More Documents About the Selling of Seroquel Show How Research Was "Subordinated to Commercial Goals"

We posted earlier this year about how documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). A new crop of documents has just been released, providing yet more insights, as reported by the St Petersburg (Florida) Times:

Behind the scenes at the global pharmaceutical company AstraZeneca, the team in charge of the blockbuster antipsychotic Seroquel had one mission: make the multibillion-dollar seller even bigger.

To that end, internal company documents released Wednesday show how the British drugmaker hid unfavorable study results, promoted unapproved uses and even considered pitching the drug as less likely to lead to suicidal thinking than competitors'.

In particular,

Documents suggest Seroquel studies were repeatedly subordinated to commercial goals.

When a study in 2002 failed to show that Seroquel's sustained release formula was any more effective than a placebo in treating schizophrenia, orders from the top were to keep the results 'in strictest confidence.'

When a scientist in England wanted to study the weight gain in rats on Seroquel, AstraZeneca declined to fund the research, saying 'we could wind up with results that are not clearly advantageous.'

In one discussion, it was suggested that authors of potentially helpful research reports who raised too many questions, slowing publication, should be asked to step down.

A researcher who pressed for results of an unfavorable trial was rebuffed for weeks before being given 'three or four sentences describing high-level results.'

AstraZeneca marketers were jealous of what they saw as competitor Lilly's ability to cast questionable study results in a positive light. 'They (Lilly) are able to spin the same data in many different ways through an effective publications team,' according to a 2003 memo. 'Negative data usually remains well hidden.'

As Seroquel's sales soared, documents reflect an ongoing struggle between the safety and marketing teams over the potentially damaging issue of weight gain. In 2000, the company's scientists said data did not support the marketing claim that Seroquel resulted in only 'limited' weight gain. Close to 23 percent of the people who took the drug gained more than 7 percent.

Despite the safety team's objections, the word 'limited' remained on Seroquel's label for two more years.

This is a reminder how beleaguered we advocates of evidence-based health care (EBHC) have become. The idea of EBHC was that health care decisions for individual patients, and policies for groups of patients ought to be guided by critical review of the best available evidence from clinical research, guided by knowledge of biology and the biopsychosocial context of health, and informed by patients' values and preferences. The idea still makes sense to me, but it only works if physicians, patients and policy-makers have access to an unbiased sample of clinical research studies, so that studies with are not selectively suppressed to support vested interests. Although critical review can account for inevitable trade-offs, compromises, and errors in how studies are designed, implemented, and analyzed, the clinical epidemiological methods it uses are really not designed to root out falsehoods and deliberate deception.

However, the ongoing story of Seroquel, and many other cases discussed on Health Care Renewal suggest that when clinical research is sponsored by those who can profit from the product or service it evaluates, that research is prone to suppression and manipulation. Although I believe there are many honest scientists who work for pharmaceutical, biotechnology, device, health information technology and other health care corporations, it seems they often have to answer to marketers whose only goal is to sell more product.

As long as clinical research is sponsored and run by the people who can profit directly from selling the products and services the research is meant to evaluate, the ideal of evidence-based health care becomes less attainable.

As we have said before, suppression and manipulation of research amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care.

Furthermore, suppression and manipulation of research can deceive physicians into prescribing tests and treatments that will fail to help, or even harm patients, and deceive patients into thinking that they are getting the best possible tests and treatments, when, again what they are getting is ineffective or even harmful.

In my humble opinion, there is an increasingly strong argument that clinical research should not be controlled, and probably should not be done at all by organizations with vested interests in the research producing results favorable to their products.

Sanofi-Aventis Settles

Here is another addition to the parade of multi-million dollar legal settlements by health care corporations. As reported by the AP:

Drugmaker Sanofi-Aventis has agreed to pay nearly $100 million to settle allegations it cheated Medicaid on the cost of nasal sprays.

The Justice Department said Aventis Pharmaceutical Inc., a wholly owned subsidiary of Sanofi-Aventis U.S. LLC, has agreed to pay the government $95.5 million to settle the charges.

The government charged that between 1995 and 2000, Aventis and its corporate predecessors did not offer Medicaid the best prices for the sprays Azmacort, Nasacort and Nasacort AQ.

In reaching the settlement, Sanofi-Aventis U.S. did not admit any wrongdoing. The company, based in Bridgewater, N.J., issued a statement saying it believed the old pricing system was legal.

Under the law, the company was required to tell Medicaid the lowest price that it charged companies for those products, and offer state Medicaid programs rebates based on those prices.

Prosecutors contend that in order to dodge that obligation, Aventis entered into a private deal with the HMO Kaiser Permanente that repackaged Aventis drugs under a new label, allowing them to overcharge Medicaid programs for the same product.

It seems that scarcely a week goes by without a settlement of charges of unethical behavior by some major health care organization. The ongoing parade of such cases ought to inspire some worry about the ethics of the leaders of such organization. Given the current very public discussion of how expensive health care has become, one would think that there would be some discussion of how much of this expense is due to various kinds of deceptive and unethical behavior by some of the biggest, richest, and most powerful health care organizations. But perhaps that would be too upsetting for those who make so much money running these organizations.

As we have said before, most recently here, while human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a fine. In this case, the fine was, in corporate terms, of modest size. However, even a large fine, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board, dispersing the cost to all employees. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.

ADDENDUM (2 June, 2009) - See these comments on the Effect Measure blog.

Canadian Health IT Ripoff ... Is Anyone in the U.S. Paying Attention?

In my Feb. 18, 2009 Wall Street Journal letter to the editor I wrote:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Regarding my fears about waste and about the identity of the true beneficiaries, this in from the Toronto Sun in Canada:

eHealth making critics sick

Opposition wants 'walking papers' issued to minister, CEO over questionable expenditures

By Antonella Artuso, QUEEN'S PARK BUREAU CHIEF

29th May 2009

eNough, government critics say.

Opposition parties at Queen's Park are calling for heads to roll after the newest revelations of eye-popping expenditures at eHealth Ontario -- the taxpayer-funded agency established to produce electronic medical records for every citizen in the province.

One consultant with a four-month contract worth $210,600 billed taxpayers for items as small as her $1.57 Tim Hortons tea, her BBQ chicken sub, a $2.98 soup, and her muffins and pops, as well as travel to and from Alberta, and a $2,820-a-month apartment in Toronto.

Even Premier Dalton McGuinty is struggling to understand the spending and has said that he welcomes the results of an ongoing investigation of the agency by the auditor general.

... Freedom of Information documents obtained by the Progressive Conservatives have revealed that eHealth Ontario CEO Sarah Kramer approved nearly $5 million in contracts that weren't put out for a competitive bid.

Sun Media has learned that one consultant charged taxpayers $300 an hour to consult with her husband -- who also had a consulting contract with eHealth Ontario.

Taxpayers paid $7,000 to a consultant to write Kramer's speech to Health Active 2008, and hundreds of dollars more to update her biography.

Even the official spokesman for eHealth was a consultant who charged $1,600 a day to provide communications advice and talk to media, billing $33,200 for 20.75 days work in March alone.

Questions were also raised in the legislature about consultants who billed the Ontario taxpayer to read The New York Times, talk on the subway and watch TV.

On top of that, Kramer received a $114,000 bonus within months of beginning her $380,000-a-year position.

eHealth Ontario and its predecessor agency have spent $146 million on consultants since 2003, despite commitments to reign in billings for outside expertise, and overall agency spending has ballooned to $839 million.

Other provinces are ahead of Ontario in producing records although so far they have spent less money.

... During Question Period, Runciman called on the premier to give Kramer and Caplan their "walking papers."

I stand by my Wall Street Journal letter, to the letter.

