Three months ago I took JAMA to task over a Viewpoint opinion piece about conflict of interest. The authors proposed dancing around the reality of financial conflict of interest in medicine by talking instead about confluence of interest. I countered with a proposal for the term competing interests, which would not paper over the problem. In that post I also included a letter I had sent to JAMA in response to the opinion piece, but which JAMA had declined to publish. I questioned whether JAMA had deep sixed all the critical replies it received.
Now I can report that, in the April 26, 2016 print edition, JAMA has finally published one critical letter and a replyfrom the original authors. So JAMA didn’t deep six everything. This new correspondence appears 174 days after print publication and 214 days after on-line publication of the original Viewpoint article. That glacial delay is problematic – it disables meaningful dialogue.
The new critical letter is from a group in Europe, and it thoughtfully discusses weaknesses in the Viewpoint authored by Cappola and FitzGerald. These Viewpoint authors did not do justice to the critical letter in their reply. Moreover, they disclosed multiple potential competing interests, but they did not follow their own advice by clarifying why we should disregard those obvious competing interests. As we all know, the mere disclosure of competing interests does not by itself remove the problem. It can be a device for hiding in plain sight. Substantively, the reply from Cappola and FitzGerald is mostly hand waving and restatement of biased opinion, without real analysis or incisive thought.
The closing sentences of their reply letter illustrate these issues: “Everyone has biases. Rather than present these pejoratively, as a clash of values that undermines validity, it seems more constructive to mine the complexity of these biases, present them in an accessible fashion, and seek to determine whether they are confluent with the interests of patients, scientists, and regulators who might base their decisions on the results of a given piece of work.” The reference to complexity of biases concerns the matter of nonfinancial bias like fame and careerism in science. The reference to presenting biases in an accessible fashion concerns the ill-considered proposal to include a bias heat map on patients’ consent forms. This idea rightly was panned by the European critics. Meanwhile, where did the compromised and disgraced key opinion leaders disappear to in all this wishful thinking? Where did the corrupt corporations disappear to? They paid billions of dollars in penalties for felony crimes and plea-bargained settlements. They have been airbrushed out of the Cappola-FitzGerald narrative. These authors come across like Bambi confronting Godzilla.
If this is the best that an associate editor of JAMA and a fellow of the Royal Society can do then JAMA needs a fix. This effort is too little and much too late.
I have become blue in the face writing about healthcare information technology mismanagement over the years. In fact, the original focus of my 1998 website on health IT (its descendant now at http://cci.drexel.edu/faculty/ssilverstein/cases) was on HIT project mismanagement.
If this industry actually had learned anything from history, I would not be reading nor writing about brutally mismanaged HIT endeavors in 2016. Sadly, that is not the case.
The Coast Guard, founded by Alexander Hamilton, has this as its motto and mission:
The Coast Guard is one of our nation's five military services. We exist to defend and preserve the United States. We protect the personal safety and security of our people; the marine transportation system and infrastructure; our natural and economic resources; and the territorial integrity of our nation–from both internal and external threats, natural and man-made. We protect these interests in U.S. ports and inland waterways, along the coasts, on international waters.
We are a military, multi-mission, maritime force offering a unique blend of military, law enforcement, humanitarian, regulatory, and diplomatic capabilities. These capabilities underpin our three broad roles: maritime safety, maritime security, and maritime stewardship. There are 11 missions that are interwoven within these roles.
It seems the Coast Guard personnel need personal protection from the HIT industry, for the motto of that industry, sadly appears to be something like "Stupra Acetabulus" (Screw the Suckers).
From Politico, one of only a few publications that in recent years has taken a critical approach to this industry and pulls no punches:
EHR debacle leads to paper-based care for Coast Guard servicemembers By Darius Tahir 04/25/16
The botched implementation of an electronic health records system sent Coast Guard doctors scurrying to copy digital records onto paper last fall and has disrupted health care for 50,000 active troops and civilian members and their families.
Five years after signing a $14 million contract with industry leader Epic Systems, the Coast Guard ended its relationship with the Wisconsin vendor, while recovering just more than $2.2 million from the company. But it couldn’t revert back to its old system, leaving its doctors reliant on paper.
This state of affairs is simple inexcusable. It represents gross negligence and severe multi-axial incompetence at best - but likely primarily not by the Coast Guard, whose core competency does not include HIT.
There’s no clear evidence the EHR disaster has harmed patients, and a Coast Guard spokesman said the use of paper records hasn’t affected “the quality of health care provided to our people.”
Proof by lack of evidence is not reassuring in a debacle of this kind. However, the Coast Guard admits that paper records aren't the clear and present danger the IT pundits make them out to be.
Politico is skeptical of the claim:
That seems unlikely. Without digital records, if a patient goes outside a Coast Guard clinic, it can take weeks for the paper record to follow him or her back to the Coast Guard, says Michael Little of the Association of the United States Navy. And since the Coast Guard primarily provides outpatient, rather than hospital, services, many of its patients seek outside care.
