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.

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), to be held in Glasgow in June - add to the debate over what some have claimed is a distortion in the field of osteoporosis caused by the over-diagnosis of vertebral fractures.

Here are more particulars:

Sheffield has censured her for making the submission without the consent of her supervisor, Richard Eastell, head of Sheffield's Academic Unit of Bone Metabolism.

It said her actions breached the terms of a 2007 contract the unit has with pharmaceutical manufacturer Sanofi-Aventis to conduct studies relating to the osteoporosis treatment risedronate, which is sold as the drug Actonel.

It also said Dr Jiang failed to follow 'reasonable requests' to withdraw the submission.

Dr Jiang said she believed her results should be published as they had not been reflected in the unit's previous output.

She added that last December she was informed that her contract would not be renewed when it came to an end this March, which she said had prompted her to throw caution to the wind and publish without permission.

She has queried whether her work is bound by Sheffield's Sanofi-Aventis contract, which stipulates that the company must be allowed to review manuscripts and abstracts prior to publication.

She pointed out that the work was carried out in 2002 when the unit's risedronate work was funded by Procter & Gamble in partnership with Aventis. Dr Jiang added that she had not seen or signed the full Sanofi-Aventis contract.

Dr Jiang is still under threat:

The disciplinary hearing, scheduled to take place on 18 February, will consider the allegation that Dr Jiang 'acted inappropriately in making a direct submission of an abstract to a journal outside unit protocol and in contravention of the terms of the research contract'.

It will also consider the charge that she 'failed to follow a request by her head of unit and head of department to rectify her actions', which 'aggravated a situation which otherwise could have been quickly resolved'.

A long time ago, in a galaxy far, far away, academics had the expectation that they could publish or present their research without first acquiring the express approval of their academic superiors (at least as long as their work was original, the research project was under their control, and that they had properly protected the rights of any human subjects). Furthermore, in at least the US, academics are citizens who expect to have free speech.

But as academic institutions became more enamored of and dependent on "external funding," faculty were increasingly pressured to do only sponsored research. The growing dependence on sponsored research allowed the sponsors to try to get more control over how research was done.

In the 1990s, there were several important cases in North America in which academic researchers tried to present or publish results that clashed with their research sponsors' vested interests. Doing so resulted in lesser or greater threats to the faculty. Two of the classic cases of research suppression in the 1990's demonstrated this issue.


* In the "David Kern case," a textile manufacturer, Microfibres Inc., tried to prevent Dr. David Kern, a general internist and occupational medicine physicians at Memorial Hospital of Rhode Island and faculty member at Brown University, from presenting an abstract that described a case-series of a new pulmonary disease, flock-workers lung, that affected workers at Microfibres Inc. factories. Kern did present the abstract, but under a threat, never carried out, of law-suit, Memorial Hospital of Rhode Island removed Kern as head of the Occupational Medicine program, and refused to renew his contract, even though he was an Associate Professor. Brown University was unable to reverse these moves by the hospital, and Brown officials blamed Kern for signing an agreement to protect trade secrets, even though the agreement was unrelated to the research Kern did on the disease, and his research did not obviously reveal any trade secrets. [1-4]

* In the "Nancy Olivieri case," Apotex, a pharmaceutical company, acted against Dr. Nancy Olivieri for revealing preliminary data from a trial of deferiprone, a chelating agent for the treatment of iron overload in thalassemia, suggesting that the drug was often ineffective in treating iron overload, and appeared to be associated with hepatic fibrosis. Ultimately, a report by the Canadian Association of University Teachers also held that her academic freedom was abridged, in the context of a negotiation between the University of Toronto and Apotex over a large donation, and that the hospital harassed Dr. Olivieri during her dispute with Apotex (link here for report)
 
In the early 21st century, there was a case in the UK with spooky similarites to the present case: at the same university involved in the present case, and with at least one participant in common with that case.  About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. Our most recent summary of the case was here. Dr Blumsohn was also doing clinical research on the drug Actonel, again at the University of Sheffield.  He was denied access to the very data he had collected, and to analyses of the data by Procter and Gamble, the then manufacturer of the drug and sponsor of the research.  Dr Blumsohn found that Procter and Gamble seemed to be arranging for ghost-writers to author abstracts about the research based on these hidden analyses.  After he complained to numerous officials at Sheffield, including Dr Richard Eastell, to no avail, he spoke to the press, and thereafter lost his academic position.  The case was just recapped in an interview of Dr Blumsohn published in the British Medical Journal(5).
 
