Thursday, August 18, 2022

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

 Impunity: an Introduction

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

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

But consider two important cases.  

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

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

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

In 2010 we wrote:

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

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

and

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

Purdue Pharma Executives Convicted in 2007

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

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

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

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

Today, as the New York Times reported:

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

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

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

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

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

Conclusion

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

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

 

Sunday, January 09, 2022

The New Business Coup? Increasing Evidence that Large Health Care Corporations are Funding Threats to Democracy

Introduction: Health Care Corporations' Political Contributions: From Bipartisan to Trumpian

 At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and political organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 


 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). In October, 2018, we discussed important but incomplete revelations about corporate contributions to such dark money groups that mainly favored again right-wing ideology, the Republican party, and Trump and associates. In November, 2018, we noted that health care corporations funneled funds through dark money organizations to specifically attack designated left-wing, Democratic politicians. In March, 2019, we discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post, this July 7, 2021, post, and this September 7, 2021 post).

Now just after the anniversary of an insurrection that almost prevented the certification of the 2020 US presidential election results, there are new indications that leaders of big health care corporations are continuing to support Republicans in Congress who voted to overrule the results of that election.

Health Care Corporate Sponsorship of the Attempt to Overturn the 2020 Election 

Citizens for Responsibility and Ethics in Washington (CREW) has updated their report on corporate sponsorship of the politicians who wanted to overturn the election.  The January 3, 2022 version is entitled "The Corporate Insurrection: How companies have broken promises and funded seditionists." It described the "717 corporations and industry groups have donated over $18 million to 143 of the 147 members of Congress who objected to the results of the 2020 presidential election, as well as the National Republican Senatorial Committee and the National Republican Congressional Committee."  It referred to the updated data about the largest corporate funders appearing in the current version of CREW's previous report.  The health care corporations that appear in this list of 80 are:

Pfizer                                        $71,000

Merck                                      $68,000

Eli Lilly                                   $42,000

Johnson & Johnson                   $38,500

Anthem                                   $32,500

Cigna                                       $30,000

CVS Health                            $30,000 

AstraZeneca                           $26,500

Humana                                $15,000

Blue Cross & Blue Shield         $15,000 

Keep in mind that these amounts only reflect corporate donations directly to members of Congress, their own leadership PACs, and to the national Republican campaign committees, which must be disclosed by law. They do not include any amounts given by corporate executives, or amounts given to various kinds of dark money organizations, which do not have to be disclosed according to law.  Thus they may seriously undercount the financial support given by health care corporations to support those who wanted to nullify the election. But at least these figures suggest that 5 large pharmaceutical/ biotechnology companies, 4 health care insurance companies, and one diversified pharmacy company continue to be strong supporters of legislators who were willing to do so.  

Furthermore, as noted in a January 5, 2022, article in Fierce Pharma, spokespeople for some of these corporations declared they were no longer worrying about whether politicians support democracy or tried to overturn an election, but only about whether the politicians support policies that would improve their corporate bottom lines.  For example, see this from Pfizer:

Pfizer’s PAC supports policymakers who value innovation and expanded access to breakthrough medicines and vaccines that change patients’ lives,

And see this from Eli Lilly: 

[the company] supports candidates across the political spectrum who understand the value of a vibrant pharmaceutical ecosystem to address unmet patient needs.

Billionaires Who Made Their Money from Health Care Corporations Who Supported the Attempt to Overturn the Election  

A January 6, 2022 article in Forbes listed the "more than 50 billionaires [who] donated in the second half of 2021 to legislators who voted against certifying the presidential election, according to an analysis of Federal Election Commission records."  Two the billionaires made their fortunes from health care corporations.  They were: 

- Phillip Frost, worth $2,500,000,000, described as "a long-time health care investor, inventor and founder, Phillip Frost now runs diagnostics-maker Opko Health." He "joined Key Pharmaceuticals in 1972, reformulated its asthma drug and sold the company in 1986 for $836 million." Also, he "founded Ivax, a generic drugmaker, in 1987. He sold it to Teva Pharmaceuticals for $7.6 billion in 2005"  Frost supported Sen Hawley (R-MO). 

- James Leininger, worth $1,500,000,000, described as having "made his fortune founding medical devices company Kinetic Concepts (KCI), which focuses on wound care." He also runs "Medcare Investment Funds, which manages $1 billion in assets." Leininger supported Rep Cloud (R-TX). 

 Discussion

 As we said before, most health care corporations publish high-minded aspirational statements that promise pluralism, support of the community, and of our representative democratic society. Data revealed recently and discussed in our previous three posts increasingly show that some leaders of  large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would challenge election outcomes in the absence of very clear evidence of election irregularities seems to violate high-minded corporate pledges of inclusiveness.

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

Also, the quotes above support the idea that corporate leaders put their own bottom lines ahead of supporting the republican form of government that partially made their revenues possible.

On the other hand, maybe it is not just about money.  Again, as we said before, by virtue of being top corporate managers, particular individuals can control political funds far beyond what they would  be able to control as private persons, and to do so quietly and sometimes anonymously.  Corporate leaders may thus be able to promote their own interests through their corporations' political giving.  Those interests may go beyond just personal enrichment.   Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, authoritarian, even openly fascist national political leadership.  

Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)  

There was at least one previous instance in which US business leaders tried to effect a coup to oust a President they considered too left wing.  This was sometimes called the "business coup."  According to a Washington Post article from 2021, its sponsors included "included J.P. Morgan Jr., Irénée du Pont and the CEOs of General Motors, Birds Eye and General Foods."  Their goal was to depose President Franklin D Roosevelt and 

install a dictator who was more business friendly. After all, they reasoned, that had been working well in Italy

The plot failed because the former military officer they chose to lead it informed the government.  So far, the attempt by now former President Trump and his followers to do something similar has also failed. That does not mean, however, that the next attempt will not succeed.

 


IMHO, all citizens need to wake up and  protect our republic.  Furthermore, all medical and public health professionals specifically need to take action to wake up and protect our republic specifically from self-interested health care corporate leaders.  Imagine what health care and public health might be like were they to exert near absolute control facilitated by an authoritarian they installed in office 

 

 

Friday, December 24, 2021

Guest Blog: Susan Levenstein, MD, on the Omicron Variant

To encourage wider dissemination, we're pleased to provide here an author-abridged and -authorized version of a recent number of the Stethoscope on Rome blog by Susan Levenstein, MD. A long time resident of and practicing internist in Rome, she has been interviewed in many countries both in the US and in Europe. She here dissects the latest news, as of four days ago, on the Covid-19 omicron variant.

Dr. Levenstein, trained in the US and an avid student of its medical system, is a reader of HCR.  Her own blog beautifully complements and extends what we do here. Readers would do well to subscribe to both, as well as to consider dipping into her recently published, and most illuminating ,autobiography, Dottoressa. This account of a life and career spanning two cultures is a masterful overview not just of a major component of European medicine — one of the EU's most successful systems — but of the comparative aspects of national health systems across two continents.

[Jump to succinct run-down on holiday tips — what to do and not to do: skip to the end.]

-------------------------------------------------------------

An Update and Some Advice on Safe Celebration from Dr. Levenstein


Vaccines

Evidence that the Omicron variant escapes vaccine protection is mounting. Take the 7 young, healthy German visitors to South Africa who all fell ill with Omicron despite being triple vaccinated, perfect demonstration that neutralizing antibodies from boosters do not necessarily translate into real-life protection. 

Our best data come from a UK study. Vaccine effectiveness against symptomatic Omicron, 15 or more weeks after dose 2, was nil for AstraZeneca, 35% for Pfizer. A Pfizer booster raised it to 71% following AstraZeneca, to 76% following Pfizer. Two-dose Pfizer was considerably more effective against Omicron in the short run, 88% at 2-9 weeks after dose two. Since higher doses of medications generally last longer, simply hiking up Pfizer’s 30 mg to Moderna’s 100 mg or even Moderna’s 50 mg booster might make that high effectiveness longer-lasting. That’s purely my own, possibly crazy, idea. 

Another study, from a South African insurance company, found double vaccination with Pfizer 70% protective against Omicron hospitalization, but just 60% at ages 70-79. Against any COVID-19, effectiveness was only 33%. Too few South Africans have received boosters for this study to gauge their effect.

Are new vaccines or new versions of old vaccines necessary? As of December 15th Anthony Fauci was still saying no, because “Our booster vaccine regimens work against Omicron.” I say yes: even 76% protection is not good enough. 

Transmissibility

Omicron is definitely a superspreader. In South Africa the most useful measure (Rt) for COVID-19 reproduction rose from 0.8 late in the Delta wave to well over 2 now. But most South Africans have some immunity from prior exposure (seropositivity rate 60-70%), so the rate of spread could be even faster elsewhere. Indeed, confirmed Omicron cases double in the UK every 3 days, for an estimated Rt  of 3.7, meaning every case infects about 4 others. If anything, it’s worse in the US: 0.7% of infections 2 weeks ago, 12.6% one week ago, 73% now.

A laboratory study from Hong Kong gives early hints of why Omicron behaves as it does. Researchers exposed surgical specimens of bronchial and lung tissue to the Wuhan, Delta, and Omicron strains, then watched for 48 hours. Omicron multiplied faster than the others in bronchial cells but more slowly in the lung, perhaps explaining both sky-high transmissibility and low virulence. 


Severity

In Denmark the new variant is rapidly taking over. But as of December 12th they’d had only 27 hospitalizations out of 2471 cases, compared with a Delta-wave hospitalization rate of around 10%. Danish scientists are concerned nonetheless: 

  • The new variant has spread thus far mostly in young people, who rarely get very sick
  • COVID-19 patients often deteriorate a week or more after symptom onset, so it’s early to judge 
  • Denmark is the most highly vaccinated country in Europe, but most have had only two doses of vaccine, and boosting everybody will be a logistical nightmare
  • The variant spreads like wildfire, so even with less severe disease, the hospitals could be overwhelmed 

Currently that wildfire is burning its way through the US, where only 72% of adults have had even two doses of vaccine (versus 96% in Denmark) and where 15% of all adults – including 5% of those over 65 – have still not had a single shot.

