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

Went Walkabout. Brought back Google Wave.

Back in early 2004, Google took an interest in a tiny mapping startup called Where 2 Tech, founded by my brother Jens and me. We were excited to join Google and help create what would become Google Maps. But we also started thinking about what might come next for us after maps.

As always, Jens came up with the answer: communication. He pointed out that two of the most spectacular successes in digital communication, email and instant messaging, were originally designed in the '60s to imitate analog formats — email mimicked snail mail, and IM mimicked phone calls. Since then, so many different forms of communication had been invented — blogs, wikis, collaborative documents, etc. — and computers and networks had dramatically improved. So Jens proposed a new communications model that presumed all these advances as a starting point, and I was immediately sold. (Jens insists it took him hours to convince me, but I like my version better.)

We had a blast the next couple years turning Where 2's prototype mapping site into Google Maps. But finally we decided it was time to leave the Maps team and turn Jens' new idea into a project, which we codenamed "Walkabout." We started with a set of tough questions:

• Why do we have to live with divides between different types of communication — email versus chat, or conversations versus documents?
• Could a single communications model span all or most of the systems in use on the web today, in one smooth continuum? How simple could we make it?
• What if we tried designing a communications system that took advantage of computers' current abilities, rather than imitating non-electronic forms? 

After months holed up in a conference room in the Sydney office, our five-person "startup" team emerged with a prototype. And now, after more than two years of expanding our ideas, our team, and technology, we're very eager to return and see what the world might think. Today we're giving developers an early preview of Google Wave.

A "wave" is equal parts conversation and document, where people can communicate and work together with richly formatted text, photos, videos, maps, and more.


Here's how it works: In Google Wave you create a wave and add people to it. Everyone on your wave can use richly formatted text, photos, gadgets, and even feeds from other sources on the web. They can insert a reply or edit the wave directly. It's concurrent rich-text editing, where you see on your screen nearly instantly what your fellow collaborators are typing in your wave. That means Google Wave is just as well suited for quick messages as for persistent content — it allows for both collaboration and communication. You can also use "playback" to rewind the wave and see how it evolved.

As with Android, Google Chrome, and many other Google efforts, we plan to make the code open source as a way to encourage the developer community to get involved. Google Wave is very open and extensible, and we're inviting developers to add all kinds of cool stuff before our public launch. Google Wave has three layers: the product, the platform, and the protocol:

• The Google Wave product (available as a developer preview) is the web application people will use to access and edit waves. It's an HTML 5 app, built on Google Web Toolkit. It includes a rich text editor and other functions like desktop drag-and-drop (which, for example, lets you drag a set of photos right into a wave). 
• Google Wave can also be considered a platform with a rich set of open APIs that allow developers to embed waves in other web services, and to build new extensions that work inside waves.
• The Google Wave protocol is the underlying format for storing and the means of sharing waves, and includes the "live" concurrency control, which allows edits to be reflected instantly across users and services. The protocol is designed for open federation, such that anyone's Wave services can interoperate with each other and with the Google Wave service. To encourage adoption of the protocol, we intend to open source the code behind Google Wave. 

So, this leaves one big question we need your help answering: What else can we do with this?

If you're a developer and you'd like to roll up your sleeves and start working on Google Wave with us, you can read more on the Google Wave Developer blog about the Google Wave APIs, and check out the Google Code blog to learn more about the Google Wave Federation Protocol. 

If you'd like to be notified when we launch Google Wave as a public product, you can sign up at http://wave.google.com/. We don't have a specific timeframe for public release, but we're planning to continue working on Google Wave for a number of months more as a developer preview. We're excited to see what feedback we get from our early tinkerers, and we'll undoubtedly make lots of changes to the Google Wave product, platform, and protocol as we go.

We look forward to seeing what you come up with!

Update @ 7:07PM: The video of the Google Wave keynote presentation is now available:

Posted by Lars Rasmussen, Software Engineering Manager

Search engineer stories

I came to Google because I wanted to work on hard problems and have a big impact on the world. Four years later, I'm still constantly awed by how challenging search is. We work on improving the entire search process, including formulating queries, evaluating results, reading and understanding information, and digging deeper with this new information. Every day we work on ways, both big and small, for search to be better, faster, and more effortless.