So we seem to have made little progress.  Most clinical research at academic medical institutions is sponsored by firms that make drugs and devices.  The firms try to secure contracts that give them control over most aspects of the research.  Thus, they can determine how the research is designed, implemented, ana analyzed.  If the resulting manipulation still does not yield results that make the firms' products look good, the sponsors can then just suppress them.  Academics who naively think it is their duty to find and disseminate the truth are in jeopardy when they attempt to present or publish results that challenge their research sponsors' vested interests.
 
Suppression of clinical research, however, is bad for patients and honest health care professionals, since it misleads about the benefits and harms of tests and treatments.  Suppression of clinical research dishonors research subjects who volunteer for studies, often at risk to themselves, thinking they may help to advance science and clinical care.  Suppression of clinical research undermines the fundamental mission of academia: to seek out and disseminate the truth.
 
Those who truly want better health care, here in the US and globally, should advocate for clinical research done without the influence of those with vested interests in how the research comes out. 
 
Thanks to an anonymous Health Care Renewal scout who located the Times article. 
 
References


1. DG Kern, RS Crausman, TH Durand et al. Flock worker's lung: chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med 1998; 129: 261-272. (link here)
2. Shuchman M. Secrecy in science: the flock worker's lung investigation. Ann Intern Med 1998; 129: 341-344. (link here)
3. Marsh DJ. Intimidation of researchers by special interest groups. N Engl J Med 1997; 337: 1317-1318. (link here)
4. Shuchman M. Consequences of blowing the whistle in medical research. Ann Intern Med 2000; 132: 1013-1015. (link here)
5.  Cyer C. Aubrey Blumsohn: academic who took on industry. Brit Med J 2009; 339:b5293. (link here)

British Medical Journal Interviews Dr Aubrey Blumsohn

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest.  Our most recent summary of the case was here.  The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.

The case was just re-capped in some detail on the occaision of an interview of Dr Blumsohn published in the British Medical Journal, just available on-line yesterday.  [Cyer C. Aubrey Blumsohn: academic who took on industry.  Brit Med J 2009; 339:b5293.  Link here.]  Dr Blumsohn's final words in the interview were:

It’s hard to encourage anyone to speak out about poor practice in the current environment. This case sums up what has gone wrong with systems set in place to ensure safety and integrity in scientific medicine. It would help if regulators put as much effort into responding to serious critics and whistleblowers as they do producing glossy brochures and yet more guidance.

My hat is off to Dr Blumsohn for his determination to pursue this case, and to the British Medical Journal for getting it into the "main-stream" health care literature.

Hat-tip to PharmaGossip.

The Reappearance of a Ghost of Seasons Past

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. The early posts were here, here, here, and here. In this post, we summarized the case thus:

• Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.
• Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.
• Despite numerous requests, (like this one), P&G refused access to this data repeatedly.
  Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.
• Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially related to a graph shown to him that omitted 40% of patient data.
• Blumsohn objected to P&G arranging for papers and abstracts to be written by a professional writer, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.
• Eastell warned Blumsohn not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."
• After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including Eastell, medical school Dean Tony Weetman, University Vice-Chancellor Robert Boucher, and the Head of the University's Department of Human Resources, Ms R Valerio.
• Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then offered him a severance agreement if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.

So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research. Although Health Care Renewal, being US based, most often writes about such issues in the US, this case is a reminder that they are global. (Note that we posted more about this case in 2006, here, here and here, but since then it has not gotten much public attention.)

Last weekend the (UK) Guardian returned to it:

The Guardian has learned that one of Britain's leading bone specialists is facing disciplinary action over accusations that he was involved in 'ghost writing'.