The South African insurer’s study found a 29% lower hospitalization rate than in early 2020. And a government presentation (screenshots above) reports strikingly lower mortality and ICU admission rates among hospitalized patients than in earlier waves. Maybe doctors are hospitalizing people who are less sick, but that seems improbable. More relevant is that South Africans’ widespread previous exposure to SARS-CoV-2 and their relative youth (median age 28, versus 39 in the US) predict milder disease whatever the viral strain. 

Yet more hints: 4 of those 7 young Germans in South Africa had only cold-like symptoms, but 3 became short of breath despite their age, triple-vaccination, and normal oxygen saturations. And 85 Omicron-related hospitalizations, mostly in double-vaccinated individuals, have been reported in the UK, with 7 deaths.

Predicting the future

A recent Bloomberg headline — "England could face 75,000 deaths this winter" — is terrifying. But if you look at the related study itself you see less dire results. The researchers constructed models based on different levels of vaccine efficacy and immune escape, with the 75,000-death figure assuming high immune escape and boosted vaccine efficacy of 50%-60%. But with our best estimate of boosted effectiveness over 70%, the number of hospitalizations and deaths will be lower. Even more crucially, the models assume that Omicron is just as virulent as Delta. Since considerable evidence indicates the contrary, those dire predictions should be further adjusted downward. The authors cautiously call their report not a preprint but a work in progress, to be updated as more data become available. 

However… Tedros Adhanom Ghebreyesus, the non-alarmist Director-General of the WHO, emphasizes, as I do, that even if Omicron does cause milder disease it is so contagious that it could still overwhelm health care systems if huge numbers of people get sick at once. A giant surge of even mild cases could wreak havoc on economies, healthcare systems, and people’s lives, with swab-positives and their contacts staying home in isolation or quarantine. A giant pandemic of long COVID would likely ensue, since it can follow mild disease – possibly (questionably) even asymptomatic infection. In the long run Omicron should be the variant from heaven, infecting more people than Delta while causing fewer deaths, but it could sure be hell in the next few months.  

What to do? It seems obvious that we need to vaccinate the unvaccinated like crazy, boost the vaccinated like crazy, work like crazy on Omicron-specific vaccines, and intensify masking, ventilation, and distancing. I personally support even more drastic measures: institute Green Passes everywhere (coming soon in the UK), close down restaurants and other public-facing businesses for several weeks (happening already in the Netherlands), promote working from home, quarantine people entering countries, or US states, from high-risk areas, and consider brief lockdowns. Time will tell.

++++++++++++++++++++++++++++++++++

Some tips to make yourself safer.

  • keep the guest list down, so seats can be spaced out at the table
  • make sure everyone is vaccinated (with boosters if they’re five months out)
  • everybody should do rapid tests that morning
  • anyone with the slightest symptom should stay home
  • party outdoors if weather permits
  • everybody wash their hands when they come in
  • leave a window at least partly open
  • consider wearing masks when not actually eating or drinking
  • consider investing in a portable HEPA air purifier: examples in the US and Italy
  • hugs and kisses: try to resist the temptation
  • separate unvaccinated kids from older adults
  • no Christmas carols! (singing is the best way to spread droplets)
  • be extra careful if anyone is over 65, chronically ill, immunosuppressed, or pregnant 
  • be extra careful if there’s high community transmission
  • coming in by train, bus, or airplane? Wear KN-95 masks when travelling, grab bites quickly, open a window if you can…
  • and, ideally, self-isolate for 3-5 days before the event

Saturday, December 04, 2021

The Irresponsibility of Political Leaders Encouraging Vaccine Resistance by Health Care Professionals: One Small Response to a Local Example

[Below is the text of a letter to the editor I wrote to the Providence Journal about one state legislator who praised the "joyful" resistance of health care professionals to vaccination.  It was published today, December 4, 2021, but appears to be unavailable on the internet. I believe that it applies to many other similarly irresponsible, reckless political leaders throughout the US.]

Dear Editor:

State Senator de la Cruz (Political Scene, Nov 29, 2021)  extolled “joyful defiance” of  health-care workers refusing vaccination: “I am so proud of them for standing firm in their convictions. ... 'No one is going to have a say over my body but me.'”

However, their “joyful defiance” was of the prime directive for health care professionals: to put the health and safety of their patients ahead of all other concerns.  We have a duty to protect their patients from unnecessary health risks.  

During the COVID era, that duty includes the risk of acquiring COVID, a dangerous, sometimes deadly disease.  It also includes protecting their fellow health care professionals from COVID so that they can continue to care for their patients.

Good evidence from randomized controlled trials shows that the currently available vaccines  decrease risk of acquiring COVID.  At least plausible data from observational studies shows vaccination decreases the risk of transmitting COVID once acquired.

Therefore, health care professionals have a duty to be fully vaccinated against COVID to protect their patients and other health care professionals.  Individuals may have an intrinsic right to refuse medical treatments, but that  does not give health care professionals the right not to minimize the risks that they will transmit COVID to patients or other professionals.  Uunvaccinated health care professionals should have no contact with patients or other health care professionals.

It is irresponsible and reckless for a political leader to advocate or facilitate health care professionals’ refusal of COVID vaccination, no matter how “joyful.”

Tuesday, November 23, 2021

The New New Abnormal: What Should We Do in a World Becoming Increasingly Irrational?

We Health Care Renewal (http://hcrenewal.blogspot.com) bloggers once again apologize for our chronic lack of posting on the blog. However, we remain perplexed about what contribution to make on now an old-school, long-form web-based publication.  
 
