Sunday, April 29, 2007

Dr David Kern's "dilemma" - learning from history

In November 1996 Dr David Kern, Professor of Occupational Health Medicine at Brown University in Rhode Island received a letter.

Dr Kern's dilemma

The integrity of medical research is under threat. Many cases have arisen which have demonstrated the inclination of our profession to act in a way that damages both science and the interests of the patients we serve. In many instances, organizations charged with maintaining integrity have colluded, almost routinely, to pervert science, to bully those raising concerns, and to obscure problems. These organizations include our medical Journals, professional regulatory bodies, drug regulators and even formal bodies devoted to maintaining "integrity".

The story of Dr David Kern and the "dilemma" of flock workers' lung is one of many such stories. The letter mentioned Kern's "dilemma". The problem was that Kern had no dilemma. Kern knew that the integrity of a doctor is paramount. The dilemma was one for Brown University.

What happened to David Kern is a stain on the reputation of Brown University. In 1994 Kern reviewed a patient with unusual lung disease. He wondered whether the disease might be due to occupational exposure. Kern visited the patient's place of work - Microfibres Inc. Before visiting he signed a standard confidentiality agreement forbidding the disclosure of any "trade secrets" he might discover during his visit. Over the next two years at least 6 more cases arose, and Kern believed he had sufficient evidence to prove the existence of a new lung disease. He informed the company of his decision to publish his findings, initially in the form of an abstract at the annual meeting of the American Thoracic Society in May 1997.

In response to this, Microfibres Inc., threatened to sue citing the confidentiality agreement prohibiting disclosure of any "trade secrets". However occupational lung disease is not such a "trade secret". The associate Dean of Medicine, Paul Shank attempted to force Kern to withdraw his abstract, and to prevent publication of the findings. Kern refused. He next received correspondence from Francis Diez, president of Memorial Hospital instructing him to withdraw. The hospital, the letter added, was shutting down his entire program "effective immediately". Shamefully, six months after the actions of Shank and Diez, Brown University pretended in a duplicitous statement that they had supported Kern's academic freedom and integrity all along. Less than a week after that, Kern received a letter informing his that his teaching and research positions had been eliminated. Brown University appeared to see nothing to gain from honest research or medicine. Microfibres’ owner and two relatives sat on the hospital’s board, and the company had helped to fund the hospital’s facilities.

University obfuscation in the Kern case was damaging both to our profession and to our patients: In the words of Dr Kern:
Extracts from speech delivered at MIT March 29, 1999

"A small group of Brown University faculty members rallied and called for university administrators to take a principled stand. Instead, the Dean of Medicine hand-picked a Committee of Inquiry comprised of two associate deans whose subsequent report side-stepped nearly every critical issue."

"Moreover, far more important issues such as the suppression of scientific findings critically important to public health and interference with a physician's responsibilities to care for his patients were not addressed at all."

The ATS [American Thoracic Society] admonished: "Barriers to the open communication of scientific information must be resisted. In particular, the threat of litigation and/or elimination of financial support to prevent the open communication of scientific information is abhorrent."

Democracy can coexist with the belief that all humans are sinners but not with the belief that all sins are equal. Democracy has within each of its camps, not excluding the civilitarian camp, thugs in number. And when you're in an argument with a thug, there are things much more important than civility."

I do not like incivility. Yet, I like thugs even less. What I am asking, rather, what I demand of us all is honesty and truth. For without honesty and truth, there is nothing.

In my case, representatives of the company, the hospital, and Brown University have gone to great lengths to distort the truth. Yet, even were their claims true, their points of contention are irrelevant to the critical issues that remain (a) their attempts to suppress the dissemination of scientific findings critically important to the public health, (b) their interference with my professional responsibilities to care for patients, and (c) their immediate termination of the state's only occupational health program.