The Toronto Sun article concluded with this:

NDP MPP France Gelinas also called for heads to roll, saying eHealth Ontario and its predecessor agency have produced next to nothing for more than three-quarters of a billion dollars.

I reiterate, I hope patients in the U.S. actually get something for the $20+ billion we're about to spend to force health IT down doctors' throats.

-- SS

Harvard's EMR Justification: We Just Have To Do Something?

I think what I termed "irrational exuberance" over health IT is now devolving into just simple irrationality.

I am unfamiliar with the reasoning employed below (in boldface) by the Harvard researcher, Ashish Jha, MD, MPH (who authored the April 2009 EHR usage survey "Use of Electronic Health Records in U.S. Hospitals" in the NEJM).

From "Cash for Computers", HealthLeaders Media, May 11, 2009. First, my opinions:

... "This forced timeline [by 2014] is a very bad thing. I'm concerned it is going to take an experimental technology and turn it into a train wreck," Silverstein [me - ed.] says. "We need a more gradual process where we can learn from mistakes on a small scale to avoid reproducing them on a large scale ... So now, Silverstein says, healthcare providers are caught between their mission to provide quality care and the financial pressure to install an unproven technology that may threaten the mission.

"Health IT, when it's done correctly, can improve healthcare and reduce costs. But health IT when it is not done well has the exact reverse potential," Silverstein says. "It can impair healthcare, decrease quality, and create other adverse effects for patients. That is the missing element in this discussion."

Then, Jha's:

A need to act

Others aren't so pessimistic. Jha [Ashish Jha, MD, MPH, the lead author of the survey, and an associate professor of health policy and management at Harvard] says hospitals will have five years to establish EHR before federal penalties kick in. And because it involves the federal government, Jha says it's more than likely that those deadlines will get pushed back even further [not according to ONC chair and fellow Harvard professor David Blumenthal, who as I noted in this post said HIT timelines were "cemented in law" - ed.]

Jha says critics are "missing the point."

"I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records."

$20+ billion and penalties upon already squeezed practitioners and hospitals for non-adoption of expensive, experimental technology is a lot of "doing something.", especially at a time when many are medically uninsured or underserved.

I am also not sure about what point critics are "missing." (Note: I am not a critic, but am a gadfly of healthcare IT mis-design, mismanagement and fraud.)

It appears that reasoning at Harvard has dropped to the level of "we should do it, because we have to do something." Good intentions trump outcomes. Not to make a comparison between HIT and other types of medical experimentation, but it's likely the PI's of the Tuskegee Experiment felt the same way.

Ironically, Harvard is home to Medical Informatics pioneers such as Dr. Octo Barnett, coauthor of the National Research Council report warning that approaches to today's HIT are inadequate.

-- SS

Health IT Failure Never Puts Patients at Risk

At "Dangerous Health IT Mismanagement, Spin Control and the World's Longest Teething Pains" I commented that executives always find that "patient safety is not compromised" when health IT malfunctions.

Here's another hair-raising story from Down Under. Just a wee glitch:

Power failure lasting 36 hours cripples hospital care

By Kate Benson
healthcareitaustralia.blogspot.com

DOCTORS at more than 100 hospitals in the state could not access patient records or vital test results for up to 36 hours last weekend after a power failure crippled NSW Health's computerised database.

Some records were lost, X-ray and pathology results could not be accessed and staff were forced to use whiteboards to keep track of emergency patients after the main server shut down at 9am on Saturday because of a faulty circuit-breaker.

Back-up power from the Cumberland Data Centre, which provides computer access to the Greater Western, Greater Southern and Sydney West area health services also failed, plunging some of the busiest hospitals in the state into chaos.

Thousands of patients were affected, with doctors and nurses forced to take notes on paper and go to other parts of the hospital to collect hard copies of results, extending treatment times and adding to the confusion.

Some staff, who did not want to be named, said the weekend was chaotic and a shambles. One surgeon said it was fortunate no lives were lost.

The chief executive of Sydney West Area Health Service, Steven Boyages, said hospital blackouts that lasted more than 30 to 60 minutes were unacceptable, but the Health Minister, John Della Bosca, insisted patients were not put at risk. "At no time was there any threat to patient care or safety," he said yesterday.

The Opposition spokeswoman on health, Jillian Skinner, said the blackout was "a serious failure" with great potential for disaster.

"Hospitals affected not only lost access to patient records, some lost some patient records altogether … and couldn't access X-rays unless they physically went to the X-ray department for a film copy," she said. "John Della Bosca should explain why the patient records system lost power, why back-up systems also failed, and whether patient safety was compromised."

A spokesman for Mr Della Bosca said workers doing routine maintenance at the data centre had triggered the outage. No patients had reported problems connected to the blackout but a full investigation would be launched. "If necessary changes will be implemented to prevent a recurrence," he said.

with Louise Hall

BLACKED OUT
Hospitals at Westmead, Auburn, Blacktown, Nepean, Lithgow, Mount Druitt, Cumberland, Blue Mountains, Dubbo, Bathurst, Orange, Mudgee, Parkes, Bourke, Albury, Queanbeyan and Goulburn were affected.

Move along, nothing to see here. Patients were not put at risk. Who needs regulation? It would only stifle innovation.

-- SS

The FDA Commissioner Divests

Dr Margaret Hamburg, having been confirmed by the US Senate, is the new commissioner of the US Food and Drug Administration (FDA). We posted twice about whether her and her family's financial relationships might be relevant to her nomination.

Here we discussed her position on the board of directors of Henry Schein, Inc a medical supply company. My concern was whether someone who had spent years being ultimately responsible for maximizing the profits of a medical supply company would be able to be a fair, and when necessary, tough regulator of the companies that supply Henry Schein with products to sell.

Here we discussed Dr Hamburg's husband's leadership of the hedge fund management company, Renaissance Technologies. My concern was whether someone who is part of a family that had gotten rich from buying and selling stocks and financial instruments, of which a likely substantial but unknown fraction were of health care corporations, would again be able to be a fair, and when necessary tough regulator of some of these same companies.

At the time, it did not seem that anyone else shared these concerns. As far as I could tell, there was no discussion of them in the press, or at Dr Hamburg's confirmation hearings.

However, today the Wall Street Journal reported:

The new commissioner of the Food and Drug Administration is among the wealthiest Obama administration appointees, with income of at least $10 million in 2008 thanks mostly to her husband, a hedge-fund executive, according to financial disclosure forms.

Margaret Hamburg and her husband, Peter Fitzhugh Brown, must divest themselves of several hedge-fund holdings as well as some of Mr. Brown's inherited drug-company stocks so Dr. Hamburg can take the post as the nation's top food and drug regulator. Mr. Brown is a lieutenant to hedge-fund magnate James Simons

The couple's income in 2008 came from stocks, money-market accounts, trusts and funds including several affiliated with hedge-fund sponsor Renaissance Technologies, where Mr. Brown works.

The couple controls assets worth between $21 million and $40 million, according to disclosure forms Dr. Hamburg gave the White House. The forms don't reveal exact figures, just ranges.

Before her FDA nomination, Dr. Hamburg also served for five years on the board of Henry Schein Inc., a $4 billion firm that distributes medical and dental supplies including vaccines. Her remuneration has been in the form of Schein shares.

She will forfeit $100,000 to $250,000 in restricted stock and more than 11,000 unvested stock options, all of which have a strike price above market value. She will also have to sell vested stock, valued between $250,000 and $500,000.

Mr. Brown, an expert in artificial intelligence, is vice president and director at Renaissance Technologies. The fund company said recently its total assets were about $18 billion. Mr. Simons was the top-paid hedge-fund manager in 2008, receiving $2.5 billion, according to Alpha magazine.

