The bystander effect: would you stop for Britney Begonia?

Local 6, a Florida TV station has been conducting a series of experiments on the bystander effect.

In the latest "missing child experiment" they placed numerous posters in a mall with photographs of a missing 8 year old "Britney Begonia". Britney herself sat next to some of the signs. Hundreds of people walked past and saw the posters, but only two stopped to ask Britney anything. Many bystanders questioned later said they noticed the strange resemblance between Britney and the poster but were "fearful of getting involved."

An earlier Local 6 experiment involved a fake burglar breaking into a home. See also this publication on the bystander response to a mock casualty involving arterial bleeding.

The bystander effect has been extensively studied. The more people who observe an event, the less likely it is that anyone will intervene to help. Observers assume that someone else will do something and they feel less responsible. The obviousness of the problem makes little difference.

This is something that will be familiar most people who have tried to raise problems in science and in medicine. It is the underlying message of at least a dozen E-mails I get each week. Local academic colleagues very rarely engage with problems that go right to the heart of what it is to be an academic (or a doctor). They are happy to allow principles to be ignored, patients to be abused and for those raising concerns to be bullied into unemployment or even suicide. The silence and collusion with misconduct and fraud extends to professional regulatory bodies, drug regulators and government. It is hardly surprising concerns are never raised until it is too late.

Here is a selection of quotes about collaborators, bystanders and the shame of all those who fail to speak, and who fail to ask questions.

Science may have found a cure for most evils; but it has found no remedy for the worst of them all - the apathy of human beings.
Helen Keller

Truth is not only violated by falsehood; it may be equally outraged by silence.
Henri Frederic Amiel

To assist Enron all they had to do is to do nothing, and they did nothing very well

He who passively accepts evil is as much involved in it as he who helps to perpetuate it.
Martin Luther King, Jr

Our lives begin to end the day we become silent about things that matter.
Martin Luther King, Jr.

What luck for the rulers that men do not think.
Adolph Hitler

And the multitude was silent, not a voice, not a sound was heard upon the hillsides, across the valleys where they stood.
Richard Bach, Illusions

To sin by silence when they should protest makes cowards of men.
Abraham Lincoln

There is no shame in not knowing; the shame lies in not finding out.
Russian proverb

A society of sheep must in time beget a government of wolves.
Juvenal

The average age of the world's greatest civilizations has been two hundred years. These nations have progressed through this sequence: From bondage to spiritual faith; from spiritual faith to great courage; from courage to liberty; from liberty to abundance; from abundance to selfishness; from selfishness to complacency; from complacency to apathy; from apathy to dependence and back into bondage.
Fraser Tyler

You may never know what results come from your action. But if you do nothing, there will be no results.
Gandhi

The world is a dangerous place to live; not because of the people who are evil, but because of the people who don't do anything about it.
Albert Einstein

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The case of Dr Z

A report in the British Medical Journal yesterday is fascinating:
Dyer, Clare (2008-01-12). "Whistleblower who was excluded from work for five years wins apology". BMJ 336 (7635): 63.

The bullying of doctors and patients who raise concerns, and the gagging of information about those concerns is the most fundamental element of clinical risk. The various "Clinical Governance" policies put in place to (ostensibly) control clinical risk take no account of what actually happens.

What we are allowed to know about this story is that:

• A junior doctor (known only as Dr Z) was excluded from her job in Cambridgeshire Primary Care Trust for 5 years. Her apparent crime was that she objected to inclusion of medical records in a research database without patient consent. Those medical records included her own.
• The reason we do not know her name is that she is under a gagging order.
• Many years before Dr Z suffered from a rare "serious life threatening condition". She wanted the details kept private.
• However her medical details were distributed as part of this research to Addenbrooke's Hospital, Cambridge and from there to personnel involved in her employment.
• Despite giving no consent she was harassed by the researchers.
• The interesting (but common) response of her employers was to suggest that she was ill and to refer her to an "occupational health consultant". She was then put on "special leave from her employment".
• Her employers tried to suggest that her "fitness to practice was an issue" and seemingly tried to (or actually did) refer her to the General Medical Council to be struck off.
• Her employers generated false accusations that she had given a wrong name and address to her own doctor, and had falsified sick notes.
• Her employers maintained that it "was not possible" that her records were held in the research database.
• In September 2006 her employment was terminated.
• Acting on her own she brought a libel action against her employers. The Trust admitted that all the accusations that they had made in their apparent attempts at bullying were false, and that her records were indeed in the research database.
• In this case the person bullied was not only a doctor raising concerns about patients but also a research participant who was apparently told lies.

What can we say of all of this? The same basic elements are played out in variable form over and over again.

