Tuesday, November 22, 2016

Round Up No Suspects: the Bio Telemetry Settlement Demonstrates the Continuing Impunity of Health Care Organizational (and Other) Leaders

The march of legal settlements by important health care organizations continues, although now producing barely an additional ripple on top of the white-capped covered ocean of news and commentary roiled by the recent US election.  However, even the latest small settlement is a reminder of all the problems that continue under the surface.  (And I have now beaten this metaphor to death, sorry.)

The Settlement

As reported very briefly in NJ.com:

A company that monitors cardiac devices worn by heart patients has agreed to pay $1.3 million in civil fines to resolve allegations it paid kickbacks to doctors to persuade them to use their services, the U.S. Attorney's Office announced.

Mednet Healthcare Technologies, Inc. of Ewing, arranged 'fee-for-service' and 'direct-bill' agreements with certain hospital and physician customers for two services - event monitoring and telemetry - and charged them a fee, the office said.

But Mednet then allowed the physicians to directly bill Medicare for the same services, and keep any reimbursements they received that exceeded the fee that Mednet charged them.

U.S. Attorney Paul Fishman's office contends Mednet set up the remuneration agreements so their medical customers would continue to send referrals to Mednet, and were illegal under the federal Anti-Kickback Statute.

The Classic Elements

In this case, the allegations were that a company paid kickbacks (aka "bribes") to physicians to cause patients to use their products.  This appears to fit the ethical definition of corruption per Transparency International, "the abuse of entrusted power for private gain."  The physicians were entrusted to make the best decisions for patients, yet allowed their decisions to be influenced by the prospect of making more money (private gain).  The company was entrusted to provide safe and effective products, yet over-promoted their products presumably to increase revenue, regardless of whether the ensuing use of it would lead to net benefit, or harm for patients, leading to private gain by their top executives and presumably private gain through bonuses for the sales people involved.

However, as has become usual in enforcement of laws regarding kickbacks, bribes, fraud etc, the case was resolved by a relatively small fine.  (According to Yahoo Financials, Bio Telemetry's 2015 total revenue exceeded $178 million.)  The settlement occurred years after the alleged bad behavior (which was said to occur from 2006 -2014.) There was no determination of guilt: 

The claims settled in the agreement are allegations only, and there has been no determination of liability, [US Attorney Paul] Fishman's office said....
Of course, there was no determination of lack of liability, or that the allegations were false either.  Left unanswered was why the company settled if no one had done anything wrong. 

No one who enabled, authorized, directed or implemented the alleged kickbacks was named, much less suffered any negative consequences. Thus, they exhibited impunity.

All that is missing is the de rigeur statement that usually goes something like this: "We will move on from now.  Our company stands for the highest principles and will continue to provide wonderful products and services," yada, yada, yada...


We have gone on and on that settlements like this do nothing to deter continued bad behavior by large health care organizations.  Such settlements have been the norm in health care for years.  They have also been the norm in finance.  There were some famous statements to the effect that no one with major responsibility for the global financial crisis or great recession of 2008 went to jail.  I contend that the impunity of top leaders in health care, in finance, and in other spheres has led to increasing health care and societal dysfunction.

Such settlements now seem to be the norm for very politically connected figures involved with large for profit education companies.  To wit, per the New York Times,

Donald J. Trump has reversed course and agreed on Friday to pay $25 million to settle a series of lawsuits stemming from his defunct for-profit education venture, Trump University, finally putting to rest fraud allegations by former students, which have dogged him for years and hampered his presidential campaign.

The allegations were that the "university," and Mr Trump himself, committed fraud:

Students paid up to $35,000 in tuition for a programs that, according to the testimony of former Trump University employees, used high-pressure sales tactics and employed unqualified instructors.

The agreement wraps together the outstanding Trump University litigation, including two federal class-action cases in San Diego, and a separate lawsuit by Eric T. Schneiderman, the New York attorney general. The complaints alleged that students were cheated out of thousands of dollars in tuition through deceptive claims about what they would learn and high-pressure sales tactics.

The settlement was for $25 million, a lot of money, but peanuts for Mr Trump, who privately owned the company, and says he is worth billions.

