Tuesday, November 17, 2009

Twitter and information accuracy

I am going out on a limb: I do not wish to offend anyone, particularly those for whom I have a great deal of respect. However, this is potentially a moment where opinions need to be exchanged in the name of improved mutual understanding.

The other day I re-tweeted a tweet from someone whose Twitter activity I enjoy very much.  I like where his links take me, and I appreciate the intellectual and emotional honesty of his own writing. The message I re-tweeted was about Gardasil, Merck’s HPV vaccine marketed in the US. Diane Harper of the University of Missouri is a prominent researcher who was heavily involved in the Gardasil development program. Over the last several months she has cast serious doubt on both the cost-effectiveness and the risk-benefit profile of the vaccine. One of the facts she pointed out at the recent 4th International Public Conference on Vaccination in VA was that, though the drug is marketed to girls as young as 11 years old, the vaccine has never been formally evaluated in girls under the age of 16 years. Neither its safety nor efficacy, let alone effectiveness, is known in the younger population.

A link in the re-tweeted message took me to a newspaper article summarizing Dr. Harper’s objections to the wide-spread use of Gardasil in the US. As luck would have it, shortly following the first tweet, the author re-tweeted another message. This one directed one to a blog post by a British EBM celebrity railing against a deliberate fabrication of information by anti-vaccination ideologue reporters to cast doubt on GSK’s Cervarix in a story published in the British tabloid Sunday Express. In this blatantly sensationalist anti-vaccination article, the journalists were allegedly quoting Dr. Harper’s objections to Cervarix, objections that seemed identical to those she has voiced with regard to Gardasil. Being dubious of the veracity of such claims, the blogger diligently fact-checked with Dr. Harper directly, who promptly denied ever making any claims, or indeed having more than superficial familiarity with the data on Cervarix. In fact, the journal has removed the story from its web site. So, the blog recounted a necessary he-said she-said anatomy of distorting facts in service of the tabloid rag's sales. Perhaps in the UK these disreputable pseudo-news outlets have wider credibility than in the US. But I do not see that I need to get involved in further discrediting a source that would just as likely put news of alien abductions on its front page as the lies about a vaccine.

Since I have been following the Gardasil saga, I was interested in Diane Harper’s views of the data in the context of the epidemiology of both HPV infection and cervical cancer. Additionally, being a health services researcher, the cost-effectiveness questions also caught my eye. Not to mention the information about the age thresholds in the trials. For these reasons I re-tweeted the story. And while the debunking of the anti-Cervarix rhetoric was interesting, it did not add to my knowledge base, other than to trust all tabloids even less, if that is even possible. The blog post thus made the point that there is no evidence to date for any of the dire events that the reporters in their anti-vaccination zeal had made up. This does not excite me: as I keep pointing out, the absence of evidence does not mean that there is evidence of absence. The best we can say is that the vaccine proved safe enough in trials to be approved, and to date we have not seen any red flags. No new information here, other than confirmation of the lies, though, given the source, no big surprise. So, the post being simply more of voyeuristic than scientific interest to me, I chose not to re-tweet the second tweet. Particularly since this is a “controversy” I had not been following closely.

Shockingly, when I got back on Twitter a few hours later, I had a polite but insistent request from the author of the tweet to re-tweet his second, Cervarix, tweet. Now, because I respect this person, and because I am confident that, being an accomplished journalist, he was simply seeking balanced information, I complied without further ado. After all, this was harmless enough. However, I got to thinking about when it might be OK for a tweeter to insist that a particular tweet get re-tweeted. Journalists seek balance in reporting. Scientists seek balance when summarizing evidence. Both are averse to cherry picking. I am sure that my esteemed colleague felt that I was cherry picking the information to fit my point of view. In fact, I wish to assure him that I was cherry picking simply on the basis of what advanced my knowledge on the subject: a story about an important public meeting on vaccination vs. a recount of a tabloid inaccuracy. And even if my intentions had been nefarious, Twitter is neither a responsible journalism vehicle nor a peer-reviewed publication. The cynical view is that information chaos reigns, and while we should all strive for responsible diffusion of information, there is no contract to this effect. The less cynical way to look at it is that Twitter is an egalitarian vehicle, where individuals can make up their own minds as to what they deem important.

So based on this experience, let me respectfully suggest an alternative course of action around similar future situations, should they arise. Rather than emphatically asking to re-tweet a specific post, why not inquire why the person chose not to in the first place. And though it may be challenging to give a full explanation in 140 characters, it is worth a shot, as it is guaranteed to advance our mutual understanding and to build better relationships.
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Monday, November 16, 2009

AstraZeneca Settles

Here is the latest in the parade of legal settlements of cases of alleged wrong-doing by health care organizations.  As reported by Duff Wilson in the New York Times,
The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to 'selected physicians who participated in clinical trials involving Seroquel,' AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.

The name of the whistle-blowers and other details of the suits remained sealed in federal court. Stephen A. Sheller, a lawyer in Philadelphia for the whistle-blowers, and Patricia Hartman, a spokeswoman for the United States attorney in Philadelphia, both declined to comment.

Here we go again. As the Times article noted,
AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.

Does anyone really still believe that integrity agreements, and settlements assessed against huge corporations deter such profitable bad behavior? A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years. As in the case of many other previously announced settlements, it appears that nobody who authorized, directed, or implemented the bad behavior that led to the settlement will suffer any sort of negative consequences.

We previously discussed allegations that AstraZeneca manipulated and suppressed clinical research, and organized deceptive marketing campaigns in support of Seroquel sales (here, and here).  If we do not discourage such practices, they will continue to bias the clinical evidence making expensive drugs and devices seem more effective and less dangerous than they really are.  Is it any wonder that we over-use and over-pay for these products?  Anyone seriously interested in reforming health care to improve quality and access while moderating costs ought to pay attention to behavior that leads to such over-use and over-payment. 

(However, there may be hope.  Perhaps in the future there will be more effective deterrence.  A recent indictment named not only the device company Stryker Biotech (a subsidiary of Stryker Corporation), but also its former CEO and three managers.)
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Sunday, November 15, 2009

Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:

Switch to electronic records alarms Jefferson Regional physicians

By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Friday, October 30, 2009

Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety.
In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians."
Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed.
"It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."

Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying.

I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns.

Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions:

  • How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?
  • Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?

I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations.

HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason.

On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer.

This is especially true when conflicts of interest exist.

According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.

I find this an interesting finding. After a short Google search, the following appeared:

Western Pennsylvania Hospital News
20 Years of Hospital Information Technology
by John Fries
(December 2005)


... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System.
At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades.

The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy.

This raises a number of questions:

  • Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?
  • Who did/does the Site Executive report to?
  • Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?
  • What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?

These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest.

I have noted that a Congressional investigation of the health IT industry is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys.

Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."

He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns.

This is typical of the Wild West environment of Health IT.

-- SS
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Friday, November 13, 2009

Conflict of interest in healthcare research

I have been in San Diego for nearly an entire week, and am eagerly getting ready to head back to my beloved New England tomorrow after I chair my last session in the morning on the extra-pulmonary complications of critical illness. Guess what my talk is on? That's right, C diff.