Our oft-stated, somewhat nuanced concerns about aspects of health care dysfunction (see: What the US "Health Care Reform" Debate Did Not Address) now seem quaint.  These included:
 
- threats to the integrity of the medical evidence base (eg, suppression and manipulation of research)
- distortion of health care regulation and policy (eg, through deceptive public relations practices, conflicts of interest, particularly the revolving door, and regulatory capture) 
- bad leadership and governance that might be ill-informed, mission-hostile, or corrupt
- abandonment of health care as a calling, often through the rise of the corporate physician 
- perverse incentives putting money ahead of patient care, education and research 
- the cult of leadership, which may be suffering from "CEO disease
- taboos, including the anechoic effect  now seem quaint.  Even our updated concerns about the "new normal" (see: https://hcrenewal.blogspot.com/2019/05/the-new-abnormal-in-health-care.html)  have been eclipsed.  

Back before the COVID epidemic, we tried to develop an organized picture of what we called the "new abnormal." But even that seems out of date after the onset of the COVID pandemic.

For example, we have gone from addressing relatively subtle distortions in the clinical research base (eg from manipulation of specific aspects of controlled trials, and their dissemination) by highly trained professionals working for health care corporations in the pursuit of greater product sales at higher prices to the promotion of quack cures based on outright lies and nonsensical arguments by extremist politicians sometimes with the support of snake -oil salesman, often with the goals of not only selling useless or harmful nostrums but of promoting extremist, if not authoritarian political agendas (see early examples in posts here, here, and here).  When we argued with the subtle research manipulators, the worst we were called was "pharmascolds."  Now my Twitter comments include insults ranging from "dense" to "idiot" to unprintable.  Some people trying to promote evidence based medicine have received death threats.  And that is just a sample of what is going on, as many of you know.

Meanwhile, this is all far from anechoic.However, the old-school news items on which we used to rely, eg a corporate CEO paid disproportionately given his company's contribution to human health, have all but disappeared.

So what can we write on Health Care Renewal that will add to the light but not the heat? The HCR bloggers would appreciate your suggestions. Please add some comments below, or email me. 

 

Tuesday, October 19, 2021

On the primacy of the physician-patient relationship, from an unlikely source - the Attorney General of Nebraska

I have not written much at this site, or any site, in recent years due to being kept busy supporting litigation regarding bad healthcare information technology as an expert witness.

A recent letter, however, so caught my eye regarding both current events and my past writing about bad health IT, that I decided to write about it.

It is perhaps a poignant reminder of the craziness of the times in which we physicians find ourselves that a well researched letter on the primacy of the doctor-patient relationship, and the non-interference with that relationship by outside forces based on opinions of non-clinicians, half-baked ideas, overzealous government, media hysteria to garner audience share, etc. comes not from the hallowed halls of academia or a prestigious medical journal - but from a state Attorney General, namely, of Nebraska.

The letter, dated Oct. 14, 2021 and entitled "Prescription of Ivermectin or Hydroxychloroquine as Off-Label Medicines for the Prevention or Treatment of Covid-19", is located at this link: https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf

It was requested by Dannette R. Smith, the Chief Executive Officer of the Nebraska Department of Health and Human Services.

I recommend reading it in its entirety.

In this 48-page letter, arguments regarding sanctioning of Nebraska physicians for their decisions on how to treat their patients with FDA-approved drugs for off-label purposes are discussed in significant detail and with significant literature references.  The letter reaches the conclusion that:

...  Based on the available data, we do not find clear and convincing evidence that a physician who first obtains informed consent and then utilizes ivermectin or hydroxychloroquine for COVID-19 violates the UCA (Nebraska Uniform Credentialing Act). This conclusion is subject to the limits noted throughout this opinion. Foremost among them are that if physicians who prescribe ivermectin or hydroxychloroquine neglect to obtain informed consent, deceive their patients, prescribe excessively high doses, fail to check for contraindications, or engage in other misconduct, they might be subject to discipline, no less than they would be in any other context ... Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained healthcare system.


No matter one's opinion on the specifics of this particular controversy, the primacy of the physician-patient relationship - absent extreme circumstances of malfeasance/malpractice - is a principle that should not now, and should never need a 48 page letter for its justification

I find the following passage on pg. 36 particularly intriguing relative to my many essays in the past on observations by many parties that healthcare information technology (e.g., EMRs) are unhelpful and even harmful to provision of medical care, and the response from the Medical Informatics "establishment" and HIT industry that those observations are "anecdotal" and meaningless (e.g., see my 2010-2011 posts "Health IT: On Anecdotalism and Totalitarianism" at https://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html and its linked posts, also "The Dangers of Critical Thinking in A Politicized, Irrational Culture" at https://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html and "Australian ED EHR Study: An End to the Line 'Your Evidence Is Anecdotal, Thus Worthless?'" at https://hcrenewal.blogspot.com/2011/03/australian-ed-ehr-study-putting-lie-to.html).

... To be sure, these data derive from large-scale observational studies rather than RCTs, and we understand that RCTs are considered the gold standard in medicine. But for at least two reasons, we find these observational studies sufficient for our purposes.  

