"How Employed Physicians' Contracts May Threaten Their Patients and Professionalism" Authored by Health Care Renewal Bloggers Published in Annals of Internal Medicine

Annals of Internal Medicine contracts corporate physician generic managers hospital systems hospitals

"How Employed Physicians' Contracts May Threaten Their Patients and Professionalism" Authored by Health Care Renewal Bloggers Published in Annals of Internal Medicine

Unknown 3/10/2016 Komentar

We have noted that increasing numbers of physicians provide patient care as employees of large organizations, often hospital systems, sometimes for-profit.  Since in these settings physicians must answer to generic management which may be more concerned with short-term revenues than patient care, these new arrangements are frought with hazards for physicians and patients.

One set of hazards may be found in the contracts employed physicians must sign.  

My fellow blogger, Dr Wally Smith, and I authored an article just published online "How Employed Physicians' Contracts May Threaten Their Patients and Professionalism." Here is the link.

In it we listed multiple contractual provisions that may be found in employed physicians contracts  that may threaten professionalism and good patient care:

 Confidentiality clauses - which may hide quality and safety problems, medical errors, unethical conduct, other problematic contract clauses, and malfeasance
Productivity clauses - which may provide incentives for actions that primarily increase employers' revenues, and thus may encourage overtreatment
"Leakage control" clauses - which may discourage referrals outside of the employers' systems and thus discourage appropriate referrals for particular patients, potentially threatening quality
Clauses that allow termination without cause - which may reduce access for the terminated physicians' patients, and may discourage complaints by physicians about quality, safety, unethical behavior, or malfeasance
Noncompete clauses - which may reduce access and physicians' ability to leave unsatisfactory positions
Clauses that restrict outside activites - which may restrict teaching or research, or academic freedom or free speech

We also noted clauses in contracts that employers may sign with third parties that may also threaten professionalism and good patient care:

"Gag" clauses affecting employees - which may hide quality and safety problems, medical errors, unethical conduct and malfeasance
"Anti-poaching" clauses - which may reduce patients' access to care, and physicians' ability to leave unsatisfactory positions.

We were able to find cases illustrating all the clauses published in the news media, or publications such as Medscape or Medical Economics.  However, they have largely anechoic in the scholarly medical and health services literature, and largely unaddressed by the medical societies that ostensbibly protect physicians' professionalism and patients' and the public's health.   

We suggested that such contractual problems may be becoming more frequent in a health care system in which physicians more often are corporate. We suggested that all physicians confronted with new employment contracts should seek competent legal connsel and try to negotiate egregious provisions.  However, such actions may now be futile given the increasing market dominance of the hospital systems that are employing increasing numbers of physicians.

We urged medical societies to inform physicians about such employment issues, and better support physicians who struggle with them.  However, these contract problems may merely be a reflection of an increasingly commercialized, deregulated health care system run by generic managers who may put revenue generation ahead of supporting physicians' professionalism.  So, better enforcement of existing laws, and new laws including bans on the commercial practice of medicine may be the only solutions to this newly recognized plight of corporate physicians and their patients.   

Baca selengkapnya

Trumped Up "Nutritional" Products - A Cautionary Tale of Immediate Relevance

complementary/ alternative medicine deception Donald Trump marketing

Trumped Up "Nutritional" Products - A Cautionary Tale of Immediate Relevance

Unknown 3/04/2016 Komentar

On Health Care Renewal, we frequently discuss deceptive marketing schemes designed to sell tests and treatments whose benefits for patients do not clearly outweigh their harms, and sometimes which are useless or dangerous.  In fact, we have to be selective about discussing such cases, because they are all too common.  Therefore, we tend to focus on cases involving the biggest and most powerful health care organizations, and/or the worst risks to patients.

We have generally not discussed the myriad promotions of dubious "nutritional" tests and therapies, because there are just so many of them, the players involved are generally small, and these products were effectively deregulated in the US by the 1994 Dietary Supplement Health and Education Act.  However, last year we discussed how the marketing of a "nutritional supplement" containing an amphetamine like substance was seemingly facilitated by the revolving door at the US Food and Drug Administration (FDA).

The Trump Network -Background

But a story recently republished by Stat is now suddenly relevant because one of the players involved is now so influential.  It recounted the rise and fall of The Trump Network, a network marketing scheme to sell nutritional products.

Actually, the most colorful version of the background of this story comes from a 2011 article in New York Magazine.  Here is how the network marketing worked, using an example centered around a Trump Network marketer-to-be named Izzo:

He would order the vitamins from a company called Ideal Health. She would earn a commission on the sale and he, in turn, would become a part of her team and encourage other people to buy the vitamins. For those sales, Izzo would earn a commission, as would she (his 'upline'), and then the people he sold the vitamins to would become part of his sales team and would go on to create their own sales teams, who would go on to create their own sales teams, etc., ad infinitum, all of them funneling commissions from their sales up to Izzo and the woman on the phone. As he listened, 'something clicked,' Izzo says. 'I saw the beauty of the business model. And I said, ‘How can I do this, and do this big?’ '

The idea was so big it was picked up by no other than "The Donald" Trump.

'The name is hot!” Donald Trump booms over the speakerphone from his office at 725 Fifth Avenue, where, ever since The Apprentice breathed new life into his brand, he has presided over an ever-diversifying array of businesses. He is, of course, speaking of his own name. “It’s on fire!”

In March 2009, Trump purchased Ideal Health, rebranding it the Trump Network. Though the packaging has now been imprinted with the Trump family crest, the product line is still much the same. There are the two multivitamins: Prime Essentials and the more expensive Custom Essentials, the ingredients of which are determined by the Trump Network–branded PrivaTest, a urine test that claims to determine which vitamins the user needs. There’s also a line of healthy snacks for kids called Snazzle Snaxxs, QuikStik energy drinks, and a Silhouette Solutions diet program. With the Trump investment, the company has added a skin-care line that goes by the seductively foreign name BioCé Cosmeceuticals.

Back then, Mr Trump thought the sky would be the limit.

Next year, the Trump Network plans to add more products and extend its reach to Europe and Asia. The goal, Trump says, is to eventually become bigger than Amway, now an $8.4 billion company and the giant in the field. Whether or not the people of Laos will spring for a skin-care line from a man famous for his perma-tan, some Long Islanders seem convinced.

“People have said, ‘This is Donald Trump’s network-marketing company? I want in,’ ” says Alex, Izzo’s pretty 29-year-old daughter, who quit her job and moved back in with her parents last year in order to become a marketer, as the people in the network call themselves. “I was talking to a woman the other day and she said, ‘If I can’t trust Donald Trump, who can I trust?’ And I said, ‘You’re totally right.’ ”

As Stat noted, Trump helped market the network with great enthusiasm back then.


Donald Trump was ready to make some money on vitamins.

On a Friday night in November 2009, Trump stood before a crowd of thousands at the Hyatt Regency in Miami to launch a new enterprise, The Trump Network. Behind him was a gigantic image of his family crest and an enormous photograph of himself.

