Retrospective on the Blumsohn - Procter and Gamble -Sheffield University Affair: the Unhappy Lives of Whistleblowers and the Anechoic Effect

Introduction - the Unhappy Lives of Whistleblowers

The UK Times Higher Education Supplement just published a feature on the unhappy fate of academic, including academic medical whistleblowers.

Whistleblowers in universities can hit the national headlines for shining light on issues of public interest, only for their careers to end up in very dark places.

Some of higher education’s most prominent whistleblowers paint a bleak picture about the impact on their subsequent careers. They talk about being persecuted by colleagues after coming forward. But even after leaving their jobs, some believe they still suffer a legacy. One talks about being 'effectively blackballed' from ever working again in higher education.

For other whistleblowers, exile is self-enforced.

It is noteworthy that the graphic for the article showed a whistleblower with a ball and chain, but the ball is in the shape of a whistle.

Summary - The Blumsohn - Actonel - Procter and Gamble - Sheffield University Case

The article focused on the case of Dr Aubrey Blumsohn, which we discussed recently, and have posted about since 2005 (here).  For all relevant posts, look here.

The Times provided a good summary.  It is worth quoting it here, as a reminder of a very important case which has had far too few echoes.

[The] case began in 2002, when he was working in the research unit led by Richard Eastell, professor of bone metabolism at Sheffield. The unit was researching the effects on patients of Procter & Gamble’s anti-osteoporosis drug Actonel.

Blumsohn raised concerns about abstracts for conference papers submitted by P&G, under his primary authorship, but without the firm having granted him full access to the drug trial data.

His concerns were first raised with senior colleagues and then reported in Times Higher Education in 2005.

The data analysis for the research was carried out by P&G, which paid for the research and which did not release key data to Eastell and Blumsohn. According to Blumsohn, this prevented honest publication of research.

After coming forward, Blumsohn has previously said, his other research work was used as the basis for a series of research grant applications that Eastell sponsored and signed off for a PhD student, without acknowledging Blumsohn’s input and despite his objections.

In 2005, he told the university that he was speaking to the media after losing faith in its internal systems for dealing with such allegations. He was subsequently suspended and told by Sheffield that he could lose his job over alleged 'conduct incompatible with the duties of office', including 'briefing journalists' and 'distributing information, including a Times Higher article, to third parties with apparent intent to cause embarrassment'.

He later reached a settlement with the university and it dropped all disciplinary charges. However, he left the university in 2006.

Blumsohn says of what happened afterwards: 'I withdrew from medicine completely, I withdrew from academia and ultimately withdrew my medical registration as well.'

Given the impact on his career, does Blumsohn regret coming forward with his concerns? 'I had to do that,' he says. 'As a scientist, I couldn’t just go along with having my name attached to manipulated publications, based on secret data ghost-analysed by pharmaceutical companies.'

Could Sheffield have dealt with his concerns more effectively? 'I don’t know how Sheffield could have done better, or indeed how any medical school could have done,' Blumsohn replies.

He clarifies: 'The problem these days is that some parts of universities – most notably medical schools but some other parts as well – have so many conflicts of interest and financial imperatives guiding what they do, I’m not sure other universities would necessarily have behaved differently from Sheffield. When millions of pounds are at stake both in private fees for academics and university funding, and a pharmaceutical company is wanting you to dance, the pressure to go along and to get staff to remain quiet is overwhelming.'

A few comments are in order.  While universities appear to be places of free speech and open discussion, note that Sheffield apparently could punish Dr Blumsohn simply for talking to journalists, but particularly for simply saying things that might embarrass university leaders.  So university leaders wish not to be embarrassed seems to trump free speech and academic freedom.

Second, Dr Blumsohn rightly pointed out that the issue was really scientific integrity, not embarrassment.  He tried to stop what he perceived as manipulation of clinical research by a pharmaceutical company to support its vested interests in selling a particular drug.  Such manipulation threatened scientific integrity, and ultimately threatened patients' health.

Third, Dr Blumsohn also rightly pointed out in retrospect that what university managers really seemed to fear was not just personal embarrassment, but curtailment of money flows from industry to their institution that made them look good, and presumably become more wealthy.

Few Echoes in the Discussion of Whether the Former Procter and Gamble Executive on Whose Watch the Affair Occurred Should be US Veterans Affairs Secretary

As we discussed here, a top executive at Procter and Gamble whose remit at the time the affair occurred seemed to include Actonel and research related to it was nominated to run the US Department of Veterans Affairs, and hence the whole VA health system.  Only two blogs, including this one, raised the issue of the Blumsohn - Actonel - Procter and Gamble - Sheffield University affair as relevant.  There was no other public discussion of this connection.  The former Procter and Gamble executive was confirmed, and now runs the Department of Veterans Affairs.

