Thursday, October 19, 2017

Worst Health Care Revolving Door Case So Far, Version 2.0? - From President of Lilly USA to US Secretary of Health and Human Services?

Last week, we discussed what appeared to be the most egregious case of the health care revolving door seen so far.  A health care corporate lobbyist without any direct medical, health care, public health or biomedical science experience was named Acting US Secretary of Health and Human Services after being confirmed as Deputy Secretary.


Former Top Executive of Pharmaceutical Company Eli Lilly Considered for Nomination as Secretary of Health and Human Services

Only a week later, an even more egregious case may be in the works.  The name being "floated" as nominee to be the next Secretary of Health and Human Services is Mr Alex Azar, who through this year was a top pharmaceutical executive.  Again, he has no experience in medicine, the health professions, public health or biomedical sciences.

To repeat, you cannot make this stuff up.

As reported by Politco on October 17, 2017...

Azar has spent most of the past decade inside the drug industry, one of the key sectors he’ll regulate at HHS. Azar joined pharmaceutical giant Eli Lilly and Company in June 2007 as a senior vice president of corporate affairs and communications right after leaving the Bush administration.

He rose to head Lilly’s U.S. operations in 2012, a position he held until this January, when he left the company. At Lilly he worked on both international and federal government affairs and public policy. Other areas of focus included counterfeit medicines and health information technology.
By the way,

As part of his role at Lilly, Azar served on the board of directors for BIO, a drug lobby.

Mr Azar did have prior experience in the Department of Health and Human Services, but essentially as a lawyer/ administrator,

He served as the department’s general counsel and deputy secretary during the Bush administration.

Political, but No Medical, Health Care Professional, Public Health or Biomedical Science Credentials

To emphasize his lack of medical, health care, public health or biomedical science background, see this quote from what Mr Azar wrote this in his alumni profile for the Yale Law School,

I entered healthcare largely by accident. After law school, I clerked for Justice Antonin Scalia and then joined a D.C. law firm. I went to work for my mentor Ken Starr immediately after he became the Whitewater independent counsel.

While at my law firm, Wiley, Rein & Fielding, I was active in the Bush-Cheney campaign in 2000. After Bush won, I received a call from the office of Tommy Thompson, Secretary of the Department of Health & Human Services, asking me if I'd have interest in being General Counsel of HHS. I'll confess that I wrestled with the question, since I had not focused on health law in my legal career.

The Politico article suggests that the Trump regime might consider most of Mr Azar's credentials to be the top US health official are political,

He has also been a harsh critic of Obamacare and cheered GOP efforts to repeal and replace it, telling Fox Business in May that the Obamacare is 'fundamentally broken' and 'circling the drain.'

Azar emerged as a strong backer of former Florida Gov. Jeb Bush’s Republican presidential campaign in 2016, serving on Bush’s 30-member Indiana steering committee in the lead-up to the election.

Azar knows Vice President Mike Pence from his time at Lilly, which is headquartered in Indianapolis.
 Note that were he to become Secretary of DHHS, unless the Affordable Care Act ("Obamacare") were to be repealed, he would be charged with enforcing it.

And years prior to that, according to the Washington Post,

Azar clerked for Supreme Court Justice Antonin Scalia and, after Bill Clinton became president, worked under special counsel Kenneth Starr as he investigated Clinton’s failed Whitewater real estate investments.

Lilly's Poor Ethical Track Record on his Watch

Unlike the Mr Hargan, who transited the revolving door from a lobbying position, Mr Azar had direct operational responsibility, in this case, for Eli Lilly's US operations.  Thus he ought to be held responsible for the company's ethical misadventures during the time he was there.  In fact, the company has had a few such misadventures, some of which we have previously discussed.


Jury Found Takeda and Eli Lilly Concealed Cancer Risks of Actos, Company Subject to Punitive Damages of $36.8 Million - 2014

We discussed this in 2014.  This case seemed to involve serious deceptions, since the judge said in one ruling:

the evidence during the trial showed that the companies 'disregarded, denied, obfuscated and concealed' for more than a decade that Actos could increase patients' risk for bladder cancer.


Lilly Pleaded Guilty to Charges Related to Deceptive Marketing of Zypresa as Part of an Over $1 Billion Settlement - 2009

At the time, this was considered a landmark case.  Eli Lilly pleaded guilty to a misdemeanor criminal charges and settled allegations about questionable marketing practices for its anti-psychotic drug Zyprexa for over $1 billion in 2009 (see post here).  The settlement provided some instructive information about how big pharmaceutical companies employ ghost writing to sell product (see this post). The company pushed Zyprexa for elderly patients with dementia, despite the lack of evidence that the drug's benefits outweighed its clear harms, thus likely leading to patient harm.

Many other cases of dubious Lilly practices that did not necessarily lead to legal settlements or criminal charges can be found here.  These practices include older, lesser cases involving the revolving door; and various instances of apparently deceptive marketing practices such as planned obsolescence of drugs, use of physician "thought leaders" as covert drug marketers, payments to patient advocacy groups presumably to encourage them to act also as covert drug marketers, etc, etc

Furthermore, the company was involved in several major cases of misbehavior overseas about which  Mr Azar may or may not have been aware.  These included:

-  Lilly Fined by Brazil for "Sham" Litigation to Extend Patent on Gemzar - 2015

Per the Wall Street Journal, the government deemed the company to have engaged in anti-competitive behavior.

-  Lilly Settled Case Alleging it Bribed Foreign Officials to Win Business - 2012

We discussed this here.  This case seemed serious since it involved lavish gifts and payments made from 2006-2009 to Chinese physicians who worked for the government , bribes to health officials to Brazil starting in 2007, and other such transactions in other countries in previous years.

Discussion

Last week we noted that Mr Trump famously promised to "drain the swamp" in Washington.  Last week, despite his previous pledges to not appoint lobbyists to powerful positions, he appointed a lobbyist to be acting DHHS Secretary.  This week he is apparently strongly considering Mr Alex Azar, a pharmaceutical executive to be permanent DHHS Secretary, even though the FDA, part of DHHS, has direct regulatory authority over the pharmaceutical industry, and many other DHHS policies strongly affect the pharmaceutical industry.  (By the way, Mr Azar was also in charge of one lobbying effort.) 

So should Mr Azar be confirmed as Secretary of DHHS, the fox guarding the hen house appears to be a reasonable analogy.

Moreover, several serious legal cases involving bad behavior by his company, and multiple other instances of apparently unethical behavior occurred on Mr Azar's watch at Eli Lilly.  So the fox might be not the most reputable member of the species.

So you know the drill....     The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,
The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door from industry to the Trump administration once again suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works, and that the country is still increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort and now this most flagrant example of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

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

Let me at least try to provide a new picture of the revolving door...


Wednesday, October 11, 2017

Worst Health Care Revolving Door Case So Far? - From Lobbyist to Acting Secretary of Department of Health and Human Services

Once again, you just cannot make this stuff up.

Last week we posted our latest revolving door roundup, one of many we have done during the Trump administration.  At the time we noted that a lobbyist, Mr Eric D Hargan, at Greenberg Taurig Alston & Bird, had been nominated to be Deputy Secretary of the Department of Health and Human Services (DHHS).

Wikepedia provides a little more information about his past lobbying employment.