'We’re gonna come out with new and different products,' Trump told the crowd. 'They’re gonna be wonderful products.'

Marketing videos that include Mr Trump are still readily available online,



In the video, Mr Trump said"Americans need a new plan. They need a new dream. The Trump Network means to give millions of people a new hope."

The Problems with the Trump Network

Well, how did that work out?

The Stat article described the Network's big product:

The Trump Network asserted that it could use a urine test to recommend customized nutritional supplements, its signature products. It also offered products that purportedly tested for allergies and bone health.

In particular,

The Trump Network sold many health and wellness products, and its main one was a customized nutritional supplement whose composition was determined by a urine test, called the PrivaTest.

A former marketer provided STAT with a kit for Ideal Health’s PrivaTest. It contained a urine collection cup, five test tubes, a cold pack, a biohazard bag, a prepaid FedEx mailing label, and detailed instructions. Customers collected their urine and shipped it to a lab for analysis. That lab analyzed the urine with three tests and produced a report, which was sent to The Trump Network.

The Trump Network bundled the report with a package of pills and shipped it all back to the customer. The pills were marketed as 'Custom Essentials,' formulations based on the results of the test and manufactured by another lab. In all, there were 48 formulations.

According to an archived version of The Trump Network’s website that can still be found online, the PrivaTest, along with a month’s worth of the Custom Essentials, cost $139.95. Retesting was available for $99.95, plus shipping and handling. The company recommended retesting every nine to 12 months.

Other products purportedly tested for food allergies, stress, and digestive health. One claimed to measure 'the balance between your ‘good’ estrogen and your ‘bad’ estrogen.'

The problem is that there is no evidence that these products, particularly PrivaTest, worked in any sense. First, there appeared to be no publicly available data on how the tests worked, what they actually tested, or how accurate they were.  Then there was no data about how the test results could rationally be used to suggest particular mixes of vitamin supplements.  Also, there was apparently no public data about what vitamins were in the potions sent to consumers, their purity, their strength, etc.

Worse, there was no evidence that any of this provided any benefits to the people who ended up taking the vitamins.

To support the necessity of supplements, The Trump Network’s website cited a 2002 article from the Journal of the American Medical Association. The article, it said, 'stated that every adult needs to supplement their nutrition to remain healthy.'

But the article also specifically cautioned against the types of products that The Trump Network sold.  'The Internet and health food stores are filled with promotions for these special-purpose multivitamins, which are often costly,” the article said. “The only evidence-based arguments for taking more than a common multivitamin once a day pertain to the elderly and women who might become pregnant.'

The JAMA article warned against tests that claimed they can help consumers determine which vitamins they should take.

Worse,

While the FDA may not have evaluated the tests or supplements, independent scientists have — and raised many questions.

Cohen, one of several scientists who reviewed materials from Ideal Health and The Trump Network, said that the tests were marketed too broadly and seemed to be 'pathologizing normal human life.'

The website, for example, recommended its “AllerTest” to anyone who had dark circles under their eyes, occasional digestive problems, fluctuating blood sugar, sinus and respiratory problems, or tiredness after eating.

'Does your blood sugar fluctuate?' Cohen said, laughing. 'If your blood sugar does not fluctuate, you are extremely ill. You will not be long on this planet.'

What’s more, the AllerTest did not measure food allergies, as the network’s website claimed it would, according to outside analysis of materials from the testing lab and Ideal Health publications.

The test measured information about an antibody known as immunoglobulin G, or IgG, according to company publications. The antibody is normally produced in the body and not indicative of a food allergy, said Dr. Robert Wood, director of pediatric allergy and immunology at Johns Hopkins School of Medicine.

'There’s no disease condition for which the IgG antibodies have any relevance at all,' Wood said.

So while Mr Trump, his company, and some of his marketers might have made money from the Trump Network, there is no evidence that its products actually provided any health benefits.

Also, in the long run, Mr Trump's grandiose claims about how the riches his new marketers would receive also proved wanting.  Despite Trump's initial enthusiasm, the Trump Network hardly went global,

Regardless of the science, Trump’s name did wonders for Ideal Health in the short term. Former marketers said the company grew significantly in the months following the name change.

Then, the network began experiencing financial difficulties.

'The Trump Network had gotten in trouble financially,' said Bonnie Futrell, a former marketer and 'diamond director' — one of the top-tier marketers in the company. 'They weren’t being able to pay [the lab]. They weren’t paying vendors. They weren’t paying us.'

Futrell said she was involved in discussions with company higher-ups about how to salvage the organization.

On Dec. 31, 2011, the license agreement expired, said Garten, the general counsel for The Trump Organization. It was not renewed.

Note that this story was also summarized in an AP article available via CBS.   The Network's products were also reviewed, not favorably, on QuackWatch.

Summary

The Trump Network sold nutritional testing and products any clear evidence that they provided any benefits to patients, or that they worked at all in any sense.  Some of the products, like the allergy test discussed above, did not appear to be what they were advertised to be.  Since the Network's products and the outcomes of people using them apparently never were the subject of any clinical research, whether the products did any harm is unknown.  Thus, the Network was like many other dodgy efforts to sell totally unproven "nutritional" products.  Its main results seem to have been transferring money from the pockets of the gullible to the marketers, and to Mr Trump himself.  While Mr Trump recruited marketers with boastful assertions of giving people "new hope," that hope was false.

The increasing commercialization of health care, enabled by deregulation justified by market fundamentalism,  now means that health care has become increasingly a means of transferring money from the little people to big corporations, in this example, those corporations owned by Mr Trump, without providing any net health benefit to those whose pockets have been invaded.  This is bad enough.

But at the moment, Mr Trump is considered the front runner for the Republican presidential nomination, although he is attracting more enmity, much of it from the Republican party. It is ironic that Mr Trump seems to be winning support from a lot of "little people" whom he has promised to defend.  Yet it was the little people who marketed the Trump Network and bought its products who were eventually left hanging. 

The Stat article mentioned that some minor candidates for the Republican nomination this year were also tarred with stories about their involvement in questionable health marketing schemes.  And previous major party candidates have certainly had some health care conflicts of interest.  In fact, we discussed that the current First Lady once was a top executive of a big hospital chain, and the last Republican presidential candidate was a leader of a private equity firm that owned numerous health companies.   It may be unprecedented, at least in recent history, for someone who had been directly involved in the shady marketing of dubious health remedies to be a genuine contender for the US presidency.

There are many bigger issues in the current election than health care.  But now we are faced with Mr Trump, who once hawked unsubstantiated health benefits of dodgy nutritional products, and recruited marketers for these products with false promises of wealth to come.  And Mr Trump has some real possibility of  becoming the President of the US, to whom the Department of Health and Human Services, and the Department of Veterans Affairs report.  What damage could such a leader do to health care?  And what other damage could a man who so cavalierly fleeced the little people with his dubious nutritional product marketing scheme  do, especially to the little people who now so unconditionally support him?