Summary

This is another example of how leaders of big health care organizations remain unaccountable for their organizations' misdeeds.  The lack of any mainstream discussion of the Blumsohn - Actonel - Procter and Gamble - Sheffield University affair in connection to the VA nomination demonstrate the anechoic effect.  Even the most determined whistleblowers often do not get the public notice they deserve, and their revelations do not have the effects they ought to have, even after the whistleblowers have paid a very high price to try to spark public discussion.

So anyone thinking about trying to get public notice for some fact or issue that threatens the powers that be will think twice, both about the potential downsides to the whistleblower, and the potential ineffectiveness of these attempts.    

In the past two weeks, I have heard in confidence about three stories in which discussion of issues that might offend the powers that be, specifically, the leaders of big health care organizations, has been suppressed.  I am convinced that for every Dr Aubrey Blumsohn, there are dozens who are aware of deception, other unethical conduct, even crime and corruption that could harm patients and patient care, but are afraid to speak out.

Of course, as long as these issues remain hidden, the damage to patients and the public's health continues to be done.

We clearly need changes in public policy to protect whistleblowers and foster free speech about important issues in academics and health care.  We need health care professionals, health care researchers, health care policy makers, and those among the public who care about health care and health care need to organize to support free speech and academic freedom.  Otherwise, the anechoic effect will continue to befog all of health care.

Hat tip to Dr Carl Elliott writing for the Fear and Loathing in Bioethics blog.

11:31 AM

Philadelphia VA Hospital Brachytherapy Debacle: For The Want of One Competent and Industrious IT Person

This post should perhaps be subtitled "The Theatre of the Absurd."

At Healthcare Renewal and other sites I've often commented on the remarkable accommodation given to IT personnel in hospitals, even when these personnel make capricious decisions that are contrary to the support of the mission of healthcare organizations, or contrary to the mission itself.

I wrote that many HIT problems observationally appeared due to ill-informed, capricious edicts of overempowered (relative to clinical leadership) MIS leaders, sanctioned by equally ill-informed executive leadership, for which the IT personnel were rarely held accountable.

Endangerment of ICU patients via PC's entirely inappropriate for a biohazards environment, chaos in a critical procedure area from IT complacency and incompetence, payment of millions of dollars for HIT with gross defects rendering it unusable by clinicians without consultation of in-house medical informatics expertise, and denial of access for hundreds of drug discovery scientists to the informatics tools their own leaders said were essential to new drug discovery are just a few of the situations I've personally observed due to IT department whimsy.

Remarkably, none of these situations nor others reported from numerous sources resulted in repercussions against the teflon-coated IT deities (other than, in some cases, generous promotions), thereby obstructing remediation of the attitudinal and competency problems that created the scenarios. If physicians had it this good, they'd be chopping off wrong limbs, removing the wrong organs, and failing to diagnose and treat with impunity.

At my June 2009 posting regarding an unfolding clinical debacle of national import at the Philadelphia VA hospital entitled "Bungled Brachytherapy, Computer Interfaces and Other Mysteries At The Philadelphia Veterans Administration Hospital" I wrote:

... I am uncertain how "computer interface problems" (in the Philadelphia Inquirer, they were referred to as "glitches") prevented medical personnel from determining treatment success over several years. I would be most interested in hearing more about these "interface problems."

That question has now been answered, and I am disappointed (but not surprised) at the results. Having rewritten a poor interface between a gamma scintillation camera and a PDP-11 computer in medical school during a nuclear medicine rotation at Boston City Hospital, allowing endusers to identify ROI's (regions of interest) with a light pen for automated calculation of intensities, I thought perhaps some arcane coding or driver configuration was the culprit at the VAMC Philadelphia. That was not the case:

VA radiation errors laid to offline computer

By Marie McCullough and Josh Goldstein

Philadelphia Inquirer
July 19, 2009

... It is not surprising, then, that NRC and VA investigators spent considerable time delving into why the calculations weren't done for more than a year at the Philadelphia VA.

Their investigative reports blamed a "computer interface problem" - the same terminology Kao used during his testimony last month at a congressional hearing.

The implication was that some intractable technology breakdown was behind the lapse in care [i.e., some cryptic problem requiring magical incantations and byzantine scripts that mere mortals could not understand nor remedy - ed.]

In fact, technology had little to do with the breakdown, as James Bagian discovered when he led an inquiry at the Philadelphia VA and the veterans' health system's 12 other brachytherapy programs.

Bagian, a Philadelphia-born physician and former astronaut who is now the national VA's patient-safety director, discovered that the "interface problem" was nothing more than the disconnected computer.

Here's what else his inquiry found:

The computer was initially unplugged so that another medical device could use the network port. Then, various departments dithered and ducked a request for an additional network port, which was finally installed - after a year. ["Various departments dithered and ducked?" Which departments, exactly? See below - ed.]