“It’s one thing if you’re doing paper-based [care] in Ohio, but what about if you’re on paper records in [an] icebreaker or cutter in Alaska, and you need your gall bladder removed?” said Little, the organization’s director of legislative affairs.
In this case, I disagree that the lack of records is so dangerous. There's the telephone, FAX machines, the patient himself or herself, and the hand-carried note. Used with care, those serve care reasonably well.
With the Department of Veterans Affairs weighing whether to buy a top-of-the-line commercial electronic health record and the Pentagon beginning a multibillion-dollar EHR implementation, the Coast Guard case displays how poorly the process can go for the government, even when the biggest names in health IT are involved.
Not just the government. I'd also argue that this shows that the "biggest names" are, at best, overextended, and at worst, badly needing external investigation as to their software development, customization, implementation and support practices, as well as hiring practices (e.g., see my August 15, 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" at http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html) and contracting.
Reversion to a purely paper-based system is a rare event in the recent annals of electronic records, said Thomas Payne, a health IT expert at the University of Washington. “I can think of examples where that has happened, but in the last decade that is much less common.”
I believe that is because of the general invisibility of, and immunity from, the risks and harms that occur from "making do" with bad health IT due to financial pressures. Hence one sees hair-raising examples like I wrote of at my Nov. 17, 2013 post "Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications 'Only a Matter of Time' in Open Letter"at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html where going back to paper to allow a complete rethinking of the EHR implementation would likely have been the safe response.
The Coast Guard is tight-lipped about the causes, timeline and responsibility for the debacle. “Various irregularities were uncovered, which are currently being reviewed,” a spokesman said.
There’s no shortage of candidates: the service relied on five separate vendors to build the new system, and its own planning seems to have been at fault.
Lawmakers are looking into the matter, said a spokesman for the Senate Appropriations Committee, which is “monitoring the situation."
This is symptomatic, in my view, of the fact that there are a lot of "Beltway Bandit" IT consultant companies doing business, few of them very good.
Bungled implementation, followed by chaos
In September 2010, the Coast Guard bid out the contract to Epic Systems, then added an array of other contracts to software vendors and consultants to help implement it. Since 2010, the agency spent, on net, just more than $34 million on health IT.
In a January 2011 speech, Coast Guard Chief Medical Officer Mark Tedesco cited the success of Epic installations at Kaiser Permanente and Cleveland Clinic. He predicted that the Epic implementation would improve the health of its population and save money.
“Overall it’s a cheaper system for us to run than to upgrade to [the next generation military EHR], because of what that would’ve meant to us infrastructure-wise and support-personnel wise,” he said.
It's stunning to think what this says about the next-generation military EHR. The previous one was not very good, either (see my June 4, 2009 post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html).
Trouble, apparently, struck quickly. The solicitation for the EHR contract envisioned rolling out the software within six months at two to three pilot sites, before deploying it to a total of 43 clinics and the sickbays aboard the Coast Guard’s fleet.
That didn’t occur; the system never deployed to any clinic or cutter, said Eric Helsher, an executive with Epic. The next missed deadline was March 2012, which Trent Janda — the Coast Guard doctor serving as project leader — announced in a summer 2011 newsletter of the Uniformed Services Academy of Family Physicians.
One can only wonder what penalties the contract called for if the goals and timelines were not met. That software was not deployed even to any pilot sites is nearly unimaginable to me.
As Janda set the new goal, he acknowledged there had been “multiple hurdles and delays,” and explained that the service had expanded its ambitions.
“Immediately upon award of the contract, we began a comprehensive analysis of the clinical workflows and existing information systems,” Janda wrote. “Many of the weaknesses became apparent as we compared ourselves to industry standards and best practices. Frequently, a weakness would lead to others, ultimately leading to the need for an additional system. The work-flow analysis quickly grew into a system wide re-engineering project like a snowball rolling down the mountainside.”
This sounds like a groundbreaking level of project mayhem and chaos, even for HIT.
The comment reveals that the agency failed to do necessary advance planning, says Theresa Cullen, an informatics executive with the Regenstrief Institute who formerly worked with Veterans Health Affairs and the Indian Health Service.
“They should have done a full needs assessment,” she said. “One would have normally done the workflow evaluation prior to the release of the RFP.”
If true, I believe it was an obligation of EPIC and the multiple contractors to have pointed that out to their future customer, and adjusted their bids accordingly, taking into account the time and resources needed for this type of work - or not placed a bid at all. Such deficiencies and what they mean towards project progress and failure are obvious - to anyone who's learned from history.
... Cullen also found it odd that the Coast Guard didn’t hire consultants to implement the new system until September 2012. The service ended up hiring Leidos, which also maintained its old EHR.
The Coast Guard further complicated the process by deciding to team up with the State Department. Its original request was complicated enough, with installations spanning six time zones. The partnership with State meant implementing across 170 countries. (A spokeswoman for State said the agency was investigating its options, but refused additional comment).