A lengthy review by the Government Ethics Office, which included direct discussions with Renaissance managers, determined that both Dr. Hamburg and her husband will have to get rid of their interest in four Renaissance funds—the Renaissance Institutional Equities Fund, the Renaissance Institutional Futures Fund, Meritage Investors and Topspin Partners.

However, the couple will be allowed to retain their interest in Renaissance's Medallion fund. An administration official said Medallion was exempted because its computerized quantitative model trades rapidly and holds shares only briefly, creating the equivalent of 'a very blind trust.'

Mr. Brown has already sold his stock in Abbott Laboratories and shares in Johnson & Johnson, Merck & Co. and Medco Health Solutions Inc., which he inherited from his father.

So it appears, in retrospect, that the Government Ethics Office also felt that Dr Hamburg's position on the Henry Schein Inc board constituted a conflict of interest. Furthermore, the Office felt that Dr Hamburg's and Mr Brown's holdings in several hedge funds constituted conflicts of interest. So, in retrospect, it is odd that these financial relationships attracted no attention other than that of Health Care Renewal prior to Dr Hamburg's confirmation by the Senate. I do hope that now, having severed significant relationships and sold financial holdings, Dr Hamburg will prove to be a fair, and tough when necessary regulator of companies that have too often misbehaved.

What Influenced a Paean to Karen Ignagne?

As the discussion here in the US about health care reform gathers steam, the Washington Post published a rather uncritical profile of one of the prominent participants, Ms Karen Ignagni, CEO of America's Health Insurance Plans (AHIP), the trade group for the health insurance/ managed care industry. It included some compliments from Princeton Professor and prominent health care economist Uwe Reinhardt:

'Whatever AHIP pays her, it's not enough. She's unbelievably effective,' said Princeton economist Uwe Reinhardt. 'It's just amazing what she's achieved for them against all odds.'

Ignagni's total compensation, according to AHIP's most recent filing from 2007, was $1.58 million, which includes $700,000 in base salary, $370,000 in deferred compensation and a bonus. Ignagni won't say how many hours a week she works. The number's so high it's embarrassing, she said.

Among successes cited by Reinhardt and others is helping persuade the Bush administration to develop private insurance plans within Medicare that are producing unexpectedly high payments for private insurers.

What the Washington Post article did not bother to mention was that in addition to being on the Princeton faculty, Professor Reinhardt is a member of the board of directors of Amerigroup, a health insurance company specializing in providing Medicaid and Medicare managed care (see this previous post), and a member of AHIP. Former Amerigroup CEO Jeffrey McWalters was on the board of AHIP. According to Amerigroup's 2009 proxy statement, Professor Reinhardt controls (via ownership or options) 144,558 shares of Amerigroup stock, and received $226,531 in compensation from Amerigroup in 2008.

Perhaps Professor Reinhardt's enthusiasm for Karen Ignagne's performance as CEO of AHIP derived more from his leadership of Amerigroup than a scholarly analysis.

Note also that Professor Reinhardt is a member of the board of directors of Boston Scientific, a medical device company. Furthermore, per proxy statements from the above companies, Professor Reinhardt is on the board of two funds from H&Q Healthcare Investors, and is a Trustee of Duke University and the Duke University Health System.

Professor Reinhardt's leadership roles in US publicly traded corporations are public, but not easily found unless one knows where to look. We had first discussed these relationships on Health Care Renewal in 2006. However, many of the more academically tinged biographies of him publicly available omit his leadership roles in the for-profit world. At the moment, biographies of Professor Reinhardt on the Princeton web-site, and furnished by the Princeton Bioethics Forum, the Commonwealth Fund, and the Henry J Kaiser Foundation did not note these relationships.

This illustrates once more participation in the current health policy debate may be driven by vested interests, rather than ideology, much less dispassionate analysis. Were the participants yo disclose, at least, their financial interests, the debate would become that much clearer. Meanwhile, when listening to the debate, always ask, "cui bono?" (Who benefits?)

Hat tip to the Health Care Blog.

BLOGSCAN - Comparative Effectiveness Research, the Partnership to Improve Patient Care, and PhRMA

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody dissected a campaign to redirect comparative effectiveness research by making it responsible to a new governing board that would include "insurance" and "industry" members. And surprise, surprise, the campaign is run by the Partnership to Improve Patient Care, a group that seems to have multiple connections to PhRMA, the pharmaceutical industry trade organization. More stealth health policy advocacy?

"A Breach of Trust"

This new variation on a now old theme first appeared in the New York Times:

A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday.

An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots.

'It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed,' Colonel Coots said in a telephone interview on Tuesday. 'So this really was all falsified information.'

The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter.

Dr. Kuklo, 48, now an associate professor at the Washington University medical school in St. Louis, did not respond to numerous e-mail messages and telephone calls to his office and home seeking comment over the last two weeks. Walter Reed officials say he did not respond to their inquiries during their investigation.

Army investigators found that Dr. Kuklo forged the signatures of four Walter Reed doctors on the article before submitting it last year to a British medical journal, falsely claiming them as co-authors. He also did not obtain the Army’s required permission to conduct the study.

In its March edition, at the Army’s request, the journal retracted the article — something that has gone largely unnoticed outside orthopedic circles.

While at Walter Reed and since, Dr. Kuklo has given talks to other doctors around the country about the bone-growth product, a protein called Infuse, according to meeting agendas and published documents.

A Medtronic spokeswoman, Marybeth Thorsgaard, confirmed that Dr. Kuklo was a paid consultant to the company and that the company financially supported some of his research at Walter Reed, through a foundation affiliated with the hospital.

During his time at Walter Reed Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report.

Colonel Coots said Tuesday that the total number of patients Dr. Kuklo reported as having been treated for extensive lower leg wounds at Walter Reed during the study period — 138 soldiers — was greater than the number for which the hospital could find records.

'It is a significant breach of academic protocol,' Colonel Coots said. 'It’s a breach of trust.'

This story has several familiar elements, but combines them in some interesting ways.

We have discussed how health care corporations, particularly pharmaceutical manufacturers, cultivate "key opinion leaders," and use them to market their products. This may amount to stealth marketing, since KOLs rarely disclose in detail their relationships with corporate sponsors, and instead further their marketing objectives cloaked as academics.

We have also discussed how health care corporations, particularly pharmaceutical manufacturers, may sponsor clinical research on their own products. However, such sponsors often manipulate the research projects' design, implementation, analysis, and dissemination so as to favor their products. While the sponsorship may be disclosed, the extent of the sponsors' control over the project may not be. Furthermore, scientific investigators running such projects may have their own personal financial relationships with the sponsors.

This case apparently shows how a medical academic can both be a paid "key opinion leader," and manipulative clinical researcher. While many examples of key opinion leaders as stealth marketers, and manipulated research involved pharmaceutical companies, this one involves a medical device company. In addition, this research project was not just manipulated, but allegedly falsified.

This variation has at least one other interesting element. Again, from the New York Times,

A former Walter Reed colleague, Dr. David W. Polly Jr., who is also a Medtronic consultant, said he believed that Dr. Kuklo’s data was “strong” and the episode had been overblown.

According to the Center for Public Integrity Paper Trail blog,

A former colleague of Kuklo’s at Walter Reed Army Medical Center, Dr. David W. Polly Jr., took even more expensive trips than Kuklo. Polly went on at least 12 Medtronic-sponsored trips costing about $30,000, including a $10,000 trip to Switzerland.

Furthermore, the New York Times reported,

[Senator Charles] Grassley, the ranking Republican [from Iowa] on the Senate Finance Committee, has been investigating since last year whether Medtronic illegally promoted unapproved uses for Infuse. Medtronic, which has denied that accusation, provided him last year with a list of Infuse consultants.