Some doctors, physicists, and other professionals at the VA acknowledged it was "clinically inappropriate" to omit the post-implant calculations. Some said they had informed their "chain of command."

When asked why they didn't tell the hospital's patient-safety officer, they said "it had not occurred to them to do so."

["Had not occurred to them to do so?" I've seen situations where physicians and scientists were afraid of IT leaders, due to the latter's often overinflated political influence and proficiency in playing games of political intrigue. Did this occur here, I wonder? - ed.]

So, it appears that for the want of one network connection, installed by one competent, industrious, non-complacent IT person, a national scandal has erupted that has injured many patients.

First, I ask the following questions regarding the "various departments" that "dithered and ducked" the responsibility to install an additional network connection in the brachytherapy suite:

• Was the job the responsibility of the Department of Medicine? The doctors and nurses? Could they have done so?
  
• Perhaps it was the responsibility of the Public Relations Department (who now have to pick up the pieces?)
• Was it the reponsibility of the Facilities Department?
  
• Was it the responsibility of the Housekeeping Department?
• Or, was it the responsibility of the IT Department and CIO?
  

(If you need help answering these questions, stop reading now.)

I also ask:

• Why was the IT department's failing to perform this task kept low profile through use of cryptic "interface problem" language that implied complex IT problems, as opposed to simple people problems?
  
• Who originated this language?
• Did they believe the truth could remain hidden?
  
• Why do we use the term "medical malpractice" to describe negligence in medical care, not "provider glitch?" Why the different standards?
  

I can visualize what went on behind the scenes in the IT department, refrains I have heard before - "we don't have the resources ... we need to hold more meetings to consider the issues ... it's the vendor's responsibility ... it's the network group's job, not the hardware group ... putting a new network outlet in there will cause packet storms and interfere with system XYZ ... we need to get consensus .... you [doctors] can't understand the complexities of the problem, but don't worry, we'll make it better ... hey, the docs don't need it anyway ..."

What would happen to, say, the Facilities Department if a plumbing problem led to failure of a piece of vital equipment in the OR's, and they failed to repair it for a year?

This is not to excuse the multiple layers of complacency among clinicians, safety staff, and others for toleration of this network denial situation and the lack of QC on the procedures themselves, but at the heart of this debacle is this attitude, which seems common in hospital IT departments:

"Doctors and nurses toil in hospitals so IT personnel can have comfy jobs and nifty computers."

Perhaps on this occasion, IT leaders and personnel may end up on the witness stand and be held accountable, and perhaps lose their jobs instead of being promoted. However, even this is doubtful, and it has taken a congressional investigation led by Sen. Arlen Specter to get even this far, to simply find out that the mysterious "interface glitches" were a lack of a network jack due to laziness and complacency.

Finally, I point out that it is hospital IT personnel upon whom clinicians will depend for acquisition and implementation of the HIT tools the President of the United States said are essential to changing the culture of healthcare.

As I have written, before the IT profession can change the culture of healthcare (in a positive manner, that is), its own culture must change.

IT personnel in hospitals must become part of the clinical team and support the mission of clinicians, not the other way around.

July 22 addendum:

I note again that multiple people failed here, including executives, physicians, safety officers, etc. I believe responsibility needs to be fairly assigned. However, IT needs to be included. I've witnessed or heard about too many HIT incidents where IT personnel and leadership remained scot-free when their behavior and attitudes were contributors or root causes.

As per my letter to the editor published in JAMA on July 22, "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", IT privilege and accommodation must stop. HIT is not business IT used for widget inventory or payroll. As the VA incident shows, patient lives and well being are at stake.

July 24 addendum:

More on this from a blog on medical physics, "The Sharp End of the Photon", here:

... the errors in the placement of the radioactive seeds went undiscovered for so long because post-implant dosimetry was not performed. This involves CT scanning the patient, finding the positions of the seeds and calculating the ultimate dose the patient received. In the NRC report, the explanation was that a problem with the interface between the CT scanner and the treatment planning computer prevented transferring the CT images.

A "problem with the interface", indeed.

Also provided is a link to testimonies from witnesses at the house.gov website, which are here.

Notable is the absence of any testimony from IT leadership. The only allusion to IT is in testimony by the doctor who performed the procedures who stated:

"There should be a method of categorizing systematic problems by level of urgency so that serious problems, such as those involving failures of medical equipment or transfer of patient-related data, will receive immediate attention from the proper personnel and be quickly resolved."

Perhaps, but not in this case. A simple phone call to IT should have been adequate to resolve this particular simple problem.

-- SS

6:10 AM

Bungled Brachytherapy, Computer Interfaces and Other Mysteries At The Philadelphia Veterans Administration Hospital

The Philadelphia VA Hospital has had some problems with brachytherapy (implantation of small radioactive pellets for prostate cancer) recently. Multiple procedures were bungled, including wrong placement and incorrect dosages.