First, our role is not to set a standard for the practice of medicine. Rather, we must simply confirm whether reasonable medical evidence supports the use of hydroxychloroquine as an early COVID-19 treatment, and we determine that a collection of large-scale observational studies suffices for that purpose. Second, a seminal review of the scientific literature has revealed that “on average, there is little evidence for significant effect estimate differences between observational studies and RCTs, regardless of specific observational study design, heterogeneity, or inclusion of studies of pharmacological interventions.” 235 There is thus no basis to cast aside the observational studies demonstrating hydroxychloroquine’s efficacy as an early COVID-19 treatment.  

235 Andrew Anglemyer et al., Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials, Cochrane Database of Systematic Reviews, at 1 (2014), available at https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.MR000034.pub2/epdf/full (last visited Oct. 14, 2021)

I find the second observation in that paragraph about outcomes of observational studies vs. RCTs truly fascinating.

The arguments by the HIT hyper-enthusiasts that observational data from a wide variety of qualified personnel is "anecdotal" and thus invalid (e.g., from physicians such as at my Jan. 2010 post "An Honest Physician Survey on EHR's" at https://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html as just a small example of the observational data accumulated over many years) and demands that only RCT's (which are, in fact, nearly impossible to conduct) could validate efficacy and safety risks of EHRs fail under the above.

Observational data by qualified observers needs be taken more seriously in all of biomedicine, and not dismissed with the refrain that "it's not a RCT."

If that had happened in the domain of HIT, perhaps I would not now be spending so much time assisting litigation regarding HIT evidentiary obfuscation, HIT-related patient harms, and other litigation issues.

-- SS



Tuesday, September 07, 2021

More Large Health Care Corporations Are Again Funding Politicians Who Threatened Representative Democratic Governance

Introduction: Health Care Corporations' Political Contributions: From Bipartisan to Trumpian

 At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and political organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 


 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). In October, 2018, we discussed important but incomplete revelations about corporate contributions to such dark money groups that mainly favored again right-wing ideology, the Republican party, and Trump and associates. In November, 2018, we noted that health care corporations funneled funds through dark money organizations to specifically attack designated left-wing, Democratic politicians. In March, 2019, we discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post, and this July 7, 2021, post).

Now yet another report shows continuing support by large health care corporations for Republican legislators who supported the nullification of the election.

 Health Care Corporate Funding of Politicians Who Would Overturn an Election

On August 17, 2021, Popular Information published The January 6 Corporate Accountability Index.  It promised to be results of a comprehensive monitoring efforts of corporate pledges to make changes in their political giving to the "147 Republicans who voted to overturn the election, setting the stage for the riot." It included several categories of pledge violations.  Its results included some of the companies who went back on their pledges as described in our April and July posts.  It also included many more companies that did not make it to previous reports.  The relevant results by category were as follows

Corporations that pledged to suspend donations to the 147 Republican objectors but directly donated to those Republicans

Not included in previous reports: none

Included in previous reports: Cigna, Eli Lilly

Corporations that pledged to suspend donations to all 147 Republican objectors but violated the spirit of the pledge

Not included in previous reports: 

"After January 6, Genentech [part of the "Roche group'] said it would suspend contributions to Republican objectors. Genentech donated $15,000 to the NRCC and $15,000 to the NRSC on June 30."

"After January 6, Sanofi said it would suspend contributions to Republican objectors. Sanofi donated $15,000 to the NRSC on 3/17."

Corporations that pledged to suspend all PAC donations and then directly donates to the 147 Republican objectors

Not included in previous reports:

DaVita 

Included in previous reports: Abbott Laboratories, Gilead, Novo Nordisk

Corporations that pledged to suspend all PAC donations and then indirectly donated to the 147 Republican objectors

Not included in previous reports:

Baxter International

Included in previous reports: United Healthcare

Corporations that pledged to reevaluate their donation criteria after January 6 and directly donated to GOP objectors

Not included in previous reports:

Amgen, Laboratory Company of America

Corporations that pledged to reevaluate their donation criteria after January 6 and then indirectly donated to the 147 Republican objectors

Not included in previous reports: none

Included in previous reports: CVS

Discussion

As we said before, most health care corporations publish high-minded aspirational statements that promise pluralism, support of the community, and of our representative democratic society.  For example, Sanofi Pasteur claims:

Sanofi’s social impact strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the world’s poorest people
However, the new data revealed above, and data discussed in our two previous posts showed that leaders of  more and more large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would challenge election outcomes in the absence of very clear evidence of election irregularities seem s to violate high-minded corporate pledges of inclusiveness like those above.   

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

On the other hand, maybe it is not just about money.  Again, as we said before, by virtue of being top managers corporations, particular individuals can control political funds far beyond what they would  be able to control as private persons, and to do so quietly and sometimes anonymously.  Corporate leaders may thus be able to promote their own interests through their corporations' political giving.  Those interests may go beyond just personal enrichment.   Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, authoritarian, even openly fascist national political leadership.  Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)

Leaders of large corporations now appear willing to wield large amounts of political power leveraged by the organizations they control.  Yet until recently they may have been able to do so without disclosure to society at large.  That society may be greatly affected by this power, but when it can be wielded quietly, have had little say in who has it and its uses.  

