Another Human Bites Dog Story? Health Affairs Briefing on Healthcare IT Challenges

I recently received the announcement below. It announces a briefing to herald the release of a new edition of Health Affairs dedicated to healthcare IT.

The key phrase is this:

At this crucial moment [in healthcare IT] , Health Affairs devotes its forthcoming March-April 2009 issue to health IT—its transformative promise, but also the challenges to its adoption and the substantial dangers it could pose if that adoption is not done right. The issue will be released at a briefing on Tuesday, March 10, at the JW Marriott in Washington , D.C.

/Semi tongue-in-cheek tone ON

Substantial dangers from Health IT? Dangers as in - possible adverse effects? I'm stunned. Who knew?

... This sounds a lot like what I've been writing and taking heat for, for the past ten years:

While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition: the benefits will be realized only if clinical IT is done well. For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources. Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity.

The reason I call this story another possible "human bites dog" scenario (the first being here) is due to the speaker's list below.

Who knew?

Who knew that companies and foundations such as Cerner and Microsoft and Markle and Google acknowledged and embraced the concept that health IT could pose substantial dangers if adoption is not done right?

I certainly didn't. The press releases and seminars I attended by those organizations and the articles and advertisements I saw in journals always seemed to present HIT as a magic bullet, a panacea, a cybernetic miracle with no downsides, a plug and play solution to healthcare's ills.

I ponder this: a Google search on "Healthcare IT Failure" or similar concept turns up my web site and a few other writings on this issue, but precious little from the likes of Cerner, Microsoft, Markle, Google Inc., etc.

Google's search engine must be wrong! It's not listing all the links from these organizations going back years on the possible dangers of ill conceived and poorly implemented HIT. Someone call the Googleplex!

In fact, I authored an AMIA poster in '06 on this curious phenomenon, that search engine queries on the concept of healthcare information technology failure (a form of IT misadventure or IT malpractice) returned my website and writings and a few others' work, while a search on "medical malpractice" returned tons and tons of relevant hits:

Access Patterns to a Website on Healthcare IT Failure. AMIA 2006 Poster. Abstract [pdf], Poster [ppt].

(Even at AMIA the word "failure" in the same sentence as "Healthcare IT" did not seem to go over well, and the site now wears the term "difficulty" instead of the "F" word.)

When I spoke to representatives of some of these organizations about my work and similar work of others studying HIT failure, I received disdain at best, and at worst the response was as if I had lost my senses - or something.

Maybe these organizations were just afraid to tell me ten year's work was simply redundant, as their leaders -- through critical thinking, scholarly examination of the evidence, and candid corporate wide discussion -- had discovered these issues years before.

There are some known candid speakers at the briefing as well. The announcement is below:

Save The Date: HEALTH AFFAIRS Briefing

Stimulating Health Information Technology

Tuesday, March 10, 2009 – Washington , D.C.

There is widespread agreement that greater investment in information technology (IT) is critical to reforming U.S. health care. The use of such technologies as electronic health record systems, personal health records, e-prescribing, and computerized physician order entry holds the potential for vastly improving care at reasonable cost. Debate is now under way in Congress over how much to invest in health IT as a component of the economic recovery, or stimulus, package now being developed. The likelihood is that major public and private investments in the sector now lie ahead.

At this crucial moment, Health Affairs devotes its forthcoming March-April 2009 issue to health IT—its transformative promise, but also the challenges to its adoption and the substantial dangers it could pose if that adoption is not done right. The issue will be released at a briefing on Tuesday, March 10, at the JW Marriott in Washington , D.C. At the briefing, speakers will discuss the public policy issues surrounding health IT, particularly those raised by the health IT provisions in the stimulus package. Speakers will also discuss pioneering health IT initiatives, the privacy concerns raised by health IT, and industry health IT innovations.

The briefing and the new Health Affairs issue are supported by grants from the Markle Foundation, the California HealthCare Foundation, and the federal Agency for Healthcare Research and Quality.

Here are the details:

WHEN: Tuesday, March 10, 2009

9:00 a.m. – 12:30 p.m.

WHERE: JW Marriott [Metro Center]

1331 Pennsylvania Ave., NW, Washington, DC 20004

RSVP: RSVP for this event online at http://www.burnesscommunications.com/new/new_rsvp.htm?doc_id=824981 . For more information call Staci Gorden at 301-652-1558.

SPEAKERS: Carol Diamond , The Markle Foundation

Linda Dimitropoulos , RTI International

Colin Evans , Dossia Consortium

Louise Liang , Kaiser Permanente

Deven McGraw , Center for Democracy and Technology

Farzad Mostashari , New York City Department of Health

Peter Neupert , Microsoft Health Solutions Group

Neal Patterson , Cerner Corporation*

Deborah Peel , Patient Privacy Rights Foundation

Eric Schmidt , Google Inc.*

Mark Smith , California HealthCare Foundation

James Walker , Geisinger Health System

Jonathan White , Agency for Healthcare Research and Quality

/Semi tongue-in-cheek tone OFF

I conclude by wondering exactly what's caused some of these HIT cheerleaders to "get religion" about the possible dark sides of health IT.