No individual, including Mr Trump, who enabled, authorized, directed or implemented the alleged fraud will suffer any negative consequences.  Thus the leaders of Trump University, and the Trump Organization exhibited impunity in this case. 

And here is what Mr Trump publicly said about the university previously:

When political opponents pressed him on the claims during the campaign, Mr. Trump doubled down, saying he would eventually reopen Trump University.

'It’s something I could have settled many times,' Mr. Trump said during a debate in February. 'I could settle it right now for very little money, but I don’t want to do it out of principle.'

He added, 'The people that took the course all signed — most — many — many signed report cards saying it was fantastic, it was wonderful, it was beautiful.'

Mr Trump did settle, of course, but in a way that did not directly contradict his statement that the university was "fantastic, ... wonderful,... beautiful."  But the settlement did not affirm that statement either. And the settlement allows Mr Trump to proclaim, per his lawyer,

Mr. Petrocelli said Mr. Trump had settled the case 'without an acknowledgment of fault or liability.'
But the settlement did not refute the allegations either. 

So as we just said...   Thus the 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 like this, 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. Furthermore, as in this case, these stories are often relatively anechoic, noted often only briefly in the media, and have inspired no real action by the US government. 

This adds to the evidence suggesting that US health care, at least, is rigged to benefit its top insiders and cronies, and as such, is part of a larger rigged system.  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.   In health care, 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.  Little has changed, while perceptions that the system is rigged have become more common.  Failure up to now of the "establishment" do do anything about the rigging of the system leads to cynicism, and the search for quick and dirty solutions. 

But now we see that the US president-elect has personally benefited from this aspect of the rigged system.  Do we really think he will now take the lead in unrigging it?  Can I sell you a bridge connecting Brooklyn to Manhattan? 

Instead, true health care reform would encourage open, widespread discussion of all aspects of health care dysfunction, particularly bad behavior by those who profit most from it, and would encourage health care leadership that puts patients' and the public health first, is willing to be accountable for its actions, is transparent, honest and ethical.  
And there is a parallel case to be made for larger reform of government and society.  

Friday, November 18, 2016

Trumping En Masse Through the Revolving Door - the Trump Advisory and Transition Teams

We have frequently posted on the revolving door as a type of severe conflict of interest, if not corruption, affecting health care.  Our posts have covered various cases of people going from influential positions in or related to health care and some anti-health corporations, and government positions that make health care policy or regulate health care. 

Donald J Trump, the president elect, has pledged to "drain the swamp," that is, to generally reduce crony capitalism, conflicts of interest, the revolving door, and government corruption (e.g., look here.)  However, it appears that his campaign advisory/ transition team has been full of people who had just traversed the revolving door.  Examples I have found so far follow, in alphabetical order.

Rich Bagger

Back in July, 2016, per BioCentury Extra

EVP of Consumer Affairs and Market Access Rich Bagger has taken a leave of absence from Celgene Corp to work on the transition team for presidential candidate Donald Trump....

Mr Bagger recently left the transition team, apparently as part of the purge of Chris Christie associates.  Celgene is a pharmaceutical company that was one of the leaders in pushing the envelope in drug pricing (upward that is, e.g., see this post). 

Stephen Feinberg

the co-founder of Cerberus Capital Management LP ... was relieved by Mr. Trump’s victory, a person familiar with the matter said. Mr. Feinberg came on board as an economic adviser [per the Wall Street Journal, November 10, 2016]

As we have discussed here, Cerberus Capital Management bought the former Caritas Christi Health system in Massachusetts, which it renamed Steward Health Care, and subsequently managed, or some would say mismanaged so that Cerberus could extract as much money as possible from Steward.

Mike Ferguson

Reported by Stat News, November 15, 2016,

Not long after Trump’s victory, the law firm where he works, BakerHostetler, circulated an email touting former Representative Mike Ferguson’s 'genuine connection' to Trump, Vice President-elect Mike Pence, and others on the transition team.

The message noted the firm’s 'in-depth relationships' with 'many people who are positioned for senior roles in the incoming administration' at the Department of Health and Human Services, Food and Drug Administration, and the Centers for Medicare and Medicaid Services.

