FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just 'Tip of Iceberg'

The Office of the National Coordinator for Health IT held a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available at this link.At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA�s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking:He wrote:... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm � including 44 reported injuries...

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Cool Technology of the Week

I try to be an early adopter of emerging technologies so that I can assess their readiness for the marketplace, reporting on the good and the bad in an effort to benefit my colleagues. On the green energy front, I retired incandescent bulbs in my household and converted to compact fluorescents (CFL) very early in the product development cycle. All in all it was a great experience, although the first CFLs had a harsh cool white light.Recently, I've explored the next generation of replaceable home light bulbs - Ultra LEDs. Sylvania has introduced 40 watt LED light bulbs with an essentially infinite lifespan, no mercury, little heat, and a...

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Food Allergy Conferences

Have you registered for "Every Bite Counts", the annual conference sponsored by FAAN (Food Allergy and Anaphylaxis Network)? This year marks the 17th year of this conference. A fourth location has been offered, Las Vegas. I always wondered why there wasn't a location available for those on the left coast. This new venue offers an opportunity for those who live in west to attend the conference without traveling to the East coast or Chicago.The other exciting news about the conference is that multiple tracks will be offered. Those of us who attended in the past noted that the conference was virtually the same each year. Food allergy veterans did not need to hear about basic food allergy information. Now, newbies can attend a session for the newly diagnosed, while those of us who have been at...

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Bring Back the DSI*? - the Avandia Case as Spy Novel

Starting in 2007, we posted quite a bit about the "Avandia case," which centered on whether Avandia (rosiglitazone, by GlaxoSmithKline), a glucose lowering drug for type 2 diabetes, presented excess cardiovascular risks, and how evidence about these risks was handled.  SummaryThe Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone then available.  Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug which remained unpublished.  These...

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Where You Start Is Not Where You End

I've written about my daughter's exploration of colleges and my sense that college fit for her including teaching style, student peers, setting, culture, and extracurricular activities is more important than US News and World Report rankings or the parental ego boost from the college prestige beauty contest.As an experiment, I asked several of my staff where they went to college.There was no correlation between their current roles and the prestige ranking of their college. College was a nurturing experience that enabled them to explore their interests, find themselves, and build the skills to succeed in life. Graduate school did correlate a bit. Aiming for a great Master's program (MS, MBA, MPH, MPA) is an enabler to find a good job.Interestingly, of the folks I work with in Washington,...

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The February meeting of the HIT Standards Committee

At the February 24 meeting of the HIT Standards Committee we heard reports from each of our workgroups reviewing the Interim Final Rule.Clinical Operations*If regulatory language allows, the best way to support standards specificity while still enabling standards to evolve is to list general classes of standards in the regulation i.e. HL7 Version 2 and then provide very specific implementation guidance outside the regulation. If specificity is needed within the regulation, then the inclusion of a single implementation guide as a floor, with the intent that it will evolve, would meet this need.*Standards should refer to data exchanges between organizations, not within an organization. An entity should be free to use whatever proprietary approaches to content and vocabulary standards support...

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The Argument Over Insurance Rate Hikes: A Systemic Problem with Health Care Organizations' Leadership and Governance?

There has been a tremendous amount of news coverage of a large rate increase proposed by Anthem Blue Cross, a subsidiary of WellPoint, in California.  For example, the Los Angeles Times reported last week,Congress opened an investigation Tuesday into Anthem Blue Cross' impending rate increases in California as President Obama cited the premium hikes -- some as high as 39% -- in his bid to pass national healthcare legislation.The House Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations announced they were examining the increases, which are set to take effect March 1. The subcommittee has scheduled a Feb. 24 hearing in Washington, while an Assembly committee in Sacramento has set a hearing for Feb 23.'Reports of premium increases up to 39% are deeply...

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Forgotten First Principles in Healthcare IT

A review of several first principles might serve as a useful addendum to the posting "Health IT Caused Death & Injury, Extent Unknown, But Regulation Bad."First principle: A computer can free professionals from tedious, repetitive work which does not require judgment. It can provide facts and figures with lightning speed, giving domain experts more time to exercise their judgment thoughtfully [source].Reality: HIT commonly makes work more tedious for clinicians, and there seems to be a not-so-subtle view in the industry that HIT can -- and should -- replace or oversee their judgment, and that clinicians are luddites for not embracing the "platform opportunities."First principle: Clinicians need sysems built upon user-centric design principles (PDF) that provide cognitive...