A hot topic at this meeting of the American College of Chest Physicians (affectionately known as Chest) has been conflicts of interest. Yesterday I chaired and spoke at a session talking about what good collaborations look like between the Industry and Academia. Today there was a fascinating session on a related topic, which included talks from Catherine DeAngelis, the Editor-in-Chief of JAMA, as well as Richard Irwin, the Editor-in-Chief of the journal Chest, and two other speakers: Jim Roach, MD, representing the Industry point of view, and Ian Nathanson, MD, who is a part of the Chest COI working group. Although all speakers attempted to be balanced, the sum total amounted, as one would expect, to at least some Industry bashing and finger-pointing. It is interesting to me that, while people do not hesitate, appropriately, to include all fraud and result falsification, they usually conflate these into the "Evils of the Industry", regardless of the funding received by those defrauding the system. Also, what is not mentioned are the denominators of this potential relationship of fraud with manufacturers. The story is usually told thusly: 1). Look at the proportion of research funded by private vs. public funds (~85% of all clinical research, according to Dr. DeAngelis). 2). Look at the systematic reviews that indicate that Industry-sponsored trials are more likely to show results favorable to the product in question (true, but could this be because Industry-funded studies are designed with more precision? Or perhaps it is because of the nature of our regulatory process: early phase studies shed light on what can be expected, and the later phase studies merely build on that information. It is possible that our regulatory path promotes lack of equipoise, but that is a discussion for a different time). 3). Here are a bunch of case studies of fraud that we have uncovered (usually quite a few from the Industry, but also a number not funded by private dollars), 4). Therefore, the fraud is a big problem with Industry-funded work.

If I were structuring a scientific argument in this manner, I would be accused of using ecological data for hypothesis testing. The leaps of faith required are considerable. I do not wish to minimize the abominable behavior exhibited by those with a considerable monetary interest at stake, or by those that have benefitted at the trough: their lack of ethics and concern for the public has brought public cynicism and apprehension about everything we do. However, it is not OK to mitigate this terrible situation by singling out only the most visible potential culprit, made visible simply because of the volume (denominator) of work it supports. This tactic reeks of scape goating for personal gain -- so as to divert the spot light from transgressions of other stake holders, no matter how egregious.

The reason that manufacturers present an easy target is that they have in the past been unethical in so many visible cases. Another reason is that the source of the conflict of interest that exists for the Industry and investigators they fund -- money given for work that will advance the cause of the particular technology the company owns and benefits from financially --is particularly easy to identify. To be sure, we do need to deal with this source of COI carefully if we do not want to lose our credibility completely as the scientific community. At the same time, turning this process into a witch hunt is a mistake. Barring Industry scientists from presenting their work in a CME forum at professional society meetings, fro example, runs counter to the transparency mandate of authorship guidelines. Further, it denigrates the achievements of often prominent and dedicated scientists, and assumes guilt until innocence is proven.

In so many ways, this reactive stance is a response to the Congress's interest in the issue, and the mad rush to deal with it surely reflects an earnest attempt to clean our house. While I salute journals and societies for addressing this difficult issue, if some of the parties are locked out of the discussion, the attempts will look like and amount to nothing more than window dressing. Unless we are willing to overhaul completely how we do medicine in this country and take out the profit motive altogether for everyone (this is in fact my preferred solution, but given how difficult it has been to pass even the current anemic public option, universal socialized healthcare system does not stand a chance), it is critical to be inclusive and to find the most sensible and well thought-out solution to this visible violation of public trust.
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The simple math of healthcare access

Look, here is the bottom line in broad strokes.

The costs of healthcare have been rising exponentially, but people's incomes have not. Despite the biggest economic expansion over the last 50 years, and despite astronomic rise in our productivity, the real wages for the bottom 80% of all earners have not increased one iota since 1975! This means that, while the costs for all products and services have grown at the pace of inflation or more rapidly (as in the case of healthcare), our buying power has remained stagnant.

What is the result of this disparity? Well, one result was the implosion of the mortgage-backed derivatives market. Some economists posit that the productivity-wages gap allowed corporations to stockpile enormous wealth. This wealth, in turn, was translated by the Wall Street Wizards into the obscure mortgage-backed derivatives Ponzi scheme, where mortgage loans lent to people with no way to pay them back were being used as collateral for these assets. The math is simple: productivity was up, wages stagnant, consumerism rampant, cash abundant -- bingo! The nation lived beyond its means for over a decade, imaginary wealth made and lost in a blink of an eye.

What does any of this have to do with healthcare? The connection is pretty obvious to me: rapidly escalating costs in the face of stagnant wages and diminished capital. Without any changes in the trajectory of the healthcare costs even more people will be unable to afford health coverage. This simple arithmetic should not be so difficult to grasp. Closer to home, anyone who now says "Not my problem, I can still get 'everything' ", prepare for it to become your problem. Who will pay for "everything"? Without the needed cost containment, the faces of those left behind by our cruelly inequitable system will be getting more and more familiar.
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Thursday, November 12, 2009

30 poems in 30 days

Check this out! Great fundraiser idea. If you want to sponsor me, please e-mail me at Healthcareetcblog@gmail.com.

Better late than never

Just heard about this fundraiser
To support literacy education.
Seemed like a good cause to get behind,
So here I am trying to rhyme.

I am not poetically inclined,
But do indulge me in this task.
Please do not judge these sorry lines,
Just go with the flow, and do not ask

For perfect rhymes -- they will not come.
I turn a phrase in mostly prose.
In fact I write about science,
And fear that poetry will expose

My inability to rhyme,
My inclination to be free
In how I say and what I find
To be of importance to me.

This verse is done for greater good.
So please won't you support this cause!
If you so choose, why then I would
Consider ending without pause.
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Public Option: the Democrats' albatross

I have purposely held off on putting in my 2 cents on the House healthcare bill passed last weekend -- there has been enough noise about it. As the dust is settling, I am thinking this is a good time to weigh in.

The big elephant in the room is whether or not Public Option included in this version of the bill will achieve the essential goals of improved access and quality, and curbed expenditures. As I understand it, the Public Option is meant to make coverage available to a larger swath of the US population than who is covered today. It does so by qualifying people, particularly those too poor to afford private insurance yet too well-off to qualify for government-sponsored programs, and small business owners. It claims to have a lower overhead due to reduced emphasis on profit and lower administrative costs. It is also meant to contain costs by its ability to negotiate reimbursements at the point of care, though the legislation does not allow the government to pool its negotiating muscle across all of its subsidized healthcare programs (Medicare, Medicaid, CHIP). Therefore, the Public Option reimbursements are mandated to be no lower than Medicare and no higher than the average private payments.

So, the way I read the legislation, the downward cost pressure is still at the interface of the patient and the provider/intervention. So, how is this any different from what is happening today? I would argue that the private sector insurers are probably pretty aggressive at holding the providers' feet to the fire already, and so far they have been unable to contain costs. Additionally, if we look at Medicare, its expenditures have also been sky-rocketing, despite a strong negotiating position at the provider level. So, why would an additional government-funded mechanism, that is different from and weaker from negotiating standpoint than Medicare, succeed at this Sisyphean task?