1. Individuals are gagged and neither our profession nor patients nor the general public discover the truth.
2. There is abuse through accusations of mental illness.
3. The very bodies who are charged with integrity in medicine (such as the General Medical Council) are used by medical leadership to obfuscate the truth. At the same time the GMC shows no intent to deal with the powerful liars, falsifiers and bullies. Those individuals are neither named nor sanctioned.
4. False accusations are made to divert attention from the real problems.
5. There is almost no support for abused individuals.

There are implications for the confidentiality of medical data. This is another timely incident given the foolish inclination of the Labour government to take control by force of our medical records in a central "database".

John M. Grohol at Psych Central has written an interesting article "Why Would You Lie to Your Therapist?". Patients tell half-truths for many reasons. Concerns that the state or others will abuse the relationship of confidentiality is a powerful one.

We are entitled to ask several questions of Addenbrooke's Hospital, Cambridge:

Why have the full details not been placed into the public domain? What is this research, and has it been published? What are the names of the researchers involved? Did the work receive ethical approval? Did any publication state that some participants had refused consent? What action has been taken to deal with the individuals who bullied Dr Z?

Did any of the various agencies who are supposed to ensure integrity in this context do anything at all to assist Dr Z? Perhaps the General Medical Council did something, or Public Concern at Work, or the British Medical Association, or the UK Panel for Research Integrity, or the Ethics Committee at Addenbrookes Hospital, or the local Medical Staff Committee?

And why did the BMJ use the word "whistleblower"? Dr Z was simply doing her job. It is the job of a doctor to tell the truth in the interests of our patients (and in this case Z was one of those patients). Instead of dealing with her concerns she was bullied, told lies (and probably made ill). Whistleblowing has nothing whatever to do with this -- particularly since everything that the scientific community has to know and has to discuss has actually been suppressed.

Have we learned anything since Bristol? Or Shipman? Or Chan? .... or any of the incidents which have placed our patients and clinical science at risk?

Dr Z said in a statement:

"I raised concerns relating to unethical research practices which threatened patient confidentiality and were being conducted in breach of the law. I was then excluded from work for a period of five years, on the basis of allegations which the trust now concedes were groundless.

See also comments by Ferretfancier and Longrider

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Memory Hole (2 November): The undoing of a thalidomide hero

19 years ago today: The undoing of William McBride, Thalidomide hero

On 2 November 1988 William McBride was found guilty of research misconduct and resigned from his research post in Australia. Twenty fine years earlier Mcbride had been the hero of thalidomide. He published a landmark letter in The Lancet on December 16th 1961 pointing out a curious coincidence he had noticed. He is credited with identifying the dangers of the drug.

His later research was problematical. The 1988 report stated: "we are forced to conclude that Dr. McBride did publish statements which he either knew were untrue or which he did no genuinely believe to be true, and in that respect was guilty of scientific fraud".

There are several illustrative aspects of this case:

1. McBride was also de-registered as a medical doctor. The de-registration was reversed in 1998 on the perverse basis that "his deregistration occurred as a result of work he did as a researcher, and not because of work he did as a medical practitioner". There were many reasons to restore McBride, but this was not an appropriate reason. What this says is that damaging patients through deliberately faulty research is acceptable because medical research and science are not part of being a doctor.
2. His exposure as a fraud was only as a result of the tireless work of the journalist Dr Norman Swan who broadcast about the fraud in December 1987. Sadly (and despite platitudes to the contrary), the mechanisms of science, journals, peer review and institutional procedures have demonstrated their inability to restrain fraudsters with any degree of reliability or honesty. In the case of McBride, institutional investigation was only launched after massive media exposure. The Australian Journal of Biological Sciences had already declined to publish a letter sent by McBride's colleagues Vardy and French. When Vardy had confronted McBride, he was sacked. The public press is likely to remain an important safeguard.

For additional useful notes see Fraud and Australian academics and Scientific fraud and the power structure of science both by Professor Brian Martin.

This is a sad but illustrative case given the very real contributions of McBride.

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Memory Hole (13 October): A process known as lying

Scientific Misconduct Blog Memory Hole: Events of October the 13th

Quote of the day

Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing had happened.
Winston Churchill

19 years ago today: North Pole explorer - raw data discovered

On 13 October 1988 the discovery of a famous set of scientific raw data (a notebook) was announced. These gave Peary's sightings on the day he was supposed to have reached the Pole on 6 April 1909. These notes were said to indicate that Peary missed the Pole by 120 miles, and suggest that Peary knew that he had missed.

The truth remains unclear. The National Geographic Society has stood by Peary's claim through thick and thin. It is said it suited the businessmen who were backing the Geographic society. Their judgment was confirmed by no less than a committee of the U.S. House of Representatives in 1911. Peary has also been criticised for his treatment of the Inuit.

Source: "Peary's Notes Said to Imply He Fell Short of the Pole," New York Times, 13 October 1988

7 years ago today: William Simmons admits faking results

On 13 October 2000 it was announced that scientist William Simmons had admitted to falsifying research.