The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study's conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.

Experts believe the practice is widespread in Britain.

In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he stated: 'In the original paper one of the authors, a statistician working for P&G, Ian Barton, had full access to all the data.' The authors had full access to all the analyses of the data that they requested, he said – but those analyses were carried out by the company.

The letter, published in 2007, also acknowledged flaws in the study. A later independent analysis of the data 'identified some errors and poor practice', he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck.

Eastell's paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else.

Eastell's colleague, Dr Aubrey Blumsohn, wanted the codes which would say which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped , Eastell said he was concerned that persistent requests might damage the relationship they had with the company. Eastell is said to have told him: 'The only thing that we have to watch all the time is our relationship with P&G. Because … we have the big Sheffield Centre Grant [from P&G] which is a good source of income, we have got to really watch it.' .

So, after four years, this case has generated an official hearing of sorts. The hearing is obviously late, and seemingly will only be devoted to only one aspect of this case (ghost writing). However, at least our friends in the UK are doing something. I cannot recall a single case that resulted in any serious consideration of imposing negative consequences on anyone who was accused of suppressing research, manipulating research, endorsing ghost-writing, or intimidating a whistle-blower. In fact, many of the more troubling cases have never resulted in any sort of public discussion either at the institutions at which they occurred, or at any organization with relevant regulatory, or even just moral authority. So the GMC hearing is at least a step forward. Two cheers for the British GMC, and none for US universities, academic medical centers, professional societies, and government regulators.

(If anyone can remind me of a case in which there was a public discussion at the relevant institution, or some public consideration of the case by a regulatory agency, professional society, or some group with moral authority, please remind me of it, and I would be happy to post about it.)

Actonel, Procter and Gamble, and Things That Go Bump in the Night

We had posted a while back and again here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

This story, like those of other cases of research suppression and health care whistle-blowers, has not received a lot of press coverage, given their broad implications about the creation, as Wally Smith would call it, of pseudoevidence. To counter this version of the anechoic effect, Dr Blumsohn has his own blog, the Scientific Misconduct Blog, where he has posted updates on his ongoing efforts to get the word out about his dispute with Procter and Gamble and the University of Sheffield.

He just posted a fascinating new story. It seems that Dr Blumsohn submitted an abstract to The International Bone and Mineral Society (IBMS) Meeting (to be held in Montreal) which featured a re-analysis of some of the data of his original study of risedronate. This work failed to show a "plateau effect" in measures of bone resorbtion and fracture. The presence of such an effect was a point of contention between Dr Blumsohn and Procter and Gamble, and the failure to find such an effect did not help arguments the company was making in favor of risedronate.

At the bottom of the abstract, Dr Blumsohn noted that the study was funded by Procter and Gamble, as indeed was the original study from which this data which was re-analyzed had been derived. Blumsohn later received a message that one Dr Christopher Purple, of Medical & Technical Affairs, Procter & Gamble Pharmaceuticals had sent to the IBMS. Dr Purple, who has no known relationship to Blumsohn's study of risedronate, requested that the statement that disclosed support from Procter and Gamble be removed from the abstract. When the IBMS meeting staff learned they had been misled, they restored the funding disclosure statement.

This appears to be a new variant on ghost authorship, in which a ghost author managed temporarily to alter a manuscript without the knowledge of the manuscript's true authors. I have not previously heard of a case in which a disclosure statement was altered with the effect of erasing the support of a commercial sponsor for a project that did not turn out to provide data that fit that sponsor's vested interests.

Add this to the catalog of how pseudo-evidence is created. Add this also as a reminder that those who truly want to practice evidence-based health care need to heed this old Scottish poem:
From ghoulies and ghosties,
And long-leggedy beasties,
And things that go bump in the night,
Good Lord, deliver us!

See also this post on the Clinical Psychology and Psychiatry blog.

"Ghosts in the Machine"

We have posted several times (most recently here, with links backward) about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him, and he eventually lost his position there.