My fellow engineers and I wanted to give a peek into some of the challenges we face and how we're trying to make search even better. We created a series of short videos so you could hear straight from the engineers. Here's mine, where I talk about a change to spell suggestions.



Some of the videos may talk about things you are already familiar with and some may be new. Either way, we hope that you enjoy hearing these stories, and do stay tuned for more!

Posted by Patrick Riley, Software Engineer

Kicking off 2nd annual Google I/O developer gathering

Today is the first day of Google I/O — two days of developer talks, fireside chats and demos, all focused on the latest innovations in the web as a development platform. We're excited to have this chance to welcome more than 3,000 developers to the Moscone Center in (unusually) sunny San Francisco for a variety of interactive roundtables and talks on subjects like Android, Google Maps and Google Apps for the Enterprise.


We'll be back with more news as the conference progresses. In the meantime, you can follow updates on the @googleio Twitter stream; videos of all sessions will be available on code.google.com shortly after they conclude.

Update @ 3:20PM: Videos from Day 1 of Google I/O are now available on our YouTube playlist.

Posted by Emily Wood, Google Blog team

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."

New logo look

You may have noticed new logos at the top of some of Google's web pages, including Google Labs, Google Moderator, and Google Code. These are the result of a new logo design we are rolling out. We hope this design freshens up our look as well as improves consistency and ease of use across our sites. Now, our product names will appear in clean, simple blue lowercase type alongside the Google logo as shown here:

Since the logos appear in many different locations and sizes on our websites, our new designs are standardized to be the same size and color wherever they appear. This should make it easier for you to recognize which site you are on and navigate to wherever you want to go. They are also consistent across all our international domains, which is especially helpful for people using right-to-left languages such as Arabic and Hebrew.

We are happy with this change since it will help us streamline our user experience. Count on seeing the new logos rolling out to Google Maps, Google News, Google Docs and more over the next few weeks.

Posted by Marissa Mayer, Vice President of Search Products and User Experience, and Jamie Divine, Senior Visual Designer

Netlog integrates with Google Friend Connect

When we started building Friend Connect, we wanted to provide a fully open system — one that lets you join any website and interact with the people there in a meaningful way, regardless of where they come from. To enable this kind of engagement, we used open standards like OpenID, OAuth, and OpenSocial as underlying technologies, enabling any other service to plug into Friend Connect.

Today, we're excited to share that Netlog has used these open standards to integrate their social networking service with Google Friend Connect. Now, Netlog's more than 45 million users across Europe can:

• Sign into any of the millions of sites and blogs using Friend Connect with their Netlog credentials
• Use their Netlog profiles on these sites
• See if any of their friends are already members of the same sites and invite other Netlog friends to join
• Share their Friend Connect activities with their friends on Netlog, and
• Send messages back to their Netlog friends

Additionally, for sites that are already using Friend Connect, one of the benefits of this standards based model is that they can take advantage of any new service that chooses to join this open ecosystem, like Netlog, without any additional work. The new network option simply appears.

Any social network or service, whether they are large or small, regional or global, niche or general audience, is welcome to take advantage of these open standards to integrate with Friend Connect, and participate in an open social web.

Posted by Mussie Shore, Product Manager

Put the pedal to the metal with a faster Google Chrome

We introduced Google Chrome back in September, and it's received a great response so far. Since launching, we've been working hard on adding the top requested features and making Google Chrome even faster.

Today, we are updating to a new version of Google Chrome that is faster than ever. JavaScript-heavy web pages will now run about 30% faster. See the chart below or compare scores yourself.

Additionally, we've added some useful features like form autofill, full screen mode, and the ability to remove thumbnails from the New Tab page. Here's a short video demonstrating some of this new functionality:



If you're already using Google Chrome, you'll be automatically updated with these new features soon. If you haven't downloaded Google Chrome, get the latest version at google.com/chrome.

To read more about this update, visit the Google Chrome blog.