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Health IT Caused Death & Injury, Extent Unknown, But Regulation Bad Since it Would Slow Government's Campaign To Spur Widespread Adoption

[Note: the hyperlinks in this posting are very informative, so do check them - ed.]A workgroup of the Healthcare IT Policy Committee, a federal advisory body, will hear testimony on the safety of health information technology during a public hearing tomorrow (Feb. 25, 2010) in Washington.On the eve of that hearing, an article "FDA Considers Regulating Safety of Electronic Health Systems" was published Feb. 23, 2010 by the Huffington Post Investigative Fund, authored by Fred Schulte and Emma Schwartz.The article is bylined with "Reports of Patient Harm Include Six Deaths in Two Years."FDA Considers Regulating Safety of Electronic Health SystemsReports of Patient Harm Include Six Deaths in Two YearsBy Fred Schulte and Emma SchwartzHuffington Post Investigative Fund23 Feb 2010Concerned...

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School Districts and Food Allergies

Isn't it wonderful to read things like, "proactive", "district-wide awareness", and "inclusion of all children"? "Advocating for Allergy Education", published in the Valley News Dispatch, discusses numerous districts in the Pittsburgh PA area and how they handle food allergies.I like what I'm reading and hope to see more school districts promote education and acceptance when it comes to food allergies. Read it and see what you think. For those of you who don't have a school district that is quite so understanding, use some of the phrases from this article to talk to your school officia...

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HIT Policy Committee Meaningful Use Revisions

On February 17, the HIT Policy Committee held an important meeting to discuss its recommended revisions to meaningful use.The handouts areMeaningful Use Workgroup: Comments & Discussion on the NPRM NPRM RecommendationsAdoption/Certification Workgroup: Comments & Discussion on the NPRM and IFR on Certification Criteria Information Exchange Workgroup: Comments & Discussion on Health Information Exchange in the NPRMPrivacy & Security Policy Workgroup: Comments & Discussion on the Privacy & Security Objective in the NPRM NHIN Workgroup Recommendations Update: Strategic Plan WorkgroupThe important summary to read is the NPRM...

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Cardinal Health Settles, Novartis Settles

And the march of settlements continues....As reported by the Tulsa (Oklahoma) World,A company that provides hospital pharmacy management services in Tulsa has agreed to pay $1 million in civil penalties for failing to account for large amounts of missing prescription drugs, the U.S. Attorney's Office in Tulsa announced Friday.Cardinal Health Pharmacy Services agreed to settle allegations with the federal prosecutors' office, which alleged that the company's two Tulsa pharmacies were negligent and violated several provisions of the Controlled Substances Act.An audit showed that nearly 400,000 dosage units of hydrocodone, a painkiller, and 234,000 units of alprazolam, an anti-anxiety drug, were unaccounted for at the Hillcrest Medical Center pharmacy from October 2005 through June 2007, according...

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Vegan Doctors

In my 20's I was immortal (not immoral!), in my 30's I became obese and in my 40's I'm now aware of my own health and wellness. I believe you truly are what you eat.I think that Michael Pollan and T. Colin Campbell are right when they say "Eat food, not too much, mostly (or all) plants." Vegan eating works for me and certainly is worth trying yourself.I recently received the following email:"I ran across your blog through a google search for 'Vegan Physicians. I see that you are not a practicing (primary care) physician (to my chagrin ;-), so I wonder if you could recommend any vegan physicians who practice and/or support the vegan lifestyle through their practice?"I emailed noted author Neal Barnard for his advice. Neal responded:"We often receive requests from people looking for a doctor...

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Largest Food Allergy Study Set to Begin

After a promising pilot study, doctors at Addenbrookes Hospital in Cambridge will begin a government-funded immunotherapy trial next month. A similar study was conducted in the 1990's. It yielded serious consequences. The difference this time, explains researchers, is that rather than receiving injections of peanut protein, those in this study will receive increasing amounts of peanut flour mixed in yogurt. It is important to note that this study will only involve children. There will be a therapy and a control group. The control group will think they are getting peanut protein, but will in fact receive a substance of another type.Researchers think the children will need to continue this immunotherapy process for 2-3 years.Of course, it can not be stressed enough that this should not be tried...

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Deja Vu All Over Again - Sheffield Researcher Under Threat for Trying to Present Data that Offends Research Sponsor

It's deja vu all over again.  A case reported (so far only) in the UK Times Higher Education Supplement of a biomedical researcher apparently threatened because she tried to present data that did favor a particular commercial health care product. Here is the summary:An academic has risked the wrath of her university by submitting results to a forthcoming conference without permission.The University of Sheffield has claimed that the submission has been made in breach of a contract it has with a pharmaceutical company, which funds work in the scholar's field.Guirong Jiang, a research radiologist who has worked at Sheffield for 13 years, is due to face a disciplinary hearing over her actions this week.Her findings - submitted to a symposium of the European Calcified Tissue Society (ECTS),...

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