The bill does provide the Department of Health and Human Services with the ability to develop and pilot new coverage and reimbursement schemes. So, down the road it is possible that the Public Option will provide a laboratory for how best to fix our perversely aligned incentives to promote better health and not schemes to maximize income. Some estimates by the CBO indicate that the Public Option for various reasons will enroll only 6 million people. In addition, while all providers who now accept Medicare will have the opportunity to be on the Public Option provider panels, they can also opt out. Taking into account the impending 21% proposed cut in Medicare reimbursements and the relatively small number of patients predicted to take advantage of the Public Option, why would providers not opt out aggressively, the way many have opted out of Medicaid patients? And while some of the remaining 40 million uninsured will now be covered under Medicaid and CHIP, too many will still be left in the crevasse of no healthcare coverage to fend for themselves.  

So, the House bill's Public Option does not seem to me to be the answer. If it is to be administered in a straight-jacket of making sure that profits in the private sector can continue to climb and patient-consumers can still operate under the misapprehension of being entitled to every touted "advance", no matter how insignificant, Public Option is a recipe for failure. I am also not sure how much attention will be paid to the output of the nascent comparative effectiveness enterprise or what statutory or political backing there may be to follow through on these data. The bill does not go nearly far enough to ensure equity in the US. It has been diluted by pandering to its vocal opponents who, while counting and recounting what is in their own purses, are content to continue a system that has created a disposable class of citizens who cannot afford healthcare. Its passage may send a short-term political message to its opponents, but its long-term failure will be an albatross around the neck of the Democratic Party for decades to come. Not to mention the travesty of continuing to abandon millions of our friends and neighbors to the whims of the profiteering healthcare marketplace.    
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The House Bill Should Be Defeated on Saturday

Here's the email I just sent my Congressman, freshman "Blue Dog" Frank Kratovil of Maryland:Please vote no this weekend on the House bill.This is not health care reform.This is at least a $1 trillion entitlement expansion paid for half with only modest provider cuts and $500 billion in taxes.Real cost containment would bend the curve and produce the savings needed to accomplish universal
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Wednesday, November 11, 2009

'Meaningful use' explained

Halloween may be over, but the quest for meaningful use goes on.



I'm told that the source of this is Pat Wise of HIMSS.
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Apply Social Health Insurance

JAKARTA, KOMPAS.com - The government should immediately start the implementation of social health insurance which covers the entire population of Indonesia. It was necessary to overcome the various problems in the health sector and accelerate the achievement of the Millennium Development Goals targets.

It was raised in the Editor's Roundtable Discussion on "Health Sector Reform" in Indonesia organized by the Center for Strategic and International Studies (CSIS), Monday (9 / 11) in Jakarta.

Law Number 40 Year 2004 on National Social Security System (Forecast) mandated social health insurance is implemented in five years.

Until now, government regulations to implement the Navigation Act had also been prepared. Instead, the Government launched the Health Insurance for Poor Families (Askeskin) which changed its name to Community Health Insurance Program (Jamkesmas) to finance the treatment of the poor.

According to the medical observer who is also former Chairman of the Executive Board of the Indonesian Doctors Association, Kartono Mohammad, Jamkesmas not insurance, but social assistance for the poor. It will not sustain (ongoing) and the state's financial burden. Therefore, insurance must be made covering the entire population of Indonesia as mandated Main Navigation.

Implementation of health insurance is expected to overcome the problem of drug prices set to remember types of insurance and drug administration by doctors audited by insurance.

Equitable distribution of health personnel and facilities is also expected to be achieved because the doctors are not paid directly by the patient, but by insurance. Insurance, supported by local government commitment in accordance with the spirit of regional autonomy, the doctor can adjust the distribution of income as well as ensuring the doctor based on the number and location of population health must be maintained.

Ori Andari Sutadji, former president director of PT Askes, declared, in the health social insurance cross-subsidies occur from participants, while the premiums of poor people covered by the state. So it could happen sustainability of health funding.

100-day program

On the same day the Minister of Health explained Sedyaningsih Endang Rahayu 100-day program in the health sector of DPR Commission IX.

One of the spotlight is Jamkesmas sustainability. A number of members of Commission IX requested that the program was immediately changed. Member of Commission IX of the PDI-P faction, Surya Chandra Surapaty, hoping the government does not continue the program and encourage Jamkesmas National Social Security System is immediately run. "Roadmap 2014 Universal Health Insurance should refer to the Forecast," he said.

Endang explained, five key issues in health development in the 100-day program, namely to increase health funding to Jamkesmas. Improving public health to accelerate the achievement of MDG targets through improving rural public health, provision of drinking water facilities, restrictions on the highest retail price of generic drugs logo. Control of disease (HIV / AIDS, malaria, and tuberculosis) and prevention of health problems due to the disaster, also increase the availability, distribution, and quality of health personnel, particularly in remote areas, left, border and island.

Meanwhile, CSIS suggested roadmap for the health sector are formulated jointly by the various elements of stakeholders, such as policy makers, academics, practitioners, analysts, economists, industry, health insurance, and associations in the health sector.

According Djisman Simanjuntak of CSIS, to provide access to quality health services and affordable, reduce infant mortality, improving maternal health and combating infectious diseases is the MDG's target and improve the Human Development Index ranked Indonesia, needs to be some policy priorities.

Some priorities include a policy shift from curative to preventive orientation and promotion, health funding shift from cash and fee for service to the health social insurance, and direct the policies and strategies towards achieving the national pharmaceutical independence, resilience, and state revenues.
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Tuesday, November 10, 2009

AMA Supports the House Democratic Health Care Bill--Take Another Look

The AMA came out in support of the House Democratic health care bill this afternoon—sort of. From their press release:“The American Medical Association (AMA) today announced support for concurrent passage of H.R. 3962 and H.R. 3961, U.S. House of Representatives health system reform bills."I would suggest the operative word is "concurrent."HR 3962 is the big House health care bill. HR 3961 is the
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Our children's future: healthcare vs. peak oil

Do you believe in peak oil? What is peak oil? Peak oil, also referred to as Hubbert's peak, is a projection, based on our historic patterns of consumption, of when the demand for oil will outstrip its supplies. The world uses about 80 million barrels of oil per day, mostly in the transportation sector. So, to keep up with this demand, at least this much oil needs to be excavated from the ground daily. In reality, even more is needed to keep some in reserves. Hubbert was a geophysicist who in the 1950s predicted that, based on the current patterns of oil consumption, we would reach peak oil sometime early in the 21st century (see graph).


How is this possible, you ask? A better question is how can it be otherwise? If you really think about it, oil is the product of the earth's development and evolution. It is an alchemy of dead organic matter and glacial and volcanic catastrophes brewed slowly over hundreds of millions of years. In this sense, oil is not a renewable resource, at least not within the human time frame. And as you can see, the curve of the production until the peak appears mostly exponential, with some stops and starts. Exponential growth, by virtue of its accelerated trajectory, is unsustainable in a closed biological system, where the production of resources cannot keep up with their consumption.

So, peak oil is not hard to imagine, given our gluttonous consumption of it. So, why is it that the international body, the International Energy Agency (IEA), responsible for forecasting our oil situation has been so reluctant to admit to the impending peak oil? Turns out, according to a report in today's Guardian, that it has been cooking its numbers because of the pressure from the US. An unnamed whistle-blower has come forth to indicate that
"...the US has played an influential role in encouraging the watchdog to underplay the rate of decline from existing oil fields while overplaying the chances of finding new reserves."
Why would the US encourage such deception? Apparently because we are worried about the implications of this revelation to the markets. So, while shouting loudly about fiscal restraint and sloganeering about the impact of universal healthcare coverage on our children's financial future, our nation, with its eyes shut tightly, has been on a collision course with a very real and close wall of peak oil. This is simply unwise.