The sheer number of sites led Cullen to question whether Coast Guard and State had devoted enough resources to the project. Between Epic and Leidos, the project was budgeted for roughly $31 million. That was “an inadequate amount of funding for what you’re asking to do,” she said. Consultants receive roughly $100 an hour, and Epic’s work with clinicians is time-consuming.
Again, those hired knew, should have known, or should have made it their business to know that under such conditions, if true, project failure was the predictable outcome. They are supposed to be the HIT experts, after all, not the Coast Guard.
While a very efficient health care system could implement the EHR, she said, the Coast Guard lacks that reputation. She speculated that Epic intentionally underbid the contract. (Epic’s Helsher said that “the contract was viable and we were fully motivated to lead a successful install.”)
Someone is right, and someone is wrong. I leave it to the reader to decide who was correct and who wasn't.
Anecdotes of further delays pepper various newsletters and reports from 2012 through 2015. Server failures scuttled a pilot rollout in 2014, then developed into deeper problems, and last July the systems started failing on a more regular basis.
Perhaps the "anecdotes" need to be turned into "teachable moments" through legal discovery by federal law enforcement.
The Coast Guard advised retirees and dependents that month that, due to incompatibility between its EHR and the Department of Defense’s new medication reconciliation system, they couldn’t get their prescriptions filled at Coast Guard clinics.
Around Labor Day, Coast Guard health care personnel were directed to copy information from electronic files onto paper, for fear of losing their data.
That is just about the most pathetic sentence I've ever had to read in my 24 years in Medical Informatics.
... doctors are frustrated. One complained in the Uniformed Services Academy of Family Physicians newsletter of “unique challenges which seemed to revolve around many electronic record keeping changes.” “The question we pose is, how is this affecting shipboard life?” Little said. “This is the most important thing that’s happening right now in the Coast Guard.”
My advice to the Coast Guard is to treat the IT invaders and consultants as it would a invading maritime fleet from a hostile nation.
The vendors who worked with the Coast Guard either don’t know what went wrong, or aren’t telling. Leidos — also the lead company implementing the Pentagon’s EHR project — declined comment, as did Lockheed Martin, which was contracted to implement access to the EHR through mobile devices, and Apprio, which was to provide credentialing services.
I believe they have a very good idea of "what went wrong", and aren't telling (per the Fifth Amendment)? If they have "no idea" what went wrong, what, I ask, are they doing in the IT consulting business?
... The EHR giant [EPIC] says it’s not entirely clear why the Coast Guard pulled the plug. But the situation wasn’t Epic’s fault, company executive Eric Helsher said.
They pulled the plug out of fear for their members' well-being, hopefully.
It seems everyone seeks to escape culpability, with the blame placed on the customer.
The Coast Guard spokesman said the decision was “driven by concerns about the project's ability to deliver a viable product in a reasonable period of time and at a reasonable cost.”
... In general, software contracts deserve more scrutiny, said Kingston, who served on the House Appropriations Committee. “These things don’t get the scrutiny a weapons system does.”
Considering the reputation of military costs, that's saying quite a lot. The lesson that should have been learned from history is that HIT is both exploratory, and a relative free-for-all.
Caveat emptor.
One last piece of (free!) advice for the Coast Guard leadership.
Read this paper:
Pessimism, Computer Failure, and Information Systems Development in the Public Sector.(Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.linkto pdf
That may be the most valuable learning experience of all for their next attempt to implement EHRs.
When one of my daughters was diagnosed with multiple food allergies many years ago, our family became well acquainted with the enormous place food holds. Food rules. It dictates a lot. Even our social lives can be altered as most celebrations are centered around food.
After the news, our lives took a major new focus. There were many extra precautions, extra preparations, so much to learn, many to educate and so many worries! And, at the time, we may not have known it, but it was the spark plug to a more aware path. Although the 13 foods she was allergic to and not allowed to eat were ingredients in basically all the other foods on the store shelves, leaving very few easy choices, what seemed like a crisis turned into a catalyst.
It was a time of condensed learning. In fact, it was learning on speed dial because we had no other choice than to scrutinize every food label, teach ourselves to administer needles and teach many others to as well! But, one huge advantage of having to focus so intently on food is that it we became better schooled and certainly more cognizant of the effects food has on our bodies - the good and the not so good. Thus, food rules, Yes, it does. It has quite the impact. Come find some simplified rules for healthy eating that resulted from our experience examining food so closely that may help you feel and look your best, too!
10 Simplified Healthy Eating Rules I Live By
The food we consume is one element to leading a healthy lifestyle. The information on those food choices can overwhelm, though, does it not? What diets to follow, what foods to stay away from, which ones to include and how to best prepare it. So, for me, I like to keep it simple and pared down. I have a few parameters I like to stay within most of the time when it comes to food choices, menu planning and what I keep in our kitchen for the family to eat. I thought these food guidelines may help you and your family, too:
1. Eat lots of plants and seeds. The studies say the same thing - eat a plant based diet and the benefits are numerous: improved blood pressure, decreased risk of heart disease, lowered cholesterol, better weight control, lower cancer rates, better moods, nicer skin, slower aging, etc. Yes, I want all that! How about you?