In this story, there apparently is a computer involved. From the New York Times article "At VA Hospital, a Rogue Cancer Unit", June 20, 2009:

... The hospital suspended the brachytherapy program on June 11 last year. By then, 45 substandard implants had been found.

Two days later, the Joint Commission, which helps set standards in the hospital industry, surveyed the Philadelphia V.A. and on the next day accredited the hospital. “This organization is in full compliance with applicable standards,” the Joint Commission said.

The commission said that it had no indications of the problems in the brachytherapy program when it arrived at the hospital and that its surveys are not detailed enough to have uncovered the flawed implants. [Or, apparently, flawed computers - ed.]

Soon after, the N.R.C. sent its own inspectors to Philadelphia. And the more the inspectors looked, the more they found. All told, 57 of the implants delivered too little radiation to the prostate, either because the seeds missed the prostate or were not distributed properly inside the prostate. Thirty-five other cases involved overdoses to other parts of the body. An unspecified number of patients were both underdosed in the prostate and overdosed elsewhere.

From December 2006 to November 2007, the nuclear commission found, 16 patients received seed implants in Philadelphia even though computer interface problems prevented medical personnel from determining whether those treatments had been successful. The V.A.’s radiation officials knew of the problem but took no action, the nuclear commission charges.

I am uncertain how "computer interface problems" (in the Philadelphia Inquirer, they were referred to as "glitches") prevented medical personnel from determining treatment success over several years. I would be most interested in hearing more about these "interface problems."

Here are some questions:

• Did these problems involve the VistA system?
• What was interfaced to what, exactly?
• Who did the interfacing?
• What regulatory authorities validated the interfaces and systems?
• If no regulatory agency was involved, why not?

I have some familiarity with odd events at the Philadelphia VA Hospital. (Not including the fact that I spent a few months there as a medical intern in the early 1980's). In the mid 1990's I took my father there for evaluation for increased service-related disability. He had been treated for skin lesions in the Army in WW2 and after by the VA with Fowler's solution (an arsenical) and as a consequence of this (even then-outdated and dangerous) treatment, had developed widespread basal cell carcinomatosis over a major portion of his body, with chronic bleeding and discomfort. I accompanied my father to the exam but did not identify myself as an MD, only as his son.

My father was seen in an evaluation by several physicians and students (arsenic-caused basal cell carcinomatosis is quite rare now) in my presence, and he was then handed his (paper) chart to take with him back to the main desk. I told my dad I wanted to look at the note. The note by a physician who'd seen him stated (paraphrasing):

"Mr. Silverstein said he'd taken more than the prescribed dose of arsenic for years, and even shared it with his wife."

My father and I were shocked and dumbfounded. He'd said no such thing, and being a retired pharmacist of 40+ years, thought anyone making such a statement would have had to have been insane. (My mother had even harsher words when she heard about this.)

Needless to say, I was upset. I confronted the physician who wrote the note, but that physician would not change it, bizarrely claiming that they remembered my father telling that story in a visit several years prior. Needless to say, such a claim violated all the precepts of medical information integrity of which I was familiar.

In an initial attempt to counteract this disability exam sabotage, I actually crossed out the statement in the chart, writing "this is untrue" or words to that effect and signed my own name.

The head of the Philadelphia VA Hospital would not return my calls on this matter.

That is, until Jesse Brown, then Secretary of the Department of Veterans' Affairs, inquired directly a few days later.

Unknown to the VA examiners, my father had been sent for the disability exam after reporting problems to Sen. Jay Rockefeller's office about prolonged delays in having his case heard.  Sen. Rockefeller's staff had set up the exam!

Sen. Rockefeller's staff was rather upset at the story I reported upon my return to New Haven about the bizarre chart fabrication at my father's VA disability exam, and apparently relayed the story up the chain of command, as it were.

After that, the head of the Philadelphia VA Hospital really, really wanted to speak to me and called me at Yale several times. He wanted to set up a phone conference between me, himself, and the doctors who'd seen my father. I told his administrative assistant that there was "nothing to talk about", and that the false statement in my father's chart would be removed. Period.

I think it was. My father's increased disability was granted in the end, but what was going on here with disability exams was never fully investigated to my knowledge (having done disability exams myself years prior for the regional transit authority, police, fire etc. in Philadelphia, I suspected an "incentive" program to deny vets a disability determination). If I had not examined my father's chart, we might have never known a reason for his being turned down.

A culture of honesty and accountability seemed lacking then, and seems lacking now.

Let's hope the investigation of these brachytherapy failures and "computer interface problems" is a bit more thorough than in my father's situation.

-- SS

4:35 PM