Hargan left the government in 2007 and joined the health law department of law firm McDermott Will & Emery. Hargan joined the health and FDA business development practice of law firm Greenberg Traurig in June 2010. He is a shareholder in Greenberg Traurig's Health & FDA Business Practice.

Greenberg Taurig Austin & Bird has done considerable lobbying for health care corporations.  We previously wrote that it "has earned more than $4.4 million lobbying so far this year for health care companies and trade groups including Novartis AG, Verax Biomedical, the American Hospital Association, St. Jude Children’s Research Hospital, and Aetna...."

Prior to his most recent lobbying work, Mr Hargan was a corporate lawyer, and then served in several purely administrative positions in DHHS during the George W Bush administration.  He also apparently served on the Trump transition team (per Wikipedia). 

I can see nothing that suggests he has any direct experience or expertise in actual health care, public health or biomedical science.  

Today, as reported, for example, by CBS, the Trump administration announced he will be acting Secretary of DHHS, the most powerful government health care official.  By the way, so far today, the brief pieces on this nomination (see also Politico, CNN, The Hill) have not mentioned his lobbying background, or lack of medical, health care, public health, or biomedical science experience. 

As we noted in our last, very recent post on the revolving door in health care, candidate Trump promised to "drain the swamp" in Washington, and specifically to avoid appointing lobbyists to government positions that could influence the fortunes of the companies for which they lobbied.

Yet here is a flagrant example of a lobbyist appointed to the highest US government health care position.  We have often discussed the revolving door affecting health care.  I believe this is the worst example so far I have seen.  We will have a man most expert in pushing policies to improve the fortunes of large health care corporations and their management, but who apparently knows little about health care, medicine, public health, or biomedical science, and has no record showing he particularly cares about patients' and the public's health.  This man is now in charge of the health care and public health operations of the US government. 



 Mr Trump, at least this doctor asks, have you no sense of decency?

So, to repeat in anguish what I have said before, most recently last week. 

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


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

The ongoing parade of people transiting the revolving door from industry to the Trump administration once again suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works, and that the country is still increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort and now this most flagrant example of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

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

Sunday, October 08, 2017

Round and Round It Spins - Our Latest Health Care Revolving Door Roundup

Sorry about the bad pun.  We have accumulated a remarkable number of stories of people transiting the revolving door from working for health care corporations in various but important capacities to positions in health care policy or regulation for the Trump administration.  These stories may not always appear in the most prominent places, but their accumulation suggests they should be of prominent importance.



As the New York Times reported on May 22, 2017, the Trump administration initially promised to drain the swamp, and specifically to prevent people who had lobbied the government from taking government positions with decision making power over their former employers' scope of interests.

President Trump signed an executive order in late January — echoing language first endorsed by Mr. Obama — that prohibited lobbyists and lawyers hired as political appointees from working for two years on 'particular' government matters that involved their former clients. In the case of former lobbyists, they could not work on the same regulatory issues they had been involved in.

Furthermore,

Both Mr. Trump and Mr. Obama reserved the right to issue waivers to this ban. Mr. Obama, unlike Mr. Trump, automatically made any such waivers public, offering detailed explanations. The exceptions were typically granted for people with special skills, or when the overlap between the new federal work and a prior job was minor.

However,

The Trump administration, in a significant escalation of its clash with the government’s top ethics watchdog, has moved to block an effort to disclose the names of former lobbyists who have been granted waivers to work in the White House or federal agencies.

The latest conflict came in recent days when the White House, in a highly unusual move, sent a letter to Walter M. Shaub Jr., the head of the Office of Government Ethics, asking him to withdraw a request he had sent to every federal agency for copies of the waivers. In the letter, the administration challenged his legal authority to demand the information.

In any case, information about people transiting the revolving door from health care lobbying firms has been coming out only in bits and pieces, as has information about people transiting from other health care positions.  I have been filing the information I can find about such people and present what I have found since May, 2017 here in chronological order.

Matthew Bassett from Senior Vice President for Government Affairs at Health Management Company myNEXUS to Assistant Secretary for Legislation at Department of Health and Human Services [DHHS]

Documented by the Nashville Post, May 5, 2017

Note that the article also stated that Mr Bassett "previously worked as a health care consultant and with ReviveHealth and DaVita"

Bruce Greenstein  from Health Care Technology Company Quartet to Chief Technology Officer, DHHS

As reported by Healthcare IT News on June 9, 2017

He previously

was CEO of Blend Health Insights, a consulting firm that advised health systems, payers, health IT companies and private equity firms in the U.S. and abroad on topics such as risk-based contracting, value-based purchasing and population health management.

Before that he

served as Secretary of the Department of Health and Hospitals in the administration of Louisiana Governor Bobby Jindal.

However

That position ended in controversy, however, when he resigned in 2013 amid accusations that he'd had improper communications related to a $197 million Medicaid contract awarded to a company, Client Network Services, Inc., where he had worked. Jindal canceled the contract, and Greenstein was indicted for perjury. The case was dismissed by the Louisiana Attorney General in 2016.

Oops. So in this case, there were at least previous allegations of corrupt behavior as well, although they remain unproven.

On June 15, 2017, the Intercept reported on several revolving door travelers.  These included:

Eric Hargan from Lobbying for UnitedHealthcare for Greenberg Traurig Alston & Bird to Deputy Secretary, DHHS

Also,

Paula Stannard  from Lobbying for UnitedHealthcare for Greenberg Traurig Alston & Bird to Senior Counselor to the Secretary, DHHS

Note that we previously posted on Ms Stannard's earlier position on a Trump "beachhead team" at DHHS.  At that time we noted that Greenberg Traurig Alston & Bird "has earned more than $4.4 million lobbying so far this year for health care companies and trade groups including Novartis AG, Verax Biomedical, the American Hospital Association, St. Jude Children’s Research Hospital, and Aetna...."

Randolph Wayne Pate from Vice President for Public Policy at Health Care Services Corporation to Associate Deputy Secretary, DHHS

That corporation operates Blue Cross Blue Shield plans in five states.

Keagan Lenihan from Lobbyist for McKesson Specialty Health to Senior Counselor, Secretary of DHHS

Note that we had posted about his previous position on a "beachhead team" here.

 The article also noted Lance Leggitt moving from Baker Donelson Bearman Caldwell & Berkowitz to Chief of Staff for the Secretary of DHHS.  We had previously posted about that position in May.

On June 21, 2017, Public Citizen published "The Swamp Nominees" which included 115 sub-cabinet appointments with questionable antecedents.   These included Mr Hargan, and Mr Bassett above.  They also included two people whom we had previously discussed, Dr Scott Gottlibe, Commissioner of the US Food and Drug Administration (FDA), Seema Verma, Administrator, Center for Medicare and Medicaid Services (CMS), and Brett Giroir, Assistant Secretary, DHHS.  However, there were quite a few more on ProPublica list, including...

Stephen Parente from Principal, Health Systems Innovation Network LLC to Assistant Secretary for Planning and Evaluation, DHHS

Robert Charrow from Greenberg Taurig LLP and Registered Lobbyist, Intrexon Corp to General Counsel, DHHS

Note that Mr Charrow as "principal shareholder" of Greenberg Taurig which "represents providers, scientists, pharmaceutical companies...."  I assume that this Greenberg Taurig is the same firm as that referred to as Greenberg Taurig Alston & Bird above.