Ferguson, a Republican who represented New Jersey for eight years, 'is in close contact with members of the Trump transition team during this critical time,' said the note. The law firm lobbies for Celgene (see above), Advaxis, and the Children’s Hospital Association — and is ready for more customers. 
 Newt Gingrich

Former House Speaker Gingrich early on was chosen as a Trump insider. Not so well known are his previous health care activities, including financial ties to big health care corporations. As we posted in 2011, Mr Gingrich set up a for-profit consulting group, the Center for Health Transformation, which

brought in dues of as much as $200,000 per year from insurers and other health-care firms, offering some of them 'access to Newt Gingrich' and 'direct Newt interaction,' according to promotional materials. [per the Washington Post]

As we noted then,  The Center for Health Transformation was largely funded by big health care corporations. The Post first noted,

The biggest funders, ... [included] firms such as AstraZeneca, Blue Cross Blue Shield and Novo Nordisk,...

The center has listed scores of firms and industry groups as members over the years, amounting to a Who’s Who of the medical field, from GE Healthcare to the American Hospital Association to Wellpoint, [now Anthem] the nation’s largest health insurer.

Other clients were listed in a Bloomberg article,
Among the member companies were drugmaker Johnson & Johnson (JNJ) and health insurer Blue Cross and Blue Shield Association....

Pfizer Inc. (PFE), the world’s largest drugmaker, had consulting contracts with Gingrich, according to two people familiar with the arrangements. Pfizer spokesman Ray Kerins didn’t respond to requests for comment.

The Pharmaceutical Research and Manufacturers of America, the industry’s trade group, was also a client. His firm 'was retained by the PhRMA general counsel’s office at one time to provide advice on a positioning project,' the group said.
In addition, clients included important firms in the health care information technology (IT) sector, including GE, IBM, Microsoft, Allscripts, and Siemens.

We also then wrote about several cases in which Mr Gingrich apparently intervened on behalf of his clients to promote their business interests in the guise of promoting his views on health policy solutions.  In some cases, the views he promoted did not fit with what is generally regarded as his political philosophy, suggesting that the interests of his paying clients overrode his political views.[again, see this post]

Note that we have discussed the managerial, ethical and sometimes criminal misadventures of many of the companies listed above (see the links above for specific firms).  

Rudolph Giuliani

Mr Giuliani, like Mr Gingrich, early on became a close Trump adviser. Per the New York Times, November 15, 2016, Mr Giuliani's consulting firm's clients included Purdue Pharma,

Under contract with Purdue Pharma, the maker of the often-abused painkiller OxyContin, Mr. Giuliani used his clout with the Justice Department to press the federal authorities to offer a less onerous punishment to the company after allegations that security problems at its warehouses might have contributed to black market sales.
We have discussed, and others have discussed more extensively, the saga of Purdue Pharma, which aggressively and deceptively marketed the narcotic OxyContin, doubtless contributing to the deadly epidemic of prescription opioid abuse.

J Steven Hart

Hart, an attorney and accountant who perennially appears on lists of top D.C. lobbyists, is chairman of the law and lobbying firm Williams & Jensen [per the National Law Journal, November 10, 2016]

Hart joined Williams & Jensen in 1984 and became chairman in 1999. At the firm, he has lobbied for many Fortune 500 companies. In 2016 alone, according to filings from the U.S. Senate Lobbying Disclosure Act database, Hart’s clients have included General Electric Co., Coca-Cola Co., Pfizer Inc. and Visa Inc.

More clients of his firm include giant health insurance/ managed care company Anthem, and PhRMA, the association of pharmaceutical manufacturers, per Politico, November 11, 2016

Cindy Hayden

Trump's Homeland Security team ... is being led by Cindy Hayden, a director at the US tobacco giant Altria [per the Business Insider, November 11, 2016]

Given the well known health risks of smoking, Altria could just as well be called an anti-health care company.  As a member of its board of directors, Ms Hayden has a fiduciary responsibility to increase the company's revenue. 

