Increasing Bad Press for Today's Healthcare Information Technology - Deserved and Overdue

Here are three candid, quite revealing articles about the distaste for today's health IT that appeared recently.  I will address each,

The first seems like pure deja vu (see my June 4, 2009 post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html):

1.  Forbes:  Pentagon's $11 Billion Healthcare Record System Will Be Obsolete Before It's Even Built -  March 3, 2015
http://www.forbes.com/sites/lorenthompson/2015/03/03/military-healthcare-11-billion-record-system-will-be-obsolete-before-its-even-built/

... No doubt about it, the project managers understand how to speak the language of acquisition reform.  However, a close look at what their site proposes to do for the 9.6 million active-duty warfighters and dependents in the military healthcare system reveals that this effort is going to fail.  It will probably be better than what it replaces, but it will lag far, far behind the kind of performance that users of internet-based technologies have come to expect.  So soldiers and sailors and airmen and marines — and their dependents — aren’t going to get the quality of care they deserve, and some will suffer mightily as a result.

In order to understand why the modernization initiative is doomed to failure, you need only grasp the significance of two key phrases the program office uses in its approach to industry for proposals.  First, it says it is seeking a “state-of-the-market” electronic health record system.  Second, it says whatever it selects will be an “off-the-shelf” product.  In other words, it is seeking to acquire an electronic health record system that already exists in an industry noted for its antiquated approach to the movement of information.  Furthermore, despite the program office’s insistence that it will avoid getting locked into reliance on a single monopolistic vendor, the project manager told Politico he envisions the contract as “an extensive prenup and no divorce.”

In other words, what I have described for years as a "business computing" oriented approach to clinical computing - an approach as guaranteed to fail as confusing psychiatry with neurosurgery because they both treat brain disorders, and trying to treat a brain tumor with psychotherapy or a personality disorder with a scalpel.  Specifics matter.

Sounds like vendor lock to me.  The business model the program is pursuing resembles a proprietary enterprise software system of the sort that many major hospitals have installed.

If you don’t know what an enterprise software system is, the first sentence in Wikipedia’s entry on the subject gets to the point: “Enterprise software…is purpose-designed computer software used to satisfy the needs of an organization rather than individual users.”  Got that — rather than individual users?  This approach to information system design is a throwback to the pre-internet days of mainframe computers.  In fact, the dominant version currently in use by private healthcare providers relies on upgrades to software developed nearly half a century ago at the Massachusetts General Hospital.

It's not a throwback to the mainframe era.  It represents the now-obsolete but still dominant, defective control-mentality acculturation and over-empowerment of information technologists (e.g., http://dl.acm.org/citation.cfm?id=563354&coll=portal&dl=ACM).  This acculturation is a remnant not of mainframe days but of the card tabulator data processing era (http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html).

2.  Health Affairs:  Where Is HITECH’s $35 Billion Dollar Investment Going? - March 4, 2015
http://m.healthaffairs.org/blog/2015/03/04/where-is-hitechs-35-billion-dollar-investment-going/

by Sen. John Thune, Sen. Lamar Alexander, Sen. Pat Roberts, Sen. Richard Burr, and Sen. Mike Enzi
 
On April 16, 2013, we released “REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT,” outlining concerns with implementation of the Health Information Technology and Economic and Clinical Health (HITECH) Act. Specifically, we asked: What have the American people gotten for their $35 billion dollar investment?

Two years after releasing the white paper, and six years since enactment of the HITECH Act, the question remains. There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.

I note that the statement "there is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care" is a euphemistic way of saying "there is conclusive evidence that the program has not achieved its goals of increasing efficiency, reducing costs, and improving the quality of car."

We have been candid about the key reason for the lackluster performance of this stimulus program: the lack of progress toward interoperability. Countless electronic health record vendors, hospital leaders, physicians, researchers, and thought leaders have told us time and again that interoperability is necessary to achieve the promise of a more efficient health system for patients, providers, and taxpayers.

Instead, according to physician surveys, electronic health records (EHRs) are a leading cause of anxiety for physicians across the country. The EHR products are not meaningful to physicians, which is clear when you consider that half of all physicians will have their Medicare payments cut in 2015 for not adopting government benchmarks for EHRs. ... After spending $28 billion so far of the $35 billion total taxpayer investment, significant progress toward interoperability has been elusive.