Finally, on August 31, 2017, ProPublica reported,

Joe Grogan from Lobbyist from Gilead to White House Working Group on Drug Prices

Note that Gilead was first to market with a new group of extremely expensive drugs to treat hepatitis C.  As we have discussed, there is no evidence so far that these drugs avert the severe complications of hepatitis C or increase longevity.  Furthermore, per ProPublica

As reported by Kaiser Health News, internal documents from the working group show that, despite vows by President Trump to lower the price of medications, Grogan’s team is pushing pharma-friendly policies, such as extending a drug’s patent time in foreign markets. Grogan and the Office of Management and Budget did not respond to requests for comment.
This suggests that this particular instance of the revolving door is leading to regulatory capture.

Obama Administration Officials Transiting to Industry

During the same period, in the interest of fairness, we also note that some former Obama administration health care policy or regulatory officials now have industry positions, including

Dr Robert Califf former FDA Commissioner to Google subsidiary Verity

Per StatNews on May 17, 2017

Note that Dr Califf transited the revolving door in the opposite direction in 2015 when he became FDA leader, as we noted here.

Kevin Coulihan, former CEO of HealthCare.gov to Centene

Per the St Louis Post-Dispatch, August 2, 2017,

Drew Littman former Counselor for DHHS to Brownstein Hyatt Farber Schreck LLP

Per the Washington Examiner, Aug 14, 2017,

Note that this law firm has clients that "include companies in the healthcare and biotechnology fields."

Discussion

The revolving door has been a chronic problem for the US, but seems to only be getting worse.  We saw plenty of examples of people transiting the door to or from the US executive branch during the George W Bush and Obama administrations.  We are still seeing people transiting the door from the latter administration.  However, the number of people transiting the door into the Trump administration seems unprecedented, although admittedly that impression is based on series of cases, not systematic quantitative studies.

So, as I have said before, most recently in August, 2017,


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

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

The ongoing parade of people transiting the revolving door from industry to the Trump administration once again suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works, and that the country is still increasingly being run by a cozy group of insiders with ties to both government and industry. 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.

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

Sunday, October 01, 2017

Latest Legal Settlements Suggest Hazards of Making Pharmaceutical Regulation More Lenient, as is Apparently Favored by New FDA Leader

The new US Food and Drug Administration (FDA) commissioner Dr Scott Gottlieb is promoting making the agency's mechanisms to approve new drugs more lenient, according to the Cardiobrief blog.  Blogger Larry Husten wrote:

Gottlieb’s entire career has centered on loosening regulatory restrictions to enable industry to thrive. At the core of his philosophy is the view that with fewer restrictions the force of unbridled capitalism will unleash a torrent of industry innovation. In this view negative consequences, should they occur, will be quickly addressed by an efficient marketplace.

Should we trust pharmaceutical companies to innovate in such a light-touch regulatory climate?  On Health Care Renewal we have noted ethical violations by most of the major pharmaceutical companies, often involving deception in marketing, manipulation and suppression of clinical research, and distortions of dissemination of medical information, such as articles ghost-written by authors paid by industry.  We have documented numerous legal settlements of cases arising out of such misbehavior.

It is no surprise that more legal settlements have marched into view during the last few months to add weight to concerns about making regulation of the pharmaceutical industry more lax.  To summarize them, in chronological order...

Celgene Settled Allegations it Deceptively Marketed Thalidomid and Revlimid for $280 Million

Per the New York Times, July 25, 2017:

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

In particular, years before the company got approval to market its drug Thalidomid (generic name: thalidomide, the same drug that caused severe birth defects when marketed in Europe in the 1950s)

sales of Thalomid quickly took off, in part because — as [whistle blower] Ms. Brown claimed in her complaint — Celgene 'flooded the country' with sales representatives who were under heavy pressure to pitch the drug to oncologists for a variety of cancers. The F.D.A. sent Celgene two warning letters, in 1998 and 2000, claiming the company had been marketing the drug to treat cancer. In 2000, one Wall Street analyst estimated that 90 percent of Thalomid’s sales were to treat cancer, according to Ms. Brown’s complaint.

However, the drug was not approved for use in cancer until 2006. Also,

in 2005, the company received approval to sell Revlimid for a rare cancer, and Ms. Brown’s complaint claims that the company — as it had with Thalomid — marketed it to treat a broader range of cancers. It also pressured doctors to switch Thalomid patients to Revlimid, which is more expensive.

Ms. Brown’s complaint also claimed that Celgene’s inappropriate marketing of Thalomid exposed patients to heightened risks that included potentially fatal blood clots and other side effects. Those risks were added to the drug’s warning label only after it received the approval for cancer treatment, Mr. Guttman said.

Thus the company's actions may well have harmed patients.

We previously discussed, most recently in 2010, the immense price Celgene charged for Thalidomid, despite the fact that this compound, developed about 60 years ago, is available for pennies in many countries.  

Nonetheless, and also despite the amount of money that Celgene was making selling its drugs for unapproved uses (e.g., Revlimid's sales last year were nearly $7 billion), the US Department of Justice declined to get involved in this case.  Also, like most legal settlements involving big health care organizations, the company did not admit any wrongdoing, and no person who enabled, approved, or directed the misbehavior suffered any negative consequences.

Insys Settled Allegations of  Promotion of Narcotics for Unapproved Uses for $4.5 Million to Illinois

Per the Chicago Tribune, August 18, 2017:

An Arizona drug company has agreed to pay Illinois $4.45 million to settle allegations that it deceptively marketed and sold a prescription opioid drug for uses not approved by the U.S. Food and Drug Administration.

Insys' actions may well have contributed to the current opioid epidemic.

The company heavily marketed the drug to Illinois doctors with records of prescribing high volumes of opioids regardless of whether those doctors were prescribing opioids to treat cancer pain, the state alleged.

In particular,

According to Madigan's office, the top prescriber of Subsys in Illinois was Dr. Paul Madison, who wrote about 58 percent of all prescriptions for the drug in the state despite treating few, if any, cancer patients. Madison, an anesthesiologist and former owner of the Watertower Surgicenter on North Michigan Avenue in Chicago, was indicted in 2012 by the U.S. attorney's office in Chicago for billing insurers for procedures he didn't perform, and his medical license was suspended in November, according to Madigan's office.

We previously discussed Insys' stealth public relations campaign against medical marijuana here.

However, as in the previous case, the US DOJ was not involved, the company did not admit wrongdoing, and no individual involved in the misbehavior paid any penalty.

Novo Nordisk Settled Allegations it Minimized Risks of Victoza for Nearly $58.7 Million

Per Reuters, September 5, 2017:

Novo Nordisk will pay nearly $58.7 million to resolve claims the drugmaker’s sales staff downplayed the importance of U.S. Food and Drug Administration-mandated warnings about the cancer risks of its diabetes medication Victoza.

The U.S. Justice Department said Tuesday’s settlement would resolve claims Novo Nordisk supplied its sales representatives with information to give to doctors that created the false or misleading impression that warnings were wrong or unimportant.

In particular,

The lawsuit said that program required Novo Nordisk to provide doctors information about the potential risk of a rare form of cancer associated with the drug, which gained FDA approval in 2010.

Victoza’s FDA-approved labeling also contained a boxed warning related to that form of thyroid cancer, the lawsuit said.