Is there a better example showing why we as a society need to completely rethink who gets to become our leaders?  My only hope is we can do that rethinking in time to prevent a disaster. 

Baca selengkapnya

It Has Come to This? - Donald Trump's "Truly Absurd," "Word Salad," "Gibberish" Health Care Policy

deception health care reform health policy politics ppaca propaganda

It Has Come to This? - Donald Trump's "Truly Absurd," "Word Salad," "Gibberish" Health Care Policy

Unknown 2/28/2016 Komentar

Health Care Renewal is officially non-partisan.  We do not endorse candidates for office, or political parties.  That does not prevent us from commenting on policy issues, and on pronouncements and actions by politicians and government officials when they relate to the issues that interest us.

So, we have criticized excessive coziness among politicians and government officials on one hand, and big health care organizations and their leaders on the other.  We have noted conflicts of interest affecting politicians, particularly the revolving door, and other shadings towards corporatism.  We have noted how health care policy discussions may focus on health care financing, while ignoring some of the bigger issues we discuss  (For example, see our discussions of health care reform, and particularly this one of the then new US Affordable Care Act). These include: leadership of health care organizations by generic managers (managerialists) who are unsympathetic or even hostile to the health care mission; deceptive practices involving marketing, the manipulation and suppression of research, stealth health policy advocacy, stealth lobbying, etc; and timidity in regulation and law enforcement, leading to outright impunity of health care leaders.

We have criticized politicians and government leaders of all parties and from all sides of the political spectrum.  For example, in retrospect we criticized the (Democratic) Clinton administration's laissez faire attitude to conflicts of interest at the National Institutes of Health (see summary here and links to older posts).  We criticized flagrant examples of the revolving door involving top Bush adminstration officials (e.g., most recently here), and yet more involving Obama administration officials (e.g., most recently here).

Yet we also acknowledge that most policy discussions by political and government figures are at least well-intended and based in some degree on the facts and knowledge of the health care context (even if we think the results might be misguided, wrong-headed, or tangential.)  So, while health care is not so far the most important issue in the tumultuous 2016 US presidential race, there has been considerable discussion of it.  Most major candidates have staked out health care positions that again appear well-intended and based to some degree on the facts and context (although my point is not to comment on their merits.)

But there has been one major exception. 

The Leading Candidate with No Health Care Plan

Donald Trump currently seems to be the leading Republican presidential candidate.  As reported by the Minnesota Post,

Trump doesn’t have a health care plan. Go to the issues section of his campaign. Really, go there, you won’t believe what you see. A typical campaign website has position papers. Trump has none. The link to 'Issues' takes you to a pretty frightening page of short embedded videos of Trump himself summarizing his positions at a level of detail that you should find insulting.

But he doesn’t even have one of those on health care.

In addition to 'Issues,' the site’s homepage has a pulldown menu called 'Positions.' I don’t get the difference, but who cares? “Positions” are actual written-out position statements, not videos, but only on five issues, none of which are remotely related to health care (nor many other major issues).

So for Trump’s health-care thinking, we have to rely on what he says in debates and speeches and, I suppose, tweets, some of which have been controversial.

The Candidate with No Health Care Policy Advisers

On February 20, 2016, Politico reported that Mr Trump's campaign also apparently has no health policy advisers.  The article noted that Mr Trump had written in one of his books that he would

Lock the best health care policy minds in a room – and don’t let them out until they’ve crafted a plan for providing terrific coverage for everyone.

But he has not said who those advisers might be.  Furthermore, the reporter was unable to determine who, if anyone, is currently advising Mr Trump about health care,

Sam Clovis, Trump’s national policy adviser, insists the campaign is talking with lots of health care experts – but declined to name any of those advisers.

'We have experts around the world who help us on these various topics,' Clovis said in an interview with POLITICO. 'We get very frank and honest input if we do not expose these people to the scrutiny of the press. … As we get further along they might want to come out of the shadows.'

However,

POLITICO scoured the landscape of notable policy wonks – from academics to lobbyists to congressional staffers to think tank fellows – but was unable to find anyone, on either side of the political divide, who acknowledged whispering health care policy tips in the billionaire’s ear. Or for that matter, of hearing of anyone who had talked to his campaign.

'He seems to be a one-man policy shop,' said Michael Cannon, director of health policy studies at the libertarian Cato Institute, and a leading critic of Obamacare.

So Mr Trump has no clear health care plan, and apparently no health care advisers.  Furthermore, reports of what this candidate has said about health care reveals some anomalies, to say the least.

Reducing Pharmaceutical Costs to Zero?

The Washington Post in a "Fact Checker" feature on February 18, 2016, entitled, "Trump’s truly absurd claim he would save $300 billion a year on prescription drugs," quoted Mr Trump three times on the costs of pharmaceuticals,

'We are not allowed to negotiate drug prices. Can you believe it? We pay about $300 billion more than we are supposed to, than if we negotiated the price. So there’s $300 billion on day one we solve.' –Donald Trump, remarks at Plymouth State University, Holderness, N.H., Feb. 7, 2016

'So I said to myself wow, let me do some numbers. If we competitively bid drugs in the United States, we can save as much as $300 billion a year.' –Trump, remarks in Manchester, N.H., Feb. 8

'We’re the largest drug buyer in the world. We don’t negotiate. We don’t negotiate. You pay practically the same for the country as if you go into a drug store and buy the drugs. If we negotiated the price of drugs, Joe, we’d save $300 billion a year.' –Trump, interview on MSNBC, Feb. 17

The problem here is that the $300 billion figure turns out to be ridiculous.  The Post article noted,

To put Trump’s $300-billion-a-year claim in perspective, let’s first note that Sanders cites a 2013 estimate from the Center for Economic and Policy Research that negotiated drug prices would result in savings to Medicare of between $230 billion to $541 billion over 10 years.

So for virtually the same policy, Sanders is claiming savings averaging $38 billion a year — and Trump is promising a figure eight times larger. (Clinton offers no estimated savings.)

What’s going on here? It’s unclear, because as usual the Trump campaign refuses to respond to any queries about Trump’s numbers.

Furthermore,

total spending in Medicare Part D (prescription drugs) in 2014 was $78 billion. So Trump, in effect, is claiming to save $300 billion a year on a $78 billion program. That’s like turning water into wine.

Finally,

It’s possible that Trump is being sloppy and when he discusses Medicare, he really means to say he would force government-led pricing on all prescription drugs. But the numbers don’t add up that way either.

In fact, depending on the source you consult, total annual spending on prescription drugs in the United States is between $298 billion a year to $423 billion. So that would mean Trump is claiming that he can eliminate virtually any cost to prescription drugs. It would suddenly be free!

So Mr Trump's claims made on at least three occasions about the magnitude of savings that would result from his (unoriginal) proposal to have the government negotiate drug prices were mathematically implausible, if not impossible. 