Dr Blumsohn just wrote a brilliant essay on the integrity of clinical research for the Professional Ethics Report published by the American Association for the Advancement of Science. I will quote from his introduction and then his conclusions. (In the center of his essay is a clear discussion of his case, plus mention of some other important cases, well known and not.)

Pharmaceutical companies sell products under the banner of science and medicine. However, their raison d’être is to make money. If industry gets involved in science, it has to balance genuine hypothesis testing and transparency against commercial interests, bureaucracy of drug regulation, and the financial consequences of dishonesty. This is not in itself a criticism – it is a simple fact.
Universities exist for a different reason – to add to human knowledge and to disseminate that knowledge through publication and teaching. Subtle compromises have allowed the pharmaceutical industry to develop an extraordinary stranglehold over the scientific process, academic discourse, regulatory safeguards and common sense. It is hard to see how safeguards for dispassionate scientific discourse can be sustained when medicine flagrantly disregards them.
The pharmaceutical industry is accused of overturning the usual safeguards of science. The most fundamental of these safeguards is the accountability of authors. Readers of legitimate science expect that stated authors are truly the authors, that they vouch for the work, and that they would be able to defend their findings if challenged. They expect that authors have seen and scrutinized raw data, and would be able to provide that data if asked. That it is necessary to write this indicates how much we have lost.
Industry has been inclined to use universities to give tainted science a veneer of respectability, while denying the very basis of that respectability. 'Ghost-writing' has been repeatedly criticized. However, professional 'medical writers' may sometimes have a legitimate role if clearly acknowledged. By emphasizing the 'writing' aspect, we divert attention from the far more important problem – that of 'ghost science,' of which 'ghost-writing' is only a part.

The usual definitions of scientific misconduct do not apply to pharmaceutical research. In February 2006, Gerald Schatten was accused of research misconduct. His crime was to have coauthored a stem-cell publication with the discredited Dr. Hwang Woo Suk, while shirking the 'responsibilities of verifying the data.' Schatten might have been irked to discover that at the same time, Procter and Gamble Pharmaceuticals (P&G) declared to the media that it was 'standard industry practice' to deny authors access to raw data in drug studies.

Blumsohn concludes:

The ethical challenge in pharmaceutical medicine is to use available data in the best possible way. Data are derived from human participants who subject themselves to risk in the public interest. They have the right to know that the data derived from their assumption of risk are used properly. When data are closed to scrutiny, even by the supposed authors of research, this cannot constitute an appropriate or ethical use of that data. Patients have to be involved in solving the problem.

Most importantly, as academics we need to reassert the importance of data and the
meaning of authorship. We also need to assert “old fashioned” ideas of academic
freedom, our right to speak the truth as we see it, and to allow that truth to be
subjected to open debate.

In the words of George Orwell (1984), 'Freedom is the freedom to say that two
plus two make four. If that is granted, all else follows.'

Bravo!

Aubrey Blumsohn Joins the Blogsphere

We have posted several times (most recently here, with links backward) about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

Dr Blumsohn has now joined the blogsphere. His effort is entitled the "Scientific Misconduct Blog." Based on his upclose and personal experience with concentration and abuse of power in health care, I'm sure he will have some interesting and perceptive things to say. Stay tuned.

Dr Aubrey Blumsohn on North American Tour

We had posted a while back and again here about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

Dr Blumsohn will be in northern North America (Canada and the USA) next month, speaking at a number of venues. His schedule is below:

Penobscot Bay Medical Center, Rockport, Maine, USA - 9 June 2006
Title: Fostering Scientific Integrity in a Wasteland (Grand Rounds)
Contact Details: Cathy Hopler (207) 596-8215

Harvard School of Public Health, Cambridge, Massachusetts, USA - 12 June 2006
Time: 17:15 to 18:30pm
Location: Program on Ethical Issues in International Health Research, Kresge Building, Harvard School of Public Health, Camb, MA
Title: Where is my data? Learning from Ethical Crises at the University-Pharmaceutical Interface (Ethics workshop)
Contact Details: Emily Kaditz (617) 432-3998 before attending (may be closed to additional attendees)