Novo Nordisk’s sales force employed messages and tactics that created a false or misleading impression with doctors regarding the cancer risks, leading some physicians to be unaware of them, the lawsuit said.
Thus, again this company's actions appeared to pose a risk to patients.

This company also has a track record of ethical misadventures.  In 2011, we discussed several previous settlements by Novo Nordisk.  Nonetheless, the US DOJ decided not to be involved in this litigation, which, as in the other cases above, did not result in admission of wrongdoing, nor any penalities for individual involved in the misbehavior.

Novelion Subsidiary Aegerion Pleaded Guilty, Fined $40 Million for Misbranding Juxtapid by Minimizing its Adverse Effects

Per Reuters, September 22, 2017:

Aegerion Pharmaceuticals Inc will plead guilty to two misdemeanors and pay $40.1 million to resolve investigations into its marketing and sales of an expensive cholesterol drug, U.S. authorities said on Friday.

The settlements will resolve long-running investigations into Aegerion, a subsidiary of Canada’s Novelion Therapeutics Inc, by the U.S. Justice Department and the U.S. Securities and Exchange Commission related to its drug Juxtapid.

In particular,

Prosecutors said after the U.S. Food and Drug Administration in 2012 approved Juxtapid for treating a rare genetic condition that causes high cholesterol, Aegerion promoted it for patients who had not been diagnosed with the condition.

Juxtapid, which cost $250,000 to $300,000 annually per patient, featured a black box warning on its label that it could cause serious liver and stomach problems, prosecutors said.

Sales representatives also were trained to tell doctors and patients that Juxtapid would 'take patients out of harm’s way' and prevent 'impending' heart attacks and strokes, despite the lack of data supporting those claims, prosecutors alleged.

Numerous patients discontinued using Juxtapid after suffering conditions including liver toxicity and gastrointestinal distress, prosecutors said.
Thus, once more, the company's actions appeared to result in patient harm.

The company also signed a deferred prosecution agreement.  By pleading guilty, it admitted the misbehavior in this case.  However, again no individual involved in the misbehavior faced any penalties, despite the severe nature of the adverse effects the company deceptively minimized.

AmeriSourceBergen Settled For $260 Million Allegations of Illegally Selling Repackaged, Perhaps Adulterated Drugs so as to Avoid FDA Regulation

Per Modern Healthcare, September 27, 2017:

AmerisourceBergen Specialty Group, a wholly-owned subsidiary of the major wholesale drug distributor AmerisourceBergen Corp., pled guilty to illegally distributing misbranded drugs and agreed to pay $260 million to resolve criminal liability for skirting regulatory oversight.

Between 2001 and 2014, according to court records unsealed Wednesday, the group's now-defunct subsidiary Medical Initiatives prepared millions of syringes that had been filled with cancer drugs and shipped them to providers in all 50 states.

Medical Initiatives removed the drugs from their original glass vials and repackaged them into plastic syringes in an unclean and unsterile environment, allowing the company to sell excess drug product in the vials known as 'overfill,' according to court records. It combined the contents of multiple vials in a process known as 'pooling,' despite many of the vials carrying a 'single-use' designation.

In order to avoid the Food and Drug Administration's regulatory oversight, AmerisourceBergen Specialty Group did not register Medical Initiatives as a repackager or manufacturer with the agency, records show. Instead, the group portrayed Medical Initiatives as a state-regulated pharmacy, exploiting an exemption to the FDA registration requirement that is reserved for legitimate pharmacies, not for manufacturers or repackagers, authorities said.
Given the problems with sterility, again the company's actions possibly could have harmed patients.

However, yet again, this settlement did again involve a guilty plea, but again no individual involved in the repackaging and adulteration suffered any negative consequences.

Discussion

All the cases discussed above were of behavior that could have harmed patients.  Many of the companies involved had records of previous ethical misadventures.  While a few cases resulted in corporate guilty pleas (to misdemeanors), none resulted in monetary penalties that would have much impact on the companies' finances, and none resulted in any negative consequences for people who enabled, authorized, directed or implemented the bad behavior.


These, just the latest in the march of legal settlements by large health care organizations, again demonstrate how often and how seriously pharmaceutical companies (and other organizations) may misbehave, and how the leaders of these organizations exhibit continued impunity, never having any legal accountability for their organizations' actions.  These settlements again demonstrate the relatively light touch US regulators, including the FDA and DOJ, have exhibited when dealing with these organizations.

So what could happen if that touch is lightened still more, particularly by the ongoing initiatives of the current US FDA leader?  I submit the results will be higher drug prices, more use of minimally effective and/or seriously risky drugs, and larger compensation for top managers of pharmaceutical companies.  Will the public actually also get access to "life saving" drugs?  Perhaps, but most of the offerings of drug companies in the last years have had minimal efficacy, and rarely have been proven to extend life.

Why is Dr Gottlieb pursuing these initiatives?  Is he a true believer in market fundamentalism, perhaps untrammeled by lack of evidence supporting it?

Maybe he as he become intoxicated by all the money he previously made from the pharmaceutical industry.  Prior to his approval by the Senate, his extensive financial dealings with the pharmaceutical industry were detailed by the New York Times, and Stat News, among others.  The NYT article said:

The nominee, Dr. Scott Gottlieb, has spent the bulk of his career working in the drug and health care industry, which experts say raises the potential for myriad conflicts of interest. If confirmed to head the F.D.A., he would wield considerable power over companies and investment firms that have paid him millions of dollars over the years. From 2013 to 2015, for example, Dr. Gottlieb received more than $150,000 to advise Vertex Pharmaceuticals, a company whose two approved drugs are seen as breakthrough treatments for cystic fibrosis but carry list prices of more than $250,000 a year. He’s the acting chief executive of Cell Biotherapy, an early-stage cancer biotech firm that he helped found. He has served for years as a consultant to pharmaceutical giants like GlaxoSmithKline and Bristol-Myers Squibb and is paid by other companies for his expertise.
So Dr Gottlieb's move to the FDA was yet another example of the revolving door pheonomenon.



The Stat article concluded,

It also reflects the normalization of conflicts of interest in medicine, which has been debated in the pages of the New England Journal of Medicine and in the Lown Institute blog.

Gottlieb has criticized government efforts to shed light on conflicts of interest, such as the Physician Sunshine Act, as 'federal tinkering' leading to “the demise of American medicine.” We believe his confirmation will lead to the demise of some FDA rules that are already barely keeping a lid on useless or dangerous medical products.

That may not be so far in the future, if Husten's concerns mentioned at the top of this post are true. And when conflicts of interest start having such real world effects, they cease to be merely conflicts of interest, but become corruption.

We have long been railing against conflicts of interest and corruption.  Until recently we noted only some conflicts of interest affecting US government leaders, most often in the form of the revolving door.  Most of the conflicts we discussed involved health care professionals and leaders of health care organizations.

So we used to write things like this (in July, 2016):

True health care reform would first make transparent the web of institutional and individual conflicts of interest that seems to tie together nearly all big health care organizations, and open discussion of how to make health care organizations better serve health care rather than the narrow financial interest of their top leaders.

Or this (in June, 2016):

True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.

