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.

FDA Approval of Aducanumab

Almost twenty years ago, I was a volunteer nursing-home ombudsman. The doctor at the nursing home I visited was a huge proponent of preventive therapies, and prescribed as many preventive drugs as possible for residents (while frequently ignoring complaints about current medical problems that were bothering them). Among the drugs he very freely prescribed were cholinesterase inhibitors for Alzheimer's disease, then fairly new. I was stunned when I learned he prescribed one to a resident whom I knew well and who seemed fully oriented to me, but that was the case. From what I've learned since, these drugs don't have any really noticeable clinical benefits anyhow, so they are unimpressive.

But if prescribing those drugs so freely seemed like a dubious course of action to me then, they look almost good now by comparison to the latest drug approved by the FDA for Alzheimer's disease, aducanumab (Aduhelm). This drug doesn't have any convincing evidence that it benefits patients, AND it comes with potentially serious side effects that require a lot of monitoring.

The quality of life implications of this are troubling. As one doctor notes:

"This is a drug that medicalizes someone’s life,” said Mantyh. Besides the hourlong, once-monthly infusions, an Aduhelm prescription comes with frequent lab tests and brain scans to monitor for signs of swelling or bleeding. In two of Biogen’s clinical trials, more than one-third of participants who received Aduhelm developed painful brain swelling; about 17% to 19% had small bleeds in their brains. Headaches, dizziness, nausea — all might trigger more time spent in the hospital. Such constraints could make it difficult to travel internationally or spend time with family members in other states.

The article also notes that, except in the case of adverse side effects, it is hard to decide when to discontinue a drug when it's likely to be quite unclear whether it's benefitting the patient or not.

How did the FDA come to approve this drug without stronger evidence that it is actually beneficial? It used an "accelerated approval" pathway and based the approval on the fact that the drug diminishes the size of amyloid plaques. This was despite the fact that in multiple trials. reducing amyloid plaques has not been shown to improve things clinically for patients. As Derek Lowe wrote (and his whole post is well worth reading):

So the FDA has, for expediency’s sake, bought into the amyloid hypothesis although every single attempt to translate that into a beneficial clinical effect has failed. I really, really don’t like the precedent that this sets: what doesn’t get approved, now? I suppose only things that definitely cause harm, because otherwise why not just ask for the same deal that Biogen got, and go out and prove efficacy while you turn a profit?

A commenter on the Lowe blog ("Radioactive Man") wryly noted:

All the other companies that successfully developed anti-amyloid drugs then discontinued them for lack of efficacy must be kicking themselves to realise they were approvable all along. It makes me wonder, could they just simply dust off their old phase 3 results and go straight to applying for approval without even doing any more clinical studies? If those results are comparable to aducanumab, why not?

Elsehere too, there was speculation on whether other companies could go back and now seek approval of similar drugs that cleared plaque without showing clinical improvement.

[Could] a slew of amyloid-reducing agents from the past...now be re-evaluated under the accelerated approval pathway?...In a public defense of her agency’s decision on June 22, Woodcock said future approvals under this pathway would be possible if the magnitude of plaque reduction was great enough.

Not one of the FDA advisory committee members voted to recommend approving aducanumab. Ten voted against, and one voted "uncertain." Three have since resigned in protest. In his resignation letter, one stated this is "was probably the worst drug approval decision in recent FDA history."

A professor who has served on many FDA committees commented:

“This isn’t the first time when I was on a committee where the committee voted one way and the FDA decided another,” said biostatistician Scott Emerson....“This was the first time that nobody voted for approval of this drug — nobody — and they went against that.”

Despite the protests, proponents of the drug were breezy, lauding it as a great "breakthrough." The acting commissioner of the FDA, Janet Woodcock, said that she is “not that concerned” about criticisms of the approval. And meanwhile, the first patient got his first infused dose of aducanumab. Dr. Stephen Salloway, director of the memory and aging program at the Rhode Island hospital giving the infusion, stated at a press conference: "It's transforming how we treat Alzheimer's." He snottily added, "For those of you who don't know, it's a devastating disease."

Salloway's remarks make me really furious. A supposed medicine has to be judged by its results, not by the urgency or seriousness of the condition it is alleged to treat. And the "evidence" was totally cherry-picked post hoc after the failure of their Phase 3 trials, following the bad rule: "If you don't succeed, change the definition of success."

There's more to be said about the aducanumab approval, but this post is long enough. More in the next post.

The Big Spin Out: 2020 Revolving Door Update

In  2020, cases of the revolving door accumulated quickly. 

The Old School Outgoing Revolving Door

Let us begin with cases of the old fashioned outgoing revolving door, that is, of people leaving leadership positions in governmental bodies which regulate health care or make health care policy, then soon obtaining jobs in the health care industry, particularly organizations which they previously regulated or were affected by the policies they made.

Dr Vindell Washington from National Coordinator for Health Care Information Technology to Alphabet

Per FierceHealthCare, January 7, 2020:

Alphabet, the parent company of Google and Verily Life Sciences, continues to bolster its ranks of healthcare experts with the latest hiring of Vindell Washington, M.D.

Verily Life Sciences hired Washington as its new chief clinical officer as part of its health platforms team, Verily Life Sciences representative Kathleen Parkes confirmed to FierceHealthcare Tuesday.

Washington served as the national coordinator for health IT from August 2016 to January 2017.

As one of the highest health IT policy leaders, Washington brings to Verily a deep understanding of the industry. He is an emergency medicine physician by training.

So he moved from a position with significant influence over government health IT policy to a big IT company involved in health care.  Admittedly though, this moves comes three years after he left the ONC.

Dr Kate Goodrich from Chief Medical Officer of the Center for Medicare and Medicaid Services (CMS) to Humana Inc

Per Louisville Business First, January 17, 2020:

Humana Inc. has hired away a key regulatory insider from the federal government.

Dr. Kate Goodrich will leave the chief medical officer role at Centers for Medicare & Medicaid Services in February. Politico reported Thursday Goodrich will become a senior vice president for the company.

CMS is the agency that oversees both Medicare and Medicaid, the government-backed health plans. Goodrich was also director of the Center for Clinical Standards and Quality, the CMS website states.

Note that Humana's business is heavily influenced by the actions of CMS.

Humana's core business is providing Medicare Advantage plans, a private version of the federal health plan for seniors. It has about 4.1 million members in Medicare Advantage plans, according to its latest financial disclosure.

The Medicare Advantage segment brought in about $37.1 billion of revenue in the nine months ended Sept. 30, 2019.

Mary Sumpter Lapinski from Government Affairs at Bristol-Myers-Squibb to Counselor to the Secretary of the Department of Health and Human Services (DHHS) for Public Health and Science, then to Vice President of Global Governance Affairs for Greenwich Biosciences


Note that in this case, someone recently reported as transiting the outgoing revolving door has also had in the past transited the incoming revolving door.