Howard Lorber

Back in August, per the Washington Post, Mr Trump announced a list of core economic advisers that included Mr Lorber, "chief executive of the Vector Group." Per the company website, the Vector Group Ltd is a holding company that holds primarily tobacco companies:

Through our subsidiaries, Liggett Group LLC and Vector Tobacco Inc., we manufacture and market high quality cigarette products to adult smokers in the United States. Vector Group also owns New Valley LLC.

Vector Group’s tobacco subsidiaries have a proud history of charting an independent course in the tobacco industry, dating from Liggett’s founding in 1873.


We have also developed our e-cigarette brand, Zoom, which we believe is a superior disposable e-cigarette product.

As noted above, tobacco companies could easily be called anti-health care companies.  The more use of tobacco, the more the public health risk.  Yet Mr Lorber's job is to increase the company's revenue, and hence, presumably the use of tobacco. 

Betsy McCaughey

As reported by NPR in August, Mr Trump added a group of women to his economic advisory team. They included,

New York Lt. Gov. Betsy McCaughey, who wrote several influential but highly controversial articles criticizing Hillary Clinton's health care proposals in the 1990s, is also on the list. More recently, she has written books taking on the Affordable Care Act.

As we noted in a post in 2009, in an op-ed column for Bloomberg News that got wide attention, Betsy McCaughey, who is described as, "former lieutenant governor of New York and is an adjunct senior fellow at the Hudson Institute," attacked as "dangerous" provisions in the new Affordable Care Act (ACA, "Obamacare") which supported comparative effectiveness research.  However, not noted in Betsy McCaughey's op-ed article was that she ... [was] on the board of directors of Cantel Medical, a device company, and formerly on the board of Genta, a biotechnology company.

Furthermore, per an August article in the Huffington Post,

Betsy McCaughey built a career out of saying bombastic, completely false things about health care reform. She is reviled by actual health care policy analysts from the left, right and center for spreading frightening, but demonstrably false, misinformation while adopting the tone and posture of a serious expert.

In 1994, she claimed that Hillary Clinton’s health care reform plan would bar people from purchasing care outside the new Clinton system, which would cruelly ration treatments to curb costs. It wasn’t true. The magazine that published the article would later disavow it.

Here’s what she said about Obamacare in 2009:

'One of the most shocking things I found in this bill, and there were many, is on page 425, where the Congress would make it mandatory ― absolutely require ― that every five years, people in Medicare have a required counseling session that will tell them how to end their life sooner ... all to do what’s in society’s best interest or your family’s best interest and cut your life short. These are such sacred issues of life and death. Government should have nothing to do with this.'

Pretty scary! And totally untrue. Completely, 100 percent false. Zero correspondence with reality. But McCaughey’s nonsense took off. She made the same claim in op-eds for The Wall Street Journal and the New York Post. When Sarah Palin picked up the idea, the mandatory meetings morphed into “Obama’s death panel.” Conservative media and Republican politicians went wild.

Paula Stannard

According to Stat News, November 15, 2016, Ms Stannard served

in the last Republican administration as deputy general counsel to the Department of Health and Human Services.

She was responsible for food and drug issues and other matters, including federal health insurance and public health preparedness. On the Trump transition, she will be working under Bremberg.

However, her firm

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 — plus an untold amount doing legal and regulatory work, which does not have to be reported. 

Re her position in the transition team, Stat News quoted Dr Michael Carome, who runs the Health Research Group for Public Citizen,

I think this reflects the fact that Trump’s pledge to drain the swamp is not going to take place. Individuals who have close ties to regulated industries such as pharmaceuticals is worrisome, because such individuals are likely to pursue an agenda that is very industry friendly and not consumer and patient friendly.... 

Tommy Thompson

Also according to Stat News, November 15, 2016, Mr Thompson, a former Secretary of Health and Human Services under President George W Bush, served

as a founding member of the Bush Alumni Coalition Supporting Trump, which launched in late September. (Very late.)

Thompson, who ran the group, served as governor of Wisconsin from 1987 to 2001. He was also a partner at Akin Gump Strauss Hauer & Feld, which lobbies for the American Medical Association, PharmAthene, and the Alliance for a Stronger FDA, among other health care concerns.