St. Boniface Hospital, University of Manitoba, Winnipeg, Canada - 16 June 2006
Time: 12:00-13:00
Location: St.Boniface Hospital, Samuel Cohen Auditorium, Winnipeg
Title: From Questioning Scientist to the Unemployment Queue: Pharmaceutical Science Meets Franz Kafka (Ethics Grand Rounds)
Contact Details: Professor Arthur Schafer (204)-474-9107
Sponsored by: The University of Manitoba, Centre for Professional and Applied Ethics

University of Toronto, Toronto, Canada - 19 June 2006
Time: 16:00-18:00, reception to follow, 18:00 - 20:00
Location: Bennet Lecture Hall, University of Toronto. Reception to follow in Rowell Room (Flavelle House )
Title: Where Are My Data? - Learning from Crises in Pharmaceutical Research: A New Story About the Pharmaceutical Benefactor, the University, the Ghost, a Lone Academic and the Bill of Rights
Contact Details: Ms Valerie Joseph (416)-340-4800 x 6507
Sponsored by: Doctors for Research Integrity and The Canadian Association of University Teachers, Trudo Lemmons, Faculty of Law; Nancy Olivieri, Faculty of Medicine (hosts)

Maine Medical Center, Portland, Maine, USA - 21 June 2006
Time 08:00-09:00
Location: Dana Auditorium, Maine Medical Center, Portland,
Title: Where Are My Data? Learning from Ethical Crises at the University-Pharmaceutical Interface (Medical Grand Rounds)
Contact Details: Candy Kucharik (207)-662-2651

You heard it first on Health Care Renewal

News Flash: Procter and Gamble to Let Researchers See Their Own Data

We have posted frequently, (most recently here) about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

According to the (UK) Guardian, P&G has made a major concession, "last week [it] confirmed it had written a 'bill of rights' setting out the rights of researchers to have access to all the data relevant to their work, so that they can 'confirm the accuracy of statements and conclusions published with them as co-authors.'"

Pending the reading of the actual "bill of rights," this appears to be a step in the right direction.

Of course, that researchers should be allowed access to data from their own research product, and that they should be able to affirm the accuracy of papers that they have authored seems to be a complete no-brainer. That it is news that a pharmaceutical company has put such statements in writing says something about how low much of clinical research has sunk. That universities, medical schools, and academic medical centers have signed contracts with corporate research sponsors to permit the corporations to control the research data produced by faculty "investigators," and how the data is reported is a scandal. (See systematic evidence provided by the Mello study, and post here).)

Let's see if any other companies are brave enough to follow Procter and Gamble's good example. Let's see if any academic leaders will be emboldened to defend the academic integrity of their own faculty.

Blumsohn Tours Washington to Raise Concerns About Pharmaceutical Research Integrity

We had posted a while back about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

Blumsohn has been in Wahsington, DC, speaking with the staff of the US Senator Charles Grassley (R-Iowa) about the general problem of integrity of clinical research, prompting some renewed press coverage of this story. A brief Associated Press story summarized the issues involved. The Wall Street Journal (available here without a paid subscription) had another version, including this quote by Grassley

This isn't the first time, I bet it won't be the last, that we hear concerns about drug companies selectively witholding unfavorable clinical trial data. It's a recurring complaint and a detriment to rigorous scientific research.

Meanwhile, the British Broadcasting Service did a long radio feature on the case, (audio available here, but a transcript is not yet available).

It's time for this issue to be back in the spotlight.

The pharmaceutical industry produces many very useful products, which as a physician I frequently prescribe. Now, however, the industry seems to expect stratospheric returns for for some of its newer drugs. Numerous anecdotes, some mentioned previously on Health Care Renewal, however, have suggested that the industry has sometimes manipulated research data to make their latest products appear to be wonder drugs deserving of such high price tags. The industry is currently faced with continuing skepticism and declining trust, which may eventually make it hard to support even more modest pricing. The public, physicians, and the pharmaceutical industry itself would be better served by the industry's clear rededication to clinical research integrity.