However, since the last presidential campaign, more and more conflicts of interest and apparent examples of corruption involving President Trump, his family, and his ongoing business interests have appeared, so that at this time the Trump regime seems to be riddled with conflicts of interest and corruption (for example, see these lists compiled by the Sunlight Foundation and Newsweek).  Conflicts of interest and corruption involving the highest levels of US government have even more potential to damage patients' and the public's health than those involving, say, physicians or hospital CEOs.

 So we now must say that true health care reform in the US first requires vast reduction in the conflicts of interest and corruption of the leaders of US government.  

Friday, September 22, 2017

More Dumb Things Leaders Say About Health Policy

These days, legislative efforts to change US health care, especially to "reform and replace" the Affordable Care Act [ACA or "Obamacare"] seem to inspire displays of jaw dropping ignorance by political and sometimes business leaders on behalf of "reforming" health care.  We last posted examples on July 7, 2017.  Now there is a new game afoot to reform and replace, and it is generating new - not to put too fine a point on it - foolishness.

So herein is a roundup of a two more examples from July after our last post, plus two more revently "ripped from the headlines," actually ripped from relatively obscure media articles, because the anechoic effect persists, and the media still does not cover these sort of things much.  In chronological order:

Vice President Pence Makes "False" Statement About Ohio Medicaid Problems, Per Ohio's (Republican) Governor

Reported by the Hill on July 15, 2017...

Ohio Gov. John Kasich's (R) office has flatly rejected Vice President Pence's claim that nearly 60,000 disabled Ohioans are on waiting lists for Medicaid’s home and community-based services.

Kasich spokesman Jon Keeling told The Washington Post that such an assertion is 'not accurate' and that suggesting Medicaid expansion hurt the developmentally disabled system 'is false, as it is just the opposite of what actually happened.'

At that time, while the previous push to "repeal and replace" was still going on, and Vice President Pence was apparently trying to make a point about how bad "Obamacare" is:

'I know Gov. Kasich isn’t with us, but I suspect that he’s very troubled to know that in Ohio alone, nearly 60,000 disabled citizens are stuck on waiting lists, leaving them without the care they need for months or even years,' Pence said in a speech Friday at the National Governors Association summer meeting in Providence, R.I.

But,

According to the Post, waiting lists for such Medicaid services are common and are typically longer in states that did not take ObamaCare's Medicaid expansion than in those that did.

Ohio was among a number of Republican-controlled states that took the ACA's Medicaid expansion, which dramatically expanded the number of people who qualify for the program.

President Trump Makes Multiple Misleading Claims About His Efforts to Reform the Veterans Administration

We know that interesting things often happened at Mr Trump's campaign events, and at his later "campaign style" events as President.  Stat reported on July 28, 2017:

President Trump paints a rosy picture of an improved Department of Veterans Affairs under his watch, where accessing electronic medical records is 'so easy and so good' and health care is freely available without any delays.

The problem: It’s not true.

At a campaign-style event in Ohio this week, Trump’s claims of progress were so overstated that even his own VA secretary, David Shulkin — who stood right next to him — would have to disagree.

The article went on to list a number of specific claims which were false or misleading, including:

- Claims of huge improvements in VA information technology.  Unfortunately, a multiyear effort to improve health care IT "has barely even begun."

- Claims that the VA had doubled the number of veterans given approval to see  a "doctor of their choice" outside of the system.  In fact, the troubled VA Choice program increased the number by only "26 percent", and the program was facing new budget problems at the time Mr Trump made the claim.

- Claims that the administration had published wait times for all VA sites.  This actually started more than a year previously, under the Obama administration.

- Claims that the VA now offers same-day mental health services.  "This may be the case, but it happened before Trump took office."

In the "good old days," vice presidents and presidents who spoke publicly about issues like health care, about which one could not expect them to be expert, might have sought detailed briefings and/ or deferred some issues to their own experts.

White House Economic Advisor Misstates Basic Concept of Health Insurance

Reported by RawStory on September 19, 2017:

Donald Trump’s top economic advisor Stephen Moore on Tuesday demonstrated an apparent lack-of-knowledge of just how insurance works, telling CNBC’s John Harwood 'people want insurance for their own families, not other peoples.' Moore was explaining why it’s unfair to have an insurance system where healthy people subsidize sick people.

Trump adviser Moore on unfairness of the healthy subsidizing the sick: 'people want insurance for their own families, not other peoples' — John Harwood (@JohnJHarwood) September 19, 2017
Moore's implication seemed to be that people should not pay for insurance programs which might pay for health care for other people.  Yet the simple minded notion of insurance is that it is a tool to pool the resources of the many to pay for costs that only some will incur during a given time period.

The article went on to describe the withering responses on Twitter.  But for those who do not follow Twitter, I could only find a clear explanation of the problem with Mr Moore's statement in a column by Jodine Mayberry in the Delaware County (PA) Daily Times:

U.S. Sen. Ted Cruz, R-Texas, believes that people should be able to buy only the insurance that suits their needs. But there is no way anyone can ever know exactly what their needs will be, tomorrow, six months from now or six years from now.

You may not have diabetes or heart disease today, but a year from now, who knows?

A Trump economic adviser, Stephen Moore, said earlier this week, 'People want insurance for their own families, not other people’s families.'

He knows he is distorting how insurance works.

Our insurance premiums go to cover other people’s disasters as well as insure against our own.

That’s known as spreading the risk – the more people you can have in a pool of insureds, the more likely you’ll have affordable coverage for your own family.

I had a bad house fire in 1987 that cost about $50,000 to repair.

I certainly had not paid anywhere near $50,000 in homeowners’ insurance premiums up to that point (or ever).

Other people paid for my fire and I have helped pay for other people’s over the years.

We must have home and auto insurance, unless we don’t live in a house or drive.

We are all born and we all get sick and we all die, without exception, which is all the more reason for all of us to have affordable health insurance.
 So here we had the example of a top executive branch adviser who apparently provides input about health insurance, yet who does not seem to understand what health insurance is.


Aetna CEO Wrongly States Canada Has a De Facto National Health Service in Which the Government Owns and Runs Hospitals and Physicians' Practices

This example is of a top corporate health care executive, not a politician or government adviser.  As reported by Lee Fang writing in the Intercept on September 20, 2017:

[Aetna CEO Mark Bertolini] asked the room of investors and analysts to 'name a country that has single payer.'

When several participants named Canada, Bertolini disputed the answer and claimed that Canada has a 'government-run health care system. They’re not single payer, they’re single everything.'

But,

The suggestion, however, that Canada has a completely government-run health care system under which all medical professionals 'work for the government' is false. In Canada, medical claims for virtually all non-dental health care are paid by the government, but doctors and hospitals work in the private sector.

'Doctors in Canada are not employed by the government. They are self-employed, they are independent business people,' said Karen Palmer, an adjunct professor at Simon Fraser University. 'The system is publicly funded but privately delivered.'

Bertolini appeared to be confusing single payer with a single-provider system, such as the National Health Service in the United Kingdom, under which doctors and providers work directly for a government entity.

Bertolini is the CEO of a huge for-profit health care insurance company, so one would think we might know the difference between national health insurance and a national health system.  The example of Canada is a one often used by those who promote "single-payer" health insurance in the US, an idea which Mr Bertolini opposes.  So one would think we would be familiar with the Canadian example. 