Thompson’s participation could also be good news for the health care companies whose boards he serves on: Centene, United Therapeutics, and TherapeuticsMD. He is a former director of Cytori Therapeutics.
Note again that we have previously discussed managerial, ethical, and sometimes criminal misadventures of some of the companies with which Mr Hart, Ms McCaughey, Ms Stannard, and Mr Thompson were affiliated (see the links to the companies noted in the discussions above.)


Donald Trump's candidacy seemingly was welcomed by many people who really thought he would be an economic reformer.  They thought he would address the plight of poor, working and middle class people, who saw their incomes stagnant or falling, had trouble finding decently paying jobs, may have lost their jobs and/or their housing, saw their communities hollowed out, and generally felt the system was rigged against them. Even some health care professionals saw Mr Trump as a reformer of a rigged health system. For example, in July, 2016, Stat News published an editorial by Dr Charles D Rosen:

As a physician, I believe that Trump is absolutely right about allowing cheaper pharmaceutical drugs manufactured abroad to be sold in the United States. He is right that the pharmaceutical companies essentially sell their products to the federal government via Medicare and Medicaid without competitive bidding. In other areas of the budget, such as defense, federal laws require competitive bidding. It is outrageous this doesn’t occur with drugs and devices, especially since the health care budget is right behind defense in terms of expense.

Trump is right when he says that drug companies control the landscape. He appears to be willing to call it as it is and not worry about repercussions from the powerful drug interests, and has moved in the right direction in saying he would let Medicare negotiate with pharmaceutical companies if he becomes president.

However, by November 15, 2016, as reported by the Los Angeles Times,

the president-elect appears to have downgraded plans to act aggressively to control rising drug prices, handing the pharmaceutical industry an early victory and providing another illustration of the influence of lobbyists on the new Trump administration, despite Trump’s promise to 'drain the swamp' of special interests in Washington.

Trump, who once made the cost of pharmaceuticals a central part of his campaign healthcare pitch and included the issue on his campaign website, hasn’t mentioned the subject since the election, even though the issue is consistently cited as the top healthcare problem Americans want to see fixed.

And Trump’s transition healthcare agenda makes no mention of drug prices, though it lists six other healthcare priorities, including restricting abortion, speeding federal approval of new drugs and restructuring Medicare and Medicaid.

So like Dr Phil used to say, how is it working for you now, Dr Rosen?

Mr Trump seemed to promise economic reform, and to "drain the swamp" or Washington crony capitalism, insider dealing, conflicts of interest, and corruption.  But at least in the health care sphere, many of his cronies on his advisory and transition teams seem to be rotators through the revolving door, having gone from being corporate insiders to being political advisers.  

And as we noted previously, 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 case of the Trump transition 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.

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

But did we really think the self-proclaimed billionaire and former star of The Apprentice was going to be a reformer?  After all, its theme song was "For the Love of Money"

Wednesday, November 09, 2016

Latest Example of the Rigged Health Care System: BTG Pleaded Guilty to "Misbranding" for Marketing a Device Never Proven to Do Any Good

Just before the US Presidential election, yet another story of how the health care system is rigged slipped just barely into public view.   The only media report with any detail about it came from the Corporate Crime Reporter on November 7, 2016.

The Selling of an Unproven Invasive Device

The basics were:

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, pled guilty to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of its illegal conduct.


Biocompatibles pled guilty to a misdemeanor charge in connection with the company’s misbranding of LC Bead, in violation of the Food, Drug and Cosmetic Act.

LC Bead was cleared by the U.S. Food and Drug Administration (FDA) as an embolization device that can be placed in blood vessels to block or reduce blood flow to certain types of tumors and arteriovenous malformations.

LC Bead has never been cleared or approved by FDA as a drug-device combination product or for use as a drug-delivery device or 'drug-eluting' bead.

In fact, while

The FDA sought assurances in 2004 that Biocompatibles would not use FDA clearance for the device for embolization to market the device for drug delivery, according to a statement of offense to which the company agreed.

Biocompatibles told the FDA that 'under no circumstance' would the company use the embolization clearance to market the device for drug delivery.