And so, we are left confronting arrogance, dishonesty, and a callous disregard for the health of workers. While our medical school and university administrators continue to proclaim their dedication to truth, to the search for knowledge, and to the advancement of civilization, it is all pretense as wordsmithing triumphs over truth and as knowledge is buried. What makes such pretense infuriating goes beyond hypocrisy to the failure of these administrators to realize that people's lives hang in the balance. They either fail to appreciate or are unwilling to acknowledge that their words and actions have jeopardized the health of individual workers, have contributed to the potentially irrevocable loss of an opportunity to advance both scientific understanding and the public health, and have undermined the collective sense of trust and mission in our academic community.

For more information about David Kern see:

  1. New Disease, Old Story. Annals of Internal Medicine 15 August 1998 129(4) Pages 327-328 (by Frank Davidoff, Editor)
  2. Transcript of a speech by Dr Kern, Delivered at MIT, Cambridge, MA, March 29, 1999
  3. Objectivity Lost: University Industry Science Collaborations
  4. David G. Kern, Robert S. Crausman, Kate T.H. Durand, Ali Nayer, Charles Kuhn III. Flock Worker's Lung: Chronic Interstitial Lung Disease in the Nylon Flocking Industry. Annals of Internal Medicine 15 August 1998 Volume 129(4) 261-272 [Full Text]

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Monday, April 09, 2007

The mission of a University: Burger Flipping, Tenure, Berkeley and British Petroleum

One door or two?"Behind one of these two doors is tenure - Behind the other is flipping burgers". Which do you pick? (Hat tip Omni Brain for cartoon).

Farley appears to have missed the boat in this instance. The door leading to tenure is the same door that leads to McDonald’s, Procter and Gamble or British Petroleum.

Recent events at the University of California at Berkeley underlie the anxieties we should be feeling about the cataclysms occurring at academic-industrial interface. On the 1st of February the oil giant BP announced that it had chosen UC Berkeley to lead the largest academic-industrial research alliance in history ($500 million over 10 years).

LA journalist Jennifer Washburn writes well about the undoing of Universities as part of such deals. "Would the institutionalization of BP at Berkeley call into question the essential objectivity of the research generated by the collaboration?" Her full news report in the LA times is here, extracts are below. It is also worth reading the speech by Professor Ignacio Chapela to the Berkeley senate on 8 March 2007 (full text here, webcast here).

For anyone wondering what these sorts of partnerships mean for a university without an academic compass it is worth reading what happened to Professor Tyrone Hayes at UC Berkeley in 2003 when he tried to publish scientific findings about the pesticide atrazine -- based on collaboration with the company Syngenta (see also excellent article in the Ecologist about this incident). It is worth remembering what happened to Professor Ignacio Chapela at Berkeley in 2004 when he tried to pubish a Nature article showing that genetically modified corn had contaminated native maize in Mexico - stepping on the toes of a Berkeley-Novartis agreement.
In the absence of a compass, such partnerships have little to do with scholarship and are at odds with the fundamental mission of a University. In the worst cases, such partnerships may smooth the path to corporate research misconduct. Academics might be used to give flawed, secret or selectively reported research a veneer of university respectability, while the deal undermines the very basis of that respectability.

I have nothing against big industry or big pharmaceutical companies. However their raison d'ĂȘtre is to make money. If industry gets involved in science, it has to balance genuine hypothesis testing and transparency against commercial interests 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.

I might be inclined to choose the burger flipping.

Big Oil buys Berkeley
The BP-UC Berkeley research deal pushes academic integrity aside for profit.

By Jennifer Washburn, LA Times, March 24, 2007

Extracts - The full news report is here.

ON FEB.1, the oil giant BP announced that it had chosen UC Berkeley, in partnership with the Lawrence Berkeley National Laboratory and the University of Illinois at Urbana-Champaign, to lead the largest academic-industrial research alliance in U.S. history. If the deal is approved, BP will give $500 million over 10 years to fund a new multidisciplinary Energy Biosciences Institute devoted principally to biofuels research.

