AstraZeneca Settles

Here is the latest in the parade of legal settlements of cases of alleged wrong-doing by health care organizations.  As reported by Duff Wilson in the New York Times, The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.One of the investigations related to 'selected physicians who participated in clinical trials involving Seroquel,' AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug. Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm. Tony...

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An Alliance on Mental Illness or for Pharmaceutical Companies?

A recent article by Gardner Harris in the New York Times focused on the financial links among health care corporations and not-for-profit disease (or patient) advocacy groups.A majority of the donations made to the National Alliance on Mental Illness, one of the nation�s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry. Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request...

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The Implementation Workgroup Testimony

Yesterday I spent the day in Washington with the HIT Standards Committee's Implementation Workgroup . The online forum to comment about standards adoption and implementation is now available.The first article was posted by Aneesh Chopra, the US CTO. The second, my summary of the standards work thus far, will be posted this morning. Additional articles will be posted by others members of the HIT Standards Committee in the next week.Whenever I hear testimony from teams of smart people, I try to distill everything I've heard into "Gold Star Ideas" - those themes that surfaced over and over. Here are a few:1. We've learned from other industries that starting with simple standards works well. Mastering web transport standards such as REST takes minutes. Learning RSS takes an hour. ...

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Food Allergies at College

We're still years away from dealing with food allergies at college. I have heard from friends, though, that many campuses have set up food allergy policies. This article, in the Miami Hurricane, student newspaper of the University of Miami, features food allergy issues. FAAN (Food Allergy and Anaphylaxis Network) recently started a site where parents and students can find out how food allergy friendly campuses are. You enter the name of the university and search. The FAAN College Network seems to be fairly new with limited data at this time. But, check back as more campuses provide information. This could be a great tool for families. I love the concept.Have any of you dealt with food allergies and colleges? What's it been li...

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That 70's Show

My parents recently remodeled their 1970's home, removing the formica, shag carpeting, and textured ceilings.Seeing their modern home made me reflect on my personal history in 1976 when their home was built.I had just started high school at Palos Verdes High. I was a cross country runner and a geeky engineering type wearing aviator glasses, a shaggy haircut and weighing 120 pounds. This photo is of me, Will Snow (my best friend from high school), and a team of engineers from Rockwell. We had the opportunity to tour the Columbia Space shuttle and explore its engine components as they were being built in Southern California. Will and...

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Failing to Report Adverse Effects of Treatments

We have frequently advocated the evidence-based medicine (EBM) approach to improve the care of individual patients, and to improve health care quality at a reasonable cost for populations. Evidence-based medicine is not just medicine based on some sort of evidence. As Dr David Sackett, and colleagues wrote [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link here. ]Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. One can find...

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Implementation and Adoption Hearings

Tomorrow from 9am to 4pm at the Omni Shoreham Hotel in Washington DC, the Implementation Workgroup of the HIT Standards Committee will hold hearings to identify enablers and barriers to the adoption and implementation and standards. We've assembled a great group from non-healthcare industries, providers, vendors and quality measurement organizations. Testimony will includeNon-Healthcare Industries PanelSkip Best and Davis Miller, CovisintAdam Bosworth, XML and SQLClarence So, Salesforce.comProviders PanelAndy Wiesenthal, MD, Kaiser Permanente (IDN)Dick Taylor, MD, CMIO, Providence Health, Portland, OR (IDN)Rick Warren, VP/CIO, Allegiance Health, MI (Community Hospital)Lisa Bewley, RN, VP/CIO, Regional West Medical Center, Scotts Bluff, NE (Community Hospital)Louis Spikol, MD, Allentown,...

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Getting Enough Vitamin D

A recent study out of Harvard reveals that one in five children between the ages of one and eleven, are not getting enough Vitamin D. We need vitamin D to help maintain calcium levels to keep our bones strong. It also turns out that this vitamin might help prevent serious diseases, including infections, osteoporosis, diabetes and even some cancers. It's important. For people with food allergies, getting enough vitamin D may be challenging. In the U.S., milk is fortified with Vitamin D. For the dairy allergic, getting vitamin D by drinking milk is not an option. Turns out, milk alone (even 8 glasses a day!) is not an adequate source. A glass of milk typically contains 50-100 IU. We may need between 1,000 to 2,000 IU per day of vitamin D. Research is ongoing to pinpoint the daily requirement...

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"Project" and "Product" Certification

Last Friday night I testified to the President's Council on Science and Technology (PCAST). Many issues were discussed, but one of the most interesting was the idea of "project" verses "product" certification.Here's the significance.In Massachusetts, Partners Healthcare and Beth Israel Deaconess use home built EHR solutions based on Intersystems Cache. We both use Sun's eGate (now Oracle) and Intersystems Ensemble as middleware. We both use datamarts/data warehouses based on extracts from our clinical systems to support quality reporting, performance measurement and research. We both use NEHEN as our healthcare information exchange.We'll achieve meaningful use via this combination of applications with many moving parts. Its totality provides the tools our stakeholders need. We need...