"Word Salad" about the Mandate

Rather right-wing columnist Jennifer Rubin, writing in the Washington Post on February 22, 2016, provided two sets of quotes from interviews with Mr Trump about his position on the "mandate" within the Affordable Care Act (ACA).  Note that the mandate imposes a (relatively modest) extra tax on people who do not have health insurance, providing an incentive to have such insurance.  For example, on "Meet the Press,"

DONALD TRUMP: Well, on the mandate, if you look at the mandate, we had a situation where we were, Anderson Cooper, who’s terrific, by the way, and did a terrific job, but we were talking over each other. Look, I want, we’re going to repeal and replace Obamacare. Obamacare is a total and complete disaster. It’s going to be gone. We’re going to come up with a great healthcare plan, whether it’s healthcare savings accounts, we have a lot of different things. We’re going to get rid of the lines between states, we’re going to have great competitive bidding. But I say all the time, you can call it anything you want. People are not going to die in the middle of the street. People are not going to die on the sidewalk if I’m president, okay?

CHUCK TODD: Well, let me get something definitive from you on this.

DONALD TRUMP: But Chuck, I say that, excuse me, I say that to packed houses with thousands and thousands of people, Republicans mostly, and I get standing ovations. I’m not going to let that happen. If I’m president, we’re not going to have people dying on the streets. So you can call it whatever you want. I don’t call it a mandate, I just say it’s common sense.

CHUCK TODD: No, I understand that. Well, let me ask you this. Do you think that it should be a law that anybody who can afford health insurance has to have it?

DONALD TRUMP: I think, no, I think it’s going to be up to them, okay? I want it to be up to them. But I’m really talking about people that can’t afford it. We’re not going to let people die in squalor because we are Republicans, okay? That’s part of the problem with the Republicans, where somehow they got fed into this horrible position. We’re going to take care of people. But no, people don’t have to have it. We’re going to have great plans, they’re going to be a lot less expensive than Obamacare. They’re going to be private. There are going to be lots of different options. We’re going to have a lot of different options. Right now you have no options. You know why? Because the insurance company controlled Obama because they gave him a lot of money. That’s why you have lines around the states. And you can’t get competitive bidding.

Her summary was:

He insists whatever inanity he said earlier was a mistake, denies he took or takes a liberal position and declares there will not be people 'dying in the streets.' (Does he understand there is a duty now to treat people, but what we are debating is insurance?) Then he ends with assurances he is loved by crowds. Superlatives by the bushel may be funny, but they also substitute for concrete answers. It may seem like a word salad or stream of consciousness at first glance, but it is a salad he tosses up over and over again, each time avoiding close scrutiny.

An article on February 22, 2016, in the left leaning MotherJones stated that Mr Trump had already contradicted his previous approval of the "mandate,"

Trump has now made clear that he doesn't like the individual mandate after all—he just misspoke when he said that to Anderson Cooper a few days ago.

So while Mr Trump has drawn attention to his position on the mandate, that position seems hopelessly incoherent, or as Ms Rubin called it, "word salad."

More "Gibberish"

The Minnesota Post article also noted,

When asked Thursday night under Rubio’s prodding to describe his plan for health care, he said, as he always does, that he wants to repeal the Affordable Care Act and replace it with something 'much better.' Then he says (and this is a direct quote from the debate transcript): 'I want to keep pre-existing conditions. I think we need it. I think it’s a modern age. And I think we have to have it.' This is gibberish, especially the explanation that 'I think it’s a modern age,' which may have some meaning but I can’t imagine what.

In addition, in the most recent debate, Mr Trump did emphasize that he wanted insurance companies to be able to sell policies across state lines, although his wording was not so clear,

That weird and confusing phrasing — about 'getting rid of the lines around the states,' which Rubio mocked — as best as anyone can tell means that Trump wants national health insurers to be able to offer standardized plans all over the country, instead of having to meet the particular standards and requirements imposed by individual states. Different states require different things of health insurers, which prevents national firms from offering plans in all states.

As the article noted, this is not a new idea, and how much difference this change would make is not clear. Nonetheless, even after being badgered repeatedly, Mr Trump could not add more substance to his health care plan, nor explain how he might get more substance.

With Rubio pressing in and badgering Trump from the sidelines — the same way Rubio was badgered a few weeks ago by Chris Christie and the way Trump often badgers other candidates — and with CNN’s Dana Bash following up, Trump said his three things: Repeal Obamacare and replace it with something much better, get rid of the lines around the states, and don’t let people die in streets. I always assumed that there was more to his plan, but I never came across the details. And, during the exchange Thursday night, it came out that there is no more. Here’s that chunk of the transcript so you can decide for yourself if I’m missing something. (I’ve done a tiny bit of editing for flow.)[italics added for emphasis- Ed]

BASH: Mr. Trump, Senator Rubio just said that you support the individual mandate. Would you respond?

TRUMP: I just want to say, I agree with that 100 percent, except pre-existing conditions, I would absolutely get rid of Obamacare. We’re going to have something much better, but pre-existing conditions, when I’m referring to that, and I was referring to that very strongly on the show with Anderson Cooper, I want to keep pre-existing conditions. I think we need it. I think it’s a modern age. And I think we have to have it. (APPLAUSE)

BASH: OK, so let’s talk about pre-existing conditions. What the insurance companies say is that the only way that they can cover people [who have pre-existing conditions and would be more expensive to cover] is to have a mandate requiring everybody purchase health insurance. Are they wrong?

TRUMP: I think they’re wrong 100 percent. What we need — look, the insurance companies take care of the politicians. The insurance companies get what they want. We should have gotten rid of the lines around each state so we can have real competition. We thought that was gone, we thought those lines were going to be gone, so something happened at the last moment where Obamacare got approved, and all of that was thrown out the window.

The reason is some of the people in the audience are insurance people and insurance lobbyists and special interests. They got — I’m not going to point to these gentlemen, of course, they’re part of the problem, other than Ben [Carson], in all fairness. And, actually, the governor [John Kasich], too. Let’s just talk about these two, OK? Because I don’t think the governor had too much to do with this.

But, we should have gotten rid of the borders, we should have gotten rid of the lines around the states so there’s great competition. The insurance companies are making a fortune on every single thing they do. I’m self-funding my campaign. I’m the only one in either party self-funding my campaign. I’m going to do what’s right. We have to get rid of the lines around the states so that there’s serious, serious competition. And you’re going to see — excuse me. You’re going to see pre-existing conditions and everything else be part of it, but the price will be down, and the insurance companies can pay. Right now they’re making a fortune. (APPLAUSE)

BASH: But just to be specific here, what you’re saying is getting rid of the barriers between states, that is going to solve the problem...