After Dr. Kuklo’s links to Medtronic and Infuse came to light last week in a New York Times article, Mr. Grassley’s staff checked the consultants list and noted that Dr. Kuklo’s name was not on it. In reaction, he wrote a letter to Medtronic’s president and chief executive, William A. Hawkins III, asking why Dr. Kuklo had been omitted. Mr. Grassley entered that letter and the list he had received into The Congressional Record.

'In the future, I hope that instead of not providing me with the name of the physician involved in Infuse, or any other matter that I am looking into, that Medtronic contact me to avoid the situation in which we find ourselves,' Mr. Grassley wrote to Mr. Hawkins.

So, as soon as this case came to light, the spinning of public discussion to favor Medtronic and its key opinion leaders began. Thus, this case also involved stealth policy advocacy. Stealth marketing, clinical research manipulation, and stealth advocacy all in one case, we seem to have hit the jackpot.

The most recent development, again according to the NY Times, is

Dr. Timothy R. Kuklo, a former Army physician accused of falsifying research involving injured soldiers, has taken a leave of absence from the Washington University School of Medicine in St. Louis and its affiliated hospitals, the medical school said Friday.

Dr. Kuklo, an associate professor of orthopedic surgery, will not be performing operations, conducting research or teaching students, said a medical school spokeswoman, Joni Westerhouse. The university granted the leave, she said, so that Dr. Kuklo 'can focus on responding to queries about his research and consulting.'

At least his absence was not ascribed to the need to spend more time with his family or pursue other opportunities.

Finally, note that we posted last year that Medtronic had submitted to a corporate integrity agreement after the US Department of Justice accused it of defrauding Medicare in connection with activities by its Kyphon subsidiary. So this case additionally suggests that such agreements have little effect on the actual integrity of corporate leaders.

Hat tip to and see further commentary by Prof Margaret Soltan on the University Diaries blog.

ADDENDUM (24 May, 2009) - see further comments by Prof Soltan on the University Diaries blog.

BLOGSCAN - "Money-Driven Medicine," the Film

On the Health Care Blog, Maggie Mahar announced the screening of the new documentary film based on her book "Money-Driven Medicine."

HealthSouth's "Digital Hospital," from the "Era of Cyber Hospitals" to an Unfinished "Pipe Dream"

The trial for a civil law-suit against Richard Scrushy, the former CEO of for-profit rehabilitation hospital chain HealthSouth, is currently in progress. One bit of testimony provided a reminder about how supposed "innovations" in health care are uncritically accepted. As reported by the Birmingham (Alabama, US) News:

HealthSouth Corp. Chief Executive Jay Grinney has concluded his testimony in the Richard Scrushy civil trial, ending with a devastating critique of the so-called 'digital hospital.'

'It was a very bad business decision that made no sense,' Grinney said of the half-completed Scrushy brainchild on U.S. 280 he inherited when he took over in 2004.

Ending his sixth hour of testimony over two days, Grinney said the hospital had an original budget of $200 million, and that much had already been spent when the the project was stopped halfway through. Another $200 million was required, he said.

When it came time to cut the $3.5 billion of debt that was burdening the company, Grinney said he had no hesitation about selling the building. Scrushy had envisioned the medical center as a 200-bed centerpiece of the HealthSouth empire, and called it the 'digital hospital' because of its planned technology component.

The building has been sold to real-estate developers,....

Scrushy is on trial in Jefferson County Circuit Court after being sued by HealthSouth shareholders. They are seeking $2.6 billion in damages from him for costs related to accounting fraud, corporate waste and insider stock trading while he ran the physical therapy company from 1996 through 2002

The 56-year-old Selma native is in the Shelby County Jail awaiting his court appearance in the case. He was brought to Birmingham from federal prison in Texas, where he is two years into a seven-year sentence for bribing former Alabama Gov. Don Siegelman.

In additional coverage by a local television station (NBC13.com),

When asked about the unfinished digital hospital on Highway 280, Grinney said, 'It was a pipe dream and a figment of the imagination. It never had a chance.'

Grinney testifed on Wednesday that HealthSouth would have had to forego investments in all of the company’s other 93 hospital for 2 to 3 years to finish the digital hospital.

What a contrast this was to the hype that surrounded the announcement of Scrushy's intention to build the "digital hospital." Let me provide some samples.

ComputerWorld allowed Scrushy to wax eloquent:

Hospital chain HealthSouth Corp. and software manufacturer Oracle Corp. are teaming to build what they say is the world's first all-digital, automated hospital.

The technological features will include patient beds with display screens connected to the Internet; electronic medical records storage; digital imaging instead of traditional X-ray film; and a wireless communications network that will allow doctors, nurses and other health care professionals to securely update and access patients' medical records using handheld devices.

'This will be the hospital model for the world,' HealthSouth Chairman and CEO Richard Scrushy said in the statement. 'By creating the first automated hospital ... we will demonstrate how technology can lower health care costs, greatly reduce human errors and provide patients with the best medical care available.'

Bio-Medicine gushed:

The project will be fast tracked and hopefully completed by 2003. From the moment a patient registers at the hospital, every blood test and MRI will be recorded in a central patient record, and pharmacy visits will be tracked. All charting will be done at the patient's bedside, 'getting the nurses' back to the patient's side' and making doctors more efficient. Oracle will provide the technology that will allow Health South to improve record-keeping and patient care, officials of the two companies said in a briefing on Monday. Ultimately, they said, the improvements will reduce the overall cost of care. It was also added at the briefing that another 10 sites where the hospital can be duplicated have been identified. Its now the era of cyber hospitals!!!

Managed Care Magazine was only somewhat more measured:

The promise of HealthSouth's digital hospital is great. By planning for integration on a common platform with all suppliers involved from the start, HealthSouth is maximizing the likelihood of success.

Also, HealthSouth is attempting to make the physical facility as flexible as possible to allow for the adoption of additional new technologies as they become available.

If this hospital works, it is likely to set standards for a high level of patient care. HealthSouth is anticipating that the increased efficiency of the new facility will translate into a decrease in overall length of stay.

On the other hand, everything is still in the planning stages, and details are scarce. HealthSouth has no agreements in place with insurers. Of course, the paperless hospital evokes memories of the heralded paperless office of a generation ago — and we're still waiting.

The cutting edge can be painful. But the concept of the digital hospital, automating care and administrative operations, is so appealing, we can only hope it will succeed. Time will tell.

An article in the MIT Technology Review was just a little bit skeptical:

While others have previously failed to carry off such grand visions of high-tech medicine, the deep pockets of HealthSouth and Oracle could give them a fighting chance.

But the article's conclusion was less cautious:

Not only could electronic information management help eliminate errors, it could also eliminate two to three hours a day that nurses spend charting patient data, and dramatically improve communication between different departments. The bottom line: it could save lives.

Finally, I was able to find some discussion of the proposed "digital hospital" in a scholarly publication, in fact, in probably the most authoritative and well-read journal on health care policy in the US, Health Affairs. [Burns LR, Pauly MV. Integrated delivery networks: a detour on the road to integrated health care? Health Affairs 2002; 21: 128-143.] I would not call it gushy, but it hardly seemed skeptical:

The most radical development is the incorporation of all of these technological advances into newly designed and built 'digital hospitals.'HealthSouth, traditionally a provider of integrated rehabilitation services, has announced plans to build several digital acute care hospitals over the next decade (the first is now under way in Birmingham, Alabama). The publicity surrounding the new hospital and its partnership with Oracle not only has attracted other prominent product vendors but also has enabled HealthSouth to negotiate large discounts on all equipment supplied—in effect, lowering the cost of construction.