Summary

It would be too much to expect that health care policy debates would be rigorously evidence-based.  However, lately they seem to include loudly expressed views devoid of facts or rationality.  We have proposed that this is the result of "managerialism."  We have discussed this doctrine, promoted in business schools that people trained in management should lead every type of human organization and endeavor.  Management by people from the disciplines most relevant to the mission and nature of particular organizations should be eschewed.  So managers, not physicians or other health care professionals, should lead health care organizations.  Following that theme, managers, or those like them, rather than health care professionals and health policy experts should lead health policy. 

However, managers who run health care organizations, or make policy, have an unfortunate tendency to be ill-informed (as well as unsympathetic if not hostile to health care professionals' value and the health care mission, and subject to perverse incentives that often put short-term revenue ahead of the health of patients and the population.)  And in the latest health care reform debate, some of the politicians and political appointees who are the de facto managers of health policy have disdained the advice of health care professionals and health policy experts.  (And above we presented an example of a true managerialist corporate health care executive who also - to put it bluntly - did not seem to know what he was talking about in a discussion of various country's health insurance systems.)

Ignorance and falsehood in the health care debate could also be part of a broader trend toward anti-intelletualism or what has recently been termed "The Death of Expertise" (see this New York Times review of a book with that title.)  Managerialism could be part of that trend.  And the extreme relativism of post-modernism, which we also discussed in the context of the current debate on health care reform, could be another.  

Facts, however, are stubborn things.  Evidence is evidence, no matter what politicians or corporate executives it might offend.  Basing legislation on the sorts of alternative thinking displayed in the cases above could lead to real life, or life and death consequences for the sick, injured and vulnerable.  True health care reform requires clear thinking and the input of people who actually know something about health care.


Sunday, September 17, 2017

"The Censorship That It is" - Now Threatens US Government Health Agencies (DHHS, CMS, CDC)

On Health Care Renewal we discus the dark side of health care, particularly of the leadership and governance of health care, that has enabled health care dysfunction.  Our discussions are based on publicly available information, often produced by dogged health care journalism.

Uur work has become more difficult as journalism is challenged by economic circumstances.  Yet now there are worse threats.  Despite First Amendment protections of freedom of speech and the press, journalism is now under fire from the highest reaches of US government.

Information Blockade at the Department of Health and Human Services

Two recent articles in the Columbia Review of Journalism pointed to specific problems  The first, "Under Trump, Health Reporters Confront an Information Blockade," September 7, 2017, focused on decreasing transparency at the US Department of Health and Human Services (DHHS), and its Center for Medicare and Medicaid Services (CMS).  It provided numerous examples of officials failing to respond to apparently straightforward requests for legitimate health care information.  For example,
Washington Post healthcare reporter Paige Winfield Cunningham recently raised a few serious questions about how the Trump administration planned to manage Obamacare’s fall enrollment season. 'The six-week sign-up period will be the first handled exclusively by an administration that’s hostile to the Affordable Care Act,' Cunningham wrote, 'and one that hoped by now to see Congress pass legislation unraveling much of the law.'

Any reporter might have asked the questions Cunningham put to the Department of Health and Human Services, some of which she published in her daily Health 202 column:

Will the government contact current enrollees to alert them that sign-ups will last just 45 days, about half as long as in the past three years? Will HHS run call centers for consumers who need help as they look for plans? Will the HealthCare.gov computer system be adjusted to accommodate a possible crush of shoppers given the shorter sign-up period? And how will automatic enrollment be handled?

HHS offered no answers, although a spokesperson for the department’s communications staff did provide Cunningham with a statement: 'As open enrollment approaches, we are evaluating how best to serve the American people who access coverage on HealthCare.gov.' Even that statement did not stand for long, reported Cunningham:

An hour later, the spokeswoman, Jane Norris, requested that the statement be withdrawn, saying that she did not have permission to release it. When I asked her again for detailed answers, neither she nor anyone else at HHS responded further.

'Nobody at HHS ever reaches out to me,' Cunningham told CJR during an interview.

Also,

Matt Wynn, data reporter for MedPage Today, went public with his troubles prying loose the data underlying a series of maps CMS sent out this summer. One map published in early June identified counties without insurers selling policies on healthcare.gov this fall, and a news release announced at least 35,000 active Exchange participants live in counties projected to be without coverage in 2018.' Wynn asked CMS to see the numbers supporting those conclusions.

I shot an email to the media relations office in the department, asking for the data behind the map.

About an hour later I got a response. No further information would be shared at this time, wrote Shelby Venson-Smith, a public affairs specialist. Adding insult to injury, the non-response was not to be used as a direct quote, the email said.

However, while DHHS and CMS officials resisted responding to uncomplicated requests for information,

they seem to have plenty to say in their news releases and email blasts, which disparage the health law and sound more like campaign propaganda and GOP talking points than routine communications from a federal agency. The Obama administration was not shy about using the same PR tools to boost the ACA. But messages from HHS now feel substantively different, perhaps because they are aimed at denigrating a law they have a legal responsibility to administer.
Thus officials at DHHS seem to now be more interested in following the party line of the current administration than in providing basic information to the public.

Many other health care journalists experienced similar problems, including Charles Ornstein from ProPublica, Dan Diamond of Politico, Harris Meyer of Modern Healthcare, and Noam Levy of the Los Angeles Times.

Trudy Lieberman, the author of the CJR article, wrote,

HHS and CMS are powerful agencies that could decide the future of critical programs like Medicaid and Medicare, the Obamacare insurance marketplaces, and whether or not hospitals are considered safe. But when agency press officials avoid interviews and refuse to answer questions, it’s hard to present their positions fairly and understand whose side they are on. Government agencies are supposed to be objective about industry practices under their jurisdiction. But if reporters cannot get honest information about the industries they regulate, where can they go?
Kathryn Foxhall, who "works with the Society of Professional Journalists on freedom of information issues," put it this way,
I don't see the administration ever stopping what they are doing, unless we as journalists pull out all stops and call it the censorship that it is.

Public Health Without Public Information?

Worse, one week later, CJR published another article  on the US Centers for Disease Control (CDC).  The CDC is the lead US public health agency.

Axios published text from a late August email by a CDC public affairs officer that directs staff to route any correspondence with journalists—'everything from formal interview requests to the most basic of data requests'—through the communication office at its Atlanta headquarters:

'The message—sent by public affairs officer Jeffrey Lancashire and dated Aug. 31—instructs all CDC employees not to speak to reporters, ‘even for a simple data-related question’… Lancashire did not respond to requests for comment about the policy. But I’d love to know what harm was being done by CDC employees answering ‘the most basic of data requests.’'
Thus CDC officials now seem to want to substitute public relations for straightforward information provision.  Given that the mission of CDC is public health, this seems to be an example of mission-hostile management, a concept we have used most often to refer to the management of private health care organizations, not US government agencies.  Charles Ornstein of ProPublica commented

This is genuinely disturbing. The idea that someone at CDC headquarters needs to sign off on responses to basic data requests shows a level of media control beyond which I have ever seen. What’s next?