Sadly, our elected officials still don't quite understand that the largest drawback to today's health IT is not lack of interoperability, but lack of basic operability (usability). 

However, $7 billion of the HITECH $35 billion is still available to waste in order to learn that lesson.

... In listening to the concerns from EHR vendors and EHR users from across the care continuum, ONC has taken an important turn under the leadership of Dr. Karen DeSalvo. The previous ONC leadership did not understand the difficulty and enormity of creating government-approved products in a market that struggled to exist before government incentives arrived.

As a result, our nation’s health care providers are stuck with the huge cost of unwieldy systems trying to conform to government mandates. They are stuck adopting EHR systems which don’t fit into their established workflows. And if they actually want to share their patients’ data, they are stuck with even more costs imposed by vendors.

At the center of all this is the patient who must sit quietly in the exam room looking at her physician use a computer instead of directly talking with her, who likely has seen no better access to her own data, and who is struggling to understand why her doctor has such a difficult time getting her lab results.

This is not exactly an endorsement of ONC's prior leaders.  Perhaps the aforementioned "previous ONC leadership" should have read this blog more carefully.  Or the Wall Street Joutnal where I spelled these outcomes out in 2009.  Emphases mine:

http://www.wsj.com/articles/SB123492035330205101

Feb. 18, 2009

Dear WSJ:

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.

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

These were easy predictions to make based on experience and papers such as this.

Finally:

3.  HealthcareDive.com, Has the AMA lost its mojo?  - March 9. 2015
http://www.healthcaredive.com/news/has-the-ama-lost-its-mojo/372532/

As the mainstream media has begun to realize that organized physicians groups are doing all they can to resist adopting EHRs, the coverage of the dispute has revealed just how little impact their efforts—​led by the AMA—​are achieving in accomplishing their goals.

The AMA has come out vehemently against the Meaningful Use program and the high velocity with which the HHS and Congress want doctors to adopt EHRs, and they have written countless letters, position papers and blueprints for reform to announce their displeasure. Moreover, more than 30 other physicians groups have signed on to their copious letters. A recent USA Today piece quoted the incoming chief of the AMA about EHRs.

"Physicians passionately despise their electronic health records," says Lexington, KY, emergency physician Steven Stack, the American Medical Association's president-elect. "We use technology quickly when it works … Electronic health records don't work right now."

A 2013 AMA/RAND study revealed that EHRs are at the root of the modern doctor’s dissatisfaction with his job.

I note that up until relatively recently, the AMA was largely a defender of today's EHR technology.  They certainly got what they wished for...

"Physicians believe in the benefits of electronic health records, and most do not want to go back to paper charts," said Dr. Mark Friedberg, the study's lead author and a natural scientist at RAND, a nonprofit research organization. "But at the same time, they report that electronic systems are deeply problematic in several ways. Physicians are frustrated by systems that force them to do clerical work or distract them from paying close attention to their patients."

In fact, I believe this oft-made statement about "most do not want to go back to paper charts" is incomplete and misleading.  In terms of retrieving data such as labs and images, most probably would not want to go back to paper.  On the other hand, most probably would like to be able to document and enter orders on paper and have clerical personnel transcribe that information into computers - instead of the physicians being the clerical persons themselves, and gratis.

... According to a piece on Wall Street Cheat Sheet, there could be a couple of reasons why the AMA seems to keep getting shut out—​namely the AHA and the Blues.

While the AMA had $19 million to lobby Congress, the American Hospital Association—​which represents providers who took a financial hit after the last ICD-10 adoption delay—​spent $20.75 million last year to lobby lawmakers. Big insurer Blue Cross and Blue Shield, which would also benefit from wide adoption of EHRs and ICD-10, spent $21.3 million in 2014. That's a combined $42 million, more than double the AMA's effort.