Per a Buzzfeed News article, January 24, 2020 (which also discussed the larger revolving door problems involving the pharmaceutical industry and the Trump administration):

Mary-Sumpter Lapinski, who worked in government affairs for Bristol-Myers Squibb from 2002–2007, served as a counselor to the health and human services secretary for public health and science. As of April 2019, Lapinski is the vice president of global government affairs for biopharmaceutical company Greenwich Biosciences.

Again, most recently she moved from a senior position in DHHS affecting public health and science to a biotech company.

Roxana Weil, Lead Toxicologist from the Center for Tobacco Products at the Food and Drug Administration (FDA) and Gabriel Muniz who inspected tobacco manufacturers for the FDA to Juul Labs Inc

Per Bloomberg (via the Detroit News, February 5, 2020):

Juul Labs Inc. has hired former Food and Drug Administration employees and is recruiting more researchers as it prepares for a crucial regulatory hurdle that will determine the future of the top U.S. e-cigarette maker.

So

Roxana Weil, formerly a lead toxicologist at the agency’s Center for Tobacco Products, joined Juul as principal scientific adviser in September. Gabriel Muniz, who worked in an FDA division that inspects tobacco manufacturers, joined Juul last month as a director of regulatory compliance.

Note that

The company and its peers must submit applications to the FDA by May 12 in order to continue selling their products. The deadline is a defining moment for the e-cigarette industry, which has been under fire following a surge in teen vaping and a lung-injury outbreak that sickened thousands and was later tied to THC.

For Juul, securing a swift clearance is critical. The company has seen its once-rich valuation drop since the broader vaping backlash began. Failing to win the FDA’s blessing could shut it out of a market it has dominated.

So they moved from regulating tobacco to a company essentially involved in selling tobacco analogues.  Note that the tobacco company Altria made a major investment in Juul (look here.)

The Au Courant Incoming Revolving Door

In the Trump era, many people have come through the incoming revolving door, that is, people with significant leadership positions in health care corporations or related groups have attained leadership positions in government agencies whose regulations or policies could affect their former employers.

There are two recent examples

Brad Smith, Chief Operating Officer of Anthem's Diversified Business Group to be Director, Center for Medicare and Medicaid Innovation (CMMI) at the DHHS

Per FierceHealthcare, January 6, 2020:

The Trump administration has selected Brad Smith to serve as the director of the Center for Medicare and Medicaid Innovation (CMMI), where he will oversee the creation and stewardship of value-based payment models.

Smith most recently was the chief operating officer of Anthem’s Diversified Business Group, a division of the insurance giant that includes provider services. He was also the co-founder and CEO of palliative care services company Aspire Health.

Anthem is a health insurer which provides Medicare supplements and Medicare Advantage programs, so its business is greatly affected by any changes in how Medicare or Medicaid makes payments.

Amanda Adkins, Executive for Cerner Corp, Now Running for the House of Representatives as a Republican

This could be called a running start that will likely lead through the incoming revolving door.

Per the  Kansas City Star, January 23, 2020:

Cerner executive Amanda Adkins has taken a leave of absence from the company to focus on her campaign to unseat Democratic Rep. Sharice Davids.

Adkins, a former Kansas Republican chair, launched her bid for Kansas’ 3rd congressional district in September, but initially planned to remain as Cerner’s vice president of strategic growth through the campaign.

But as of last week, according to a company spokeswoman, Adkins went on unpaid leave after from her role after 15 years with the health care IT giant.

Note that the Star article, unlike the others quoted above, provided at least a slightly detailed discussion of why this (potential) move poses a conflict of interest:

The Kansas City-based company is a major federal contractor with a $10 billion contract to design a new health care records system for the U.S. Department of Veterans Affairs. The new system is expected launch later this year.

Federal election rules prohibit federal contractors from giving directly to federal candidates. Craig Holman, a lobbyist for Public Citizen, a national group which advocates for tougher ethics standards, said Adkins’ unpaid leave protects Cerner from violating this rule.

But Holman said the fact that she can return from leave after the election still raises questions about a conflict of interest since she could end up on committees with oversight of the company’s contracts if elected to Congress.

'The conflict still persists,' Holman said in a phone call. 'The fact that she has not resigned and remains an employee of Cerner means that conflict of interest remains front and center.'

Summary

Sigh.  So while there is much discussion of corruption in high places, and its potential link to high crimes and misdemeanors, the revolving door quietly spins on well-oiled hinges, as it has for years, including many years before the current administration.  

So as we have repeatedly said,  most recently in October, 2019, ...

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door once again suggests how the revolving door may enable certain of those with private vested interests to have disproportionate influence on how the government works.  The country is increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

Remember to ask: cui bono? Who benefits? The net results are that big health care corporations increasingly control the governmental regulatory and policy apparatus.  This will doubtless first benefit the top leadership and owners/ stockholders (when applicable) of these organizations, who are sometimes the same people, due to detriment of patients' and the public's health, the pocketbooks of tax-payers, and the values and ideals of health care professionals.  

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

Circular Logic - A Revolving Door Update

We have actually managed to go for three months without posting on the revolving door.

Since then, however, we have accumulated a sufficient number of relevant cases to post another round up.


The Old School Outgoing Revolving Door

Let us begin with cases of the old fashioned outgoing revolving door, that is, of people leaving leadership positions in governmental bodies which regulate health care or make health care policy, then soon obtaining jobs in the health care industry, particularly organizations which they previously regulated or were affected by the policies they made.

However, it is striking that many of the people recently reported as transiting the outgoing revolving door have also had in the past transited the incoming revolving door (see below).

Cynthia Ridgeway, From Department of Justice Prosecuting White Collar Crimes to Anthem

As reported on July 15, 2019 by Modern Healthcare:

Health insurer Anthem has hired Cynthia Ridgeway, a longtime attorney for the U.S. Justice Department, to be its corporate strategy director.

Ridgeway is first assistant U.S. attorney in the Southern District of Indiana. During her 15-year tenure at the U.S. attorney's office, she litigated high-profile white collar crimes

The brief report had no information about Ms Ridgeway's expected duties for Anthem.  It is possible, but not certain, that they could be relevant to her work in white collar crime investigations and prosecutions for the government.

Marilyn Tavenner, From Administrator of Center for Medicare and Medicaid Services (CMS) of the Department of Health and Human Services (DHHS) to America's Health Insurance Plans (AHIP) and Now to Blue Cross Blue Shield of Arizona

As in a July 23, 2019, PR release:

Marilyn Tavenner, R.N., the former Administrator for the Centers for Medicare and Medicaid Services (CMS) and past president and CEO of America's Health Insurance Plans (AHIP), officially joined the BCBSAZ board, which provides strategic oversight to the company.