What are the likely prospects for this intervention, either at these beta-test
sites or diffused more generally? It is plausible (although difficult to demonstrate so far) that routine patient medical and billing records can be stored or exchanged electronically. It is less obvious that this technology should lead to changes in the cost of care or help to integrate different providers of service. Indeed, the biggest chasm to bridge may be the office systems of different physicians. Kaiser Permanente is reportedly struggling to develop a clinical information system that covers its thousands of physicians and other clinicians. The (as yet undocumented) benefits will likely depend on the ability to harness technological interventions with managerial innovations and interorganizational networks, in effect creating 'socio-technical systems of care.'

So we have gone from "the hospital model for the world," with great "promise," which "could save lives," proclaiming the "era of cyber hospitals," to a "pipe dream," just the shell of half-finished building.

So I wonder, if one were to identify every highly hyped, rapidly spun, magic new "innovation" promising to revolutionize patient care, and follow them forward in time, how many would even marginally improve health care, or provide benefits that marginally out-weighed their harms? How many would never come to be, or prove to be unworkable, useless, or even harmful?

But the short-term incentives for leaders of health care organizations push them to announce innovation after innovation, collect their bonuses and perks, and be somewhere else by the time their wondrous innovations prove to be not so good.

Keep in mind that some heavily promoted innovations, such as new pharmaceuticals, must be subject to randomized controlled trials and government approval. Yet, as perusing Health Care Renewal will show, many pharmaceutical companies have managed to make their glitzy innovations appear more efficacious and less hazardous by lavish, shrewd, and sometimes deceptive marketing, and by manipulating clinical research, and sometimes suppressing results. Medical devices are not subject to as much scrutiny. Health care information technology, and programmatic innovations by hospitals, health systems, managed care and health insurance companies can appear without any research evidence to support them.

This is why we all should be extremely skeptical of whatever new "innovations" our multi-million dollar health care CEOs and their cronies are hawking these days.

Healthcare IT Timing "Cemented in Law?" A Healthcare Renewal Contest

I am quoted in the article "Liability an issue with health care software" in today's online edition of NextGov.com (link to article).

Nextgov.com is part of the National Journal Group Inc. and the Atlantic Media Company. It is a spin off of Government Executive.com and provides coverage and commentary on the management of information technology in the federal government.

Read the whole article. I reproduce a part of it below for the purposes of sponsoring the first ever Healthcare Renewal contest.

The rules are simple. Add to the blog comments section your best explanation of the interesting phrase in the last sentence of the excerpt, bolded below. The best comment will get an honorable mention appended to the text of this posting.

Keep in mind that the laws regarding health IT appeared in H.R. 1 EH, a.k.a. the Economic Recovery Act of 2009, with little or no public discussion regarding incentives, penalties or timing. See Div. B Title IV, Health Information Technology (Word file extract of a version of the bill from a few months ago) to review the Act's text on HIT.

With that in mind, here is the excerpt:

... Health IT provisions in the economic stimulus package are integral to Obama's overall health care agenda, and give doctors and hospitals incentives to adopt certified electronic records by 2014. The Recovery Act appropriates about $20 billion in Medicare and Medicaid incentives to meet that goal.

Professionals who deploy certified electronic health records between 2011 and 2014 will be eligible for Medicare bonus payments, while hospitals that implement certified e-records by 2015 also will get bonuses.

Scot M. Silverstein, a medical informatics consultant, adjunct professor at Drexel University and former director of Drexel's Institute for Healthcare Informatics, said the timeline for adoption should be extended. Starting in 2015, the administration plans to dock Medicare payments for professionals and hospitals that fail to use certified e-records.

"I think the punitive aspects that kick in need to be eliminated," Silverstein said. "I think the government needs to re-examine its justifications for shoving IT down doctors' throats by 2014."

David Blumenthal, Obama's national coordinator for health information technology, said the government will tighten oversight of the certification process to address such concerns.

"Right now, we are reviewing that process to see how it can provide stronger guarantees that [products] will perform as they are promised to perform," he said. But the timelines for rollout of health IT are cemented in law, he noted.

"Cemented in law?" Your comments, please.

-- SS

Novo Nordisk Accepts Deferred Prosecution Agreement, Settles, Pays Fine

Back in early 2007, we noted that several large drug companies were under investigation for possible involvement in the Iraq oil-for-food sanctions scandal. More than two years later, a US Department of Justice press release from last week includes the following:

Novo Nordisk A/S (Novo), a Danish corporation based in Bagsvaerd, Denmark, has agreed to pay a $9 million penalty for illegal kickbacks paid to the former Iraqi government. Novo agreed to pay the fine as part of a deferred prosecution agreement with the Department. The matter is part of the Justice Department’s ongoing investigation into the U.N. Oil-for-Food program.

A criminal information was filed today against Novo in U.S. District Court for the District of Columbia charging Novo with one count of conspiracy to commit wire fraud and to violate the books and records provisions of the Foreign Corrupt Practices Act (FCPA). Novo, an international manufacturer of insulin, medicines and other pharmaceutical supplies, has acknowledged responsibility for improper payments made by its agents to the former Iraqi government in order to obtain contracts with the Iraqi ministry of health to provide insulin and other medicines. The agreement requires the company and its subsidiaries to cooperate fully with the Justice Department’s ongoing Oil-for-Food investigation.

According to the agreement and the information filed today, between 2001 and 2003, Novo paid approximately $1.4 million to the former Iraqi government by inflating the price of contracts by 10 percent before submitting the contracts to the United Nations for approval and concealed from the United Nations the fact that the price contained a kickback to the former Iraqi government. Novo also admitted it inaccurately recorded the kickback payments as 'commissions' in its books and records.

In recognition of Novo’s thorough review of the illicit payments and its implementation of enhanced compliance policies and procedures, the Department has agreed to defer prosecution of criminal charges against Novo for a period of three years.

Also,

In a related matter, Novo reached a settlement today with the U.S. Securities and Exchange Commission (SEC) on a complaint and agreed to pay $3,025,066 in civil penalties and $6,005,079 in disgorgement of profits, including pre-judgment interest, in connection with contracts for which it paid kickbacks to the former Iraqi government.

Note that so far I can only find coverage of this story in this brief piece from Reuters.

So here we go again. Yet another big health care corporation, in this case, an international pharmaceutical company, admits to criminal conduct, and agrees to operate under a deferred prosecution agreement, while also paying additional millions in a civil settlement. In this case, the amounts of money paid were not particularly large, but the nature of the conduct involved, involving paying to play with a particularly notorious dictator, was striking.

Like most cases involving settlements for unethical behavior, or even deferred prosecutions or convictions for criminal behavior, this one has attracted almost no attention. Have such stories become like "dog bite man" stories, so commonplace that they deserve no notice from a public that has become cynical?

As we have said before, while human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a fine. In this case, the fine was, in corporate terms, tiny. However, even a large fine, however, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization, even a health care insurance company, will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.

Hat Tip to the White Collar Crime Prof Blog.

Dangerous Games and Health IT Feudalism

I am reposting a provocative open letter from Ignacio Valdes, MD, MSc (a proponent of Open Software and proprietor of the LinuxMedNews blog) on the revelations about Health IT by Penn sociology professor Ross Koppel and by Washington Post reporter Robert O'Harrow, Jr.

While I am not predicting nor recommending the elimination of the commercial HIT sector (just its major reformation!), Dr. Valdes makes many valid points about the current state of health IT and the value of open source solutions. VistA/CPRS and its derivatives are one example of an open source EHR. (Note: Dr. Valdes is an acquaintance from informatics meetings; I have no commercial connections or financial interests in his business affairs).

I cannot add much more to the letter's sentiments:

Dangerous Games and Health IT Feudalism.