Gov. Arnold Schwarzenegger, UC administrators and BP executives immediately proclaimed the alliance — which is not yet a done deal — a victory for higher education and for the environment. But here's another way to see it. For a mere $50 million a year, an oil company worth $250 billion would buy a chunk of America's premier public research institutions, all but turning them into its own profit-making subsidiary.

Robert Reich, former secretary of labor and now a professor of public policy at Berkeley, has warned that — because of its size and commercial scope — the BP alliance could be either "a huge feather in Berkeley's cap or a huge noose around Berkeley's neck." The question is, do rules and practices set up to safeguard academic integrity and independence stand up to a corporate deal of this magnitude?

Ultimately, there is an even more basic question to consider. Would the institutionalization of BP at Berkeley call into question the essential objectivity of the research generated by the collaboration?
See also An unholy alliance? and
and this piece about Stanford's deal with Exxon Mobil.

Things are Often Not what they Appear

Professor Ignacio Chapela to the Berkeley senate on 8 March 2007 (full text here, webcast here).

Remarks on the Berkeley-British Petroleum proposition prepared by invitation of the chair of the academic senate University of California, Berkeley - and presented on the floor of the Academic Senate (In eight minutes).

Things are often not what they appear

This session, for instance. It will be portrayed as the latest expression of the vibrant democratic system of shared governance for which Berkeley was once known. Far from it, this session is a last-minute hurried afterthought by a leadership caught asleep at the wheel, a session convened only because of the rising outrage and opposition to the presence of British Petroleum on our campus. May nobody claim that eight minutes of my clumsy words represent any kind of reasonable and legitimizing discussion. May nobody leave this room thinking that there is anything like a legitimate process in place to guarantee that this Faustian deal with the British transnational corporation is not what it portends, the last -and I believe final- coup de grace to the very idea of a university that can represent the best interest of the public..... more here

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Sunday, April 08, 2007

Batman and drug regulation in the UK

Thank you to the Bitter Pill Blog for pointing out the uncanny resemblance between the Right Honorable Andrew Burnham Minister of State at the Department of Health, and the psychiatrist known as the Scarecrow who works at Arkham Asylum (and has developed fear-inducing toxins) in the recent movie Batman Begins.

I have posted about the Right Honorable Andy Burnham previously:

I posted about the documented threats from the pharmaceutical industry to the Department of Health and Minister Burnham that they would withdraw from the UK if not allowed to get their own way [Link].

I posted about his praise for myself -- while he did nothing about the actual problems of research integrity I raised -- and while the MHRA, his government agency, attempted unsuccessfully to collude with others to obscure them [Link].

I posted about his rather interesting redefinition of the word transparency as it pertains to the UK drug regulator, the MHRA [Link].

batman and drug regulationBelow is the previous letter I wrote to him about a trivial but important aspect of transparency. He has not replied, no doubt because he probably doesn't read about the concerns raised by us the people, or my blog.

Anyway, here is that letter again. I'll send it by mail, and we will see if we can find out why we are not allowed to know anything at all about those who make decisions about our health and about honesty in drug regulation.

Despite the frivolity, there is a serious intent. It is clear that many patients have died as a result of a complete lack of regulatory transparency, gobbledegook regulation, and government failure to implement recommendations of the Health Select Committee report on the malfunction of the MHRA [Link].

To: Mr Andy Burnham
Minister of State, Department of Health
The House of Commons

Redated 8 April 2007

Dear Minster Burnham

I wish to let you know about a state secret, and to seek your opinion about it.

I should declare a conflict of interest. I was born in a country where a state secret involved brutal policemen and barking dogs. Secrets which could cause doctors or patients to make incorrect decisions because they have been misled (in even the tiniest way) are not legitimate secrets.

I was therefore delighted to note your letter to Stewart Hosie MP (5/9/06) about the UK drug regulator (MHRA) in which you write: "it is important for the [drug] regulatory system and indeed the regulator to operate in as transparent a way as possible".