2. Choose nutrient-dense plants have lots of shades of green and other bright colors and consume a variety of them.
The green in a plant usually indicates chlorophyll - a life sustainer. The many other colors present in fruits and vegetables indicate the different antioxidant phytochemicals they contain. Many of these chemicals help protect us against various diseases, but each in a different way. So, a variety is key. Each time I shop for vegetables and fruits, I make sure to mix it up from the last time I shopped to ensure a variety is eaten.
I steer away from foods in boxes and cans most of the time, but if I do consume them, if sugar or a form of it is listed early on, then it probably contains a lot of sugar and too much of it.
4. Do not consume any artificial sweeteners.
I just stay far, far away from the fake stuff. More chemicals. Besides, they give me a headache. That can't be good.
Half, or more than half actually, of the preservatives in some canned and boxed foods I have no idea how to pronounce or can keep track of the studies on them(as the information on them always seems to change). Thus, I just stay away from them generally speaking. Food closest to its most natural state is best. Our bodies then know what to do with it. I feel a whole (note the pun!) lot better when I eat this way, too!
When you decide to indulge, go ahead and enjoy every last bite of it. No guilt, what. so. ever! But keep it to every now and then.
Don't miss this: Here are loads ofhealthy treatsto satisfy that hankering for something kinda naughty!
8. Do not eat out too much.
Love to cook; hate the dishes. But if you eat out a lot, you really can't account for everything that is going in your mouth. If you prepare it, you know what is really there and what went in to make it.
Some foods have lower levels of pesticide than others, and it is not always possible to find organic foods or afford it. Further, when eating out, it is really difficult. But, when you can, choose it.
10. Do not preach.
By all means, provide a good example to others and share information, if interest is there. But, if you go too academic on others about food, your wanting to help them has been negated. You could create a negative impression when you really want to encourage them to eat healthier. Be gentle, everyone!
We have been ranting for a while about the dysfunctionality of the US health care system. Unfortunately, many people only realize how bad things are when they become patients, when they have bigger things to worry about than complaining. Furthermore, even if they complain, many patients may not feel they understand enough about what has gone wrong to suggest solutions.
Bad Customer Service at New York Presbyterian
This may not apply when media pundits, especially those with strong ideological views, become patients. So this week Fox News commentator and well known libertarian John Stossel disclosed his new illness, and vented his opinions about his hospital stay. Mr Stossel unfortunately developed lung cancer, although he was optimistic about his prognosis: "My doctors tell me my growth was caught early and I'll be fine. Soon I will barely notice that a fifth of my lung is gone."
However, he was not happy about his hospital's customer service:
But as a consumer reporter, I have to say, the hospital's customer service stinks. Doctors keep me waiting for hours, and no one bothers to call or email to say, 'I'm running late.' Few doctors give out their email address. Patients can't communicate using modern technology.
I get X-rays, EKG tests, echocardiograms, blood tests. Are all needed? I doubt it. But no one discusses that with me or mentions the cost.
Also,
I fill out long medical history forms by hand and, in the next office, do it again. Same wording: name, address, insurance, etc.
And,
In the intensive care unit, night after night, machines beep, but often no one responds. Nurses say things like 'old machines,' 'bad batteries,' 'we know it's not an emergency.'
Finally,
Some of my nurses were great -- concerned about my comfort and stress -- but other hospital workers were indifferent.
Unfortunately, long wait times, poor communications, excess paperwork, and misapplied technology are all too familiar problems to those in the health care system.
Moreover, this all was happening at one of the most highly rated US hospitals,
After all, I'm at New York-Presbyterian Hospital. U.S. News & World Report ranked it No. 1 in New York.
Were "Socialist Bureaucracies" Responsible?
Mr Stossel had his own ideas about the causes of these problems.
Customer service is sclerotic because hospitals are largely socialist bureaucracies. Instead of answering to consumers, which forces businesses to be nimble, hospitals report to government, lawyers and insurance companies.
Whenever there's a mistake, politicians impose new rules: the Health Insurance Portability and Accountability Act paperwork, patient rights regulations, new layers of bureaucracy...
Also,
Leftists say the solution to such problems is government health care. But did they not notice what happened at Veterans Affairs? Bureaucrats let veterans die, waiting for care. When the scandal was exposed, they didn't stop. USA Today reports that the abuse continues. Sometimes the VA's suicide hotline goes to voicemail.
Patients will have a better experience only when more of us spend our own money for care. That's what makes markets work.
A "Socialist Bureaucracy" with a VIP Penthouse?
I am sorry to hear Mr Stossel has lung cancer, and hope that his prognosis is indeed good. I am a bit surprised that a media celebrity who became a patient found big issues with "customer service" at such a prestigious hospital. After all, many big hospitals have programs to give special treatment to VIPs (for example, see these posts from 2007 and 2011).
