that due to terminal cancer is very weak.  The evidence that opioids have multiple side effects, some fatal, and can cause addiction, which has more side effects, and bad societal consequences, is strong.  So the evidence that narcotics have benefits that are worth their harms, both to individuals and society, in this setting is essentially non-existent.  So why did these guidelines go too far?  Why invoke low quality evidence, when the evidence that is low quality is about the benefits of the drugs?  Who should be sued?  Furthermore, why did the CDC cave in so readily to these critics?

The AP noted,

But industry-funded groups like the U.S. Pain Foundation and the American Academy of Pain Management warn that the CDC guidelines could block patient access to medications if adopted by state health systems, insurers and hospitals.

Of course they could reduce access.  The whole point of the guidelines is to reduce access.  But who would want more access to medicines that do more harm than good?

Then there was the issue of just who it was who opposed the guidelines. Much of the opposition seemed to come from rather obscure organizations with authoritative names.  Some of the opposition was chronicled by equally obscure, apparently journalistic organizations. (From now on, I will highlight these mysterious organizations by using bold, italic text in this color.)  For example, according to the Washington Post,

Many of the patient and physician groups opposing the CDC guidelines are part of a larger coalition called the Pain Care Forum, which meets monthly in Washington to strategize on pain issues. Officials from the White House, the FDA, NIH and other agencies have met with the group over the years, according to documents obtained by The Associated Press under the Freedom of Information Act.

The Pain Care Forum presents itself as a leaderless collective that does not take formal positions. But most members receive funding from drugmakers, including OxyContin-maker Purdue, whose chief lobbyist helped found the group and remains at its center.

The mission of the Pain Care Forum, its organizational nature (informal group, membership society, non-profit advocacy group, etc), its leadership, and its sources of funding were not entirely obvious from this article.  But certainly the drift of the article was that the organization maybe represents pharmaceutical manufacturers, particularly the previously discredited Purdue Pharma (see above) more than others.  So why not take what it says with many grains of salt.

But who threatened to sue?  Which FDA officials chimed in, and why, given that the FDA does not have a mission that includes writing guidelines?   That was not clear from the AP story.

My attempts to gain further clarity produced more mystification.  A Medscape article also claimed that the opposition to the CDC guidelines included Dr James Madara, the Executive Vice-President and CEO of the American Medical Association, and "some members of the Interagency Pain Research Coordinating Committee [who] criticized the process, according to the Pain News Network."  It was not clear whether Dr Madara's viewpoint had broad support in the AMA, which members of the Interagency Pain Research Coordinating Committee opposed the CDC guidelines, and whether this opposition was personal, or reflected the considered viewpoint of the committee.  Furthermore, that committee's purview does not obviously include clinical guideline development or public health, so why it was commenting on this issue was also unclear.  

The Pain News Network story which apparently was the source used by the Medscape in turn referred to a Politico story, but one which is only available to subscribers.  The Pain News Network also credited a survey by "the Pain News Network and the Power of Pain Foundation."

The Medscape article said nothing more about the Pain News Network.which is not exactly a household word in health care journalism.  The Pain News Network story did not give more detail about the Power of Pain Foundation, whose mission, nature, leadership, funding etc was not obvious.   

The Pain News Network story also quoted the Washington Legal Foundation's chief counsel.

The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers.

Similarly, the Washington Post article also credited the Washington Legal Foundation's opposition to the CDC guidelines,

The Washington Legal Foundation, a public interest law firm dedicated to protecting the free enterprise system, accused the CDC of trying to formulate them secretly by failing to make public the work of its original advisory committee, the Core Expert Group. The CDC disputes that accusation, but issued the recommendations in draft form Monday and will have them reviewed by another advisory panel after receiving more comment over the next 30 days, Frieden said.

Yet, neither the Pain News Network nor the Post explained why a group supporting "free enterprise" was so concerned about this issue, or what expertise it might have in this area.  It is ironic that a group that proclaims opposition to secrecy seems less than transparent about its involvement in this issue.

Finally, the nature of the Pain News Network, which claims to be a "non-profit, independent news source," is also obscure.  It appears to be one of those non-profits that has no physical address per its web page of contact information, does not disclose its sources of funding, and if it files US Internal Revenue Service 990 forms, I cannot find them.

The most detailed article I could find about the substance of the complaints about the CDC guidelines was in another obscure source, the Legal News Line.  The article mostly described the concerns of

Peter Pitts, a former associate commissioner of external affairs at the U.S. Food and Drug Administration and now president and co-founder of the Center for Medicine in the Public Interest, can be counted among those critical of how the panel was put together.

