Officer and Thug

I thought I would repeat the story of the thug and the policeman from the end of my previous post.

Think of your favorite teddy bear. Now imagine it’s been torn apart, disemboweled, and turned inside-out.

That’s what artist Kent Rogowski’s has done in his Bear series. He mangles our memories of the world.

Perhaps a metaphor for the effect of the pharmaceutical industry on the conduct of science (in collusion with our medical leadership and "regulators" of course). Usual understanding turned inside out.

Buy the book here

OFFICER AND THUG
by Ambrose Bierce (from a Subtreasury of American Humor)

A CHIEF OF POLICE who had seen an Officer beating a Thug was very indignant, and said he must not do so any more on pain of dismissal.

"Don't be too hard on me," said the Officer, smiling; "I was beating him with a stuffed club."

"Nevertheless," persisted the Chief of Police, "it was a liberty that must have been very disagreeable, though it may not have hurt. Please do not repeat it."

"But," said the Officer, still smiling, "it was a stuffed Thug."

In attempting to express his gratification the Chief of Police thrust out his right hand with such violence that his skin was ruptured at the armpit and a stream of sawdust poured from the wound.

He was a stuffed Chief of Police.

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ORI Research misconduct survey reports the obvious - again

The Office for research integrity has just published a survey in Nature.

Sandra L. Titus, James A. Wells Lawrence J. Rhoades (2008-06-19). Repairing research integrity. Nature. 453, 980-982.

The survey suggests that most research misconduct in the United States is unreported to the ORI. Furthermore, fraud is not rare.

The US National Academy of Sciences has asserted that scientists share an 'obligation to act' when suspected research misconduct is observed. However the reported number of investigations submitted to ORI has remained low: on average 24 institutional investigation reports per year.

"The 2,212 researchers we surveyed observed 201 instances of likely misconduct over a three-year period. That's 3 incidents per 100 researchers per year. A conservative extrapolation from our findings to all DHHS-funded researchers predicts that more than 2,300 observations of potential misconduct are made every year. Not all are being reported to universities and few of these are being reported to the ORI."

"These numbers indicate a sizeable disconnect between what universities are seeing and the 24 investigations evaluated by the ORI annually."

There is a leadership problem, whitewashing, bullying, and sham investigation.

The leaders of institutions may also have concerns about handling research misconduct. Because public image is important to institutions, some may try to minimize reporting and keep unfavourable information from reaching the ORI and the press. An institution may choose to ignore conducting an investigation and instead they may simply dismiss an accused person or even a whistleblower in the hope that the problem will go away without needing further examination. Additionally, institutional leaders may wish to ignore or minimize allegations of possible research misconduct to protect the revenue that the researcher generates; some may avoid investigations because they are costly in terms of time and money.

The paper makes six recommendations

1. Adopt zero tolerance. Social responsibility to the academic community and to the public who fund the research will be strengthened when it is apparent that an institution has a real commitment to integrity.
2. Protect whistleblowers: 43% reported that institutions encouraged them to drop the allegation.
3. Clarify how to report
4. Train the mentors
5. Use alternative mechanisms
6. Model ethical behaviour: People imitate the behaviour of powerful role models. Institutions successfully stop cheating, for example, when they have leaders who communicate what is acceptable behaviour, encourage faculty members and staff to follow the policies, develop fair and appropriate procedures for handling misconduct cases, focus on ways to develop and promote ethical behaviour, and provide clear deterrents that are communicated(McCabe, D. L., Trevino, L. K. & Butterfield, K. D. 2001 Ethics Behav. 11, 219–232).

The conclusion is:

"Our study calls into question the effectiveness of self-regulation. We hope it will lead individuals and institutions to evaluate their commitment to research integrity."

There are some problems here. Much serious fraud takes place at the commercial-academic interface with the acquiescence of government. The ORI has no role here. Furthermore, carefully evolved re-definitions of fraud have made it difficult to deal with the most serious instances of fraud. The ORI fails to comment on most cases of fraud which arise.

So much for leadership, role models and the rest.

Despite the appropriate conclusions, the study adds nothing beyond the long trail of other ignored studies which have reported the same. This is a never-ending loop of many roads leading from nowhere to nothing. It's all a heady mix of righteous indignation, hand sitting and some occasional wrist slapping.