More Fall-Out from the Blumsohn - Procter & Gamble - Sheffield University Case

We previously posted about the complicated case of alleged manipulation of clinical research by a commercial sponsor, and suppression of academic freedom by a university, involving Dr Aubrey Blumsohn, Sheffield University, and Procter & Gamble (P&G).
To summarize, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.
A brief article in the Guardian just revealed that Eastell "has left his job as director of research at the Sheffield Teaching Hospitals Trust following claims of financial irregularities. Eastell had been suspended from his NHS (National Health Service) work while the hospital investigated allegations that he was charging the NHS for work that should have been done privately." But, "a hospital spokesman said because Eastell had resigned before the inquiry finished, it could not reach a verdict."
My experience has been that once one instance of behavior that violates physicians' core values comes to light at an institution, others often follow, demonstrating the penumbra of bad outcomes that ill-informed, conflicted, or corrupt leadership of health care organizations often produces. More shoes may drop in this case.
[Note: for the PharmaGossip take on this incident, see this link.]

More Summary, and Much Documentation of the Blumsohn Case: "Rent-a-Researcher?"

A new article about the case of Dr Aubrey Blumsohn has just appeared in Slate, written by Jennifer Washburn. The title says it all.

It does a good job summarizing events in the case so far. What is most remarkable is that it links to a series of documents and recorded conversations that back up what has been reported previously. (See our last post here, with links to previous posts.)

The key points of the case are as follows, (with relevant links to documents and recordings):

• Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.
• Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.
• Despite numerous requests, (like this one), P&G refused access to this data repeatedly.
• Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.
• Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially related to a graph shown to him that omitted 40% of patient data.
• Blumsohn objected to P&G arranging for papers and abstracts to be written by a professional writer, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.
• Eastell warned Blumsohn not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."
• After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including Eastell, medical school Dean Tony Weetman, University Vice-Chancellor Robert Boucher, and the Head of the University's Department of Human Resources, Ms R Valerio.
• Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then offered him a severance agreement if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.

A good summary of the case written by Blumsohn (in the letter to Valerio):

I performed a large-scale research project involving samples collected as part of FDA trials used to register the drug Risedronate (RJ102356). Measurements were performed in my laboratory, and Professor Eastell was coinvestigator. The aim of the study was to address an important and controversial question relating to this class of drugs. The company failed to allow investigators access to randomisation and event codes from the study. They continued to refuse access to this information to authors even after ghost-authoring work in the names of myself and Professor Eastell, and after substantial and increasing information emerged to suggest that the company data analysis could not be trusted. This breached their contract with the university, although restrictive contracts are widely held to be unenforceable in any event. The procedure was in conflict with all of the norms of usual legitimate scientific conduct. It is not necessary for me to demonstrate exactly how data analysis was perverted. Nor is it necessary to elaborate the effect that this may have on patient care. The principle at stake is clear, and such a process involving a sponsor is not ever appropriate in clinical medicine, or in any other branch of science.

Washburn drew some important conclusions:

Why did Sheffield, a top-flight research university, try to silence and get rid of Blumsohn?
The answer appears to lie in the complex and increasingly compromised relationship that have grown up between some research universities and the pharmaceutical industry.
Universities with medical schools have become dependent on drug companies for an ever-larger share of their research budgets - roughly 80 percent of clinical research is now privately funded. And drug companies, in turn, have pressed for greater control over the research process, making it easier for them to obscure or delete negative results from published academic papers.
Universities have long accepted funding from pharmaceutical companies to conduct clinical trials. But in the past, their professors insisted on running those trials independent of the sponsor. As the Blumsohn case makes clear, this arm's-length relationship appears to be breaking down.
Whatever the solution, something needs to be done soon. Scholarly independence has taken too many hits.

Hear, hear.

Paying for Silence: Updating the Blumsohn - Procter & Gamble - Sheffield University Case

The Times (UK) Higher Education Supplement (THES) has reported more about the case of Dr Aubrey Blumsohn at Sheffield University.