We can make up all kinds of stories about the potential reserves. I am not sure why these stories seem more plausible to the same people that energetically deny human contribution to the climate change, except to say that we believe what is convenient for us to believe. Everything you see on the graph below beyond the real oil reserves is imaginary. But, even if it were feasible to get at these potential resources, they would be fraught with an enormous carbon footprint, not only while mining, but also when used as fuel.


And, by the way, haven't we learned our lesson about investing in imaginary assets? Is that not what our investment banks were doing with the mortgage-backed derivatives?

Come on, people, the writing is on the wall. Fossil fuels are on the brink of exhaustion. And we have more "stuff" than we can use in multiple lifetimes! Let's stop for a moment and take the toll of what we have done to the planet. Let's really consider our children's future, and their children's and theirs. In fact, perhaps we can remind ourselves of this old Iroquois philosophy:
"In every deliberation, we must consider the impact on the seventh generation... even if it requires having skin as thick as the bark of a pine."
This is our opportunity to consume less and to tell President Obama to make a real difference in Copenhagen!
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Monday, November 9, 2009

Academic Freedom and ED EHR's Down Under: An Update

At the post "Academic Freedom Curtailed?" I wrote:

The essay on Emergency Department electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney, that I referenced in my posts "The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" and "NSW Nightmare and Overuse of Computers" appears to have been censored. This apparently occurred at the level of the the government.


Professor Patrick has updated his web page that formerly contained a link to his essay on problems with EHR's in that state's EDs.

He advises:

... This document has been temporarily withdrawn by the university following a complaint from NSWHealth. I think the University has acted appropriately by investigating the complaint and I do not yet consider it an act of censorship. I am working through the issues with the University and expect that the essay will be re-published.

I would like to thank all the people who have written to me to offer support and I would encourage you to write to me if you are interested in the matter so that i can demonstrate to the university the importance of this issue to both the Australian and international communities. I do not wish for people to write to anyone else but me. I have no wish to run a public campaign and I am not available for statements to the press about this particular matter. This matter has brought to light many interesting and illuminating things that i will be happy to share in the next version of the Critical Essay.

Jon Patrick 27th October 2009 0930 Eastern Australian Summer time

He then follows up with this:

Update on the withdrawal of "Essay No.6"

It is now two weeks since the original essay was withdrawn. In that time I have been able to establish confidently that NSWHealth phoned my Head of Department and asked him to remove the article without giving a specific complaint. He refused. Subsequently a person from another faculty took up the cause and succeeded in persuading an appropriate person to order withdrawal of the essay. To this time i have not received a specific complaint let alone a written complaint. The Univeristy's Office of General Counsel has studied the essay at my request through my Dean, and found that it is "consistent with the University's Public Comment Policy". I am awaiting further investigations by the University.

Subsequently I have received many messages of support from around the world, and importantly much more information to be included in the essay. I am preparing a much enhanced version.

5th November 2009 1150 Eastern Australian Summer time

I sincerely hope this matter will be resolved in favor of dissemination of the enhanced and updated piece. I think it contains information that is quite valuable to a worldwide audience of clinicians, IT vendors and patients.

I also note that those who aim to suppress a document such as this in the age of informational computing, one product of which is the Internet, should be confined to using only the Commodore PET due to their technological and sociological ineptitude:


State-of-the-art computing for the would-be Health IT article police


-- SS
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Wednesday, November 4, 2009

Conflict of interest in healthcare research

I have been in San Diego for nearly an entire week, and am eagerly getting ready to head back to my beloved New England tomorrow after I chair my last session in the morning on the extra-pulmonary complications of critical illness. Guess what my talk is on? That's right, C diff.

A hot topic at this meeting of the American College of Chest Physicians (affectionately known as Chest) has been conflicts of interest. Yesterday I chaired and spoke at a session talking about what good collaborations look like between the Industry and Academia. Today there was a fascinating session on a related topic, which included talks from Catherine DeAngelis, the Editor-in-Chief of JAMA, as well as Richard Irwin, the Editor-in-Chief of the journal Chest, and two other speakers: Jim Roach, MD, representing the Industry point of view, and Ian Nathanson, MD, who is a part of the Chest COI working group. Although all speakers attempted to be balanced, the sum total amounted, as one would expect, to at least some Industry bashing and finger-pointing. It is interesting to me that, while people do not hesitate, appropriately, to include all fraud and result falsification, they usually conflate these into the "Evils of the Industry", regardless of the funding received by those defrauding the system. Also, what is not mentioned are the denominators of this potential relationship of fraud with manufacturers. The story is usually told thusly: 1). Look at the proportion of research funded by private vs. public funds (~85% of all clinical research, according to Dr. DeAngelis). 2). Look at the systematic reviews that indicate that Industry-sponsored trials are more likely to show results favorable to the product in question (true, but could this be because Industry-funded studies are designed with more precision? Or perhaps it is because of the nature of our regulatory process: early phase studies shed light on what can be expected, and the later phase studies merely build on that information. It is possible that our regulatory path promotes lack of equipoise, but that is a discussion for a different time). 3). Here are a bunch of case studies of fraud that we have uncovered (usually quite a few from the Industry, but also a number not funded by private dollars), 4). Therefore, the fraud is a big problem with Industry-funded work.

If I were structuring a scientific argument in this manner, I would be accused of using ecological data for hypothesis testing. The leaps of faith required are considerable. I do not wish to minimize the abominable behavior exhibited by those with a considerable monetary interest at stake, or by those that have benefitted at the trough: their lack of ethics and concern for the public has brought public cynicism and apprehension about everything we do. However, it is not OK to mitigate this terrible situation by singling out only the most visible potential culprit, made visible simply because of the volume (denominator) of work it supports. This tactic reeks of scape goating for personal gain -- so as to divert the spot light from transgressions of other stake holders, no matter how egregious.

The reason that manufacturers present an easy target is that they have in the past been unethical in so many visible cases. Another reason is that the source of the conflict of interest that exists for the Industry and investigators they fund -- money given for work that will advance the cause of the particular technology the company owns and benefits from financially --is particularly easy to identify. To be sure, we do need to deal with this source of COI carefully if we do not want to lose our credibility completely as the scientific community. At the same time, turning this process into a witch hunt is a mistake. Barring Industry scientists from presenting their work in a CME forum at professional society meetings, fro example, runs counter to the transparency mandate of authorship guidelines. Further, it denigrates the achievements of often prominent and dedicated scientists, and assumes guilt until innocence is proven.