TRUMP: That’s going to solve the problem. And the insurance companies are going to say that they want to keep it. They want to say — they say whatever they have to say to keep it the way it is. I know the insurance companies, they’re friends of mine. The top guys, they’re friends of mine. I shouldn’t tell you guys, you’ll say it’s terrible, I have a conflict of interest. They’re friends of mine, there’s some right in the audience. One of them was just waving to me, he was laughing and smiling. He’s not laughing so much anymore. Hi.
Look, the insurance companies are making an absolute fortune. Yes, they will keep pre-existing conditions, and that would be a great thing. Get rid of Obamacare, we’ll come up with new plans. But we should keep pre-existing conditions.

RUBIO: Dana, I was mentioned in his response, so if I may about the insurance companies...

BASH: Go ahead.

RUBIO: You may not be aware of this, Donald, because you don’t follow this stuff very closely, but here’s what happened. When they passed Obamacare they put a bailout fund in Obamacare. All these lobbyists you keep talking about, they put a bailout fund in the law that would allow public money to be used, taxpayer money, to bail out companies when they lost money. And we led the effort and wiped out that bailout fund. The insurance companies are not in favor of me, they hate that. They’re suing right now to get that bailout money put back in.

Here’s what you didn’t hear in that answer, and this is important, guys, this is an important thing. What is your plan? I understand the lines around the state, whatever that means. This is not a game where you draw maps...

TRUMP:...And you don’t know what it means?

RUBIO: What is your plan, Mr. Trump? What is your plan on health care?

TRUMP: You don’t know. The biggest problem...

RUBIO: ...What’s your plan?

TRUMP: ... You know, I watched him melt down two weeks ago with Chris Christie. I got to tell you, the biggest problem he’s got is he really doesn’t know about the lines. The biggest thing we’ve got, and the reason we’ve got no competition, is because we have lines around the state, and you have essentially....

RUBIO: ...You already mentioned that [inaudible] plan. I know what that is, but what else is part of your plan?...

TRUMP: ...You don’t know much...

RUBIO: ...So, you’re only thing is to get rid of the lines around the states. What else is part of your health-care plan?...

TRUMP: ...The lines around the states...

RUBIO: ...That’s your only plan...

TRUMP ... Excuse me. Excuse me.

RUBIO: ... His plan. That was the plan?...

TRUMP:...You get rid of the lines, it brings in competition. So, instead of having one insurance company taking care of New York or Texas, you’ll have many. They’ll compete, and it’ll be a beautiful thing.

RUBIO: Alright...So that’s the only part of the plan? Just the lines?

TRUMP: The nice part of the plan — you’ll have many different plans. You’ll have competition, you’ll have so many different plans.

RUBIO: Now he’s repeating himself.

TRUMP: No, no, no. I watched him repeat himself five times four weeks ago...

RUBIO:... I just watched you repeat yourself five times five seconds ago...

TRUMP: I watched him meltdown on the stage like that, I’ve never seen it in anybody...

BASH:...Let’s stay focused on the subject...

TRUMP:...I thought he came out of the swimming pool...

RUBIO:...I see him repeat himself every night, he says five things: Everyone’s dumb, he’s gonna make America great again...We’re going to win, win win. He’s winning in the polls...And the lines around the state. (APPLAUSE)

BASH: Senator Rubio, you will have time to respond if you would just let Mr. Trump respond to what you’ve just posed to him...

RUBIO: ... Yeah, he’s going to give us his plan now, right? OK...

BASH [to Trump]:...If you could talk a little bit more about your plan. I know you talked about...Can you be a little specific?...

TRUMP: ... We’re going to have many different plans because... competition...

RUBIO: ... He’s done it again.

TRUMP: There is going to be competition among all of the states, and the insurance companies. They’re going to have many, many different plans.

BASH: Is there anything else you would like to add to that...

TRUMP: No, there’s nothing to add. What is to add?

After being repeatedly asked about the substance of his health care policy agenda, Mr Trump only seems to have repeated the notion of selling health insurance across state lines to increase competition, interrupted by non sequiturs insulting Senator Rubio and insurance executives.  The Minnesota Post writer and I could find absolutely no other content in Mr Trump's , despite repeated inquiries about the substance of his health care plan.

It does seem reasonable to describe Mr Trump's health care policy ideas as gibberish.

Summary 

Health care and public health affect all Americans, and all people around the world.  Health care in the US is more expensive and less accessible than it is in many other developed countries.  For all the money the country spends, there is no clear evidence that the quality of patient care, or patients' outcomes are better than, or sometimes even comparable to those of other countries  The reforms embodied in the Affordable Care Act (ACA, PPACA, "Obamacare') have increased the proportion of insured patients, but insurance remains expensive for many, and insurance coverage now often has major gaps that mean a major illness can bankrupt a middle-class patient.

Furthermore, the law has done nothing to reduce concentration of power in health care.  It has done nothing to make health care leaders more accountable, especially for their organization's unethical or even criminal behavior, decrease their ability to line their pockets regardless of such behavior, and thus reduce their impunity.  It will not obviously decrease conflicts of interest affecting those who make decisions about patient care or health policy, lock the revolving door between government and the health care industry, end manipulation of clinical research to serve vested interests, or suppression of research whose results offend such interests, etc, etc.

So health care policy is increasingly important, and increasingly demands serious discussion.  A US presidential campaign ought to provide some impetus for such discussion, although health care policy is certainly not the only thing that needs to be discussed.

Most presidential candidates have at least attempted a serious discussion of health policy, if not in person, then in position papers or on their web-sites.

However, the currently leading candidate for the Republican nomination does not seem to have serious ideas about health care. Yet he has said "We’re going to come up with a great healthcare plan."  To substantiate such claims, he has repeated a few vague talking points, and when challenged, seems unable to manage any substantive conversation beyond them.  Some of his verbal pronouncements have been nothing short of ridiculous.  

"in the big lie there is always a certain force of credibility...." said a 20th century world leader who inspired adulation, and led to disaster.  

We live in perilous times when a candidate with such reckless approaches to critical problems continues to attract adulation.

ADDENDUM (29 February, 2016) - This post was republished on the Naked Capitalism blog on February 28, 2016.  

ADDENDUM (1 March, 2016) - This post was republished on OpEdNews on February 29, 2016.

Baca selengkapnya

At least former ONC chair Blumenthal now says "health IT can [even] cause safety issues." Other than that, it's unicorns and fairies in the Harvard Business Review.

David Blumenthal Glenn Reynolds Harvard Business Review healthcare IT dangers healthcare IT dissatisfaction healthcare IT utopianism Instapundit

At least former ONC chair Blumenthal now says "health IT can [even] cause safety issues." Other than that, it's unicorns and fairies in the Harvard Business Review.

Unknown 2/25/2016 Komentar

The truth about healthcare IT, that it is perilously insecure, and is causing clinician despair and patient harm, is increasingly becoming mainstream. 