We have posted before (here most recently) about how how Dr. Blumsohn had attempted, in vain, to get access to the data from a research project on the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) that he was ostensibly leading, and to control the writing of research abstracts that was done supposedly in his name. His attempts were opposed by P&G. Sheffield University failed to support his efforts, and after he talked to the media about his problems, suspended him from his duties.

THES reported that the University had offered Blumsohn 120,000 pounds sterling "compensation" and another 25,000 "for injury to feelings." However, to get the money, Blumsohn would have had to agree not to make any "detrimental or derogatory statements" about Sheffield, or its staff, including the Dean, Tony Weetman, and its Vice-Chancellor, Robert Boucher.

Blumsohn rejected the offer, stating "Effectively, I would be accepting 145,000 [pounds] in exchange for allowing part of the jigsaw of clinical and scientific debate to remain uncorrected, and this would be unconscionable."

Its remarkable how many health care leaders seem focussed on secrecy.

We have posted a few times about this (here most recently). Each of those posts was in response to sets of cases in which health care leaders tried to suppress facts or opinions they didn't want aired in public.

So I get to quote myself again - Posts on Health Care Renewal recently "demonstrated the continuing threats against transparency and openness in health care. They also demonstrate that many threats come from leaders of large health care organizations who don't like information that puts them in a bad light made public. Yet how will we improve health care without access to information about what is going wrong, and opinions about what do to improve things?"

Sunlight is the best disinfectant.

No Protection for Whistle-Blowers: The Blumsohn - Procter & Gamble - Sheffield University Case

The (UK) Guardian reported the latest developments in the case of Dr. Aubrey Blumsohn at Sheffield University. We had posted earlier (here and here) how Dr. Blumsohn had attempted, in vain, to get access to the data from a research project that he was ostensibly leading, and to control the writing of research abstracts that was done supposedly in his name. His attempts were opposed by Procter & Gamble, the company that made the drug he was studying, and paid for the research. Sheffield University failed to support his efforts, and after he talked to the media about his problems, suspended him
from his duties.
It turns out that Dr. Blumsohn "warned the Journal of Bone and Mineral Research more than a year ago that he had grave doubts about some of the research it had published in his name." At that time, Blumsohn wrote, "I am the first author on both abstracts and have serious concerns about the analysis which has been presented in my name, as first author. Is there a mechanism for comment or dissociation?" At first, no investigation was done. Now, "the Journal has confirmed that it will hold an inquiry into Blumsohn's concerns."
The Guardian also reported, "Ghostwriting and a lack of data for independent researchers are just two issues that worry academics. For years, scientists have argued that Britain needs a statutory body to investigate such problems, as well as to detect the most serious cases of academic fraud. Professor Ian Kennedy, chairman of the Healthcare Commission, has said there must be proper protection for whistleblowers. He said they were often ignored, victimised, or labelled as pathological."
This case, like those of Dr. David Kern and of Dr. Nancy Olivieri in the 1990's, (described here) illustrates how academics may be "victimised," to use Dr. Kennedy's term, when they try to secure the integrity of research in ways that offend vested interests. This case also illustrates how academic institutions seem to be willing to cooperate in this victimization, even when such actions undermine their mission to provide for free enquiry and free expression. Finally, it illustrates that at present, in neither the UK, Canada, nor the US are there organized means or protection for such victimized academics. Up to now, no health board, accrediting agency, or physicians' organization has gone to bat for them.
Maybe the unfortunate case of Dr. Blumsohn will finally spur physicians and researchers to unite to defend their own core values. Until we make it safe for researchers to produce data that displeases the powers that be, why should we trust what data the powers that be allow us to see?

Another Challenge to the Integrity of Clinical Research: The Blumsohn - Procter & Gamble - Sheffield University Case

The Times (UK) Higher Education Supplement (THES) reported an important case involving the integrity of clinical research. Unfortunately, it is not available online without a subscription, so I will quote where needed. The citations are at the bottom of this post. The case involves research carried out at Sheffield University on the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]).