So let's say it again:

1. Research fraud is not rare.
2. Investigation of fraud is a sham
3. Fraudsters are usually shielded from criticism except for the occasional random punishment that maintains the illusion.
4. Those who state the obvious are abused.
5. Official integrity bodies and regulators are entirely useless and are often complicit.
6. It is not necessary to conduct research to demonstrate the obvious. In the pharmaceutical arena the list is endless (Vioxx, Avandia, Zetia, Actonel).
7. In each and every instance there are attempts at cover-up, serious damage to the public and damage to science.
8. Most importantly, there is failure of the very organizations who claim to act as guardians of integrity to open their mouths.

It reminds me of the very old story of the Officer and the Thug

OFFICER AND THUG

A CHIEF OF POLICE who had seen an Officer beating a Thug was very indignant, and said he must not do so any more on pain of dismissal.
"Don't be too hard on me," said the Officer, smiling; "I was beating him with a stuffed club."
"Nevertheless," persisted the Chief of Police, "it was a liberty that must have been very disagreeable, though it may not have hurt. Please do not repeat it."
"But," said the Officer, still smiling, "it was a stuffed Thug."
In attempting to express his gratification the Chief of Police thrust out his right hand with such violence that his skin was ruptured at the armpit and a stream of sawdust poured from the wound.

He was a stuffed Chief of Police.

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The fall of the General Medical Council - Part I: Confidence or con

Last week I received a tentative invitation (via the group Justice in Health) to "attend" an "event" at Westminster on 24 July 2008. The event "The Future of Health Professional Regulation" is hosted by the Council for Healthcare Regulatory Excellence (CHRE) and the Department of Health. It is supposedly about sorting out professional medical regulators in the interests of patients.

I will not be attending.

Sham public consultation has become a dismal hallmark of this Labour government. They have not learned to listen.

One of those regulators is the General Medical Council (GMC). The GMC is the body that registers and is supposed to "regulate" the integrity and "fitness to practice" of UK medical doctors. This is an important job. The GMC have a huge credibility problem.

If the DoH and the General Medical Council really wanted to find out how to reform themselves in the "patient interest" then they would invite their fiercest and most thoughtful critics to explain the problems that have arisen. There are many such critics. Those critics would detail lamentable and inappropriate behaviour. They would explain how "regulators" have acted to hide fraud, misconduct, and other activities which have damaged patients and science. They would explain how the GMC has bullied some individual doctors, while ignoring parallel but far more serious integrity failings involving the "old boy's network".

There are many people they could invite to present aspects of the regulatory problem in detail. I am relatively sensible. Others provide a range of insights - Peter Wilmshurst, Rita Pal, Charles Medawar, John Abraham to name a few. Many patients tell compelling stories of obvious regulatory obstruction.

But inviting thoughtful hard-hitting criticism is not the intent.

Instead we have a profusion of "reports" which have no meaningful intersection with the real world.

Here is one from a week back:

"Implementing the White Paper - Trust, Assurance and Safety: enhancing confidence in healthcare professional regulators - final report and DH response to recommendations" (2 June 2008). Read it here.

The woefulness is implicit in the title. The report is not about the actual integrity, plausibility, honesty and consistency of medical regulators. It is about "enhancing public confidence in the regulators of healthcare professionals". It is about inducing confidence in the unacceptable. It is not about real confidence. It is a con.

I talk regularly to doctors and patients about the systems that regulate integrity in the UK. I discuss the malfunction of professional and pharmaceutical regulators, sham investigations, and the bizarrely inconsistent approach of the General Medical Council to the telling of lies by doctors. My thoughts are marginally less boring, irrelevant and nausea-inducing than "Implementing the White Paper". Here is the feedback form from my recent teaching session with postgraduate general medicine trainees in Sheffield. No nausea is reported.

So, Department of Health (and the General Medical Council), why not invite your critics to explain how you need to restore decency and relevance to regulation? Invite them to explain in detail - not under conditions of a carefully controlled "consultation". The ghosts of the Bristol babies, the many patients who have died as a result of corrupted pharmaceutical research and the victims of Harold Shipman might applaud. I doubt they would applaud throwing time and public money at an irrelevant confidence scam.

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How a new paradigm is created

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One million evil men

I am doing a bit of serious writing for a book chapter about the General Medical Council, the UK Medicines and Healthcare Products Regulatory Authority, Procter and Gamble and regulatory failings. During this hiatus I'll be posting a few offbeat things here from my amusement file, and I'll be taking a few constructive wacks at the General Medical Council (GMC). Given the current shambolic pontifications of the GMC about science in three Fitness to Practice cases (Southall, Wakefield, Eastell) I'll revisit the ethics of two of my own published studies involving injection of radioactive isotopes and some sperm.

Thank you to all those who have E-mailed to ask if I'm OK. Stay tuned.

From Chapter 17 of the book Shantaram by Gregory David Roberts




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