Note that Blue Cross Blue Shield of Arizona is a non-profit corporation.

Further note that Ms Tavenner had quite an interesting past history of revolving door transits.  According to her Wikipedia page, she worked for for-profit hospital system Columbia/ HCA, now HCA, from 1981 to 2005, starting as a nurse, and rising to President of the Central Atlantic Division.  While there, she worked for CEO Rick Scott, on whose watch the company made a huge settlement for Medicare fraud (look here).  Scott was not charged, left the company, and then was elected to be Governor of and the Senator for Florida as a Republican.  Ms Tavenner then went on to be Secretary of Health and Human Resources for Virginia, and then CMS administrator from 2013-15.

So Ms Tavenner moved from a for-profit hospital company to running the government agency that operates  government health insurance programs, and thus greatly influences hospital revenues.  The agency also obviously greatly influences the insurance industry, whose major trade association she then went on to lead.  Now she will be part of the governance of a large, albeit non-profit insurance company.

Erik Paulsen, From the House of Representatives to the Board of Cardiovascular Systems

As reported by the St Paul Business Journal, July 25, 2019:

Former U.S. Rep. Erik Paulsen has joined the board of directors for St. Paul medical device company Cardiovascular Systems Inc.

Cardiovascular Systems (Nasdaq: CSII) touted Paulsen’s support for the medical device industry and involvement with federal health care and economic policy in its announcement Thursday.

As a member of Congress from 2009 to 2019 representing Minnesota’s Third District, which covers suburbs of Hennepin County, Paulsen was co-chair of the bipartisan House Medical Technology Caucus. He also served on the House Ways and Means Committee, which covers taxes and policies governing health care, economics and trade.

Thus Mr Paulsen went from having a leadership role in government relationships with medical technology, and "taxes and policies governing health care," to a role in governance of a health technology company.

Dr Scott Gottlieb, From Commissioner of the Food and Drug Administration (FDA) to Venture Capital and the Pfizer Board of Directors, and now the Board of Aetion

Dr Scott Gottlieb has frequently appeard in posts on Health Care Renewal.  Our last summary of his relevant transits to the revolving door, from July, 2019 noted:

Dr Scott Gottlieb, FDA Commisioner from 2017 to May, 2019,  had been no stranger to the revolving door.  Prior to assuming leadership of the FDA, he had relationships with multiple for-profit health care corporations, which drew wide notice when he was appointed to head the FDA in 2017, as we noted at that time here.  Also, Dr Gottlieb was clearly very comfortable with the pharmaceutical and biotechnology industries.  For example, in 2007-2008, we discussed many examples of Dr Gottlieb's strident promotion of the interests of these industries (look here, here, here and here).

Very quickly after leaving the FDA in 2019, Dr Gottlieb rejoined his old venture capital firm, New Enterprise Associates, as a full-time partner investing partner specializing in life sciences companies.

Then in June, 2019, he joined the board of Pfizer.

His latest move was reported on September 17, 2019 by Fierce Healthcare:

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has added another position to his roster of board and advisory roles since leaving the agency back in March.

He'll be joining healthcare technology company Aetion’s board of directors, the company announced Tuesday. The New York-based company offers real-world evidence and analytics to drug companies, payers, life sciences companies and regulatory agencies.

The company has an interesting array of financial backers:

Sanofi, Amgen, UCB, McKesson Ventures and Horizon Healthcare Services have all backed Aetion as strategic investors, according to the company.

It appears that Gottlieb's former role as leader of the FDA is highly relevant to the business of Pfizer, Aetion, and Aetion's "strategic investors." In particular, regarding Aetion:

Gottlieb will advise the company as it expands the reach and utility of the Aetion Evidence Platform, a scientifically validated tool to assess the safety, effectiveness and value of treatments using real-world evidence, the company said in a press release.

During his tenure, Gottlieb also pushed for the FDA’s use of real-world evidence, recognizing its potential to advance medical products and their development, Aetion said.

'The widespread adoption of real-world evidence to the development and application of new treatments will improve the precision of prescribing decisions and help make drug discovery far more efficient,' Gottlieb said in a statement.'“As a member of Aetion’s Board, I’m inspired by the opportunity to join the company’s efforts to bring RWE to the forefront of drug research and development.'

'Dr. Gottlieb has played a pivotal role in advancing the use of real-world evidence for regulatory decision-making. As a real-world evidence advocate and standard-setter, he’s an ideal partner in our work to help define RWE's role in the development, delivery, and payment of treatments,' Carolyn Magill, CEO of Aetion, said in a statement.

And regarding Pfizer and other pharmaceutical companies:

Aetion works with 12 of the top 20 biopharma firms in the world, along with leading payers.

We had discussed the conflicts of interest presented by Gottlieb's Pfizer board decision, which Senator Elizabeth Warren (D-MA) asserted "smacks of corrupion," here.

Matthew Whitaker, From Acting US Attorney General to Legal Advisor to a Marijuana and CBD Company

As reported on August 28, 2019 by Forbes:

Toronto-based CBD company Alternate Health Corp has hired Matthew Whitaker, former acting U.S. Attorney General, and his law firm Graves Garrett to serve as outside counsel.

Previously, he

served as Chief of Staff to then Attorney General Sessions from September 2017 to November 2018

Why was he selected?

'The legal environment surrounding CBD is rapidly evolving and it is essential that Alternate Health stays at the forefront of new government and FDA regulations,' he said. 'We believe his experience in government and the Department of Justice is a significant asset as we move forward.'

So Mr Whitaker, after taking a leading role in US government law enforcement, including enforcement of laws related to drugs like marijuana, would not be advising a foreign company trying to get favorable legal treatment from the government.

Rebecca Wood, from Chief Counsel at FDA to Leader of Food and Drug Practice at Sidley Austin

Ms Wood had been Chief Counsel at the FDA.

Recently reported by ProPublica (in a October 15, 2019 article to be discussed further below):

Wood now leads the food and drug practice at Sidley Austin, a powerful law and lobbying firm in Washington, where her colleagues lobby the FDA for various clients.

She is an example of

former Trump administration staffers who go back to K Street but don’t register as lobbyists — the Lobbying Disclosure Act only requires those who spend 20% or more of their time lobbying to register.

This still generates important conflicts of interest.

Wood said she 'advises clients on FDA-related issues and, in doing so, complies with all applicable ethics requirements.'

There is nothing illegal about returning to an old employer or being hired by a new one. Nor is there anything wrong with having colleagues who lobby the federal government. But the revolving door does present the possibility of conflicts of interests.

'The most important commodity in D.C. is information,' Hauser said. 'Former insiders have rare access to strategic intelligence, which is of significant value to corporate entities, and they can do so without registering as a lobbyist.'