In particular, back in 2012 we posted about the contrast between the VIP services specifically at New York - Presbyterian Hospital and how poor patients are treated there. Then we quoted from a 21 January, 2012 article from the New York Times focused on the ritzy comforts now provided for wealthy (but perhaps not very sick) patients at the renowned New York Presbyterian/ Weill Cornell Hospital. It opened,
The feverish patient had spent hours in a crowded emergency room. When she opened her eyes in her Manhattan hospital room last winter, she recalled later, she wondered if she could be hallucinating: 'This is like the Four Seasons — where am I?'
The bed linens were by Frette, Italian purveyors of high-thread-count sheets to popes and princes. The bathroom gleamed with polished marble. Huge windows displayed panoramic East River views. And in the hush of her $2,400 suite, a man in a black vest and tie proffered an elaborate menu and told her, 'I’ll be your butler.'
A waterfall, a grand piano and the image of a giant orchid grace the soaring ninth floor atrium....
Also,
the visitors’ lounge seems to hang over the East River in a glass prow and Ciao Bella gelato is available on demand....
An architect who specializes in designing such luxury facilities for hospitals noted:
'These kinds of patients, they’re paying cash — they’re the best kind of patient to have,' she added. 'Theoretically, it trickles down.'
It appears that someone failed to book Mr Stossel into the penthouse. Instead, he found out what service was like for the masses.
Perhaps this was why Mr Stossel railed at the "socialist bureaucracies" he perceived as running New York - Presbyterian Hospital. However, calling the hospital management "socialist" seems - not to put too fine a point on it - wrong.
A "Socialist Bureaucracy" Paying Millions to its CEOs?
First of all, New York Presbyterian is hardly a government agency. It is a private, non-profit corporation. Every year as such it files a form 990 with the dread US Internal Revenue Service. (The latest publicly available version is from 2013, here.) Obviously, US government agencies do not file with the IRS.
In fact, the New York Presbyterian system seems about as far from a federal government agency as one can imagine.
First, its top managers are paid like for-profit corporate executives. In 2014, we posted about the humongous compensation given to its previous, long-serving CEO, Dr Herbert Pardes, who received multi-million dollar compensation every year through his 2011 retirement, and then continued to receive several million a year from the system in his retirement. His successor, current CEO Dr Steven Corwin, received $3.6 million in 2012. (More recent compensation figures are not yet available.)
A "Socialist Bureaucracy" Dominated by Managers, with Stewardship by Top Financial Executives, and one of the Koch Brothers?
The current leadership of New York Presbyterian is dominated by businesspeople, not physicians, nurses, or other health care professionals. Only 10 of 33 listed senior leaders are health care professionals. The rest have administrative/ management or legal backgrounds and training. Many appear to be generic managers, that is, people with background and experience primarily in administration or management, but not in medicine, health care, public health, etc.
The hospital system's board of trustees was and is filled with some of the top business executives in the US, including some finance executives who have been cited as responsible for the global financial collapse/ great recession.
For example, we wrote about Mr Dick Fuld, a trustee until recently. Mr Fuld was the CEO who presided over the bankruptcy of Lehman Brothers, which heralded the beginning of the great financial crisis/ great recession of 2008 onward. Mr Fuld seemed to lack the sort of compassionate approach one might expect from someone charged with the stewardship of a big hospital system. He had once publicly said about those who sold Lehman Brother stock short: "what I really want to do is I want to reach in, rip out their heart, and eat it before they die."
Another recently retired board member was Sanford I Weill, architect of the mergers that created the now federally bailed out Citigroup. In 2014, we posted about how Mr Weill, contemplating retirement from the board of trustees of Weill Cornell Medical School, one of the two medical schools with primary affiliations with New York Presbyterian, managed to bequeath his board seat to his daughter, Ms Jessica Bibliowicz, also the CEO of a finance firm, National Financial Partners. Ms Bibliowicz now also seems to have Mr Weill's seat on the New York Presbyterian board.
Also, still on the board are two top finance CEOs who have been blamed for the global financial collapse. These are Maurice R Greenberg of the federally bailed out AIG, and John A Thain, CEO of the nearly collapsed Merrill Lynch (merged into Bank of America). See this post for more information about their roles in the global financial collapse.
Finally, one other board member is David H Koch, described by Wikipedia
Koch is an influential libertarian. He was the 1980 candidate for Vice President of the United States from the United States Libertarian Party and helped finance the campaign. He founded Citizens for a Sound Economy. He and his brother Charles have donated to political advocacy groups and to political campaigns, almost entirely Republican
With socialists like these ...?
Summary
I do not doubt that John Stossel found the customer service at New York Presbyterian not up to his expectations. And I actually have no doubt that New York Presbyterian has to operate within a complex health care system in which government bureaucracy plays a large role, and sometimes a counter-productive one. Furthermore, I have no doubt that the management of New York Presbyterian is very bureaucratic, and this may in part may be a reason for poor customer service, and other failings.