Now, factor into that the extreme amount of influence wielded by the tech sector—​Google alone spent $17.5 million in lobbying Congress in 2014—​and the scent in the wind becomes easy to identify. The tech sector stands to make billions from EHR creation and management. Insurers need ICD-10 and EHRs to bring better cost management into their industry, enabling them to spend less as they pay for more care for more patients. Finally, hospitals need the tech because the ACA is bringing millions of new patients into their doors, and the old pegboard and paper systems that doctors are trying to cling to just won't work for hospitals that see tens of thousands of patients each month.

The AMA has set up a showdown on ICD-10 and EHRs that it will lose, and lose big, because it just plain does not carry the muscle it used to.

In other words, medicine has been invaded by the Information Technology industry and the profiteers who stand to benefit from that technology, with the bulk of the work being performed by clinicians, for free and to patient detriment.

This seems a clear formula for clinicians to simply refuse to use health IT altogether for data entry and demand a return to paper data recording with clerical transcription, but alas, it's likely too late for a revolt like that.

As health IT continues to get well-deserved and long-overdue bad press like this, one wonders if our culture will start to recover from the state of health IT delirium it is in.

I am in doubt.

(See my Jan. 20, 2011 post "Healthcare IT delirium" at http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html for more on that issue).

-- SS

3/16/15 Addendum:

A physician actually proposes physicians be paid for clerical work:

Pay doctors and nurses for the time they spend charting
http://www.kevinmd.com/blog/2015/03/pay-doctors-nurses-time-spend-charting.html

-- SS

EHRs and test ordering: Health Affairs authors reply to ONC

At my March 9, 2012 post "Increased Lab Ordering with EHR's?" I refuted ONC's response to a Harvard-based research study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that may contradict the notion that HIT reduces medical costs.

Now the authors themselves have responded to ONC. There are many similar themes in their response. I've bolded them below:

The Effect Of Physicians’ Electronic Access To Tests: A Response To Farzad Mostashari

March 12th, 2012
by Danny McCormick, David Bor, Stephanie Woolhandler, and David Himmelstein

Our recent Health Affairs article linking increased test ordering to electronic access to results has elicited heated responses, including a blog post by Farzad Mostashari, National Coordinator for Health IT. Some of the assertions in his blog post are mistaken. Some take us to task for claims we never made, or for studying only some of the myriad issues relevant to medical computing. And many reflect wishful thinking regarding health IT; an acceptance of deeply flawed evidence of its benefit, and skepticism about solid data that leads to unwelcome conclusions.