Dr Karen DeSalvo, from Assistant Secretary of Health, DHHS and Office of the National Coordinator, to the University of Texas, now to Google as Chief Health Officer

As reported by Health Care Dive on October 18, 2019

Google has hired ex-Obama administration official Karen DeSalvo as its first chief health officer, further solidifying its investment in the $3.5 trillion industry by rounding out its healthcare team.

DeSalvo, a well-respected healthcare executive and public health expert, was the acting Assistant Secretary for Health at HHS and ran the Office of the National Coordinator, which manages the nation's health IT, under President Barack Obama. She has spent the past two years teaching at the University of Texas at Austin's Dell Medical School.

Note that there was a two year delay after Dr DeSalvo left the government until her hiring by Google.  This does apparently lessen the conflicts of interest generated.  However, many think 

The Au Courant Incoming Revolving Door

In the Trump era, many people have come through the incoming revolving door, that is, people with significant leadership positions in health care corporations or related groups have attained leadership positions in government agencies whose regulations or policies could affect their former employers.

On October 15, 2019, ProPublica published a striking article on people transiting the incoming revolving door from lobbying positions to leadership positions at government agencies whose regulations or policies could affect their lobbying clients.

Two of the people recently added to the ProPublica data base got major government health care leadership positions after working as lobbyists, and then returned to lobbying after ending their government "service."

By way of background:

At the halfway mark of President Donald Trump’s first term, his administration has hired a lobbyist for every 14 political appointments made, welcoming a total of 281 lobbyists on board, a ProPublica and Columbia Journalism Investigations analysis shows.

With a combination of weakened rules and loose enforcement easing the transition to government and back to K Street, Trump’s swamp is anything but drained. The number of lobbyists who have served in government jobs is four times more than the Obama administration had six years into office. And former lobbyists serving Trump are often involved in regulating the industries they worked for.

Even government watchdogs who’ve long monitored the revolving door say that its current scale is a major shift from previous administrations. It’s a 'staggering figure,' according to Virginia Canter, ethics chief counsel for the D.C.-based legal nonprofit Citizens for Responsibility and Ethics in Washington. 'It suggests that lobbyists see themselves as more effective in furthering their clients’ special interests from inside the government rather than from outside.'

Colin Roskey,  from Health Care Lobbying for Lincoln Policy Group to Deputy Secretary, DHHS, then back to Lobbying for Lincoln Policy Group

Per ProPublica:

Consider Colin Roskey. Days after leaving a two-decade career as what one former employer called the 'smartest' health care lobbyist, he joined the Department of Health and Human Services in January. As deputy secretary for legislation for mandatory health, he headed the portfolio that he tried to influence for most of his career.

HHS declined to reveal any recusals he signed while appointed. A spokesman said that “all employees are expected to abide by the ethics rules.”

Just days before joining HHS, Roskey listed among his clients major dialysis providers that receive federal payments through Medicare, including Fresenius Medical Care — an industry juggernaut, with more than 330,000 patients in thousands of dialysis clinics in the U.S. A third of the company’s billion-dollar revenue comes from Medicare. A recent revamp in the dialysis industry ordered by Trump, expected to shift millions of dollars from dialysis centers to cheaper home-based options, put Roskey’s office at the heart of regulating how much profit or loss some of his former clients will see in coming years. Roskey said in an interview that he recused himself from this matter.

Public records show that Roskey lobbied for at least 27 clients between January 2017 and December 2018 on an array of issues other than dialysis involving public health care programs, from prescription drugs to palliative care.

In early October, Roskey stepped out of government and went straight back to work for his old lobbying firm, Lincoln Policy Group, which specializes in health care policy. “Spending time at HHS will make [Roskey] even more valuable to our team — and we are so excited to have him back,” the lobbying firm announced in a statement.

Roskey said he had no knowledge of how the new kidney care regulations will be implemented.

After his monthslong stint with the Health Department, Roskey said he plans to lobby the legislative branch, which is not prohibited by the current ethics rules. 'While working with the government I gained knowledge and background, intellectually and professionally, and I intend to unapologetically utilize those skills for my employer and clients,' he said.

The conflicts of interest generated by the moves from and to the lobbying firm are are obviously significant.

Laura Kemper from Health Care Lobbyist to Deputy Assistant Secretary of DHHS, then to Lobbying as Vice-President for Governmental Affairs for Fresenius

We had previously discussed Ms Kemper's transit from lobbyist to government health care leader here.   From the ProPublica article,

Laura Kemper, [is] a former HHS senior official who, within days of leaving her post in March, was hired by Fresenius. Now vice president for government affairs, Kemper heads the company’s policy group.

According to lobbying records, she is listed among the in-house lobbyists who have visited Congress, the White House and HHS since March, pushing everything from reimbursement for dialysis services to home dialysis. The records show Fresenius shelled out more than $2.2 million for lobbying activities during the first half of the year.

Furthermore, ProPublica noted:

Her pass through the revolving door tests the boundaries of ethics rules. Indeed, Trump’s pledge prohibits staffers-turned-registered lobbyists from advocating for the special interests of their corporate bosses before the agencies where they used to work for at least five years. It also restricts former employees from behind-the-scenes lobbying with any senior federal official for the remainder of Trump’s presidency. Kemper signed that pledge.

Kemper declined to comment. In a statement, Fresenius said Kemper “has strictly followed her legal and ethical obligations and has not been involved in lobbying the administration or anything related to the Executive Order.” Disclosure forms filed by Fresenius “cite the general activity of a team and do not ascribe any particular lobbying activity,” according to its statement.

Recently, during an earnings call to investors, Fresenius CEO Rice Powell said that the company has talked to the 'appropriate people in Washington,' without naming any particular Fresenius or government staffer. “We are in the midst of commenting and asking questions” with HHS officials, he added.

As ProPublica has reported, political appointees who return to lobbying have found ways to tiptoe around ethics rules. Some register as lobbyists but limit their interactions to Congress, leaving colleagues to lobby the executive branch. Ethics restrictions don’t apply to congressional lobbying.

Summary

We have repeatedly said,  most recently in March, 2019, ...

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door once again suggests how the revolving door may enable certain of those with private vested interests to have disproportionate influence on how the government works.  The country is increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

Remember to ask: cui bono? Who benefits? The net results are that big health care corporations increasingly control the governmental regulatory and policy apparatus.  This will doubtless first benefit the top leadership and owners/ stockholders (when applicable) of these organizations, who are sometimes the same people, due to detriment of patients' and the public's health, the pocketbooks of tax-payers, and the values and ideals of health care professionals.  