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Who Should Sponsor Comparative Effectiveness Research?

We have tried to argue why comparative effectiveness research is a good idea. To cut and paste what I wrote in a previous post,Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only...

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Miss Roben's, The Allergy Grocer, is Back

Oh, how I've missed you, Miss Roben's...For those of us who have been buying allergy friendly foods for awhile, Miss Roben's was a one-stop shop. Only available through mail order, Miss Roben's and The Allergy Grocer, offered a wide variety of foods and helpful telephone advice. Then came news that Miss Roben's was out of business. Many of us struggled to find substitutes for our favorite mixes and ingredients. Shopping several companies meant increased shipping and handling costs. It was a big loss to the food allergy community. Then, finally a few months ago, brought news that Miss Roben's and The Allergy Grocer would be back- bigger and better. Well, they're here. I just got off the phone with Seth. They've got an updated website and will offer live chat as well as online and telephone...

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Accelerating Implementation of Laboratory Standards

On October 20, the Information Exchange Workgroup of the HIT Policy Committee heard testimony from laboratory information exchange experts and stakeholders.The agenda and testifiers included:Business Issues related to the Electronic Exchange of Laboratory Data ? Mike Nolte, GE Health Systems ? Vasu Manjrekar, eClinicalWorks ? Phil Marshall, WebMD ? Tim Ryan, Quest Diagnostics ? Susan Neill, Texas Department of State Health ServicesBusiness Issues related to the Electronic Exchange of Laboratory Data ? Laura Rosas, New York City Primary Care Information Project ? Sarah Chouinard, Primary Care Systems, Inc. and Community Health Network ? Raymond Scott, Axolotl Corporation ? Areg Boyamyan and Jim Timmons, Foundation LibraryRegulatory and Policy Issues ? Joy Pritts, Georgetown University...

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Clinic's medical files vanish

At "Data Malpractice on T-Mobile Sidekick: But Don't Worry, Your Medical Data is Safe", on Oct. 16 I wrote:One of the promises made about healthcare IT is that your medical data is "safer" in electronic form than in paper form. The Hurricane Katrina example of paper records being destroyed is often used as a poster example of the dangers of paper records.However, the risk of electronic storage of information, especially the talk of national EMR's stored on the "cloud" (an amorphous term meaning distributed storage "out there" whose physical sites and boundaries are supposedly irrelevant from the user's perspective) has also been under-reported.Personal customer data had been "lost" from many of T-Mobile USA's Sidekick devices due to a computer malfunction, although the data was apparently...

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Washington Post Article: Electronic medical records not seen as a cure-all

Regarding the very well done Sunday Oct. 25, 2009 story in the Washington Post "Electronic medical records not seen as a cure-all" by staff writer Alexi Mostrous - signup may be required for access - I have several observations.(Not including the observation that Mr. Mostrous probably deserves an award for being the first major newspaper reporter to broach this topic in a serious and balanced manner.)First, I believe healthcare IT can live up to all the predictions made about its benefits - but only if done well. There is massive complexity behind those two words "done well", and that is HIT's key stumbling block in 2009. I believe we are only in the adolescent stage of knowing how to "do health IT well."Second, I should point out that the intended consequences of health IT include, among...

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Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors

Senator Grassley has sent a letter out to ten major health IT vendors seeking information on health IT problems and flaws. The letter can be retrieved from this link (PDF) at the Washington Post. Read the whole thing.It is linked via a Washington Post story "Electronic medical records not a cure-all", Sunday Oct. 25, 2009, by staff writer Alexi Mostrous. The WaPo article itself seems to require registration. I will comment on the article in future posts.Addendum 10/25: I have now commented on the article here.--...

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"Organisational Ethics Policies; A Primer"

I regret that it took me so long to find an essay on "Organisational Ethics Policies" by Howard Whitton, available from the European U4 Anti-Corruption Resource Center. While it was written with international non-governmental organisations (NGOs) who "administer aid programs" in mind, it seems applicable to all kinds of NGOs and not-for-profit organizations, including those in health care. In the US, most medical schools and their parent universities, most hospitals and academic medical centers, essentially all medical societies and disease advocacy groups, and some insurance companies and managed care organizations are not-for-profit.The main points of the paper are its summaries of the basic elements of "effective ethics policies."First, such a policy- must first have unequivocal authority...

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Cool Technology of the Week

I'm sitting at Logan Airport awaiting a plane to Washington to testify at a meeting of the President's Council of Advisors on Science and Technology at the National Academic of Sciences. A few minutes ago, I noticed that the tarmac was empty of planes and numerous black SUVs appeared. Then I noticed a few military folks running around the roof of Terminal C. I looked to the north and saw a large 747 approaching - Air Force One. Realizing that today is Friday and its time for my Cool Technology blog, I'd like to declare Air Force One the cool technology of the week. I've always wondered what electronics are on board. Here's an overview...