This is the traditional type of scientific misconduct that fits nicely within the restricted definitions proposed by those who want nice neat crimes. William Simmons, formerly of the University of Texas left his job in 1998 only to be called back to repeat an experiment that could not be repeated. The research involved HLA-B27. While doing these repeats it was noticed that he had added fluid containing radioactive chromium 51 into vials in order to shift radioactive counts in the direction he wanted. He then admitted to falsification of research results over at least a 5-year period

His penalty was a 5-year ban on receiving federal research grants.

All nice and tidy.

Source: "Texas Scientist Admits Falsifying Results," Science 290 (13 October 2000), 245-246.

5 years ago today: Dr Benbow comments about Seroxat/Paxil

On 13 October 2002 Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline stated that Paxil/Seroxat drug was well tolerated and had been used all over the world for a decade. He further stated.

"As with all prescriptions medicines, Seroxat does have side effects, but these are clearly stated in the information that's made available to doctors and to patients."

The mission statement of GSK is "to improve the quality of human life by enabling people to do more, feel better and live longer".

Source: BBC

5 years ago today: More troubles for Seroxat/Paxil

On 13 October 2002 Seroxat (Paxil in the USA) was subject of a major BBC-TV documentary on the discordance between the disclosures by GlaxoSmithKline and the addictive properties of the drug (Panorama).

That same week, GSK was ruled in breach of the pharmaceutical industry own (ABPI) code of "self regulation" for misleading promotion in the UK . The issue addressed was the company's denial that the drug is addictive and was causing great difficulty in withdrawal.

The ruling came as a result of complaints by the group Social Audit. GSK was judged in breach of three clauses of the marketing code of the Prescriptions Medicines Code of Practice Authority (PMCOPA). Complaints upheld related to the following provisions of the Code:

• "Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all evidence and reflect that evidence clearly. They must not mislead either directly or by implication." (ABPI Code, clause 7.2)
• "Information and claims about side-effects must reflect available clinical evidence or be capable of substantiation by clinical experience. It must not be stated that a product has no side effects, toxic hazards or risks of addiction. The word "safe" must not be used without qualification." (ABPI Code, clause 7.9)
• Information about medicines made available to the public ... must be "presented in a balanced way and must not be misleading with respect to the safety of the product" (ABPI Code, clause 20.2)

Sources: BBC, AHRP, Social Audit

4 years ago today: PLoS commences publication

On 13 October 2003 the Public Library of Science (PLoS) commenced publication of its first open access scientific journal, PLoS Biology. All content in PLoS Biology is published under the Creative Commons "by-attribution" license. PLoS Medicine, in contrast to most other "big" medical journals has been careful to avoid commercial interference with publication.

Source: PLoS Biology; The PLoS Medicine Editors: PLoS Medicine and the Pharmaceutical Industry. PLoS Med 2006:3:e329

3 years ago today: PPA decongestants first court case (how do they sleep at night?)

On 13 October 2004 Bayer lost the first of 1500 PPA claims pending. PPA is a nasal decongestant (phenylpropanolamine):

In the words of Mike Lascales, I sometimes wonder how the medical directors for some pharmaceutical companies sleep at night.

"How was your day at work dear?"
"Good - I think I managed to discredit those dumb scientists who tried to show our drug causes strokes."

Many consumers "suffered strokes after a landmark study (sponsored by the drug industry) concluded in October 1999 that the use of PPA was associated with an increased risk of stroke. Recently obtained internal company documents show that rather than alerting the public, drug makers launched a yearlong campaign to keep the results quiet and stall government regulation. By the time the FDA acted, 13 months and hundreds of strokes later, the companies had reformulated their brand names with little interruption in sales."

The LA Times (read here or here) used the Freedom of Information Act to get an inside look at commercial behavior when questions were asked about phenylpropanolamine (PPA):

"The Los Angeles Times reviewed thousands of pages of documents produced through discovery in PPA lawsuits and from the FDA. The documents demonstrate that the pharmaceutical industry consistently challenged any notion that PPA could be dangerous and dismissed evidence to the contrary. They also show that the manufacturers assured the public that PPA was safe even as some FDA scientists and industry officials were raising concerns."

As early as 1982, an FDA report warned that PPA had "the ability to cause cardiovascular effects, cerebral hemorrhage and cardiac arrhythmias."

Two years later, a memo from the medical-services department at Sandoz Pharmaceuticals, which made the PPA products Triaminic and Tavist-D, referred to PPA as "an agent known to cause hypertension and stroke."

Yet the drug companies accelerated their marketing of PPA, winning FDA approval to sell prescription PPA products on an over-the-counter basis and introducing flavorful formulas for children.