Posted by Darin Fisher, Google Chrome Team

Faster is better on Google Suggest

As we prepared to write this post, we discovered a common childhood passion for fast things: high-speed trains, roller coasters, firetrucks, and more. That may be a key part of why we're so excited to be working on Google Suggest, since it saves time by giving suggestions as we're typing our searches.

Today, we're introducing more features to Google Suggest to help you make your searches even faster. These features are rolling out gradually, so you should be able to see them soon.

Suggestions on the results page
Previously, we only showed suggestions based on your original search input. Now, when you make a search from a results page, we provide suggestions that relate to the current results page. As you can see in the example below, if your previous search was for roller coasters, when you begin a new query the first few suggestions are still related to roller coasters — helping you refine your search queries to quickly find what you want.


Personalized suggestions
Trying to remember that query which gave you the best results? You're not alone! We estimate that about a quarter of all signed-in searches are repeats from the past month. Now, if you're signed in with your Google account and have Web History enabled, we may show some of your relevant past searches as you type. Personalized suggestions will make it easier and faster for you to repeat searches that have worked before. Or, if you need to step away in the middle of a search task, this will help you continue your search tasks at a later time.

You can remove a personalized suggestion that you do not like by clicking "Remove", which will remove the search from your Web History. You can also remove searches from your Web History directly, manage Query Suggestions on the preferences page, or sign out of your Google account entirely to stop seeing personalized suggestions.

Navigational suggestions
If your first keystrokes indicate that you may be looking to navigate directly to a specific site, we'll list it and send you straight there if you click on it.

Sponsored links in suggestions
Similar to the navigational suggestions above, sometimes we detect that the most relevant completion for what you're typing is an ad. When an ad is shown, we mark it with the text "Sponsored Link" and a colored background, as on the results page.

We are also introducing a couple more changes to Suggest: we will no longer show the result count for items in the suggest box (we've gotten feedback that the numbers were not helpful in comparing the relevance of the queries) and we now bold the text of suggestions to help you more quickly scan the list. To learn more about Google Suggest, check out the help center.

We hope these new features save you time, so that you can get back to roller coasters, high-speed web surfing, action movies and each other that much faster.

Posted by Jonathan Effrat, David Kadouch and Matt Kulick, Product Managers

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.

Congratulations Eric Yang, winner of the 2008-2009 National Geographic Bee

1. Timis County shares its name with a tributary of the Danube and is located in the western part of which European country?

2. Name this eastern European capital city, where a flight from the southeast would approach the city by flying over the Rhodope Mountains.

3. Name this city in Oceania, the largest on South Island, where a flight from the west would approach the city by flying over the Southern Alps.

If you're stumped, you're not alone! For 55 fourth- to eighth-graders, though, these sorts of questions represented the culmination of months of hard work studying maps and absorbing geographic knowledge.

Earlier today I had the honor of speaking at the championship round of the 2008-2009 National Geographic Bee — moderated by Jeopardy!’s Alex Trebek for the 21st year. This year, Google Earth is sponsoring the Bee in support of its mission to raise awareness and support of geography education. Held at National Geographic’s Washington, D.C. headquarters and broadcast on public television stations across the country, the competition inspires and challenges students to better understand the world around them. 

Eric Yang, who didn't miss a single question in the finals, won on the third question of a tiebreaker round by answering the first question above. Eric, a 7th grader from Texas, has already scored 2200 on his SATs!

It wasn't just the students who came away from the day re-energized and excited about geography. I was also lucky enough to meet a number of passionate educators like Rebecca Montgomery, a teacher from Mississippi, who administered the state bee there this year and told me that "the bee had a tremendous impact on our schools this year and I know now what we need to do to get kids ready to learn geography."

Here at Google, we're always excited to see how innovative teachers are using tools like Google Earth and Maps to engage students by putting the world's geographic information at their fingertips. I'm particularly happy to have been part of the Bee today because geography and mapping were such a big part of what led me to help create Google Earth. I'm not the only Googler who fell in love with maps at an early age, though. Check out this video to see how some of my fellow mapmakers started down the path that eventually brought them to their current profession:



We'll be watching to see what lies ahead for today's passionate young geo whizzes. Congrats again to all the Bee competitors, and happy exploring!