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

Broken Trust: the Adulteration of Ranitidine Revealed

Adulterated Ranitidine, and Before that, Valsartan, Irbesartan and Losartan

Another case of drug adulteration has just been made public.  Per the New York Times, Sept 13, 2019,

The Food and Drug Administration said on Friday that it had detected low levels of a cancer-causing contaminant in samples of heartburn medicines containing the drug commonly known as Zantac.

Zantac, the brand-name version of the drug, is sold by Sanofi, but generic versions [ranitidine] are widely sold. The F.D.A. has not identified any specific products that were affected.

The contaminant is one that has been seen before.

The contaminant, a type of nitrosamine called N-nitrosodimethylamine, or NDMA, is the same one that was found in some versions of valsartan, a blood-pressure drug carrying the brand name Diovan.

In the current case, its source is not yet apparent,

NDMA can form during manufacturing if the chemical reactions used to make the drug are not carefully controlled and monitored, the F.D.A. has said.

Jeremy Kahn, an agency spokesman, said Friday that the agency is still investigating contamination of the heartburn drugs, and that it is unclear how many companies’ products are affected and how the problem originated.

Based on the recent case of adulterated valsartan and other angiotensin receptor blocker (ARB) drugs, tt is likely that manufacturing of the drug, at least the "active pharmaceutical ingredient" in it, was outsourced.

The valsartan recalls have renewed questions about the safety of the American drug supply, particularly of generic drugs, composed of raw ingredients that are frequently manufactured in countries like China and where F.D.A. oversight has lagged.

Note that,

The source of the contaminated valsartan was a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Company. Major Pharmaceuticals, Teva Pharmaceutical Industries and Solco Healthcare, which is owned by Huahai Pharmaceutical, sold it in the United States.

The same type of impurities were later found in two other blood-pressure drugs, irbesartan and losartan, in the same [ARB] class as valsartan. Two more nitrosamines — nitrosodiethylamine, or NDEA, and N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA — were found in the drugs. Lists of the affected products are posted on the F.D.A. website. 

Furthermore, the FDA may not yet be on top of the problem with ranitidine:

The agency’s announcement came on the same day that an online pharmacy, Valisure, petitioned the F.D.A. to request a recall of all products containing ranitidine, because it said its own tests had revealed high levels of NDMA, above the F.D.A.’s acceptable daily limit. The Valisure petition speculated that the source of the NDMA was the result of the 'inherent instability' of the ranitidine molecule, which can degrade under certain conditions, such as when it is digested, to create NDMA.

'Our feeling is that this is extremely troublesome,' said David Light, the chief executive of Valisure, which is based in Connecticut. 'We took it off our formulary right away.'

21st Century Cases of Drug Adulteration


Moreover, we should have been warned that these cases were coming.  The cases of adulterated ranitidine and ARBs are not the first important cases of drug adulteration in the 21st century.  In 2008, we wrote aabout the case of toxic adulterated heparin from pigs in China.  We later summarized of that case was:

Baxter International imported the 'active pharmaceutical ingredient' (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small 'workshops' operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.

In 2010, we noted a report by the U.S. China Economic and Security Review Commission on the perils of outsourced drug manufacturing in China.

In 2012 we documented the continuing problems with outsourcing of drug manufacturing.  We noted that at least 70-80% of the "active pharmaceutical ingredients" (APIs) that made up drugs sold in the US were actually manufactured overseas, the majority in China and India.  The regulation of manufacturing in these countries, particularly China, is extremely lax.  In China, APIs are considered chemicals, and the regulation of chemical manufacture is virtually non-existent.  There is evidence that the manufacturing processes in China, particularly at those companies that make the cheapest drugs, are sloppy or worse.  Furthermore, US pharmaceutical companies may buy drugs through brokers, further obscuring who actually made them.


In 2013, we discussed adulteration of  generic drugs made in India by Ranbaxy, a subsidiary of Daiichi Sankyo, and sold in the US.


Summary: Broken Trust

The latest cases of adulterated drugs sold in the US are disgraceful.  Patients ought to be assured that  the medications they take have not been adulterated.  Patients entrust pharmaceutical corporations to  supply pure drugs in the correct dosage.  The purpose of the first major US law to regulate drugs, the US Food and Drug Act of 1906, was to assure that drugs were pure and their dosage was accurate. The presence of adulterated drugs on pharmacy shelves is a major breach of trust, and shows a major failing of the involved pharmaceutical manufacturers and US drug regulation.

If anything, the NYT article understates the problem,

 'I think this is another good example of how our regulations need to change,' said Dinesh Thakur, a drug-safety advocate who exposed widespread quality problems as a former executive at the Indian drug maker Ranbaxy Laboratories. He said the F.D.A.’s testing is too lax. 'Things like this will never get caught, unless somebody is actually actively looking for stuff.'

Since 2008 we have had warnings that outsourced drugs may be dangerous, and that foreign and US regulation is insufficient. Yet, the warning have largely been anechoic and no major action has ensued.  Will the new cases make waves?    Will there be action this time?  Who knows?

For what it's worth, let me resurrect my thoughts from 2016:

In our rush to market fundamentalism, we seem to have deregulated, at least de facto, most aspects of health care.  We now cannot trust the drugs we take to have been made by the companies whose labels they bear, or to be pure.  We now cannot trust that regulators will find that out, or having found that out, will do anything about it in a timely manner. 

To repeatedly reiterate, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.

To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

Making the Revolving Door Great Again: Recent FDA Commissioner Dr Scott Gottlieb Joins the Pfizer Board of Directors

It has been less than six weeks since our last post on the revolving door. 

That post emphasized cases of the outgoing revolving door, that is, of people leaving leadership positions in governmental bodies which regulate health care or make health care policy, then soon obtaining jobs in the health care industry, particularly organizations which they previously regulated or were affected by the policies they made, the outgoing revolving door. Now we have another big case.

Former US Food and Drug Agency (FDA) Commissioner to Join Pfizer Board


As we discussed in May, 2019, here, Dr Scott Gottlieb, FDA Commisioner from 2017 to May, 2019,  had been no stranger to the revolving door.  Prior to assuming leadership of the FDA, he had relationships with multiple for-profit health care corporations, which drew wide notice when he was appointed to head the FDA in 2017, as we noted at that time here.  Also, Dr Gottlieb was clearly very comfortable with the pharmaceutical and biotechnology industries.  For example, in 2007-2008, we discussed many examples of Dr Gottlieb's strident promotion of the interests of these industries (look here, here, here and here).

Very quickly after leaving the FDA in 2019, Dr Gottlieb rejoined his old venture capital firm, New Enterprise Associates, as a full-time partner investing partner specializing in life sciences companies.
Then, as reported by CNBC on June 27, 2019,

Scott Gottlieb, who stepped down as Food and Drug Administration Commissioner in April, will join Pfizer’s board of directors, the company announced Thursday.

Gottlieb resigned from the FDA this spring after nearly two years at the helm.