In so many ways, this reactive stance is a response to the Congress's interest in the issue, and the mad rush to deal with it surely reflects an earnest attempt to clean our house. While I salute journals and societies for addressing this difficult issue, if some of the parties are locked out of the discussion, the attempts will look like and amount to nothing more than window dressing. Unless we are willing to overhaul completely how we do medicine in this country and take out the profit motive altogether for everyone (this is in fact my preferred solution, but given how difficult it has been to pass even the current anemic public option, universal socialized healthcare system does not stand a chance), it is critical to be inclusive and to find the most sensible and well thought-out solution to this visible violation of public trust.
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2009 a Pivotal Year in Healthcare IT

2009 is proving to be a pivotal year in healthcare IT. Recent authoritative articles and reports on health IT problems largely validate the issues presented at this blog and others focusing on health IT issues, and at my academic website on HIT difficulties started over a decade ago, in 1998, freely available to the industry.

These articles and reports have ultimately led to a U.S. Senate investigation of the healthcare IT industry initiated in Oct. 2009 (link below).

2009 may be the year that healthcare IT vendors will finally begin to understand that not lending credence to decades of teachings from Medical Informatics professionals on healthcare IT design, implementation, lifecycle support, involvement of end users, and sales and marketing has been harmful to their businesses and to their investors. Instead, the commercial health IT companies took a simplistic management information systems-based approach to building medical devices in an incomparably complex environment they did not -- or did not care to – understand.

These devices are, in fact, virtual medical devices that happen to reside on a computer, not business computing systems that happen to be used by clinicians. These medical devices are soon to undergo regulation as such in the EU (pdf report from the Swedish Medical Products Agency here), Canada, the U.S. and other countries as well.

The teachings of Medical Informatics about such devices have been documented in the extensive literature of Medical Informatics. For example, the book “A History of Medical Informatics in the United States, 1950 to 1990” by informatics pioneer Morris F. Collen (published in 1995) explicitly demonstrates the progression of the field and the wisdom of the pioneers dating back to the 1950’s, as in the bons mots here.

The 2009 articles and reports below demonstrate numerous undesirable outcomes of the management information systems approach to development and implementation of virtual clinical devices:

  • The Joint Commission’s “Sentinel Event Alert on Healthcare IT” is here.
  • The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient" and link to a full report on an investigation of healthcare IT lack of progress is here.
  • The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.
  • The Washington Post’s article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is here.
  • Hoffman and Podgurski’s paper from Case Western entitled “e-Health Hazards: Provider Liability and Electronic Health Record Systems” on EHR medical and legal risks is here.
  • My commentary on the May 2009 AMIA workshop report on healthcare IT failure with free PDF is available here.
  • My commentary on a sentinel Mar. 2009 JAMA article by University of Pennsylvania researchers Ross Koppel and David KredaHealth Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians” on unsafe contract terms demanded by healthcare IT, and the violations of Joint Commission safety standards and fiduciary responsibilities committed by hospital governance personnel who agree to such terms, is here.
  • A link to the Oct. 25, 2009 Washington Post article “Electronic medical records not seen as a cure-all” and my commentary are here.

Finally, and perhaps most importantly, the Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices is here (PDF).

I have used this medieval illustration in a prior post on these pages, but sadly in this case it is probably even more highly appropriate:


"Margaritas ante Porcos" - click to enlarge


Not to be gratuitously impolite, but hard truths are often an unpleasant medicine, especially when ignoring those truths results in adverse consequences to patients and their caregivers.

-- SS

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Tuesday, November 3, 2009

Human Need for Amino Acids

Amino acids are simple organic compounds made of carbon, hydrogen, oxygen, nitrogen, and, in a few cases, sulfur. Amino acids join together to form protein molecules, the basic building blocks of all living things. Amino acids can vary widely. Only about 20 amino acids are common in humans and animals, with 2 additional ones present in a few animal species. There are over 100 lesser known amino acids found in other living organisms, particularly plants. The first few amino acids were discovered in the early 1800s. Although scientists determined that amino acids were unique compounds, they were unsure of their exact significance. Scientists did not understand their importance in the formation of proteins—chemical compounds responsible for the structure and function of all cells—until the first part of the twentieth century.

An important characteristic of amino acids is their ability to join together in chains. The chains may contain as few as 2 or as many as 3,000 amino acid units. Amino acids become proteins when 50 or more are bonded together in a chain. All the millions of different proteins in living things are formed by the bonding of only 20 amino acids. Like the 26 letters of the alphabet that join together to form different words, the 20 amino acids join together in different combinations and sequences to form a large variety of proteins. But whereas most words are formed by about 10 or fewer letters, proteins are formed by 50 to more than 3,000 amino acids. Because each amino acid can be used many times along the chain and because there are no restrictions on the length of the chain, the number of possible combinations for the formation of protein is truly enormous. The order of amino acids in the chain, however, is extremely important. Just as not all combinations of letters make sense, not all combinations of amino acids make functioning proteins. Some amino acid combinations can cause serious problems. Sickle-cell anemia is a serious, sometimes fatal disease caused by a single amino acid being replaced by a different one at the sixth position from the end of the protein chain in the hemoglobin molecule, the oxygen-carrying particle in red blood cells.

The 20 amino acids required by humans for making protein are necessary for the growth and repair of tissue, red blood cells, enzymes, and other materials in the body. Twelve of these amino acids, called non-essential amino acids, can be made within the body. The other eight, called the essential amino acids, cannot be made by the body and must be obtained from the diet. Proteins from animal sources—meat, eggs, milk, cheese—contain all the essential amino acids. Except for soybeans, vegetable proteins do not have all the essential amino acids. Combinations of different vegetables, however, form a complete source of essential amino acids.
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Blood Supply and Diseases

Blood supply refers to the blood resources in blood banks and hospitals that are available for use by the health care community. The blood supply consists of donated blood units (in pints) that are used in blood transfusions. A blood transfusion is a procedure whereby blood is administered through a needle into the vein of a person or animal. Such transfusions are usually performed in order to replace blood lost due to injury or surgery. Blood banks are institutions that store blood to be distributed to local hospitals and medical centers. There are a number of blood banks in every country of the world. Together they contain most of the nation's supply of donated blood. Many blood banks are run by the Red Cross, an organization that also conducts frequent blood drives throughout the world. In fact, the American Red Cross gathers half the blood used in the United States. The blood supply must be replenished constantly to meet the needs of hospitals and trauma units as well as to replace blood components that have a short shelf life.

Donation of blood by volunteers is critical in maintaining the supply of blood in blood banks. Beginning in the late 1990s, blood donations in the United States began to increase by 2 to 3 percent per year. But at the same time, the demand for blood increased by 6 to 8 percent. In 2000, about 13 million units of blood were used in the United States. Blood is collected from a donor by inserting a needle attached to a thin plastic tube into a vein of the arm. Blood flows through the tube and into a sterile plastic bag. The body of an average adult human contains approximately 6 quarts (5.6 micro liters) of blood, and the removal of one pint usually has little effect (although some people—especially those with low body weights—may experience temporary dizziness, nausea, or headache). Healthy donors can make blood donations about every eight weeks without causing harm to their bodies.

The collected blood of the donor is tested for hepatitis (a disease of the liver), syphilis (an STD, or sexually transmitted disease), human immunodeficiency virus (HIV; the virus believed to cause AIDS), and related viruses. It is also classified according to blood type and the presence of Rh, or Rhesus, factor. (Blood types are A, B, AB, and O. Rhesus factor is a substance, called an antigen, in the blood of most people.) It is extremely important that blood be marked correctly. Patients receiving donated blood that is incompatible with their own may suffer serious reactions to it. After being collected and classified, whole donated blood is refrigerated.