From: LinuxMedNews announce -- breaking news of Free/Open Source in medicine.
To: linuxmednews-announce
Date: Mon, 18 May 2009 12:43 pm

Dr. Koppel,

This is an open letter that I plan to publish on Linux Medical News and elsewhere. As you probably know, your JAMA 'Hold Harmless' article presents just the tip of the iceberg. Your article and more data from the Washington Post article (link) make it abundantly clear that proprietary vendors are intent on establishing private property rights for something that private property rights are clearly not appropriate for.

It leads to the logical absurdities, expense, and moral hazards we are experiencing now. The obvious dangers, enormous conflict of interest, as well as highly practical considerations such as simple non-performance of proprietary Electronic Medical Record software is manifest. What the proprietary industry could not achieve with vendor lock-in, legislative help like Stark exceptions, trade secrets, and inadequate products they are attempting to achieve by pure politics. Politicians, proprietary vendors and its lobby are playing 'heads we win, tails you lose, we are king, it is good to be king' games with our safety, our privacy, taxpayer money, and our lives. This may well succeed in ushering in a kind of digital feudalism with the most intimate details of our lives. Such landlord type games are entirely inappropriate for the practice of medicine. They are antithetical to American history and values. A generous and virtuous society should not allow this to occur.

The medical profession no longer condones even 15 cent pens with pharmaceutical company logos on them because of the moral hazard and the perception of untoward financial coercion. Yet we are now by law embarking on a program of essentially bribing physicians with approximately $40,000 each of taxpayer money and then punishing them if they cannot be bribed in order to implement problematic proprietary health IT loaded with legal, financial, and practical minefields. Have we as a nation taken leave of our senses?

The Free/Open Source licensing in medicine crowd has been discussing these issues and showing demonstrable results for years but has received little attention and practically no funding. We have the legal, practical, and licensing means for achieving the transparency and rights guarantees that nearly everyone says that they want, solving many practical as well as moral issues. The AMIA Open Source working group white paper can be found here
http://www.amia.org/files/Final-OS-WG White Paper_11_19_08.pdf

Unfortunately, it was rejected from entering into the scientific literature by JAMIA on a technicality and voted down by the AMIA board of directors as AMIA policy on methodology and 'ideological' grounds. Such a stance and public declarations by AMIA's leaders seems to be in direct conflict with AMIA's mission.

Relying on government bureaucrats, proprietary vendor lobbies, and marketing representatives giving "trust us" type guarantees versus legally enforceable Free/Open Source licenses is a recipe for national disaster. Again, a generous and virtuous society should not allow this to occur. A practical solution is a law that only allows taxpayer money to be expended only for Electronic Medical Record software that is licensed only with Free Software Foundation approved licenses. Preferably the Affero General Public License which closes the software as a service loophole. The nations health, privacy, safety, finances and destiny are at stake.

Sincerely,

-- Ignacio Valdes, MD, MSc

-- SS

Wall Street Journal Letter Revisited

I believe yesterday's Washington Post article The Machinery Behind Health-Care Reform confirms that my Feb. 18, 2009 letter to the editor published in the Wall Street Journal was on the money (yes, that is a pun):

I wrote:

Dear Wall Street Journal:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Lobbyists do tend to present the rosiest picture possible to those with the gold. It appears the myths surrounding health IT have been deliberately engineered.

I believe it now essential and indeed socially responsible for our medical professional societies to ensure the administration is aware of the difficulties and potential downsides of health IT.

If the industry lobbyists have only presented one side of the story (and I believe that likely to be the case), then our government has been making critical social re-engineering decisions based on a dangerously and deceptively incomplete picture.

I for one would like an accounting from HIMSS and other lobbyists of exactly what literature and viewpoints they presented to our government officials, especially in recent years, that led to the massive inclusion of funds and the use of government power to enforce rapid timelines (via economic sanctions for non-meaningful users) in H.R. 1 EH , a.k.a. the Economic Recovery Act of 2009 .

I would also like to know what literature was not presented.

-- SS

The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians

(To those who linked here from "The Health Care Blog", see my footnote at the end of this post. Also, I suggest readers at least peek at each and every hyperlink I've placed in this essay. It takes time, but it's illuminating - ed.)

In many past posts on Healthcare Renewal I have commented on a bewildering healthcare and IT industry blindness to a growing body of literature and experiences of those "in the trenches" that throw doubts upon Utopian views of health IT as a panacea for healthcare's problems. Those responsible for this literature advise caution and the highest levels of scientific rigor in the large scale adoption of clinical information technology if that technology is to actually improve healthcare, myself included. We know the difficulties and risks. Bad healthcare informatics wastes money and distracts clinicians. Bad healthcare informatics can kill. "Primum non nocerum" is a critical ideology in health IT.

I first wrote about these observations a decade ago and was merely standing on the shoulders of those who preceded me with their own critical thoughts and observations regarding cybernetic miracles in medicine.

I've also been puzzled about the sudden lurch by the current administration to commit tens of billions of dollars to national HIT, along with eventual penalties for resistance, within the ridiculously short time frame of 2014 and with little public discussion. The provisions seemed to simply "appear" in H.R. 1 EH, a.k.a. the Economic Recovery Act of 2009. I wrote about this here.

Finally, I was curious about the timing of a remarkable set of reports from highly respected U.S. organizations on HIT issues, such as a Dec. 2008 Sentinel Events Alert from the Joint Commission and a Jan. 2009 report from the U.S. National Research Council. What motivated their release?

The answers to these questions have become bit clearer via a remarkable article from the Washington Post. It reveals an administration heavily influenced by - no surprise - powerful industry lobbyists. (I thought this administration had pledged a different mode of government conduct, but as has been said, campaigning is done with poetry, and governing is done with prose.)

Here is an interesting explanation of how medicine has been cross-occupationally invaded by the IT industry, probably ten or more years before that industry really has the depth of understanding, depth of talent and capabilities to make useful, usable, safe, and cost effective national health IT a reality:

The Machinery Behind Health-Care Reform
How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records

By Robert O'Harrow Jr.
Washington Post Staff Writer
Saturday, May 16, 2009
When President Obama won approval for his $787 billion stimulus package in February, large sections of the 407-page bill focused on a push for new technology that would not stimulate the economy for years.

The inclusion of as much as $36.5 billion in spending to create a nationwide network of electronic health records fulfilled one of Obama's key campaign promises -- to launch the reform of America's costly health-care system.

But it was more than a political victory for the new administration. It also represented a triumph for an influential trade group whose members now stand to gain billions in taxpayer dollars.

A Washington Post review found that the trade group, the Healthcare Information and Management Systems Society (HIMSS), had worked closely with technology vendors, researchers and other allies in a sophisticated, decade-long [lobbying] campaign to shape public opinion and win over Washington's political machinery ... At the center of those efforts is the Healthcare Information and Management Systems Society. Started a half-century ago, it represents 350 companies and about 20,000 members. Corporate members include government contractors such as Lockheed Martin and Northrop Grumman, health-care technology giants such as McKesson, Ingenix and GE Healthcare, and drug industry leaders, including the Pharmaceutical Research and Manufacturers of America.

With financial backing from the industry, they started advocacy groups, generated research to show the potential for massive savings and met routinely with lawmakers and other government officials.

A lot of voices were left out of that trade group's lobbying, including the open source EHR proponents following the traditions of the VistA effort, as one can learn about in the book "Medical Informatics 20/20" by VA pioneers Goldstein, Groen et al. These traditions are largely alien to the commercial IT sector as evidenced by the mission hostile clinical IT products they put out (see my series on that issue starting here) and even known grossly defective software for use on live patients.