However, to say that the management and governance of the hospital system is "socialist" is dead wrong. In fact, like many other large health care organizations, the New York Presbyterian system appears to be run largely by "managerialists," that is generic managers who have little experience or background in health care, may have little understanding or sympathy for its values, and approach health care with the same management techniques that might be applied to selling soap powder. Furthermore, the stewardship of this particular hospital system seems to be largely up to some of the biggest, and loudest "capitalists," and one of the most prominent "libertarians" in the US.
But to someone with a hammer, most problems look like nails.
Maybe Mr Stossel needs to complain to Mr Koch.
In conclusion, I am glad that some of the problems in the dysfunctional US health care system are getting more public attention. However, now we need to calmly and rationally consider what is causing them and what to do about them without the blinders of ideology or vested interests.
IMHO, true US health care reform would put the operation of US health care organizations more in the hands of people who have knowledge and experience in health care, and are willing to be accountable to support health care professionals' values. Furthermore, oversight and stewardship of these organizations should represent the patients and public which the organizations are supposed to serve.
Shannon Brownlee, in her keynote talk, "Introducing the Right Care Alliance," called our current US health care system "corrupt." She noted how clinical research has been "hijacked," (see our posts on the suppression and manipulation of clinical research). She noted how the multi-million dollar compensation of CEOs whose hospitals serve - not always well - primarily poor people (see our posts on executive compensation and mission-hostile management). She called for a national conversation to "expose the dark matter" of medicine, and right the wrongs of a new "gilded age."
The Right Care Alliance has a Vision Statement which calls for health care in which
Healthcare is a right, not a commodified privilege, and access to healthcare is universal, equitable, and affordable. Everybody in, nobody out.
There is meaningful public transparency around costs and outcomes that matter to patients and communities.
The science and practice of medicine is free of commercial bias and the profit motive.
among other imperatives.
Not to toot our own horns too much, but Dr Adriane Fugh-Berman of PharmedOut.org and I led a workshop on deceptive pharmaceutical and device promotion in the context of health care corruption.
Hopefully, much of the conference content will eventually show up on the web, but so far one nice video summary has been produced:
This post is brought to you by Tom's of Maine. The content and opinions expressed below are that of The Health-Minded.
There is nothing like a warm smile upon meeting someone new. It raises spirits all around - the one giving the smile as well as the one receiving it. But to keep it looking good and actually something to smile about, stepping up your oral hygiene routine could play a crucial role.
It is true that how you care for your teeth and gums can create a sparkling smile that anyone would want to see, but that is certainly not all it can do for you! Your dental routine, or lack of one, may even determine your risk for other serious diseases. Keep reading to see what the latest research is saying on that as well as lots of tips (you may not have heard of) to care for your teeth the best way.
The Link Between Your Oral Hygiene and Potential Cancer, Heart Disease, and More
It may sound like a far reach to think that how you take care of your teeth and gums could affect cancer or heart disease risk as well as diabetes and other diseases. But, according to some latest studies, it could be so. Here are some of the latest findings on how you choose to take care of your teeth and gums may affect your overall health:
5 Minutes To Your Freshest Breath, Whitest Teeth, and A Healthier Body
In pursuit of flashing a great smile, having fresh breath and keeping serious disease at bay, our daily dental care habits can really help create care-free dental check-ups and a lot less drilling - if at all!
Five minutes a day is all it takes to follow a basic daily oral hygiene routine that can do so much for your health and your appearance! That's it - five minutes! And, the cost for supplies to do it are very low as well!
A basic routine for you and your family includes brushing at least twice a day (after every meal even better) for two minutes at least and flossing at least once. But, there are other really important points, too, to keep that smile bright and filling-free:
1. Toss the tobacco.
Smoking and other tobacco habits turn your teeth yellow and harm your body in a number of ways: throat, lung, and mouth cancer for one and tar from tobacco forms a sticky film on teeth. That film attracts bacteria that promotes acid production that can cause gum inflammation and tooth decay as well.
2. Swish with water after drinking wine, tea, coffee, and sugary drinks.
I really don't think sugary drinks should play a role in our lives much at all, but if you choose to consume them, they cause cavities. Regular consumption of wine, tea and coffee can harm tooth enamel, too, and the acidity can dissolve the tooth structure and increase dental staining. Taking small sips and rinsing with water when you're done drinking is a good habit to form with all of these beverages.
3. Choose safe and effective basic tools for whiter teeth.
Check out these important ABC tools when choosing your next toothpaste, toothbrush, and dental for best results:
A. Toothpaste
There are lots of tooth whitening toothpastes on the market but many contain preservatives and enamel-harming additives. Here is a new one I was asked to review recently that you may want to try as well: Tom's of Maine Luminous White Toothpaste, part of the Made to Matter collection only available at Target. A bit about why I like this toothpaste is here:
This toothpaste is safe for enamel - so critical -- but whitens teeth!
It is gluten and paraben-free.