However, two years later, Biocompatibles began marketing LC Bead for drug delivery through the company it hired to carry out its sales and distribution in the United States.

The distribution company told its sales representatives that LC Bead was '[a] drug-delivery device' and trained its sales representatives to 'aggressively penetrate the chemoembolization market.'

Sales representatives subsequently told health care providers that the device increased the level of chemotherapy delivered to a liver tumor and resulted in “better tumor response rates,...”


In December 2009, Biocompatibles filed an application with FDA for approval of LC Bead as a drug-eluting bead combination product. However, FDA informed the company that it was not accepting the application because clinical studies did not provide adequate evidence of a therapeutic benefit.

So to summarize, this device was approved for a specific use (embolization). The company was admonished not to market the device for drug delivery, as there was no evidence that it was safe and effective for this use. The company promised not to market it for drug delivery, but allegedly did exactly that, and rather aggressively. Since there was no evidence that the device was effective or safe in that application, patients were implanted with devices that at best may have been useless, or even directly harmful, and all implanted patients were at risk of the usual complications from such devices.

The penalty to the company appeared substantial, until it is compared with the company's revenue, which was 447.5 million pounds sterling last year (look here).  

However, despite the fact that the company did what it promised the FDA it would not do, and the likelihood that patients may have been harmed by these actions, it was only charged with "misbranding." Note that at least it did actually admit to misbranding, as it pleaded guilty to this charge. Yet despite the apparent egregiousness of all this, no individual at the company who may have enabled, authorized, directed, or implemented these dishonest and likely dangerous behaviors suffered any negative consequences.

Health care professionals who lie to patients about the risks of the procedures they perform on them are liable to lose malpractice suits, if not face criminal lawsuits. People at big companies that act analogously face... usually nothing adverse.  Thus they exhibit impunity.

Thus the 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 like this, 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. Furthermore, as in this case, these stories are often relatively anechoic, noted often only briefly in the media, and have inspired no real action by the US government. 

This adds to the evidence suggesting that US health care, at least, is rigged to benefit its top insiders and cronies, and as such, is part of a larger rigged system.  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.   In health care, 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.  Little has changed, while perceptions that the system is rigged have become more common.  Failure up to now of the "establishment" do do anything about the rigging of the system leads to cynicism, and the search for quick and dirty solutions. 

Wednesday, November 02, 2016

Trumping the Evidence - The Donald Denies Asbestos Related Disease, Post-Traumatic Stress Disorder, Chronic Traumatic Encephalopathy but Asserted Vaccines Cause Autism

One of the main causes of health care dysfunction identified by demoralized health care professionals in our 2003 qualitative study was threats to evidence-based medicine, and by extension, evidence-based public health and health policy.(1) Since then, we have frequently discussed threats such as manipulation and suppression of clinical research to further vested interests, and distortion of research dissemination, such as ghost written articles, often enabled by individual and institutional conflicts of interest.

These and other causes of health care dysfunction which we discuss, however, have hardly been the stuff of political debates. In particular, US presidential campaigns often feature very bland discussions of health care, when they feature them at all. These discussions, furthermore, usually are limited to health insurance, but rarely challenge the unusual American system which relies on for-profit health care insurance.

So Health Care Renewal usually does not provide much content relevant to political campaigns.

The 2016 presidential election season has not been usual. True, one campaign, that of Hillary Clinton, has featured the detailed, but relatively bland policy points that we usually see.

Her opponent, Donald Trump, is very different. He is known for wide ranging unscripted comments. In particular (barely) reported instances, his comments have included apparent attacks on the clinical or public health research evidence base. (I used the word "appearent" since nothing Mr Trump writes or says is ever that clear.)

Denied Asbestos Related Disease

The best reported example is the oldest. A Mother Jones article from June, 2016, noted that in Mr Trump's presumably ghost-written book, Art of the Comeback, he wrote that asbestos is "100 percent safe, once applied," and it "got a bad rap." He also claimed that

the movement against asbestos was led by the mob, because it was often mob-related companies that would do the asbestos removal.

It is possible that these comments arose from Mr Trump's resentment of the costs of asbestos removal from his many real estate holdings.