Felice Freyer of the Boston Globe tweeted

CDC is employed by taxpayers. Why shouldn't its work be readily shared with them?
At Health Care Renewal, we have often discussed the anechoic effect, a taboo against public discussion of many aspects of health care dysfunction, particularly those that might discomfit people who are personally profiting from the current system.  In particular, the currently dysfunctional health care system has made the leaders of big health organizations, particularly for-profit corporations,  hugely wealthy.  Furthermore, big health care organizations have been eager to develop financial relationships with health care professionals, academics, leaders of non-profit organizations and NGOs, etc, leading to a web of conflicts of interest draped over health care.  Who wants to speak out when doing so may offend not only distant CEOs, but also one's colleagues, bosses, friends, relatives etc who may have financial ties to those CEOs' corporations?  Furthermore, who wants to speak out when large corporations command huge marketing and public relations operations that can be used to drown out unwanted ideas, and legal departments ready to threaten litigation?

Now government health care officials seem to be enlarging their own public relations efforts while shutting off access of honest information.  This will only make open discussion of the true causes of health care dysfunction more difficult. 

Even more chilling is the threat that health care officials now may be attempting actual censorship.  We have depended on health care journalists to root out bad behaviors that lead to health care dysfunction, and by doing break taboos about discussion such behaviors.  Up to now we have assumed at least that government would not make it harder for journalists to do their job, protected by the Bill of Rights protections of free speech and a free press.  But now the current administration seems to be taking the side of censorship.

From Censoship to Incitement of Violence?

Even worse, some worry that the regime's hostility to journalists  threatens their actual harm.  In early September, the New York Times reported on comments by the United Nations High Commissioner for Human Rights, who

was reacting to Mr. Trump’s recent comments at a rally in Phoenix during which he spoke of 'crooked media deceptions' in reports of the violent clashes at a white nationalist rally in Charlottesville, Va., that resulted in the death of a counterprotester.

In Phoenix, the president’s words also appeared to whip up audience hostility toward journalists.

The failing @nytimes writes false story after false story about me. They don't even call to verify the facts of a story. A Fake News Joke! — Donald J. Trump (@realDonaldTrump) June 28, 2017

'It’s really quite amazing when you think that freedom of the press, not only a cornerstone of the Constitution but very much something the United States defended over the years, is now itself under attack from the president himself,' [UN official] Mr. al-Hussein said. 'It’s a stunning turnaround.'

Furthermore,

'To call these news organizations fake does tremendous damage,' Mr. al-Hussein added. 'I believe it could amount to incitement. At an enormous rally, referring to journalists as very, very bad people — you don’t have to stretch the imagination to see then what could happen to journalists.'

Ominously, the response from the White House included more unsubstantiated charges of "false narratives," and threatened media tha fails to be responsible as judged by the regime, never mind the First Amendment and its promise of free speech and a free press. 

the White House press secretary, Sarah Huckabee Sanders, said in an emailed statement, 'We believe in free press and think it is an important part of our democracy, but the press also has a big responsibility to the American people to be truthful. Their job is to report the news, not create it.

'Is it not ‘dangerous’ for the media,' she continued, 'to create false narratives and overzealous attacks against the president that the American people chose to be their leader? The president is focused on growing our economy, creating jobs, securing our border and protecting Americans. Since those are also the priorities of most Americans, hopefully the media will make covering them theirs.'

Strong, even overzealous verbal and written attacks on politicians, the president included, have been essential parts of American democracy since the Bill of Rights was ratified.  The First Amendment shows that our political system values such boisterous discourse.  The White House press secretary thus threatened not only the press but the fundamental US system of government.  

Strategic Hostility

Finally, there is an argument that the regime's attacks on the media may not be just reckless, but  strategic and calculated.  The UN Special Rapporteur on the promotion and protection of the right of freedom of opinion and expression, Prof David Kaye of University of California - Irvine School of Law, wrote,

The President’s attacks may be reckless – who knows whether someone in his audience will take the President’s word as license to take action against enemies of the American people? – but they are not without purpose. They have concrete aims: to intimidate reporters into certain kinds of coverage, or clarify for his favored outlets what coverage he desires, or plant the seeds of doubt about news stories (such as the Russia investigation led by Robert Mueller).

Also,

However, when we tie together the jeremiads and rhetoric with what the Trump administration is doing in other governing spaces, the practice of attacking the press becomes clearer as policy than solely reckless rant.

First, the attack on the press is not merely rhetorical; it is increasingly reflected in policy.

And,

Second, Trump’s incendiary statements work in tandem with a pattern of lying and disinformation, both aiming to limit the accessibility of truthful information

And,

Third, the administration operates as if it has something to hide.
Who knows what they might be hiding.  But there certainly have been plenty of accusations of  severe conflicts of interest and corruption affecting the Trump presidency?

Summary

Up to last year, I was cautiously optimistic that the anechoic effect was starting to erode, enabling the health care discussion to begin to encompass the deeper causes of health care dysfunction.  Since November, however, we seem to be going backward.  What little openness and transparency that were developing are at risk of sinking under a new tide of propaganda and censorship.  My concerns have primarily been about health care and health care dysfunction, but the larger trends threaten our whole society and the ability of the US to maintain itself as a republic.  Ben Franklin's warning becomes more acute.  What we have is only 

A republic if you can keep it. 

That will now take some work.  

Thursday, September 07, 2017

The Shame of US Health Care Dysfunction: Hookworm Returns to Alabama

An article just published online(1), and reported so far in only one major media outlet (the Guardian, based in the UK) showed how hookworm, now considered a disease of poor, third world countries, has returned to the American south.  This in a country which spends more per capita on health care than any other supposedly developed country.

Background - the Supposed Eradication of Hookworm

A 2009 article in Health Affairs documented the supposed elimination of common diseases once found in US.(2)  The background of the article included:

In 1916 a new textbook appeared on the 'endemic diseases of the southern states.' With chapters on malaria, pellagra, and intestinal worms, the book’s authors identified the region as particularly, and peculiarly, diseased. Absent was the dominant southern disease of the nineteenth century: yellow fever. Although yellow fever had traveled hand in hand with the import trade of southern cities, the twentieth-century triad of pellagra, malaria, and hookworm was inextricably linked with the rural poverty engendered by cotton culture and the tenant labor system that evolved to replace slavery after the Civil War. The rural farm worker had little money or access to health care, ate a poor diet, and lived in a subtropical landscape that was host to parasitic worms and mosquitoes. In 1916 the South’s endemic diseases appeared to be thoroughly entrenched. Later, in the depths of the Great Depression, these diseases continued to plague southerners. Yet by 1950 southerners were almost free of them all.

The article noted that hookworm in particular was associated with the South:

Hookworm disease was once associated so much with the South that when a baseball commentator referred to southern players as coming from the 'Hookworm Belt' in 1947, the phrase needed no explanation. The hookworm is a tiny parasite that latches onto the wall of the small intestine, secretes an anticoagulant to promote bleeding, and feeds on the host’s blood. About 110 worms can consume a teaspoon of blood a day. A well-fed host with adequate iron intake can usually replace the lost iron and plasma proteins of a mild infection, but a malnourished person harboring sizable numbers of parasites will become anemic and protein deficient. In children the disease stunted physical and cognitive development. It made them weak, apathetic, and perpetually tired.

In the beginning of the 20th century, the Rockefeller Foundation launched a campaign that probably began the apparent eradication of hookworm.

In 1902, however, Charles Stiles, a medical zoologist, recognized in southerners the same symptoms he had seen among European hookworm victims. Once he started looking, he found a startling prevalence of the disease. He convinced representatives of the Rockefeller Foundation to take up the cause of hookworm eradication, and in 1909 the philanthropy launched an all-out assault on the disease. Their initial surveys found 43 percent of those surveyed to be infected with hookworm; in some areas the percentage rose into the 90s.