Most donated blood is separated into its components—plasma, red blood cells, white blood cells, and platelets—before being stored. This allows the blood of a single donor to be used for several patients who have different needs. Blood is separated by means of centrifugation, a process in which the blood is rapidly spun so that the heavier blood cells and platelets separate out from the lighter plasma. Plasma, the liquid part of blood, can be dried into a powder or frozen. Fresh frozen plasma and freeze-dried preparations containing clotting factors are used to treat patients with hemophilia. Hemophilia is an inherited disorder in which certain clotting factors are missing in the blood, resulting in excessive bleeding. Concentrated red blood cells are used to transfuse patients with anemia, a condition in which the blood contains an insufficient number of red blood cells. White blood cells and platelets are used for transfusions in patients who have a deficiency of these components in their blood.

When AIDS (acquired immunodeficiency syndrome) began to appear in hemophiliacs and surgical patients in the early 1980s, it was determined that these patients had contracted the disease through donated blood. In 1985, a test was developed to detect HIV—the virus believed to cause AIDS—in blood. Donors are now carefully screened to eliminate any who may be at risk for carrying the AIDS virus. Although the risk of contracting HIV from blood transfusions is remote, some patients who are scheduled to undergo surgery may choose to donate their own blood beforehand, in case a transfusion is necessary. It is important to know that a blood donor cannot contract AIDS or any other disease by donating blood. The equipment used to collect donated blood is used only once and then discarded. The restrictions on who can donate blood have been expanding steadily to reduce the risk of introducing infections into blood supplies. Almost all countries run a number of diagnostic tests to screen for viruses and other contaminants before shipping blood. Once-rare procedures, like stripping out white blood cells from donated blood to reduce the side effects from transfusions, is now commonplace.
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Chlorine Filter Shower Head - Reducing The Risk Of Some Serious Diseases

Chlorine filter shower head - sounds like a contradictory in terms doesn't it. After all, we have all been told that chlorination is vital to kill microbiological matter - without it, bacteria would run wild in drinking water causing serious gastrointestinal illnesses or even death.

However, as important as chlorination is, many do not realize how damaging it can be to their health.

Chlorine Health Effects - Asthma

Did you know that asthma, is one of the most common reason for Absence from school? Did you know that the U.S. swimming team has a disproportionately higher level of asthma suffers when compared to other teams within the overall U.S Olympic team.

What is the connection - you got it - chlorine. Chlorine worsens the condition of current asthma sufferers and increases the risk of getting asthma.

Whether you drink it via a glass of water or inhale it when you have a hot shower, chlorinated water can affect you.

More Health Effects - Cancer

When chlorinated water interacts with organic matter like hair, skin, urine etc - it forms disinfectant by products which scientists claim can cause cancer.

Don't think you are off the hook if you drink bottled water. You take showers don't you? Chlorine can seep through the skin or can be inhaled when it turns to steam in a hot shower.

Some scientist claim inhaling chlorine is more dangerous than drinking it via a glass of water. As a matter of fact, the EPA found that there are elevated amounts of chloroform in almost every American household due to the use of chlorinated water.

Therefore, it is vital to do what you can to lower the level of chlorine in your home.

Chlorine Filter Shower Head

This is one of the devices that can remove virtually 100% of chlorine from your shower water. It is easy to install and inexpensive.

Apart from the health effects, bathing in chlorine-free water leaves the skin and hair more radiant than bathing in regular tap water. This is because chlorine tends to dry out hair and skin.

What You Need To Do Now

Look for reputable suppliers of chlorine shower head filters. Reputable suppliers tends to sell certified filter units.

Certified devices have been tested and are guaranteed to remove contaminants of a certain class. Fort example, some certified filters can remove chlorine and sediment only others can remove a wider variety of contaminants
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Foods To Eat When Pregnant: Do You Know Your Pregnancy Nutrients?

We have all heard the cliché "you are what you eat", and like most clichés there is an element of truth in it. If you eat healthy nutritious foods then you will be healthy and full of energy. Eat unhealthy foods and the opposite applies. It's pretty simple really. This also applies to the pregnant mother when she is considering the health of her unborn child and the best foods to eat when pregnant. When she decides to eat healthy wholesome foods that are packed full of all the essential vitamins, minerals, proteins, carbohydrates and fats, she is already giving her unborn baby the fantastic start in life that it requires. It's important for expectant mother's to realise the implications of not following a proper pregnancy nutrition plan: low birth weight, birth defects, miscarriage and mortality.

So what are proteins? Proteins are known as the building blocks of life in that they are essential for cell wall development and cell repair. Basically you need proteins for the development of all the vital organs like the heart, lungs and kidneys, as well as muscle and tissue growth. Proteins cannot be stored in the body, so it's important to consume adequate amounts every day for the baby. Recommended daily intake is approximately 60 grams. Good sources of protein include lean meats such as chicken, turkey and fish, as well as pork, beef and lamb. There's also a wide variety of dairy products that you can choose from, including pasteurised cottage cheese, yogurt and hard cheeses. Of course, you should avoid uncooked eggs, soft cheeses made from unpasteurized milk like brie and feta, and blue veined cheeses which may harbour dangerous bacteria.

Calcium is essential for foetal development of bones and teeth, helps nerves and muscle formation and helps prevent blood clots. You will need about 1000mg/day while pregnant. It's very important to ensure that you are getting adequate levels during pregnancy, not just for the baby's health but also for the mother's health, as a lack of calcium during pregnancy can lead to osteoporosis for the mother later in life. Recommended foods to eat when pregnant that contain calcium include pasteurised dairy products like milk, yogurts and hard cheeses, dark green leafy vegetables and calcium-fortified foods like cereals and breads. If for some reason you have trouble getting the calcium that you require in your diet, your doctor can prescribe a pre-natal supplement.

Healthy fats are another important dietary element during pregnancy. Nut oils, olive oil, or avocados are good choices. Avoid trans-fats and aim for three servings of healthy fat each day. Trans-fats inhibit the conversion of fatty acids needed for foetal brain development and decrease the fat content of breast milk. It's not good for you and not good for your baby. If the food label includes the words "partially hydrogenated" in it, it means it has trans-fats in it and is to be avoided.

There are a variety of essential vitamins required by the developing foetus. Both vitamin A and D helps with foetal bone and teeth development, and can be sourced from milk, carrots, eggs and green vegetables. Vitamin E helps in the formation of red blood cells and can be found in vegetable oil, wheat germ and nuts, while vitamin C assists in building a healthy immune system and can be found in citrus fruits, green beans, potatoes and tomatoes.

Getting to know the right foods to eat when pregnant is the responsibility of every expectant mother. For the health of your unborn child, do it today.
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The Neutered Public Option—Where’s the Rage?

The public option contained in the House Democratic health care bill is hardly more than a neutered version of the “robust” public option one House Democrat after another said was a minimum requirement to keep their vote on health care reform. After threatening for months to fall on their swords if they didn’t get the “robust Medicare-like” version, there was nothing but enthusiastic support for
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Monday, November 2, 2009

Did a Yakuza Boss Pay "A Million Dollars for One Liver?"