For example, seen at the eclectic, widely read, multi-author website of Beauchamp Brogan Distinguished Professor of Law at the University if Tennessee Glenn Reynolds, Instapundit (http://pjmedia.com/instapundit/):

REMEMBER THE HEALTHCARE.GOV LAUNCH? Apparently so did some hackers:

“To improve the quality of our health care while lowering its cost, we will make the immediate investments necessary to ensure that, within five years, all of America’s medical records are computerized,” President Obama said. “This will cut waste, eliminate red tape and reduce the need to repeat expensive medical tests.”  While the shift Obama and many others pushed may have improved care, electronic medical records led to quite the unique hostage situation in Los Angeles this week. There, a hospital fell prey to a cyberattack — and the hospital has escaped its plight by paying hackers a $17,000 ransom.

Government mandates and electronic security don’t seem to be a very good mix.

Posted at by Stephen Green on Feb 18, 2016 at 7:31 am Link

and this:

MY USA TODAY COLUMN: Futuristic Data Security With A Pen And A Pad. “If I were running an intelligence agency, I’d have all my important stuff done in handwriting or on mechanical typewriters (the old kind that type over the same fabric ribbon multiple times) and distributed in sealed envelopes. If I were setting up a voting system, I’d use paper ballots instead of electronic voting machines. And if I were running a hospital, I’d seriously consider doing everything on paper."

Posted at by Glenn Reynolds on Feb 22, 2016 at 1:21 pm Link

and this:

YES. NEXT QUESTION: Are Mandatory Electronic Medical Records Causing Doctor Burnout?

Posted at by Sarah Hoyt on Dec 17, 2015 at 4:39 am Link

However, former ONC chair David Blumenthal (now president of the Commonwealth Fund) apparently hasn't received the message.  He and a colleague wrote the following in the Harvard Business Review.

Speeding Up the Digitization of American Health Care
https://hbr.org/2016/02/speeding-up-the-digitization-of-american-health-care 
David Blumenthal
Aneesh Chopra
February 22, 2016

No more of those infuriating forms to fill out at doctors’ offices: the information is all in the computer. Doctors and hospitals don’t repeat tests you’ve had someplace else: they’re all in the computer. All your caretakers know exactly what medicines you’re on and what you’re allergic to: that’s in the computer. When your elderly mother moves from a hospital to a rehabilitation center, the nurses and doctors there know all about her before she arrives: all in the computer.

The usual utopian trope, and as usual it ignores the self-corrective effects of being asked to repeat information that would otherwise be taken as fact from a computer, which can and does propagate errors (which can and does have deadly effects).

These and many other feats of information management will soon be routine in the United States. Indeed, in some places they are already happening. Our health system is undergoing a digital revolution that will profoundly affect the health care of Americans.

"Soon" has been the mantra of the zealots since about 1950.  Further, the assumption in such articles is that the effects are all beneficent ("profoundly affect" means "in good ways only"), and the results are quite mixed on that score.

Many providers and policy-makers tend to see these issues as technical failings of the electronic records that have been recently been adopted with federal support. This has caused some critics to say that the federal investment – estimated at $31 billion over 10 years – is not paying off.

But this diagnosis is only partly correct. Underlying the challenges facing the digital health revolution are economic and social issues that must be addressed if the potential value of electronic records is to be realized.

Aside from the conflict of interest of such passages being written by a person who contributed to those tens of billions spent, in fact, the federal investment has largely been a huge waste for healthcare and a huge boon for the IT industry, disenfranchising the medical community (including physicians and nurses) and creating mayhem for patient care, e.g., http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html and http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html).

I can also add that the "economic and social issues that must be addressed" were reasonably understood and needed to be addressed before the likes of Blumenthal and ONC put the cart before the horse, "ready, fire, aim"-style on nationsl rollout of health IT.  See my July 2010 post "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" , my Oct . 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?" and my June 5, 2012 post "Cart Before the Horse, Part 3: AHRQ's 'Health IT Hazard Manager'".

Further -

Some history on the issue of risk (this blog has a long memory):

Mr. Blumenthal, Feb. 22, 2016, in the new HBR article:

"... some electronic health records are complex and difficult to use. This is frustrating for doctors and nurses, slows them down, and can even cause safety issues."

Mr. Blumenthal, April 30, 2010:

http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented

http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html

... Blumenthal said that although an advisory committee concluded that more information was necessary, he called the evidence of the reports “anecdotal and fragmented” at best ... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangerment] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

(Ironically and tragically, just weeks later, on May 19, 2010 my mother was severely injured and later died as a result of a dangerously faulty EHR.)

Mr. Blumenthal's views on risk of 2010 as ONC chair represent either deliberate mistruths or ignorance.  Both of those traits tend to be long term, so why should any physician believe the views he expresses in the Harvard Business Review in 2016?

I grant that the views of 2016 in the new article are somewhat more in line with reality, but with significant faults including but not limited to:

1) Since the magnitude of the "safety issues" that health IT can "even" cause are unknown (best estimates are from the ECRI Deep Dive study, which are alarming as at http://healthleadersmedia.com/print/index.cfm?content_id=290834&topic=TEC), it is reckless at best to promote the continued rapid expansion of this technology.

2) On causality, Mr. Blumenthal's views are either erroneous or deliberately misdirect to blame the "health care markets":

"If health care markets functioned well in the U.S, HITECH would have been unnecessary. The industry would have wired itself like our financial, travel, and retail sectors."

Mr. Blumenthal fails to realize, still, the primary reason why healthcare practitioners have resisted computerization: bad health IT.

http://cci.drexel.edu/faculty/ssilverstein/cases/

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy, promotes evidentiary non-trustworthiness, or otherwise demonstrates suboptimal design and/or implementation. 

The Jan. 2015 letter to HHS from about 40 medical societies was clear on these issues:    http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf

The health IT industry needs to provide worthwhile products before they are shoved down physicians' and patient's throats.

Not to mention the outright peril such systems place patients under:

Feb. 18, 2016
Hollywood Presbyterian Medical Center: Negligent hospital IT leaders allow hacker invasion that cripples EHRs, disrupts clinicians ... but patient safety and confidentiality not compromised

http://hcrenewal.blogspot.com/2016/02/hollywood-presbyterian-medical-center.html

Forbes Feb. 23, 2016:
White Hat Hackers Hit 12 American Hospitals To Prove Patient Life 'Extremely Vulnerable'

http://www.forbes.com/sites/thomasbrewster/2016/02/23/hackers-tear-hospitals-apart/#1b049f9c40d7

Then this statement is made:

Patients tend to be loyal to doctors and hospitals at least in part because that’s where they’re known – that’s where their records reside. If that information can travel to another hospital or doctor at the push of a button, patients can more easily leave current providers behind. That’s not good for business.

That's risible.  Patients don't hang around care they don't like because they can't "push a button" to transfer their records.  In fact, if anything, it's an impediment to cost-cutters that it's not easy for bureaucrats to force patients to go to the cheapest "provider" due to records "stuck" at one office or organization. 

Clinicians have very clearly stated their reasons for hating health IT.  See the Medical Societies letter linked above, for example.  There's no need to make up nonsensical reasons, such as doctors and hospitals holding patients "captive" through their records.