The Rockefeller campaign stressed education, treatment, and the assumption by local and state boards of health of the responsibility to carry on what the foundation had begun. With a million dollars in their coffers, the Rockefeller men spread across the South, offering lantern shows about the hookworm, testing and treating individuals, and pushing the construction of sanitary privies. Surveys of rural schools and churches found that 80 percent lacked any sort of privy; private homes were even less likely to have sanitary facilities. Children of all classes went barefoot in the summer, often not wearing shoes until they were teenagers. By 1914, when Rockefeller ended its U.S. campaign, the prevalence of infection had been cut to 39 percent, but the message of hookworm and its implications was now well known throughout the South. The campaign also energized southern public health, leaving a legacy of empowered institutions on the state and local levels.
For more on the history of the Rockefeller Foundation campaign, look here.  I hope the Foundation will not mind me using a picture of a hookworm treatment clinic from 1923.



Hookworm persisted for a surprisingly long time after these initial eradication efforts, although it seemed to be nearly gone by the 1980s.  The article noted that

Even in the 1960s there was persistent infection in coastal South Carolina (3 percent) and eastern Kentucky (14 percent). One source reported that hookworm prevalence in southern Georgia went from 60 percent in 1910 to 13 percent in 1964 and to 6 percent in 1970.

So the disease prevalence fell from over 40% in the early 20th century to a few percent by the 1980s.  One particular mechanism for the decrease was basically better plumbing.

Concerns about typhoid, which was frequently fatal, drove the cities to put in sewers and running water, and fears that the privies of the poor would infect the affluent meant that even the poorer sections of towns had sanitary waste disposal throughout much of South in the 1920s. Slowly the expectation grew that the sanitary privy was essential for adequate housing. In North Carolina in the 1940s, the state board of health required them by law.

So the problem appeared to be solved.  I learned about hookworm in a course in tropical diseases in medical school in the 1970s.  At the time, since I was not planning to go into global health, the knowledge did not seem very relevent.  I suspect that such courses were no longer very prevalent in medical school.

That was then.  This is now.

Hookworm Returns to the Impoverished US South

The new article by McKenna et al noted that hookworm is still very common globally.  In addition, it noted that the conditions are again ripe for the return of hookworm, and presumably other ailments now considered irrelevant to developed countries, to parts of the US.  In particular, the advances in plumbing so important to the eradication of hookworm are no longer so much in evidence.

According to the Alabama Center for Rural Enterprise (ACRE), an organization that addresses poverty and economic development in one of the poorest areas of the nation, there continues to be residences without adequate sanitation systems, increasing exposure to open sewage near dwellings. The “Black-Belt” soil native to this area is composed of a firm sedimentary limestone bed overlain with a layer of dark, rich soils, which requires expensive septic systems for proper waste disposal. In Lowndes County, Alabama, where the per capita income is $18,046, and 31.4% of the population lives below the poverty line, sanitation systems are unaffordable. For rural, impoverished individuals, the main form of waste removal involves use of 'straight piping,' a method involving a series of ditches or crudely constructed piping systems to guide human waste away from the residence. Most pipes never reach more than 10 meters in length, and during rainstorms or flooding, the residents report visible stool entering their homes (reported by ACRE, unpublished data).

The investigators therefore performed an epidemiological study in Lowndes County.  There sample size was small.  However, their findings were striking.  More than one-third (34.%) of subjects tested positive for necator americanus, the American hookworm.  This is close to the prevalence reported back in the early twentieth century.

The Guardian article provided vivid anecdotal evidence about the state of public health in rural Alabama that likely contributed to this result.  The reporter's tour of Lowndes county revealed vividly inadequate sewage systems.  He documented that in Alabama, "public health" was ostensibly insured by making it a criminal offense for people to have inadequate sewage systems.

people were afraid to report the problems, given the spate of criminal prosecutions that were launched by Alabama state between 2002 and 2008 against residents who were open-piping sewage from their homes, unable to afford proper treatment systems. One grandmother was jailed over a weekend for failing to buy a septic tank that cost more than her entire annual income.

'People are scared. They don’t like to speak out as they’re worried the health department will come round and cause trouble,' [community activist Aaron] Thigpen said.

Apparently the state government does not see that it has any resonsibility to provide adequate sewer systems, or provide any help to people to improve sanitation, even those clearly unable to affort it on their own.  Consider, for example, the plight of Ruby Rudolf

Rudolph, now 66, does have her own septic tank at the back of her house, which she shows us in the sweltering 41C (105F) heat. But it doesn’t function properly and when it rains the tank spills over, spreading raw waste all over the yard. 'That’s better than when it flushes back into the house, and I’ve had that too,' she said.

She’s been told a replacement system would cost her at least $12,000, which is beyond her means. She runs through her finances: she gets up at 4am every day to do an early shift at a Mapco convenience store, which brings in less than $1,200 a month. From that amount she has to pay $611 for her mortgage and there’s the electricity bill that can be more than $300 a month when it’s hot and the air conditioning is busy. There’s not a lot left to put toward a new tank.

Left entirely unsaid in the scholarly article or the Guardian story is the likelihood that any residents of these rural Alabama counties have access to any other ways to mitigate the hookworm problem.  Left also unsaid is whether they have access to health care professionals who could test them or treat them for hookworm.

Conclusions

As we have noted endlessly, the US spends more per capita on health care than any other developed country.  US politicians used to make the claim that the country has the best health care system in the world, often to ward off any attempts at true health care reform.  However, US rankings on various measures - some of which may be disputed - of health care processes and outcomes have been decidedly mediocre.  (See for example the latest Commonwealth Fund study here.)

The new study of hookworm prevalence was not based on a big, systematic, or geographically diverse sample.  However it is striking, and dismaying that a disease once thought to be eradicated is again alive and well in the poorer parts of a very rich country. 

Note that while the eradication of hookworm was partially attributed to the energizing of public health in the south, currently public health officials seem to think their job is to arrest poor people who cannot afford adequate sanitation.  The government does not seem to think it has a responsibility to assure working sewers or other forms of basic sanitation.  There also seems to be a governmental abandonment of public health focused on reaching individuals who might most be at risk of disease.

Meanwhile, the country, as we have said before, has seen the diversion of tremendous amounts of health care and public health dollars into the pockets of health care managers, their cronies, health care management and administration in general, and in some cases investors.  This appears in turn to be a consequence of deregulating the system, allowing concentration of power,  allowing the commercialization of various kinds of health care organizations (insurance, hospitals, medical practices, etc), and of turning health care leadership over to managers trained in business schools (managerialism) with no appreciation of health care professionals' values, and with perverse incentives focused on increasing their organizations' revenue and hence their personal enrichment.  We can spend untold sums on new treatments with dubious margins of benefits vs harms, but not on basic public health or access to primary care. 

And hookworm is back. 

Shame on us. 

References

1.  McKenna ML, McAtee S, Bryan PE et al.  Human intestinal parasite burden and poor sanitation in rural Alabama.  Am J Trop Med Hygeine 2017; https://doi.org/10.4269/ajtmh.17-0396

2.  Humphreys M. How four once common diseases were eliminated from the American south.  Health Aff 2009; 28: 1734-1744.  Link here