We as health care professionals, policy makers, patients and members of the public at large deserve to know how health care corporate leadership is directing money to political causes, and how they benefit from doing so. If they are not doing this in our interests, our we need to make sure things change.

Friday, July 23, 2021

Money and Aducanumab

In my previous posts, I haven't talked too much about the price set for aducanumab. Since I think it should not have been approved on current evidence regardless of price, the approval has been my focus. But of course the price is an issue, especially given that there is a HUGE pool of potential patients and that most are probably Medicare age, meaning that this drug can have huge impacts on Medicare costs.

Before and after approval, there was speculation that this "potentially zillion-dollar moneymaker" (as Sharon Begley called it in October 2019) might be the most lucrative drug ever. Last November it was noted that if it brought in even a fraction of potential patients, it could still realistically be a $60 billion/year drug, changing Biogen's revenue picture dramatically.

Taking a high-side estimate of $110 billion/year, Nicholas Bagley and Rachel Sachs speculated in The Atlantic that Aduhelm could be the drug that breaks Medicare, given that that cost exceeds total current Part D medication expenses of $90 billion dollars.

Even at a much lower total, Aduhelm's costs would still balloon Medicare costs and would exceed the total NASA budget of $23 billion. Regardless of the exact total, the hit to Medicare would be big.

The cost to Medicare...could be substantial.... In 2017, nearly 2 million Medicare beneficiaries used one or more of the currently-available Alzheimer’s treatments covered under Part D, based on an analysis by the Kaiser Family Foundation. If one-quarter of those beneficiaries are prescribed Aduhelm, or 500,000 beneficiaries, total spending for Aduhelm in one year would be nearly $29 billion. This assumes Medicare will pay 103% of the list price until an average sales price is established. In any event, the Kaiser estimate suggests the total cost would far exceed spending on any other drug covered under Medicare Part B or Part D, based on 2019 spending data. “To put this $29 billion amount in context, total Medicare spending for all Part B drugs was $37 billion in 2019,” Kaiser wrote.

We get to these high numbers because the company set the cost at $56,000/year. $56,000 is a very high price for a drug no one thinks has more than a moderate and subtle clinical benefit. I was struck by this reflection:

“I cannot think of a justification for that price for this drug given the evidence thus far except that Medicare will pay it,” said Walid Gellad, an associate professor of medicine who heads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “If $56,000 is a reasonable price for this drug, then what [would be] a reasonable price for a drug that has a large impact on changing the course of Alzheimer’s?"

That's an excellent question. Another meaningful question is whether anyone will put in the effort to develop really good drugs for Alzheimer's, if you can make this kind of money from a drug that is at best marginally beneficial and possibly not beneficial at all.

Because, for all this money, how meaningful are the benefits? In short:

“Absolutely tiny,” said UCL’s Howard. Aducanumab “didn’t stop dementia or reverse it, and even if we take the data at face value, the benefits are practically undetectable. As a clinician, it would be nearly impossible to tell if it works in one of your patients.”

Nonetheless, the Biogen CEO said he wasn't worried about blowback on the price, comparing the price to that charged for other monoclonal antibody treatments like Humira and Keytruda.

Even some who are enthusiasts, like the Alzheimer's Association, have questioned the high price of the drug, although there is some question about whether some of that is performative. This doubt partly arises because

months ago, the association also gave Biogen some cover for setting a higher price for its drug. It repeatedly sparred, for example, with the drug pricing watchdog ICER after the group suggested Aduhelm was only worth between $2,500 and $8,300 per year. (Meyer, the group’s spokesman, pushed back against the idea that its criticism of ICER had made it easier for Biogen set a higher price, calling the idea “patently false.”)

One thing that has not been much noted is that the price for many individuals will be HIGHER than $56,000/year, because the drug is dosed by weight, and $56,000 is the price per maintenance dose year for an "average weight" of 74 kg (about 163 pounds), so many will have higher costs (and higher co-pays).

Although it won't likely change the total financial impact, Biogen's share of the market may be reduced quickly, because after aducanumab's accelerated approval, other companies, including Eli Lilly and perhaps Roche, are hoping to speed up approval of other such drugs. Biogen too with its partner Eisai has another amyloid-clearing drug in the works.

There's more to say about spending so much money for so little benefit and I may or may not get around to another post on that topic. But meanwhile, I have been a bit gratified - and Biogen has been very put out - to see that there has been major pushback from multiple players on the accelerated drug approval and on the cost. Insurers and major hospital systems alike are reluctant to get the ball rolling on this. It's probably just a slowdown, but Biogen is whining a lot. In an open letter, Alfred Sandrock, their Research and Development head, wrote:

Unfortunately, ADUHELM’s approval has been the subject of extensive misinformation and misunderstanding. It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data. That is how science advances and we welcome these discussions. Recently, however, there has been a turn outside the boundaries of legitimate scientific deliberation.... ADUHELM is the first Alzheimer’s treatment approved since 2003. An important question is being overlooked by many: what would be the impact of deferring access to this treatment, despite the clinical data underlying its approval? Based on our current estimates of the progression rates of the disease, every day over 1,000 Americans will advance from early stages of disease to moderate and severe stages of disease, and thus may progress beyond the stages during which ADUHELM should be initiated. We feel a strong obligation to be able to offer new options to patients with this devastating disease.