Pitts' main issue was that a member of the group that developed the CDC guidelines was biased. He said,

'So you have to have as open of a mind as possible.'

And that’s exactly where the CDC went wrong, Pitts said, pointing to Jane Ballantyne. Ballantyne served as a member of the CDC’s “Core Expert Group,” which played a key role in developing the agency’s opioid guidelines.

Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and last year was named president of the Physicians for Responsible Opioid Prescribing, or PROP.

PROP’s mission, according to its website, is to 'reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.'

'Not only does she have strong opinions, but extra strong opinions -- almost on the lunatic fringe -- on pain medicine issues,' Pitts said.

'For the CDC to say, we’re going to put someone who comes to the discussion with such preconceived notions on such a committee, you have to ask yourself, why? And then why was it hidden from the public?'

The Legal New Line's example of supposed journalism did not apparently ask Pitts what was "lunatic" about wanting to promote cautious and responsible prescribing of opioids.  That seems to me like common clinical sense, the opposite of insanity.  

Also, Pitts complained that beyond this alleged bias, Dr Ballantyne had a conflict of interest,

Pitts noted Ballantyne’s connection to law firm Cohen Milstein Sellers & Toll PLLC -- a plaintiffs law firm that is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.

Ballantyne reportedly disclosed her services as a paid consultant for Cohen Milstein to the CDC. The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers.

Note that in the first paragraph above, the writer apparently meant that the law firm donated to the campaigns of the attorney generals.

More importantly, why the apparent conflict of interest affecting a single member of a large group - the core expert group of which Dr Ballantyne sat included 17 people - was so important was not apparent from Mr Pitts' argument.  Mr Pitts did not explain how any sort of advisory group that included experts in the field could avoid people who already had strong opinions about that field.  The Legal News Line article did not discuss Mr Pitts' own background, or provide any information about the Center for Medicine in the Public Interest, which he leads.  

I could not find reporting in major news outlets or medical/ health care scholarly publications about the opposition to the CDC guidelines beyond the stories in the Washington Post, AP, and Medscape, and a brief report in Modern Healthcare.  I did find numerous articles on yet another little known website called the National Pain Report, (e.g. see this one).

So to summarize so far, the opposition to the new CDC opioid guidelines was apparently strong enough to delay, if not derail them.  Yet who was in the opposition, their funding, and their interests remains obscure.  The arguments of the opposition remain unclear.  Even some of the purported journalists reporting on the opposition remain mysterious.  There seems to be a tremendous amount of fog surrounding the opposition to more conservative prescribing of narcotics for non-cancerous chronic pain.

The Common Thread - Stealth Health Policy Advocacy


It was striking that much of the opposition seemed to come from rather mysterious organizations, the Pain Care Forum, Power of Pain Foundation, Washington Legal Foundation, and Center for Medicine in the Public Interest.  However, the reporting on these organizations was minimal.  Furthermore, some of the news sources reporting on the opposition to the CDC guidelines also were rather mysterious, such as the Pain News Network, National Pain Report, and Legal News Line.

One recent media article, and some of our previous blogging, though suggest that the opposition organizations all have ties to the pharmaceutical industry, and in several cases, directly to one of the major producers of legal opioids.  On December 23, 2015, Lee Fang wrote in the Intercept by way of an introduction,

The pharmaceutical companies that manufacture and market OxyContin, Vicodin, and other highly addictive opioid painkillers — drugs that have fueled the epidemic of overdoses and heroin addiction — are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.

In particular,

An investigation by The Intercept has found that the pharmaceutical companies that dominate the $9 billion a year opioid painkiller market have funded organizations attacking reform of the prescribing guidelines:

The Washington Legal Foundation, a nonprofit that litigates to defend 'free-market principles,' threatened the CDC with legal action if the agency moved forward with the proposed opioid guidelines. The WLG claimed the CDC’s advisory panel for the guidelines lacked 'fair ideological balance,' because it included a doctor who is part of an advocacy effort against opioid addiction. The WLF does not disclose donor information, but has filed friend-of-the-court briefs on behalf of Purdue Pharma, the makers of OxyContin. In a recent article with Pain News Network, a spokesperson for Purdue Pharma conceded: 'We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants.'

The Pain Care Forum organized opposition to the CDC prescribing guidelines, mobilizing regular meetings among stakeholders opposed to the idea, according to an investigation by AP reporter Matthew Perrone. A recently re-filed complaint by the City of Chicago found that Burt Rosen, the chief in-house lobbyist for Purdue Pharma, controls the Pain Care Forum. A former drug company employee allegedly told investigators that Rosen tells the Pain Care Forum 'what to do and how we do it.' The Pain Care Forum is funded through contributions by Purdue Pharma, as well as major opioid manufacturers Cephalon, Endo, and Janssen, a subsidiary of Johnson & Johnson.