In 2002, Professor Richard Eastell, of the Bone Metabolism Research Group at Sheffield University, was quizzed by a colleague after presenting a paper on a clinical trial of risedronate to the International Osteoporosis Foundation. Eastell then wrote to P&G statistician Ian Barton, "I think that to avoid criticism in the future it would be good if we could say that we had done the analyses independently." However, Mike Manhart, director of clinical development at P&G, did not agree, saying that letting the academics do an independent analysis would mean that "industry loses the opportunity to demonstrate its ability to be a true partner in scientific endeavors." Furthermore, he said the company had invested "hundreds of millions of dollars" in its drug trials data, so that giving out the data was not "something to be taken lightly."

Yet, when results of the trial were reported (Eastell R, Barton I, Hannon RA et al. Relationship of Early Changes in Bone Resorption to the Reduction in Fracture Risk With Risedronate. J Bone Mineral Research 2003; 18(6):1051-6.), the THES reported that the journal stated, "all authors had full access to the data and the analyses." Another author, Rosemary Hannon, however, denied that she saw all the data, but also noted "neither did I request access to all the data."

In 2002, the research unit signed another contract with P&G to do a another trial (the HIP trial) of risedronate. Aubrey Blumsohn, a Senior Lecturer, was the principal investigator. Eastell again asked Barton, "Could I suggest that Aubrey works with you to see how you did the analyis for the [previous] VERT trial, and then, when we have the HIP data, we could have the analyses run by you and by Aubrey so that we can say that we got the same result with independent analyses?" But Barton again replied, "we ... don't need to ask an independent person to analyse the data just to make a few people happy." Blumsohn later also tried to get access to the data, but by 2003 was not succesful.

However, in 2003, Blumsohn discovered that P&G had written three research abstracts and had submitted two to the American Society for Bone and Joint Metabolism and one to the American College of Rheumatology. In all cases, P&G had listed Blumsohn as first author, but Blumsohn had not written the abstracts. Blumsohn presented the latter abstract, but then said, "In retrospect I might have refused to present this work."

Furthermore, P&G started pushing Blumsohn to write a manuscript reporting trial results. Blumsohn again requested access to the data. But Barton once more replied that this would be a "distraction" from getting the manuscript "written and submitted before ... our competitors pip us to the post."

Blumsohn and P&G started to argue about the interpretation of what analyses were done. In 2004, Blumsohn formally complained to Eastell, "no self-respecting scientist could ever be expected to publish findings based on data to which they do not have free and full access." No paper has been published to date.

Eastell later said that Blumsohn should have taken his concerns "through the appropriate university channels." The university did not launch a formal investigation of Blumsohn's complaints. Instead, "Dr. Blumsohn is suspended from duties, facing disciplinary action for disussing concerns with the Times Higher."

In summary, this case illustrates

• a commercial clinical research sponsor which would not share raw data with or allow analyses by the academics who were ostensibly the principal investigators for the studies it sponsored;
• a commercial research sponsor which ghost-wrote research abstracts;
• a university which seems to have punished one of its faculty for complaining about the sponsor's excess control of clinical research.

Letters subsequently published in the Times Higher Education Supplement made valid points about all this.

When universities become dependent on drug company money they risk losing their fundamental commitment to the truth - Arthur Schafer, University of Manitoba

More than half a century ago, sociologist Robert Merton observed that the normative structure of science should be based on free and open exchange of knowledge. The situation of Aubrey Blumsohn and the acknowledgement that limiting academics' access to data is 'standard industry practice', illustrates the extent to which Merton's ideals have been eroded - Nancy Olivieri, University of Toronto

It is extremely troubling then that a university hides behind procedure and refuses to take a strong and principled stance in support of a researcher who demands full access to research data - Trudo Lemmons, University of Toronto

Stories about ghostwritten journal articles, hidden research data, a bullied academic and a university kowtowing to its industry funders have become depressingly familiar - Carl Elliott, University of Minnesota

Enough said.
References
Baty P. Data row sparks research debate. Times Higher Education Supplement, November 25, 2005.
Baty P. When access to data is a real bone of contention. Times Higher Education Supplement, November 25, 2005.
Letters & Opinion: Ensure integrity in industry links. Times Higher Education Supplement, December 2, 2005.