And as for vendors, if you can move information from one vendor system to another, providers can switch out or build upon records more easily in search of a better product. That’s lost revenue for the company.

On that point I am in agreement.

But technical fixes and better records won’t be enough. We need incentives that reward quality and safety improvement and cost reduction.

Not mentioned is reasonable regulation regarding compromised safety, for which "incentives" alone are insufficient.

And we need penalties for providers and vendors that slow-walk the digital revolution to protect their economic interests.

These words are totalitarian.  Responses to glaringly obvious adverse consequences, such as protecting patients from cybernetic harm and the ability to practice good medicine without distraction and burnout don't seem to count.  All that matters is the "revolution."

If we make the market for good health care work, a lot of our current [wicked (https://en.wikipedia.org/wiki/Wicked_problem), intractable - ed.]technical problems will melt away as providers and vendors compete to make service and care better for their customers: the nation’s patients.

My comment about this statement, that massive healthcare IT sociotechnical problems will simply "melt away" is best summarized in a picture of a land where that can plausibly occur:

Mr, Blumenthal seems unaware of the domain of Social Informatics, "the interdisciplinary study of the design, uses and consequences of information technologies that takes into account their interaction with institutional and cultural contexts" (see http://www.dlib.org/dlib/january99/kling/01kling.html).  Problems in fields as wickedly complex as at the intersection of healthcare and IT do not and will not "melt away."  However, they need to be managed.  What we have now is mismanagement of those problems, with imposition of painfully inappropriate mandates and lack of meaningful regulation and safety surveillance, among other defects.

"Speeding up" healthcare digitization as a national plan in 2016?  No. 

National implementation needs to be seriously rethought in 2016, and massively scaled back and slowed down until we have more of a handle on how to manage change correctly. 

Anything else is reckless.

End note: the grandiose term "revolution" with respect to health IT is a hyper-enthusiast's or zealot's term, is hyperbolic, hackneyed and no longer believed except by the most seriously deluded, and needs to be promptly abandoned.  Leave "revolutions" to the Lenins and Trotskys of the world.

-- SS

Baca selengkapnya

Ho-hum, Another Month, Another Set of Multi-Million Dollar Settlements by Health Care Corporations Acting Badly

adverse effects deception Fresenius health care prices impunity legal settlements Merck Pfizer Vioxx You heard it here first

Ho-hum, Another Month, Another Set of Multi-Million Dollar Settlements by Health Care Corporations Acting Badly

Unknown 2/21/2016 Komentar

Amazingly, with a US presidential election looming, there is finally some public discussion here of the impunity of top corporate executives.  Columnist Gretcher Moregenson wrote on February 6, 2016 in the New York Times,

Ho-hum, another week, another multimillion-dollar settlement between regulators and a behemoth bank acting badly.

Then,

As has become all too common in these cases, not one individual was identified as being responsible for the activities. Once again, shareholders are shouldering the costs of unethical behavior they had nothing to do with.

It could not be clearer: Years of tighter rules from legislators and bank regulators have done nothing to fix the toxic, me-first cultures that afflict big financial firms.

Similarly, but more broadly, Senator Elizabeth Warren (D - Massachusetts) published a report in January, 2016, entitled "Rigged Justice: 2016 - How Weak Enforcement Lets Corporate Offenders Off Easy." She summarized its main conclusions in a New York Times op-ed,

Corporate criminals routinely escape meaningful prosecution for their misconduct.

Furthermore,

In a single year, in case after case, across many sectors of the economy, federal agencies caught big companies breaking the law — defrauding taxpayers, covering up deadly safety problems, even precipitating the financial collapse in 2008 — and let them off the hook with barely a slap on the wrist. Often, companies paid meager fines, which some will try to write off as a tax deduction.

The failure to adequately punish big corporations or their executives when they break the law undermines the foundations of this great country. Justice cannot mean a prison sentence for a teenager who steals a car, but nothing more than a sideways glance at a C.E.O. who quietly engineers the theft of billions of dollars.

These enforcement failures demean our principles. They also represent missed opportunities to address some of the nation’s most pressing challenges.

In particular, she cited this example involving health care.

When Novartis, a major drug company that was already effectively on federal probation for misconduct, paid kickbacks to pharmacies to push certain drugs, it cost taxpayers hundreds of millions of dollars and undermined patient health. Under the law, the government can boot companies that defraud Medicare and Medicaid out of those programs, but when Novartis got caught, it just paid a penalty — one so laughably small that its C.E.O. said afterward that it 'remains to be seen' whether his company would actually consider changing its behavior.

Note that we discussed the Novartis settlement here.  The case referred to by Senator Warren was just the latest in a series of ethical misadventures by Novartis which led to legal actions in the US and around the world, but feeble penalties.

But while Ms Morgenson wrote about financial institutions, now we can also write:

Ho-hum, another month, another set of multimillion-dollar settlements between regulators and  behemoth health care companies acting badly.

In chronological order, since mid-January, 2016...

For $830 Million, Merck Settled Shareholders Lawsuit Alleging Deceptions by Corporate Management

On January 15, 2016, the Wall Street Journal reported,

Merck said Friday it agreed to pay $830 million to resolve a class-action lawsuit brought by shareholders, alleging the drug maker and its executives made false and misleading statements about the safety of Vioxx between its introduction in 1999 and its market withdrawal in 2004.

The shareholders alleged they paid inflated prices for Merck shares because of the company’s conduct.

Note that if the company misled its shareholders, it also misled health care professionals and the public about the harms of Vioxx,  putting many patients at risk. Of course, the Vioxx case is now old news, but it continues to be an example of a case in which the corporation paid fines, presumably at the expense of shareholders, employees and patients, but in which no one who authorized or directed the bad behavior paid any penalty.

As is typical in such cases,

Merck, which is based in Kenilworth, N.J., said Friday the settlement of the shareholders’ lawsuit doesn’t constitute an admission of liability or wrongdoing by the company or individual executives named as defendants in the case.

Merck has paid billions to settle multiple lawsuits related to Vioxx, yet what it paid was much less than the revenue produced by the drug.

The bulk of Merck’s Vioxx-related costs came from its 2007 agreement to pay $4.85 billion to settle thousands of product-liability lawsuits alleging that patients’ use of Vioxx caused heart attacks and strokes, and that Merck failed to properly warn people of the risks. Merck didn’t admit liability in that settlement.

In addition, Merck agreed in 2011 to pay $950 million to resolve allegations by the U.S. Justice Department and state governments that the company deceived the government about the safety of Vioxx, and marketed it for uses not included in the prescribing label approved by the Food and Drug Administration.

Merck recorded more than $11 billion in Vioxx sales during the drug’s years on the market from mid-1999 to September 2004.

The company did plead guilty to one criminal charge related to Vioxx.

 As part of the 2011 settlement, Merck pleaded guilty to a misdemeanor criminal violation of a federal drug law, admitting that it promoted Vioxx to treat rheumatoid arthritis before that use was approved by the FDA.