Your comments relate to urgent concerns raised by many including The Health Select Committee 18 months ago. MP Hosie seemed upset by the rest of your response, since you suggested no time-scale to implement any sort of plausible or honest review of the MHRA. Given your emphasis on transparency Minister, might we consider the legal and moral implications of a small state secret.

Let me paint a picture: Let us suppose you were a doctor Mr Burnham. You are standing there, syringe in hand, about to inject a potentially toxic drug into a patient. You do so in the knowledge that the MHRA, your government agency, has given a stamp of approval. It would be your fundamental right to know why the MHRA approved that drug before inflicting potential harm on a fellow human being. You might imagine you would have a right to know that the MHRA scrutinised evidence, what named persons were involved, and how precisely those persons were qualified. You might imagine that it should be your moral obligation to know these things.

So let us consider a small secret. Mr Ian Oulsnam is operations manager of the GCP inspectorate of the MHRA. This is a key role in this public body. He makes pronouncements about matters of science and medicine. He makes decisions which impact on life and death. He "investigates" matters upon which patients and doctors depend. He was involved in the MHRA self-"investigation" of the TGN1412 disaster. He makes public statements to the press on behalf of the MHRA. He received parliamentary instruction to conduct the fascinating "investigation" of P&G's conduct in Sheffield. He informed me that he "has a "relevant" university degree and a postgraduate degree in statistics.

I was thus surprised to note on the MHRA website a Freedom of Information request from Mr RC (MHRA FOI 06/185). The MHRA declined to convey a list of Mr Oulsnam's scientific publications [on Pubmed there are none]. The MHRA declined to say what university degrees Oulsnam has (if any). It was stated this is personal information. In the same spirit of transparency, the MHRA refused to sign this FOI response. When asked repeatedly to reply in writing, they posted an unsigned printout of their Emailed response to RC.

Oulsnam then made a scientifically incorrect and bizarre statement to the press about a drug. That statement was reproduced by yourself in correspondence to a MP. I therefore repeated the FOI request. I did not ask whether Oulsnam felt himself qualified to do his job. I simply wished to know what precise university degree(s) Oulsnam has (if any), and at which University. This was again refused on the basis that it is "personal information".

The REQUEST (FOI 06/303): "Mr Oulsnam stated to me that he has a degree, and that he also has postgraduate degree in statistics"..... "it is not clear whether I was misled. I request under the FOI a list of the university degrees and postgraduate university qualifications held by Mr Ian Oulsnam of the MHRA (and the names of awarding institutions)."

The MHRA RESPONSE (FOI 06/303): "The full details of Mr Oulsnam's qualifications are not released as this is considered to be personal information." [the absence of "full details" in MHRA language = "no details"]

Given Mr Oulsnam's job and public scientific pronouncements, this is not personal information. My refusal to convey my degree(s) would be a disciplinary offense. The DoH website urges patients to insist that surgeons, doctors, dentists, nurses and beauty therapists disclose their qualifications. Universities themselves consider degree awards to be public information (eg here, here, here, here, here). Even professional hypnotists are required to make their qualifications available upon request!

Question 1 Mr Burnham: Would YOU inject the drug Mr Burnham?

Question 2 Mr Burnham: Is this behaviour restricted to the MHRA?

A similar FOI request to the Water Inspectorate (DEFRA) requesting degrees of an official yielded a remarkably comprehensive response within 2 days listing all degrees, Universities, subjects taken and dates. I feel strangely confident when I drink water.

Yet the MHRA, which (unlike the Water Authority) uses an intermediary - doctors - to administer potential harm to other humans is as transparent as mud. In another instance the MHRA refused to provide any names of officials who had made decisions about Vioxx on the laughable basis that this might expose them to animal rights activists!

There will always be potential concerns about the training, common sense and conflicts of interest of public officials. But the point is that you, as that syringe-holding doctor are not even allowed to know.

Something is wrong Minister Burnham.

Yours Sincerely

Dr Aubrey Blumsohn
and if it matters .... MB BCh, PhD, MSc, BSc hons, MRCPath

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