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Food Allergies: A YouTube Sensation

Do you know there are over 2,000 YouTube videos devoted to food allergy? You can find everything from a mom conversation with Disney chefs about food allergies to recipes to back to school tips.The ones I like the best are devoted to teaching children about food allergies. Look through the list and see if you can find a few that help your family deal with food aller...

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The Books on My Nightstand

A year ago I wrote about the books on my nightstand. Here's an update of what I'm currently reading:The Deadly Dinner Party by Jonathan Edlow - a great collection of medical mysteries written by my colleague in the BIDMC emergency department. You'll find hard to solve cases with diagnoses such as botulism, typhoid, and bath water infected with tropical organisms from pira�a. House meets Sherlock Holmes.The Lady and the Monk by Pico Iyer - The story of world traveler Pico Iyer's year in Kyoto and his immersion into Japanese culture. As a fan of Japan, I can certainly relate to the rich experiences he describes in his travels. Some folks have suggested that my disciplined life, black attire, and continual pursuit of a simpler existence gives me a monk-like character.The China Study...

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National eHealth Collaborative Forums

I'm posting this on behalf of the National eHealth Collaborative.Please join the National eHealth Collaborative (NeHC) Board of Directors as it hosts a series of interactive discussions with experts and stakeholders on important and timely topics in health information technology.Bedside to Bench: How Health IT Can Power Better Clinical ResearchNeHC Board Member Stephen Ruberg, PhD will talk with a panel of experts about how interoperable electronic health records and other technology tools can significantly improve the quality and efficiency of clinical research. The discussion will cover a number of perspectives in this area, from clinical trials and drug surveillance to government-funded research to cure chronic disease.The Backbone of the Healthcare System: Nurses� Critical Role in Health...

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My conflicts of interest - FY10 edition

Every year I publish my conflicts of interest publicly, such 2008 and 2009 It's that time again.My salary is paid by Beth Israel Deaconess Medical Center for my duties as CIO.BIDMC invoices Harvard Medical School for the time I spend there.In 2009, NEHEN and MA-Share merged, so my only position in state-level healthcare IT is Chair of NEHEN, an unpaid position with no benefits/authority/special treatment of any kind.I will serve as the chair of HITSP until January 31, 2010 when my term expires. For the past 4 years of HITSP service, I have not received any compensation or benefits. My plane flights to Washington have been reimbursed at cost.I will serve at the vice-chair of the HIT Standards Committee for as long as it suits ONC and the Committee. I will not receive any compensation...

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Flu Vaccine for Egg Allergic?

The Food Allergy Asssistant received many comments on the post related to HINI vaccine and egg allergy. There is much confusion and alarm for our children with egg allergies who are affected by the egg-based method for making flu vaccine. I've done more research and this is what I found:There is much interest in a cell-based flu vaccine that would be safe for those with egg allergy.The technology currently used to make our chicken egg-based flu vaccine is over 50 years old.The new technology is animal cell based, rather than egg based. This process could save weeks in manufacture time and is less likely to become contaminated.One company, Novartis, is close. They are building a plant in Holly Springs, NC with hopes of completion in 2010 or 2011. Novartis clinical trials of a cell based flu...

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Gisborne Fimmaker Finalist In Los Angeles film festival

From http://www.infonews.co.nz/news.cfm?l=1&t=72&id=43589FILM 20 October 2009, 1:18PMGisborne Filmmaker Finalist In Los Angeles Film FestivalBy Adage Business & Media ServicesGISBORNEGisborne Filmmaker, Polly Green�s latest film Soft Power Health, a short documentary film about professional kayaker Dr. Jessie Stone�s humanitarian aid efforts in Uganda, has just been announced as a finalist in the My Hero Short Film Festival in Los Angeles, and is up for the Dan Eldon Activist Award.Three years after the debut of her first short film, Nomads, filmmaker Polly Green returned to Uganda to follow the progress of Soft Power Health, the...

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What keeps me up at night - FY10 edition

Life as a CIO is never boring. In Sunday's Boston Globe, Microsoft CEO Steve Ballmer said �What�s the old movie line from �Annie Hall�? Relationships are like sharks; they move forward, or they die. Well, technology companies either move forward, too, or they die. They become less relevant.�No matter what an IT organization has accomplished in the past, what matters is daily infrastructure performance and the ability to constantly improve applications. I call this problem "changing the wings on 747 while its flying". Rapid change and complete stability must be achieved at the same time.Here are the change management issues keeping me up at night in my various organizations.BIDMCIntranet - we're introducing a new intranet organized around social media concepts : tag clouds, blogs,...

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