It is a good choice if you are cavity prone as it does contain fluoride.
This toothpaste is free of artificial dyes, fragrances, flavors and preservatives and never tested on animals.
If you are interested in purchasing this toothpaste or several other natural personal care products, please roll on down to the last section of this post for Target coupon discounts.
B. Toothbrush
Here are some important points about choosing a toothbrush and how to keep it germ-free:
Choose a soft-bristled brush to not injure your gums but still clean the teeth effectively.
Replace your brush at least every few months and especially after you have been sick to not reinfect yourself.
Store your toothbrush upright and keep it where air can circulate to dry the brush quickly.
If you floss, great! If not, begin today as it is one of the best things you can do to take care of your teeth and perhaps the most important daily habit to prevent gum disease. It only adds a minute to your routine (included in the five daily minutes mentioned above) and once you start, you can't imagine NOT doing it. Specifically, regular flossing can do this for you:
Flossing helps prevent tooth decay by removing plaque and debris that sticks to teeth and gums where the toothbrush can't reach. My hygienist always flosses after she polishes my teeth, but I always floss first so that I can more easily brush away anything that I was not able to reach with my toothbrush. What about you
Dental floss polishes the tooth's surface providing a brighter smile!
If you are pregnant, pay extra attention to your teeth and gums as some studies show a link between untreated gum disease and low-birth-weight babies. Further, changes in hormone levels during pregnancy can cause inflammation of the gums and gingivitis (red, swollen, tender gums) and may require extra care.
A dry mouth is bad for your teeth and breath. Saliva washes away cavity-causing, bad-breath making bacteria and neutralizes harmful acids.
6. Try ancient practices.
Oil-pulling may seem trendy but it is an ancient practice of Ayurveda medicine that may promise a healthier mouth and gums, whiter teeth, fresher breath and less bacteria in the mouth and, therefore, in the body. Here is a bit more about it:
Oil pulling is basically swishing about 1 tablespoon of oil -- usually coconut, sesame, or sunflower oil -- in your mouth for about 20 minutes and then spitting it out.
I tried oil pulling some time ago but found it a bit cumbersome to add to my morning routine. However, I am planning on trying it again for shorter increments, as I have read research like this on oil pulling benefits that has further convinced me. Even a few minutes should offer some benefit and I can build up from there, depending on my morning time rush!
Coconut oil may be the best choice as it has the added benefit of lauric acid, which is well-known for its anti-microbial agents.
Whatever you do, do not swallow all that swished stuff! And, don't spit it down the sink either as the oil could clog your pipes. Just discard the used oil into a tissue and deposit it in the nearest trash can.
Target Product Discounts
Switching to more natural personal care products makes a lot of sense to protect you and your family. See the code below if you want to purchase the Luminous WhiteToothpaste as well as two other new Toms's of Maine personal care products from Target's Made to Matter collection like these:
Wicked Cool!Deodorant: their first natural deodorant for boys and girls, providing 24-hour odor protection and free of aluminum, parabens, and artificial fragrances
North WoodsAntiperspirant: their first natural antiperspirant made for men that provides all day odor and wetness protection without petrochemicals, artificial fragrances, or irritation
So, what have you found helpful for keeping your teeth and gums their best? What are your favorite natural products? Are you a floss first or last person?
The story of the contaminated heparin just will not go away. We first wrote about it in 2008 (see first post here, most related posts here, and the longer summary at the end of this post.)
Quick Summary
Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.
Heparin tainted with unauthorized Chinese-made ingredients may be on the market in the U.S. and the Food and Drug Administration hasn’t moved swiftly enough to prevent it, according to a congressional probe nearly a decade after hundreds of deaths were linked to sullied batches of the blood-thinning drug.
This possible contamination is different from the earlier one, when Chinese producers made crude heparin containing a deadly chemical. They may be using cow and sheep intestines to produce the raw material for heparin that is supposed to be derived only from the intestinal membranes of pigs, according to a letter the House Energy and Commerce Committee sent Tuesday to the FDA. The agency has known about the risky practice since 2007, around the time it discovered the chemically enhanced crude heparin, the panel said.
The FDA didn’t react early on 'to credible evidence of non-porcine contamination of the Chinese heparin supply,' according to the letter, only putting out testing guidelines for pharmaceutical companies in 2012. Even after the tragedy of the chemically soiled heparin, the committee said, 'loopholes and exemptions that permit part of the Chinese drug supply chain to operate outside government scrutiny still remain.'
The committee charged that nothing much as changed since the 2008 episode of deadly heparin made from Chinese pigs
The letter from the House committee said the FDA dropped the ball on many fronts and may have allowed unsafe blood thinners to remain on the market longer than necessary. Regulators didn’t properly or widely enough share information and didn’t follow up on leads about tainted heparin from other governments, according to the letter. Agency investigators failed to inform others about dodgy crude heparin makers, the panel said. It also said the FDA didn’t follow up on concerns that heparin with the chemical was recycled after the poison was removed and may have entered the U.S. market. The claims are based on documents that Baxter, Scientific Protein and FDA provided the committee as well as interviews with FDA employees, according to footnotes in the letter.