But apparently no Merck manager was ever charged with a crime, much less convicted.  We have discussed the Vioxx case here, and other issues with Merck here.

Note that this settlement comes soon after a smaller settlement in 2015 that was barely mentioned in the press,Merck to pay $5.9 million for misleading marketing of pink eye drug: U.S [Reuters]

For $785 Million, Pfizer Settled Suit Alleging Overcharging of Medicaid

On February 16, 2016, per the Wall Street Journal,

Drugmaker Pfizer Inc. on Tuesday said it reached an agreement in principle to pay $784.6 million to settle a long-running U.S. government investigation of allegations that its Wyeth unit overcharged government Medicaid health programs for the heartburn drug Protonix.

Of course,

Pfizer said the agreement doesn’t include any admission of liability by Wyeth.

Much less did the agreement include any penalties for anyone at Wyeth or Pfizer who authorized or directed the overcharging. Yet some people must have.

Note that this settlement did not seem informed by Pfizer's amazingly lengthy record of legal settlements, and some guilty pleas and/or convictions (for illegal marketing/ misbranding, and for violating the racketeering influenced corrupt organization [RICO]  statute), as most recently summarized here.

Note also, pertinent to the report by Senator Warren mentioned above, every week people pay severe penalties for defrauding Medicaid, Medicare, or other federal health programs.  Today, a quick Google search for "medicaid fraud prison" found such stories from the last month as a woman sentenced to five years in Louisville, and another women sentenced again to five years in Dallas. Yet no person at Pfizer paid any penalty for for practices that deprived the government of hundreds of millions of dollars.  

For $250 Million, Fresenius Settled Lawsuits Alleging it Withheld Information About the its Products' Hazards

Per the New York Times, January 18, 2016,

The world’s largest provider of kidney dialysis equipment and services has agreed to pay $250 million to settle thousands of lawsuits from dialysis patients and their relatives claiming that the company’s products had caused heart problems and deaths.

The settlement was announced by Fresenius Medical Care, a German company whose North American division is one of the two large dialysis providers in the United States.

The lawsuits arose after Fresenius’s own medical office sent an internal memo to doctors in the company’s dialysis centers saying that failure to properly use one of the company’s products appeared to be causing a sharp increase in sudden deaths from cardiac arrest.

But the company did not warn doctors in non-Fresenius clinics who were also using the product, called GranuFlo. It did so only after the internal memo was sent anonymously to the Food and Drug Administration, which began an investigation.

 The company conducted a recall, which was actually a change in the label, not the removal of the product from the market.

Note that this settlement was of allegations not of financial chicanery, but of behavior that put patients in harms way. Nonetheless,

Kent Jarrell, a spokesman for the company, said the initial internal memo was actually incorrect and contradicted by further careful analysis. He said the warning language added to the GranuFlo label in 2012 was eventually removed. GranuFlo, and a related product called NaturaLyte, are used in dialysis machines to help cleanse patients’ blood.

In the first case to go to trial, a jury in Massachusetts state court ruled that Fresenius was negligent, for not distributing the memo more widely, but that a patient’s death could not be attributed to GranuFlo, so no monetary damages were awarded, according to Mr. Jarrell and to Christopher Seeger, a lawyer who led the settlement negotiations for the plaintiffs.

But if the initial concern was unwarranted and Fresenius won the first trial, why would it pay $250 million to settle? Mr. Jarrell suggested that a reason was to put the more than 10,000 lawsuits behind it.

'Fresenius deeply regrets the confusion and concern temporarily generated by the November 2011 memorandum,' he said in an emailed statement.

Again, there were no admissions or findings of guilt, no apologies (except for causing "confusion and concern"), and no negative consequences for the corporate managers who authorized or directed the actions in question.  While the FDA apparently issued a recall notice for GranuFlo, no federal agency apparently took action against the company or any individuals within it.    Also, this settlement seemed uninformed by previous settlements made by Fresenius, which were made in 2011 of allegations of false claims, in 2010 again of allegations of false claims, and in 2007 of allegations of restraint of trade (look here).

Summary

We first discussed how legal settlements may serve as markers for misbehavior by large health care organizations, but not as deterrents to future bad behavior in 2006.  Then we wrote ...

 Why do the mainly monetary penalties seem mainly to come out of the hides of stock-holders and consumers, rather than the people who actually made the decisions that lead to the offenses?

In 2008, we wrote,

After all, a fine or settlement paid years later can just be written off as a cost of doing business. Furthermore, although such a payment may have a (minimal) effect on the company's bottom line, it has no real effect on the people whose decisions and actions lead to the problem.

So rather than repeating our usual verbiage about the impunity of health care leaders, let me defer to Senator Warren:

Laws are effective only to the extent they are enforced. A law on the books has little impact if prosecution is highly unlikely.

This country devotes substantial resources to the prosecution of crimes such as murder, assault, kidnapping, burglary and theft, both in an effort to deter future criminal activity and to provide victims with some degree of justice. Strong enforcement of corporate criminal laws serves similar goals: to deter future criminal activity by making would-be lawbreakers think twice before breaking the law and, sometimes, by helping victims recover from their injuries.

When government regulators and prosecutors fail to pursue big corporations or their executives who violate the law, or when the government lets them off with a slap on the wrist, corporate criminals have free rein to operate outside the law. They can game the system, cheat families, rip off taxpayers, and even take actions that result in the death of innocent victims—all with no serious consequences.

The failure to punish big corporations or their executives when they break the law undermines the foundations of this great country: If justice means a prison sentence for a teenager who steals a car, but it means nothing more than a sideways glance at a CEO who quietly engineers the theft of billions of dollars, then the promise of equal justice under the law has turned into a lie. The failure to prosecute big, visible crimes has a corrosive effect on the fabric of democracy and our shared belief that we are all equal in the eyes of the law.

Under the current approach to enforcement, corporate criminals routinely escape meaningful prosecution for their misconduct. This is so despite the fact that the law is unambiguous: if a corporation has violated the law, individuals within the corporation must also have violated the law. If the corporation is subject to charges of wrongdoing, so are those in the corporation who planned, authorized or took the actions. But even in cases of flagrant corporate law breaking, federal law enforcement agencies – and particularly the Department of Justice (DOJ) – rarely seek prosecution of individuals. In fact, federal agencies rarely pursue convictions of either large corporations or their executives in a court of law. Instead, they agree to criminal and civil settlements with corporations that rarely require any admission of wrongdoing and they let the executives go free without any individual accountability.

Keep in mind that the impunity of health care leaders, especially in contrast with the tough enforcement efforts against small fry health care offenders, not only has a corrosive effect on the fabric of democracy but endangers patients' and the public's health, and makes health care more expensive and inaccessible.

Maybe now that the impunity of corporate leaders is becoming a mainstream topic of discussion, we can start talking about, and then doing something about the impunity of corporate leaders in health care. 

Baca selengkapnya