This seemed like an even more consequential case of the outgoing revolving door, obviously, because Dr Gottlieb held an extremely important position of responsibility in health care regulation, and because he quickly moved on to hold an important position of governance in one of the world's largest pharmaceutical/ biotechnology companies.  It also occurs as the next big thing after an unrelenting stream of revolving door issues affecting health care policy and regulation in the Trump regime (look here)

An Immediate Protest by Senator Elizabeth Warren


So this time, not only did dissidents like your obedient servant mutter online, but a US Senator authored a swift rebuke.  As reported by Sheila Kaplan in the New York Times,

Senator Elizabeth Warren on Tuesday called on Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, to resign from the board of Pfizer, saying his decision to join one of the country’s leading pharmaceutical companies 'smacks of corruption.'

Ms. Warren, who is seeking the Democratic presidential nomination, said in a public letter to Dr. Gottlieb that the revolving door between government and industry 'makes the American people rightly cynical and distrustful about whether high-level Trump administration officials are working for them, or for their future corporate employers.'

The explicit reference to "corruption" is notable.  Most people would think of cases of the outgoing revolving door as conflicts of interest.  The concern is that people in government regulatory or policy positions might bias their decision making, possibly unconsciously, to increase the likelihood of lucrative employment after the end of their government service.  Transparency International's definition of corruption is abuse of entrusted power for private gain.  The outgoing revolving door seems to make such abuse more likely, but does not mandate it.

However, as we noted here, some, including experts from the distinguished European anti-corruption group U4, think the revolving door is corruption

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

Senator Warren now seems to agree, at least in the case of Dr Gottlieb's move to the Pfizer board.

Did Dr Gottlieb's FDA Favor Pfizer?

In fact, within days, two reports surfaced that suggested possible reasons to think that Dr Gottlieb's FDA had taken actions that would have benefited Pfizer, and hence that his appointment to its board might be corrupt.

Drop in FDA Enforcement Activities During Gottlieb's Tenure

First, Science Magazine noted considerable evidence that the FDA during the Trump and Gottlieb era had notably deregulated the pharmaceutical industry.

By several measures ... FDA’s compliance and enforcement actions have plummeted since President Donald Trump took office, Science has found.

In particular,

The agency’s 'warning letters'—a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through 22 May show the agency issued 1033 warning letters, compared with 1532 for the most recent equivalent period under former President Barack Obama.

Also,

Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years.

And,

Several other FDA actions under Trump show similar declines when measured against the end of the Obama administration. FDA inspection reports labeled 'official action indicated'—typically a trigger for warning letters or similar actions—have fallen by about half under Trump and are continuing to trend downward. Even FDA’s rare injunctions, a more forceful step than warnings to prevent sales or distribution of unsafe or otherwise illegal products, fell from 35 in the last part of the Obama administration to 26 under Trump. (During a comparable period at the start of the Obama years, FDA issued 51 injunctions.) The agency’s 'untitled letters'—for concerns that fall short of thresholds for formal warnings—also have dropped sharply under Trump.

Several experts interviewed by Science emphasized the importance of these findings.

'FDA’s power to enforce its requirements is an important part of how it achieves its public health mission,' says Patricia Zettler, a law professor at Ohio State University in Columbus and former FDA attorney. 'If FDA is not using that power, it sends a signal that violations will be tolerated.'

Dr Gottlieb defended his former agency's regulatory role, and implied, of course, that any criticisms were political:

Scott Gottlieb, Trump’s first FDA commissioner, defended his record after reviewing a summary of Science’s data. 'We were pretty aggressive,' he wrote in an email. 'I don’t think you can paint us with a political narrative—that just because we were a Republican administration, somehow we must have ratcheted down enforcement activity. We didn’t.'

However, given the magnitude of the changes found, it is reasonable to wonder if Pfizer executives noted, and approved.

Lax Regulation of a Pfizer Drug (Xeljanz)

The next day, an article in the Milwaukee Journal Sentinel by John Fauber noted what appeared to be lax enforcement specifically involving a Pfizer product.

Unlike European drug regulators, the U.S. Food and Drug Administration under Scott Gottlieb did not say doctors should stop prescribing a potentially dangerous dose of a drug made by Pfizer — a company whose board Gottlieb soon joined.

In February, when Gottlieb still was head of the FDA, a Pfizer safety trial showed that rheumatoid arthritis patients who got a higher dose of the drug Xeljanz had a 'statistically and clinically important difference' of blood clots in the lungs and deaths.

The safety trial, which was required by the FDA, did not focus on the other two conditions for which the drug is approved — ulcerative colitis and psoriatic arthritis. The trial involved patients 50 or older with at least one risk factor for cardiovascular disease.

After safety concerns were found, Pfizer immediately stopped giving the higher dose to those in the trial.

Regulators in Europe went further.

The European Medicines Agency said in May doctors must stop giving the high dose to all patients who were at higher risk for blood clots, including those with ulcerative colitis for whom the higher dose was already recommended.

The FDA did not take that action, though it warned doctors about the safety findings that were discovered in the trial.

One ethics expert interviewed by Mr Fauber raised clear concerns about corruption.

'It sounds like a reward for a job well done,' said Carl Elliot, a physician and professor of bioethics at the University of Minnesota, when told by the Milwaukee Journal Sentinel about the FDA's failure to halt prescribing of the potentially dangerous high dose of the drug.

'It sure does look suspicious.'

Dr Gottlieb, not unexpectedly, denied direct involvement in the decision.

Decisions regarding Xeljanz were made by the agency’s career professional staff without my involvement. I did not participate in any matters involving this drug while I was at FDA

However, Senator Warren's concerns about corruption were heightened:

'Unfortunately, Scott Gottlieb joining the board of Pfizer will raise these kinds of questions about FDA decisions concerning Pfizer, whether it’s this or others,' Warren said in a statement to the Journal Sentinel. 'He shouldn’t have joined Pfizer’s board.'

IMHO, concerns that under the Dr Gottlieb the FDA could have taken a lax approach to drug industry regulation, particularly in the case of Pfizer's Xeljanz, ought to be enough to launch an investigation into whether his appointment to the Pfizer board was corrupt.

Dr Gottlieb Will Now Engage in Governance of a Company with an Already Spotty Ethical Record

Dr Gottlieb's appointment to the Pfizer board shuld raise major ethical questions.

Another set of questions he ought to contemplate is how he will deal with his new responsibility for Pfizer's conduct given the company's chequered ethical record.

We have long been posting about an amazing series of ethical missteps by Pfizer leadership, evidenced by various legal settlements, regulatory sanctions, and occasional guilty pleas.    Our most recent post on the subject, in 2018, noted how Pfizer settled charges of giving kickbacks to patients through disease advocacy organization to mask the prices of its drugs.  Our over 100 posts on Pfizer can be found here.