And when Biogen is not whining, it's rolling out an aggressive marketing campaign to get people to worry about their memory capacities. Its website with a doubt-inducing quiz sends all comers (even if they answer all questions negatively!) to consult with their doctor for cognitive testing to determine if they may have early Alzheimer's and be a candidate to take Biogen's at-most-marginally-effective and expensive drug.

Thursday, July 08, 2021

The Future of Aducanumab - as a Medicine and as a Financial Product - What Happens Now?

To recap: the FDA recently (and foolishly) approved Biogen's monoclonal antibody aducanumab as a treatment for Alzheimer's. It did this on the basis of a surrogate endpoint, amyloid plaque reduction, even though, in NUMEROUS trials, that has not been associated with clinical improvement. The company is claiming that there IS clinical improvement based on high-dose patients in one of two clinical trials that were stopped for futility, based on a post hoc analysis. According to an NEJM Viewpoint article authored by three of the FDA advisory committee members, those patients had an absolute improvement of 0.39 on a clinical scale (the Clinical Dementia Rating-Sum of Boxes) but "the minimum clinically important difference [on this scale from 0 to 18] is generally considered to be 1 to 2." The FDA advisory committee was overwhelmingly unconvinced this showed the drug to be effective, but the FDA went the "accelerated approval" route and approved it anyhow, on the basis that it shrinks amyloid plaque.

Rescission of approval - best case future, but unlikely

Best case for what happens now is that approval is rescinded, and I think that we SHOULD absolutely push for that sliver of a chance that that could happen. The volume of informed voices protesting the accelerated approval is somewhat heartening, and might indicate wide support for such a move. All the same, that's a very remote possibility, with FDA leadership firmly opposed, even though a couple of congressional committees are supposed to be looking into the approval. So if rescission doesn't happen (and I'd have to say it won't), what now?

The future according to proponents

If one listens to the proponents of the drug, what happens next is likely to be a golden era of progress in treatment for Alzheimer's. Yes, maybe Aduhelm isn't very effective overall, but it's a start and may help some people much more than the average outcome indicates. As a start, it will be followed by better drugs and is the beginning of a new era. The high price is warranted because Alzheimer's is a huge problem, so even marginal help is of immense value, especially if it accelerates greater progress as more drugmakers jump on the bandwagon.

A more realistic rosy scenario

I think some people, including acting FDA head Janet Woodcock, have convinced themselves of the above golden future, but I believe this is a ridiculous fairy tale and about as likely as snow in July. So here's my version of a rosy scenario: insurers and legislators force down the price of Aduhelm somewhat, and it's prescribed to a large number of people but not as large as originally predicted. The brain swelling side effects prove to be not too troubling, and although clinical effects overall are marginal to none, it does help some people more than averages would indicate, and some individuals do realize a substantial benefit for themselves.

Even in this most rosy of realistic scenarios, the financial impact of the drug will be major, causing huge financial stress on both individuals with Alzheimer's and on the medical/insurance systems. As well, research on more promising avenues to treat Alzheimer's will likely be impeded, both because it will be more difficult and complicated to enroll people in clinical trials, and because if companies are incented to develop lousy drugs and can make a fortune that way, the incentive to produce really great drugs is thereby diminished. And, as Elizabeth Rosenthal pointed out in an excellent and interesting column, after the accelerated approval, we may in fact never learn whether Aduhelm actually works or not.

The most likely future

A less rosy but perhaps more probable scenario - the one I personally would wager on though I could be wrong - is that the drug will be approved, be widely prescribed, and provide no discernible or provable benefit to anyone, while worsening the lives of patients financially and by additional medical procedures and tests and side effects. Desperate people will be provided with false hopes and real costs.

I think this is most likely, because there is not something like an even chance that aducanumab is effective. Given the dicey nature of post hoc analyses and the many failures of amyloid-targeting drugs, the smart bet is that this drug doesn't work, although that's not a certainty.

Aducanumab and money

The future of aducanumab as a medical product is murky and uncertain, but the future of aducanumab as a financial product is something else. It looks to extract vast amounts of money from people in the form of premiums, taxes, and co-pays, and to greatly enrich Biogen and its stockholders.

Vinay Prasad had comments on drugs that are primarily financial products on a recent podcast (at 18.05 minutes in, but to get the full context, start listening at 15.51). He was not specifically addressing aducanumab, which had not been approved at that time, but thinking more of some cancer drugs. Prasad noted:

[When the FDA approves drugs without good evidence,] they keep so many people happy in the ecosystem, the companies are happy, the providers are happy, the people running the trials are happy, the patient advocacy groups, who are funded by the companies, they're happy, but the people who aren't happy are, the average person in society, whose premiums are going up, whose real wages are stagnating or declining. because we're paying more in health care, and this person is seeing more and more of their paycheck going off to health care, and what is that really saying?

it's saying that we're going to take this money from you, and we're going to collect it from everybody, and offer a service to everybody that we believe is a human right, the right to have good health care, and I actually support that, I believe that is a human right, but it's a human right to have things that actually benefit you - is it a human right to have snake oils or things that don't work? That I think is actually a financial product.