The HIMSS trade group's massive conflicts of interest also seem to have blinded it to the longstanding concerns of many experts in medical informatics, social science and related fields that current approaches to health IT are insufficient and may impair healthcare quality initiatives (let's be frank about what that really means - it means patient harm).

The creation of advocacy groups backed by industry financing also seems eerily similar to many stories on HC Renewal and other blogs about the pharmaceutical industry, as does "generated research." That "research" may also have been industry funded, and it is my belief the impartiality and soundness of such research needs to be critically and impartially re-examined.

Their proposals made little headway in Congress, in part because of the complexity of the issues and questions about whether the technology and federal subsidies would work as billed.

In other words, Congress was doing its job regarding lobbying by proponents of an experimental technology in which they had a major financial stake. Until...

As the downturn worsened last year, advocates helped persuade Obama's advisers to dust off [i.e., uncritically accept lock, stock and barrel - ed.] electronic records legislation that had stalled in Congress -- legislation that the advocates had a hand in writing, the Post review found.
Their sudden success shows how the economic crisis created a remarkable opening for a political and financial windfall: the enactment of a sweeping new policy with no bureaucratic delays and virtually no public debate about an initiative aimed at transforming a sector that accounts for more than a sixth of the American economy.

Let me add that while the advocates "had a hand" in writing the legislation [i.e., they wrote the legislation - ed.], researchers and critical thinkers regarding the downsides of health IT industry in its present state seem to have had little voice in this legislation.

"It was perhaps a once-in-a-generation opportunity to make something happen," said H. Stephen Lieber, the trade group's president. Obama "identified the vehicle that he could use to move his policy agenda forward without the crippling policy debate."

I find this simply outrageous. The reason for policy debates in healthcare and especially healthcare IT is to avoid crippling or killing patients.
Lieber is not a clinician. Who is he to cheer (and perhaps to have spearheaded) the short circuiting of "policy debate" on health IT? According to his bio, he holds an MA from the School of Social Service Administration at the University of Chicago, a BA in Psychology from the University of Arkansas, and has completed additional course work at the graduate schools of business at both universities and at the Keller Graduate School of Management.

... Many technology advocates, including health policy specialists, say that networked electronic patient records that can be transmitted instantly would make health care more efficient and provide valuable insights about costs and care.... Some advocates also say the savings could amount to tens of billions of dollars each year from reduced paperwork, faster communication and the prevention of harmful drug interactions. An equally important benefit, they say, could be to enable researchers to determine the most effective procedures for an ailment. Such an approach would rely on unprecedented data-mining into medical records and the practices of doctors, a kind of surveillance that also would enable insurers to cut costs by controlling more precisely the care that patients receive [Leading to rationing to increase profits? - ed.]

These assertions have never been proven in a scientifically robust manner. Further, there is a growing body of literature expressing significant doubts about these predictions of cybernetic miracles from health IT (see short partial lists of examples here and here) that has largely been ignored - in the worst traditions of pseudoscience and scientific fraud - by the industry and its lobbyists. In fact, the latter assertion - comparative effectiveness research based on EHR data - may have moved from scientific possibility (e.g., better detection of major adverse drug and therapy events) to anti-scientific pipe dream, as in my essay "Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?" I am not even considering massive potential for abuses created by online national health records.

"Finally, we're going to have access to millions and millions of patient records online," said Blackford Middleton, a physician, Harvard professor and chairman of the Center for Information Technology Leadership, whose studies have concluded the health-care system could save $77.8 billion each year through the universal use of information technology networks. "This is the biggest step for health-care information technology in this country's history."
But others said the case was far from being so clear. Some observers said the projected savings are overly optimistic and that launching such vast computer networks under tight deadlines is risky, a lesson learned by the Bush administration when it botched a variety of homeland security systems rushed into place after the Sept. 11 terrorist attacks.

While I respect Blackford Middleton as a former leader of the EHR company from which I selected the EHR for Christiana Care Health System in the late 1990's, I also respect those "others" who say the case is far from clear. It is through science and an open political process that such debates need to be resolved, not through lobbying and utopianism. The potential for adverse, unexpected consequences in such a major social re-engineering effort are simply too great for cavalier attitudes or utopianism. We are already seeing adverse consequences - just the most recent examples are here and here.

Industry "roll out HIT no matter what, patient and clinician informed consent be damned" attitudes also teeter on the precipice of human rights violation. In fact, the corporatization of health IT and the treatment of health IT as if it were any other IT not involving third parties with special rights (i.e., patients) may have already resulted in serious breaches of hospital executive fiduciary responsibilities towards safety and (in the U.S.) of their Joint Commission safety standards obligations as well; see my essay here.

Some proponents said they worry that an over-reliance on technology as a solution could distract the health-care system from difficult questions about quality of care. They said efforts to find a quick technological fix will likely run up against complex cultural challenges.

The latter quote sounds like me, stating the obvious. Allow me to translate the applied, real world meaning of "cultural challenges." It means increased political infighting between stakeholders, power grabs, distractions and chaos on the medical floor and in the medical office, and other social and political upheavals within medicine that will likely distract from the ability of already harried clinicians to provide care.

"I would like to believe that the effective use of technology to augment health care will lead to substantial savings and improvements in the quality of care," said Mark Frisse, a physician and professor of biomedical informatics at Vanderbilt University, who leads an electronic health record program in Nashville. "But the evidence does not consistently bear this out."

Dr. Frisse is quite correct, although I would add that the evidence that does not bear out these beliefs is many, many times stronger than that which, say, caused VIOXX to be pulled off the market.

"HIMSS has a very effective grass roots advocacy program that reaches all levels of government," Dave Roberts, a senior executive, said in the group's literature... HIMSS has a "strategic alliance" with the Center for Information Technology Leadership, a nonprofit that produces research reports -- which HIMSS prints and distributes to Congress and elsewhere.

I agree with that description. Missing from the description, and one I would not add, is a "scientific organization."

After volunteering on John Kerry's presidential campaign in 2004, [now-chairman of the board of HIMSS and their ally, the Center for Information Technology Leadership] Middleton said he was recruited as an Obama volunteer last year and provided information about electronic records to the candidate's health-care policy group. Middleton said he worked with several campaign officials, including David Blumenthal, a colleague at Partners HealthCare and a Harvard professor, who was Obama's health-care adviser and is now the administration's national coordinator for health technology.

"We didn't have to go very far to get our information," said one senior Obama adviser, who was not authorized to speak publicly and discussed the campaign on the condition of anonymity. Blumenthal "taught all the rest of us everything we know."

He may have taught them "everything they know", but he apparently did not teach them everything that is important to know. Obama's team has seemingly thrown a significant body of literature on HIT drawbacks and risks under the bus. This is the essence of scientific naïveté and quackery.

Middleton said he provided many of those details.
"I sent them a LOT of stuff, many papers and most of the reports. I probably spoke or communicated with David Blumenthal, David Cutler (the health economist on the team), or Dora Hughes about every other week during the heat of the campaign," Middleton said in an e-mail.

While Blumenthal goes on in the article to minimize Middleton's influence, I can only wonder if any of the HIT industry lobbyists sent "this stuff" to the campaign.

The stimulus bill suggests that the government will recoup about a third of the spending allocated for electronic health records over the next decade, an assumption that some health-care observers question, in part because of a critical analysis by the Congressional Budget Office last year.

The CBO, then led by Orszag, examined the industry-funded study behind the $77.8 billion assertion, among other things, and concluded that it relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology.

I can add that not only is there much unknown about the potential, but there is much unknown about the true difficulties of making it all actually work as promised. See this seminal short article on why this is so.

This is a spectacularly poor way to run major national initiatives costing tens of billions of dollars and upon which patient wellbeing rides. Blindly.