One of the more bizarre stories to appear on Health Care Renewal just resurfaced.  To summarize, in June, 2008, we posted about the strange case of four Japanese men, allegedly affiliated with Yakuza criminal organizations, who received liver transplants from the UCLA Medical Center, apparently with some alacrity. All likely paid full list prices for their procedures, and two later donated $100,000 each to the medical center. The case raised concerns by several notables (including Senator Charles Grassley, and Professor Arthur Caplan) about the integrity of the transplant system. Presumably these concerns were based on suspicions that the four may have received a higher priority than others on the list. More concerns should have been raised after it was revealed that shadowy characters threatened a reporter who started to investigate the case in Japan, and the reporter's family (see post here).  Later, the Chancellor for Medical Sciences and Dean of the David Geffen School of Medicine's public response to the case side-stepped all the important concerns while deploying a series of logical fallacies (see post here).

Then, despite all the colorful details and ethical concerns presented by this story, it faded from view for a year and a half. 

Last night, the US investigative reporting television show "60 Minutes" aired a follow-up on the Yakuza transplants, following closely on the publication of a book, Tokyo Vice, by Jake Adelstein, the reporter who first broke the story.

The web-based version of the 60 Minutes story reprised the main points, but added emphasis to a few of interest to Health Care Renewal. 

First, the 60 Minutes piece raised suspicions that the Yakuza members paid a premium to jump the UCLA liver transplant priority list:
Getting into the U.S. was one thing, but getting a liver transplant at a leading American medical center like UCLA was something else altogether.

'What's the average waiting time for someone in California waiting for a liver transplant?' [CBS correspondent Lara] Logan asked California attorney Larry Eisenberg.

'It's probably realistically three years. And it could be much longer,' he replied.

Not for Tadamasa Goto, who got a liver in just six weeks. Eisenberg finds that surprising, especially since Goto was number 80 on the waiting list.

'It should not be possible that an unsavory character from out of the country, with ties to organized crime, comes into the United States and gets a priority and obtains a transplant,' Eisenberg said.

Two families, Eisenberg's clients, both lost loved ones waiting for livers at another transplant center in the same area: Salvador Ceja was number two on the waiting list; John Rader was number five.

'Do you think, for one second, that this was legitimate? That they stood in line and waited just like your husband did?' Logan asked Rader's widow Cheryl.

'Absolutely not,' she replied. 'No. Because nobody gets a liver that quickly.'

'I think they were playing God,' Yolanda Carballo, Ceja's stepdaughter, added. 'Now, I think they were picking and choosing who they wanted to give a liver to.'

'So, in your minds, what was this about?' Logan asked.

'Money,' Rader said. 'Spoke loud and clear. And they listened.'

'That's what it was all about. Money,' Carballo agreed.

Three of Goto's Yakuza cronies also got liver transplants at UCLA. For them, money was no object. UCLA says each of their transplants cost about $400,000 dollars; the Yakuza all paid cash.


The hospital also acknowledged Goto and another Yakuza each made $100,000 donations to the transplant center.


Adelstein says Goto paid even more. 'According to police documents and sources, a million dollars for Goto. A million dollars,' he told Logan.

'A million dollars for one liver?' she asked.

'A million dollars for one liver,' Adelstein said.

Second, 60 Minutes emphasized the risk Mr Adelstein faced after he drew attention to the story of the Yakuza liver transplants at UCLA:
Tadamasa Goto returned to his life of crime as a Yakuza godfather and it all stayed hidden until Adelstein was tipped off. It took him years to piece together the details for a newspaper story. Then, when word got out that Adelstein knew, the Yakuza tried to buy his silence, offering him half a million dollars.

Asked if he was tempted by the cash offer, Adelstein said, 'Of course I'm tempted. You know? When someone offers you half a million dollars not to write something, but then again, you know I don't want to be owned by organized crime the rest of my life.'

Adelstein wrote the story for 'The Washington Post' and it eventually made its way back to Japan. The news infuriated the Yakuza bosses. For Goto, it was a humiliating blow from which he would never recover.

'I heard from someone very close to him that as he was leaving and getting in his car he said, 'That goddamn American Jew reporter, I wanna kill him,'' Adelstein said.

Japanese and U.S. law enforcement agents took Goto's threat seriously.

Adelstein now lives alone, under Tokyo police protection; his wife and children are in hiding.

'Are you concerned that there is an American citizen here whose life is at risk?' Logan asked the U.S. Embassy's Mike Cox.

'Very much so. I mean, we think the Japanese police are doing what they can to make sure that no harm comes to Mr. Adelstein. I mean, we certainly don't want to see anything happen to him,' Cox said.

'What do you have to do in your daily life to stay alive?' Logan asked Adelstein.

'You have to keep your rooms shuttered, because you don't want a sniper to pick you off across from somebody’s house,' he said.

Asked if he lives in darkness, Adelstein said, 'When I'm up in my room typing, yes. All the rooms are shuttered. You gotta be very careful on rainy days. Because when Yakuza take people out, they like to do it on rainy days, because fewer people are on the streets and the rain washes away trace evidence.'

Even in disgrace, Tadamasa Goto still has a small army of loyal soldiers and a hit out on Jake Adelstein. The Yakuza say he will never be safe.

'When someone does something that causes them (Yakuza) to lose face, they will use any means possible, legal or illegal, to crush the person who has gotten in their way, who has humiliated them,' the disguised Yakuza boss told Logan.

Finally, 60 Minutes found that the UCLA Medical Center continued to be uncooperative, cloaking its refusal to categorically refute allegations that it sold a liver for a million dollars in concerns with patient confidentiality:
Asked if UCLA knew who these people were, Adelstein said, 'When you see guys with lots of tattoos, missing fingers, wouldn't it occur to you, like, 'Oh, this guy is a gangster.' I can't believe they didn't know.'

Attorney Eisenberg says transplant rules require extensive background checks on every patient. Yet, UCLA insisted to federal investigators they had 'no knowledge' that Goto or his cronies had ties to Japanese organized crime.

UCLA declined all of 60 Minutes' requests for interviews. The only thing the medical center will say on the record is that their program has been reviewed and found to be in 'total compliance' with liver transplant rules.

The hospital told us, 'state and federal patient confidentiality laws prohibit UCLA from responding to the…issues raised by 60 Minutes.'

'In my opinion, the medical center has a moral and ethical obligation to determine the source of those funds,' Eisenberg said.

'A moral and ethical obligation, but apparently no legal obligation?' Logan asked.

'Well, it's not addressed in the rules specifically,' Eisenberg said

As I wrote in my first post on this case, you just can't make this stuff up...

However, the colorfulness of the case should not distract from its very serious implications.  We have written a lot in this blog about the anechoic effect, how cases with important implications about ethics, governance and leadership in health care often fail to attract the attention they deserve.  We have opined that academics and professionals have realized that it is simply "not done" to discuss cases which might offend the powerful leaders of health care organizations.  We have written about whistle-blowers who have lost jobs or been theatened with lawsuits.  But in this case, the journalist who wrote about the case allegedly has received death threats and lives in hiding under police protection.  This may be the most serious case of the anechoic effect known.