The possible change of heart on this formerly proscribed topic puzzles me.

-- SS

Post Title → Another Human Bites Dog Story? Health Affairs Briefing on Healthcare IT Challenges

Health Affairs Interview Lets Dr David Baltimore Sing the Praises of Biotechnology

Health Affairs recently interviewed Dr David Baltimore, the current President of the California Institute of Technology, and winner of a Nobel Prize. Its abstract stated, "as a man with equal interests in science and science policy, David Baltimore has been at the forefront of many of the important debates that have shaped science since the 1970s." [Culliton BJ. Science for life: a conversation with Nobel Laureate David Baltimore. Health Aff 2006; 25: w235-240.]

The interviewer pretty much let Dr Baltimore sing the praises of biotechnology. The article included his justification for the extremely high prices of biotechnology drugs. He acknowledged prices were high, but felt the prices were justified by the benefits, and to some extent the small size of the market for the drugs.

Well, the people who do benefit, benefit enormously. I would only support a system that enabled those people to get them. Now, the cost of their getting it could be very high. But we’re willing to pay enormous sums of money for people to get drugs that are worthwhile.... But they’ve been able to charge hundreds of thousands of dollars per patient per year for the drug because people believe that it’s important for it to be available. And it’s not because the drug is so expensive to make. It’s because there are so few patients who need it that to have a supply of it and therefore to make it valuable to the company to produce it, they’ve got to charge a lot for it.

Furthermore, Dr Baltimore argued that the US is rich enough to afford high-priced biotechnology drugs.

We’re in a highly developed country where it’s a matter of, Do you spend the money to keep a few people alive, or do you spend the money on something crazy like the war in Iraq? In my opinion, it is much more important to keep those few people alive.

Also

That industry has provided expensive treatments for life-threatening diseases. It’s clearly met previously unmet medical needs. And the overall financial burden on the health care system, as I understand it, is not enormous because drugs are still 10–15 percent of medical costs. So for all the development of biotechnology, it has not overwhelmed the health care industry.

Finally, he argued for the economic benefits of the biotechnology industry.

And the amount of revenue that comes to the state of California is clearly in the billions of dollars. You know, a company like Amgen—one of the early biotech companies—probably employs 15,000 researchers and other workers. So, sure, these are big companies. Amgen is the cornerstone of the wealth of Thousand Oaks.

The interview did include a brief aside about conflict of interest, an issue that Dr Baltimore did not find very problematic.

This can be a sticky issue, but I think most universities have handled it well. The major conflicts relate not to basic research but to clinical research.
We have not instituted new policies at Caltech, but we do monitor the situation closely.

All in all, it amounted almost to a hymn of praise for biotechnology, unmarred by any doubts about its usefulness or value to society, or any doubts that society should pay every dollar charged by biotechnology companies. It was quite a striking testimonial, coming as it did from a Nobel Laureate.

What the article left out was that it was also coming from someone with very strong financial ties to the biotechnology industry. In fact, Dr Baltimore sits on the board of directors of three biotechnology companies: Amgen, MedImmune, and Cellerant Therapeutics. Note that Dr Baltimore above praised the economic contribution of Amgen to California without acknowledging his legal responsibility to maximize the profits of that self-same corporation.

Perhaps the interviewer could be excused for not discovering these apparent conflicts of interest. Caltech's main presidential biographical page on Dr Baltimore fails to list his board memberships, as does his page in the Biology Division, as does the press release announcing his appointment as president.

If Health Affairs wants to let a member of the board of directors of Amgen sing the praises of biotechnology, that is fine, but the journal should thus identify that person. Readers ought to know about strong financial interests, and in this case, fiduciary interests, that may have bearing on the content of what they publish.

Post Title → Health Affairs Interview Lets Dr David Baltimore Sing the Praises of Biotechnology

Don't Ask, Don't Tell: Health Affairs Interviews Guidant CEO Ron Dollens

Health Affairs, which bills itself as " the leading journal of health policy thought and research," just published a lengthy (18 page in the PDF version) interview of Guidant CEO Ronald W. Dollens by Founding Editor John K. Iglehart. The interview was notable for the interviewer's extreme deference to the interviewee, and more for what the interviewer didn't raise that what he did.

The Case of Guidant's ICDs

An accompanying editor's note stated, "On May 24, 2005, one month after the interview that follows was conducted (25 April), the New York Times reported that an implantable cardiac defibrillator (ICD) sold by the Guidant Corporation had failed to operate properly while a twenty-one year old college student who had the device implanted in his chest was suffering a cardiac arrest. The student later died. Following the Times report, John Iglehart posed an additional question...." Furthermore, the note stated that Guidant had issued a press release on June 17, 2005, that Guidant was "volunatarily advising physicians about important safety information regarding certain devices [three ICD models]"; and that the Associated Press quoted a US Food and Drug Administration spokesman as saying "This is a voluntary recall." It also noted that Guidant confirmed reports of 45 failures of ICDs out of 63,000 implanted worldwide. Finally, the note quoted Dollens, "Patient safety is paramount and our highest priority."
The question that Iglehard asked Dollens about this issue was:

• "A recent New York Times story, which focused specifically on ICDs, raised broad questions relating to the inherent risk associated with invasive procedures and the understanding of various groups of risk. Could you share with us your thoughts on the specific issues addressed in the Times article?"