Answers: 1. ɐıuɐɯoɹ 2. ɐıɟos 3. ɥɔɹnɥɔʇsıɹɥɔ 

Posted by Brian McClendon, Director of Engineering, Google Earth and Maps

Announcing the 2009 Doodle 4 Google Winner

Nearly six million online votes helped us pick the winners of this year's Doodle 4 Google competition from a very creative pool of doodles. Today, we're pleased to announce the results.

Congratulations to Christin Engelberth, a sixth grader at Bernard Harris Middle School in San Antonio, Texas. She titled her doodle "A New Beginning" to express her wish that "out of the current crisis, discoveries will be found to help the Earth prosper once more."


Christin will receive a $15,000 college scholarship, a laptop, and a $25,000 technology grant for her school. Her doodle will be featured on the Google.com homepage tomorrow for millions of people around the world to see.

Our congratulations also go out to the three national finalists. They were selected as having the best doodle in their grade groups and will each receive a laptop computer:

Grades K-3
Miriam Elizabeth Lowery ~ Grade K, Austin Peay Elementary
Covington, TN
"Friendship Around the World"

Grades 7-9
Blakely Linz ~ Grade 7, Indian Hill Middle School,
Cincinnati, OH
"Stop to Smell the Flowers"

Grades 10-12
Emerald Lu ~ Grade 10, Covington Latin School
Covington, KY
"From the Ashes"

Our four winners were announced at a special event today at the Smithsonian's Cooper-Hewitt, National Design Museum, where we also unveiled an exhibit of the top doodles that will be on view until July 5, 2009. The finalists were treated to a day in New York City that included activities which promote peace, sustainability and wellness — all inspired by this year's theme, "What I Wish for the World." And of course, Dennis Hwang and our doodle team led a doodling class for all top regional finalists in New York city.

We have one more winner to announce: Clark County School District in Las Vegas, Nevada, is the recipient of the District Quality Participation Prize. They will receive a $10,000 technology grant for having the greatest quality participation.

Thanks to all those who voted and helped us find this year's winners. And thank you to all the creative kids out there who submitted entries. We hope you'll doodle with us next year!

Update @ 10:45 AM: We've posted all of the state finalists — several hundred doodles in all —on the Doodle 4 Google website and we encourage you to take a look at the beautiful artwork created by these very talented young artists.

Posted by Marissa Mayer, Vice President of Search Products and User Experience, and Dennis Hwang, Webmaster Manager

Energized about our first Google PowerMeter partners

Earlier this year I blogged about energy information and a tool our engineers developed called Google PowerMeter, a Google gadget that can show consumers their personal electricity consumption right on a home computer. Our software relies on "smart meters" (or other metering devices) as a data source. Over the past several months we've been looking to partner with utilities that are installing (or have already installed) this equipment in their customers' homes. We're energized by our very first Google PowerMeter partners:

• San Diego Gas & Electric® (California)
  
• TXU Energy (Texas)
• JEA (Florida)
• Reliance Energy (India)
• Wisconsin Public Service Corporation (Wisconsin)
• White River Valley Electric Cooperative (Missouri)
• Toronto Hydro–Electric System Limited (Canada)
• Glasgow EPB (Kentucky)

Our initial partners include utilities with millions of customers as well as smaller ones. They are rural and urban, privately held and municipally run. Some are in the United States, others in Canada and India. They all have one thing in common — a desire to serve their customers by providing access to detailed information that helps save energy and money. For now, Google PowerMeter is only available to a limited group of customers, but we plan to expand our roll out later this year. Our utility partners are leading the charge to make the electricity grid smarter and we look forward to working with them and others.

In addition to utilities, we're also seeking partnerships with companies that can enable the implementation of our software. Our first such partner is Itron, a leading meter and data management company that serves over 8,000 utilities and is helping some of their customers, including San Diego Gas & Electric, integrate with Google PowerMeter. If you're a utility or company with a smart meter project that might be interested in plugging in to our efforts, visit our website for more information.

Posted by Ed Lu, Engineering team

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.