I mean, if I make a molecule, that is patentable, and I give it to cancer patients in a trial and I find some changing biomarker, and I give it to people in the real world, not a single one of them or nobody in aggregate lives a day longer and their quality of life is the same, what have I created? It's something that you call a medicine, you call it a medicine, but people aren't living longer, they're not living better, with my medicine, hypothetically - it's not a medicine, it's a financial product.

It's a product that actually collects wealth from lots of people, from middle-class people, from poor people, and it shovels that wealth into the hands of a few shareholders of this company, it is a reverse financial product, it's like a regressive financial product. ...there have long been feudal systems, where average workers kick up some of their wealth to the elites, and to some degree, when you have cancer drugs that don't work, you have created a feudal system, we're all kicking up our wealth, so that some people get really rich, and whether or not we get better health for it, is an uncertainty. and I think that's the crux of the issue.

We do not know if aducanumab is a medicine in any true sense of the word at all. We are pretty certain that it's a good business proposition and a money-maker, even if it might be snake oil. And we know that, like so many things nowadays, it will suction money upwards from the less well-off to the richer, and contribute to inequality.

And how MUCH money will it suction away from other uses? That too is an interesting question, although one with no certain answer other than "a lot," and perhaps the one that has caused the most speculation and discussion to date. I'll post more on the finances and perhaps some other aspects later.

Wednesday, July 07, 2021

Leadership of Big Health Care Corporations Go Back to Financially Supporting the Opponents of Democratic Governance

At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and poltical organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). In October, 2018, we discussed important but incomplete revelations about corporate contributions to such dark money groups that mainly favored again right-wing ideology, the Republican party, and Trump and associates. In November, 2018, we noted that health care corporations funneled funds through dark money organizations to specifically attack designated left-wing, Democratic politicians. In March, 2019, we discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 


 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post).

Now two new reports show continuing support by large health care corporations for Republican legislators who also supported the nullification of the election, and legislation that might decrease voting by citizens who oppose Trump

Health Care Corporate Sponsorship of Voter Suppression

In April, 2021, Public Citizen published "The Corporate Sponsorship of Voter Suppression." It detailed support from direct corporate contributions and corporate political action committees (PACs) from 2015 through March, 2021, to state legislators who authored, sponsored or voted for 245 bills that could have made it more difficult for citizens to vote in elections. 

The 25 companies contributing the largest amounts of money to these legislators included UnitedHealth Group ($411,200 total); Pfizer ($308,085); and Centene Corp ($205,200).  Companies that gave somewhat less included Merck ($180,000),  CVS ($174,000), Anthem ($138,150) Eli Lilly ($124,000) and Cigna ($109,225).

Two health care related trade groups also gave significant funds to these legislators: the Virginia Dental Association ($223,000) and the  Pharmaceutical Research and Manufacturers Association of America/PhRMA ($200,000).   

Note that the data did not include personal contributions from corporate leaders, and could not include corporate money directed to dark money organizations that ended up supporting these legislators.

Health Care Corporate Sponsorship of the Attempt to Overturn the 2020 Election

In June, 2021, Citizens for Responsibility and Ethics in Washington (CREW) published "This Sedition is Brought to You By..." It detailed contributions from corporate PACS and trade groups to those in the US Congress who voted against certifying the results of the 2020 election and the two main party organizations that supported them, the National Republican Senatorial Committee (NRSC) and National Republican Congressional Committee (NRCC) since the vote not to certify.  

The largest contributions from health care corporate PACs included those tied to Fresenius Medical Care Holdings ($76,000); CVS ($45,000); Cigna ($42,500); Johnson & Johnson ($30,000); Pfizer ($20,000); and Humana ($15,000).

Note that the data also did not include contributions from corporate leaders, and could not include corporate money directed to dark money organizations that ended up supporting these legislators. 

Discussion

Most health care corporations profess to missions that are pluralistic and support the community and society as a whole.  For example, Pfizer's mission statement includes:

We partner with governments, non-profits, and other organizations to ensure that more people around the world have access to the medicine and resources they require.

UnitedHealthCare's mission statement includes:

UnitedHealthcare is dedicated to helping people live healthier lives and making the health system work better for everyone

Merck's mission statement includes:

We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships

However, leaders of some large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would restrict voting rights in ways likely to impact already disadvantaged groups, and challenge election outcomes without strong evidence of irregularities would seem to violate high-minded corporate pledges of inclusiveness like those above.    

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

However, there are problems with this formulation.  As we wrote before,  it is obvious why a pharmaceutical company might want to defeat legislation that would lower its prices or raise its taxes.  It is not obvious why it would want to consistently support actions by one party, or by people at one end of the political spectrum, even if some such people seem generally "pro-business."  After all, for years big corporations and their executives openly gave money to both US parties and their candidates, apparently in the belief that this would at least allow more visibility for the corporations' priorities no matter who was in power.

Maybe it is not just about money.  Again, as we said before, by virtue of being top management of a corporation, particular individuals can control political funds far beyond what they may be able to control as private persons, and to do so anonymously.  It may be that top corporate leaders are not just interested in making more money.  Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, if not openly fascist national political leadership.  Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)

At least health care professionals, policy makers, patients and the public at large deserve to know how health care corporate leadership is directing money to political causes, and how they benefit from doing so. 

 

    

Wednesday, June 30, 2021

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
  2. and
  3. 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.