Dollens replied,

• "The article focused on the communications issues surrounding the continuous evaluation of patient risk when using novel, life-sustaining medical technology. We encourage public debate and discussion about the pros and cons of broader dissemination of infomation about product safety. Guidant looks forward to participating in that discussion."

This interview and the accompanying editor's note, however, left out some important information. In particular, the New York Times article of May 24 reported not only on the failure of the defibrillator that was associated with the death of the young patient, but also that Guidant had known for three years of a flaw in the design of that particular defibrillator, the Ventak Prizm 2, that could cause the unit to short-circuit and fail, and that the company had made changes in its manufacturing process three years earlier to correct this flaw. We posted about this New York Times article on Health Care Renewal, and concluded, " there seems to be no good excuse to hide data about this device's flaws from the public and from doctors."
Furthermore, there was other news about Guidant that appeared after the May 24 but before the June 17, 2005 press release. On June 2, the New York Times reported that Guidant continued to sell ICDs from stock manufactured before the flaw was corrected after it had started manufacturing an upgraded version that corrected the flaw. (See our post here.)
A day after the Guidant press release, the New York Times published another article disclosing flaws in additional models of Guidant ICDs, that Guidant had also failed to previously disclose these flaws to doctors as soon as it knew of them, and also that Guidant continued to ship the old version of these models of ICDs from stock after it started manufacturing new models which corrected the flaw. (See our post here.)
Thus, the prominent, lengthy interview in Health Affairs of Guidant CEO Dollen, done by the most senior Health Affairs editor, avoided mentioning most of the serious criticisms made of how Guidant handled the problem of faulty ICDs. Iglehart characterized the problem only in the most general terms, and allowed Dollen to provide an answer that was equally vague. Although the editor's note suggested that Health Affairs editorial personnel were aware of news about Guidant made public from May 24 to June 17, 2005, it failed to mention that the news after May 24 had raised additional issues about Guidant ICDs.

The Case of the Ancure Endograft System

Iglehart asked Dollens to opine about such diverse matters as "the era of evidence-based medicine," how Guidant provides health care coverage to its employees, and how "the American way of delivering and financing health care is flawed." Yet he never mentioned another serious problem in Guidant's past that eerily presaged the ICD problem.
In 2003, Guidant agreed to plead guilty to multiple felony counts for hiding, as the New York Times put it, "serious health problems, including 12 deaths, caused by one of its products." Guidant agreed to pay over $90 million in civil and criminal penalties, the largest fine ever paid by a device-maker for concealing problems with one of its products.
In summary, the facts reported by the Times in 2003 were as follows. In 1999, Guidant began marketing a new type of aortic graft that was inserted via a catheter, the Ancure Endograft System. Soon after the device was marketed, physicians who inserted it began complaining that the device would be become lodged prior to achieving correct positioning, requiring abdominal surgery to repair the problem. Guidant sales represented began instructing doctors to break the device into pieces and then extract them, even though this method had never been clinically tested, and despite the sales representatives' lack of qualifications to give such clinical advice. Guidant eventually reported 172 reports of problems with the device to the FDA, but later prosecutors charged that Guidant had concealed more than 2000 of the the reports it had received. The FDA heard of the scope of the problem in 2000 after seven anonymous whistle-blowers sent it a letter. Guidant pulled the aortic graft system off the market in 2001, and then revealed it had received thousands of reports of problems with the device. (See summaries of other news articles here, but most original articles are no longer on the web.)
Yet the Iglehart interview never mentioned the case of the Ancure Endograft System, which was undoubtably important, and seemed relevant not only to the more recent case involving ICDs, but indicative of the extent that Guidant really regards safety as "paramount."

In Summary

A prominent editor of a prominent health policy journal devoted considerable effort to and published considerable pages of an interview with the CEO of a large device manufacturing firm, yet avoided asking skeptical or probing questions about a current problem that raises substantive concerns about the quality of the company's products, and even bigger concerns about how the company has dealt with quality problems. The interviewer avoided asking any questions about a similar case from a few years ago.
This is only one article, but it seems to indicate how deferentially the health services and policy literature may treat leaders of large health care organizations. This literature is a major source of information about the health care system and health care policy for physicians, researchers, and policy-makers. While it may show deference to leaders of large organizations, however, this literature often includes pointed criticisms of physicians.
Here is another example of the "anechoic effect," the curious lack of echoes resulting from cases that show the down-sides of concentration and abuse of power.
But to fix these problems, we will at least have to start talking about them.
To help us do that, journals about health services and health policy should begin to show skepticism of the powers that be befiting these journals' scholarly aspirations.

Post Title → Don't Ask, Don't Tell: Health Affairs Interviews Guidant CEO Ron Dollens