The company's track record from 2000 to 2017 is staggering.

Since 2000, Pfizer's troubles started, according to the Philadelphia Inquirer, with the following...

- In 2002, Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2004, Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.
- In 2007, Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter,

- In 2009, Pfizer paid a $2.3 billion settlement of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).
- Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  In that year the company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).
- In early 2011, Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York (see post here).
- In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).
- In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).
- In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).
- In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).
- In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post).
- In July, 2013, Pfizer settled charges of illegal marketing of Rapamune (see this post.)
- In April, 2014, Pfizer settled allegations of anti-trust law violations for delaying generic versions of Neurontin( see this post).
- In June, 2014, Pfizer settled another lawsuit alleging illegal marketing of Neurontin (see this post).
- In 2015, a settlement by Pfizer of a shareholders' lawsuit stemming from charges of illegal marketing was announced (see this post).
- In October, 2015, a  UK judge found that the company had threatened health care professionals for using a generic competitor (see this post).
- In February, 2016, Pfizer settled a lawsuit for $785 million for overcharging the US government for Protonix (look here).
- In August, 2016, Pfizer made a $486 million settlement of allegations it bilked shareholders by concealing research showing the harms of Celebrex (look here for this and next two items)
- In December, 2016, Pfizer fined $106M in UK for using monopoly on production of generic phenytoin to overcharge National Health Service
- In November, 2017, Pfizer made $94 million settlement of allegations of fraud to delay generic competition

That Dr Gottlieb waltzed through the revolving door to a major role in the governance of Prizer does not give me great confidence that he will be part of the solution to the company's ongoing ethics problems.

Discussion: the Swamp Gets Swampier

 President Trump came to office promising to drain the swamp.

[An alligator in the Everglades, 1963]

At least in terms of health care, Dr Gottlieb's transit through the revolving door is just the latest example of how the swamp waters are rising.  So, as we have said again and again...

Our health care system appears to be rigged to favor of leadership and management of large companies, as opposed to health professionals, and particularly as opposed to patients.  For years now we have discussed stories which include allegations of severe misbehavior by large health care companies affirmed by legal settlements, but which only involve paltry financial penalties to the companies, and almost never any negative consequences to any humans, demonstrating the impunity of health care managers and executives. Furthermore, these stories are often relatively anechoic, noted often only briefly in the media, and have inspired no real action by the US government. We have previously discussed how market fundamentalism (or neoliberalism) led to deregulation, which enabled deception, fraud, bribery, and intimidation to become standard business practices, and allowed increasing concentration of power by large corporations. Managerialism allowed the top leaders of these corporations and their insider cronies to amass increasing power and money. Everyone else, other employees, stockholders of public corporations, customers, vendors and suppliers, and the public at large lost out.   These changes led to an increasingly costly system which produced increasingly bad results for patients and the public.

We have called for years for what we sometimes term "true health care reform" to derig the system. Unfortunately, despite our hopes, perceptions of a rigged system may not always inspire honest reform. Instead, they can enable the rise of demagogues and would be dictators who promise only they can solve the problem.  Donald Trump cried out that only he could fix our problems and drain our swamps.  However, at least in terms of policing white-collar crime, particularly in health care, he seems to be letting the swamp waters rise.

Nonetheless, let us remember the need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, and would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.

That Old Time Revolving Door Keeps Spinning

Traditionally, the American examples we have seen of the revolving door involved people leaving leadership positions in governmental bodies which regulate health care or make health care policy then soon obtaining jobs in the health care industry, particularly organizations which they previously regulated or were affected by the policies they made, the outgoing revolving door.  These examples occurred during Democratic and Republican administrations.  However, during the Trump regime, we began to see many examples of the incoming revolving door, people coming form leadership positions in the health care industry to take government health care regulatory or policy positions that could affect their former organizations' interests (look here).

However, the old-time bipartisan outgoing revolving door keeps spinning.  Here is a collection of examples in chronologic order by the date they were made public.  Also, I found an example of the incoming revolving door at the US state level, involving Democrats, not Republicans.


From Secretary of Veterans Affairs to the Board of Armada Health

On March 12, 2019, a brief item in Modern Healthcare stated:

Former Veterans Affairs Secretary Dr. David Shulkin has joined the board of ArmadaHealth, a Maryland health data company that offers a database for patients to find physicians.

President Donald Trump fired Shulkin last year from the top post at the VA, where the former secretary also served under President Barack Obama.

I could find little further information.  Note that Dr Shulkin served in both Democratic and Republican administrations.  Note further that with the increasing push to privatize the VA, its operations may have more to do with companies like ArmadaHealth.

From US Senate to Lobbying Firm Akin Gump Strauss Hauer & Feld

On March 14, 2019, Maplight.com noted:

Months after advising the Democratic Party to abandon the idea of 'Medicare for All,' a former U.S. senator has been hired by a lobbying firm whose clients are leading the fight against changes to the nation’s health care system.

Akin Gump Strauss Hauer & Feld LLP, a Washington, D.C.-based law and lobbying firm, announced on Wednesday that former Sen. Joe Donnelly is joining the firm as a partner and will be counseling clients in the health care and financial industries.

In particular, the article stated that:

Akin Gump has lobbied for the Healthcare Leadership Council since 2016. The trade organization’s members include health insurance, pharmaceutical, and hospital interests -- industries whose profits could be threatened by a single-payer system. The firm has also lobbied for Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization, two powerful drug industry trade groups.

PhRMA, BIO and the Healthcare Leadership Council are members of the Partnership for America’s Healthcare Future, a coalition created last year to oppose Medicare for All, as well as any of the weaker measures offered by Democrats to provide health care coverage or insurance to more Americans.

Donnelly seemed like a pretty good candidate to lobby for thiese firms because:

He campaigned against Medicare for All, even though polling by Data for Progress and the Kaiser Family Foundation last year estimated that 55 percent of Indiana residents support a universal health insurance plan. In one Donnelly campaign ad, a narrator warned that 'socialists want to turn health care over to the government.' Donnelly replied: 'Over my dead body.'

Since his loss, Donnelly has continued to warn Democrats against pushing for a single payer health care system. 'When you talk Medicare For All … you start losing the people in my state,' he said in December. 'When we start talking about, 'Hey, we're going to work together with the insurance companies to lower premiums,' that's what connects. The talk on the coasts just doesn't get it done in the middle.'

So Donnelly's new position lobbying for industry groups that oppose single payer health insurance, which they presumably see as a threat to their revenues, could be viewed as a reward for his previous advocacy of their positions.

In that vein, the article quoted health care insurance whistleblower Wendell Potter:

a former health insurance executive who has spent a decade investigating the industry’s predatory practices, panned Donnelly’s career move.