Dr. Mostashari’s critique of our paper, will, we hope, open a fruitful dialogue. We trust that in the interest of fairness he will direct readers to our response on his agency’s site. [If not, HC Renewal posts get highly ranked by Google - ed.]
Our study analyzed government survey data on a nationally representative sample of 28,741 patient visits to 1187 office-based physicians. We found that electronic access to computerized imaging results (either the report or the actual image) was associated with a 40% -70% increase in imaging tests, including sharp increases in expensive tests like MRIs and CT scans; the findings for blood tests were similar. Although the survey did not collect data on payments for the tests, it’s hard to imagine how a 40% to 70% increase in testing could fail to increase imaging costs.
Dr. Mostashari’s statement that “reducing test orders is not the way that health IT is meant to reduce costs” is surprising, and contradicts statements by his predecessor as National Coordinator that electronic access to a previous CT scan helped him to avoid ordering a duplicate and “saved a whole bunch of money.” A Rand study, widely cited by health IT advocates including President Obama, estimated that health IT would save $6.6 billion annually on outpatient imaging and lab testing. Another frequently quoted estimate of HIT-based savings projected annual cost reductions of $8.3 billion on imaging and $8.1 billion on lab testing.
We focused on electronic access to results because the common understanding of how health IT might decrease test ordering is that it would facilitate retrieval of previous results, avoiding duplicate tests. Indeed, it’s clear from the extensive press coverage that our study was seen as contravening this “conventional wisdom”.
Nonetheless, Dr. Mostashari criticizes us for analyzing the impact of physicians’ electronic access to imaging and test results, but not other aspects of electronic health record (EHR) use. We did, however, analyze the relationship of EHRs to test ordering in a subsidiary analysis. While physicians use of a full EHR was associated with a 19% increase in image ordering, as we noted in the paper this finding was not statistically significant. While we cautiously (and properly) interpreted this as a “null” finding, these data are inconsistent with Mostashari’s optimistic view that use of a full EHR reduces costs.
He asserts that our 2008 data are passe, and that health IT meeting today’s “meaningful use” criteria definitely saves money. The data we analyzed were the latest available data when we initiated the study. While the proportion of outpatient physicians utilizing health IT has grown since 2008, we are unaware of any “game changing” health IT developments in the past four years that are would produce substantially different results if the study were repeated today. The EHR vendors that dominated the market in 2008 remain, by and large, today’s market leaders, and their products have undergone mostly modest tweaks. Mostashari’s contention that 2012 EHRs – incorporating decision support and electronic information exchange – save money in ways not possible in 2008 should be tested through additional research but remains merely a hypothesis. We hope that some day his predicted savings can be achieved.
Dr. Mostashari offers his own explanation for our findings, suggesting that doctors who are inclined to order more tests are also inclined to purchase health IT for viewing test results electronically rather than on paper. He offers no evidence for this assertion and ignores the fact that we explored (and rejected) this explanation by analyzing subgroups of doctors who are unlikely to be the decision maker for IT purchases – e.g. employed physicians, those working in an HMO setting etc. In other words, electronic access to results predicted more test ordering whether or not the ordering physician was responsible for health IT purchases.
He incorrectly states that our analysis did not take into account patients’ severity of illness, physicians’ level of training, and the nature of physicians’ financial arrangements. In fact, we reported subsidiary multivariate analyses that included several serious diagnoses; all of our models included physician specialty (which we specified in several different ways); and all models included adjustment for an extensive list of indicators of financial arrangements (e.g. whether the physician owned the practice or was an employee; the type of office; whether the practice was owned by a hospital; whether the physician was a solo practitioner; whether the physician’s compensation was based, in part or whole on “profiling”; and whether the practice was predominantly prepaid). We also performed a series of subsidiary analyses that explored whether physicians with a proclivity to “self refer” patients for imaging tests accounted for our finding; they didn’t.
Dr. Mostashari criticizes us for failing to assess whether health IT improved the quality or appropriateness of care. Of course, these were not the topic of our research. Those are different studies for a different time. However, we would note that other large-scale studies have found no, or trivial quality improvements associated with HIT outside of a few flagship institutions^4-6.
Dr. Mostashari’s strongest claim is that observational studies like ours (and most other health policy studies, including some by Dr. Mostashari himself) cannot prove causation. This is surely true. As long time teachers of evidence based medicine we took care to couch our conclusions in cautious terms, stating only that “Computerization, whatever its other benefits, remains unproven as a cost control strategy.”
But Dr. Motashari is less cautious, asserting that the case for HIT is closed. The paper he cites to buttress this claim (authored by members of his own agency) culled studies reporting any impact of HIT on virtually any aspect of care, and accepted authors’ claims of benefit without regard to study quality or statistical niceties. Thus, a focus group’s impressions of benefit are accorded the same weight as nationwide studies of Medicare data showing virtually no impact of computerization on quality measures. Reports of a reduction from 70% to 38 % in “missed billing opportunities” or a $7,000 reduction in office supply costs are among the 92% of studies judged “positive”. While the literature review he cites is interesting, nothing in it contradicts our findings.
Dr. Mostashari is also correct in reiterating that randomized trials are the best way to assess health IT. In fact, no randomized trial has ever been published that examines patients’ outcomes or costs associated with off-the-shelf health IT systems that dominate the U.S. market. No drug or new medical device could pass FDA review based on such thin evidence as we have on health IT. Yet his agency is disbursing $19 billion in federal funds to stimulate the adoption of this inadequately evaluated technology. Dr. Mostashari is perhaps the only person in our nation who commands the resources needed to mount a well done randomized controlled trial to fairly assess the impact of health IT, and the comparative efficacy of the various EHR options.
Finally, Dr. Mostashari’s unbridled faith in technology is mirrored by his belief that ACOs are the next panacea for health costs and quality. That health policy flavor-of-the-month also remains wholly unproven.

I think readers comparing my response to the authors', and who are familiar with the many posts at HC Renewal going back to 2004, will recognize the themes I have bolded in the author's response to HHS.

-- SS

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

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.

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.