Upon learning that the 1999 study had found a stroke link, the drug makers opened a relentless assault on its methodology and on the integrity of the Yale University researchers who conducted it. They did so despite having paid for the five-year, $5 million study, approving its protocol and handpicking investigators who had previously expressed skepticism about a link between PPA and stroke.

The FDA eventually recommended the withdrawal of more than 100 PPA products. FDA officials said they did not move faster because the industry's efforts to discredit the Yale results effectively delayed the final report.

Once the FDA stepped in, the manufacturers issued news releases, but neither the companies nor the FDA mounted major advertising or direct-mail campaigns to warn Americans they might have dangerous products at home.
A survey estimated that 3.5 million U.S. households still possessed PPA formulations 15 months after the withdrawal in November 2000. (Read more).

Selected Sources: Bayer loses first of 1,500 PPA claims pending, Seattle Times

2 years ago today: Texas TMAP and a process known as lying

On 13 October 2005 the Rutherford Institute interviewed Allen Jones about a Texas drug research scam linked to then Governor George W. Bush.

Jones was appointed lead investigator for the Pennsylvania Office of the Inspector General in July 2002 in a case concerning off-the-books payments from pharmaceutical companies in Texas. He uncovered documents showing "state officials accepting large honorariums. His discoveries cost him his career. His findings showed that the drug company Janssen had paid honorariums to key state officials with influence over prescriptions for state institutions. Although accounts were marked for "educational grants," funds were channeled to employees who developed guidelines recommending new psychiatric drugs rather than older and potentially safer drugs.

After revealing his discoveries to OIG managers, Jones was taken off the case. When he went public with his findings, he was fired. The formulary investigated by Jones is based on the Texas Medication Algorithm Project (TMAP). "It has also been revealed that TMAP personnel may have tampered with research results through a process known as Retrospective Analysis. Patients who had previously been treated with the new medications were researched, and files showing positive results were selected and reported on."

See complete interview here

2 years ago today: Merck - bad language and failure to release data

On 13 October 2005 Merck's former research chief testified that his insulting description of federal regulators in a 2001 e-mail was meant as a joke.

Edward Scolnick was asked by an attorney about his description of FDA regulators as "grade D high school students" after Merck faced officials at a government advisory committee meeting. "In another memo a few months later, Scolnick described regulators as "bastards" after they demanded Merck cite on its Vioxx label the fact that five times as many patients on Vioxx than on a placebo had suffered heart attacks during a clinical trial."

"My language was clearly, clearly inappropriate and was not respectful to the FDA," Scolnick said.

"Earlier yesterday, a current Merck executive, Alise Reicin (see her other adventures in integrity), insisted repeatedly that she never thought Vioxx was dangerous and therefore did not initially release all the data on deaths of Vioxx users in another study"

"Asked whether Merck's revenue would have suffered if it had publicized the results of a study showing more deaths - from all causes - in patients using Vioxx than a placebo", Reicin responded: "Yes, you would expect sales would go down. But that would not influence the way I made decisions."

Approximately 100 000 people are thought to have died as a result of taking Vioxx. Today, two years later, it is reported that the FDA are very reluctant to hand over documents that show Merck’s relationships with the FDA (See Pharmalot).

Source Philadelphia Inquirer

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Power silences scrutiny

This isn't to do with science or the pharmaceutical industry. However it is directly related. It is about the way in which the powerful avoid illumination of their dealings.

Arsenal Football Club's newest shareholder, the Uzbek minerals billionaire Alisher Usmanov complained about a blog posting by Craig Murray. Usmanov ranks 278th on the listings of world billionaires at $2.6 billion. Murray is a former British ambassador to Uzbekistan. Over the past few hours Murray's ISP pulled the plug on his blog, also killing sites of several other customers (including MP and London mayoral candidate Boris Johnson). There appear to have been emails to Arsenal Football Club fan sites threatening libel action. Whoever suggested blogging was dull?

The Google-cache of Murray's blog is here. As it happens I thought it an irrational embarrassment, but such is the nature of ex ambassadors.

For recent discussion see:

Uzbek billionaire Usmanov censors critic and many UK MPs' blogs
Craig Murray, Boris Johnson and Arsenal's Uzkek billionaire
Alisher Usmanov: Unspeakable
Usmanov allegations
Perhaps He Is Confused As To Which Country He Is In?
This is what pissed off that fat fellow, Mr Alisher Usmanov
Bloggers for Craig Murray
Alisher Usmanov: A big, fat bully
craig murray muzzled, bloggers rally
Alisher Usmanov - porkey Russian oligarch(post 2
Bloggers and freedom of speech v Alisher Usmanov
Alisher Usmanov Did Not Use His noodle
Uzbek billionaire silences bloggers

The very powerful and the very stupid have one thing in common.
Instead of altering their views to fit the facts, they alter the facts to fit their views...
Doctor Who

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