'Sen. Donnelly kept health care reform efforts at bay his whole tenure in Congress, and on his way out he went on national news to tell Democrats that Medicare for All was dangerous,' said Potter. 'Now we see his reward: A cush lobbying gig working for the health-care industry.'

'Color me shocked,' he said.

Were Senator Donnelly to have advocated the industry position because he thought it would enhance the chances of eventually getting a lucrative industry position, that could have appeared to be an abuse of entrusted power (as a Senator, to set public policy) for private gain, that is, as corruption in the ethical, if not the legal sense.

An article in the Indianapolois Star found this response from the Republican Party:

Indiana's GOP criticized Donnelly's decision.

'While Donnelly may have moved back to Granger, he clearly can’t get enough of the swamp,' said Pete Seat, executive director of strategic communications for Indiana Republicans. 'From this day forward, consider ‘Democrat Donnelly’ retired, and ‘D.C. Lobbyist Donnelly’ deployed.'

That is a reasonable criticism, but I wonder if they would make the same criticism of similar behavior by a Republican politician?   

Meanwhile, in April, Politico briefly noted

Former Rep. Lamar Smith (R-Texas), meanwhile, who also joined Akin Gump after leaving Congress in January, reported lobbying for four clients. They include HerdX, a ranching logistics company; Otis Eastern Service, an oil-and-gas pipeline company; Pebble Limited Partnership, which is trying to develop an open-pit mine in Alaska; and Pfizer, the giant pharmaceutical company.

So this particular pathway from the Senate to this lobbying firm and then to health care industry clients is a well trodden one.

From the US  Drug Enforcement Administration to Consultant for Purdue Pharma

On March 20, 2019, NBC News reported:

A former senior U.S. Drug Enforcement Administration official who testified before Congress on the government's efforts to stop the opioid epidemic is now paid to advise one of the largest opioid manufacturers in the country, Purdue Pharma, according to people familiar with the matter.

Demetra Ashley, the former acting assistant administrator of the DEA who told a Senate committee in 2017 about the need for a 'robust regulatory program' to stop the diversion of opioids and other controlled prescription drugs, left the DEA last spring and started a consulting firm called Dashley Consulting, LLC

The arrangement inspired some critcism, for example,

'This should not be allowed,' said Dr. Andrew Kolodny, the co-director of opioid policy research at Brandeis University. 'Former DEA and FDA officials should not be allowed to take money from companies they regulated.'

The issues here seem obvious.

From Top White House Adviser to Adviser to Juul

On May 21, 2019, the Washington Post reported that Johnny "DeStefano, a counselor to the president who served as a bridge between the Republican Party and the administration, is leaving on Friday." As to his destination,

He is expected to advise a number of companies, including Juul, the e-cigarette company, while helping on the campaign, according to people familiar with his plans. Juul has significant business in front of the Food and Drug Administration

I could not find much more about this. However, as a top White  House adviser without a specific portfolio, DeStafano could have affected health care and specifically FDA policy.

From Venture Capital Firm New Enterprise Associates to Director of the US Food and Drug Administration (FDA) and Back to New Enterprise Associates

On May 22, 2019, Axios reported that

Scott Gottlieb, who recently stepped down as the head of the Food and Drug Administration, has rejoined venture capital firm New Enterprise Associates as a full-time investing partner, Axios has learned.

Context: Gottlieb had been a venture partner with NEA before President Trump tapped him to lead the FDA, where he became known for cracking down on e-cigarettes and working to battle the opioid epidemic.

Gottlieb previously spent a decade with NEA, but the new role is more substantive. He's expected to lead investments in life sciences startups and take board seats.

Again, there was little other information and no substantive commentary publicly available about Dr Gottlieb's return to his old firm.

We briefly noted the considerable public discussion about Dr Gottlieb's conflicts of interest at the time of his ascension to the FDA post here. He had multiple relationships with multiple for-profit health care corporations in the years leading up to his 2017 appointment.    I should note that we have discussed previous examples, in 2007 and 2008 (look here, here, here and here), of Dr Gottlieb's strident promotion of the interests of pharmaceutical and biotechnology companies.  After 2008, I  naively thought further discussion of this topic would be redundant. 

From Director of the National Institute of Mental Health (NIMH) to Google's Verily, to Mental Health App Developer Mindstrong, to California "Czar" for Mental Health

Last, but not least, also on May 22, 2019, StatNews reported:

Noted psychiatrist and former Verily leader Dr. Tom Insel is going to be the 'mental health czar' for the state of California, Democratic Gov. Gavin Newsom announced Tuesday.

Insel, the former National Institute of Mental Health director, will also continue his work with Mindstrong, a startup that is working on a mental health app, a company spokesperson confirmed. Insel joined the company in 2017 after leaving Verily, Google’s life sciences arm.

Insel’s new job will be to 'inform the state’s work as California builds the mental health system of tomorrow, serving people whether they are living in the community, on the streets or if they are in jails, schools or shelters,' according to a press release from the governor’s office.

In a press conference, Newsom said Insel was 'volunteering' his time as an adviser. 'I’m calling him the mental health czar in the state of California,' he said.

The article also noted that

Mindstrong, which is focused on using data on how people use their smartphone to detect trends in their mental health, already has a relationship with public officials in California. One of Mindstrong’s first large-scale rollouts was slated to happen in the state through county-level public mental health systems, STAT reported in October.

A spokesperson for Mindstrong said that Insel would recuse himself from conversations about the company, and noted that he will have 'no fiscal or regulatory authority and will have no oversight of current programs in this voluntary role.'

Note that even after such specific recusal, Dr Insel would be in a position to generally influence state policy in ways that could favor Mindstrong.  Futhermore, state officials working for a "mental health czar" would be aware of his commercial ties and might thus tend to try to favor Mindstrong to please him.  

Note also that in 2010 our late blogger, Dr Bernard Carroll, wrote a series of posts about conflicts of interest and other ethical questions about Dr Insel's tenure as director of the National Institute of Mental Health (NIMH) here, here, here, here, and here.  Also, in 2015 I noted that Dr Insel transited the revolving door from the NIMH to Google Life Sciences.  This is just another example of how people and organizations that get on our radar once for ethical and leadership lapses tend to appear again and again.

[photo of Dr Carroll]


Discussion

We have repeatedly said,  most recently in March, 2019, ...

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door once again suggests how the revolving door may enable certain of those with private vested interests to have disproportionate influence on how the government works.  The country is increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

Remember to ask: cui bono? Who benefits? The net results are that big health care corporations increasingly control the governmental regulatory and policy apparatus.  This will doubtless first benefit the top leadership and owners/ stockholders (when applicable) of these organizations, who are sometimes the same people, due to detriment of patients' and the public's health, the pocketbooks of tax-payers, and the values and ideals of health care professionals.  

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