Furthermore, we have written a lot in this blog about how leaders of health care organizations ought to uphold their organizations' mission and the core values to which physicians and other health care professionals have sworn devotion.  The continued disinclination of UCLA leadership to respond to charges that its medical center accepted $1 million to put Japanese gangsters at the head of the liver transplant list may reflect fear of gangsters who also allegedly threatened the life of the journalist who reported the case.  But by failing to rebut such charges, the leadership leaves the impression that they cannot claim to be better than the moral equivalents of gangsters.  Institutions that aspire to join "the ranks of the nations [sic] elite medical schools" ought also to aspire to have leaders that have better ethics than Yakuza bosses.  

Transparency International has suggested that health care corruption is a global scourge that costs lives.  Serious health care reform cannot ignore health care corruption as a cause of excess costs, denied access, and poor quality.  Health care organizations ought to be held to a higher standard of ethics, and be less prone to corruption than, for example, garbage hauling firms.  Health care organizations ought to subscribe to rigorous codes of ethics, impartially enforced, which apply to all within the organizations, including top leaders.  While the accused need to be afforded due process, whistle-blowers must also be protected.  In my humble opinion, true health care reform requires so confronting health care corruption.  Maybe the leadership of the Gefen School of Medicine might want to consider setting an example in this regard. 

Note: Jake Adelstein's book is available here, and it was reviewed by Reuters here and by the AP (via the Canadian Press) here.
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A Bridge in Brooklyn and an Electronic Medical Records Bargain: Only One Hundred Nineteen Million Dollars Per User - Tolls Included

One of the favorite debates people involved in IT seem to like to have is over the meaning of "failure" of IT projects.

Merriam-Webster dictionary:

Main Entry: fail·ure
Pronunciation: \ˈfāl-yər\
Function: noun
Etymology: alteration of earlier failer, from Anglo-French, from Old French faillir to fail
Date: 1643

1 a : omission of occurrence or performance; specifically : a failing to perform a duty or expected action b (1) : a state of inability to perform a normal function <kidney failure> — compare heart failure (2) : an abrupt cessation of normal functioning c : a fracturing or giving way under stress
2 a : lack of success b : a failing in business : bankruptcy
3 a : a falling short : deficiency b : deterioration, decay
4 : one that has failed


The UK House of Commons Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

Only the most stubborn would argue that this case and the latest data is not representative of a "failure" in the truest sense of that word:


Only 175 people using flagship NHS software, says minister

Lorenzo care records system is likely to be costing taxpayer hundreds of thousands of pounds per user per year

Written by Tom Young

There are only 174 clinicians using Lorenzo patient software across the five early adopter trusts, according to Mike O'Brien, minister for the National Programme for IT (NPfIT).

Five Boroughs Partnership, Bradford Teaching Hospitals NHS Foundation Trust, University Hospitals of Morecambe Bay, Hereford Hospitals and South Birmingham have only ever had 19 clinicians using the systems at the same time.

Lorenzo is one of two software packages being used to set up centralised electronic health records as part of the £12.7bn National Programme for IT. This part of the programme is already running four years late.

Lorenzo is being supplied by services company CSC to trusts in the north of England and by its developer iSoft directly to trusts in the south after Fujitsu was fired from the programme.

The other patient software package is Cerner Millennium, being supplied by BT in London and a handful of trusts in the south.


By Google:

£12,700,000,000 = USD $20,770,850,000

By my calculations, that works out to:

£72,571,429 or USD $118,690,571 per user of this software.

While a somewhat satirical and sardonic calculation, that's about 73 million pounds or 119 million dollars per user, after almost a decade of work.

What more can be said than "stunning?"

The information came from a parliamentary question tabled by Richard Bacon MP.

Last week in the Commons he said:

"I tabled a question yesterday about the number of hospital trusts where Lorenzo has been partially deployed, asking how many users — how many concurrent users — of Lorenzo there are.

"It is literally just a handful, which means that the cost per user is not what one would expect… the cost is going to be many hundreds of thousands — possibly even more than a million — pounds per user per year."

Bacon said there has not been a single deployment of Lorenzo in 2009 because these early adopter trusts were having such problems.

"The reason is that the handful of deployments attempted have been an absolute mess, causing chaos in the hospitals where they were tried," he said.


Operations of entire hospitals were disrupted by software. This represents unconsented IT experiments on human subjects gone massively awry. Whether the "chaos" caused anyone harm seems never to be stated.


Deployments of Cerner Millennium have also caused problems, with St Barts in London now facing fines of £400,000 a month for missing patient care targets as a result of problems with the system.

Bacon also points out that the recently signed contracts with BT to deploy Cerner Millennium at hospitals in the south require BT to be paid even if the hospitals refuse the systems – a possibility if they think they will not work.


I would suggest someone in the UK provide screen shots and/or a YouTube video of these systems in operation so others can understand how such results can occur. (Oh, wait: the vendor contracts probably prohibit that, the hospital executives having signed such contracts also having signed away their fiduciary responsibilities to patients and clinicians.)


... Junior Treasury minister Sarah McCarthy-Fry defended The NPfIT in the debate.

She said: "We all acknowledge that the NHS IT project is hugely ambitious [profoundly overambitious would perhaps be more accurate - ed.] and that it is essential that we get it right. [The Minister appears to be a master of the obvious - ed.] It is obvious to everybody that many challenges remain.

"We still believe that Cerner Millennium and Lorenzo will be able to support the NHS in the long term."


Right.

I have a bridge in Brooklyn, NY for sale. Perhaps the UK teams responsible for this debacle would be interested. After all, the cost per user of the bridge would be remarkably low, far less than USD $118 million - and the users could even be made to pay a toll for each use:



For sale: a bridge in Brooklyn.


Perhaps in our own U.S. national health IT initiative, we'll come in at a lower cost per user than $118,690,571 - perhaps about $118,690,570.99 ?

After all, those Medical Informatics specialists act like know-it-alls about healthcare IT, and since domain-specific education and expertise are irrelevant in healthcare management, why should anyone listen to them?

-- SS
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Saturday, October 31, 2009

The BIL:PIL unconference: Challenges and opportunities

Yesterday and today I have been privileged to attend the BIL:PIL "unconference" in San Diego, organized by Jonathan Sheffi and colleagues. Yesterday was awesome with amazing speakers and brilliant ideas. For someone who is used to hard data presentations to and from physicians and scientists, it is great to get out of that silo and see what the rest of the world is thinking about the challenging state of healthcare. Some of the speakers dazzled us with new more efficient approaches to drug development, while others took us on futuristic voyages of the brain's dark matter, artificial intelligence and the promise of stem cells. I cannot wait to hear today's presentations -- tickles my brain just to think of all the new stuff I am learning! It is also neat to meet and rub elbows with such luminaries as Val Jones (speaking today at noon PST) and Gregg Masters, who are not just smart and eloquent, but also really delightful people.

Today I get to give my "untalk". Just by way of a preview, very little of what I will be talking about is new. In fact, when I was putting it together, I tried to look up the antonym of "innovation". Guess what? There is not one in the English language. So, I will have to call myself something else, since, though creative, I certainly do not rise to the ranks of the brilliant innovators I stand beside. At the same time, I believe my approach will bring something valuable to the table. Perhaps I need to come up with an adequate moniker that describes my philosophy. Wait, I think I've got it! But I think I'll wait to unveil it during my talk. It is at 3:00 PM PST and you can see the live stream here. See you at BIL:PIL!
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