Also, efforts to investigate the 2008 problem seem to have failed,
The chemical, oversulfated chondroitin sulfate, was connected to 246 deaths and sickened hundreds of people who took the blood-thinning medicine, the FDA said at the time. Regulators never found at what point in the chain in China that the drug, sold in the U.S. by Baxter International Inc., was corrupted. The FDA closed its initial criminal investigation after it became difficult to obtain evidence in China, though it has since re-opened a related inquiry, according to the House committee. Baxter, which recalled its heparin in 2008, hasn’t sold the anticoagulant since. It said at the time it was alarmed that the contamination appeared to have been deliberate, but had no proof of how it happened.
Now the problem appears to be more bovine. It appears that French regulators first noted the problem of imported heparin derived from Chinese cows.
The French National Agency for Medicines and Health Products Safety called non-pig blending a 'critical' violation in an inspection report released in February. France cited China’s Dongying Tiandong Pharmaceutical Co. for making heparin with ruminant DNA, which includes cows and sheep. Dongying is registered with the FDA as a manufacturer of active ingredients and isn’t on the agency’s list of companies banned from importing to the U.S.
Yet, the FDA
considers heparin adulterated if it contains oversulfated chondroitin sulfate or non-pig material, according to an FDA document for the pharmaceutical industry on monitoring heparin quality. Material from cows could pose a risk because of possible contamination with mad cow disease.
Oddly enough, the Bloomberg article did not mention any criticism by the committee of the US based manufacturers who outsourced their heparin production to China.
Outsourcing Continues Unabated
In 2012 we noted that outsourcing by big multinational drug companies based in the US and other developed countries of active pharmaceutical ingredient (API) production to dubious manufacturers based in countries with much less robust regulation was continuing. I wrote then
To put it more directly, most so called pharmaceutical companies in the US and other developed countries have outsourced the actual manufacturing of drugs. Thus, most companies that appear to be pharmaceutical manufacturing companies are really just pharmaceutical marketing and development companies. (And not so much the latter, look here: Light DW, Lexchin JR. Pharmaceutical R&D; what do we get for all that money? Brit Med J 2012; 345: 22-25. Link here.) Pharmaceutical companies appear to be abandoning their core essence, but are content to market drugs under their logos without telling the patients who take them the real source of these products. This would appear to be a big scandal, but one that stays curiously anechoic.
In 2016, outsourcing of drugs by big multinational corporations with prestigious names seems to be continuing at a rapid pace. Per Bloomberg,
The U.S. depends heavily on China for medicine. Along with India, the country is one of the top two producers of base ingredients for drugs in the world, according to the National Academies of Sciences, Engineering, and Medicine.
There is still no clear way for US patients or doctors to identify outsourced medicines, and efforts to better regulate them seem feeble. Thus the danger that patients may be getting ineffective, adulterated, even deadly outsourced medicine in bottles with the logos of big, famous pharmaceutical companies seems to be ongoing.
I have yet to see any discussion with pharmaceutical executives about why their companies hardly make drugs anymore. In the absence of such discussion, I can only speculate that most likely, this is first a product of financialization. Drug company executives, like most organizational leaders, have fallen under the spell that says their only goal should be to increase short-term revenues. It may be cheaper to buy drugs from perhaps dodgy outsourced suppliers rather than manufacturing them them themselves. Continuing stories like those above, and that of the contaminated Chinese heparin suggest that these outsourced drugs are cheap for a reason. It appears that to save money short-term, pharmaceutical executives may be abandoning their most central mission, to provide pure, unadulterated drugs.
The continuing story of outsourced pharmaceutical manufacturing provides yet more evidence that current management dogma may be literally toxic. Once again, I suggest that true health care reform requires leadership of health care organization who put patients' and the public's health ahead of short-term revenue (and the personal enrichment that may result).
It is likely that a number of policy changes will be needed to reduce the threats posed by contaminated or adulterated outsourced pharmaceuticals. There is one simple step that ought to be taken quickly to at least make the problem more transparent. In the US, most manufactured products have a label disclosing the country of origin. In parallel with that, all pharmaceutical containers, and all pharmaceutical labels and marketing materials ought to disclose the country in which the active pharmaceutical ingredient was manufactured, and the name and location of the company responsible for that manufacture.
There seems to be no need to rewrite or update this.
The fact that this problem has been known for 2008 year, but not clearly addressed, shows the pitiful state of American health care dysfunction. But those with vested interests in preserving the current system remain fat and happy, like the pigs of China.
Appendix - Heparin Case Summary
- We have posted several times, recently here about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts here and here.)
- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops." - Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.) Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here). A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).
- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)
- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.) Efforts to make documents to be used in these cases public so far have not succeeded (see post here).
- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)
- Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)
- In February, 2011, a congressional investigation of the case was announced, but results were unavailable until now (see above)
- In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post here).