Nonetheless, the evidence that asbestos is a major health hazard is old, but quite clear. (See summaries by The National Cancer Institute, the Agency for Toxic Substances and Disease Registry, the Occupational Safety and Health Adminstration.) Asbestos can cause asbestosis, which may lead to severe respiratory insufficiency, lung cancer, and mesothelioma. The application of asbestos can be very hazardous, but once applied it can still endanger not only those who remove it, but firefighters, other first responders, etc.

Ridiculed the Concept of Post-Traumatic Stress Disorder (PTSD)

On October 3, 2016, the Washington Post reported,

Donald Trump told a group of military veterans on Monday that some members of the military develop mental health issues because they are not 'strong' and 'can't handle it.

'When you talk about the mental health problems, when people come back from war and combat, they see things that maybe a lot of the folks in this room have seen many times over. And you're strong and you can handle it, but a lot of people can't handle it,' the Republican presidential nominee told an audience of military veterans at an event in Northern Virginia on Monday morning.

Allowing for Mr Trump's famously chronically garbled syntax, he appeared to say that PTSD is not a mental illness, but simply a manifestation of weakness. However, there seems to be no data to support this assertion, rather the contrary seems more likely to be true (for example, see the links in this article.)

Scoffed at Chronic Traumatic Encephalopathy (CTE)

In a story apparently only reported in the sports sections of the media (for example, here in USA Today on October 12, 2016), Mr Trump appeared to dismiss the dangers of concussions,

Trump likewise demonstrated a poor grasp of concussions and lashed out at the NFL when he commented on a woman who passed out in the crowd.

From the speech:

'That woman was out cold, and now she’s coming back. We don’t go by these new, and very much softer, NFL rules. Concussions..’oh, oh! Got a little ding on the head. No, no, you can’t play for the rest of the season.’ Our people are tough.'

This isn’t the first time Trump has ridiculed the NFL for its increased awareness of brain injuries. At a rally in Iowa earlier this year, he made similar comments.

Via Mic:

'Football’s become soft. Football has become soft,' GOP presidential candidate Donald Trump said (twice) at a rally in Iowa on Sunday.

'But football’s become soft like our country has become soft,' he added to cheers and nods. 'It’s true. It’s true.'

'What used to be considered a great tackle, a violent head-on [tackle]. … You used to see these tackles and it was incredible to watch, right?' Trump said.

Rather than being a "little ding on the head," there is pretty convincing evidence that concussions can lead to real neurological problems. See the website of the Boston University CTE (chronic traumatic encephalopathy) Center, which provides this summary,

Chronic Traumatic Encephalopathy (CTE) is a progressive degenerative disease of the brain found in athletes (and others) with a history of repetitive brain trauma, including symptomatic concussions as well as asymptomatic subconcussive hits to the head. CTE has been known to affect boxers since the 1920s. However, recent reports have been published of neuropathologically confirmed CTE in retired professional football players and other athletes who have a history of repetitive brain trauma. This trauma triggers progressive degeneration of the brain tissue, including the build-up of an abnormal protein called tau. These changes in the brain can begin months, years, or even decades after the last brain trauma or end of active athletic involvement. The brain degeneration is associated with memory loss, confusion, impaired judgment, impulse control problems, aggression, depression, and, eventually, progressive dementia.

The Center's personnel wrote a 2009 review article(2), available here, which supplies considerably more detail.

Asserted Vaccines Cause Autism

A September, 20, 2016, Huffington Post article noted that Mr Trump has been a proponent of the theory that vaccines cause autism at least since 2012,

The Republican nominee is a full-blown proponent of the notion that vaccines cause autism, a theory that researchers have studied and rejected over and over after a medical journal helped launch the notion with a 1998 article since retracted.