Joseph Antos, a health-care policy specialist who has examined the legislation, said the risks of the technology plan are high because of the haste with which it is being implemented and the special interests seeking to profit from it.

"This is the real way things get done [and the "real" way true disasters such as our recent world wide financial chaos get initiated - ed.]," said Antos, of the American Enterprise Institute, a Washington think tank. "The stimulus bill looked like a bonanza to an awful lot of people." [I tend to take "awful lot of people" quite literally in this case.]

Haste is an understatement. A more reasonable timeframe might have been 2024, not 2014.

I can add that if this initiative blows up as it has in the UK, then the only triumph will be the financial triumph of the trade group and its apparatchiks. The losers will be the administration, patients, clinicians, and everyone else in the healthcare system. [6/29/09 addendum: it's worse than I thought. The UK's NPfIT in the NHS was suspected to have been doomed from the start, but proceeded anyway; see "16 key points in Gateway Reviews on NHS IT scheme" and the Gateway Reviews themselves, released under a UK FOI request - ed.]

In all seriousness, and with recognition of the harshness of this observation, I add that the patients who might die as a result of hastily and poorly designed and implemented health IT under this rushed "real way" initiative, will have in effect been murdered by this lobby.

-- SS

Footnote:

It is interesting to watch the "circling of the wagons" that is starting over the WaPO story. It is in fact predictable that ad hominem, distortion of views, etc. will follow. For example, Matthew Holt of The Health Care Blog, who writes (emphases mine):

I draw your attention to a troika of articles, all of which show how things can be slightly misinterpreted.

First, who knew that Blackford Middleton was either the most influential health policy wonk out there, or single-handedly responsible for the Haliburtonization of health IT? If you read the WaPo article about it, it looks as though there was some kind of terrible conspiracy to impose an evil fraud in terms of unnecessary health IT spending on the taxpayer. And for example MedinfomaticsMD over at Health Care Renewal (who appears to have jumped from the position that some health IT installations have real problems to the less tenable one that all EMRs kill) is just one going loopy about it.

"Loopy?"

Merriam-Webster:

Loopy:

1 : having or characterized by loops
2 : crazy, bizarre

— loop·i·ly \-pə-lē\ adverb

— loop·i·ness \-pē-nəs\ noun

Ad hominem (link) is no substitute for a logical argument, in fact it is a logical fallacy. Further, an over the top statement that I've "jumped to a less tenable position that all EMR's kill" is quite disappointing from someone who clearly has the intellect to know how amateurishly political an attack that is on a physician-informaticist in this field for almost two decades. One who is trying to take a strong pro-patient, ethical stance while balancing the need to develop safe and effective health IT along more reasonable timelines, and without the behind-the-scenes corporate influence we write about at Healthcare Renewal.

-- SS

2012 Addendum:  see the end of my post regarding my keynote presentation to the Health Informatics Society of Australia at this link for more on Matthew Holt's apparent disdain for my positions regarding HIT ethcs.

Dangerous Health IT Mismanagement, Spin Control and the World's Longest Teething Pains

I've written about a physician who documents the HIT travails Down Under that parallel the ones we have here - and are going to have a lot more of in a mad rush to universal health IT supposedly by 2014.

Staff in an Australian Hospital's ED basically revolted against a new system that totally failed ... twice in three days. The two accounts of the incident are interesting regarding the incompetence level that hospital IT departments are permitted and that is widely tolerated as if they were a priesthood, and the spin control often used as CYA for events that carry great potential for patient harm.

Physicians should only have it one hundredth as well as IT personnel.

Account 1:

Hospital records system fails twice in one week

ABC (Australian Broadcasting Company) News

Posted Fri May 8, 2009 7:37am AEST

Emergency doctors at Nepean Hospital in Sydney's west are scaling back a new electronic records system because of two failures in the space of four days.

Hospital management says there was a slowdown in the system for two hours on Tuesday, following a widespread outage on Saturday.
Staff at the Nepean Hospital have now stopped using some parts of the system, saying they have lost confidence in it. Medics will in some cases go back to using pen and paper to record patients' progress.
The chief executive of the Sydney West Area Health Service Professor Steven Boyages has apologised to staff, but says the problems could continue for a year and a half, while the technology is being rolled out.
"Like in every other industry, whether its banking or retail or travel, teething problems do occur," he said.
"Whenever you experience a computer slowdown it's enormously frustrating. Particularly if you're dealing with patients."
But Professor Boyages says patient safety has not been compromised. "The important thing to re-assure your listeners is that we have very effective back up systems in place," he said. [That's what's known as "spin control" - ed.]

This raises several questions:

• Computer systems that are up 24/7 are fairly common, including health IT systems. Who, exactly, is having "teething pains?" Surely not the entire healthcare or health IT industry, unless one considers the possibility of a baby that has thirty years worth of little teeth coming in. Perhaps it's incompetent IT department leaders who are doing the teething, at patient and physician expense?
• A year and a half of more problems expected during "rollout?" [That's simply insane -ed.] What in hell is being rolled out?
• Why, exactly, did the system slow down and then fail? Who was in charge of the project and of system architecture and redundancy? What sanctions do they face as a result of this debacle?
• In the often chaotic environment of emergency medicine, disruptions to record keeping, even short lived ones, run the risk of irreversible error or catastrophe. Evidence of the concern of staff is their rejection of the system. How can the chief executive state that safety has "not been compromised?"
• "Very effective backup systems in place?" Since the computer system went down, clearly this exec is not talking about IT. Perhaps the "backup system" is good, old fashioned paper and pencil?

Others share my concerns, as well as concerns that these systems can be more of a hindrance than a help if designed improperly (the identity of the system is not mentioned, unfortunately).

Account 2 of same story:

Electronic medical records putting patients at risk – Nepean Hospital

Posted 07/05/2009 at 05:12 PM by StreetCorner.AU

Staff in the Nepean Hospital Emergency Department have banned the use of the new electronic medical records system after it failed for the second time in three days on Tuesday, putting patients at risk, Shadow Minister for Health Jillian Skinner said today.

According to Jillian Skinner, medical officers have revealed the latest shut down at the Nepean Hospital ED on Tuesday lasted for two hours, leading to staff deciding on Wednesday they no longer had faith in the new system.

“Staff report the electronic medical records system is so cumbersome that senior medical officers who previously saw 8-10 patients in a shift, are only getting through 5-7 because they spend so much time trying to access or enter information” said Mrs Skinner [a.k.a. a mission hostile user experience, itself potentially deadly in an emergency department - ed.]

“When the system failed again on Tuesday it meant there were no records of what a patient was there for, no record of treatment so far, no record of tests ordered, no record of test results and no record about what medication may have been given. Skinner reported that emergency staff at Nepean Hospital decided yesterday to pull the pin on using electronic records and are now working with pen and paper because they don’t trust electronic medical records system.

A situation in an ED where "there are no records of what a patient was there for, no record of treatment so far, no record of tests ordered, no record of test results and no record about what medication(s) may have been given" would seem to my medical mind to reflect a risk to patient safety. Fortunately there are some in the press who report such issues in a credible manner.

It also seems this system either presented a Mission Hostile User Experience, or a Blue Screen of Death User Experience to clinical users.




Considering the contractual blackout that exists in the U.S. on information regarding health IT failures, one wonders how many situations of failure "that don't compromise patient safety" occur on a daily basis on this side of the equator.

At some point, hospital IT departments and leaders will need to be subject to the same rigor as other key hospital employees. Letting them act as an unaccountable priesthood who, when they screw up, are given absolution by executives equally complicit in defending the mediocre, rather than being subjected to Darwinian forces, must end before patients get killed.

-- SS