 The Power of Pain Foundation, a group funded by Purdue Pharma, asked supporters to contact the CDC in opposition to the guidelines, claiming that 'taking away pain medication and making providers afraid to prescribe due to your guidelines is only going to make more abusers, increase suicides, and tear apart the lives of millions.'

Fang also noted that the Legal News Line, the source of the story documenting Peter Pitts' problems with the CDC guidelines, also is tied to the pharmaceutical industry:

The U.S. Chamber of Commerce, a corporate lobbying group that represents opioid manufacturers, including Johnson & Johnson, issued a press release masquerading as a news story [published by the Legal News Line] criticizing the CDC guidelines. (The U.S. Chamber operates a public relations effort dressed up as a bona fide media outlet called Legal Newsline, which it uses to disseminate stories that support the political priorities of its member companies.)

In addition, on Health Care Renewal we have previously discussed the Center for Medicine in the Public Interest.  Back in 2008, we noted that when writing for the New York Times, Mr Pitts had to disclose that the Center for Medicine in the Public Interest receives pharmaceutical industry funding, including from Pfizer and the PhRMA.  At that time, Mr Pitts' day job was  Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee had many big pharmaceutical accounts  Since then, he moved on to become director for global healthcare at Porter Novelli, also a public relations/ communications company with many health care corporate clients, including pharmaceutical companies, and now appears to be a consultant in the life sciences area for YourEncore.  I cannot find any updated information on current Center for Medicine in the Public Interest funding, but there is no reason to think that it is not still funded by the pharmaceutical industry.

Mr Pitts' published objections to the CDC guidelines had to do with the supposed bias and conflicts of interests of a single member of the guideline expert panel, and the alleged lack of transparency of the guideline project.  Yet Mr Pitts was not very transparent about his own background, and his and his organizations' financial interests.  For Mr Pitts to condemn the guideline panel member's conflict while hiding his own conflict amounts to a garish example of the logical fallacy of special pleading.  Similarly, the Washington Legal Foundation's objections to the alleged biases of the guideline panel, given that  foundation is apparently funded by Purdue Pharma, is another garish example of the same logical fallacy.

On the other hand, the Pain News Network and the National Pain Report remain obscure.   The former claims to be a non-profit organization, but I cannot find its federal 990 filing, identify its board of trustees, or even determine its physical address. It does claim an affiliation with the Power of Pain Foundation.  The National Pain Report at least has a physical address, which it shares with the equally obscure American News Report. Other details, like its ownership, remain obscure.  The failure of supposedly journalistic organizations to publicly reveal basic information about their nature and operations does raise suspicions that they are not really so journalistic.

Summary

In summary, the organizations most widely mentioned as opposing the new CDC guidelines that recommend more conservative use of opioids for chronic pain seem to be heavily involved with the pharmaceutical companies that make such opioids.  Thus, the opposition to the guidelines seems to be arising from a stealth public relations campaign leading to stealth health policy advocacy.  Furthermore, at least so far, the objections to the guidelines do not seem clearly based on logic and good evidence from clinical research, again suggesting they are more about financial interests than improving patient outcomes and reducing risks.

Overuse and misuse of opioids, which may lead to all the individual and social consequences of opioid addiction, are clearly major, worsening medical and public health issues.  We need earnest effort to address these problems, which should be informed by a logical, evidence-based discussion of the clinical and social realities.  Such a discussion is only hindered by the growing fog of objections launched by mysterious organizations funded by the companies who have made the most money selling narcotics.  So we also need some societal response to the growing domination of the public debate by marketing and public relations, often based on emotional manipulation, logical fallacies, and outright deception.

We cannot address our worsening health care dysfunction when public discussion and policy making blunders about in the fog of stealth health policy advocacy, stealth lobbying, and stealth marketing.  If the leaders of big health care corporations really believe they are making good products and providing good services that add value and improve patients' and the public's health, they ought to be able to rely on honest and open communications.  If they cannot disavow stealth public relations and stealth marketing, we ought to disavow the companies that practice them.

Not So Cheerful Musical Interlude

Unfortunately, given the topic of this post, here is Lou Reed singing Heroin



ADDENDUM (4 January, 2016) - This post was republished on the Naked Capitalism blog, sadly without Lou Reed. See the interesting comments appended to that version.

Also, this post was republished in its entirety on OpEdNews.