Lots of autism and vaccine response. Stop these massive doses immediately. Go back to single, spread out shots! What do we have to lose.
— Donald J. Trump (@realDonaldTrump) October 22, 2012

I am being proven right about massive vaccinations—the doctors lied. Save our children & their future.
— Donald J. Trump (@realDonaldTrump) September 3, 2014

Again, at best, the link between vaccines and autism is very controversial at best.  Most reviews suggest that the evidence supporting any relationship is very limited, for example, see the 2003 review by Wilson et al(3) and the 2016 review by Taylor et al.(4)

The Republican Party Platform Which Trump Presumably Approved Asserted that Pornography is a Public Health Hazard

At least partially related is this story, as reported by CNN in July, 2016,

The Republican Party will declare internet pornography a 'public health crisis' under an amendment added to the draft party platform Monday at preliminary meetings in Cleveland.

North Carolina delegate Mary Frances Forrester successfully proposed the amendment in a subcommittee of the platform committee Monday morning.

'The internet must not become a safe haven for predators,' the provision states. 'Pornography, with its harmful effects, especially on children, has become a public health crisis that is destroying the life of millions....'

It appears that this provision conflates adult and child pornography.  There seems to be no good evidence that adult pornography creates health risks.

(Note: there is some irony in this story, as Mr Trump has appeared, albeit fully dressed, in several softcore porn videos, see stories here and here.  He also nominally wrote a racy novel, which was actually ghost written, see story here.  Also, his current wife also has appeared in one "lad mag" photo shoot sans clothes, see story here.)  


We have been discussing threats to the clinical and public health evidence base for a while.  We are used to discussing distortions of the evidence base that serve to support vested interests.

However, I cannot recall casual attacks on specific parts of the evidence base by apparently woefully uninformed political candidates.  It is not unusual for candidates for public office to talk about health care, public health, and related policies.  It is unusual for them to make assertions about specific evidence about particular diseases, and their risk factors and causation.

It is disturbing when one candidate for the most powerful political office in the US repeatedly disregards the best clinical and public health evidence, and offers ill considered opinions about public health that could potentially harm patients.

But Mr Donald Trump is a very unusual candidate.  Perhaps this is why Scientific American, which "is not in the business of endorsing political candidates," took a strong position against what Mr Trump has been saying about science.

'If it disagrees with experiment it is wrong.'
—Richard Feynman

Four years ago in these pages, writer Shawn Otto warned our readers of the danger of a growing antiscience current in American politics. 'By turning public opinion away from the antiauthoritarian principles of the nation's founders,' Otto wrote, 'the new science denialism is creating an existential crisis like few the country has faced before.'

Otto wrote those words in the heat of a presidential election race that now seems quaint by comparison to the one the nation now finds itself in. As if to prove his point, one of the two major party candidates for the highest office in the land has repeatedly and resoundingly demonstrated a disregard, if not outright contempt, for science. Donald Trump also has shown an authoritarian tendency to base policy arguments on questionable assertions of fact and a cult of personality.

Americans have long prided themselves on their ability to see the world for what it is, as opposed to what someone says it is or what most people happen to believe. In one of the most powerful lines in American literature, Huck Finn says: 'It warn't so. I tried it.' A respect for evidence is not just a part of the national character. It goes to the heart of the country's particular brand of democratic government. When the founding fathers, including Benjamin Franklin, scientist and inventor, wrote arguably the most important line in the Declaration of Independence—'We hold these truths to be self-evident'—they were asserting the fledgling nation's grounding in the primacy of reason based on evidence.

While this election may have effects that go way beyond science, particularly the integrity of the clinical and public health evidence base, those concerned about these issues need to take heed now before the voting is finished.  


1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14 (2003) 123–130.  Link here.

2. McKee AC, Cantu Rc, Nowinski CJ et al. Chronic Traumatic Encephalopathy in Athletes: Progressive Tauopathy following Repetitive Head Injury. J Neuropathol Exp Neurol. 2009 July ; 68(7): 709–735. doi:10.1097/NEN.0b013e3181a9d503.

3. Wilson K, Mills E, Ross C et al. Association of Autistic Spectrum Disorder and the Measles, Mumps, and Rubella Vaccine: A Systematic Review of Current Epidemiological Evidence. Arch Pediatr Adolesc Med. 2003;157(7):628-634. doi:10.1001/archpedi.157.7.628. Link here.

4. Taylor LE, Swerdfeger AL, Eslick GD. Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies. Vaccine 2016; 32: 3623–3629. Link here.